Jo Ellen Sherow Ohio University Office of Research Compliance Researchers’ Financial Disclosures in the Spotlight Conflicts of interest, always an emotional topic, returned to the headlines.
Download ReportTranscript Jo Ellen Sherow Ohio University Office of Research Compliance Researchers’ Financial Disclosures in the Spotlight Conflicts of interest, always an emotional topic, returned to the headlines.
Slide 1
Jo Ellen Sherow
Ohio University
Office of Research Compliance
Researchers’ Financial Disclosures in the
Spotlight
Conflicts of interest, always an emotional topic,
returned to the headlines this week as Sen.
Charles Grassley, a longtime critic of the drug
industry’s potential influence on research,
released new evidence that prominent Harvard
University scientists had failed to disclose much
of their outside income from pharmaceutical
companies over the past eight years.
http://www.insidehighered.com/news/2008/06/12/conflict January 15, 2008
WEDNESDAY, JANUARY 21, 2009
In a review of the literature regarding the relationship between
smokeless tobacco use and cancer, a conflict of interest of one of the
article's authors was initially not disclosed (see: Boffetta P, Hecht S, Gray
N, Gupta P, Straif K. Smokeless tobacco and cancer. Lancet Oncology
2008; 9:667-675). The original article was published in July, 2008. That
article stated: "The authors declare no conflicts of interest." After the
editor of the journal was notified by a researcher with knowledge of a
potential conflict of interest of Dr. Stephen Hecht (one of the study
authors), an erratum was published in September 2008, which noted:
"During the immediate months preceding submission of the review SH
was acting in the capacity of an expert witness for the plaintiff in a
future court case against a smokeless tobacco company. SH declares his
participation in this case in no way influenced his writing or involvement
in the review."
http://tobaccoanalysis.blogspot.com/2009/01/conflict-of-interestnot.html
January 16, 2009 — More than one third of new
drug marketing applications approved by the US
Food and Drug Administration (FDA) were
missing information about potential conflicts of
interest for clinical trial investigators, which
could allow bias to creep into the approvals
process, a government report released this week
has found. The FDA has said that it agrees with
most of the report's findings.
http://www.medscape.com/viewarticle/586980
Do collaborations between biotech companies
and academic centers constitute a conflict of
interest?
Biotechnology industry partnerships with
universities and academic centers have been
fruitful for both. So why is there so much
concern about conflict of interest and is that
concern appropriate?
http://www.redorbit.com/news/health/750100/genetic_engineering_news_p
osts_podcast_on_industrialacademic_collaborations_are_these/index.html
Universities are responsible for use of public
funds and therefore must maintain the public
trust.
Identifying and mitigating situations that may
have the potential for conflict maintains the
integrity of the university.
Maintaining integrity allows the university to
do credible academic research.
To provide information on the purpose of the
conflict of interest requirements.
To provide a basic overview of conflicts of
interest
To introduce the disclosure process and the use
of management plans
To provide information on the need for updates
and annual renewals.
Situations where financial considerations
compromise your professional judgment.
“Actual Conflict of Interest”
◦ Not permitted
Situations where an independent observer
might reasonably question whether your
professional actions or decisions are
determined by considerations of personal
gain. “Perceived Conflict of Interest”
◦ Managed
Potential conflicts may be financial or may be
a conflict of time, effort and/or commitment.
Potential conflicts can occur as a result of
administrative, scientific, academic, fiduciary
or familial situations.
They are situations that can be PERCEIVED to
be conflicting, whether a “real” conflict exists
or not.
Ohio University Policy has a mandatory
disclosure policy if you:
Earn over $10,000 in a twelve month period
from your outside activity OR
Have over 5% equity in the entity
Applies to members of your immediate family
(spouse, domestic partner, dependent
children) as well as yourself.
Anything of monetary value, including but not
limited to:
◦
◦
◦
◦
Salary
Payments for services
Equity interests over 5%
Intellectual property rights
Excludes mutual, pension and other
investments over which you have no control
Outside work during regular academic year
should not exceed equivalent of 1 day per
week.
Consulting work must avoid activities that
involve a conflict of interest with assigned
Ohio University activities and programs
Faculty Handbook, section IV-D
Outside interests cannot interfere with
primary loyalty to Ohio University and your
academic role
Use of university resources must have prior
approval of Chair, Dean and VPR.
Your outside interests should not be in
direct competition with university interests
Full time administrative employees are
expected to devote their full-time
professional loyalty, time and energy to their
position.
You must use non-work hours and no
university resources
Federal Agencies
State Law
University Policies
Many Academic Publications
45 CFR Part 50, Subpart F
“Responsibility of Applicants for Promoting
Objectivity in Research for Which PHS Funding
is Sought”
Authority: 42 U.S.C. 216, 289b-1, 299c-3.
Intent is to assure objectivity by establishing
standards that preclude bias in design, conduct, or
reporting of research
Focuses on financial conflicts of interest
(FCOI)
Regulations apply to investigators, including
sub grantees, contractors, and collaborating
investigators.
Does not apply to applications for support
under Phase I of SBIR and STTR programs
An institutional conflict of interest policy should
require that each investigator disclose to a
responsible representative of the institution all
significant financial interests of the investigator
(including those of the investigator’s spouse and
dependent children) (i) that would reasonably
appear to be affected by the research or
educational activities funded or proposed for
funding by NSF; or (ii) in entities whose financial
interests would reasonably appear to be affected
by such activities.
Chapter 1 (Subchapter A) (Part 54)
Financial Disclosure by Clinical Investigators
The Food and Drug Administration (FDA)
regulations state that investigators that
receive compensation in excess of $25,000
from a corporate sponsor of a trial in which
the investigator is engaged must disclose to
the FDA at the time of filing for a new drug
application.
19.058, Conflict of Interest in Research,
Educational, and Public Service Activities
19.059, Employee Participation in Authorized
Private Companies Commercializing Ohio
University Research
“Conflict of Interest in Research, Educational,
and Public Service Activities”
Most conflict disclosures fall within the
parameters of this policy
States that faculty are primarily responsible
for their academic, research and service
obligations
“Employee Participation in Authorized Private
Companies Commercializing Ohio University
Research”
Applies to “employees, faculty, staff and students,
who create intellectual property owned by the Ohio
University and who desire to hold an equity interest
in a firm, corporation, or other association to which
Ohio University has assigned, licensed or
transferred Ohio University’s interests…”
Consulting
Licensing University Technology
Clinical Studies
Procurement
Mentoring
Institutional
A disclosure is filed specific to the funding
application.
If you have a potential conflict for one
proposal, it does not automatically apply to
all of your proposals.
Research conflicts of interest are usually
disclosed using LEO as you apply for funding
by completing the conflict of interest section
of the electronic transmittal
If you are not using LEO, you can download
the appropriate disclosure form from
www.ohio.edu/research/compliance
“A” is selected if you have no conflicts to
disclose
“B” is selected if you have a potential conflict
to disclose relative to the submission.
(Requires a subsequent paper process)
“C” is selected if you have a current disclosure
on file, but it is not relevant to the proposal
you are submitting
Still uses option A, B or C
Requires that you gather signatures on paper
for all options, however
Generally used for personnel not listed on the
grant proposal or “key personnel”
We have revised the COI forms to word forms
This should be easier to complete than the
previous form
PDF versions are also available
Should be on the compliance web site soon,
but we can e-mail them to you until then
Use this form only if you are unable to use
the LEO transmittal form to assure that no
conflict of interest exists. A form must be
completed for each proposal.
I assure that I have read Ohio University
Policy 19.058, “Conflict of Interest in
Research, Educational, and Public Service
Activities” and declare that I have nothing
that is, or could be perceived to be a conflict
of interest with this proposal.
Use this form to disclose a potential conflict
of interest situation.
A separate disclosure form must be used for
each entity with which you conduct business
Conflict includes any member of your
immediate family (spouse, domestic partner
or children)
Require that you complete an option “B”
disclosure statement in addition to
completing the LEO transmittal form.
Require you to obtain signatures from Center
or Institute (if applicable), Chair and Dean on
the additional disclosure statement!!
The B disclosure form is available at
www.ohio.edu/research/compliance
Use this form only if you are unable to use
the LEO transmittal form. Complete this form
if you have a current conflict of interest
disclosure on file with the Office of Research
Compliance, but that disclosure is not
applicable to this proposal.
*New Option for 2008*
A management plan is developed for some
disclosures to mitigate the potential conflict
Management plans are specific to each
disclosure
May require submission of additional pieces,
such as a student employment plan
Reduce or remove the financial interest creating the
conflict
Place safeguards that mitigate the conflict potential,
such having some decisions made by an independent
entity
Limit participation in portions of the proposed
research likely to create a conflict
Require that the researcher disclose his or her
conflicting financial interests to all collaborators and
any proposed trainees;
Disclose the conflict in publications
Work to remove students from being directly advised
or taught by faculty where a conflict exists
Assure publication rights for student participants
Student Use
Nepotism and Cronyism
Intellectual Property
Use of University Resources
Publication provisions
Use of Human Subjects
Oversight Requirements
Reporting and Annual Reviews
You must submit an annual renewal for your
disclosure
◦ If the potential conflict no longer exists you must
notify us
If significant changes occur during the year
you should submit an update to your
disclosure as they occur
Yes. We encourage employees to disclose
potential conflicts that do not meet the
financial threshold, but may still be
problematic, such as student employment.
This allows you to be transparent with
respect to outside interests.
Allowable situations
Situations that require disclosure but may not
need an extensive management plan
Situations that require disclosure and have
problematic elements that will require
mitigation and/or a management plan
Situations that are not permitted
Receipt of royalties or honoraria for
published scholarly works, seminars,
teaching, etc.
Honoraria for serving as a special reviewer
or work on review panels
Royalties under our intellectual property
policies if no other relationship with entity
Clinical income at OUCOM
You participate in research developed in
whole or part by you, and you or your
family receive royalties from an existing
agreement with the business, but have
no other significant financial interest
You assign students, etc. to research
projects where you are entitled to
receive royalties, but have no other
significant financial interest
You assign students, etc. to projects supported
by the business through an SRA, and have a
significant financial interest other than royalty
income
You receive research support from a business in
which you serve on the board of directors, or
other advisory board, even if you are not
compensated.
You hold an executive position in a business
engaged in commercial or research activities
directly related to your Ohio University
responsibilities.
Any situation in which an actual conflict
exists is not permitted.
The only “exceptions” are those handled
under Ohio University Policy and Procedure
19.059 where faculty entrepreneurship is
addressed.
Participation in clinical trials or evaluation
of other research in which you have a
significant financial interest other than
royalty income.
In the context of your position at Ohio
University, you make professional referrals
to a business in which you have a
significant financial interest.
Letter of admonition
Ineligibility to submit grant applications
Withholding of IRB or IACUC approvals
Suspension
Non-Renewal
Loss of Tenure
Consulting
Procurement
Mentoring
Clinical Studies
Avoid consulting relationships that have
the potential to divert time and effort from
your responsibilities to Ohio University.
Do not use students.
Be wary of situations that limit publication.
Do not use university stationary, etc. that
could create an impression the university
is involved with the activities.
Make sure you are devoting sufficient time
to your university obligations.
Be cautious that the potential financial gain
cannot be perceived to influence your
university mentoring relationships.
Disclose any personal or familial financial
interest or equity in a company that is
doing business with Ohio University.
If you make purchases using public funds,
you should not use companies which will
benefit you or your family. If there is no
alternative you must seek and receive
permission prior to purchasing.
Any relationship in which there is a real or
perceived power or influence imbalance has
the potential for conflict. (Faculty:Student)
Isolating these relationships with respect to
areas of personal financial gain is best.
If they cannot be isolated, then safeguards
must be created.
If you have a financial interest, it is best to
isolate yourself from the study.
At a minimum, expect a more intense review
and a robust management plan if you have a
financial interest.
If both the institution and you have financial
interests the clinical study should be
conducted elsewhere.
You have administrative responsibilities on
behalf of Ohio University that is beneficial to
the business in which you have a significant
financial interest
You have administrative responsibilities on
behalf of Ohio University with respect to an
SRA where you have a significant financial
interest
Slide 2
Jo Ellen Sherow
Ohio University
Office of Research Compliance
Researchers’ Financial Disclosures in the
Spotlight
Conflicts of interest, always an emotional topic,
returned to the headlines this week as Sen.
Charles Grassley, a longtime critic of the drug
industry’s potential influence on research,
released new evidence that prominent Harvard
University scientists had failed to disclose much
of their outside income from pharmaceutical
companies over the past eight years.
http://www.insidehighered.com/news/2008/06/12/conflict January 15, 2008
WEDNESDAY, JANUARY 21, 2009
In a review of the literature regarding the relationship between
smokeless tobacco use and cancer, a conflict of interest of one of the
article's authors was initially not disclosed (see: Boffetta P, Hecht S, Gray
N, Gupta P, Straif K. Smokeless tobacco and cancer. Lancet Oncology
2008; 9:667-675). The original article was published in July, 2008. That
article stated: "The authors declare no conflicts of interest." After the
editor of the journal was notified by a researcher with knowledge of a
potential conflict of interest of Dr. Stephen Hecht (one of the study
authors), an erratum was published in September 2008, which noted:
"During the immediate months preceding submission of the review SH
was acting in the capacity of an expert witness for the plaintiff in a
future court case against a smokeless tobacco company. SH declares his
participation in this case in no way influenced his writing or involvement
in the review."
http://tobaccoanalysis.blogspot.com/2009/01/conflict-of-interestnot.html
January 16, 2009 — More than one third of new
drug marketing applications approved by the US
Food and Drug Administration (FDA) were
missing information about potential conflicts of
interest for clinical trial investigators, which
could allow bias to creep into the approvals
process, a government report released this week
has found. The FDA has said that it agrees with
most of the report's findings.
http://www.medscape.com/viewarticle/586980
Do collaborations between biotech companies
and academic centers constitute a conflict of
interest?
Biotechnology industry partnerships with
universities and academic centers have been
fruitful for both. So why is there so much
concern about conflict of interest and is that
concern appropriate?
http://www.redorbit.com/news/health/750100/genetic_engineering_news_p
osts_podcast_on_industrialacademic_collaborations_are_these/index.html
Universities are responsible for use of public
funds and therefore must maintain the public
trust.
Identifying and mitigating situations that may
have the potential for conflict maintains the
integrity of the university.
Maintaining integrity allows the university to
do credible academic research.
To provide information on the purpose of the
conflict of interest requirements.
To provide a basic overview of conflicts of
interest
To introduce the disclosure process and the use
of management plans
To provide information on the need for updates
and annual renewals.
Situations where financial considerations
compromise your professional judgment.
“Actual Conflict of Interest”
◦ Not permitted
Situations where an independent observer
might reasonably question whether your
professional actions or decisions are
determined by considerations of personal
gain. “Perceived Conflict of Interest”
◦ Managed
Potential conflicts may be financial or may be
a conflict of time, effort and/or commitment.
Potential conflicts can occur as a result of
administrative, scientific, academic, fiduciary
or familial situations.
They are situations that can be PERCEIVED to
be conflicting, whether a “real” conflict exists
or not.
Ohio University Policy has a mandatory
disclosure policy if you:
Earn over $10,000 in a twelve month period
from your outside activity OR
Have over 5% equity in the entity
Applies to members of your immediate family
(spouse, domestic partner, dependent
children) as well as yourself.
Anything of monetary value, including but not
limited to:
◦
◦
◦
◦
Salary
Payments for services
Equity interests over 5%
Intellectual property rights
Excludes mutual, pension and other
investments over which you have no control
Outside work during regular academic year
should not exceed equivalent of 1 day per
week.
Consulting work must avoid activities that
involve a conflict of interest with assigned
Ohio University activities and programs
Faculty Handbook, section IV-D
Outside interests cannot interfere with
primary loyalty to Ohio University and your
academic role
Use of university resources must have prior
approval of Chair, Dean and VPR.
Your outside interests should not be in
direct competition with university interests
Full time administrative employees are
expected to devote their full-time
professional loyalty, time and energy to their
position.
You must use non-work hours and no
university resources
Federal Agencies
State Law
University Policies
Many Academic Publications
45 CFR Part 50, Subpart F
“Responsibility of Applicants for Promoting
Objectivity in Research for Which PHS Funding
is Sought”
Authority: 42 U.S.C. 216, 289b-1, 299c-3.
Intent is to assure objectivity by establishing
standards that preclude bias in design, conduct, or
reporting of research
Focuses on financial conflicts of interest
(FCOI)
Regulations apply to investigators, including
sub grantees, contractors, and collaborating
investigators.
Does not apply to applications for support
under Phase I of SBIR and STTR programs
An institutional conflict of interest policy should
require that each investigator disclose to a
responsible representative of the institution all
significant financial interests of the investigator
(including those of the investigator’s spouse and
dependent children) (i) that would reasonably
appear to be affected by the research or
educational activities funded or proposed for
funding by NSF; or (ii) in entities whose financial
interests would reasonably appear to be affected
by such activities.
Chapter 1 (Subchapter A) (Part 54)
Financial Disclosure by Clinical Investigators
The Food and Drug Administration (FDA)
regulations state that investigators that
receive compensation in excess of $25,000
from a corporate sponsor of a trial in which
the investigator is engaged must disclose to
the FDA at the time of filing for a new drug
application.
19.058, Conflict of Interest in Research,
Educational, and Public Service Activities
19.059, Employee Participation in Authorized
Private Companies Commercializing Ohio
University Research
“Conflict of Interest in Research, Educational,
and Public Service Activities”
Most conflict disclosures fall within the
parameters of this policy
States that faculty are primarily responsible
for their academic, research and service
obligations
“Employee Participation in Authorized Private
Companies Commercializing Ohio University
Research”
Applies to “employees, faculty, staff and students,
who create intellectual property owned by the Ohio
University and who desire to hold an equity interest
in a firm, corporation, or other association to which
Ohio University has assigned, licensed or
transferred Ohio University’s interests…”
Consulting
Licensing University Technology
Clinical Studies
Procurement
Mentoring
Institutional
A disclosure is filed specific to the funding
application.
If you have a potential conflict for one
proposal, it does not automatically apply to
all of your proposals.
Research conflicts of interest are usually
disclosed using LEO as you apply for funding
by completing the conflict of interest section
of the electronic transmittal
If you are not using LEO, you can download
the appropriate disclosure form from
www.ohio.edu/research/compliance
“A” is selected if you have no conflicts to
disclose
“B” is selected if you have a potential conflict
to disclose relative to the submission.
(Requires a subsequent paper process)
“C” is selected if you have a current disclosure
on file, but it is not relevant to the proposal
you are submitting
Still uses option A, B or C
Requires that you gather signatures on paper
for all options, however
Generally used for personnel not listed on the
grant proposal or “key personnel”
We have revised the COI forms to word forms
This should be easier to complete than the
previous form
PDF versions are also available
Should be on the compliance web site soon,
but we can e-mail them to you until then
Use this form only if you are unable to use
the LEO transmittal form to assure that no
conflict of interest exists. A form must be
completed for each proposal.
I assure that I have read Ohio University
Policy 19.058, “Conflict of Interest in
Research, Educational, and Public Service
Activities” and declare that I have nothing
that is, or could be perceived to be a conflict
of interest with this proposal.
Use this form to disclose a potential conflict
of interest situation.
A separate disclosure form must be used for
each entity with which you conduct business
Conflict includes any member of your
immediate family (spouse, domestic partner
or children)
Require that you complete an option “B”
disclosure statement in addition to
completing the LEO transmittal form.
Require you to obtain signatures from Center
or Institute (if applicable), Chair and Dean on
the additional disclosure statement!!
The B disclosure form is available at
www.ohio.edu/research/compliance
Use this form only if you are unable to use
the LEO transmittal form. Complete this form
if you have a current conflict of interest
disclosure on file with the Office of Research
Compliance, but that disclosure is not
applicable to this proposal.
*New Option for 2008*
A management plan is developed for some
disclosures to mitigate the potential conflict
Management plans are specific to each
disclosure
May require submission of additional pieces,
such as a student employment plan
Reduce or remove the financial interest creating the
conflict
Place safeguards that mitigate the conflict potential,
such having some decisions made by an independent
entity
Limit participation in portions of the proposed
research likely to create a conflict
Require that the researcher disclose his or her
conflicting financial interests to all collaborators and
any proposed trainees;
Disclose the conflict in publications
Work to remove students from being directly advised
or taught by faculty where a conflict exists
Assure publication rights for student participants
Student Use
Nepotism and Cronyism
Intellectual Property
Use of University Resources
Publication provisions
Use of Human Subjects
Oversight Requirements
Reporting and Annual Reviews
You must submit an annual renewal for your
disclosure
◦ If the potential conflict no longer exists you must
notify us
If significant changes occur during the year
you should submit an update to your
disclosure as they occur
Yes. We encourage employees to disclose
potential conflicts that do not meet the
financial threshold, but may still be
problematic, such as student employment.
This allows you to be transparent with
respect to outside interests.
Allowable situations
Situations that require disclosure but may not
need an extensive management plan
Situations that require disclosure and have
problematic elements that will require
mitigation and/or a management plan
Situations that are not permitted
Receipt of royalties or honoraria for
published scholarly works, seminars,
teaching, etc.
Honoraria for serving as a special reviewer
or work on review panels
Royalties under our intellectual property
policies if no other relationship with entity
Clinical income at OUCOM
You participate in research developed in
whole or part by you, and you or your
family receive royalties from an existing
agreement with the business, but have
no other significant financial interest
You assign students, etc. to research
projects where you are entitled to
receive royalties, but have no other
significant financial interest
You assign students, etc. to projects supported
by the business through an SRA, and have a
significant financial interest other than royalty
income
You receive research support from a business in
which you serve on the board of directors, or
other advisory board, even if you are not
compensated.
You hold an executive position in a business
engaged in commercial or research activities
directly related to your Ohio University
responsibilities.
Any situation in which an actual conflict
exists is not permitted.
The only “exceptions” are those handled
under Ohio University Policy and Procedure
19.059 where faculty entrepreneurship is
addressed.
Participation in clinical trials or evaluation
of other research in which you have a
significant financial interest other than
royalty income.
In the context of your position at Ohio
University, you make professional referrals
to a business in which you have a
significant financial interest.
Letter of admonition
Ineligibility to submit grant applications
Withholding of IRB or IACUC approvals
Suspension
Non-Renewal
Loss of Tenure
Consulting
Procurement
Mentoring
Clinical Studies
Avoid consulting relationships that have
the potential to divert time and effort from
your responsibilities to Ohio University.
Do not use students.
Be wary of situations that limit publication.
Do not use university stationary, etc. that
could create an impression the university
is involved with the activities.
Make sure you are devoting sufficient time
to your university obligations.
Be cautious that the potential financial gain
cannot be perceived to influence your
university mentoring relationships.
Disclose any personal or familial financial
interest or equity in a company that is
doing business with Ohio University.
If you make purchases using public funds,
you should not use companies which will
benefit you or your family. If there is no
alternative you must seek and receive
permission prior to purchasing.
Any relationship in which there is a real or
perceived power or influence imbalance has
the potential for conflict. (Faculty:Student)
Isolating these relationships with respect to
areas of personal financial gain is best.
If they cannot be isolated, then safeguards
must be created.
If you have a financial interest, it is best to
isolate yourself from the study.
At a minimum, expect a more intense review
and a robust management plan if you have a
financial interest.
If both the institution and you have financial
interests the clinical study should be
conducted elsewhere.
You have administrative responsibilities on
behalf of Ohio University that is beneficial to
the business in which you have a significant
financial interest
You have administrative responsibilities on
behalf of Ohio University with respect to an
SRA where you have a significant financial
interest
Slide 3
Jo Ellen Sherow
Ohio University
Office of Research Compliance
Researchers’ Financial Disclosures in the
Spotlight
Conflicts of interest, always an emotional topic,
returned to the headlines this week as Sen.
Charles Grassley, a longtime critic of the drug
industry’s potential influence on research,
released new evidence that prominent Harvard
University scientists had failed to disclose much
of their outside income from pharmaceutical
companies over the past eight years.
http://www.insidehighered.com/news/2008/06/12/conflict January 15, 2008
WEDNESDAY, JANUARY 21, 2009
In a review of the literature regarding the relationship between
smokeless tobacco use and cancer, a conflict of interest of one of the
article's authors was initially not disclosed (see: Boffetta P, Hecht S, Gray
N, Gupta P, Straif K. Smokeless tobacco and cancer. Lancet Oncology
2008; 9:667-675). The original article was published in July, 2008. That
article stated: "The authors declare no conflicts of interest." After the
editor of the journal was notified by a researcher with knowledge of a
potential conflict of interest of Dr. Stephen Hecht (one of the study
authors), an erratum was published in September 2008, which noted:
"During the immediate months preceding submission of the review SH
was acting in the capacity of an expert witness for the plaintiff in a
future court case against a smokeless tobacco company. SH declares his
participation in this case in no way influenced his writing or involvement
in the review."
http://tobaccoanalysis.blogspot.com/2009/01/conflict-of-interestnot.html
January 16, 2009 — More than one third of new
drug marketing applications approved by the US
Food and Drug Administration (FDA) were
missing information about potential conflicts of
interest for clinical trial investigators, which
could allow bias to creep into the approvals
process, a government report released this week
has found. The FDA has said that it agrees with
most of the report's findings.
http://www.medscape.com/viewarticle/586980
Do collaborations between biotech companies
and academic centers constitute a conflict of
interest?
Biotechnology industry partnerships with
universities and academic centers have been
fruitful for both. So why is there so much
concern about conflict of interest and is that
concern appropriate?
http://www.redorbit.com/news/health/750100/genetic_engineering_news_p
osts_podcast_on_industrialacademic_collaborations_are_these/index.html
Universities are responsible for use of public
funds and therefore must maintain the public
trust.
Identifying and mitigating situations that may
have the potential for conflict maintains the
integrity of the university.
Maintaining integrity allows the university to
do credible academic research.
To provide information on the purpose of the
conflict of interest requirements.
To provide a basic overview of conflicts of
interest
To introduce the disclosure process and the use
of management plans
To provide information on the need for updates
and annual renewals.
Situations where financial considerations
compromise your professional judgment.
“Actual Conflict of Interest”
◦ Not permitted
Situations where an independent observer
might reasonably question whether your
professional actions or decisions are
determined by considerations of personal
gain. “Perceived Conflict of Interest”
◦ Managed
Potential conflicts may be financial or may be
a conflict of time, effort and/or commitment.
Potential conflicts can occur as a result of
administrative, scientific, academic, fiduciary
or familial situations.
They are situations that can be PERCEIVED to
be conflicting, whether a “real” conflict exists
or not.
Ohio University Policy has a mandatory
disclosure policy if you:
Earn over $10,000 in a twelve month period
from your outside activity OR
Have over 5% equity in the entity
Applies to members of your immediate family
(spouse, domestic partner, dependent
children) as well as yourself.
Anything of monetary value, including but not
limited to:
◦
◦
◦
◦
Salary
Payments for services
Equity interests over 5%
Intellectual property rights
Excludes mutual, pension and other
investments over which you have no control
Outside work during regular academic year
should not exceed equivalent of 1 day per
week.
Consulting work must avoid activities that
involve a conflict of interest with assigned
Ohio University activities and programs
Faculty Handbook, section IV-D
Outside interests cannot interfere with
primary loyalty to Ohio University and your
academic role
Use of university resources must have prior
approval of Chair, Dean and VPR.
Your outside interests should not be in
direct competition with university interests
Full time administrative employees are
expected to devote their full-time
professional loyalty, time and energy to their
position.
You must use non-work hours and no
university resources
Federal Agencies
State Law
University Policies
Many Academic Publications
45 CFR Part 50, Subpart F
“Responsibility of Applicants for Promoting
Objectivity in Research for Which PHS Funding
is Sought”
Authority: 42 U.S.C. 216, 289b-1, 299c-3.
Intent is to assure objectivity by establishing
standards that preclude bias in design, conduct, or
reporting of research
Focuses on financial conflicts of interest
(FCOI)
Regulations apply to investigators, including
sub grantees, contractors, and collaborating
investigators.
Does not apply to applications for support
under Phase I of SBIR and STTR programs
An institutional conflict of interest policy should
require that each investigator disclose to a
responsible representative of the institution all
significant financial interests of the investigator
(including those of the investigator’s spouse and
dependent children) (i) that would reasonably
appear to be affected by the research or
educational activities funded or proposed for
funding by NSF; or (ii) in entities whose financial
interests would reasonably appear to be affected
by such activities.
Chapter 1 (Subchapter A) (Part 54)
Financial Disclosure by Clinical Investigators
The Food and Drug Administration (FDA)
regulations state that investigators that
receive compensation in excess of $25,000
from a corporate sponsor of a trial in which
the investigator is engaged must disclose to
the FDA at the time of filing for a new drug
application.
19.058, Conflict of Interest in Research,
Educational, and Public Service Activities
19.059, Employee Participation in Authorized
Private Companies Commercializing Ohio
University Research
“Conflict of Interest in Research, Educational,
and Public Service Activities”
Most conflict disclosures fall within the
parameters of this policy
States that faculty are primarily responsible
for their academic, research and service
obligations
“Employee Participation in Authorized Private
Companies Commercializing Ohio University
Research”
Applies to “employees, faculty, staff and students,
who create intellectual property owned by the Ohio
University and who desire to hold an equity interest
in a firm, corporation, or other association to which
Ohio University has assigned, licensed or
transferred Ohio University’s interests…”
Consulting
Licensing University Technology
Clinical Studies
Procurement
Mentoring
Institutional
A disclosure is filed specific to the funding
application.
If you have a potential conflict for one
proposal, it does not automatically apply to
all of your proposals.
Research conflicts of interest are usually
disclosed using LEO as you apply for funding
by completing the conflict of interest section
of the electronic transmittal
If you are not using LEO, you can download
the appropriate disclosure form from
www.ohio.edu/research/compliance
“A” is selected if you have no conflicts to
disclose
“B” is selected if you have a potential conflict
to disclose relative to the submission.
(Requires a subsequent paper process)
“C” is selected if you have a current disclosure
on file, but it is not relevant to the proposal
you are submitting
Still uses option A, B or C
Requires that you gather signatures on paper
for all options, however
Generally used for personnel not listed on the
grant proposal or “key personnel”
We have revised the COI forms to word forms
This should be easier to complete than the
previous form
PDF versions are also available
Should be on the compliance web site soon,
but we can e-mail them to you until then
Use this form only if you are unable to use
the LEO transmittal form to assure that no
conflict of interest exists. A form must be
completed for each proposal.
I assure that I have read Ohio University
Policy 19.058, “Conflict of Interest in
Research, Educational, and Public Service
Activities” and declare that I have nothing
that is, or could be perceived to be a conflict
of interest with this proposal.
Use this form to disclose a potential conflict
of interest situation.
A separate disclosure form must be used for
each entity with which you conduct business
Conflict includes any member of your
immediate family (spouse, domestic partner
or children)
Require that you complete an option “B”
disclosure statement in addition to
completing the LEO transmittal form.
Require you to obtain signatures from Center
or Institute (if applicable), Chair and Dean on
the additional disclosure statement!!
The B disclosure form is available at
www.ohio.edu/research/compliance
Use this form only if you are unable to use
the LEO transmittal form. Complete this form
if you have a current conflict of interest
disclosure on file with the Office of Research
Compliance, but that disclosure is not
applicable to this proposal.
*New Option for 2008*
A management plan is developed for some
disclosures to mitigate the potential conflict
Management plans are specific to each
disclosure
May require submission of additional pieces,
such as a student employment plan
Reduce or remove the financial interest creating the
conflict
Place safeguards that mitigate the conflict potential,
such having some decisions made by an independent
entity
Limit participation in portions of the proposed
research likely to create a conflict
Require that the researcher disclose his or her
conflicting financial interests to all collaborators and
any proposed trainees;
Disclose the conflict in publications
Work to remove students from being directly advised
or taught by faculty where a conflict exists
Assure publication rights for student participants
Student Use
Nepotism and Cronyism
Intellectual Property
Use of University Resources
Publication provisions
Use of Human Subjects
Oversight Requirements
Reporting and Annual Reviews
You must submit an annual renewal for your
disclosure
◦ If the potential conflict no longer exists you must
notify us
If significant changes occur during the year
you should submit an update to your
disclosure as they occur
Yes. We encourage employees to disclose
potential conflicts that do not meet the
financial threshold, but may still be
problematic, such as student employment.
This allows you to be transparent with
respect to outside interests.
Allowable situations
Situations that require disclosure but may not
need an extensive management plan
Situations that require disclosure and have
problematic elements that will require
mitigation and/or a management plan
Situations that are not permitted
Receipt of royalties or honoraria for
published scholarly works, seminars,
teaching, etc.
Honoraria for serving as a special reviewer
or work on review panels
Royalties under our intellectual property
policies if no other relationship with entity
Clinical income at OUCOM
You participate in research developed in
whole or part by you, and you or your
family receive royalties from an existing
agreement with the business, but have
no other significant financial interest
You assign students, etc. to research
projects where you are entitled to
receive royalties, but have no other
significant financial interest
You assign students, etc. to projects supported
by the business through an SRA, and have a
significant financial interest other than royalty
income
You receive research support from a business in
which you serve on the board of directors, or
other advisory board, even if you are not
compensated.
You hold an executive position in a business
engaged in commercial or research activities
directly related to your Ohio University
responsibilities.
Any situation in which an actual conflict
exists is not permitted.
The only “exceptions” are those handled
under Ohio University Policy and Procedure
19.059 where faculty entrepreneurship is
addressed.
Participation in clinical trials or evaluation
of other research in which you have a
significant financial interest other than
royalty income.
In the context of your position at Ohio
University, you make professional referrals
to a business in which you have a
significant financial interest.
Letter of admonition
Ineligibility to submit grant applications
Withholding of IRB or IACUC approvals
Suspension
Non-Renewal
Loss of Tenure
Consulting
Procurement
Mentoring
Clinical Studies
Avoid consulting relationships that have
the potential to divert time and effort from
your responsibilities to Ohio University.
Do not use students.
Be wary of situations that limit publication.
Do not use university stationary, etc. that
could create an impression the university
is involved with the activities.
Make sure you are devoting sufficient time
to your university obligations.
Be cautious that the potential financial gain
cannot be perceived to influence your
university mentoring relationships.
Disclose any personal or familial financial
interest or equity in a company that is
doing business with Ohio University.
If you make purchases using public funds,
you should not use companies which will
benefit you or your family. If there is no
alternative you must seek and receive
permission prior to purchasing.
Any relationship in which there is a real or
perceived power or influence imbalance has
the potential for conflict. (Faculty:Student)
Isolating these relationships with respect to
areas of personal financial gain is best.
If they cannot be isolated, then safeguards
must be created.
If you have a financial interest, it is best to
isolate yourself from the study.
At a minimum, expect a more intense review
and a robust management plan if you have a
financial interest.
If both the institution and you have financial
interests the clinical study should be
conducted elsewhere.
You have administrative responsibilities on
behalf of Ohio University that is beneficial to
the business in which you have a significant
financial interest
You have administrative responsibilities on
behalf of Ohio University with respect to an
SRA where you have a significant financial
interest
Slide 4
Jo Ellen Sherow
Ohio University
Office of Research Compliance
Researchers’ Financial Disclosures in the
Spotlight
Conflicts of interest, always an emotional topic,
returned to the headlines this week as Sen.
Charles Grassley, a longtime critic of the drug
industry’s potential influence on research,
released new evidence that prominent Harvard
University scientists had failed to disclose much
of their outside income from pharmaceutical
companies over the past eight years.
http://www.insidehighered.com/news/2008/06/12/conflict January 15, 2008
WEDNESDAY, JANUARY 21, 2009
In a review of the literature regarding the relationship between
smokeless tobacco use and cancer, a conflict of interest of one of the
article's authors was initially not disclosed (see: Boffetta P, Hecht S, Gray
N, Gupta P, Straif K. Smokeless tobacco and cancer. Lancet Oncology
2008; 9:667-675). The original article was published in July, 2008. That
article stated: "The authors declare no conflicts of interest." After the
editor of the journal was notified by a researcher with knowledge of a
potential conflict of interest of Dr. Stephen Hecht (one of the study
authors), an erratum was published in September 2008, which noted:
"During the immediate months preceding submission of the review SH
was acting in the capacity of an expert witness for the plaintiff in a
future court case against a smokeless tobacco company. SH declares his
participation in this case in no way influenced his writing or involvement
in the review."
http://tobaccoanalysis.blogspot.com/2009/01/conflict-of-interestnot.html
January 16, 2009 — More than one third of new
drug marketing applications approved by the US
Food and Drug Administration (FDA) were
missing information about potential conflicts of
interest for clinical trial investigators, which
could allow bias to creep into the approvals
process, a government report released this week
has found. The FDA has said that it agrees with
most of the report's findings.
http://www.medscape.com/viewarticle/586980
Do collaborations between biotech companies
and academic centers constitute a conflict of
interest?
Biotechnology industry partnerships with
universities and academic centers have been
fruitful for both. So why is there so much
concern about conflict of interest and is that
concern appropriate?
http://www.redorbit.com/news/health/750100/genetic_engineering_news_p
osts_podcast_on_industrialacademic_collaborations_are_these/index.html
Universities are responsible for use of public
funds and therefore must maintain the public
trust.
Identifying and mitigating situations that may
have the potential for conflict maintains the
integrity of the university.
Maintaining integrity allows the university to
do credible academic research.
To provide information on the purpose of the
conflict of interest requirements.
To provide a basic overview of conflicts of
interest
To introduce the disclosure process and the use
of management plans
To provide information on the need for updates
and annual renewals.
Situations where financial considerations
compromise your professional judgment.
“Actual Conflict of Interest”
◦ Not permitted
Situations where an independent observer
might reasonably question whether your
professional actions or decisions are
determined by considerations of personal
gain. “Perceived Conflict of Interest”
◦ Managed
Potential conflicts may be financial or may be
a conflict of time, effort and/or commitment.
Potential conflicts can occur as a result of
administrative, scientific, academic, fiduciary
or familial situations.
They are situations that can be PERCEIVED to
be conflicting, whether a “real” conflict exists
or not.
Ohio University Policy has a mandatory
disclosure policy if you:
Earn over $10,000 in a twelve month period
from your outside activity OR
Have over 5% equity in the entity
Applies to members of your immediate family
(spouse, domestic partner, dependent
children) as well as yourself.
Anything of monetary value, including but not
limited to:
◦
◦
◦
◦
Salary
Payments for services
Equity interests over 5%
Intellectual property rights
Excludes mutual, pension and other
investments over which you have no control
Outside work during regular academic year
should not exceed equivalent of 1 day per
week.
Consulting work must avoid activities that
involve a conflict of interest with assigned
Ohio University activities and programs
Faculty Handbook, section IV-D
Outside interests cannot interfere with
primary loyalty to Ohio University and your
academic role
Use of university resources must have prior
approval of Chair, Dean and VPR.
Your outside interests should not be in
direct competition with university interests
Full time administrative employees are
expected to devote their full-time
professional loyalty, time and energy to their
position.
You must use non-work hours and no
university resources
Federal Agencies
State Law
University Policies
Many Academic Publications
45 CFR Part 50, Subpart F
“Responsibility of Applicants for Promoting
Objectivity in Research for Which PHS Funding
is Sought”
Authority: 42 U.S.C. 216, 289b-1, 299c-3.
Intent is to assure objectivity by establishing
standards that preclude bias in design, conduct, or
reporting of research
Focuses on financial conflicts of interest
(FCOI)
Regulations apply to investigators, including
sub grantees, contractors, and collaborating
investigators.
Does not apply to applications for support
under Phase I of SBIR and STTR programs
An institutional conflict of interest policy should
require that each investigator disclose to a
responsible representative of the institution all
significant financial interests of the investigator
(including those of the investigator’s spouse and
dependent children) (i) that would reasonably
appear to be affected by the research or
educational activities funded or proposed for
funding by NSF; or (ii) in entities whose financial
interests would reasonably appear to be affected
by such activities.
Chapter 1 (Subchapter A) (Part 54)
Financial Disclosure by Clinical Investigators
The Food and Drug Administration (FDA)
regulations state that investigators that
receive compensation in excess of $25,000
from a corporate sponsor of a trial in which
the investigator is engaged must disclose to
the FDA at the time of filing for a new drug
application.
19.058, Conflict of Interest in Research,
Educational, and Public Service Activities
19.059, Employee Participation in Authorized
Private Companies Commercializing Ohio
University Research
“Conflict of Interest in Research, Educational,
and Public Service Activities”
Most conflict disclosures fall within the
parameters of this policy
States that faculty are primarily responsible
for their academic, research and service
obligations
“Employee Participation in Authorized Private
Companies Commercializing Ohio University
Research”
Applies to “employees, faculty, staff and students,
who create intellectual property owned by the Ohio
University and who desire to hold an equity interest
in a firm, corporation, or other association to which
Ohio University has assigned, licensed or
transferred Ohio University’s interests…”
Consulting
Licensing University Technology
Clinical Studies
Procurement
Mentoring
Institutional
A disclosure is filed specific to the funding
application.
If you have a potential conflict for one
proposal, it does not automatically apply to
all of your proposals.
Research conflicts of interest are usually
disclosed using LEO as you apply for funding
by completing the conflict of interest section
of the electronic transmittal
If you are not using LEO, you can download
the appropriate disclosure form from
www.ohio.edu/research/compliance
“A” is selected if you have no conflicts to
disclose
“B” is selected if you have a potential conflict
to disclose relative to the submission.
(Requires a subsequent paper process)
“C” is selected if you have a current disclosure
on file, but it is not relevant to the proposal
you are submitting
Still uses option A, B or C
Requires that you gather signatures on paper
for all options, however
Generally used for personnel not listed on the
grant proposal or “key personnel”
We have revised the COI forms to word forms
This should be easier to complete than the
previous form
PDF versions are also available
Should be on the compliance web site soon,
but we can e-mail them to you until then
Use this form only if you are unable to use
the LEO transmittal form to assure that no
conflict of interest exists. A form must be
completed for each proposal.
I assure that I have read Ohio University
Policy 19.058, “Conflict of Interest in
Research, Educational, and Public Service
Activities” and declare that I have nothing
that is, or could be perceived to be a conflict
of interest with this proposal.
Use this form to disclose a potential conflict
of interest situation.
A separate disclosure form must be used for
each entity with which you conduct business
Conflict includes any member of your
immediate family (spouse, domestic partner
or children)
Require that you complete an option “B”
disclosure statement in addition to
completing the LEO transmittal form.
Require you to obtain signatures from Center
or Institute (if applicable), Chair and Dean on
the additional disclosure statement!!
The B disclosure form is available at
www.ohio.edu/research/compliance
Use this form only if you are unable to use
the LEO transmittal form. Complete this form
if you have a current conflict of interest
disclosure on file with the Office of Research
Compliance, but that disclosure is not
applicable to this proposal.
*New Option for 2008*
A management plan is developed for some
disclosures to mitigate the potential conflict
Management plans are specific to each
disclosure
May require submission of additional pieces,
such as a student employment plan
Reduce or remove the financial interest creating the
conflict
Place safeguards that mitigate the conflict potential,
such having some decisions made by an independent
entity
Limit participation in portions of the proposed
research likely to create a conflict
Require that the researcher disclose his or her
conflicting financial interests to all collaborators and
any proposed trainees;
Disclose the conflict in publications
Work to remove students from being directly advised
or taught by faculty where a conflict exists
Assure publication rights for student participants
Student Use
Nepotism and Cronyism
Intellectual Property
Use of University Resources
Publication provisions
Use of Human Subjects
Oversight Requirements
Reporting and Annual Reviews
You must submit an annual renewal for your
disclosure
◦ If the potential conflict no longer exists you must
notify us
If significant changes occur during the year
you should submit an update to your
disclosure as they occur
Yes. We encourage employees to disclose
potential conflicts that do not meet the
financial threshold, but may still be
problematic, such as student employment.
This allows you to be transparent with
respect to outside interests.
Allowable situations
Situations that require disclosure but may not
need an extensive management plan
Situations that require disclosure and have
problematic elements that will require
mitigation and/or a management plan
Situations that are not permitted
Receipt of royalties or honoraria for
published scholarly works, seminars,
teaching, etc.
Honoraria for serving as a special reviewer
or work on review panels
Royalties under our intellectual property
policies if no other relationship with entity
Clinical income at OUCOM
You participate in research developed in
whole or part by you, and you or your
family receive royalties from an existing
agreement with the business, but have
no other significant financial interest
You assign students, etc. to research
projects where you are entitled to
receive royalties, but have no other
significant financial interest
You assign students, etc. to projects supported
by the business through an SRA, and have a
significant financial interest other than royalty
income
You receive research support from a business in
which you serve on the board of directors, or
other advisory board, even if you are not
compensated.
You hold an executive position in a business
engaged in commercial or research activities
directly related to your Ohio University
responsibilities.
Any situation in which an actual conflict
exists is not permitted.
The only “exceptions” are those handled
under Ohio University Policy and Procedure
19.059 where faculty entrepreneurship is
addressed.
Participation in clinical trials or evaluation
of other research in which you have a
significant financial interest other than
royalty income.
In the context of your position at Ohio
University, you make professional referrals
to a business in which you have a
significant financial interest.
Letter of admonition
Ineligibility to submit grant applications
Withholding of IRB or IACUC approvals
Suspension
Non-Renewal
Loss of Tenure
Consulting
Procurement
Mentoring
Clinical Studies
Avoid consulting relationships that have
the potential to divert time and effort from
your responsibilities to Ohio University.
Do not use students.
Be wary of situations that limit publication.
Do not use university stationary, etc. that
could create an impression the university
is involved with the activities.
Make sure you are devoting sufficient time
to your university obligations.
Be cautious that the potential financial gain
cannot be perceived to influence your
university mentoring relationships.
Disclose any personal or familial financial
interest or equity in a company that is
doing business with Ohio University.
If you make purchases using public funds,
you should not use companies which will
benefit you or your family. If there is no
alternative you must seek and receive
permission prior to purchasing.
Any relationship in which there is a real or
perceived power or influence imbalance has
the potential for conflict. (Faculty:Student)
Isolating these relationships with respect to
areas of personal financial gain is best.
If they cannot be isolated, then safeguards
must be created.
If you have a financial interest, it is best to
isolate yourself from the study.
At a minimum, expect a more intense review
and a robust management plan if you have a
financial interest.
If both the institution and you have financial
interests the clinical study should be
conducted elsewhere.
You have administrative responsibilities on
behalf of Ohio University that is beneficial to
the business in which you have a significant
financial interest
You have administrative responsibilities on
behalf of Ohio University with respect to an
SRA where you have a significant financial
interest
Slide 5
Jo Ellen Sherow
Ohio University
Office of Research Compliance
Researchers’ Financial Disclosures in the
Spotlight
Conflicts of interest, always an emotional topic,
returned to the headlines this week as Sen.
Charles Grassley, a longtime critic of the drug
industry’s potential influence on research,
released new evidence that prominent Harvard
University scientists had failed to disclose much
of their outside income from pharmaceutical
companies over the past eight years.
http://www.insidehighered.com/news/2008/06/12/conflict January 15, 2008
WEDNESDAY, JANUARY 21, 2009
In a review of the literature regarding the relationship between
smokeless tobacco use and cancer, a conflict of interest of one of the
article's authors was initially not disclosed (see: Boffetta P, Hecht S, Gray
N, Gupta P, Straif K. Smokeless tobacco and cancer. Lancet Oncology
2008; 9:667-675). The original article was published in July, 2008. That
article stated: "The authors declare no conflicts of interest." After the
editor of the journal was notified by a researcher with knowledge of a
potential conflict of interest of Dr. Stephen Hecht (one of the study
authors), an erratum was published in September 2008, which noted:
"During the immediate months preceding submission of the review SH
was acting in the capacity of an expert witness for the plaintiff in a
future court case against a smokeless tobacco company. SH declares his
participation in this case in no way influenced his writing or involvement
in the review."
http://tobaccoanalysis.blogspot.com/2009/01/conflict-of-interestnot.html
January 16, 2009 — More than one third of new
drug marketing applications approved by the US
Food and Drug Administration (FDA) were
missing information about potential conflicts of
interest for clinical trial investigators, which
could allow bias to creep into the approvals
process, a government report released this week
has found. The FDA has said that it agrees with
most of the report's findings.
http://www.medscape.com/viewarticle/586980
Do collaborations between biotech companies
and academic centers constitute a conflict of
interest?
Biotechnology industry partnerships with
universities and academic centers have been
fruitful for both. So why is there so much
concern about conflict of interest and is that
concern appropriate?
http://www.redorbit.com/news/health/750100/genetic_engineering_news_p
osts_podcast_on_industrialacademic_collaborations_are_these/index.html
Universities are responsible for use of public
funds and therefore must maintain the public
trust.
Identifying and mitigating situations that may
have the potential for conflict maintains the
integrity of the university.
Maintaining integrity allows the university to
do credible academic research.
To provide information on the purpose of the
conflict of interest requirements.
To provide a basic overview of conflicts of
interest
To introduce the disclosure process and the use
of management plans
To provide information on the need for updates
and annual renewals.
Situations where financial considerations
compromise your professional judgment.
“Actual Conflict of Interest”
◦ Not permitted
Situations where an independent observer
might reasonably question whether your
professional actions or decisions are
determined by considerations of personal
gain. “Perceived Conflict of Interest”
◦ Managed
Potential conflicts may be financial or may be
a conflict of time, effort and/or commitment.
Potential conflicts can occur as a result of
administrative, scientific, academic, fiduciary
or familial situations.
They are situations that can be PERCEIVED to
be conflicting, whether a “real” conflict exists
or not.
Ohio University Policy has a mandatory
disclosure policy if you:
Earn over $10,000 in a twelve month period
from your outside activity OR
Have over 5% equity in the entity
Applies to members of your immediate family
(spouse, domestic partner, dependent
children) as well as yourself.
Anything of monetary value, including but not
limited to:
◦
◦
◦
◦
Salary
Payments for services
Equity interests over 5%
Intellectual property rights
Excludes mutual, pension and other
investments over which you have no control
Outside work during regular academic year
should not exceed equivalent of 1 day per
week.
Consulting work must avoid activities that
involve a conflict of interest with assigned
Ohio University activities and programs
Faculty Handbook, section IV-D
Outside interests cannot interfere with
primary loyalty to Ohio University and your
academic role
Use of university resources must have prior
approval of Chair, Dean and VPR.
Your outside interests should not be in
direct competition with university interests
Full time administrative employees are
expected to devote their full-time
professional loyalty, time and energy to their
position.
You must use non-work hours and no
university resources
Federal Agencies
State Law
University Policies
Many Academic Publications
45 CFR Part 50, Subpart F
“Responsibility of Applicants for Promoting
Objectivity in Research for Which PHS Funding
is Sought”
Authority: 42 U.S.C. 216, 289b-1, 299c-3.
Intent is to assure objectivity by establishing
standards that preclude bias in design, conduct, or
reporting of research
Focuses on financial conflicts of interest
(FCOI)
Regulations apply to investigators, including
sub grantees, contractors, and collaborating
investigators.
Does not apply to applications for support
under Phase I of SBIR and STTR programs
An institutional conflict of interest policy should
require that each investigator disclose to a
responsible representative of the institution all
significant financial interests of the investigator
(including those of the investigator’s spouse and
dependent children) (i) that would reasonably
appear to be affected by the research or
educational activities funded or proposed for
funding by NSF; or (ii) in entities whose financial
interests would reasonably appear to be affected
by such activities.
Chapter 1 (Subchapter A) (Part 54)
Financial Disclosure by Clinical Investigators
The Food and Drug Administration (FDA)
regulations state that investigators that
receive compensation in excess of $25,000
from a corporate sponsor of a trial in which
the investigator is engaged must disclose to
the FDA at the time of filing for a new drug
application.
19.058, Conflict of Interest in Research,
Educational, and Public Service Activities
19.059, Employee Participation in Authorized
Private Companies Commercializing Ohio
University Research
“Conflict of Interest in Research, Educational,
and Public Service Activities”
Most conflict disclosures fall within the
parameters of this policy
States that faculty are primarily responsible
for their academic, research and service
obligations
“Employee Participation in Authorized Private
Companies Commercializing Ohio University
Research”
Applies to “employees, faculty, staff and students,
who create intellectual property owned by the Ohio
University and who desire to hold an equity interest
in a firm, corporation, or other association to which
Ohio University has assigned, licensed or
transferred Ohio University’s interests…”
Consulting
Licensing University Technology
Clinical Studies
Procurement
Mentoring
Institutional
A disclosure is filed specific to the funding
application.
If you have a potential conflict for one
proposal, it does not automatically apply to
all of your proposals.
Research conflicts of interest are usually
disclosed using LEO as you apply for funding
by completing the conflict of interest section
of the electronic transmittal
If you are not using LEO, you can download
the appropriate disclosure form from
www.ohio.edu/research/compliance
“A” is selected if you have no conflicts to
disclose
“B” is selected if you have a potential conflict
to disclose relative to the submission.
(Requires a subsequent paper process)
“C” is selected if you have a current disclosure
on file, but it is not relevant to the proposal
you are submitting
Still uses option A, B or C
Requires that you gather signatures on paper
for all options, however
Generally used for personnel not listed on the
grant proposal or “key personnel”
We have revised the COI forms to word forms
This should be easier to complete than the
previous form
PDF versions are also available
Should be on the compliance web site soon,
but we can e-mail them to you until then
Use this form only if you are unable to use
the LEO transmittal form to assure that no
conflict of interest exists. A form must be
completed for each proposal.
I assure that I have read Ohio University
Policy 19.058, “Conflict of Interest in
Research, Educational, and Public Service
Activities” and declare that I have nothing
that is, or could be perceived to be a conflict
of interest with this proposal.
Use this form to disclose a potential conflict
of interest situation.
A separate disclosure form must be used for
each entity with which you conduct business
Conflict includes any member of your
immediate family (spouse, domestic partner
or children)
Require that you complete an option “B”
disclosure statement in addition to
completing the LEO transmittal form.
Require you to obtain signatures from Center
or Institute (if applicable), Chair and Dean on
the additional disclosure statement!!
The B disclosure form is available at
www.ohio.edu/research/compliance
Use this form only if you are unable to use
the LEO transmittal form. Complete this form
if you have a current conflict of interest
disclosure on file with the Office of Research
Compliance, but that disclosure is not
applicable to this proposal.
*New Option for 2008*
A management plan is developed for some
disclosures to mitigate the potential conflict
Management plans are specific to each
disclosure
May require submission of additional pieces,
such as a student employment plan
Reduce or remove the financial interest creating the
conflict
Place safeguards that mitigate the conflict potential,
such having some decisions made by an independent
entity
Limit participation in portions of the proposed
research likely to create a conflict
Require that the researcher disclose his or her
conflicting financial interests to all collaborators and
any proposed trainees;
Disclose the conflict in publications
Work to remove students from being directly advised
or taught by faculty where a conflict exists
Assure publication rights for student participants
Student Use
Nepotism and Cronyism
Intellectual Property
Use of University Resources
Publication provisions
Use of Human Subjects
Oversight Requirements
Reporting and Annual Reviews
You must submit an annual renewal for your
disclosure
◦ If the potential conflict no longer exists you must
notify us
If significant changes occur during the year
you should submit an update to your
disclosure as they occur
Yes. We encourage employees to disclose
potential conflicts that do not meet the
financial threshold, but may still be
problematic, such as student employment.
This allows you to be transparent with
respect to outside interests.
Allowable situations
Situations that require disclosure but may not
need an extensive management plan
Situations that require disclosure and have
problematic elements that will require
mitigation and/or a management plan
Situations that are not permitted
Receipt of royalties or honoraria for
published scholarly works, seminars,
teaching, etc.
Honoraria for serving as a special reviewer
or work on review panels
Royalties under our intellectual property
policies if no other relationship with entity
Clinical income at OUCOM
You participate in research developed in
whole or part by you, and you or your
family receive royalties from an existing
agreement with the business, but have
no other significant financial interest
You assign students, etc. to research
projects where you are entitled to
receive royalties, but have no other
significant financial interest
You assign students, etc. to projects supported
by the business through an SRA, and have a
significant financial interest other than royalty
income
You receive research support from a business in
which you serve on the board of directors, or
other advisory board, even if you are not
compensated.
You hold an executive position in a business
engaged in commercial or research activities
directly related to your Ohio University
responsibilities.
Any situation in which an actual conflict
exists is not permitted.
The only “exceptions” are those handled
under Ohio University Policy and Procedure
19.059 where faculty entrepreneurship is
addressed.
Participation in clinical trials or evaluation
of other research in which you have a
significant financial interest other than
royalty income.
In the context of your position at Ohio
University, you make professional referrals
to a business in which you have a
significant financial interest.
Letter of admonition
Ineligibility to submit grant applications
Withholding of IRB or IACUC approvals
Suspension
Non-Renewal
Loss of Tenure
Consulting
Procurement
Mentoring
Clinical Studies
Avoid consulting relationships that have
the potential to divert time and effort from
your responsibilities to Ohio University.
Do not use students.
Be wary of situations that limit publication.
Do not use university stationary, etc. that
could create an impression the university
is involved with the activities.
Make sure you are devoting sufficient time
to your university obligations.
Be cautious that the potential financial gain
cannot be perceived to influence your
university mentoring relationships.
Disclose any personal or familial financial
interest or equity in a company that is
doing business with Ohio University.
If you make purchases using public funds,
you should not use companies which will
benefit you or your family. If there is no
alternative you must seek and receive
permission prior to purchasing.
Any relationship in which there is a real or
perceived power or influence imbalance has
the potential for conflict. (Faculty:Student)
Isolating these relationships with respect to
areas of personal financial gain is best.
If they cannot be isolated, then safeguards
must be created.
If you have a financial interest, it is best to
isolate yourself from the study.
At a minimum, expect a more intense review
and a robust management plan if you have a
financial interest.
If both the institution and you have financial
interests the clinical study should be
conducted elsewhere.
You have administrative responsibilities on
behalf of Ohio University that is beneficial to
the business in which you have a significant
financial interest
You have administrative responsibilities on
behalf of Ohio University with respect to an
SRA where you have a significant financial
interest
Slide 6
Jo Ellen Sherow
Ohio University
Office of Research Compliance
Researchers’ Financial Disclosures in the
Spotlight
Conflicts of interest, always an emotional topic,
returned to the headlines this week as Sen.
Charles Grassley, a longtime critic of the drug
industry’s potential influence on research,
released new evidence that prominent Harvard
University scientists had failed to disclose much
of their outside income from pharmaceutical
companies over the past eight years.
http://www.insidehighered.com/news/2008/06/12/conflict January 15, 2008
WEDNESDAY, JANUARY 21, 2009
In a review of the literature regarding the relationship between
smokeless tobacco use and cancer, a conflict of interest of one of the
article's authors was initially not disclosed (see: Boffetta P, Hecht S, Gray
N, Gupta P, Straif K. Smokeless tobacco and cancer. Lancet Oncology
2008; 9:667-675). The original article was published in July, 2008. That
article stated: "The authors declare no conflicts of interest." After the
editor of the journal was notified by a researcher with knowledge of a
potential conflict of interest of Dr. Stephen Hecht (one of the study
authors), an erratum was published in September 2008, which noted:
"During the immediate months preceding submission of the review SH
was acting in the capacity of an expert witness for the plaintiff in a
future court case against a smokeless tobacco company. SH declares his
participation in this case in no way influenced his writing or involvement
in the review."
http://tobaccoanalysis.blogspot.com/2009/01/conflict-of-interestnot.html
January 16, 2009 — More than one third of new
drug marketing applications approved by the US
Food and Drug Administration (FDA) were
missing information about potential conflicts of
interest for clinical trial investigators, which
could allow bias to creep into the approvals
process, a government report released this week
has found. The FDA has said that it agrees with
most of the report's findings.
http://www.medscape.com/viewarticle/586980
Do collaborations between biotech companies
and academic centers constitute a conflict of
interest?
Biotechnology industry partnerships with
universities and academic centers have been
fruitful for both. So why is there so much
concern about conflict of interest and is that
concern appropriate?
http://www.redorbit.com/news/health/750100/genetic_engineering_news_p
osts_podcast_on_industrialacademic_collaborations_are_these/index.html
Universities are responsible for use of public
funds and therefore must maintain the public
trust.
Identifying and mitigating situations that may
have the potential for conflict maintains the
integrity of the university.
Maintaining integrity allows the university to
do credible academic research.
To provide information on the purpose of the
conflict of interest requirements.
To provide a basic overview of conflicts of
interest
To introduce the disclosure process and the use
of management plans
To provide information on the need for updates
and annual renewals.
Situations where financial considerations
compromise your professional judgment.
“Actual Conflict of Interest”
◦ Not permitted
Situations where an independent observer
might reasonably question whether your
professional actions or decisions are
determined by considerations of personal
gain. “Perceived Conflict of Interest”
◦ Managed
Potential conflicts may be financial or may be
a conflict of time, effort and/or commitment.
Potential conflicts can occur as a result of
administrative, scientific, academic, fiduciary
or familial situations.
They are situations that can be PERCEIVED to
be conflicting, whether a “real” conflict exists
or not.
Ohio University Policy has a mandatory
disclosure policy if you:
Earn over $10,000 in a twelve month period
from your outside activity OR
Have over 5% equity in the entity
Applies to members of your immediate family
(spouse, domestic partner, dependent
children) as well as yourself.
Anything of monetary value, including but not
limited to:
◦
◦
◦
◦
Salary
Payments for services
Equity interests over 5%
Intellectual property rights
Excludes mutual, pension and other
investments over which you have no control
Outside work during regular academic year
should not exceed equivalent of 1 day per
week.
Consulting work must avoid activities that
involve a conflict of interest with assigned
Ohio University activities and programs
Faculty Handbook, section IV-D
Outside interests cannot interfere with
primary loyalty to Ohio University and your
academic role
Use of university resources must have prior
approval of Chair, Dean and VPR.
Your outside interests should not be in
direct competition with university interests
Full time administrative employees are
expected to devote their full-time
professional loyalty, time and energy to their
position.
You must use non-work hours and no
university resources
Federal Agencies
State Law
University Policies
Many Academic Publications
45 CFR Part 50, Subpart F
“Responsibility of Applicants for Promoting
Objectivity in Research for Which PHS Funding
is Sought”
Authority: 42 U.S.C. 216, 289b-1, 299c-3.
Intent is to assure objectivity by establishing
standards that preclude bias in design, conduct, or
reporting of research
Focuses on financial conflicts of interest
(FCOI)
Regulations apply to investigators, including
sub grantees, contractors, and collaborating
investigators.
Does not apply to applications for support
under Phase I of SBIR and STTR programs
An institutional conflict of interest policy should
require that each investigator disclose to a
responsible representative of the institution all
significant financial interests of the investigator
(including those of the investigator’s spouse and
dependent children) (i) that would reasonably
appear to be affected by the research or
educational activities funded or proposed for
funding by NSF; or (ii) in entities whose financial
interests would reasonably appear to be affected
by such activities.
Chapter 1 (Subchapter A) (Part 54)
Financial Disclosure by Clinical Investigators
The Food and Drug Administration (FDA)
regulations state that investigators that
receive compensation in excess of $25,000
from a corporate sponsor of a trial in which
the investigator is engaged must disclose to
the FDA at the time of filing for a new drug
application.
19.058, Conflict of Interest in Research,
Educational, and Public Service Activities
19.059, Employee Participation in Authorized
Private Companies Commercializing Ohio
University Research
“Conflict of Interest in Research, Educational,
and Public Service Activities”
Most conflict disclosures fall within the
parameters of this policy
States that faculty are primarily responsible
for their academic, research and service
obligations
“Employee Participation in Authorized Private
Companies Commercializing Ohio University
Research”
Applies to “employees, faculty, staff and students,
who create intellectual property owned by the Ohio
University and who desire to hold an equity interest
in a firm, corporation, or other association to which
Ohio University has assigned, licensed or
transferred Ohio University’s interests…”
Consulting
Licensing University Technology
Clinical Studies
Procurement
Mentoring
Institutional
A disclosure is filed specific to the funding
application.
If you have a potential conflict for one
proposal, it does not automatically apply to
all of your proposals.
Research conflicts of interest are usually
disclosed using LEO as you apply for funding
by completing the conflict of interest section
of the electronic transmittal
If you are not using LEO, you can download
the appropriate disclosure form from
www.ohio.edu/research/compliance
“A” is selected if you have no conflicts to
disclose
“B” is selected if you have a potential conflict
to disclose relative to the submission.
(Requires a subsequent paper process)
“C” is selected if you have a current disclosure
on file, but it is not relevant to the proposal
you are submitting
Still uses option A, B or C
Requires that you gather signatures on paper
for all options, however
Generally used for personnel not listed on the
grant proposal or “key personnel”
We have revised the COI forms to word forms
This should be easier to complete than the
previous form
PDF versions are also available
Should be on the compliance web site soon,
but we can e-mail them to you until then
Use this form only if you are unable to use
the LEO transmittal form to assure that no
conflict of interest exists. A form must be
completed for each proposal.
I assure that I have read Ohio University
Policy 19.058, “Conflict of Interest in
Research, Educational, and Public Service
Activities” and declare that I have nothing
that is, or could be perceived to be a conflict
of interest with this proposal.
Use this form to disclose a potential conflict
of interest situation.
A separate disclosure form must be used for
each entity with which you conduct business
Conflict includes any member of your
immediate family (spouse, domestic partner
or children)
Require that you complete an option “B”
disclosure statement in addition to
completing the LEO transmittal form.
Require you to obtain signatures from Center
or Institute (if applicable), Chair and Dean on
the additional disclosure statement!!
The B disclosure form is available at
www.ohio.edu/research/compliance
Use this form only if you are unable to use
the LEO transmittal form. Complete this form
if you have a current conflict of interest
disclosure on file with the Office of Research
Compliance, but that disclosure is not
applicable to this proposal.
*New Option for 2008*
A management plan is developed for some
disclosures to mitigate the potential conflict
Management plans are specific to each
disclosure
May require submission of additional pieces,
such as a student employment plan
Reduce or remove the financial interest creating the
conflict
Place safeguards that mitigate the conflict potential,
such having some decisions made by an independent
entity
Limit participation in portions of the proposed
research likely to create a conflict
Require that the researcher disclose his or her
conflicting financial interests to all collaborators and
any proposed trainees;
Disclose the conflict in publications
Work to remove students from being directly advised
or taught by faculty where a conflict exists
Assure publication rights for student participants
Student Use
Nepotism and Cronyism
Intellectual Property
Use of University Resources
Publication provisions
Use of Human Subjects
Oversight Requirements
Reporting and Annual Reviews
You must submit an annual renewal for your
disclosure
◦ If the potential conflict no longer exists you must
notify us
If significant changes occur during the year
you should submit an update to your
disclosure as they occur
Yes. We encourage employees to disclose
potential conflicts that do not meet the
financial threshold, but may still be
problematic, such as student employment.
This allows you to be transparent with
respect to outside interests.
Allowable situations
Situations that require disclosure but may not
need an extensive management plan
Situations that require disclosure and have
problematic elements that will require
mitigation and/or a management plan
Situations that are not permitted
Receipt of royalties or honoraria for
published scholarly works, seminars,
teaching, etc.
Honoraria for serving as a special reviewer
or work on review panels
Royalties under our intellectual property
policies if no other relationship with entity
Clinical income at OUCOM
You participate in research developed in
whole or part by you, and you or your
family receive royalties from an existing
agreement with the business, but have
no other significant financial interest
You assign students, etc. to research
projects where you are entitled to
receive royalties, but have no other
significant financial interest
You assign students, etc. to projects supported
by the business through an SRA, and have a
significant financial interest other than royalty
income
You receive research support from a business in
which you serve on the board of directors, or
other advisory board, even if you are not
compensated.
You hold an executive position in a business
engaged in commercial or research activities
directly related to your Ohio University
responsibilities.
Any situation in which an actual conflict
exists is not permitted.
The only “exceptions” are those handled
under Ohio University Policy and Procedure
19.059 where faculty entrepreneurship is
addressed.
Participation in clinical trials or evaluation
of other research in which you have a
significant financial interest other than
royalty income.
In the context of your position at Ohio
University, you make professional referrals
to a business in which you have a
significant financial interest.
Letter of admonition
Ineligibility to submit grant applications
Withholding of IRB or IACUC approvals
Suspension
Non-Renewal
Loss of Tenure
Consulting
Procurement
Mentoring
Clinical Studies
Avoid consulting relationships that have
the potential to divert time and effort from
your responsibilities to Ohio University.
Do not use students.
Be wary of situations that limit publication.
Do not use university stationary, etc. that
could create an impression the university
is involved with the activities.
Make sure you are devoting sufficient time
to your university obligations.
Be cautious that the potential financial gain
cannot be perceived to influence your
university mentoring relationships.
Disclose any personal or familial financial
interest or equity in a company that is
doing business with Ohio University.
If you make purchases using public funds,
you should not use companies which will
benefit you or your family. If there is no
alternative you must seek and receive
permission prior to purchasing.
Any relationship in which there is a real or
perceived power or influence imbalance has
the potential for conflict. (Faculty:Student)
Isolating these relationships with respect to
areas of personal financial gain is best.
If they cannot be isolated, then safeguards
must be created.
If you have a financial interest, it is best to
isolate yourself from the study.
At a minimum, expect a more intense review
and a robust management plan if you have a
financial interest.
If both the institution and you have financial
interests the clinical study should be
conducted elsewhere.
You have administrative responsibilities on
behalf of Ohio University that is beneficial to
the business in which you have a significant
financial interest
You have administrative responsibilities on
behalf of Ohio University with respect to an
SRA where you have a significant financial
interest
Slide 7
Jo Ellen Sherow
Ohio University
Office of Research Compliance
Researchers’ Financial Disclosures in the
Spotlight
Conflicts of interest, always an emotional topic,
returned to the headlines this week as Sen.
Charles Grassley, a longtime critic of the drug
industry’s potential influence on research,
released new evidence that prominent Harvard
University scientists had failed to disclose much
of their outside income from pharmaceutical
companies over the past eight years.
http://www.insidehighered.com/news/2008/06/12/conflict January 15, 2008
WEDNESDAY, JANUARY 21, 2009
In a review of the literature regarding the relationship between
smokeless tobacco use and cancer, a conflict of interest of one of the
article's authors was initially not disclosed (see: Boffetta P, Hecht S, Gray
N, Gupta P, Straif K. Smokeless tobacco and cancer. Lancet Oncology
2008; 9:667-675). The original article was published in July, 2008. That
article stated: "The authors declare no conflicts of interest." After the
editor of the journal was notified by a researcher with knowledge of a
potential conflict of interest of Dr. Stephen Hecht (one of the study
authors), an erratum was published in September 2008, which noted:
"During the immediate months preceding submission of the review SH
was acting in the capacity of an expert witness for the plaintiff in a
future court case against a smokeless tobacco company. SH declares his
participation in this case in no way influenced his writing or involvement
in the review."
http://tobaccoanalysis.blogspot.com/2009/01/conflict-of-interestnot.html
January 16, 2009 — More than one third of new
drug marketing applications approved by the US
Food and Drug Administration (FDA) were
missing information about potential conflicts of
interest for clinical trial investigators, which
could allow bias to creep into the approvals
process, a government report released this week
has found. The FDA has said that it agrees with
most of the report's findings.
http://www.medscape.com/viewarticle/586980
Do collaborations between biotech companies
and academic centers constitute a conflict of
interest?
Biotechnology industry partnerships with
universities and academic centers have been
fruitful for both. So why is there so much
concern about conflict of interest and is that
concern appropriate?
http://www.redorbit.com/news/health/750100/genetic_engineering_news_p
osts_podcast_on_industrialacademic_collaborations_are_these/index.html
Universities are responsible for use of public
funds and therefore must maintain the public
trust.
Identifying and mitigating situations that may
have the potential for conflict maintains the
integrity of the university.
Maintaining integrity allows the university to
do credible academic research.
To provide information on the purpose of the
conflict of interest requirements.
To provide a basic overview of conflicts of
interest
To introduce the disclosure process and the use
of management plans
To provide information on the need for updates
and annual renewals.
Situations where financial considerations
compromise your professional judgment.
“Actual Conflict of Interest”
◦ Not permitted
Situations where an independent observer
might reasonably question whether your
professional actions or decisions are
determined by considerations of personal
gain. “Perceived Conflict of Interest”
◦ Managed
Potential conflicts may be financial or may be
a conflict of time, effort and/or commitment.
Potential conflicts can occur as a result of
administrative, scientific, academic, fiduciary
or familial situations.
They are situations that can be PERCEIVED to
be conflicting, whether a “real” conflict exists
or not.
Ohio University Policy has a mandatory
disclosure policy if you:
Earn over $10,000 in a twelve month period
from your outside activity OR
Have over 5% equity in the entity
Applies to members of your immediate family
(spouse, domestic partner, dependent
children) as well as yourself.
Anything of monetary value, including but not
limited to:
◦
◦
◦
◦
Salary
Payments for services
Equity interests over 5%
Intellectual property rights
Excludes mutual, pension and other
investments over which you have no control
Outside work during regular academic year
should not exceed equivalent of 1 day per
week.
Consulting work must avoid activities that
involve a conflict of interest with assigned
Ohio University activities and programs
Faculty Handbook, section IV-D
Outside interests cannot interfere with
primary loyalty to Ohio University and your
academic role
Use of university resources must have prior
approval of Chair, Dean and VPR.
Your outside interests should not be in
direct competition with university interests
Full time administrative employees are
expected to devote their full-time
professional loyalty, time and energy to their
position.
You must use non-work hours and no
university resources
Federal Agencies
State Law
University Policies
Many Academic Publications
45 CFR Part 50, Subpart F
“Responsibility of Applicants for Promoting
Objectivity in Research for Which PHS Funding
is Sought”
Authority: 42 U.S.C. 216, 289b-1, 299c-3.
Intent is to assure objectivity by establishing
standards that preclude bias in design, conduct, or
reporting of research
Focuses on financial conflicts of interest
(FCOI)
Regulations apply to investigators, including
sub grantees, contractors, and collaborating
investigators.
Does not apply to applications for support
under Phase I of SBIR and STTR programs
An institutional conflict of interest policy should
require that each investigator disclose to a
responsible representative of the institution all
significant financial interests of the investigator
(including those of the investigator’s spouse and
dependent children) (i) that would reasonably
appear to be affected by the research or
educational activities funded or proposed for
funding by NSF; or (ii) in entities whose financial
interests would reasonably appear to be affected
by such activities.
Chapter 1 (Subchapter A) (Part 54)
Financial Disclosure by Clinical Investigators
The Food and Drug Administration (FDA)
regulations state that investigators that
receive compensation in excess of $25,000
from a corporate sponsor of a trial in which
the investigator is engaged must disclose to
the FDA at the time of filing for a new drug
application.
19.058, Conflict of Interest in Research,
Educational, and Public Service Activities
19.059, Employee Participation in Authorized
Private Companies Commercializing Ohio
University Research
“Conflict of Interest in Research, Educational,
and Public Service Activities”
Most conflict disclosures fall within the
parameters of this policy
States that faculty are primarily responsible
for their academic, research and service
obligations
“Employee Participation in Authorized Private
Companies Commercializing Ohio University
Research”
Applies to “employees, faculty, staff and students,
who create intellectual property owned by the Ohio
University and who desire to hold an equity interest
in a firm, corporation, or other association to which
Ohio University has assigned, licensed or
transferred Ohio University’s interests…”
Consulting
Licensing University Technology
Clinical Studies
Procurement
Mentoring
Institutional
A disclosure is filed specific to the funding
application.
If you have a potential conflict for one
proposal, it does not automatically apply to
all of your proposals.
Research conflicts of interest are usually
disclosed using LEO as you apply for funding
by completing the conflict of interest section
of the electronic transmittal
If you are not using LEO, you can download
the appropriate disclosure form from
www.ohio.edu/research/compliance
“A” is selected if you have no conflicts to
disclose
“B” is selected if you have a potential conflict
to disclose relative to the submission.
(Requires a subsequent paper process)
“C” is selected if you have a current disclosure
on file, but it is not relevant to the proposal
you are submitting
Still uses option A, B or C
Requires that you gather signatures on paper
for all options, however
Generally used for personnel not listed on the
grant proposal or “key personnel”
We have revised the COI forms to word forms
This should be easier to complete than the
previous form
PDF versions are also available
Should be on the compliance web site soon,
but we can e-mail them to you until then
Use this form only if you are unable to use
the LEO transmittal form to assure that no
conflict of interest exists. A form must be
completed for each proposal.
I assure that I have read Ohio University
Policy 19.058, “Conflict of Interest in
Research, Educational, and Public Service
Activities” and declare that I have nothing
that is, or could be perceived to be a conflict
of interest with this proposal.
Use this form to disclose a potential conflict
of interest situation.
A separate disclosure form must be used for
each entity with which you conduct business
Conflict includes any member of your
immediate family (spouse, domestic partner
or children)
Require that you complete an option “B”
disclosure statement in addition to
completing the LEO transmittal form.
Require you to obtain signatures from Center
or Institute (if applicable), Chair and Dean on
the additional disclosure statement!!
The B disclosure form is available at
www.ohio.edu/research/compliance
Use this form only if you are unable to use
the LEO transmittal form. Complete this form
if you have a current conflict of interest
disclosure on file with the Office of Research
Compliance, but that disclosure is not
applicable to this proposal.
*New Option for 2008*
A management plan is developed for some
disclosures to mitigate the potential conflict
Management plans are specific to each
disclosure
May require submission of additional pieces,
such as a student employment plan
Reduce or remove the financial interest creating the
conflict
Place safeguards that mitigate the conflict potential,
such having some decisions made by an independent
entity
Limit participation in portions of the proposed
research likely to create a conflict
Require that the researcher disclose his or her
conflicting financial interests to all collaborators and
any proposed trainees;
Disclose the conflict in publications
Work to remove students from being directly advised
or taught by faculty where a conflict exists
Assure publication rights for student participants
Student Use
Nepotism and Cronyism
Intellectual Property
Use of University Resources
Publication provisions
Use of Human Subjects
Oversight Requirements
Reporting and Annual Reviews
You must submit an annual renewal for your
disclosure
◦ If the potential conflict no longer exists you must
notify us
If significant changes occur during the year
you should submit an update to your
disclosure as they occur
Yes. We encourage employees to disclose
potential conflicts that do not meet the
financial threshold, but may still be
problematic, such as student employment.
This allows you to be transparent with
respect to outside interests.
Allowable situations
Situations that require disclosure but may not
need an extensive management plan
Situations that require disclosure and have
problematic elements that will require
mitigation and/or a management plan
Situations that are not permitted
Receipt of royalties or honoraria for
published scholarly works, seminars,
teaching, etc.
Honoraria for serving as a special reviewer
or work on review panels
Royalties under our intellectual property
policies if no other relationship with entity
Clinical income at OUCOM
You participate in research developed in
whole or part by you, and you or your
family receive royalties from an existing
agreement with the business, but have
no other significant financial interest
You assign students, etc. to research
projects where you are entitled to
receive royalties, but have no other
significant financial interest
You assign students, etc. to projects supported
by the business through an SRA, and have a
significant financial interest other than royalty
income
You receive research support from a business in
which you serve on the board of directors, or
other advisory board, even if you are not
compensated.
You hold an executive position in a business
engaged in commercial or research activities
directly related to your Ohio University
responsibilities.
Any situation in which an actual conflict
exists is not permitted.
The only “exceptions” are those handled
under Ohio University Policy and Procedure
19.059 where faculty entrepreneurship is
addressed.
Participation in clinical trials or evaluation
of other research in which you have a
significant financial interest other than
royalty income.
In the context of your position at Ohio
University, you make professional referrals
to a business in which you have a
significant financial interest.
Letter of admonition
Ineligibility to submit grant applications
Withholding of IRB or IACUC approvals
Suspension
Non-Renewal
Loss of Tenure
Consulting
Procurement
Mentoring
Clinical Studies
Avoid consulting relationships that have
the potential to divert time and effort from
your responsibilities to Ohio University.
Do not use students.
Be wary of situations that limit publication.
Do not use university stationary, etc. that
could create an impression the university
is involved with the activities.
Make sure you are devoting sufficient time
to your university obligations.
Be cautious that the potential financial gain
cannot be perceived to influence your
university mentoring relationships.
Disclose any personal or familial financial
interest or equity in a company that is
doing business with Ohio University.
If you make purchases using public funds,
you should not use companies which will
benefit you or your family. If there is no
alternative you must seek and receive
permission prior to purchasing.
Any relationship in which there is a real or
perceived power or influence imbalance has
the potential for conflict. (Faculty:Student)
Isolating these relationships with respect to
areas of personal financial gain is best.
If they cannot be isolated, then safeguards
must be created.
If you have a financial interest, it is best to
isolate yourself from the study.
At a minimum, expect a more intense review
and a robust management plan if you have a
financial interest.
If both the institution and you have financial
interests the clinical study should be
conducted elsewhere.
You have administrative responsibilities on
behalf of Ohio University that is beneficial to
the business in which you have a significant
financial interest
You have administrative responsibilities on
behalf of Ohio University with respect to an
SRA where you have a significant financial
interest
Slide 8
Jo Ellen Sherow
Ohio University
Office of Research Compliance
Researchers’ Financial Disclosures in the
Spotlight
Conflicts of interest, always an emotional topic,
returned to the headlines this week as Sen.
Charles Grassley, a longtime critic of the drug
industry’s potential influence on research,
released new evidence that prominent Harvard
University scientists had failed to disclose much
of their outside income from pharmaceutical
companies over the past eight years.
http://www.insidehighered.com/news/2008/06/12/conflict January 15, 2008
WEDNESDAY, JANUARY 21, 2009
In a review of the literature regarding the relationship between
smokeless tobacco use and cancer, a conflict of interest of one of the
article's authors was initially not disclosed (see: Boffetta P, Hecht S, Gray
N, Gupta P, Straif K. Smokeless tobacco and cancer. Lancet Oncology
2008; 9:667-675). The original article was published in July, 2008. That
article stated: "The authors declare no conflicts of interest." After the
editor of the journal was notified by a researcher with knowledge of a
potential conflict of interest of Dr. Stephen Hecht (one of the study
authors), an erratum was published in September 2008, which noted:
"During the immediate months preceding submission of the review SH
was acting in the capacity of an expert witness for the plaintiff in a
future court case against a smokeless tobacco company. SH declares his
participation in this case in no way influenced his writing or involvement
in the review."
http://tobaccoanalysis.blogspot.com/2009/01/conflict-of-interestnot.html
January 16, 2009 — More than one third of new
drug marketing applications approved by the US
Food and Drug Administration (FDA) were
missing information about potential conflicts of
interest for clinical trial investigators, which
could allow bias to creep into the approvals
process, a government report released this week
has found. The FDA has said that it agrees with
most of the report's findings.
http://www.medscape.com/viewarticle/586980
Do collaborations between biotech companies
and academic centers constitute a conflict of
interest?
Biotechnology industry partnerships with
universities and academic centers have been
fruitful for both. So why is there so much
concern about conflict of interest and is that
concern appropriate?
http://www.redorbit.com/news/health/750100/genetic_engineering_news_p
osts_podcast_on_industrialacademic_collaborations_are_these/index.html
Universities are responsible for use of public
funds and therefore must maintain the public
trust.
Identifying and mitigating situations that may
have the potential for conflict maintains the
integrity of the university.
Maintaining integrity allows the university to
do credible academic research.
To provide information on the purpose of the
conflict of interest requirements.
To provide a basic overview of conflicts of
interest
To introduce the disclosure process and the use
of management plans
To provide information on the need for updates
and annual renewals.
Situations where financial considerations
compromise your professional judgment.
“Actual Conflict of Interest”
◦ Not permitted
Situations where an independent observer
might reasonably question whether your
professional actions or decisions are
determined by considerations of personal
gain. “Perceived Conflict of Interest”
◦ Managed
Potential conflicts may be financial or may be
a conflict of time, effort and/or commitment.
Potential conflicts can occur as a result of
administrative, scientific, academic, fiduciary
or familial situations.
They are situations that can be PERCEIVED to
be conflicting, whether a “real” conflict exists
or not.
Ohio University Policy has a mandatory
disclosure policy if you:
Earn over $10,000 in a twelve month period
from your outside activity OR
Have over 5% equity in the entity
Applies to members of your immediate family
(spouse, domestic partner, dependent
children) as well as yourself.
Anything of monetary value, including but not
limited to:
◦
◦
◦
◦
Salary
Payments for services
Equity interests over 5%
Intellectual property rights
Excludes mutual, pension and other
investments over which you have no control
Outside work during regular academic year
should not exceed equivalent of 1 day per
week.
Consulting work must avoid activities that
involve a conflict of interest with assigned
Ohio University activities and programs
Faculty Handbook, section IV-D
Outside interests cannot interfere with
primary loyalty to Ohio University and your
academic role
Use of university resources must have prior
approval of Chair, Dean and VPR.
Your outside interests should not be in
direct competition with university interests
Full time administrative employees are
expected to devote their full-time
professional loyalty, time and energy to their
position.
You must use non-work hours and no
university resources
Federal Agencies
State Law
University Policies
Many Academic Publications
45 CFR Part 50, Subpart F
“Responsibility of Applicants for Promoting
Objectivity in Research for Which PHS Funding
is Sought”
Authority: 42 U.S.C. 216, 289b-1, 299c-3.
Intent is to assure objectivity by establishing
standards that preclude bias in design, conduct, or
reporting of research
Focuses on financial conflicts of interest
(FCOI)
Regulations apply to investigators, including
sub grantees, contractors, and collaborating
investigators.
Does not apply to applications for support
under Phase I of SBIR and STTR programs
An institutional conflict of interest policy should
require that each investigator disclose to a
responsible representative of the institution all
significant financial interests of the investigator
(including those of the investigator’s spouse and
dependent children) (i) that would reasonably
appear to be affected by the research or
educational activities funded or proposed for
funding by NSF; or (ii) in entities whose financial
interests would reasonably appear to be affected
by such activities.
Chapter 1 (Subchapter A) (Part 54)
Financial Disclosure by Clinical Investigators
The Food and Drug Administration (FDA)
regulations state that investigators that
receive compensation in excess of $25,000
from a corporate sponsor of a trial in which
the investigator is engaged must disclose to
the FDA at the time of filing for a new drug
application.
19.058, Conflict of Interest in Research,
Educational, and Public Service Activities
19.059, Employee Participation in Authorized
Private Companies Commercializing Ohio
University Research
“Conflict of Interest in Research, Educational,
and Public Service Activities”
Most conflict disclosures fall within the
parameters of this policy
States that faculty are primarily responsible
for their academic, research and service
obligations
“Employee Participation in Authorized Private
Companies Commercializing Ohio University
Research”
Applies to “employees, faculty, staff and students,
who create intellectual property owned by the Ohio
University and who desire to hold an equity interest
in a firm, corporation, or other association to which
Ohio University has assigned, licensed or
transferred Ohio University’s interests…”
Consulting
Licensing University Technology
Clinical Studies
Procurement
Mentoring
Institutional
A disclosure is filed specific to the funding
application.
If you have a potential conflict for one
proposal, it does not automatically apply to
all of your proposals.
Research conflicts of interest are usually
disclosed using LEO as you apply for funding
by completing the conflict of interest section
of the electronic transmittal
If you are not using LEO, you can download
the appropriate disclosure form from
www.ohio.edu/research/compliance
“A” is selected if you have no conflicts to
disclose
“B” is selected if you have a potential conflict
to disclose relative to the submission.
(Requires a subsequent paper process)
“C” is selected if you have a current disclosure
on file, but it is not relevant to the proposal
you are submitting
Still uses option A, B or C
Requires that you gather signatures on paper
for all options, however
Generally used for personnel not listed on the
grant proposal or “key personnel”
We have revised the COI forms to word forms
This should be easier to complete than the
previous form
PDF versions are also available
Should be on the compliance web site soon,
but we can e-mail them to you until then
Use this form only if you are unable to use
the LEO transmittal form to assure that no
conflict of interest exists. A form must be
completed for each proposal.
I assure that I have read Ohio University
Policy 19.058, “Conflict of Interest in
Research, Educational, and Public Service
Activities” and declare that I have nothing
that is, or could be perceived to be a conflict
of interest with this proposal.
Use this form to disclose a potential conflict
of interest situation.
A separate disclosure form must be used for
each entity with which you conduct business
Conflict includes any member of your
immediate family (spouse, domestic partner
or children)
Require that you complete an option “B”
disclosure statement in addition to
completing the LEO transmittal form.
Require you to obtain signatures from Center
or Institute (if applicable), Chair and Dean on
the additional disclosure statement!!
The B disclosure form is available at
www.ohio.edu/research/compliance
Use this form only if you are unable to use
the LEO transmittal form. Complete this form
if you have a current conflict of interest
disclosure on file with the Office of Research
Compliance, but that disclosure is not
applicable to this proposal.
*New Option for 2008*
A management plan is developed for some
disclosures to mitigate the potential conflict
Management plans are specific to each
disclosure
May require submission of additional pieces,
such as a student employment plan
Reduce or remove the financial interest creating the
conflict
Place safeguards that mitigate the conflict potential,
such having some decisions made by an independent
entity
Limit participation in portions of the proposed
research likely to create a conflict
Require that the researcher disclose his or her
conflicting financial interests to all collaborators and
any proposed trainees;
Disclose the conflict in publications
Work to remove students from being directly advised
or taught by faculty where a conflict exists
Assure publication rights for student participants
Student Use
Nepotism and Cronyism
Intellectual Property
Use of University Resources
Publication provisions
Use of Human Subjects
Oversight Requirements
Reporting and Annual Reviews
You must submit an annual renewal for your
disclosure
◦ If the potential conflict no longer exists you must
notify us
If significant changes occur during the year
you should submit an update to your
disclosure as they occur
Yes. We encourage employees to disclose
potential conflicts that do not meet the
financial threshold, but may still be
problematic, such as student employment.
This allows you to be transparent with
respect to outside interests.
Allowable situations
Situations that require disclosure but may not
need an extensive management plan
Situations that require disclosure and have
problematic elements that will require
mitigation and/or a management plan
Situations that are not permitted
Receipt of royalties or honoraria for
published scholarly works, seminars,
teaching, etc.
Honoraria for serving as a special reviewer
or work on review panels
Royalties under our intellectual property
policies if no other relationship with entity
Clinical income at OUCOM
You participate in research developed in
whole or part by you, and you or your
family receive royalties from an existing
agreement with the business, but have
no other significant financial interest
You assign students, etc. to research
projects where you are entitled to
receive royalties, but have no other
significant financial interest
You assign students, etc. to projects supported
by the business through an SRA, and have a
significant financial interest other than royalty
income
You receive research support from a business in
which you serve on the board of directors, or
other advisory board, even if you are not
compensated.
You hold an executive position in a business
engaged in commercial or research activities
directly related to your Ohio University
responsibilities.
Any situation in which an actual conflict
exists is not permitted.
The only “exceptions” are those handled
under Ohio University Policy and Procedure
19.059 where faculty entrepreneurship is
addressed.
Participation in clinical trials or evaluation
of other research in which you have a
significant financial interest other than
royalty income.
In the context of your position at Ohio
University, you make professional referrals
to a business in which you have a
significant financial interest.
Letter of admonition
Ineligibility to submit grant applications
Withholding of IRB or IACUC approvals
Suspension
Non-Renewal
Loss of Tenure
Consulting
Procurement
Mentoring
Clinical Studies
Avoid consulting relationships that have
the potential to divert time and effort from
your responsibilities to Ohio University.
Do not use students.
Be wary of situations that limit publication.
Do not use university stationary, etc. that
could create an impression the university
is involved with the activities.
Make sure you are devoting sufficient time
to your university obligations.
Be cautious that the potential financial gain
cannot be perceived to influence your
university mentoring relationships.
Disclose any personal or familial financial
interest or equity in a company that is
doing business with Ohio University.
If you make purchases using public funds,
you should not use companies which will
benefit you or your family. If there is no
alternative you must seek and receive
permission prior to purchasing.
Any relationship in which there is a real or
perceived power or influence imbalance has
the potential for conflict. (Faculty:Student)
Isolating these relationships with respect to
areas of personal financial gain is best.
If they cannot be isolated, then safeguards
must be created.
If you have a financial interest, it is best to
isolate yourself from the study.
At a minimum, expect a more intense review
and a robust management plan if you have a
financial interest.
If both the institution and you have financial
interests the clinical study should be
conducted elsewhere.
You have administrative responsibilities on
behalf of Ohio University that is beneficial to
the business in which you have a significant
financial interest
You have administrative responsibilities on
behalf of Ohio University with respect to an
SRA where you have a significant financial
interest
Slide 9
Jo Ellen Sherow
Ohio University
Office of Research Compliance
Researchers’ Financial Disclosures in the
Spotlight
Conflicts of interest, always an emotional topic,
returned to the headlines this week as Sen.
Charles Grassley, a longtime critic of the drug
industry’s potential influence on research,
released new evidence that prominent Harvard
University scientists had failed to disclose much
of their outside income from pharmaceutical
companies over the past eight years.
http://www.insidehighered.com/news/2008/06/12/conflict January 15, 2008
WEDNESDAY, JANUARY 21, 2009
In a review of the literature regarding the relationship between
smokeless tobacco use and cancer, a conflict of interest of one of the
article's authors was initially not disclosed (see: Boffetta P, Hecht S, Gray
N, Gupta P, Straif K. Smokeless tobacco and cancer. Lancet Oncology
2008; 9:667-675). The original article was published in July, 2008. That
article stated: "The authors declare no conflicts of interest." After the
editor of the journal was notified by a researcher with knowledge of a
potential conflict of interest of Dr. Stephen Hecht (one of the study
authors), an erratum was published in September 2008, which noted:
"During the immediate months preceding submission of the review SH
was acting in the capacity of an expert witness for the plaintiff in a
future court case against a smokeless tobacco company. SH declares his
participation in this case in no way influenced his writing or involvement
in the review."
http://tobaccoanalysis.blogspot.com/2009/01/conflict-of-interestnot.html
January 16, 2009 — More than one third of new
drug marketing applications approved by the US
Food and Drug Administration (FDA) were
missing information about potential conflicts of
interest for clinical trial investigators, which
could allow bias to creep into the approvals
process, a government report released this week
has found. The FDA has said that it agrees with
most of the report's findings.
http://www.medscape.com/viewarticle/586980
Do collaborations between biotech companies
and academic centers constitute a conflict of
interest?
Biotechnology industry partnerships with
universities and academic centers have been
fruitful for both. So why is there so much
concern about conflict of interest and is that
concern appropriate?
http://www.redorbit.com/news/health/750100/genetic_engineering_news_p
osts_podcast_on_industrialacademic_collaborations_are_these/index.html
Universities are responsible for use of public
funds and therefore must maintain the public
trust.
Identifying and mitigating situations that may
have the potential for conflict maintains the
integrity of the university.
Maintaining integrity allows the university to
do credible academic research.
To provide information on the purpose of the
conflict of interest requirements.
To provide a basic overview of conflicts of
interest
To introduce the disclosure process and the use
of management plans
To provide information on the need for updates
and annual renewals.
Situations where financial considerations
compromise your professional judgment.
“Actual Conflict of Interest”
◦ Not permitted
Situations where an independent observer
might reasonably question whether your
professional actions or decisions are
determined by considerations of personal
gain. “Perceived Conflict of Interest”
◦ Managed
Potential conflicts may be financial or may be
a conflict of time, effort and/or commitment.
Potential conflicts can occur as a result of
administrative, scientific, academic, fiduciary
or familial situations.
They are situations that can be PERCEIVED to
be conflicting, whether a “real” conflict exists
or not.
Ohio University Policy has a mandatory
disclosure policy if you:
Earn over $10,000 in a twelve month period
from your outside activity OR
Have over 5% equity in the entity
Applies to members of your immediate family
(spouse, domestic partner, dependent
children) as well as yourself.
Anything of monetary value, including but not
limited to:
◦
◦
◦
◦
Salary
Payments for services
Equity interests over 5%
Intellectual property rights
Excludes mutual, pension and other
investments over which you have no control
Outside work during regular academic year
should not exceed equivalent of 1 day per
week.
Consulting work must avoid activities that
involve a conflict of interest with assigned
Ohio University activities and programs
Faculty Handbook, section IV-D
Outside interests cannot interfere with
primary loyalty to Ohio University and your
academic role
Use of university resources must have prior
approval of Chair, Dean and VPR.
Your outside interests should not be in
direct competition with university interests
Full time administrative employees are
expected to devote their full-time
professional loyalty, time and energy to their
position.
You must use non-work hours and no
university resources
Federal Agencies
State Law
University Policies
Many Academic Publications
45 CFR Part 50, Subpart F
“Responsibility of Applicants for Promoting
Objectivity in Research for Which PHS Funding
is Sought”
Authority: 42 U.S.C. 216, 289b-1, 299c-3.
Intent is to assure objectivity by establishing
standards that preclude bias in design, conduct, or
reporting of research
Focuses on financial conflicts of interest
(FCOI)
Regulations apply to investigators, including
sub grantees, contractors, and collaborating
investigators.
Does not apply to applications for support
under Phase I of SBIR and STTR programs
An institutional conflict of interest policy should
require that each investigator disclose to a
responsible representative of the institution all
significant financial interests of the investigator
(including those of the investigator’s spouse and
dependent children) (i) that would reasonably
appear to be affected by the research or
educational activities funded or proposed for
funding by NSF; or (ii) in entities whose financial
interests would reasonably appear to be affected
by such activities.
Chapter 1 (Subchapter A) (Part 54)
Financial Disclosure by Clinical Investigators
The Food and Drug Administration (FDA)
regulations state that investigators that
receive compensation in excess of $25,000
from a corporate sponsor of a trial in which
the investigator is engaged must disclose to
the FDA at the time of filing for a new drug
application.
19.058, Conflict of Interest in Research,
Educational, and Public Service Activities
19.059, Employee Participation in Authorized
Private Companies Commercializing Ohio
University Research
“Conflict of Interest in Research, Educational,
and Public Service Activities”
Most conflict disclosures fall within the
parameters of this policy
States that faculty are primarily responsible
for their academic, research and service
obligations
“Employee Participation in Authorized Private
Companies Commercializing Ohio University
Research”
Applies to “employees, faculty, staff and students,
who create intellectual property owned by the Ohio
University and who desire to hold an equity interest
in a firm, corporation, or other association to which
Ohio University has assigned, licensed or
transferred Ohio University’s interests…”
Consulting
Licensing University Technology
Clinical Studies
Procurement
Mentoring
Institutional
A disclosure is filed specific to the funding
application.
If you have a potential conflict for one
proposal, it does not automatically apply to
all of your proposals.
Research conflicts of interest are usually
disclosed using LEO as you apply for funding
by completing the conflict of interest section
of the electronic transmittal
If you are not using LEO, you can download
the appropriate disclosure form from
www.ohio.edu/research/compliance
“A” is selected if you have no conflicts to
disclose
“B” is selected if you have a potential conflict
to disclose relative to the submission.
(Requires a subsequent paper process)
“C” is selected if you have a current disclosure
on file, but it is not relevant to the proposal
you are submitting
Still uses option A, B or C
Requires that you gather signatures on paper
for all options, however
Generally used for personnel not listed on the
grant proposal or “key personnel”
We have revised the COI forms to word forms
This should be easier to complete than the
previous form
PDF versions are also available
Should be on the compliance web site soon,
but we can e-mail them to you until then
Use this form only if you are unable to use
the LEO transmittal form to assure that no
conflict of interest exists. A form must be
completed for each proposal.
I assure that I have read Ohio University
Policy 19.058, “Conflict of Interest in
Research, Educational, and Public Service
Activities” and declare that I have nothing
that is, or could be perceived to be a conflict
of interest with this proposal.
Use this form to disclose a potential conflict
of interest situation.
A separate disclosure form must be used for
each entity with which you conduct business
Conflict includes any member of your
immediate family (spouse, domestic partner
or children)
Require that you complete an option “B”
disclosure statement in addition to
completing the LEO transmittal form.
Require you to obtain signatures from Center
or Institute (if applicable), Chair and Dean on
the additional disclosure statement!!
The B disclosure form is available at
www.ohio.edu/research/compliance
Use this form only if you are unable to use
the LEO transmittal form. Complete this form
if you have a current conflict of interest
disclosure on file with the Office of Research
Compliance, but that disclosure is not
applicable to this proposal.
*New Option for 2008*
A management plan is developed for some
disclosures to mitigate the potential conflict
Management plans are specific to each
disclosure
May require submission of additional pieces,
such as a student employment plan
Reduce or remove the financial interest creating the
conflict
Place safeguards that mitigate the conflict potential,
such having some decisions made by an independent
entity
Limit participation in portions of the proposed
research likely to create a conflict
Require that the researcher disclose his or her
conflicting financial interests to all collaborators and
any proposed trainees;
Disclose the conflict in publications
Work to remove students from being directly advised
or taught by faculty where a conflict exists
Assure publication rights for student participants
Student Use
Nepotism and Cronyism
Intellectual Property
Use of University Resources
Publication provisions
Use of Human Subjects
Oversight Requirements
Reporting and Annual Reviews
You must submit an annual renewal for your
disclosure
◦ If the potential conflict no longer exists you must
notify us
If significant changes occur during the year
you should submit an update to your
disclosure as they occur
Yes. We encourage employees to disclose
potential conflicts that do not meet the
financial threshold, but may still be
problematic, such as student employment.
This allows you to be transparent with
respect to outside interests.
Allowable situations
Situations that require disclosure but may not
need an extensive management plan
Situations that require disclosure and have
problematic elements that will require
mitigation and/or a management plan
Situations that are not permitted
Receipt of royalties or honoraria for
published scholarly works, seminars,
teaching, etc.
Honoraria for serving as a special reviewer
or work on review panels
Royalties under our intellectual property
policies if no other relationship with entity
Clinical income at OUCOM
You participate in research developed in
whole or part by you, and you or your
family receive royalties from an existing
agreement with the business, but have
no other significant financial interest
You assign students, etc. to research
projects where you are entitled to
receive royalties, but have no other
significant financial interest
You assign students, etc. to projects supported
by the business through an SRA, and have a
significant financial interest other than royalty
income
You receive research support from a business in
which you serve on the board of directors, or
other advisory board, even if you are not
compensated.
You hold an executive position in a business
engaged in commercial or research activities
directly related to your Ohio University
responsibilities.
Any situation in which an actual conflict
exists is not permitted.
The only “exceptions” are those handled
under Ohio University Policy and Procedure
19.059 where faculty entrepreneurship is
addressed.
Participation in clinical trials or evaluation
of other research in which you have a
significant financial interest other than
royalty income.
In the context of your position at Ohio
University, you make professional referrals
to a business in which you have a
significant financial interest.
Letter of admonition
Ineligibility to submit grant applications
Withholding of IRB or IACUC approvals
Suspension
Non-Renewal
Loss of Tenure
Consulting
Procurement
Mentoring
Clinical Studies
Avoid consulting relationships that have
the potential to divert time and effort from
your responsibilities to Ohio University.
Do not use students.
Be wary of situations that limit publication.
Do not use university stationary, etc. that
could create an impression the university
is involved with the activities.
Make sure you are devoting sufficient time
to your university obligations.
Be cautious that the potential financial gain
cannot be perceived to influence your
university mentoring relationships.
Disclose any personal or familial financial
interest or equity in a company that is
doing business with Ohio University.
If you make purchases using public funds,
you should not use companies which will
benefit you or your family. If there is no
alternative you must seek and receive
permission prior to purchasing.
Any relationship in which there is a real or
perceived power or influence imbalance has
the potential for conflict. (Faculty:Student)
Isolating these relationships with respect to
areas of personal financial gain is best.
If they cannot be isolated, then safeguards
must be created.
If you have a financial interest, it is best to
isolate yourself from the study.
At a minimum, expect a more intense review
and a robust management plan if you have a
financial interest.
If both the institution and you have financial
interests the clinical study should be
conducted elsewhere.
You have administrative responsibilities on
behalf of Ohio University that is beneficial to
the business in which you have a significant
financial interest
You have administrative responsibilities on
behalf of Ohio University with respect to an
SRA where you have a significant financial
interest
Slide 10
Jo Ellen Sherow
Ohio University
Office of Research Compliance
Researchers’ Financial Disclosures in the
Spotlight
Conflicts of interest, always an emotional topic,
returned to the headlines this week as Sen.
Charles Grassley, a longtime critic of the drug
industry’s potential influence on research,
released new evidence that prominent Harvard
University scientists had failed to disclose much
of their outside income from pharmaceutical
companies over the past eight years.
http://www.insidehighered.com/news/2008/06/12/conflict January 15, 2008
WEDNESDAY, JANUARY 21, 2009
In a review of the literature regarding the relationship between
smokeless tobacco use and cancer, a conflict of interest of one of the
article's authors was initially not disclosed (see: Boffetta P, Hecht S, Gray
N, Gupta P, Straif K. Smokeless tobacco and cancer. Lancet Oncology
2008; 9:667-675). The original article was published in July, 2008. That
article stated: "The authors declare no conflicts of interest." After the
editor of the journal was notified by a researcher with knowledge of a
potential conflict of interest of Dr. Stephen Hecht (one of the study
authors), an erratum was published in September 2008, which noted:
"During the immediate months preceding submission of the review SH
was acting in the capacity of an expert witness for the plaintiff in a
future court case against a smokeless tobacco company. SH declares his
participation in this case in no way influenced his writing or involvement
in the review."
http://tobaccoanalysis.blogspot.com/2009/01/conflict-of-interestnot.html
January 16, 2009 — More than one third of new
drug marketing applications approved by the US
Food and Drug Administration (FDA) were
missing information about potential conflicts of
interest for clinical trial investigators, which
could allow bias to creep into the approvals
process, a government report released this week
has found. The FDA has said that it agrees with
most of the report's findings.
http://www.medscape.com/viewarticle/586980
Do collaborations between biotech companies
and academic centers constitute a conflict of
interest?
Biotechnology industry partnerships with
universities and academic centers have been
fruitful for both. So why is there so much
concern about conflict of interest and is that
concern appropriate?
http://www.redorbit.com/news/health/750100/genetic_engineering_news_p
osts_podcast_on_industrialacademic_collaborations_are_these/index.html
Universities are responsible for use of public
funds and therefore must maintain the public
trust.
Identifying and mitigating situations that may
have the potential for conflict maintains the
integrity of the university.
Maintaining integrity allows the university to
do credible academic research.
To provide information on the purpose of the
conflict of interest requirements.
To provide a basic overview of conflicts of
interest
To introduce the disclosure process and the use
of management plans
To provide information on the need for updates
and annual renewals.
Situations where financial considerations
compromise your professional judgment.
“Actual Conflict of Interest”
◦ Not permitted
Situations where an independent observer
might reasonably question whether your
professional actions or decisions are
determined by considerations of personal
gain. “Perceived Conflict of Interest”
◦ Managed
Potential conflicts may be financial or may be
a conflict of time, effort and/or commitment.
Potential conflicts can occur as a result of
administrative, scientific, academic, fiduciary
or familial situations.
They are situations that can be PERCEIVED to
be conflicting, whether a “real” conflict exists
or not.
Ohio University Policy has a mandatory
disclosure policy if you:
Earn over $10,000 in a twelve month period
from your outside activity OR
Have over 5% equity in the entity
Applies to members of your immediate family
(spouse, domestic partner, dependent
children) as well as yourself.
Anything of monetary value, including but not
limited to:
◦
◦
◦
◦
Salary
Payments for services
Equity interests over 5%
Intellectual property rights
Excludes mutual, pension and other
investments over which you have no control
Outside work during regular academic year
should not exceed equivalent of 1 day per
week.
Consulting work must avoid activities that
involve a conflict of interest with assigned
Ohio University activities and programs
Faculty Handbook, section IV-D
Outside interests cannot interfere with
primary loyalty to Ohio University and your
academic role
Use of university resources must have prior
approval of Chair, Dean and VPR.
Your outside interests should not be in
direct competition with university interests
Full time administrative employees are
expected to devote their full-time
professional loyalty, time and energy to their
position.
You must use non-work hours and no
university resources
Federal Agencies
State Law
University Policies
Many Academic Publications
45 CFR Part 50, Subpart F
“Responsibility of Applicants for Promoting
Objectivity in Research for Which PHS Funding
is Sought”
Authority: 42 U.S.C. 216, 289b-1, 299c-3.
Intent is to assure objectivity by establishing
standards that preclude bias in design, conduct, or
reporting of research
Focuses on financial conflicts of interest
(FCOI)
Regulations apply to investigators, including
sub grantees, contractors, and collaborating
investigators.
Does not apply to applications for support
under Phase I of SBIR and STTR programs
An institutional conflict of interest policy should
require that each investigator disclose to a
responsible representative of the institution all
significant financial interests of the investigator
(including those of the investigator’s spouse and
dependent children) (i) that would reasonably
appear to be affected by the research or
educational activities funded or proposed for
funding by NSF; or (ii) in entities whose financial
interests would reasonably appear to be affected
by such activities.
Chapter 1 (Subchapter A) (Part 54)
Financial Disclosure by Clinical Investigators
The Food and Drug Administration (FDA)
regulations state that investigators that
receive compensation in excess of $25,000
from a corporate sponsor of a trial in which
the investigator is engaged must disclose to
the FDA at the time of filing for a new drug
application.
19.058, Conflict of Interest in Research,
Educational, and Public Service Activities
19.059, Employee Participation in Authorized
Private Companies Commercializing Ohio
University Research
“Conflict of Interest in Research, Educational,
and Public Service Activities”
Most conflict disclosures fall within the
parameters of this policy
States that faculty are primarily responsible
for their academic, research and service
obligations
“Employee Participation in Authorized Private
Companies Commercializing Ohio University
Research”
Applies to “employees, faculty, staff and students,
who create intellectual property owned by the Ohio
University and who desire to hold an equity interest
in a firm, corporation, or other association to which
Ohio University has assigned, licensed or
transferred Ohio University’s interests…”
Consulting
Licensing University Technology
Clinical Studies
Procurement
Mentoring
Institutional
A disclosure is filed specific to the funding
application.
If you have a potential conflict for one
proposal, it does not automatically apply to
all of your proposals.
Research conflicts of interest are usually
disclosed using LEO as you apply for funding
by completing the conflict of interest section
of the electronic transmittal
If you are not using LEO, you can download
the appropriate disclosure form from
www.ohio.edu/research/compliance
“A” is selected if you have no conflicts to
disclose
“B” is selected if you have a potential conflict
to disclose relative to the submission.
(Requires a subsequent paper process)
“C” is selected if you have a current disclosure
on file, but it is not relevant to the proposal
you are submitting
Still uses option A, B or C
Requires that you gather signatures on paper
for all options, however
Generally used for personnel not listed on the
grant proposal or “key personnel”
We have revised the COI forms to word forms
This should be easier to complete than the
previous form
PDF versions are also available
Should be on the compliance web site soon,
but we can e-mail them to you until then
Use this form only if you are unable to use
the LEO transmittal form to assure that no
conflict of interest exists. A form must be
completed for each proposal.
I assure that I have read Ohio University
Policy 19.058, “Conflict of Interest in
Research, Educational, and Public Service
Activities” and declare that I have nothing
that is, or could be perceived to be a conflict
of interest with this proposal.
Use this form to disclose a potential conflict
of interest situation.
A separate disclosure form must be used for
each entity with which you conduct business
Conflict includes any member of your
immediate family (spouse, domestic partner
or children)
Require that you complete an option “B”
disclosure statement in addition to
completing the LEO transmittal form.
Require you to obtain signatures from Center
or Institute (if applicable), Chair and Dean on
the additional disclosure statement!!
The B disclosure form is available at
www.ohio.edu/research/compliance
Use this form only if you are unable to use
the LEO transmittal form. Complete this form
if you have a current conflict of interest
disclosure on file with the Office of Research
Compliance, but that disclosure is not
applicable to this proposal.
*New Option for 2008*
A management plan is developed for some
disclosures to mitigate the potential conflict
Management plans are specific to each
disclosure
May require submission of additional pieces,
such as a student employment plan
Reduce or remove the financial interest creating the
conflict
Place safeguards that mitigate the conflict potential,
such having some decisions made by an independent
entity
Limit participation in portions of the proposed
research likely to create a conflict
Require that the researcher disclose his or her
conflicting financial interests to all collaborators and
any proposed trainees;
Disclose the conflict in publications
Work to remove students from being directly advised
or taught by faculty where a conflict exists
Assure publication rights for student participants
Student Use
Nepotism and Cronyism
Intellectual Property
Use of University Resources
Publication provisions
Use of Human Subjects
Oversight Requirements
Reporting and Annual Reviews
You must submit an annual renewal for your
disclosure
◦ If the potential conflict no longer exists you must
notify us
If significant changes occur during the year
you should submit an update to your
disclosure as they occur
Yes. We encourage employees to disclose
potential conflicts that do not meet the
financial threshold, but may still be
problematic, such as student employment.
This allows you to be transparent with
respect to outside interests.
Allowable situations
Situations that require disclosure but may not
need an extensive management plan
Situations that require disclosure and have
problematic elements that will require
mitigation and/or a management plan
Situations that are not permitted
Receipt of royalties or honoraria for
published scholarly works, seminars,
teaching, etc.
Honoraria for serving as a special reviewer
or work on review panels
Royalties under our intellectual property
policies if no other relationship with entity
Clinical income at OUCOM
You participate in research developed in
whole or part by you, and you or your
family receive royalties from an existing
agreement with the business, but have
no other significant financial interest
You assign students, etc. to research
projects where you are entitled to
receive royalties, but have no other
significant financial interest
You assign students, etc. to projects supported
by the business through an SRA, and have a
significant financial interest other than royalty
income
You receive research support from a business in
which you serve on the board of directors, or
other advisory board, even if you are not
compensated.
You hold an executive position in a business
engaged in commercial or research activities
directly related to your Ohio University
responsibilities.
Any situation in which an actual conflict
exists is not permitted.
The only “exceptions” are those handled
under Ohio University Policy and Procedure
19.059 where faculty entrepreneurship is
addressed.
Participation in clinical trials or evaluation
of other research in which you have a
significant financial interest other than
royalty income.
In the context of your position at Ohio
University, you make professional referrals
to a business in which you have a
significant financial interest.
Letter of admonition
Ineligibility to submit grant applications
Withholding of IRB or IACUC approvals
Suspension
Non-Renewal
Loss of Tenure
Consulting
Procurement
Mentoring
Clinical Studies
Avoid consulting relationships that have
the potential to divert time and effort from
your responsibilities to Ohio University.
Do not use students.
Be wary of situations that limit publication.
Do not use university stationary, etc. that
could create an impression the university
is involved with the activities.
Make sure you are devoting sufficient time
to your university obligations.
Be cautious that the potential financial gain
cannot be perceived to influence your
university mentoring relationships.
Disclose any personal or familial financial
interest or equity in a company that is
doing business with Ohio University.
If you make purchases using public funds,
you should not use companies which will
benefit you or your family. If there is no
alternative you must seek and receive
permission prior to purchasing.
Any relationship in which there is a real or
perceived power or influence imbalance has
the potential for conflict. (Faculty:Student)
Isolating these relationships with respect to
areas of personal financial gain is best.
If they cannot be isolated, then safeguards
must be created.
If you have a financial interest, it is best to
isolate yourself from the study.
At a minimum, expect a more intense review
and a robust management plan if you have a
financial interest.
If both the institution and you have financial
interests the clinical study should be
conducted elsewhere.
You have administrative responsibilities on
behalf of Ohio University that is beneficial to
the business in which you have a significant
financial interest
You have administrative responsibilities on
behalf of Ohio University with respect to an
SRA where you have a significant financial
interest
Slide 11
Jo Ellen Sherow
Ohio University
Office of Research Compliance
Researchers’ Financial Disclosures in the
Spotlight
Conflicts of interest, always an emotional topic,
returned to the headlines this week as Sen.
Charles Grassley, a longtime critic of the drug
industry’s potential influence on research,
released new evidence that prominent Harvard
University scientists had failed to disclose much
of their outside income from pharmaceutical
companies over the past eight years.
http://www.insidehighered.com/news/2008/06/12/conflict January 15, 2008
WEDNESDAY, JANUARY 21, 2009
In a review of the literature regarding the relationship between
smokeless tobacco use and cancer, a conflict of interest of one of the
article's authors was initially not disclosed (see: Boffetta P, Hecht S, Gray
N, Gupta P, Straif K. Smokeless tobacco and cancer. Lancet Oncology
2008; 9:667-675). The original article was published in July, 2008. That
article stated: "The authors declare no conflicts of interest." After the
editor of the journal was notified by a researcher with knowledge of a
potential conflict of interest of Dr. Stephen Hecht (one of the study
authors), an erratum was published in September 2008, which noted:
"During the immediate months preceding submission of the review SH
was acting in the capacity of an expert witness for the plaintiff in a
future court case against a smokeless tobacco company. SH declares his
participation in this case in no way influenced his writing or involvement
in the review."
http://tobaccoanalysis.blogspot.com/2009/01/conflict-of-interestnot.html
January 16, 2009 — More than one third of new
drug marketing applications approved by the US
Food and Drug Administration (FDA) were
missing information about potential conflicts of
interest for clinical trial investigators, which
could allow bias to creep into the approvals
process, a government report released this week
has found. The FDA has said that it agrees with
most of the report's findings.
http://www.medscape.com/viewarticle/586980
Do collaborations between biotech companies
and academic centers constitute a conflict of
interest?
Biotechnology industry partnerships with
universities and academic centers have been
fruitful for both. So why is there so much
concern about conflict of interest and is that
concern appropriate?
http://www.redorbit.com/news/health/750100/genetic_engineering_news_p
osts_podcast_on_industrialacademic_collaborations_are_these/index.html
Universities are responsible for use of public
funds and therefore must maintain the public
trust.
Identifying and mitigating situations that may
have the potential for conflict maintains the
integrity of the university.
Maintaining integrity allows the university to
do credible academic research.
To provide information on the purpose of the
conflict of interest requirements.
To provide a basic overview of conflicts of
interest
To introduce the disclosure process and the use
of management plans
To provide information on the need for updates
and annual renewals.
Situations where financial considerations
compromise your professional judgment.
“Actual Conflict of Interest”
◦ Not permitted
Situations where an independent observer
might reasonably question whether your
professional actions or decisions are
determined by considerations of personal
gain. “Perceived Conflict of Interest”
◦ Managed
Potential conflicts may be financial or may be
a conflict of time, effort and/or commitment.
Potential conflicts can occur as a result of
administrative, scientific, academic, fiduciary
or familial situations.
They are situations that can be PERCEIVED to
be conflicting, whether a “real” conflict exists
or not.
Ohio University Policy has a mandatory
disclosure policy if you:
Earn over $10,000 in a twelve month period
from your outside activity OR
Have over 5% equity in the entity
Applies to members of your immediate family
(spouse, domestic partner, dependent
children) as well as yourself.
Anything of monetary value, including but not
limited to:
◦
◦
◦
◦
Salary
Payments for services
Equity interests over 5%
Intellectual property rights
Excludes mutual, pension and other
investments over which you have no control
Outside work during regular academic year
should not exceed equivalent of 1 day per
week.
Consulting work must avoid activities that
involve a conflict of interest with assigned
Ohio University activities and programs
Faculty Handbook, section IV-D
Outside interests cannot interfere with
primary loyalty to Ohio University and your
academic role
Use of university resources must have prior
approval of Chair, Dean and VPR.
Your outside interests should not be in
direct competition with university interests
Full time administrative employees are
expected to devote their full-time
professional loyalty, time and energy to their
position.
You must use non-work hours and no
university resources
Federal Agencies
State Law
University Policies
Many Academic Publications
45 CFR Part 50, Subpart F
“Responsibility of Applicants for Promoting
Objectivity in Research for Which PHS Funding
is Sought”
Authority: 42 U.S.C. 216, 289b-1, 299c-3.
Intent is to assure objectivity by establishing
standards that preclude bias in design, conduct, or
reporting of research
Focuses on financial conflicts of interest
(FCOI)
Regulations apply to investigators, including
sub grantees, contractors, and collaborating
investigators.
Does not apply to applications for support
under Phase I of SBIR and STTR programs
An institutional conflict of interest policy should
require that each investigator disclose to a
responsible representative of the institution all
significant financial interests of the investigator
(including those of the investigator’s spouse and
dependent children) (i) that would reasonably
appear to be affected by the research or
educational activities funded or proposed for
funding by NSF; or (ii) in entities whose financial
interests would reasonably appear to be affected
by such activities.
Chapter 1 (Subchapter A) (Part 54)
Financial Disclosure by Clinical Investigators
The Food and Drug Administration (FDA)
regulations state that investigators that
receive compensation in excess of $25,000
from a corporate sponsor of a trial in which
the investigator is engaged must disclose to
the FDA at the time of filing for a new drug
application.
19.058, Conflict of Interest in Research,
Educational, and Public Service Activities
19.059, Employee Participation in Authorized
Private Companies Commercializing Ohio
University Research
“Conflict of Interest in Research, Educational,
and Public Service Activities”
Most conflict disclosures fall within the
parameters of this policy
States that faculty are primarily responsible
for their academic, research and service
obligations
“Employee Participation in Authorized Private
Companies Commercializing Ohio University
Research”
Applies to “employees, faculty, staff and students,
who create intellectual property owned by the Ohio
University and who desire to hold an equity interest
in a firm, corporation, or other association to which
Ohio University has assigned, licensed or
transferred Ohio University’s interests…”
Consulting
Licensing University Technology
Clinical Studies
Procurement
Mentoring
Institutional
A disclosure is filed specific to the funding
application.
If you have a potential conflict for one
proposal, it does not automatically apply to
all of your proposals.
Research conflicts of interest are usually
disclosed using LEO as you apply for funding
by completing the conflict of interest section
of the electronic transmittal
If you are not using LEO, you can download
the appropriate disclosure form from
www.ohio.edu/research/compliance
“A” is selected if you have no conflicts to
disclose
“B” is selected if you have a potential conflict
to disclose relative to the submission.
(Requires a subsequent paper process)
“C” is selected if you have a current disclosure
on file, but it is not relevant to the proposal
you are submitting
Still uses option A, B or C
Requires that you gather signatures on paper
for all options, however
Generally used for personnel not listed on the
grant proposal or “key personnel”
We have revised the COI forms to word forms
This should be easier to complete than the
previous form
PDF versions are also available
Should be on the compliance web site soon,
but we can e-mail them to you until then
Use this form only if you are unable to use
the LEO transmittal form to assure that no
conflict of interest exists. A form must be
completed for each proposal.
I assure that I have read Ohio University
Policy 19.058, “Conflict of Interest in
Research, Educational, and Public Service
Activities” and declare that I have nothing
that is, or could be perceived to be a conflict
of interest with this proposal.
Use this form to disclose a potential conflict
of interest situation.
A separate disclosure form must be used for
each entity with which you conduct business
Conflict includes any member of your
immediate family (spouse, domestic partner
or children)
Require that you complete an option “B”
disclosure statement in addition to
completing the LEO transmittal form.
Require you to obtain signatures from Center
or Institute (if applicable), Chair and Dean on
the additional disclosure statement!!
The B disclosure form is available at
www.ohio.edu/research/compliance
Use this form only if you are unable to use
the LEO transmittal form. Complete this form
if you have a current conflict of interest
disclosure on file with the Office of Research
Compliance, but that disclosure is not
applicable to this proposal.
*New Option for 2008*
A management plan is developed for some
disclosures to mitigate the potential conflict
Management plans are specific to each
disclosure
May require submission of additional pieces,
such as a student employment plan
Reduce or remove the financial interest creating the
conflict
Place safeguards that mitigate the conflict potential,
such having some decisions made by an independent
entity
Limit participation in portions of the proposed
research likely to create a conflict
Require that the researcher disclose his or her
conflicting financial interests to all collaborators and
any proposed trainees;
Disclose the conflict in publications
Work to remove students from being directly advised
or taught by faculty where a conflict exists
Assure publication rights for student participants
Student Use
Nepotism and Cronyism
Intellectual Property
Use of University Resources
Publication provisions
Use of Human Subjects
Oversight Requirements
Reporting and Annual Reviews
You must submit an annual renewal for your
disclosure
◦ If the potential conflict no longer exists you must
notify us
If significant changes occur during the year
you should submit an update to your
disclosure as they occur
Yes. We encourage employees to disclose
potential conflicts that do not meet the
financial threshold, but may still be
problematic, such as student employment.
This allows you to be transparent with
respect to outside interests.
Allowable situations
Situations that require disclosure but may not
need an extensive management plan
Situations that require disclosure and have
problematic elements that will require
mitigation and/or a management plan
Situations that are not permitted
Receipt of royalties or honoraria for
published scholarly works, seminars,
teaching, etc.
Honoraria for serving as a special reviewer
or work on review panels
Royalties under our intellectual property
policies if no other relationship with entity
Clinical income at OUCOM
You participate in research developed in
whole or part by you, and you or your
family receive royalties from an existing
agreement with the business, but have
no other significant financial interest
You assign students, etc. to research
projects where you are entitled to
receive royalties, but have no other
significant financial interest
You assign students, etc. to projects supported
by the business through an SRA, and have a
significant financial interest other than royalty
income
You receive research support from a business in
which you serve on the board of directors, or
other advisory board, even if you are not
compensated.
You hold an executive position in a business
engaged in commercial or research activities
directly related to your Ohio University
responsibilities.
Any situation in which an actual conflict
exists is not permitted.
The only “exceptions” are those handled
under Ohio University Policy and Procedure
19.059 where faculty entrepreneurship is
addressed.
Participation in clinical trials or evaluation
of other research in which you have a
significant financial interest other than
royalty income.
In the context of your position at Ohio
University, you make professional referrals
to a business in which you have a
significant financial interest.
Letter of admonition
Ineligibility to submit grant applications
Withholding of IRB or IACUC approvals
Suspension
Non-Renewal
Loss of Tenure
Consulting
Procurement
Mentoring
Clinical Studies
Avoid consulting relationships that have
the potential to divert time and effort from
your responsibilities to Ohio University.
Do not use students.
Be wary of situations that limit publication.
Do not use university stationary, etc. that
could create an impression the university
is involved with the activities.
Make sure you are devoting sufficient time
to your university obligations.
Be cautious that the potential financial gain
cannot be perceived to influence your
university mentoring relationships.
Disclose any personal or familial financial
interest or equity in a company that is
doing business with Ohio University.
If you make purchases using public funds,
you should not use companies which will
benefit you or your family. If there is no
alternative you must seek and receive
permission prior to purchasing.
Any relationship in which there is a real or
perceived power or influence imbalance has
the potential for conflict. (Faculty:Student)
Isolating these relationships with respect to
areas of personal financial gain is best.
If they cannot be isolated, then safeguards
must be created.
If you have a financial interest, it is best to
isolate yourself from the study.
At a minimum, expect a more intense review
and a robust management plan if you have a
financial interest.
If both the institution and you have financial
interests the clinical study should be
conducted elsewhere.
You have administrative responsibilities on
behalf of Ohio University that is beneficial to
the business in which you have a significant
financial interest
You have administrative responsibilities on
behalf of Ohio University with respect to an
SRA where you have a significant financial
interest
Slide 12
Jo Ellen Sherow
Ohio University
Office of Research Compliance
Researchers’ Financial Disclosures in the
Spotlight
Conflicts of interest, always an emotional topic,
returned to the headlines this week as Sen.
Charles Grassley, a longtime critic of the drug
industry’s potential influence on research,
released new evidence that prominent Harvard
University scientists had failed to disclose much
of their outside income from pharmaceutical
companies over the past eight years.
http://www.insidehighered.com/news/2008/06/12/conflict January 15, 2008
WEDNESDAY, JANUARY 21, 2009
In a review of the literature regarding the relationship between
smokeless tobacco use and cancer, a conflict of interest of one of the
article's authors was initially not disclosed (see: Boffetta P, Hecht S, Gray
N, Gupta P, Straif K. Smokeless tobacco and cancer. Lancet Oncology
2008; 9:667-675). The original article was published in July, 2008. That
article stated: "The authors declare no conflicts of interest." After the
editor of the journal was notified by a researcher with knowledge of a
potential conflict of interest of Dr. Stephen Hecht (one of the study
authors), an erratum was published in September 2008, which noted:
"During the immediate months preceding submission of the review SH
was acting in the capacity of an expert witness for the plaintiff in a
future court case against a smokeless tobacco company. SH declares his
participation in this case in no way influenced his writing or involvement
in the review."
http://tobaccoanalysis.blogspot.com/2009/01/conflict-of-interestnot.html
January 16, 2009 — More than one third of new
drug marketing applications approved by the US
Food and Drug Administration (FDA) were
missing information about potential conflicts of
interest for clinical trial investigators, which
could allow bias to creep into the approvals
process, a government report released this week
has found. The FDA has said that it agrees with
most of the report's findings.
http://www.medscape.com/viewarticle/586980
Do collaborations between biotech companies
and academic centers constitute a conflict of
interest?
Biotechnology industry partnerships with
universities and academic centers have been
fruitful for both. So why is there so much
concern about conflict of interest and is that
concern appropriate?
http://www.redorbit.com/news/health/750100/genetic_engineering_news_p
osts_podcast_on_industrialacademic_collaborations_are_these/index.html
Universities are responsible for use of public
funds and therefore must maintain the public
trust.
Identifying and mitigating situations that may
have the potential for conflict maintains the
integrity of the university.
Maintaining integrity allows the university to
do credible academic research.
To provide information on the purpose of the
conflict of interest requirements.
To provide a basic overview of conflicts of
interest
To introduce the disclosure process and the use
of management plans
To provide information on the need for updates
and annual renewals.
Situations where financial considerations
compromise your professional judgment.
“Actual Conflict of Interest”
◦ Not permitted
Situations where an independent observer
might reasonably question whether your
professional actions or decisions are
determined by considerations of personal
gain. “Perceived Conflict of Interest”
◦ Managed
Potential conflicts may be financial or may be
a conflict of time, effort and/or commitment.
Potential conflicts can occur as a result of
administrative, scientific, academic, fiduciary
or familial situations.
They are situations that can be PERCEIVED to
be conflicting, whether a “real” conflict exists
or not.
Ohio University Policy has a mandatory
disclosure policy if you:
Earn over $10,000 in a twelve month period
from your outside activity OR
Have over 5% equity in the entity
Applies to members of your immediate family
(spouse, domestic partner, dependent
children) as well as yourself.
Anything of monetary value, including but not
limited to:
◦
◦
◦
◦
Salary
Payments for services
Equity interests over 5%
Intellectual property rights
Excludes mutual, pension and other
investments over which you have no control
Outside work during regular academic year
should not exceed equivalent of 1 day per
week.
Consulting work must avoid activities that
involve a conflict of interest with assigned
Ohio University activities and programs
Faculty Handbook, section IV-D
Outside interests cannot interfere with
primary loyalty to Ohio University and your
academic role
Use of university resources must have prior
approval of Chair, Dean and VPR.
Your outside interests should not be in
direct competition with university interests
Full time administrative employees are
expected to devote their full-time
professional loyalty, time and energy to their
position.
You must use non-work hours and no
university resources
Federal Agencies
State Law
University Policies
Many Academic Publications
45 CFR Part 50, Subpart F
“Responsibility of Applicants for Promoting
Objectivity in Research for Which PHS Funding
is Sought”
Authority: 42 U.S.C. 216, 289b-1, 299c-3.
Intent is to assure objectivity by establishing
standards that preclude bias in design, conduct, or
reporting of research
Focuses on financial conflicts of interest
(FCOI)
Regulations apply to investigators, including
sub grantees, contractors, and collaborating
investigators.
Does not apply to applications for support
under Phase I of SBIR and STTR programs
An institutional conflict of interest policy should
require that each investigator disclose to a
responsible representative of the institution all
significant financial interests of the investigator
(including those of the investigator’s spouse and
dependent children) (i) that would reasonably
appear to be affected by the research or
educational activities funded or proposed for
funding by NSF; or (ii) in entities whose financial
interests would reasonably appear to be affected
by such activities.
Chapter 1 (Subchapter A) (Part 54)
Financial Disclosure by Clinical Investigators
The Food and Drug Administration (FDA)
regulations state that investigators that
receive compensation in excess of $25,000
from a corporate sponsor of a trial in which
the investigator is engaged must disclose to
the FDA at the time of filing for a new drug
application.
19.058, Conflict of Interest in Research,
Educational, and Public Service Activities
19.059, Employee Participation in Authorized
Private Companies Commercializing Ohio
University Research
“Conflict of Interest in Research, Educational,
and Public Service Activities”
Most conflict disclosures fall within the
parameters of this policy
States that faculty are primarily responsible
for their academic, research and service
obligations
“Employee Participation in Authorized Private
Companies Commercializing Ohio University
Research”
Applies to “employees, faculty, staff and students,
who create intellectual property owned by the Ohio
University and who desire to hold an equity interest
in a firm, corporation, or other association to which
Ohio University has assigned, licensed or
transferred Ohio University’s interests…”
Consulting
Licensing University Technology
Clinical Studies
Procurement
Mentoring
Institutional
A disclosure is filed specific to the funding
application.
If you have a potential conflict for one
proposal, it does not automatically apply to
all of your proposals.
Research conflicts of interest are usually
disclosed using LEO as you apply for funding
by completing the conflict of interest section
of the electronic transmittal
If you are not using LEO, you can download
the appropriate disclosure form from
www.ohio.edu/research/compliance
“A” is selected if you have no conflicts to
disclose
“B” is selected if you have a potential conflict
to disclose relative to the submission.
(Requires a subsequent paper process)
“C” is selected if you have a current disclosure
on file, but it is not relevant to the proposal
you are submitting
Still uses option A, B or C
Requires that you gather signatures on paper
for all options, however
Generally used for personnel not listed on the
grant proposal or “key personnel”
We have revised the COI forms to word forms
This should be easier to complete than the
previous form
PDF versions are also available
Should be on the compliance web site soon,
but we can e-mail them to you until then
Use this form only if you are unable to use
the LEO transmittal form to assure that no
conflict of interest exists. A form must be
completed for each proposal.
I assure that I have read Ohio University
Policy 19.058, “Conflict of Interest in
Research, Educational, and Public Service
Activities” and declare that I have nothing
that is, or could be perceived to be a conflict
of interest with this proposal.
Use this form to disclose a potential conflict
of interest situation.
A separate disclosure form must be used for
each entity with which you conduct business
Conflict includes any member of your
immediate family (spouse, domestic partner
or children)
Require that you complete an option “B”
disclosure statement in addition to
completing the LEO transmittal form.
Require you to obtain signatures from Center
or Institute (if applicable), Chair and Dean on
the additional disclosure statement!!
The B disclosure form is available at
www.ohio.edu/research/compliance
Use this form only if you are unable to use
the LEO transmittal form. Complete this form
if you have a current conflict of interest
disclosure on file with the Office of Research
Compliance, but that disclosure is not
applicable to this proposal.
*New Option for 2008*
A management plan is developed for some
disclosures to mitigate the potential conflict
Management plans are specific to each
disclosure
May require submission of additional pieces,
such as a student employment plan
Reduce or remove the financial interest creating the
conflict
Place safeguards that mitigate the conflict potential,
such having some decisions made by an independent
entity
Limit participation in portions of the proposed
research likely to create a conflict
Require that the researcher disclose his or her
conflicting financial interests to all collaborators and
any proposed trainees;
Disclose the conflict in publications
Work to remove students from being directly advised
or taught by faculty where a conflict exists
Assure publication rights for student participants
Student Use
Nepotism and Cronyism
Intellectual Property
Use of University Resources
Publication provisions
Use of Human Subjects
Oversight Requirements
Reporting and Annual Reviews
You must submit an annual renewal for your
disclosure
◦ If the potential conflict no longer exists you must
notify us
If significant changes occur during the year
you should submit an update to your
disclosure as they occur
Yes. We encourage employees to disclose
potential conflicts that do not meet the
financial threshold, but may still be
problematic, such as student employment.
This allows you to be transparent with
respect to outside interests.
Allowable situations
Situations that require disclosure but may not
need an extensive management plan
Situations that require disclosure and have
problematic elements that will require
mitigation and/or a management plan
Situations that are not permitted
Receipt of royalties or honoraria for
published scholarly works, seminars,
teaching, etc.
Honoraria for serving as a special reviewer
or work on review panels
Royalties under our intellectual property
policies if no other relationship with entity
Clinical income at OUCOM
You participate in research developed in
whole or part by you, and you or your
family receive royalties from an existing
agreement with the business, but have
no other significant financial interest
You assign students, etc. to research
projects where you are entitled to
receive royalties, but have no other
significant financial interest
You assign students, etc. to projects supported
by the business through an SRA, and have a
significant financial interest other than royalty
income
You receive research support from a business in
which you serve on the board of directors, or
other advisory board, even if you are not
compensated.
You hold an executive position in a business
engaged in commercial or research activities
directly related to your Ohio University
responsibilities.
Any situation in which an actual conflict
exists is not permitted.
The only “exceptions” are those handled
under Ohio University Policy and Procedure
19.059 where faculty entrepreneurship is
addressed.
Participation in clinical trials or evaluation
of other research in which you have a
significant financial interest other than
royalty income.
In the context of your position at Ohio
University, you make professional referrals
to a business in which you have a
significant financial interest.
Letter of admonition
Ineligibility to submit grant applications
Withholding of IRB or IACUC approvals
Suspension
Non-Renewal
Loss of Tenure
Consulting
Procurement
Mentoring
Clinical Studies
Avoid consulting relationships that have
the potential to divert time and effort from
your responsibilities to Ohio University.
Do not use students.
Be wary of situations that limit publication.
Do not use university stationary, etc. that
could create an impression the university
is involved with the activities.
Make sure you are devoting sufficient time
to your university obligations.
Be cautious that the potential financial gain
cannot be perceived to influence your
university mentoring relationships.
Disclose any personal or familial financial
interest or equity in a company that is
doing business with Ohio University.
If you make purchases using public funds,
you should not use companies which will
benefit you or your family. If there is no
alternative you must seek and receive
permission prior to purchasing.
Any relationship in which there is a real or
perceived power or influence imbalance has
the potential for conflict. (Faculty:Student)
Isolating these relationships with respect to
areas of personal financial gain is best.
If they cannot be isolated, then safeguards
must be created.
If you have a financial interest, it is best to
isolate yourself from the study.
At a minimum, expect a more intense review
and a robust management plan if you have a
financial interest.
If both the institution and you have financial
interests the clinical study should be
conducted elsewhere.
You have administrative responsibilities on
behalf of Ohio University that is beneficial to
the business in which you have a significant
financial interest
You have administrative responsibilities on
behalf of Ohio University with respect to an
SRA where you have a significant financial
interest
Slide 13
Jo Ellen Sherow
Ohio University
Office of Research Compliance
Researchers’ Financial Disclosures in the
Spotlight
Conflicts of interest, always an emotional topic,
returned to the headlines this week as Sen.
Charles Grassley, a longtime critic of the drug
industry’s potential influence on research,
released new evidence that prominent Harvard
University scientists had failed to disclose much
of their outside income from pharmaceutical
companies over the past eight years.
http://www.insidehighered.com/news/2008/06/12/conflict January 15, 2008
WEDNESDAY, JANUARY 21, 2009
In a review of the literature regarding the relationship between
smokeless tobacco use and cancer, a conflict of interest of one of the
article's authors was initially not disclosed (see: Boffetta P, Hecht S, Gray
N, Gupta P, Straif K. Smokeless tobacco and cancer. Lancet Oncology
2008; 9:667-675). The original article was published in July, 2008. That
article stated: "The authors declare no conflicts of interest." After the
editor of the journal was notified by a researcher with knowledge of a
potential conflict of interest of Dr. Stephen Hecht (one of the study
authors), an erratum was published in September 2008, which noted:
"During the immediate months preceding submission of the review SH
was acting in the capacity of an expert witness for the plaintiff in a
future court case against a smokeless tobacco company. SH declares his
participation in this case in no way influenced his writing or involvement
in the review."
http://tobaccoanalysis.blogspot.com/2009/01/conflict-of-interestnot.html
January 16, 2009 — More than one third of new
drug marketing applications approved by the US
Food and Drug Administration (FDA) were
missing information about potential conflicts of
interest for clinical trial investigators, which
could allow bias to creep into the approvals
process, a government report released this week
has found. The FDA has said that it agrees with
most of the report's findings.
http://www.medscape.com/viewarticle/586980
Do collaborations between biotech companies
and academic centers constitute a conflict of
interest?
Biotechnology industry partnerships with
universities and academic centers have been
fruitful for both. So why is there so much
concern about conflict of interest and is that
concern appropriate?
http://www.redorbit.com/news/health/750100/genetic_engineering_news_p
osts_podcast_on_industrialacademic_collaborations_are_these/index.html
Universities are responsible for use of public
funds and therefore must maintain the public
trust.
Identifying and mitigating situations that may
have the potential for conflict maintains the
integrity of the university.
Maintaining integrity allows the university to
do credible academic research.
To provide information on the purpose of the
conflict of interest requirements.
To provide a basic overview of conflicts of
interest
To introduce the disclosure process and the use
of management plans
To provide information on the need for updates
and annual renewals.
Situations where financial considerations
compromise your professional judgment.
“Actual Conflict of Interest”
◦ Not permitted
Situations where an independent observer
might reasonably question whether your
professional actions or decisions are
determined by considerations of personal
gain. “Perceived Conflict of Interest”
◦ Managed
Potential conflicts may be financial or may be
a conflict of time, effort and/or commitment.
Potential conflicts can occur as a result of
administrative, scientific, academic, fiduciary
or familial situations.
They are situations that can be PERCEIVED to
be conflicting, whether a “real” conflict exists
or not.
Ohio University Policy has a mandatory
disclosure policy if you:
Earn over $10,000 in a twelve month period
from your outside activity OR
Have over 5% equity in the entity
Applies to members of your immediate family
(spouse, domestic partner, dependent
children) as well as yourself.
Anything of monetary value, including but not
limited to:
◦
◦
◦
◦
Salary
Payments for services
Equity interests over 5%
Intellectual property rights
Excludes mutual, pension and other
investments over which you have no control
Outside work during regular academic year
should not exceed equivalent of 1 day per
week.
Consulting work must avoid activities that
involve a conflict of interest with assigned
Ohio University activities and programs
Faculty Handbook, section IV-D
Outside interests cannot interfere with
primary loyalty to Ohio University and your
academic role
Use of university resources must have prior
approval of Chair, Dean and VPR.
Your outside interests should not be in
direct competition with university interests
Full time administrative employees are
expected to devote their full-time
professional loyalty, time and energy to their
position.
You must use non-work hours and no
university resources
Federal Agencies
State Law
University Policies
Many Academic Publications
45 CFR Part 50, Subpart F
“Responsibility of Applicants for Promoting
Objectivity in Research for Which PHS Funding
is Sought”
Authority: 42 U.S.C. 216, 289b-1, 299c-3.
Intent is to assure objectivity by establishing
standards that preclude bias in design, conduct, or
reporting of research
Focuses on financial conflicts of interest
(FCOI)
Regulations apply to investigators, including
sub grantees, contractors, and collaborating
investigators.
Does not apply to applications for support
under Phase I of SBIR and STTR programs
An institutional conflict of interest policy should
require that each investigator disclose to a
responsible representative of the institution all
significant financial interests of the investigator
(including those of the investigator’s spouse and
dependent children) (i) that would reasonably
appear to be affected by the research or
educational activities funded or proposed for
funding by NSF; or (ii) in entities whose financial
interests would reasonably appear to be affected
by such activities.
Chapter 1 (Subchapter A) (Part 54)
Financial Disclosure by Clinical Investigators
The Food and Drug Administration (FDA)
regulations state that investigators that
receive compensation in excess of $25,000
from a corporate sponsor of a trial in which
the investigator is engaged must disclose to
the FDA at the time of filing for a new drug
application.
19.058, Conflict of Interest in Research,
Educational, and Public Service Activities
19.059, Employee Participation in Authorized
Private Companies Commercializing Ohio
University Research
“Conflict of Interest in Research, Educational,
and Public Service Activities”
Most conflict disclosures fall within the
parameters of this policy
States that faculty are primarily responsible
for their academic, research and service
obligations
“Employee Participation in Authorized Private
Companies Commercializing Ohio University
Research”
Applies to “employees, faculty, staff and students,
who create intellectual property owned by the Ohio
University and who desire to hold an equity interest
in a firm, corporation, or other association to which
Ohio University has assigned, licensed or
transferred Ohio University’s interests…”
Consulting
Licensing University Technology
Clinical Studies
Procurement
Mentoring
Institutional
A disclosure is filed specific to the funding
application.
If you have a potential conflict for one
proposal, it does not automatically apply to
all of your proposals.
Research conflicts of interest are usually
disclosed using LEO as you apply for funding
by completing the conflict of interest section
of the electronic transmittal
If you are not using LEO, you can download
the appropriate disclosure form from
www.ohio.edu/research/compliance
“A” is selected if you have no conflicts to
disclose
“B” is selected if you have a potential conflict
to disclose relative to the submission.
(Requires a subsequent paper process)
“C” is selected if you have a current disclosure
on file, but it is not relevant to the proposal
you are submitting
Still uses option A, B or C
Requires that you gather signatures on paper
for all options, however
Generally used for personnel not listed on the
grant proposal or “key personnel”
We have revised the COI forms to word forms
This should be easier to complete than the
previous form
PDF versions are also available
Should be on the compliance web site soon,
but we can e-mail them to you until then
Use this form only if you are unable to use
the LEO transmittal form to assure that no
conflict of interest exists. A form must be
completed for each proposal.
I assure that I have read Ohio University
Policy 19.058, “Conflict of Interest in
Research, Educational, and Public Service
Activities” and declare that I have nothing
that is, or could be perceived to be a conflict
of interest with this proposal.
Use this form to disclose a potential conflict
of interest situation.
A separate disclosure form must be used for
each entity with which you conduct business
Conflict includes any member of your
immediate family (spouse, domestic partner
or children)
Require that you complete an option “B”
disclosure statement in addition to
completing the LEO transmittal form.
Require you to obtain signatures from Center
or Institute (if applicable), Chair and Dean on
the additional disclosure statement!!
The B disclosure form is available at
www.ohio.edu/research/compliance
Use this form only if you are unable to use
the LEO transmittal form. Complete this form
if you have a current conflict of interest
disclosure on file with the Office of Research
Compliance, but that disclosure is not
applicable to this proposal.
*New Option for 2008*
A management plan is developed for some
disclosures to mitigate the potential conflict
Management plans are specific to each
disclosure
May require submission of additional pieces,
such as a student employment plan
Reduce or remove the financial interest creating the
conflict
Place safeguards that mitigate the conflict potential,
such having some decisions made by an independent
entity
Limit participation in portions of the proposed
research likely to create a conflict
Require that the researcher disclose his or her
conflicting financial interests to all collaborators and
any proposed trainees;
Disclose the conflict in publications
Work to remove students from being directly advised
or taught by faculty where a conflict exists
Assure publication rights for student participants
Student Use
Nepotism and Cronyism
Intellectual Property
Use of University Resources
Publication provisions
Use of Human Subjects
Oversight Requirements
Reporting and Annual Reviews
You must submit an annual renewal for your
disclosure
◦ If the potential conflict no longer exists you must
notify us
If significant changes occur during the year
you should submit an update to your
disclosure as they occur
Yes. We encourage employees to disclose
potential conflicts that do not meet the
financial threshold, but may still be
problematic, such as student employment.
This allows you to be transparent with
respect to outside interests.
Allowable situations
Situations that require disclosure but may not
need an extensive management plan
Situations that require disclosure and have
problematic elements that will require
mitigation and/or a management plan
Situations that are not permitted
Receipt of royalties or honoraria for
published scholarly works, seminars,
teaching, etc.
Honoraria for serving as a special reviewer
or work on review panels
Royalties under our intellectual property
policies if no other relationship with entity
Clinical income at OUCOM
You participate in research developed in
whole or part by you, and you or your
family receive royalties from an existing
agreement with the business, but have
no other significant financial interest
You assign students, etc. to research
projects where you are entitled to
receive royalties, but have no other
significant financial interest
You assign students, etc. to projects supported
by the business through an SRA, and have a
significant financial interest other than royalty
income
You receive research support from a business in
which you serve on the board of directors, or
other advisory board, even if you are not
compensated.
You hold an executive position in a business
engaged in commercial or research activities
directly related to your Ohio University
responsibilities.
Any situation in which an actual conflict
exists is not permitted.
The only “exceptions” are those handled
under Ohio University Policy and Procedure
19.059 where faculty entrepreneurship is
addressed.
Participation in clinical trials or evaluation
of other research in which you have a
significant financial interest other than
royalty income.
In the context of your position at Ohio
University, you make professional referrals
to a business in which you have a
significant financial interest.
Letter of admonition
Ineligibility to submit grant applications
Withholding of IRB or IACUC approvals
Suspension
Non-Renewal
Loss of Tenure
Consulting
Procurement
Mentoring
Clinical Studies
Avoid consulting relationships that have
the potential to divert time and effort from
your responsibilities to Ohio University.
Do not use students.
Be wary of situations that limit publication.
Do not use university stationary, etc. that
could create an impression the university
is involved with the activities.
Make sure you are devoting sufficient time
to your university obligations.
Be cautious that the potential financial gain
cannot be perceived to influence your
university mentoring relationships.
Disclose any personal or familial financial
interest or equity in a company that is
doing business with Ohio University.
If you make purchases using public funds,
you should not use companies which will
benefit you or your family. If there is no
alternative you must seek and receive
permission prior to purchasing.
Any relationship in which there is a real or
perceived power or influence imbalance has
the potential for conflict. (Faculty:Student)
Isolating these relationships with respect to
areas of personal financial gain is best.
If they cannot be isolated, then safeguards
must be created.
If you have a financial interest, it is best to
isolate yourself from the study.
At a minimum, expect a more intense review
and a robust management plan if you have a
financial interest.
If both the institution and you have financial
interests the clinical study should be
conducted elsewhere.
You have administrative responsibilities on
behalf of Ohio University that is beneficial to
the business in which you have a significant
financial interest
You have administrative responsibilities on
behalf of Ohio University with respect to an
SRA where you have a significant financial
interest
Slide 14
Jo Ellen Sherow
Ohio University
Office of Research Compliance
Researchers’ Financial Disclosures in the
Spotlight
Conflicts of interest, always an emotional topic,
returned to the headlines this week as Sen.
Charles Grassley, a longtime critic of the drug
industry’s potential influence on research,
released new evidence that prominent Harvard
University scientists had failed to disclose much
of their outside income from pharmaceutical
companies over the past eight years.
http://www.insidehighered.com/news/2008/06/12/conflict January 15, 2008
WEDNESDAY, JANUARY 21, 2009
In a review of the literature regarding the relationship between
smokeless tobacco use and cancer, a conflict of interest of one of the
article's authors was initially not disclosed (see: Boffetta P, Hecht S, Gray
N, Gupta P, Straif K. Smokeless tobacco and cancer. Lancet Oncology
2008; 9:667-675). The original article was published in July, 2008. That
article stated: "The authors declare no conflicts of interest." After the
editor of the journal was notified by a researcher with knowledge of a
potential conflict of interest of Dr. Stephen Hecht (one of the study
authors), an erratum was published in September 2008, which noted:
"During the immediate months preceding submission of the review SH
was acting in the capacity of an expert witness for the plaintiff in a
future court case against a smokeless tobacco company. SH declares his
participation in this case in no way influenced his writing or involvement
in the review."
http://tobaccoanalysis.blogspot.com/2009/01/conflict-of-interestnot.html
January 16, 2009 — More than one third of new
drug marketing applications approved by the US
Food and Drug Administration (FDA) were
missing information about potential conflicts of
interest for clinical trial investigators, which
could allow bias to creep into the approvals
process, a government report released this week
has found. The FDA has said that it agrees with
most of the report's findings.
http://www.medscape.com/viewarticle/586980
Do collaborations between biotech companies
and academic centers constitute a conflict of
interest?
Biotechnology industry partnerships with
universities and academic centers have been
fruitful for both. So why is there so much
concern about conflict of interest and is that
concern appropriate?
http://www.redorbit.com/news/health/750100/genetic_engineering_news_p
osts_podcast_on_industrialacademic_collaborations_are_these/index.html
Universities are responsible for use of public
funds and therefore must maintain the public
trust.
Identifying and mitigating situations that may
have the potential for conflict maintains the
integrity of the university.
Maintaining integrity allows the university to
do credible academic research.
To provide information on the purpose of the
conflict of interest requirements.
To provide a basic overview of conflicts of
interest
To introduce the disclosure process and the use
of management plans
To provide information on the need for updates
and annual renewals.
Situations where financial considerations
compromise your professional judgment.
“Actual Conflict of Interest”
◦ Not permitted
Situations where an independent observer
might reasonably question whether your
professional actions or decisions are
determined by considerations of personal
gain. “Perceived Conflict of Interest”
◦ Managed
Potential conflicts may be financial or may be
a conflict of time, effort and/or commitment.
Potential conflicts can occur as a result of
administrative, scientific, academic, fiduciary
or familial situations.
They are situations that can be PERCEIVED to
be conflicting, whether a “real” conflict exists
or not.
Ohio University Policy has a mandatory
disclosure policy if you:
Earn over $10,000 in a twelve month period
from your outside activity OR
Have over 5% equity in the entity
Applies to members of your immediate family
(spouse, domestic partner, dependent
children) as well as yourself.
Anything of monetary value, including but not
limited to:
◦
◦
◦
◦
Salary
Payments for services
Equity interests over 5%
Intellectual property rights
Excludes mutual, pension and other
investments over which you have no control
Outside work during regular academic year
should not exceed equivalent of 1 day per
week.
Consulting work must avoid activities that
involve a conflict of interest with assigned
Ohio University activities and programs
Faculty Handbook, section IV-D
Outside interests cannot interfere with
primary loyalty to Ohio University and your
academic role
Use of university resources must have prior
approval of Chair, Dean and VPR.
Your outside interests should not be in
direct competition with university interests
Full time administrative employees are
expected to devote their full-time
professional loyalty, time and energy to their
position.
You must use non-work hours and no
university resources
Federal Agencies
State Law
University Policies
Many Academic Publications
45 CFR Part 50, Subpart F
“Responsibility of Applicants for Promoting
Objectivity in Research for Which PHS Funding
is Sought”
Authority: 42 U.S.C. 216, 289b-1, 299c-3.
Intent is to assure objectivity by establishing
standards that preclude bias in design, conduct, or
reporting of research
Focuses on financial conflicts of interest
(FCOI)
Regulations apply to investigators, including
sub grantees, contractors, and collaborating
investigators.
Does not apply to applications for support
under Phase I of SBIR and STTR programs
An institutional conflict of interest policy should
require that each investigator disclose to a
responsible representative of the institution all
significant financial interests of the investigator
(including those of the investigator’s spouse and
dependent children) (i) that would reasonably
appear to be affected by the research or
educational activities funded or proposed for
funding by NSF; or (ii) in entities whose financial
interests would reasonably appear to be affected
by such activities.
Chapter 1 (Subchapter A) (Part 54)
Financial Disclosure by Clinical Investigators
The Food and Drug Administration (FDA)
regulations state that investigators that
receive compensation in excess of $25,000
from a corporate sponsor of a trial in which
the investigator is engaged must disclose to
the FDA at the time of filing for a new drug
application.
19.058, Conflict of Interest in Research,
Educational, and Public Service Activities
19.059, Employee Participation in Authorized
Private Companies Commercializing Ohio
University Research
“Conflict of Interest in Research, Educational,
and Public Service Activities”
Most conflict disclosures fall within the
parameters of this policy
States that faculty are primarily responsible
for their academic, research and service
obligations
“Employee Participation in Authorized Private
Companies Commercializing Ohio University
Research”
Applies to “employees, faculty, staff and students,
who create intellectual property owned by the Ohio
University and who desire to hold an equity interest
in a firm, corporation, or other association to which
Ohio University has assigned, licensed or
transferred Ohio University’s interests…”
Consulting
Licensing University Technology
Clinical Studies
Procurement
Mentoring
Institutional
A disclosure is filed specific to the funding
application.
If you have a potential conflict for one
proposal, it does not automatically apply to
all of your proposals.
Research conflicts of interest are usually
disclosed using LEO as you apply for funding
by completing the conflict of interest section
of the electronic transmittal
If you are not using LEO, you can download
the appropriate disclosure form from
www.ohio.edu/research/compliance
“A” is selected if you have no conflicts to
disclose
“B” is selected if you have a potential conflict
to disclose relative to the submission.
(Requires a subsequent paper process)
“C” is selected if you have a current disclosure
on file, but it is not relevant to the proposal
you are submitting
Still uses option A, B or C
Requires that you gather signatures on paper
for all options, however
Generally used for personnel not listed on the
grant proposal or “key personnel”
We have revised the COI forms to word forms
This should be easier to complete than the
previous form
PDF versions are also available
Should be on the compliance web site soon,
but we can e-mail them to you until then
Use this form only if you are unable to use
the LEO transmittal form to assure that no
conflict of interest exists. A form must be
completed for each proposal.
I assure that I have read Ohio University
Policy 19.058, “Conflict of Interest in
Research, Educational, and Public Service
Activities” and declare that I have nothing
that is, or could be perceived to be a conflict
of interest with this proposal.
Use this form to disclose a potential conflict
of interest situation.
A separate disclosure form must be used for
each entity with which you conduct business
Conflict includes any member of your
immediate family (spouse, domestic partner
or children)
Require that you complete an option “B”
disclosure statement in addition to
completing the LEO transmittal form.
Require you to obtain signatures from Center
or Institute (if applicable), Chair and Dean on
the additional disclosure statement!!
The B disclosure form is available at
www.ohio.edu/research/compliance
Use this form only if you are unable to use
the LEO transmittal form. Complete this form
if you have a current conflict of interest
disclosure on file with the Office of Research
Compliance, but that disclosure is not
applicable to this proposal.
*New Option for 2008*
A management plan is developed for some
disclosures to mitigate the potential conflict
Management plans are specific to each
disclosure
May require submission of additional pieces,
such as a student employment plan
Reduce or remove the financial interest creating the
conflict
Place safeguards that mitigate the conflict potential,
such having some decisions made by an independent
entity
Limit participation in portions of the proposed
research likely to create a conflict
Require that the researcher disclose his or her
conflicting financial interests to all collaborators and
any proposed trainees;
Disclose the conflict in publications
Work to remove students from being directly advised
or taught by faculty where a conflict exists
Assure publication rights for student participants
Student Use
Nepotism and Cronyism
Intellectual Property
Use of University Resources
Publication provisions
Use of Human Subjects
Oversight Requirements
Reporting and Annual Reviews
You must submit an annual renewal for your
disclosure
◦ If the potential conflict no longer exists you must
notify us
If significant changes occur during the year
you should submit an update to your
disclosure as they occur
Yes. We encourage employees to disclose
potential conflicts that do not meet the
financial threshold, but may still be
problematic, such as student employment.
This allows you to be transparent with
respect to outside interests.
Allowable situations
Situations that require disclosure but may not
need an extensive management plan
Situations that require disclosure and have
problematic elements that will require
mitigation and/or a management plan
Situations that are not permitted
Receipt of royalties or honoraria for
published scholarly works, seminars,
teaching, etc.
Honoraria for serving as a special reviewer
or work on review panels
Royalties under our intellectual property
policies if no other relationship with entity
Clinical income at OUCOM
You participate in research developed in
whole or part by you, and you or your
family receive royalties from an existing
agreement with the business, but have
no other significant financial interest
You assign students, etc. to research
projects where you are entitled to
receive royalties, but have no other
significant financial interest
You assign students, etc. to projects supported
by the business through an SRA, and have a
significant financial interest other than royalty
income
You receive research support from a business in
which you serve on the board of directors, or
other advisory board, even if you are not
compensated.
You hold an executive position in a business
engaged in commercial or research activities
directly related to your Ohio University
responsibilities.
Any situation in which an actual conflict
exists is not permitted.
The only “exceptions” are those handled
under Ohio University Policy and Procedure
19.059 where faculty entrepreneurship is
addressed.
Participation in clinical trials or evaluation
of other research in which you have a
significant financial interest other than
royalty income.
In the context of your position at Ohio
University, you make professional referrals
to a business in which you have a
significant financial interest.
Letter of admonition
Ineligibility to submit grant applications
Withholding of IRB or IACUC approvals
Suspension
Non-Renewal
Loss of Tenure
Consulting
Procurement
Mentoring
Clinical Studies
Avoid consulting relationships that have
the potential to divert time and effort from
your responsibilities to Ohio University.
Do not use students.
Be wary of situations that limit publication.
Do not use university stationary, etc. that
could create an impression the university
is involved with the activities.
Make sure you are devoting sufficient time
to your university obligations.
Be cautious that the potential financial gain
cannot be perceived to influence your
university mentoring relationships.
Disclose any personal or familial financial
interest or equity in a company that is
doing business with Ohio University.
If you make purchases using public funds,
you should not use companies which will
benefit you or your family. If there is no
alternative you must seek and receive
permission prior to purchasing.
Any relationship in which there is a real or
perceived power or influence imbalance has
the potential for conflict. (Faculty:Student)
Isolating these relationships with respect to
areas of personal financial gain is best.
If they cannot be isolated, then safeguards
must be created.
If you have a financial interest, it is best to
isolate yourself from the study.
At a minimum, expect a more intense review
and a robust management plan if you have a
financial interest.
If both the institution and you have financial
interests the clinical study should be
conducted elsewhere.
You have administrative responsibilities on
behalf of Ohio University that is beneficial to
the business in which you have a significant
financial interest
You have administrative responsibilities on
behalf of Ohio University with respect to an
SRA where you have a significant financial
interest
Slide 15
Jo Ellen Sherow
Ohio University
Office of Research Compliance
Researchers’ Financial Disclosures in the
Spotlight
Conflicts of interest, always an emotional topic,
returned to the headlines this week as Sen.
Charles Grassley, a longtime critic of the drug
industry’s potential influence on research,
released new evidence that prominent Harvard
University scientists had failed to disclose much
of their outside income from pharmaceutical
companies over the past eight years.
http://www.insidehighered.com/news/2008/06/12/conflict January 15, 2008
WEDNESDAY, JANUARY 21, 2009
In a review of the literature regarding the relationship between
smokeless tobacco use and cancer, a conflict of interest of one of the
article's authors was initially not disclosed (see: Boffetta P, Hecht S, Gray
N, Gupta P, Straif K. Smokeless tobacco and cancer. Lancet Oncology
2008; 9:667-675). The original article was published in July, 2008. That
article stated: "The authors declare no conflicts of interest." After the
editor of the journal was notified by a researcher with knowledge of a
potential conflict of interest of Dr. Stephen Hecht (one of the study
authors), an erratum was published in September 2008, which noted:
"During the immediate months preceding submission of the review SH
was acting in the capacity of an expert witness for the plaintiff in a
future court case against a smokeless tobacco company. SH declares his
participation in this case in no way influenced his writing or involvement
in the review."
http://tobaccoanalysis.blogspot.com/2009/01/conflict-of-interestnot.html
January 16, 2009 — More than one third of new
drug marketing applications approved by the US
Food and Drug Administration (FDA) were
missing information about potential conflicts of
interest for clinical trial investigators, which
could allow bias to creep into the approvals
process, a government report released this week
has found. The FDA has said that it agrees with
most of the report's findings.
http://www.medscape.com/viewarticle/586980
Do collaborations between biotech companies
and academic centers constitute a conflict of
interest?
Biotechnology industry partnerships with
universities and academic centers have been
fruitful for both. So why is there so much
concern about conflict of interest and is that
concern appropriate?
http://www.redorbit.com/news/health/750100/genetic_engineering_news_p
osts_podcast_on_industrialacademic_collaborations_are_these/index.html
Universities are responsible for use of public
funds and therefore must maintain the public
trust.
Identifying and mitigating situations that may
have the potential for conflict maintains the
integrity of the university.
Maintaining integrity allows the university to
do credible academic research.
To provide information on the purpose of the
conflict of interest requirements.
To provide a basic overview of conflicts of
interest
To introduce the disclosure process and the use
of management plans
To provide information on the need for updates
and annual renewals.
Situations where financial considerations
compromise your professional judgment.
“Actual Conflict of Interest”
◦ Not permitted
Situations where an independent observer
might reasonably question whether your
professional actions or decisions are
determined by considerations of personal
gain. “Perceived Conflict of Interest”
◦ Managed
Potential conflicts may be financial or may be
a conflict of time, effort and/or commitment.
Potential conflicts can occur as a result of
administrative, scientific, academic, fiduciary
or familial situations.
They are situations that can be PERCEIVED to
be conflicting, whether a “real” conflict exists
or not.
Ohio University Policy has a mandatory
disclosure policy if you:
Earn over $10,000 in a twelve month period
from your outside activity OR
Have over 5% equity in the entity
Applies to members of your immediate family
(spouse, domestic partner, dependent
children) as well as yourself.
Anything of monetary value, including but not
limited to:
◦
◦
◦
◦
Salary
Payments for services
Equity interests over 5%
Intellectual property rights
Excludes mutual, pension and other
investments over which you have no control
Outside work during regular academic year
should not exceed equivalent of 1 day per
week.
Consulting work must avoid activities that
involve a conflict of interest with assigned
Ohio University activities and programs
Faculty Handbook, section IV-D
Outside interests cannot interfere with
primary loyalty to Ohio University and your
academic role
Use of university resources must have prior
approval of Chair, Dean and VPR.
Your outside interests should not be in
direct competition with university interests
Full time administrative employees are
expected to devote their full-time
professional loyalty, time and energy to their
position.
You must use non-work hours and no
university resources
Federal Agencies
State Law
University Policies
Many Academic Publications
45 CFR Part 50, Subpart F
“Responsibility of Applicants for Promoting
Objectivity in Research for Which PHS Funding
is Sought”
Authority: 42 U.S.C. 216, 289b-1, 299c-3.
Intent is to assure objectivity by establishing
standards that preclude bias in design, conduct, or
reporting of research
Focuses on financial conflicts of interest
(FCOI)
Regulations apply to investigators, including
sub grantees, contractors, and collaborating
investigators.
Does not apply to applications for support
under Phase I of SBIR and STTR programs
An institutional conflict of interest policy should
require that each investigator disclose to a
responsible representative of the institution all
significant financial interests of the investigator
(including those of the investigator’s spouse and
dependent children) (i) that would reasonably
appear to be affected by the research or
educational activities funded or proposed for
funding by NSF; or (ii) in entities whose financial
interests would reasonably appear to be affected
by such activities.
Chapter 1 (Subchapter A) (Part 54)
Financial Disclosure by Clinical Investigators
The Food and Drug Administration (FDA)
regulations state that investigators that
receive compensation in excess of $25,000
from a corporate sponsor of a trial in which
the investigator is engaged must disclose to
the FDA at the time of filing for a new drug
application.
19.058, Conflict of Interest in Research,
Educational, and Public Service Activities
19.059, Employee Participation in Authorized
Private Companies Commercializing Ohio
University Research
“Conflict of Interest in Research, Educational,
and Public Service Activities”
Most conflict disclosures fall within the
parameters of this policy
States that faculty are primarily responsible
for their academic, research and service
obligations
“Employee Participation in Authorized Private
Companies Commercializing Ohio University
Research”
Applies to “employees, faculty, staff and students,
who create intellectual property owned by the Ohio
University and who desire to hold an equity interest
in a firm, corporation, or other association to which
Ohio University has assigned, licensed or
transferred Ohio University’s interests…”
Consulting
Licensing University Technology
Clinical Studies
Procurement
Mentoring
Institutional
A disclosure is filed specific to the funding
application.
If you have a potential conflict for one
proposal, it does not automatically apply to
all of your proposals.
Research conflicts of interest are usually
disclosed using LEO as you apply for funding
by completing the conflict of interest section
of the electronic transmittal
If you are not using LEO, you can download
the appropriate disclosure form from
www.ohio.edu/research/compliance
“A” is selected if you have no conflicts to
disclose
“B” is selected if you have a potential conflict
to disclose relative to the submission.
(Requires a subsequent paper process)
“C” is selected if you have a current disclosure
on file, but it is not relevant to the proposal
you are submitting
Still uses option A, B or C
Requires that you gather signatures on paper
for all options, however
Generally used for personnel not listed on the
grant proposal or “key personnel”
We have revised the COI forms to word forms
This should be easier to complete than the
previous form
PDF versions are also available
Should be on the compliance web site soon,
but we can e-mail them to you until then
Use this form only if you are unable to use
the LEO transmittal form to assure that no
conflict of interest exists. A form must be
completed for each proposal.
I assure that I have read Ohio University
Policy 19.058, “Conflict of Interest in
Research, Educational, and Public Service
Activities” and declare that I have nothing
that is, or could be perceived to be a conflict
of interest with this proposal.
Use this form to disclose a potential conflict
of interest situation.
A separate disclosure form must be used for
each entity with which you conduct business
Conflict includes any member of your
immediate family (spouse, domestic partner
or children)
Require that you complete an option “B”
disclosure statement in addition to
completing the LEO transmittal form.
Require you to obtain signatures from Center
or Institute (if applicable), Chair and Dean on
the additional disclosure statement!!
The B disclosure form is available at
www.ohio.edu/research/compliance
Use this form only if you are unable to use
the LEO transmittal form. Complete this form
if you have a current conflict of interest
disclosure on file with the Office of Research
Compliance, but that disclosure is not
applicable to this proposal.
*New Option for 2008*
A management plan is developed for some
disclosures to mitigate the potential conflict
Management plans are specific to each
disclosure
May require submission of additional pieces,
such as a student employment plan
Reduce or remove the financial interest creating the
conflict
Place safeguards that mitigate the conflict potential,
such having some decisions made by an independent
entity
Limit participation in portions of the proposed
research likely to create a conflict
Require that the researcher disclose his or her
conflicting financial interests to all collaborators and
any proposed trainees;
Disclose the conflict in publications
Work to remove students from being directly advised
or taught by faculty where a conflict exists
Assure publication rights for student participants
Student Use
Nepotism and Cronyism
Intellectual Property
Use of University Resources
Publication provisions
Use of Human Subjects
Oversight Requirements
Reporting and Annual Reviews
You must submit an annual renewal for your
disclosure
◦ If the potential conflict no longer exists you must
notify us
If significant changes occur during the year
you should submit an update to your
disclosure as they occur
Yes. We encourage employees to disclose
potential conflicts that do not meet the
financial threshold, but may still be
problematic, such as student employment.
This allows you to be transparent with
respect to outside interests.
Allowable situations
Situations that require disclosure but may not
need an extensive management plan
Situations that require disclosure and have
problematic elements that will require
mitigation and/or a management plan
Situations that are not permitted
Receipt of royalties or honoraria for
published scholarly works, seminars,
teaching, etc.
Honoraria for serving as a special reviewer
or work on review panels
Royalties under our intellectual property
policies if no other relationship with entity
Clinical income at OUCOM
You participate in research developed in
whole or part by you, and you or your
family receive royalties from an existing
agreement with the business, but have
no other significant financial interest
You assign students, etc. to research
projects where you are entitled to
receive royalties, but have no other
significant financial interest
You assign students, etc. to projects supported
by the business through an SRA, and have a
significant financial interest other than royalty
income
You receive research support from a business in
which you serve on the board of directors, or
other advisory board, even if you are not
compensated.
You hold an executive position in a business
engaged in commercial or research activities
directly related to your Ohio University
responsibilities.
Any situation in which an actual conflict
exists is not permitted.
The only “exceptions” are those handled
under Ohio University Policy and Procedure
19.059 where faculty entrepreneurship is
addressed.
Participation in clinical trials or evaluation
of other research in which you have a
significant financial interest other than
royalty income.
In the context of your position at Ohio
University, you make professional referrals
to a business in which you have a
significant financial interest.
Letter of admonition
Ineligibility to submit grant applications
Withholding of IRB or IACUC approvals
Suspension
Non-Renewal
Loss of Tenure
Consulting
Procurement
Mentoring
Clinical Studies
Avoid consulting relationships that have
the potential to divert time and effort from
your responsibilities to Ohio University.
Do not use students.
Be wary of situations that limit publication.
Do not use university stationary, etc. that
could create an impression the university
is involved with the activities.
Make sure you are devoting sufficient time
to your university obligations.
Be cautious that the potential financial gain
cannot be perceived to influence your
university mentoring relationships.
Disclose any personal or familial financial
interest or equity in a company that is
doing business with Ohio University.
If you make purchases using public funds,
you should not use companies which will
benefit you or your family. If there is no
alternative you must seek and receive
permission prior to purchasing.
Any relationship in which there is a real or
perceived power or influence imbalance has
the potential for conflict. (Faculty:Student)
Isolating these relationships with respect to
areas of personal financial gain is best.
If they cannot be isolated, then safeguards
must be created.
If you have a financial interest, it is best to
isolate yourself from the study.
At a minimum, expect a more intense review
and a robust management plan if you have a
financial interest.
If both the institution and you have financial
interests the clinical study should be
conducted elsewhere.
You have administrative responsibilities on
behalf of Ohio University that is beneficial to
the business in which you have a significant
financial interest
You have administrative responsibilities on
behalf of Ohio University with respect to an
SRA where you have a significant financial
interest
Slide 16
Jo Ellen Sherow
Ohio University
Office of Research Compliance
Researchers’ Financial Disclosures in the
Spotlight
Conflicts of interest, always an emotional topic,
returned to the headlines this week as Sen.
Charles Grassley, a longtime critic of the drug
industry’s potential influence on research,
released new evidence that prominent Harvard
University scientists had failed to disclose much
of their outside income from pharmaceutical
companies over the past eight years.
http://www.insidehighered.com/news/2008/06/12/conflict January 15, 2008
WEDNESDAY, JANUARY 21, 2009
In a review of the literature regarding the relationship between
smokeless tobacco use and cancer, a conflict of interest of one of the
article's authors was initially not disclosed (see: Boffetta P, Hecht S, Gray
N, Gupta P, Straif K. Smokeless tobacco and cancer. Lancet Oncology
2008; 9:667-675). The original article was published in July, 2008. That
article stated: "The authors declare no conflicts of interest." After the
editor of the journal was notified by a researcher with knowledge of a
potential conflict of interest of Dr. Stephen Hecht (one of the study
authors), an erratum was published in September 2008, which noted:
"During the immediate months preceding submission of the review SH
was acting in the capacity of an expert witness for the plaintiff in a
future court case against a smokeless tobacco company. SH declares his
participation in this case in no way influenced his writing or involvement
in the review."
http://tobaccoanalysis.blogspot.com/2009/01/conflict-of-interestnot.html
January 16, 2009 — More than one third of new
drug marketing applications approved by the US
Food and Drug Administration (FDA) were
missing information about potential conflicts of
interest for clinical trial investigators, which
could allow bias to creep into the approvals
process, a government report released this week
has found. The FDA has said that it agrees with
most of the report's findings.
http://www.medscape.com/viewarticle/586980
Do collaborations between biotech companies
and academic centers constitute a conflict of
interest?
Biotechnology industry partnerships with
universities and academic centers have been
fruitful for both. So why is there so much
concern about conflict of interest and is that
concern appropriate?
http://www.redorbit.com/news/health/750100/genetic_engineering_news_p
osts_podcast_on_industrialacademic_collaborations_are_these/index.html
Universities are responsible for use of public
funds and therefore must maintain the public
trust.
Identifying and mitigating situations that may
have the potential for conflict maintains the
integrity of the university.
Maintaining integrity allows the university to
do credible academic research.
To provide information on the purpose of the
conflict of interest requirements.
To provide a basic overview of conflicts of
interest
To introduce the disclosure process and the use
of management plans
To provide information on the need for updates
and annual renewals.
Situations where financial considerations
compromise your professional judgment.
“Actual Conflict of Interest”
◦ Not permitted
Situations where an independent observer
might reasonably question whether your
professional actions or decisions are
determined by considerations of personal
gain. “Perceived Conflict of Interest”
◦ Managed
Potential conflicts may be financial or may be
a conflict of time, effort and/or commitment.
Potential conflicts can occur as a result of
administrative, scientific, academic, fiduciary
or familial situations.
They are situations that can be PERCEIVED to
be conflicting, whether a “real” conflict exists
or not.
Ohio University Policy has a mandatory
disclosure policy if you:
Earn over $10,000 in a twelve month period
from your outside activity OR
Have over 5% equity in the entity
Applies to members of your immediate family
(spouse, domestic partner, dependent
children) as well as yourself.
Anything of monetary value, including but not
limited to:
◦
◦
◦
◦
Salary
Payments for services
Equity interests over 5%
Intellectual property rights
Excludes mutual, pension and other
investments over which you have no control
Outside work during regular academic year
should not exceed equivalent of 1 day per
week.
Consulting work must avoid activities that
involve a conflict of interest with assigned
Ohio University activities and programs
Faculty Handbook, section IV-D
Outside interests cannot interfere with
primary loyalty to Ohio University and your
academic role
Use of university resources must have prior
approval of Chair, Dean and VPR.
Your outside interests should not be in
direct competition with university interests
Full time administrative employees are
expected to devote their full-time
professional loyalty, time and energy to their
position.
You must use non-work hours and no
university resources
Federal Agencies
State Law
University Policies
Many Academic Publications
45 CFR Part 50, Subpart F
“Responsibility of Applicants for Promoting
Objectivity in Research for Which PHS Funding
is Sought”
Authority: 42 U.S.C. 216, 289b-1, 299c-3.
Intent is to assure objectivity by establishing
standards that preclude bias in design, conduct, or
reporting of research
Focuses on financial conflicts of interest
(FCOI)
Regulations apply to investigators, including
sub grantees, contractors, and collaborating
investigators.
Does not apply to applications for support
under Phase I of SBIR and STTR programs
An institutional conflict of interest policy should
require that each investigator disclose to a
responsible representative of the institution all
significant financial interests of the investigator
(including those of the investigator’s spouse and
dependent children) (i) that would reasonably
appear to be affected by the research or
educational activities funded or proposed for
funding by NSF; or (ii) in entities whose financial
interests would reasonably appear to be affected
by such activities.
Chapter 1 (Subchapter A) (Part 54)
Financial Disclosure by Clinical Investigators
The Food and Drug Administration (FDA)
regulations state that investigators that
receive compensation in excess of $25,000
from a corporate sponsor of a trial in which
the investigator is engaged must disclose to
the FDA at the time of filing for a new drug
application.
19.058, Conflict of Interest in Research,
Educational, and Public Service Activities
19.059, Employee Participation in Authorized
Private Companies Commercializing Ohio
University Research
“Conflict of Interest in Research, Educational,
and Public Service Activities”
Most conflict disclosures fall within the
parameters of this policy
States that faculty are primarily responsible
for their academic, research and service
obligations
“Employee Participation in Authorized Private
Companies Commercializing Ohio University
Research”
Applies to “employees, faculty, staff and students,
who create intellectual property owned by the Ohio
University and who desire to hold an equity interest
in a firm, corporation, or other association to which
Ohio University has assigned, licensed or
transferred Ohio University’s interests…”
Consulting
Licensing University Technology
Clinical Studies
Procurement
Mentoring
Institutional
A disclosure is filed specific to the funding
application.
If you have a potential conflict for one
proposal, it does not automatically apply to
all of your proposals.
Research conflicts of interest are usually
disclosed using LEO as you apply for funding
by completing the conflict of interest section
of the electronic transmittal
If you are not using LEO, you can download
the appropriate disclosure form from
www.ohio.edu/research/compliance
“A” is selected if you have no conflicts to
disclose
“B” is selected if you have a potential conflict
to disclose relative to the submission.
(Requires a subsequent paper process)
“C” is selected if you have a current disclosure
on file, but it is not relevant to the proposal
you are submitting
Still uses option A, B or C
Requires that you gather signatures on paper
for all options, however
Generally used for personnel not listed on the
grant proposal or “key personnel”
We have revised the COI forms to word forms
This should be easier to complete than the
previous form
PDF versions are also available
Should be on the compliance web site soon,
but we can e-mail them to you until then
Use this form only if you are unable to use
the LEO transmittal form to assure that no
conflict of interest exists. A form must be
completed for each proposal.
I assure that I have read Ohio University
Policy 19.058, “Conflict of Interest in
Research, Educational, and Public Service
Activities” and declare that I have nothing
that is, or could be perceived to be a conflict
of interest with this proposal.
Use this form to disclose a potential conflict
of interest situation.
A separate disclosure form must be used for
each entity with which you conduct business
Conflict includes any member of your
immediate family (spouse, domestic partner
or children)
Require that you complete an option “B”
disclosure statement in addition to
completing the LEO transmittal form.
Require you to obtain signatures from Center
or Institute (if applicable), Chair and Dean on
the additional disclosure statement!!
The B disclosure form is available at
www.ohio.edu/research/compliance
Use this form only if you are unable to use
the LEO transmittal form. Complete this form
if you have a current conflict of interest
disclosure on file with the Office of Research
Compliance, but that disclosure is not
applicable to this proposal.
*New Option for 2008*
A management plan is developed for some
disclosures to mitigate the potential conflict
Management plans are specific to each
disclosure
May require submission of additional pieces,
such as a student employment plan
Reduce or remove the financial interest creating the
conflict
Place safeguards that mitigate the conflict potential,
such having some decisions made by an independent
entity
Limit participation in portions of the proposed
research likely to create a conflict
Require that the researcher disclose his or her
conflicting financial interests to all collaborators and
any proposed trainees;
Disclose the conflict in publications
Work to remove students from being directly advised
or taught by faculty where a conflict exists
Assure publication rights for student participants
Student Use
Nepotism and Cronyism
Intellectual Property
Use of University Resources
Publication provisions
Use of Human Subjects
Oversight Requirements
Reporting and Annual Reviews
You must submit an annual renewal for your
disclosure
◦ If the potential conflict no longer exists you must
notify us
If significant changes occur during the year
you should submit an update to your
disclosure as they occur
Yes. We encourage employees to disclose
potential conflicts that do not meet the
financial threshold, but may still be
problematic, such as student employment.
This allows you to be transparent with
respect to outside interests.
Allowable situations
Situations that require disclosure but may not
need an extensive management plan
Situations that require disclosure and have
problematic elements that will require
mitigation and/or a management plan
Situations that are not permitted
Receipt of royalties or honoraria for
published scholarly works, seminars,
teaching, etc.
Honoraria for serving as a special reviewer
or work on review panels
Royalties under our intellectual property
policies if no other relationship with entity
Clinical income at OUCOM
You participate in research developed in
whole or part by you, and you or your
family receive royalties from an existing
agreement with the business, but have
no other significant financial interest
You assign students, etc. to research
projects where you are entitled to
receive royalties, but have no other
significant financial interest
You assign students, etc. to projects supported
by the business through an SRA, and have a
significant financial interest other than royalty
income
You receive research support from a business in
which you serve on the board of directors, or
other advisory board, even if you are not
compensated.
You hold an executive position in a business
engaged in commercial or research activities
directly related to your Ohio University
responsibilities.
Any situation in which an actual conflict
exists is not permitted.
The only “exceptions” are those handled
under Ohio University Policy and Procedure
19.059 where faculty entrepreneurship is
addressed.
Participation in clinical trials or evaluation
of other research in which you have a
significant financial interest other than
royalty income.
In the context of your position at Ohio
University, you make professional referrals
to a business in which you have a
significant financial interest.
Letter of admonition
Ineligibility to submit grant applications
Withholding of IRB or IACUC approvals
Suspension
Non-Renewal
Loss of Tenure
Consulting
Procurement
Mentoring
Clinical Studies
Avoid consulting relationships that have
the potential to divert time and effort from
your responsibilities to Ohio University.
Do not use students.
Be wary of situations that limit publication.
Do not use university stationary, etc. that
could create an impression the university
is involved with the activities.
Make sure you are devoting sufficient time
to your university obligations.
Be cautious that the potential financial gain
cannot be perceived to influence your
university mentoring relationships.
Disclose any personal or familial financial
interest or equity in a company that is
doing business with Ohio University.
If you make purchases using public funds,
you should not use companies which will
benefit you or your family. If there is no
alternative you must seek and receive
permission prior to purchasing.
Any relationship in which there is a real or
perceived power or influence imbalance has
the potential for conflict. (Faculty:Student)
Isolating these relationships with respect to
areas of personal financial gain is best.
If they cannot be isolated, then safeguards
must be created.
If you have a financial interest, it is best to
isolate yourself from the study.
At a minimum, expect a more intense review
and a robust management plan if you have a
financial interest.
If both the institution and you have financial
interests the clinical study should be
conducted elsewhere.
You have administrative responsibilities on
behalf of Ohio University that is beneficial to
the business in which you have a significant
financial interest
You have administrative responsibilities on
behalf of Ohio University with respect to an
SRA where you have a significant financial
interest
Slide 17
Jo Ellen Sherow
Ohio University
Office of Research Compliance
Researchers’ Financial Disclosures in the
Spotlight
Conflicts of interest, always an emotional topic,
returned to the headlines this week as Sen.
Charles Grassley, a longtime critic of the drug
industry’s potential influence on research,
released new evidence that prominent Harvard
University scientists had failed to disclose much
of their outside income from pharmaceutical
companies over the past eight years.
http://www.insidehighered.com/news/2008/06/12/conflict January 15, 2008
WEDNESDAY, JANUARY 21, 2009
In a review of the literature regarding the relationship between
smokeless tobacco use and cancer, a conflict of interest of one of the
article's authors was initially not disclosed (see: Boffetta P, Hecht S, Gray
N, Gupta P, Straif K. Smokeless tobacco and cancer. Lancet Oncology
2008; 9:667-675). The original article was published in July, 2008. That
article stated: "The authors declare no conflicts of interest." After the
editor of the journal was notified by a researcher with knowledge of a
potential conflict of interest of Dr. Stephen Hecht (one of the study
authors), an erratum was published in September 2008, which noted:
"During the immediate months preceding submission of the review SH
was acting in the capacity of an expert witness for the plaintiff in a
future court case against a smokeless tobacco company. SH declares his
participation in this case in no way influenced his writing or involvement
in the review."
http://tobaccoanalysis.blogspot.com/2009/01/conflict-of-interestnot.html
January 16, 2009 — More than one third of new
drug marketing applications approved by the US
Food and Drug Administration (FDA) were
missing information about potential conflicts of
interest for clinical trial investigators, which
could allow bias to creep into the approvals
process, a government report released this week
has found. The FDA has said that it agrees with
most of the report's findings.
http://www.medscape.com/viewarticle/586980
Do collaborations between biotech companies
and academic centers constitute a conflict of
interest?
Biotechnology industry partnerships with
universities and academic centers have been
fruitful for both. So why is there so much
concern about conflict of interest and is that
concern appropriate?
http://www.redorbit.com/news/health/750100/genetic_engineering_news_p
osts_podcast_on_industrialacademic_collaborations_are_these/index.html
Universities are responsible for use of public
funds and therefore must maintain the public
trust.
Identifying and mitigating situations that may
have the potential for conflict maintains the
integrity of the university.
Maintaining integrity allows the university to
do credible academic research.
To provide information on the purpose of the
conflict of interest requirements.
To provide a basic overview of conflicts of
interest
To introduce the disclosure process and the use
of management plans
To provide information on the need for updates
and annual renewals.
Situations where financial considerations
compromise your professional judgment.
“Actual Conflict of Interest”
◦ Not permitted
Situations where an independent observer
might reasonably question whether your
professional actions or decisions are
determined by considerations of personal
gain. “Perceived Conflict of Interest”
◦ Managed
Potential conflicts may be financial or may be
a conflict of time, effort and/or commitment.
Potential conflicts can occur as a result of
administrative, scientific, academic, fiduciary
or familial situations.
They are situations that can be PERCEIVED to
be conflicting, whether a “real” conflict exists
or not.
Ohio University Policy has a mandatory
disclosure policy if you:
Earn over $10,000 in a twelve month period
from your outside activity OR
Have over 5% equity in the entity
Applies to members of your immediate family
(spouse, domestic partner, dependent
children) as well as yourself.
Anything of monetary value, including but not
limited to:
◦
◦
◦
◦
Salary
Payments for services
Equity interests over 5%
Intellectual property rights
Excludes mutual, pension and other
investments over which you have no control
Outside work during regular academic year
should not exceed equivalent of 1 day per
week.
Consulting work must avoid activities that
involve a conflict of interest with assigned
Ohio University activities and programs
Faculty Handbook, section IV-D
Outside interests cannot interfere with
primary loyalty to Ohio University and your
academic role
Use of university resources must have prior
approval of Chair, Dean and VPR.
Your outside interests should not be in
direct competition with university interests
Full time administrative employees are
expected to devote their full-time
professional loyalty, time and energy to their
position.
You must use non-work hours and no
university resources
Federal Agencies
State Law
University Policies
Many Academic Publications
45 CFR Part 50, Subpart F
“Responsibility of Applicants for Promoting
Objectivity in Research for Which PHS Funding
is Sought”
Authority: 42 U.S.C. 216, 289b-1, 299c-3.
Intent is to assure objectivity by establishing
standards that preclude bias in design, conduct, or
reporting of research
Focuses on financial conflicts of interest
(FCOI)
Regulations apply to investigators, including
sub grantees, contractors, and collaborating
investigators.
Does not apply to applications for support
under Phase I of SBIR and STTR programs
An institutional conflict of interest policy should
require that each investigator disclose to a
responsible representative of the institution all
significant financial interests of the investigator
(including those of the investigator’s spouse and
dependent children) (i) that would reasonably
appear to be affected by the research or
educational activities funded or proposed for
funding by NSF; or (ii) in entities whose financial
interests would reasonably appear to be affected
by such activities.
Chapter 1 (Subchapter A) (Part 54)
Financial Disclosure by Clinical Investigators
The Food and Drug Administration (FDA)
regulations state that investigators that
receive compensation in excess of $25,000
from a corporate sponsor of a trial in which
the investigator is engaged must disclose to
the FDA at the time of filing for a new drug
application.
19.058, Conflict of Interest in Research,
Educational, and Public Service Activities
19.059, Employee Participation in Authorized
Private Companies Commercializing Ohio
University Research
“Conflict of Interest in Research, Educational,
and Public Service Activities”
Most conflict disclosures fall within the
parameters of this policy
States that faculty are primarily responsible
for their academic, research and service
obligations
“Employee Participation in Authorized Private
Companies Commercializing Ohio University
Research”
Applies to “employees, faculty, staff and students,
who create intellectual property owned by the Ohio
University and who desire to hold an equity interest
in a firm, corporation, or other association to which
Ohio University has assigned, licensed or
transferred Ohio University’s interests…”
Consulting
Licensing University Technology
Clinical Studies
Procurement
Mentoring
Institutional
A disclosure is filed specific to the funding
application.
If you have a potential conflict for one
proposal, it does not automatically apply to
all of your proposals.
Research conflicts of interest are usually
disclosed using LEO as you apply for funding
by completing the conflict of interest section
of the electronic transmittal
If you are not using LEO, you can download
the appropriate disclosure form from
www.ohio.edu/research/compliance
“A” is selected if you have no conflicts to
disclose
“B” is selected if you have a potential conflict
to disclose relative to the submission.
(Requires a subsequent paper process)
“C” is selected if you have a current disclosure
on file, but it is not relevant to the proposal
you are submitting
Still uses option A, B or C
Requires that you gather signatures on paper
for all options, however
Generally used for personnel not listed on the
grant proposal or “key personnel”
We have revised the COI forms to word forms
This should be easier to complete than the
previous form
PDF versions are also available
Should be on the compliance web site soon,
but we can e-mail them to you until then
Use this form only if you are unable to use
the LEO transmittal form to assure that no
conflict of interest exists. A form must be
completed for each proposal.
I assure that I have read Ohio University
Policy 19.058, “Conflict of Interest in
Research, Educational, and Public Service
Activities” and declare that I have nothing
that is, or could be perceived to be a conflict
of interest with this proposal.
Use this form to disclose a potential conflict
of interest situation.
A separate disclosure form must be used for
each entity with which you conduct business
Conflict includes any member of your
immediate family (spouse, domestic partner
or children)
Require that you complete an option “B”
disclosure statement in addition to
completing the LEO transmittal form.
Require you to obtain signatures from Center
or Institute (if applicable), Chair and Dean on
the additional disclosure statement!!
The B disclosure form is available at
www.ohio.edu/research/compliance
Use this form only if you are unable to use
the LEO transmittal form. Complete this form
if you have a current conflict of interest
disclosure on file with the Office of Research
Compliance, but that disclosure is not
applicable to this proposal.
*New Option for 2008*
A management plan is developed for some
disclosures to mitigate the potential conflict
Management plans are specific to each
disclosure
May require submission of additional pieces,
such as a student employment plan
Reduce or remove the financial interest creating the
conflict
Place safeguards that mitigate the conflict potential,
such having some decisions made by an independent
entity
Limit participation in portions of the proposed
research likely to create a conflict
Require that the researcher disclose his or her
conflicting financial interests to all collaborators and
any proposed trainees;
Disclose the conflict in publications
Work to remove students from being directly advised
or taught by faculty where a conflict exists
Assure publication rights for student participants
Student Use
Nepotism and Cronyism
Intellectual Property
Use of University Resources
Publication provisions
Use of Human Subjects
Oversight Requirements
Reporting and Annual Reviews
You must submit an annual renewal for your
disclosure
◦ If the potential conflict no longer exists you must
notify us
If significant changes occur during the year
you should submit an update to your
disclosure as they occur
Yes. We encourage employees to disclose
potential conflicts that do not meet the
financial threshold, but may still be
problematic, such as student employment.
This allows you to be transparent with
respect to outside interests.
Allowable situations
Situations that require disclosure but may not
need an extensive management plan
Situations that require disclosure and have
problematic elements that will require
mitigation and/or a management plan
Situations that are not permitted
Receipt of royalties or honoraria for
published scholarly works, seminars,
teaching, etc.
Honoraria for serving as a special reviewer
or work on review panels
Royalties under our intellectual property
policies if no other relationship with entity
Clinical income at OUCOM
You participate in research developed in
whole or part by you, and you or your
family receive royalties from an existing
agreement with the business, but have
no other significant financial interest
You assign students, etc. to research
projects where you are entitled to
receive royalties, but have no other
significant financial interest
You assign students, etc. to projects supported
by the business through an SRA, and have a
significant financial interest other than royalty
income
You receive research support from a business in
which you serve on the board of directors, or
other advisory board, even if you are not
compensated.
You hold an executive position in a business
engaged in commercial or research activities
directly related to your Ohio University
responsibilities.
Any situation in which an actual conflict
exists is not permitted.
The only “exceptions” are those handled
under Ohio University Policy and Procedure
19.059 where faculty entrepreneurship is
addressed.
Participation in clinical trials or evaluation
of other research in which you have a
significant financial interest other than
royalty income.
In the context of your position at Ohio
University, you make professional referrals
to a business in which you have a
significant financial interest.
Letter of admonition
Ineligibility to submit grant applications
Withholding of IRB or IACUC approvals
Suspension
Non-Renewal
Loss of Tenure
Consulting
Procurement
Mentoring
Clinical Studies
Avoid consulting relationships that have
the potential to divert time and effort from
your responsibilities to Ohio University.
Do not use students.
Be wary of situations that limit publication.
Do not use university stationary, etc. that
could create an impression the university
is involved with the activities.
Make sure you are devoting sufficient time
to your university obligations.
Be cautious that the potential financial gain
cannot be perceived to influence your
university mentoring relationships.
Disclose any personal or familial financial
interest or equity in a company that is
doing business with Ohio University.
If you make purchases using public funds,
you should not use companies which will
benefit you or your family. If there is no
alternative you must seek and receive
permission prior to purchasing.
Any relationship in which there is a real or
perceived power or influence imbalance has
the potential for conflict. (Faculty:Student)
Isolating these relationships with respect to
areas of personal financial gain is best.
If they cannot be isolated, then safeguards
must be created.
If you have a financial interest, it is best to
isolate yourself from the study.
At a minimum, expect a more intense review
and a robust management plan if you have a
financial interest.
If both the institution and you have financial
interests the clinical study should be
conducted elsewhere.
You have administrative responsibilities on
behalf of Ohio University that is beneficial to
the business in which you have a significant
financial interest
You have administrative responsibilities on
behalf of Ohio University with respect to an
SRA where you have a significant financial
interest
Slide 18
Jo Ellen Sherow
Ohio University
Office of Research Compliance
Researchers’ Financial Disclosures in the
Spotlight
Conflicts of interest, always an emotional topic,
returned to the headlines this week as Sen.
Charles Grassley, a longtime critic of the drug
industry’s potential influence on research,
released new evidence that prominent Harvard
University scientists had failed to disclose much
of their outside income from pharmaceutical
companies over the past eight years.
http://www.insidehighered.com/news/2008/06/12/conflict January 15, 2008
WEDNESDAY, JANUARY 21, 2009
In a review of the literature regarding the relationship between
smokeless tobacco use and cancer, a conflict of interest of one of the
article's authors was initially not disclosed (see: Boffetta P, Hecht S, Gray
N, Gupta P, Straif K. Smokeless tobacco and cancer. Lancet Oncology
2008; 9:667-675). The original article was published in July, 2008. That
article stated: "The authors declare no conflicts of interest." After the
editor of the journal was notified by a researcher with knowledge of a
potential conflict of interest of Dr. Stephen Hecht (one of the study
authors), an erratum was published in September 2008, which noted:
"During the immediate months preceding submission of the review SH
was acting in the capacity of an expert witness for the plaintiff in a
future court case against a smokeless tobacco company. SH declares his
participation in this case in no way influenced his writing or involvement
in the review."
http://tobaccoanalysis.blogspot.com/2009/01/conflict-of-interestnot.html
January 16, 2009 — More than one third of new
drug marketing applications approved by the US
Food and Drug Administration (FDA) were
missing information about potential conflicts of
interest for clinical trial investigators, which
could allow bias to creep into the approvals
process, a government report released this week
has found. The FDA has said that it agrees with
most of the report's findings.
http://www.medscape.com/viewarticle/586980
Do collaborations between biotech companies
and academic centers constitute a conflict of
interest?
Biotechnology industry partnerships with
universities and academic centers have been
fruitful for both. So why is there so much
concern about conflict of interest and is that
concern appropriate?
http://www.redorbit.com/news/health/750100/genetic_engineering_news_p
osts_podcast_on_industrialacademic_collaborations_are_these/index.html
Universities are responsible for use of public
funds and therefore must maintain the public
trust.
Identifying and mitigating situations that may
have the potential for conflict maintains the
integrity of the university.
Maintaining integrity allows the university to
do credible academic research.
To provide information on the purpose of the
conflict of interest requirements.
To provide a basic overview of conflicts of
interest
To introduce the disclosure process and the use
of management plans
To provide information on the need for updates
and annual renewals.
Situations where financial considerations
compromise your professional judgment.
“Actual Conflict of Interest”
◦ Not permitted
Situations where an independent observer
might reasonably question whether your
professional actions or decisions are
determined by considerations of personal
gain. “Perceived Conflict of Interest”
◦ Managed
Potential conflicts may be financial or may be
a conflict of time, effort and/or commitment.
Potential conflicts can occur as a result of
administrative, scientific, academic, fiduciary
or familial situations.
They are situations that can be PERCEIVED to
be conflicting, whether a “real” conflict exists
or not.
Ohio University Policy has a mandatory
disclosure policy if you:
Earn over $10,000 in a twelve month period
from your outside activity OR
Have over 5% equity in the entity
Applies to members of your immediate family
(spouse, domestic partner, dependent
children) as well as yourself.
Anything of monetary value, including but not
limited to:
◦
◦
◦
◦
Salary
Payments for services
Equity interests over 5%
Intellectual property rights
Excludes mutual, pension and other
investments over which you have no control
Outside work during regular academic year
should not exceed equivalent of 1 day per
week.
Consulting work must avoid activities that
involve a conflict of interest with assigned
Ohio University activities and programs
Faculty Handbook, section IV-D
Outside interests cannot interfere with
primary loyalty to Ohio University and your
academic role
Use of university resources must have prior
approval of Chair, Dean and VPR.
Your outside interests should not be in
direct competition with university interests
Full time administrative employees are
expected to devote their full-time
professional loyalty, time and energy to their
position.
You must use non-work hours and no
university resources
Federal Agencies
State Law
University Policies
Many Academic Publications
45 CFR Part 50, Subpart F
“Responsibility of Applicants for Promoting
Objectivity in Research for Which PHS Funding
is Sought”
Authority: 42 U.S.C. 216, 289b-1, 299c-3.
Intent is to assure objectivity by establishing
standards that preclude bias in design, conduct, or
reporting of research
Focuses on financial conflicts of interest
(FCOI)
Regulations apply to investigators, including
sub grantees, contractors, and collaborating
investigators.
Does not apply to applications for support
under Phase I of SBIR and STTR programs
An institutional conflict of interest policy should
require that each investigator disclose to a
responsible representative of the institution all
significant financial interests of the investigator
(including those of the investigator’s spouse and
dependent children) (i) that would reasonably
appear to be affected by the research or
educational activities funded or proposed for
funding by NSF; or (ii) in entities whose financial
interests would reasonably appear to be affected
by such activities.
Chapter 1 (Subchapter A) (Part 54)
Financial Disclosure by Clinical Investigators
The Food and Drug Administration (FDA)
regulations state that investigators that
receive compensation in excess of $25,000
from a corporate sponsor of a trial in which
the investigator is engaged must disclose to
the FDA at the time of filing for a new drug
application.
19.058, Conflict of Interest in Research,
Educational, and Public Service Activities
19.059, Employee Participation in Authorized
Private Companies Commercializing Ohio
University Research
“Conflict of Interest in Research, Educational,
and Public Service Activities”
Most conflict disclosures fall within the
parameters of this policy
States that faculty are primarily responsible
for their academic, research and service
obligations
“Employee Participation in Authorized Private
Companies Commercializing Ohio University
Research”
Applies to “employees, faculty, staff and students,
who create intellectual property owned by the Ohio
University and who desire to hold an equity interest
in a firm, corporation, or other association to which
Ohio University has assigned, licensed or
transferred Ohio University’s interests…”
Consulting
Licensing University Technology
Clinical Studies
Procurement
Mentoring
Institutional
A disclosure is filed specific to the funding
application.
If you have a potential conflict for one
proposal, it does not automatically apply to
all of your proposals.
Research conflicts of interest are usually
disclosed using LEO as you apply for funding
by completing the conflict of interest section
of the electronic transmittal
If you are not using LEO, you can download
the appropriate disclosure form from
www.ohio.edu/research/compliance
“A” is selected if you have no conflicts to
disclose
“B” is selected if you have a potential conflict
to disclose relative to the submission.
(Requires a subsequent paper process)
“C” is selected if you have a current disclosure
on file, but it is not relevant to the proposal
you are submitting
Still uses option A, B or C
Requires that you gather signatures on paper
for all options, however
Generally used for personnel not listed on the
grant proposal or “key personnel”
We have revised the COI forms to word forms
This should be easier to complete than the
previous form
PDF versions are also available
Should be on the compliance web site soon,
but we can e-mail them to you until then
Use this form only if you are unable to use
the LEO transmittal form to assure that no
conflict of interest exists. A form must be
completed for each proposal.
I assure that I have read Ohio University
Policy 19.058, “Conflict of Interest in
Research, Educational, and Public Service
Activities” and declare that I have nothing
that is, or could be perceived to be a conflict
of interest with this proposal.
Use this form to disclose a potential conflict
of interest situation.
A separate disclosure form must be used for
each entity with which you conduct business
Conflict includes any member of your
immediate family (spouse, domestic partner
or children)
Require that you complete an option “B”
disclosure statement in addition to
completing the LEO transmittal form.
Require you to obtain signatures from Center
or Institute (if applicable), Chair and Dean on
the additional disclosure statement!!
The B disclosure form is available at
www.ohio.edu/research/compliance
Use this form only if you are unable to use
the LEO transmittal form. Complete this form
if you have a current conflict of interest
disclosure on file with the Office of Research
Compliance, but that disclosure is not
applicable to this proposal.
*New Option for 2008*
A management plan is developed for some
disclosures to mitigate the potential conflict
Management plans are specific to each
disclosure
May require submission of additional pieces,
such as a student employment plan
Reduce or remove the financial interest creating the
conflict
Place safeguards that mitigate the conflict potential,
such having some decisions made by an independent
entity
Limit participation in portions of the proposed
research likely to create a conflict
Require that the researcher disclose his or her
conflicting financial interests to all collaborators and
any proposed trainees;
Disclose the conflict in publications
Work to remove students from being directly advised
or taught by faculty where a conflict exists
Assure publication rights for student participants
Student Use
Nepotism and Cronyism
Intellectual Property
Use of University Resources
Publication provisions
Use of Human Subjects
Oversight Requirements
Reporting and Annual Reviews
You must submit an annual renewal for your
disclosure
◦ If the potential conflict no longer exists you must
notify us
If significant changes occur during the year
you should submit an update to your
disclosure as they occur
Yes. We encourage employees to disclose
potential conflicts that do not meet the
financial threshold, but may still be
problematic, such as student employment.
This allows you to be transparent with
respect to outside interests.
Allowable situations
Situations that require disclosure but may not
need an extensive management plan
Situations that require disclosure and have
problematic elements that will require
mitigation and/or a management plan
Situations that are not permitted
Receipt of royalties or honoraria for
published scholarly works, seminars,
teaching, etc.
Honoraria for serving as a special reviewer
or work on review panels
Royalties under our intellectual property
policies if no other relationship with entity
Clinical income at OUCOM
You participate in research developed in
whole or part by you, and you or your
family receive royalties from an existing
agreement with the business, but have
no other significant financial interest
You assign students, etc. to research
projects where you are entitled to
receive royalties, but have no other
significant financial interest
You assign students, etc. to projects supported
by the business through an SRA, and have a
significant financial interest other than royalty
income
You receive research support from a business in
which you serve on the board of directors, or
other advisory board, even if you are not
compensated.
You hold an executive position in a business
engaged in commercial or research activities
directly related to your Ohio University
responsibilities.
Any situation in which an actual conflict
exists is not permitted.
The only “exceptions” are those handled
under Ohio University Policy and Procedure
19.059 where faculty entrepreneurship is
addressed.
Participation in clinical trials or evaluation
of other research in which you have a
significant financial interest other than
royalty income.
In the context of your position at Ohio
University, you make professional referrals
to a business in which you have a
significant financial interest.
Letter of admonition
Ineligibility to submit grant applications
Withholding of IRB or IACUC approvals
Suspension
Non-Renewal
Loss of Tenure
Consulting
Procurement
Mentoring
Clinical Studies
Avoid consulting relationships that have
the potential to divert time and effort from
your responsibilities to Ohio University.
Do not use students.
Be wary of situations that limit publication.
Do not use university stationary, etc. that
could create an impression the university
is involved with the activities.
Make sure you are devoting sufficient time
to your university obligations.
Be cautious that the potential financial gain
cannot be perceived to influence your
university mentoring relationships.
Disclose any personal or familial financial
interest or equity in a company that is
doing business with Ohio University.
If you make purchases using public funds,
you should not use companies which will
benefit you or your family. If there is no
alternative you must seek and receive
permission prior to purchasing.
Any relationship in which there is a real or
perceived power or influence imbalance has
the potential for conflict. (Faculty:Student)
Isolating these relationships with respect to
areas of personal financial gain is best.
If they cannot be isolated, then safeguards
must be created.
If you have a financial interest, it is best to
isolate yourself from the study.
At a minimum, expect a more intense review
and a robust management plan if you have a
financial interest.
If both the institution and you have financial
interests the clinical study should be
conducted elsewhere.
You have administrative responsibilities on
behalf of Ohio University that is beneficial to
the business in which you have a significant
financial interest
You have administrative responsibilities on
behalf of Ohio University with respect to an
SRA where you have a significant financial
interest
Slide 19
Jo Ellen Sherow
Ohio University
Office of Research Compliance
Researchers’ Financial Disclosures in the
Spotlight
Conflicts of interest, always an emotional topic,
returned to the headlines this week as Sen.
Charles Grassley, a longtime critic of the drug
industry’s potential influence on research,
released new evidence that prominent Harvard
University scientists had failed to disclose much
of their outside income from pharmaceutical
companies over the past eight years.
http://www.insidehighered.com/news/2008/06/12/conflict January 15, 2008
WEDNESDAY, JANUARY 21, 2009
In a review of the literature regarding the relationship between
smokeless tobacco use and cancer, a conflict of interest of one of the
article's authors was initially not disclosed (see: Boffetta P, Hecht S, Gray
N, Gupta P, Straif K. Smokeless tobacco and cancer. Lancet Oncology
2008; 9:667-675). The original article was published in July, 2008. That
article stated: "The authors declare no conflicts of interest." After the
editor of the journal was notified by a researcher with knowledge of a
potential conflict of interest of Dr. Stephen Hecht (one of the study
authors), an erratum was published in September 2008, which noted:
"During the immediate months preceding submission of the review SH
was acting in the capacity of an expert witness for the plaintiff in a
future court case against a smokeless tobacco company. SH declares his
participation in this case in no way influenced his writing or involvement
in the review."
http://tobaccoanalysis.blogspot.com/2009/01/conflict-of-interestnot.html
January 16, 2009 — More than one third of new
drug marketing applications approved by the US
Food and Drug Administration (FDA) were
missing information about potential conflicts of
interest for clinical trial investigators, which
could allow bias to creep into the approvals
process, a government report released this week
has found. The FDA has said that it agrees with
most of the report's findings.
http://www.medscape.com/viewarticle/586980
Do collaborations between biotech companies
and academic centers constitute a conflict of
interest?
Biotechnology industry partnerships with
universities and academic centers have been
fruitful for both. So why is there so much
concern about conflict of interest and is that
concern appropriate?
http://www.redorbit.com/news/health/750100/genetic_engineering_news_p
osts_podcast_on_industrialacademic_collaborations_are_these/index.html
Universities are responsible for use of public
funds and therefore must maintain the public
trust.
Identifying and mitigating situations that may
have the potential for conflict maintains the
integrity of the university.
Maintaining integrity allows the university to
do credible academic research.
To provide information on the purpose of the
conflict of interest requirements.
To provide a basic overview of conflicts of
interest
To introduce the disclosure process and the use
of management plans
To provide information on the need for updates
and annual renewals.
Situations where financial considerations
compromise your professional judgment.
“Actual Conflict of Interest”
◦ Not permitted
Situations where an independent observer
might reasonably question whether your
professional actions or decisions are
determined by considerations of personal
gain. “Perceived Conflict of Interest”
◦ Managed
Potential conflicts may be financial or may be
a conflict of time, effort and/or commitment.
Potential conflicts can occur as a result of
administrative, scientific, academic, fiduciary
or familial situations.
They are situations that can be PERCEIVED to
be conflicting, whether a “real” conflict exists
or not.
Ohio University Policy has a mandatory
disclosure policy if you:
Earn over $10,000 in a twelve month period
from your outside activity OR
Have over 5% equity in the entity
Applies to members of your immediate family
(spouse, domestic partner, dependent
children) as well as yourself.
Anything of monetary value, including but not
limited to:
◦
◦
◦
◦
Salary
Payments for services
Equity interests over 5%
Intellectual property rights
Excludes mutual, pension and other
investments over which you have no control
Outside work during regular academic year
should not exceed equivalent of 1 day per
week.
Consulting work must avoid activities that
involve a conflict of interest with assigned
Ohio University activities and programs
Faculty Handbook, section IV-D
Outside interests cannot interfere with
primary loyalty to Ohio University and your
academic role
Use of university resources must have prior
approval of Chair, Dean and VPR.
Your outside interests should not be in
direct competition with university interests
Full time administrative employees are
expected to devote their full-time
professional loyalty, time and energy to their
position.
You must use non-work hours and no
university resources
Federal Agencies
State Law
University Policies
Many Academic Publications
45 CFR Part 50, Subpart F
“Responsibility of Applicants for Promoting
Objectivity in Research for Which PHS Funding
is Sought”
Authority: 42 U.S.C. 216, 289b-1, 299c-3.
Intent is to assure objectivity by establishing
standards that preclude bias in design, conduct, or
reporting of research
Focuses on financial conflicts of interest
(FCOI)
Regulations apply to investigators, including
sub grantees, contractors, and collaborating
investigators.
Does not apply to applications for support
under Phase I of SBIR and STTR programs
An institutional conflict of interest policy should
require that each investigator disclose to a
responsible representative of the institution all
significant financial interests of the investigator
(including those of the investigator’s spouse and
dependent children) (i) that would reasonably
appear to be affected by the research or
educational activities funded or proposed for
funding by NSF; or (ii) in entities whose financial
interests would reasonably appear to be affected
by such activities.
Chapter 1 (Subchapter A) (Part 54)
Financial Disclosure by Clinical Investigators
The Food and Drug Administration (FDA)
regulations state that investigators that
receive compensation in excess of $25,000
from a corporate sponsor of a trial in which
the investigator is engaged must disclose to
the FDA at the time of filing for a new drug
application.
19.058, Conflict of Interest in Research,
Educational, and Public Service Activities
19.059, Employee Participation in Authorized
Private Companies Commercializing Ohio
University Research
“Conflict of Interest in Research, Educational,
and Public Service Activities”
Most conflict disclosures fall within the
parameters of this policy
States that faculty are primarily responsible
for their academic, research and service
obligations
“Employee Participation in Authorized Private
Companies Commercializing Ohio University
Research”
Applies to “employees, faculty, staff and students,
who create intellectual property owned by the Ohio
University and who desire to hold an equity interest
in a firm, corporation, or other association to which
Ohio University has assigned, licensed or
transferred Ohio University’s interests…”
Consulting
Licensing University Technology
Clinical Studies
Procurement
Mentoring
Institutional
A disclosure is filed specific to the funding
application.
If you have a potential conflict for one
proposal, it does not automatically apply to
all of your proposals.
Research conflicts of interest are usually
disclosed using LEO as you apply for funding
by completing the conflict of interest section
of the electronic transmittal
If you are not using LEO, you can download
the appropriate disclosure form from
www.ohio.edu/research/compliance
“A” is selected if you have no conflicts to
disclose
“B” is selected if you have a potential conflict
to disclose relative to the submission.
(Requires a subsequent paper process)
“C” is selected if you have a current disclosure
on file, but it is not relevant to the proposal
you are submitting
Still uses option A, B or C
Requires that you gather signatures on paper
for all options, however
Generally used for personnel not listed on the
grant proposal or “key personnel”
We have revised the COI forms to word forms
This should be easier to complete than the
previous form
PDF versions are also available
Should be on the compliance web site soon,
but we can e-mail them to you until then
Use this form only if you are unable to use
the LEO transmittal form to assure that no
conflict of interest exists. A form must be
completed for each proposal.
I assure that I have read Ohio University
Policy 19.058, “Conflict of Interest in
Research, Educational, and Public Service
Activities” and declare that I have nothing
that is, or could be perceived to be a conflict
of interest with this proposal.
Use this form to disclose a potential conflict
of interest situation.
A separate disclosure form must be used for
each entity with which you conduct business
Conflict includes any member of your
immediate family (spouse, domestic partner
or children)
Require that you complete an option “B”
disclosure statement in addition to
completing the LEO transmittal form.
Require you to obtain signatures from Center
or Institute (if applicable), Chair and Dean on
the additional disclosure statement!!
The B disclosure form is available at
www.ohio.edu/research/compliance
Use this form only if you are unable to use
the LEO transmittal form. Complete this form
if you have a current conflict of interest
disclosure on file with the Office of Research
Compliance, but that disclosure is not
applicable to this proposal.
*New Option for 2008*
A management plan is developed for some
disclosures to mitigate the potential conflict
Management plans are specific to each
disclosure
May require submission of additional pieces,
such as a student employment plan
Reduce or remove the financial interest creating the
conflict
Place safeguards that mitigate the conflict potential,
such having some decisions made by an independent
entity
Limit participation in portions of the proposed
research likely to create a conflict
Require that the researcher disclose his or her
conflicting financial interests to all collaborators and
any proposed trainees;
Disclose the conflict in publications
Work to remove students from being directly advised
or taught by faculty where a conflict exists
Assure publication rights for student participants
Student Use
Nepotism and Cronyism
Intellectual Property
Use of University Resources
Publication provisions
Use of Human Subjects
Oversight Requirements
Reporting and Annual Reviews
You must submit an annual renewal for your
disclosure
◦ If the potential conflict no longer exists you must
notify us
If significant changes occur during the year
you should submit an update to your
disclosure as they occur
Yes. We encourage employees to disclose
potential conflicts that do not meet the
financial threshold, but may still be
problematic, such as student employment.
This allows you to be transparent with
respect to outside interests.
Allowable situations
Situations that require disclosure but may not
need an extensive management plan
Situations that require disclosure and have
problematic elements that will require
mitigation and/or a management plan
Situations that are not permitted
Receipt of royalties or honoraria for
published scholarly works, seminars,
teaching, etc.
Honoraria for serving as a special reviewer
or work on review panels
Royalties under our intellectual property
policies if no other relationship with entity
Clinical income at OUCOM
You participate in research developed in
whole or part by you, and you or your
family receive royalties from an existing
agreement with the business, but have
no other significant financial interest
You assign students, etc. to research
projects where you are entitled to
receive royalties, but have no other
significant financial interest
You assign students, etc. to projects supported
by the business through an SRA, and have a
significant financial interest other than royalty
income
You receive research support from a business in
which you serve on the board of directors, or
other advisory board, even if you are not
compensated.
You hold an executive position in a business
engaged in commercial or research activities
directly related to your Ohio University
responsibilities.
Any situation in which an actual conflict
exists is not permitted.
The only “exceptions” are those handled
under Ohio University Policy and Procedure
19.059 where faculty entrepreneurship is
addressed.
Participation in clinical trials or evaluation
of other research in which you have a
significant financial interest other than
royalty income.
In the context of your position at Ohio
University, you make professional referrals
to a business in which you have a
significant financial interest.
Letter of admonition
Ineligibility to submit grant applications
Withholding of IRB or IACUC approvals
Suspension
Non-Renewal
Loss of Tenure
Consulting
Procurement
Mentoring
Clinical Studies
Avoid consulting relationships that have
the potential to divert time and effort from
your responsibilities to Ohio University.
Do not use students.
Be wary of situations that limit publication.
Do not use university stationary, etc. that
could create an impression the university
is involved with the activities.
Make sure you are devoting sufficient time
to your university obligations.
Be cautious that the potential financial gain
cannot be perceived to influence your
university mentoring relationships.
Disclose any personal or familial financial
interest or equity in a company that is
doing business with Ohio University.
If you make purchases using public funds,
you should not use companies which will
benefit you or your family. If there is no
alternative you must seek and receive
permission prior to purchasing.
Any relationship in which there is a real or
perceived power or influence imbalance has
the potential for conflict. (Faculty:Student)
Isolating these relationships with respect to
areas of personal financial gain is best.
If they cannot be isolated, then safeguards
must be created.
If you have a financial interest, it is best to
isolate yourself from the study.
At a minimum, expect a more intense review
and a robust management plan if you have a
financial interest.
If both the institution and you have financial
interests the clinical study should be
conducted elsewhere.
You have administrative responsibilities on
behalf of Ohio University that is beneficial to
the business in which you have a significant
financial interest
You have administrative responsibilities on
behalf of Ohio University with respect to an
SRA where you have a significant financial
interest
Slide 20
Jo Ellen Sherow
Ohio University
Office of Research Compliance
Researchers’ Financial Disclosures in the
Spotlight
Conflicts of interest, always an emotional topic,
returned to the headlines this week as Sen.
Charles Grassley, a longtime critic of the drug
industry’s potential influence on research,
released new evidence that prominent Harvard
University scientists had failed to disclose much
of their outside income from pharmaceutical
companies over the past eight years.
http://www.insidehighered.com/news/2008/06/12/conflict January 15, 2008
WEDNESDAY, JANUARY 21, 2009
In a review of the literature regarding the relationship between
smokeless tobacco use and cancer, a conflict of interest of one of the
article's authors was initially not disclosed (see: Boffetta P, Hecht S, Gray
N, Gupta P, Straif K. Smokeless tobacco and cancer. Lancet Oncology
2008; 9:667-675). The original article was published in July, 2008. That
article stated: "The authors declare no conflicts of interest." After the
editor of the journal was notified by a researcher with knowledge of a
potential conflict of interest of Dr. Stephen Hecht (one of the study
authors), an erratum was published in September 2008, which noted:
"During the immediate months preceding submission of the review SH
was acting in the capacity of an expert witness for the plaintiff in a
future court case against a smokeless tobacco company. SH declares his
participation in this case in no way influenced his writing or involvement
in the review."
http://tobaccoanalysis.blogspot.com/2009/01/conflict-of-interestnot.html
January 16, 2009 — More than one third of new
drug marketing applications approved by the US
Food and Drug Administration (FDA) were
missing information about potential conflicts of
interest for clinical trial investigators, which
could allow bias to creep into the approvals
process, a government report released this week
has found. The FDA has said that it agrees with
most of the report's findings.
http://www.medscape.com/viewarticle/586980
Do collaborations between biotech companies
and academic centers constitute a conflict of
interest?
Biotechnology industry partnerships with
universities and academic centers have been
fruitful for both. So why is there so much
concern about conflict of interest and is that
concern appropriate?
http://www.redorbit.com/news/health/750100/genetic_engineering_news_p
osts_podcast_on_industrialacademic_collaborations_are_these/index.html
Universities are responsible for use of public
funds and therefore must maintain the public
trust.
Identifying and mitigating situations that may
have the potential for conflict maintains the
integrity of the university.
Maintaining integrity allows the university to
do credible academic research.
To provide information on the purpose of the
conflict of interest requirements.
To provide a basic overview of conflicts of
interest
To introduce the disclosure process and the use
of management plans
To provide information on the need for updates
and annual renewals.
Situations where financial considerations
compromise your professional judgment.
“Actual Conflict of Interest”
◦ Not permitted
Situations where an independent observer
might reasonably question whether your
professional actions or decisions are
determined by considerations of personal
gain. “Perceived Conflict of Interest”
◦ Managed
Potential conflicts may be financial or may be
a conflict of time, effort and/or commitment.
Potential conflicts can occur as a result of
administrative, scientific, academic, fiduciary
or familial situations.
They are situations that can be PERCEIVED to
be conflicting, whether a “real” conflict exists
or not.
Ohio University Policy has a mandatory
disclosure policy if you:
Earn over $10,000 in a twelve month period
from your outside activity OR
Have over 5% equity in the entity
Applies to members of your immediate family
(spouse, domestic partner, dependent
children) as well as yourself.
Anything of monetary value, including but not
limited to:
◦
◦
◦
◦
Salary
Payments for services
Equity interests over 5%
Intellectual property rights
Excludes mutual, pension and other
investments over which you have no control
Outside work during regular academic year
should not exceed equivalent of 1 day per
week.
Consulting work must avoid activities that
involve a conflict of interest with assigned
Ohio University activities and programs
Faculty Handbook, section IV-D
Outside interests cannot interfere with
primary loyalty to Ohio University and your
academic role
Use of university resources must have prior
approval of Chair, Dean and VPR.
Your outside interests should not be in
direct competition with university interests
Full time administrative employees are
expected to devote their full-time
professional loyalty, time and energy to their
position.
You must use non-work hours and no
university resources
Federal Agencies
State Law
University Policies
Many Academic Publications
45 CFR Part 50, Subpart F
“Responsibility of Applicants for Promoting
Objectivity in Research for Which PHS Funding
is Sought”
Authority: 42 U.S.C. 216, 289b-1, 299c-3.
Intent is to assure objectivity by establishing
standards that preclude bias in design, conduct, or
reporting of research
Focuses on financial conflicts of interest
(FCOI)
Regulations apply to investigators, including
sub grantees, contractors, and collaborating
investigators.
Does not apply to applications for support
under Phase I of SBIR and STTR programs
An institutional conflict of interest policy should
require that each investigator disclose to a
responsible representative of the institution all
significant financial interests of the investigator
(including those of the investigator’s spouse and
dependent children) (i) that would reasonably
appear to be affected by the research or
educational activities funded or proposed for
funding by NSF; or (ii) in entities whose financial
interests would reasonably appear to be affected
by such activities.
Chapter 1 (Subchapter A) (Part 54)
Financial Disclosure by Clinical Investigators
The Food and Drug Administration (FDA)
regulations state that investigators that
receive compensation in excess of $25,000
from a corporate sponsor of a trial in which
the investigator is engaged must disclose to
the FDA at the time of filing for a new drug
application.
19.058, Conflict of Interest in Research,
Educational, and Public Service Activities
19.059, Employee Participation in Authorized
Private Companies Commercializing Ohio
University Research
“Conflict of Interest in Research, Educational,
and Public Service Activities”
Most conflict disclosures fall within the
parameters of this policy
States that faculty are primarily responsible
for their academic, research and service
obligations
“Employee Participation in Authorized Private
Companies Commercializing Ohio University
Research”
Applies to “employees, faculty, staff and students,
who create intellectual property owned by the Ohio
University and who desire to hold an equity interest
in a firm, corporation, or other association to which
Ohio University has assigned, licensed or
transferred Ohio University’s interests…”
Consulting
Licensing University Technology
Clinical Studies
Procurement
Mentoring
Institutional
A disclosure is filed specific to the funding
application.
If you have a potential conflict for one
proposal, it does not automatically apply to
all of your proposals.
Research conflicts of interest are usually
disclosed using LEO as you apply for funding
by completing the conflict of interest section
of the electronic transmittal
If you are not using LEO, you can download
the appropriate disclosure form from
www.ohio.edu/research/compliance
“A” is selected if you have no conflicts to
disclose
“B” is selected if you have a potential conflict
to disclose relative to the submission.
(Requires a subsequent paper process)
“C” is selected if you have a current disclosure
on file, but it is not relevant to the proposal
you are submitting
Still uses option A, B or C
Requires that you gather signatures on paper
for all options, however
Generally used for personnel not listed on the
grant proposal or “key personnel”
We have revised the COI forms to word forms
This should be easier to complete than the
previous form
PDF versions are also available
Should be on the compliance web site soon,
but we can e-mail them to you until then
Use this form only if you are unable to use
the LEO transmittal form to assure that no
conflict of interest exists. A form must be
completed for each proposal.
I assure that I have read Ohio University
Policy 19.058, “Conflict of Interest in
Research, Educational, and Public Service
Activities” and declare that I have nothing
that is, or could be perceived to be a conflict
of interest with this proposal.
Use this form to disclose a potential conflict
of interest situation.
A separate disclosure form must be used for
each entity with which you conduct business
Conflict includes any member of your
immediate family (spouse, domestic partner
or children)
Require that you complete an option “B”
disclosure statement in addition to
completing the LEO transmittal form.
Require you to obtain signatures from Center
or Institute (if applicable), Chair and Dean on
the additional disclosure statement!!
The B disclosure form is available at
www.ohio.edu/research/compliance
Use this form only if you are unable to use
the LEO transmittal form. Complete this form
if you have a current conflict of interest
disclosure on file with the Office of Research
Compliance, but that disclosure is not
applicable to this proposal.
*New Option for 2008*
A management plan is developed for some
disclosures to mitigate the potential conflict
Management plans are specific to each
disclosure
May require submission of additional pieces,
such as a student employment plan
Reduce or remove the financial interest creating the
conflict
Place safeguards that mitigate the conflict potential,
such having some decisions made by an independent
entity
Limit participation in portions of the proposed
research likely to create a conflict
Require that the researcher disclose his or her
conflicting financial interests to all collaborators and
any proposed trainees;
Disclose the conflict in publications
Work to remove students from being directly advised
or taught by faculty where a conflict exists
Assure publication rights for student participants
Student Use
Nepotism and Cronyism
Intellectual Property
Use of University Resources
Publication provisions
Use of Human Subjects
Oversight Requirements
Reporting and Annual Reviews
You must submit an annual renewal for your
disclosure
◦ If the potential conflict no longer exists you must
notify us
If significant changes occur during the year
you should submit an update to your
disclosure as they occur
Yes. We encourage employees to disclose
potential conflicts that do not meet the
financial threshold, but may still be
problematic, such as student employment.
This allows you to be transparent with
respect to outside interests.
Allowable situations
Situations that require disclosure but may not
need an extensive management plan
Situations that require disclosure and have
problematic elements that will require
mitigation and/or a management plan
Situations that are not permitted
Receipt of royalties or honoraria for
published scholarly works, seminars,
teaching, etc.
Honoraria for serving as a special reviewer
or work on review panels
Royalties under our intellectual property
policies if no other relationship with entity
Clinical income at OUCOM
You participate in research developed in
whole or part by you, and you or your
family receive royalties from an existing
agreement with the business, but have
no other significant financial interest
You assign students, etc. to research
projects where you are entitled to
receive royalties, but have no other
significant financial interest
You assign students, etc. to projects supported
by the business through an SRA, and have a
significant financial interest other than royalty
income
You receive research support from a business in
which you serve on the board of directors, or
other advisory board, even if you are not
compensated.
You hold an executive position in a business
engaged in commercial or research activities
directly related to your Ohio University
responsibilities.
Any situation in which an actual conflict
exists is not permitted.
The only “exceptions” are those handled
under Ohio University Policy and Procedure
19.059 where faculty entrepreneurship is
addressed.
Participation in clinical trials or evaluation
of other research in which you have a
significant financial interest other than
royalty income.
In the context of your position at Ohio
University, you make professional referrals
to a business in which you have a
significant financial interest.
Letter of admonition
Ineligibility to submit grant applications
Withholding of IRB or IACUC approvals
Suspension
Non-Renewal
Loss of Tenure
Consulting
Procurement
Mentoring
Clinical Studies
Avoid consulting relationships that have
the potential to divert time and effort from
your responsibilities to Ohio University.
Do not use students.
Be wary of situations that limit publication.
Do not use university stationary, etc. that
could create an impression the university
is involved with the activities.
Make sure you are devoting sufficient time
to your university obligations.
Be cautious that the potential financial gain
cannot be perceived to influence your
university mentoring relationships.
Disclose any personal or familial financial
interest or equity in a company that is
doing business with Ohio University.
If you make purchases using public funds,
you should not use companies which will
benefit you or your family. If there is no
alternative you must seek and receive
permission prior to purchasing.
Any relationship in which there is a real or
perceived power or influence imbalance has
the potential for conflict. (Faculty:Student)
Isolating these relationships with respect to
areas of personal financial gain is best.
If they cannot be isolated, then safeguards
must be created.
If you have a financial interest, it is best to
isolate yourself from the study.
At a minimum, expect a more intense review
and a robust management plan if you have a
financial interest.
If both the institution and you have financial
interests the clinical study should be
conducted elsewhere.
You have administrative responsibilities on
behalf of Ohio University that is beneficial to
the business in which you have a significant
financial interest
You have administrative responsibilities on
behalf of Ohio University with respect to an
SRA where you have a significant financial
interest
Slide 21
Jo Ellen Sherow
Ohio University
Office of Research Compliance
Researchers’ Financial Disclosures in the
Spotlight
Conflicts of interest, always an emotional topic,
returned to the headlines this week as Sen.
Charles Grassley, a longtime critic of the drug
industry’s potential influence on research,
released new evidence that prominent Harvard
University scientists had failed to disclose much
of their outside income from pharmaceutical
companies over the past eight years.
http://www.insidehighered.com/news/2008/06/12/conflict January 15, 2008
WEDNESDAY, JANUARY 21, 2009
In a review of the literature regarding the relationship between
smokeless tobacco use and cancer, a conflict of interest of one of the
article's authors was initially not disclosed (see: Boffetta P, Hecht S, Gray
N, Gupta P, Straif K. Smokeless tobacco and cancer. Lancet Oncology
2008; 9:667-675). The original article was published in July, 2008. That
article stated: "The authors declare no conflicts of interest." After the
editor of the journal was notified by a researcher with knowledge of a
potential conflict of interest of Dr. Stephen Hecht (one of the study
authors), an erratum was published in September 2008, which noted:
"During the immediate months preceding submission of the review SH
was acting in the capacity of an expert witness for the plaintiff in a
future court case against a smokeless tobacco company. SH declares his
participation in this case in no way influenced his writing or involvement
in the review."
http://tobaccoanalysis.blogspot.com/2009/01/conflict-of-interestnot.html
January 16, 2009 — More than one third of new
drug marketing applications approved by the US
Food and Drug Administration (FDA) were
missing information about potential conflicts of
interest for clinical trial investigators, which
could allow bias to creep into the approvals
process, a government report released this week
has found. The FDA has said that it agrees with
most of the report's findings.
http://www.medscape.com/viewarticle/586980
Do collaborations between biotech companies
and academic centers constitute a conflict of
interest?
Biotechnology industry partnerships with
universities and academic centers have been
fruitful for both. So why is there so much
concern about conflict of interest and is that
concern appropriate?
http://www.redorbit.com/news/health/750100/genetic_engineering_news_p
osts_podcast_on_industrialacademic_collaborations_are_these/index.html
Universities are responsible for use of public
funds and therefore must maintain the public
trust.
Identifying and mitigating situations that may
have the potential for conflict maintains the
integrity of the university.
Maintaining integrity allows the university to
do credible academic research.
To provide information on the purpose of the
conflict of interest requirements.
To provide a basic overview of conflicts of
interest
To introduce the disclosure process and the use
of management plans
To provide information on the need for updates
and annual renewals.
Situations where financial considerations
compromise your professional judgment.
“Actual Conflict of Interest”
◦ Not permitted
Situations where an independent observer
might reasonably question whether your
professional actions or decisions are
determined by considerations of personal
gain. “Perceived Conflict of Interest”
◦ Managed
Potential conflicts may be financial or may be
a conflict of time, effort and/or commitment.
Potential conflicts can occur as a result of
administrative, scientific, academic, fiduciary
or familial situations.
They are situations that can be PERCEIVED to
be conflicting, whether a “real” conflict exists
or not.
Ohio University Policy has a mandatory
disclosure policy if you:
Earn over $10,000 in a twelve month period
from your outside activity OR
Have over 5% equity in the entity
Applies to members of your immediate family
(spouse, domestic partner, dependent
children) as well as yourself.
Anything of monetary value, including but not
limited to:
◦
◦
◦
◦
Salary
Payments for services
Equity interests over 5%
Intellectual property rights
Excludes mutual, pension and other
investments over which you have no control
Outside work during regular academic year
should not exceed equivalent of 1 day per
week.
Consulting work must avoid activities that
involve a conflict of interest with assigned
Ohio University activities and programs
Faculty Handbook, section IV-D
Outside interests cannot interfere with
primary loyalty to Ohio University and your
academic role
Use of university resources must have prior
approval of Chair, Dean and VPR.
Your outside interests should not be in
direct competition with university interests
Full time administrative employees are
expected to devote their full-time
professional loyalty, time and energy to their
position.
You must use non-work hours and no
university resources
Federal Agencies
State Law
University Policies
Many Academic Publications
45 CFR Part 50, Subpart F
“Responsibility of Applicants for Promoting
Objectivity in Research for Which PHS Funding
is Sought”
Authority: 42 U.S.C. 216, 289b-1, 299c-3.
Intent is to assure objectivity by establishing
standards that preclude bias in design, conduct, or
reporting of research
Focuses on financial conflicts of interest
(FCOI)
Regulations apply to investigators, including
sub grantees, contractors, and collaborating
investigators.
Does not apply to applications for support
under Phase I of SBIR and STTR programs
An institutional conflict of interest policy should
require that each investigator disclose to a
responsible representative of the institution all
significant financial interests of the investigator
(including those of the investigator’s spouse and
dependent children) (i) that would reasonably
appear to be affected by the research or
educational activities funded or proposed for
funding by NSF; or (ii) in entities whose financial
interests would reasonably appear to be affected
by such activities.
Chapter 1 (Subchapter A) (Part 54)
Financial Disclosure by Clinical Investigators
The Food and Drug Administration (FDA)
regulations state that investigators that
receive compensation in excess of $25,000
from a corporate sponsor of a trial in which
the investigator is engaged must disclose to
the FDA at the time of filing for a new drug
application.
19.058, Conflict of Interest in Research,
Educational, and Public Service Activities
19.059, Employee Participation in Authorized
Private Companies Commercializing Ohio
University Research
“Conflict of Interest in Research, Educational,
and Public Service Activities”
Most conflict disclosures fall within the
parameters of this policy
States that faculty are primarily responsible
for their academic, research and service
obligations
“Employee Participation in Authorized Private
Companies Commercializing Ohio University
Research”
Applies to “employees, faculty, staff and students,
who create intellectual property owned by the Ohio
University and who desire to hold an equity interest
in a firm, corporation, or other association to which
Ohio University has assigned, licensed or
transferred Ohio University’s interests…”
Consulting
Licensing University Technology
Clinical Studies
Procurement
Mentoring
Institutional
A disclosure is filed specific to the funding
application.
If you have a potential conflict for one
proposal, it does not automatically apply to
all of your proposals.
Research conflicts of interest are usually
disclosed using LEO as you apply for funding
by completing the conflict of interest section
of the electronic transmittal
If you are not using LEO, you can download
the appropriate disclosure form from
www.ohio.edu/research/compliance
“A” is selected if you have no conflicts to
disclose
“B” is selected if you have a potential conflict
to disclose relative to the submission.
(Requires a subsequent paper process)
“C” is selected if you have a current disclosure
on file, but it is not relevant to the proposal
you are submitting
Still uses option A, B or C
Requires that you gather signatures on paper
for all options, however
Generally used for personnel not listed on the
grant proposal or “key personnel”
We have revised the COI forms to word forms
This should be easier to complete than the
previous form
PDF versions are also available
Should be on the compliance web site soon,
but we can e-mail them to you until then
Use this form only if you are unable to use
the LEO transmittal form to assure that no
conflict of interest exists. A form must be
completed for each proposal.
I assure that I have read Ohio University
Policy 19.058, “Conflict of Interest in
Research, Educational, and Public Service
Activities” and declare that I have nothing
that is, or could be perceived to be a conflict
of interest with this proposal.
Use this form to disclose a potential conflict
of interest situation.
A separate disclosure form must be used for
each entity with which you conduct business
Conflict includes any member of your
immediate family (spouse, domestic partner
or children)
Require that you complete an option “B”
disclosure statement in addition to
completing the LEO transmittal form.
Require you to obtain signatures from Center
or Institute (if applicable), Chair and Dean on
the additional disclosure statement!!
The B disclosure form is available at
www.ohio.edu/research/compliance
Use this form only if you are unable to use
the LEO transmittal form. Complete this form
if you have a current conflict of interest
disclosure on file with the Office of Research
Compliance, but that disclosure is not
applicable to this proposal.
*New Option for 2008*
A management plan is developed for some
disclosures to mitigate the potential conflict
Management plans are specific to each
disclosure
May require submission of additional pieces,
such as a student employment plan
Reduce or remove the financial interest creating the
conflict
Place safeguards that mitigate the conflict potential,
such having some decisions made by an independent
entity
Limit participation in portions of the proposed
research likely to create a conflict
Require that the researcher disclose his or her
conflicting financial interests to all collaborators and
any proposed trainees;
Disclose the conflict in publications
Work to remove students from being directly advised
or taught by faculty where a conflict exists
Assure publication rights for student participants
Student Use
Nepotism and Cronyism
Intellectual Property
Use of University Resources
Publication provisions
Use of Human Subjects
Oversight Requirements
Reporting and Annual Reviews
You must submit an annual renewal for your
disclosure
◦ If the potential conflict no longer exists you must
notify us
If significant changes occur during the year
you should submit an update to your
disclosure as they occur
Yes. We encourage employees to disclose
potential conflicts that do not meet the
financial threshold, but may still be
problematic, such as student employment.
This allows you to be transparent with
respect to outside interests.
Allowable situations
Situations that require disclosure but may not
need an extensive management plan
Situations that require disclosure and have
problematic elements that will require
mitigation and/or a management plan
Situations that are not permitted
Receipt of royalties or honoraria for
published scholarly works, seminars,
teaching, etc.
Honoraria for serving as a special reviewer
or work on review panels
Royalties under our intellectual property
policies if no other relationship with entity
Clinical income at OUCOM
You participate in research developed in
whole or part by you, and you or your
family receive royalties from an existing
agreement with the business, but have
no other significant financial interest
You assign students, etc. to research
projects where you are entitled to
receive royalties, but have no other
significant financial interest
You assign students, etc. to projects supported
by the business through an SRA, and have a
significant financial interest other than royalty
income
You receive research support from a business in
which you serve on the board of directors, or
other advisory board, even if you are not
compensated.
You hold an executive position in a business
engaged in commercial or research activities
directly related to your Ohio University
responsibilities.
Any situation in which an actual conflict
exists is not permitted.
The only “exceptions” are those handled
under Ohio University Policy and Procedure
19.059 where faculty entrepreneurship is
addressed.
Participation in clinical trials or evaluation
of other research in which you have a
significant financial interest other than
royalty income.
In the context of your position at Ohio
University, you make professional referrals
to a business in which you have a
significant financial interest.
Letter of admonition
Ineligibility to submit grant applications
Withholding of IRB or IACUC approvals
Suspension
Non-Renewal
Loss of Tenure
Consulting
Procurement
Mentoring
Clinical Studies
Avoid consulting relationships that have
the potential to divert time and effort from
your responsibilities to Ohio University.
Do not use students.
Be wary of situations that limit publication.
Do not use university stationary, etc. that
could create an impression the university
is involved with the activities.
Make sure you are devoting sufficient time
to your university obligations.
Be cautious that the potential financial gain
cannot be perceived to influence your
university mentoring relationships.
Disclose any personal or familial financial
interest or equity in a company that is
doing business with Ohio University.
If you make purchases using public funds,
you should not use companies which will
benefit you or your family. If there is no
alternative you must seek and receive
permission prior to purchasing.
Any relationship in which there is a real or
perceived power or influence imbalance has
the potential for conflict. (Faculty:Student)
Isolating these relationships with respect to
areas of personal financial gain is best.
If they cannot be isolated, then safeguards
must be created.
If you have a financial interest, it is best to
isolate yourself from the study.
At a minimum, expect a more intense review
and a robust management plan if you have a
financial interest.
If both the institution and you have financial
interests the clinical study should be
conducted elsewhere.
You have administrative responsibilities on
behalf of Ohio University that is beneficial to
the business in which you have a significant
financial interest
You have administrative responsibilities on
behalf of Ohio University with respect to an
SRA where you have a significant financial
interest
Slide 22
Jo Ellen Sherow
Ohio University
Office of Research Compliance
Researchers’ Financial Disclosures in the
Spotlight
Conflicts of interest, always an emotional topic,
returned to the headlines this week as Sen.
Charles Grassley, a longtime critic of the drug
industry’s potential influence on research,
released new evidence that prominent Harvard
University scientists had failed to disclose much
of their outside income from pharmaceutical
companies over the past eight years.
http://www.insidehighered.com/news/2008/06/12/conflict January 15, 2008
WEDNESDAY, JANUARY 21, 2009
In a review of the literature regarding the relationship between
smokeless tobacco use and cancer, a conflict of interest of one of the
article's authors was initially not disclosed (see: Boffetta P, Hecht S, Gray
N, Gupta P, Straif K. Smokeless tobacco and cancer. Lancet Oncology
2008; 9:667-675). The original article was published in July, 2008. That
article stated: "The authors declare no conflicts of interest." After the
editor of the journal was notified by a researcher with knowledge of a
potential conflict of interest of Dr. Stephen Hecht (one of the study
authors), an erratum was published in September 2008, which noted:
"During the immediate months preceding submission of the review SH
was acting in the capacity of an expert witness for the plaintiff in a
future court case against a smokeless tobacco company. SH declares his
participation in this case in no way influenced his writing or involvement
in the review."
http://tobaccoanalysis.blogspot.com/2009/01/conflict-of-interestnot.html
January 16, 2009 — More than one third of new
drug marketing applications approved by the US
Food and Drug Administration (FDA) were
missing information about potential conflicts of
interest for clinical trial investigators, which
could allow bias to creep into the approvals
process, a government report released this week
has found. The FDA has said that it agrees with
most of the report's findings.
http://www.medscape.com/viewarticle/586980
Do collaborations between biotech companies
and academic centers constitute a conflict of
interest?
Biotechnology industry partnerships with
universities and academic centers have been
fruitful for both. So why is there so much
concern about conflict of interest and is that
concern appropriate?
http://www.redorbit.com/news/health/750100/genetic_engineering_news_p
osts_podcast_on_industrialacademic_collaborations_are_these/index.html
Universities are responsible for use of public
funds and therefore must maintain the public
trust.
Identifying and mitigating situations that may
have the potential for conflict maintains the
integrity of the university.
Maintaining integrity allows the university to
do credible academic research.
To provide information on the purpose of the
conflict of interest requirements.
To provide a basic overview of conflicts of
interest
To introduce the disclosure process and the use
of management plans
To provide information on the need for updates
and annual renewals.
Situations where financial considerations
compromise your professional judgment.
“Actual Conflict of Interest”
◦ Not permitted
Situations where an independent observer
might reasonably question whether your
professional actions or decisions are
determined by considerations of personal
gain. “Perceived Conflict of Interest”
◦ Managed
Potential conflicts may be financial or may be
a conflict of time, effort and/or commitment.
Potential conflicts can occur as a result of
administrative, scientific, academic, fiduciary
or familial situations.
They are situations that can be PERCEIVED to
be conflicting, whether a “real” conflict exists
or not.
Ohio University Policy has a mandatory
disclosure policy if you:
Earn over $10,000 in a twelve month period
from your outside activity OR
Have over 5% equity in the entity
Applies to members of your immediate family
(spouse, domestic partner, dependent
children) as well as yourself.
Anything of monetary value, including but not
limited to:
◦
◦
◦
◦
Salary
Payments for services
Equity interests over 5%
Intellectual property rights
Excludes mutual, pension and other
investments over which you have no control
Outside work during regular academic year
should not exceed equivalent of 1 day per
week.
Consulting work must avoid activities that
involve a conflict of interest with assigned
Ohio University activities and programs
Faculty Handbook, section IV-D
Outside interests cannot interfere with
primary loyalty to Ohio University and your
academic role
Use of university resources must have prior
approval of Chair, Dean and VPR.
Your outside interests should not be in
direct competition with university interests
Full time administrative employees are
expected to devote their full-time
professional loyalty, time and energy to their
position.
You must use non-work hours and no
university resources
Federal Agencies
State Law
University Policies
Many Academic Publications
45 CFR Part 50, Subpart F
“Responsibility of Applicants for Promoting
Objectivity in Research for Which PHS Funding
is Sought”
Authority: 42 U.S.C. 216, 289b-1, 299c-3.
Intent is to assure objectivity by establishing
standards that preclude bias in design, conduct, or
reporting of research
Focuses on financial conflicts of interest
(FCOI)
Regulations apply to investigators, including
sub grantees, contractors, and collaborating
investigators.
Does not apply to applications for support
under Phase I of SBIR and STTR programs
An institutional conflict of interest policy should
require that each investigator disclose to a
responsible representative of the institution all
significant financial interests of the investigator
(including those of the investigator’s spouse and
dependent children) (i) that would reasonably
appear to be affected by the research or
educational activities funded or proposed for
funding by NSF; or (ii) in entities whose financial
interests would reasonably appear to be affected
by such activities.
Chapter 1 (Subchapter A) (Part 54)
Financial Disclosure by Clinical Investigators
The Food and Drug Administration (FDA)
regulations state that investigators that
receive compensation in excess of $25,000
from a corporate sponsor of a trial in which
the investigator is engaged must disclose to
the FDA at the time of filing for a new drug
application.
19.058, Conflict of Interest in Research,
Educational, and Public Service Activities
19.059, Employee Participation in Authorized
Private Companies Commercializing Ohio
University Research
“Conflict of Interest in Research, Educational,
and Public Service Activities”
Most conflict disclosures fall within the
parameters of this policy
States that faculty are primarily responsible
for their academic, research and service
obligations
“Employee Participation in Authorized Private
Companies Commercializing Ohio University
Research”
Applies to “employees, faculty, staff and students,
who create intellectual property owned by the Ohio
University and who desire to hold an equity interest
in a firm, corporation, or other association to which
Ohio University has assigned, licensed or
transferred Ohio University’s interests…”
Consulting
Licensing University Technology
Clinical Studies
Procurement
Mentoring
Institutional
A disclosure is filed specific to the funding
application.
If you have a potential conflict for one
proposal, it does not automatically apply to
all of your proposals.
Research conflicts of interest are usually
disclosed using LEO as you apply for funding
by completing the conflict of interest section
of the electronic transmittal
If you are not using LEO, you can download
the appropriate disclosure form from
www.ohio.edu/research/compliance
“A” is selected if you have no conflicts to
disclose
“B” is selected if you have a potential conflict
to disclose relative to the submission.
(Requires a subsequent paper process)
“C” is selected if you have a current disclosure
on file, but it is not relevant to the proposal
you are submitting
Still uses option A, B or C
Requires that you gather signatures on paper
for all options, however
Generally used for personnel not listed on the
grant proposal or “key personnel”
We have revised the COI forms to word forms
This should be easier to complete than the
previous form
PDF versions are also available
Should be on the compliance web site soon,
but we can e-mail them to you until then
Use this form only if you are unable to use
the LEO transmittal form to assure that no
conflict of interest exists. A form must be
completed for each proposal.
I assure that I have read Ohio University
Policy 19.058, “Conflict of Interest in
Research, Educational, and Public Service
Activities” and declare that I have nothing
that is, or could be perceived to be a conflict
of interest with this proposal.
Use this form to disclose a potential conflict
of interest situation.
A separate disclosure form must be used for
each entity with which you conduct business
Conflict includes any member of your
immediate family (spouse, domestic partner
or children)
Require that you complete an option “B”
disclosure statement in addition to
completing the LEO transmittal form.
Require you to obtain signatures from Center
or Institute (if applicable), Chair and Dean on
the additional disclosure statement!!
The B disclosure form is available at
www.ohio.edu/research/compliance
Use this form only if you are unable to use
the LEO transmittal form. Complete this form
if you have a current conflict of interest
disclosure on file with the Office of Research
Compliance, but that disclosure is not
applicable to this proposal.
*New Option for 2008*
A management plan is developed for some
disclosures to mitigate the potential conflict
Management plans are specific to each
disclosure
May require submission of additional pieces,
such as a student employment plan
Reduce or remove the financial interest creating the
conflict
Place safeguards that mitigate the conflict potential,
such having some decisions made by an independent
entity
Limit participation in portions of the proposed
research likely to create a conflict
Require that the researcher disclose his or her
conflicting financial interests to all collaborators and
any proposed trainees;
Disclose the conflict in publications
Work to remove students from being directly advised
or taught by faculty where a conflict exists
Assure publication rights for student participants
Student Use
Nepotism and Cronyism
Intellectual Property
Use of University Resources
Publication provisions
Use of Human Subjects
Oversight Requirements
Reporting and Annual Reviews
You must submit an annual renewal for your
disclosure
◦ If the potential conflict no longer exists you must
notify us
If significant changes occur during the year
you should submit an update to your
disclosure as they occur
Yes. We encourage employees to disclose
potential conflicts that do not meet the
financial threshold, but may still be
problematic, such as student employment.
This allows you to be transparent with
respect to outside interests.
Allowable situations
Situations that require disclosure but may not
need an extensive management plan
Situations that require disclosure and have
problematic elements that will require
mitigation and/or a management plan
Situations that are not permitted
Receipt of royalties or honoraria for
published scholarly works, seminars,
teaching, etc.
Honoraria for serving as a special reviewer
or work on review panels
Royalties under our intellectual property
policies if no other relationship with entity
Clinical income at OUCOM
You participate in research developed in
whole or part by you, and you or your
family receive royalties from an existing
agreement with the business, but have
no other significant financial interest
You assign students, etc. to research
projects where you are entitled to
receive royalties, but have no other
significant financial interest
You assign students, etc. to projects supported
by the business through an SRA, and have a
significant financial interest other than royalty
income
You receive research support from a business in
which you serve on the board of directors, or
other advisory board, even if you are not
compensated.
You hold an executive position in a business
engaged in commercial or research activities
directly related to your Ohio University
responsibilities.
Any situation in which an actual conflict
exists is not permitted.
The only “exceptions” are those handled
under Ohio University Policy and Procedure
19.059 where faculty entrepreneurship is
addressed.
Participation in clinical trials or evaluation
of other research in which you have a
significant financial interest other than
royalty income.
In the context of your position at Ohio
University, you make professional referrals
to a business in which you have a
significant financial interest.
Letter of admonition
Ineligibility to submit grant applications
Withholding of IRB or IACUC approvals
Suspension
Non-Renewal
Loss of Tenure
Consulting
Procurement
Mentoring
Clinical Studies
Avoid consulting relationships that have
the potential to divert time and effort from
your responsibilities to Ohio University.
Do not use students.
Be wary of situations that limit publication.
Do not use university stationary, etc. that
could create an impression the university
is involved with the activities.
Make sure you are devoting sufficient time
to your university obligations.
Be cautious that the potential financial gain
cannot be perceived to influence your
university mentoring relationships.
Disclose any personal or familial financial
interest or equity in a company that is
doing business with Ohio University.
If you make purchases using public funds,
you should not use companies which will
benefit you or your family. If there is no
alternative you must seek and receive
permission prior to purchasing.
Any relationship in which there is a real or
perceived power or influence imbalance has
the potential for conflict. (Faculty:Student)
Isolating these relationships with respect to
areas of personal financial gain is best.
If they cannot be isolated, then safeguards
must be created.
If you have a financial interest, it is best to
isolate yourself from the study.
At a minimum, expect a more intense review
and a robust management plan if you have a
financial interest.
If both the institution and you have financial
interests the clinical study should be
conducted elsewhere.
You have administrative responsibilities on
behalf of Ohio University that is beneficial to
the business in which you have a significant
financial interest
You have administrative responsibilities on
behalf of Ohio University with respect to an
SRA where you have a significant financial
interest
Slide 23
Jo Ellen Sherow
Ohio University
Office of Research Compliance
Researchers’ Financial Disclosures in the
Spotlight
Conflicts of interest, always an emotional topic,
returned to the headlines this week as Sen.
Charles Grassley, a longtime critic of the drug
industry’s potential influence on research,
released new evidence that prominent Harvard
University scientists had failed to disclose much
of their outside income from pharmaceutical
companies over the past eight years.
http://www.insidehighered.com/news/2008/06/12/conflict January 15, 2008
WEDNESDAY, JANUARY 21, 2009
In a review of the literature regarding the relationship between
smokeless tobacco use and cancer, a conflict of interest of one of the
article's authors was initially not disclosed (see: Boffetta P, Hecht S, Gray
N, Gupta P, Straif K. Smokeless tobacco and cancer. Lancet Oncology
2008; 9:667-675). The original article was published in July, 2008. That
article stated: "The authors declare no conflicts of interest." After the
editor of the journal was notified by a researcher with knowledge of a
potential conflict of interest of Dr. Stephen Hecht (one of the study
authors), an erratum was published in September 2008, which noted:
"During the immediate months preceding submission of the review SH
was acting in the capacity of an expert witness for the plaintiff in a
future court case against a smokeless tobacco company. SH declares his
participation in this case in no way influenced his writing or involvement
in the review."
http://tobaccoanalysis.blogspot.com/2009/01/conflict-of-interestnot.html
January 16, 2009 — More than one third of new
drug marketing applications approved by the US
Food and Drug Administration (FDA) were
missing information about potential conflicts of
interest for clinical trial investigators, which
could allow bias to creep into the approvals
process, a government report released this week
has found. The FDA has said that it agrees with
most of the report's findings.
http://www.medscape.com/viewarticle/586980
Do collaborations between biotech companies
and academic centers constitute a conflict of
interest?
Biotechnology industry partnerships with
universities and academic centers have been
fruitful for both. So why is there so much
concern about conflict of interest and is that
concern appropriate?
http://www.redorbit.com/news/health/750100/genetic_engineering_news_p
osts_podcast_on_industrialacademic_collaborations_are_these/index.html
Universities are responsible for use of public
funds and therefore must maintain the public
trust.
Identifying and mitigating situations that may
have the potential for conflict maintains the
integrity of the university.
Maintaining integrity allows the university to
do credible academic research.
To provide information on the purpose of the
conflict of interest requirements.
To provide a basic overview of conflicts of
interest
To introduce the disclosure process and the use
of management plans
To provide information on the need for updates
and annual renewals.
Situations where financial considerations
compromise your professional judgment.
“Actual Conflict of Interest”
◦ Not permitted
Situations where an independent observer
might reasonably question whether your
professional actions or decisions are
determined by considerations of personal
gain. “Perceived Conflict of Interest”
◦ Managed
Potential conflicts may be financial or may be
a conflict of time, effort and/or commitment.
Potential conflicts can occur as a result of
administrative, scientific, academic, fiduciary
or familial situations.
They are situations that can be PERCEIVED to
be conflicting, whether a “real” conflict exists
or not.
Ohio University Policy has a mandatory
disclosure policy if you:
Earn over $10,000 in a twelve month period
from your outside activity OR
Have over 5% equity in the entity
Applies to members of your immediate family
(spouse, domestic partner, dependent
children) as well as yourself.
Anything of monetary value, including but not
limited to:
◦
◦
◦
◦
Salary
Payments for services
Equity interests over 5%
Intellectual property rights
Excludes mutual, pension and other
investments over which you have no control
Outside work during regular academic year
should not exceed equivalent of 1 day per
week.
Consulting work must avoid activities that
involve a conflict of interest with assigned
Ohio University activities and programs
Faculty Handbook, section IV-D
Outside interests cannot interfere with
primary loyalty to Ohio University and your
academic role
Use of university resources must have prior
approval of Chair, Dean and VPR.
Your outside interests should not be in
direct competition with university interests
Full time administrative employees are
expected to devote their full-time
professional loyalty, time and energy to their
position.
You must use non-work hours and no
university resources
Federal Agencies
State Law
University Policies
Many Academic Publications
45 CFR Part 50, Subpart F
“Responsibility of Applicants for Promoting
Objectivity in Research for Which PHS Funding
is Sought”
Authority: 42 U.S.C. 216, 289b-1, 299c-3.
Intent is to assure objectivity by establishing
standards that preclude bias in design, conduct, or
reporting of research
Focuses on financial conflicts of interest
(FCOI)
Regulations apply to investigators, including
sub grantees, contractors, and collaborating
investigators.
Does not apply to applications for support
under Phase I of SBIR and STTR programs
An institutional conflict of interest policy should
require that each investigator disclose to a
responsible representative of the institution all
significant financial interests of the investigator
(including those of the investigator’s spouse and
dependent children) (i) that would reasonably
appear to be affected by the research or
educational activities funded or proposed for
funding by NSF; or (ii) in entities whose financial
interests would reasonably appear to be affected
by such activities.
Chapter 1 (Subchapter A) (Part 54)
Financial Disclosure by Clinical Investigators
The Food and Drug Administration (FDA)
regulations state that investigators that
receive compensation in excess of $25,000
from a corporate sponsor of a trial in which
the investigator is engaged must disclose to
the FDA at the time of filing for a new drug
application.
19.058, Conflict of Interest in Research,
Educational, and Public Service Activities
19.059, Employee Participation in Authorized
Private Companies Commercializing Ohio
University Research
“Conflict of Interest in Research, Educational,
and Public Service Activities”
Most conflict disclosures fall within the
parameters of this policy
States that faculty are primarily responsible
for their academic, research and service
obligations
“Employee Participation in Authorized Private
Companies Commercializing Ohio University
Research”
Applies to “employees, faculty, staff and students,
who create intellectual property owned by the Ohio
University and who desire to hold an equity interest
in a firm, corporation, or other association to which
Ohio University has assigned, licensed or
transferred Ohio University’s interests…”
Consulting
Licensing University Technology
Clinical Studies
Procurement
Mentoring
Institutional
A disclosure is filed specific to the funding
application.
If you have a potential conflict for one
proposal, it does not automatically apply to
all of your proposals.
Research conflicts of interest are usually
disclosed using LEO as you apply for funding
by completing the conflict of interest section
of the electronic transmittal
If you are not using LEO, you can download
the appropriate disclosure form from
www.ohio.edu/research/compliance
“A” is selected if you have no conflicts to
disclose
“B” is selected if you have a potential conflict
to disclose relative to the submission.
(Requires a subsequent paper process)
“C” is selected if you have a current disclosure
on file, but it is not relevant to the proposal
you are submitting
Still uses option A, B or C
Requires that you gather signatures on paper
for all options, however
Generally used for personnel not listed on the
grant proposal or “key personnel”
We have revised the COI forms to word forms
This should be easier to complete than the
previous form
PDF versions are also available
Should be on the compliance web site soon,
but we can e-mail them to you until then
Use this form only if you are unable to use
the LEO transmittal form to assure that no
conflict of interest exists. A form must be
completed for each proposal.
I assure that I have read Ohio University
Policy 19.058, “Conflict of Interest in
Research, Educational, and Public Service
Activities” and declare that I have nothing
that is, or could be perceived to be a conflict
of interest with this proposal.
Use this form to disclose a potential conflict
of interest situation.
A separate disclosure form must be used for
each entity with which you conduct business
Conflict includes any member of your
immediate family (spouse, domestic partner
or children)
Require that you complete an option “B”
disclosure statement in addition to
completing the LEO transmittal form.
Require you to obtain signatures from Center
or Institute (if applicable), Chair and Dean on
the additional disclosure statement!!
The B disclosure form is available at
www.ohio.edu/research/compliance
Use this form only if you are unable to use
the LEO transmittal form. Complete this form
if you have a current conflict of interest
disclosure on file with the Office of Research
Compliance, but that disclosure is not
applicable to this proposal.
*New Option for 2008*
A management plan is developed for some
disclosures to mitigate the potential conflict
Management plans are specific to each
disclosure
May require submission of additional pieces,
such as a student employment plan
Reduce or remove the financial interest creating the
conflict
Place safeguards that mitigate the conflict potential,
such having some decisions made by an independent
entity
Limit participation in portions of the proposed
research likely to create a conflict
Require that the researcher disclose his or her
conflicting financial interests to all collaborators and
any proposed trainees;
Disclose the conflict in publications
Work to remove students from being directly advised
or taught by faculty where a conflict exists
Assure publication rights for student participants
Student Use
Nepotism and Cronyism
Intellectual Property
Use of University Resources
Publication provisions
Use of Human Subjects
Oversight Requirements
Reporting and Annual Reviews
You must submit an annual renewal for your
disclosure
◦ If the potential conflict no longer exists you must
notify us
If significant changes occur during the year
you should submit an update to your
disclosure as they occur
Yes. We encourage employees to disclose
potential conflicts that do not meet the
financial threshold, but may still be
problematic, such as student employment.
This allows you to be transparent with
respect to outside interests.
Allowable situations
Situations that require disclosure but may not
need an extensive management plan
Situations that require disclosure and have
problematic elements that will require
mitigation and/or a management plan
Situations that are not permitted
Receipt of royalties or honoraria for
published scholarly works, seminars,
teaching, etc.
Honoraria for serving as a special reviewer
or work on review panels
Royalties under our intellectual property
policies if no other relationship with entity
Clinical income at OUCOM
You participate in research developed in
whole or part by you, and you or your
family receive royalties from an existing
agreement with the business, but have
no other significant financial interest
You assign students, etc. to research
projects where you are entitled to
receive royalties, but have no other
significant financial interest
You assign students, etc. to projects supported
by the business through an SRA, and have a
significant financial interest other than royalty
income
You receive research support from a business in
which you serve on the board of directors, or
other advisory board, even if you are not
compensated.
You hold an executive position in a business
engaged in commercial or research activities
directly related to your Ohio University
responsibilities.
Any situation in which an actual conflict
exists is not permitted.
The only “exceptions” are those handled
under Ohio University Policy and Procedure
19.059 where faculty entrepreneurship is
addressed.
Participation in clinical trials or evaluation
of other research in which you have a
significant financial interest other than
royalty income.
In the context of your position at Ohio
University, you make professional referrals
to a business in which you have a
significant financial interest.
Letter of admonition
Ineligibility to submit grant applications
Withholding of IRB or IACUC approvals
Suspension
Non-Renewal
Loss of Tenure
Consulting
Procurement
Mentoring
Clinical Studies
Avoid consulting relationships that have
the potential to divert time and effort from
your responsibilities to Ohio University.
Do not use students.
Be wary of situations that limit publication.
Do not use university stationary, etc. that
could create an impression the university
is involved with the activities.
Make sure you are devoting sufficient time
to your university obligations.
Be cautious that the potential financial gain
cannot be perceived to influence your
university mentoring relationships.
Disclose any personal or familial financial
interest or equity in a company that is
doing business with Ohio University.
If you make purchases using public funds,
you should not use companies which will
benefit you or your family. If there is no
alternative you must seek and receive
permission prior to purchasing.
Any relationship in which there is a real or
perceived power or influence imbalance has
the potential for conflict. (Faculty:Student)
Isolating these relationships with respect to
areas of personal financial gain is best.
If they cannot be isolated, then safeguards
must be created.
If you have a financial interest, it is best to
isolate yourself from the study.
At a minimum, expect a more intense review
and a robust management plan if you have a
financial interest.
If both the institution and you have financial
interests the clinical study should be
conducted elsewhere.
You have administrative responsibilities on
behalf of Ohio University that is beneficial to
the business in which you have a significant
financial interest
You have administrative responsibilities on
behalf of Ohio University with respect to an
SRA where you have a significant financial
interest
Slide 24
Jo Ellen Sherow
Ohio University
Office of Research Compliance
Researchers’ Financial Disclosures in the
Spotlight
Conflicts of interest, always an emotional topic,
returned to the headlines this week as Sen.
Charles Grassley, a longtime critic of the drug
industry’s potential influence on research,
released new evidence that prominent Harvard
University scientists had failed to disclose much
of their outside income from pharmaceutical
companies over the past eight years.
http://www.insidehighered.com/news/2008/06/12/conflict January 15, 2008
WEDNESDAY, JANUARY 21, 2009
In a review of the literature regarding the relationship between
smokeless tobacco use and cancer, a conflict of interest of one of the
article's authors was initially not disclosed (see: Boffetta P, Hecht S, Gray
N, Gupta P, Straif K. Smokeless tobacco and cancer. Lancet Oncology
2008; 9:667-675). The original article was published in July, 2008. That
article stated: "The authors declare no conflicts of interest." After the
editor of the journal was notified by a researcher with knowledge of a
potential conflict of interest of Dr. Stephen Hecht (one of the study
authors), an erratum was published in September 2008, which noted:
"During the immediate months preceding submission of the review SH
was acting in the capacity of an expert witness for the plaintiff in a
future court case against a smokeless tobacco company. SH declares his
participation in this case in no way influenced his writing or involvement
in the review."
http://tobaccoanalysis.blogspot.com/2009/01/conflict-of-interestnot.html
January 16, 2009 — More than one third of new
drug marketing applications approved by the US
Food and Drug Administration (FDA) were
missing information about potential conflicts of
interest for clinical trial investigators, which
could allow bias to creep into the approvals
process, a government report released this week
has found. The FDA has said that it agrees with
most of the report's findings.
http://www.medscape.com/viewarticle/586980
Do collaborations between biotech companies
and academic centers constitute a conflict of
interest?
Biotechnology industry partnerships with
universities and academic centers have been
fruitful for both. So why is there so much
concern about conflict of interest and is that
concern appropriate?
http://www.redorbit.com/news/health/750100/genetic_engineering_news_p
osts_podcast_on_industrialacademic_collaborations_are_these/index.html
Universities are responsible for use of public
funds and therefore must maintain the public
trust.
Identifying and mitigating situations that may
have the potential for conflict maintains the
integrity of the university.
Maintaining integrity allows the university to
do credible academic research.
To provide information on the purpose of the
conflict of interest requirements.
To provide a basic overview of conflicts of
interest
To introduce the disclosure process and the use
of management plans
To provide information on the need for updates
and annual renewals.
Situations where financial considerations
compromise your professional judgment.
“Actual Conflict of Interest”
◦ Not permitted
Situations where an independent observer
might reasonably question whether your
professional actions or decisions are
determined by considerations of personal
gain. “Perceived Conflict of Interest”
◦ Managed
Potential conflicts may be financial or may be
a conflict of time, effort and/or commitment.
Potential conflicts can occur as a result of
administrative, scientific, academic, fiduciary
or familial situations.
They are situations that can be PERCEIVED to
be conflicting, whether a “real” conflict exists
or not.
Ohio University Policy has a mandatory
disclosure policy if you:
Earn over $10,000 in a twelve month period
from your outside activity OR
Have over 5% equity in the entity
Applies to members of your immediate family
(spouse, domestic partner, dependent
children) as well as yourself.
Anything of monetary value, including but not
limited to:
◦
◦
◦
◦
Salary
Payments for services
Equity interests over 5%
Intellectual property rights
Excludes mutual, pension and other
investments over which you have no control
Outside work during regular academic year
should not exceed equivalent of 1 day per
week.
Consulting work must avoid activities that
involve a conflict of interest with assigned
Ohio University activities and programs
Faculty Handbook, section IV-D
Outside interests cannot interfere with
primary loyalty to Ohio University and your
academic role
Use of university resources must have prior
approval of Chair, Dean and VPR.
Your outside interests should not be in
direct competition with university interests
Full time administrative employees are
expected to devote their full-time
professional loyalty, time and energy to their
position.
You must use non-work hours and no
university resources
Federal Agencies
State Law
University Policies
Many Academic Publications
45 CFR Part 50, Subpart F
“Responsibility of Applicants for Promoting
Objectivity in Research for Which PHS Funding
is Sought”
Authority: 42 U.S.C. 216, 289b-1, 299c-3.
Intent is to assure objectivity by establishing
standards that preclude bias in design, conduct, or
reporting of research
Focuses on financial conflicts of interest
(FCOI)
Regulations apply to investigators, including
sub grantees, contractors, and collaborating
investigators.
Does not apply to applications for support
under Phase I of SBIR and STTR programs
An institutional conflict of interest policy should
require that each investigator disclose to a
responsible representative of the institution all
significant financial interests of the investigator
(including those of the investigator’s spouse and
dependent children) (i) that would reasonably
appear to be affected by the research or
educational activities funded or proposed for
funding by NSF; or (ii) in entities whose financial
interests would reasonably appear to be affected
by such activities.
Chapter 1 (Subchapter A) (Part 54)
Financial Disclosure by Clinical Investigators
The Food and Drug Administration (FDA)
regulations state that investigators that
receive compensation in excess of $25,000
from a corporate sponsor of a trial in which
the investigator is engaged must disclose to
the FDA at the time of filing for a new drug
application.
19.058, Conflict of Interest in Research,
Educational, and Public Service Activities
19.059, Employee Participation in Authorized
Private Companies Commercializing Ohio
University Research
“Conflict of Interest in Research, Educational,
and Public Service Activities”
Most conflict disclosures fall within the
parameters of this policy
States that faculty are primarily responsible
for their academic, research and service
obligations
“Employee Participation in Authorized Private
Companies Commercializing Ohio University
Research”
Applies to “employees, faculty, staff and students,
who create intellectual property owned by the Ohio
University and who desire to hold an equity interest
in a firm, corporation, or other association to which
Ohio University has assigned, licensed or
transferred Ohio University’s interests…”
Consulting
Licensing University Technology
Clinical Studies
Procurement
Mentoring
Institutional
A disclosure is filed specific to the funding
application.
If you have a potential conflict for one
proposal, it does not automatically apply to
all of your proposals.
Research conflicts of interest are usually
disclosed using LEO as you apply for funding
by completing the conflict of interest section
of the electronic transmittal
If you are not using LEO, you can download
the appropriate disclosure form from
www.ohio.edu/research/compliance
“A” is selected if you have no conflicts to
disclose
“B” is selected if you have a potential conflict
to disclose relative to the submission.
(Requires a subsequent paper process)
“C” is selected if you have a current disclosure
on file, but it is not relevant to the proposal
you are submitting
Still uses option A, B or C
Requires that you gather signatures on paper
for all options, however
Generally used for personnel not listed on the
grant proposal or “key personnel”
We have revised the COI forms to word forms
This should be easier to complete than the
previous form
PDF versions are also available
Should be on the compliance web site soon,
but we can e-mail them to you until then
Use this form only if you are unable to use
the LEO transmittal form to assure that no
conflict of interest exists. A form must be
completed for each proposal.
I assure that I have read Ohio University
Policy 19.058, “Conflict of Interest in
Research, Educational, and Public Service
Activities” and declare that I have nothing
that is, or could be perceived to be a conflict
of interest with this proposal.
Use this form to disclose a potential conflict
of interest situation.
A separate disclosure form must be used for
each entity with which you conduct business
Conflict includes any member of your
immediate family (spouse, domestic partner
or children)
Require that you complete an option “B”
disclosure statement in addition to
completing the LEO transmittal form.
Require you to obtain signatures from Center
or Institute (if applicable), Chair and Dean on
the additional disclosure statement!!
The B disclosure form is available at
www.ohio.edu/research/compliance
Use this form only if you are unable to use
the LEO transmittal form. Complete this form
if you have a current conflict of interest
disclosure on file with the Office of Research
Compliance, but that disclosure is not
applicable to this proposal.
*New Option for 2008*
A management plan is developed for some
disclosures to mitigate the potential conflict
Management plans are specific to each
disclosure
May require submission of additional pieces,
such as a student employment plan
Reduce or remove the financial interest creating the
conflict
Place safeguards that mitigate the conflict potential,
such having some decisions made by an independent
entity
Limit participation in portions of the proposed
research likely to create a conflict
Require that the researcher disclose his or her
conflicting financial interests to all collaborators and
any proposed trainees;
Disclose the conflict in publications
Work to remove students from being directly advised
or taught by faculty where a conflict exists
Assure publication rights for student participants
Student Use
Nepotism and Cronyism
Intellectual Property
Use of University Resources
Publication provisions
Use of Human Subjects
Oversight Requirements
Reporting and Annual Reviews
You must submit an annual renewal for your
disclosure
◦ If the potential conflict no longer exists you must
notify us
If significant changes occur during the year
you should submit an update to your
disclosure as they occur
Yes. We encourage employees to disclose
potential conflicts that do not meet the
financial threshold, but may still be
problematic, such as student employment.
This allows you to be transparent with
respect to outside interests.
Allowable situations
Situations that require disclosure but may not
need an extensive management plan
Situations that require disclosure and have
problematic elements that will require
mitigation and/or a management plan
Situations that are not permitted
Receipt of royalties or honoraria for
published scholarly works, seminars,
teaching, etc.
Honoraria for serving as a special reviewer
or work on review panels
Royalties under our intellectual property
policies if no other relationship with entity
Clinical income at OUCOM
You participate in research developed in
whole or part by you, and you or your
family receive royalties from an existing
agreement with the business, but have
no other significant financial interest
You assign students, etc. to research
projects where you are entitled to
receive royalties, but have no other
significant financial interest
You assign students, etc. to projects supported
by the business through an SRA, and have a
significant financial interest other than royalty
income
You receive research support from a business in
which you serve on the board of directors, or
other advisory board, even if you are not
compensated.
You hold an executive position in a business
engaged in commercial or research activities
directly related to your Ohio University
responsibilities.
Any situation in which an actual conflict
exists is not permitted.
The only “exceptions” are those handled
under Ohio University Policy and Procedure
19.059 where faculty entrepreneurship is
addressed.
Participation in clinical trials or evaluation
of other research in which you have a
significant financial interest other than
royalty income.
In the context of your position at Ohio
University, you make professional referrals
to a business in which you have a
significant financial interest.
Letter of admonition
Ineligibility to submit grant applications
Withholding of IRB or IACUC approvals
Suspension
Non-Renewal
Loss of Tenure
Consulting
Procurement
Mentoring
Clinical Studies
Avoid consulting relationships that have
the potential to divert time and effort from
your responsibilities to Ohio University.
Do not use students.
Be wary of situations that limit publication.
Do not use university stationary, etc. that
could create an impression the university
is involved with the activities.
Make sure you are devoting sufficient time
to your university obligations.
Be cautious that the potential financial gain
cannot be perceived to influence your
university mentoring relationships.
Disclose any personal or familial financial
interest or equity in a company that is
doing business with Ohio University.
If you make purchases using public funds,
you should not use companies which will
benefit you or your family. If there is no
alternative you must seek and receive
permission prior to purchasing.
Any relationship in which there is a real or
perceived power or influence imbalance has
the potential for conflict. (Faculty:Student)
Isolating these relationships with respect to
areas of personal financial gain is best.
If they cannot be isolated, then safeguards
must be created.
If you have a financial interest, it is best to
isolate yourself from the study.
At a minimum, expect a more intense review
and a robust management plan if you have a
financial interest.
If both the institution and you have financial
interests the clinical study should be
conducted elsewhere.
You have administrative responsibilities on
behalf of Ohio University that is beneficial to
the business in which you have a significant
financial interest
You have administrative responsibilities on
behalf of Ohio University with respect to an
SRA where you have a significant financial
interest
Slide 25
Jo Ellen Sherow
Ohio University
Office of Research Compliance
Researchers’ Financial Disclosures in the
Spotlight
Conflicts of interest, always an emotional topic,
returned to the headlines this week as Sen.
Charles Grassley, a longtime critic of the drug
industry’s potential influence on research,
released new evidence that prominent Harvard
University scientists had failed to disclose much
of their outside income from pharmaceutical
companies over the past eight years.
http://www.insidehighered.com/news/2008/06/12/conflict January 15, 2008
WEDNESDAY, JANUARY 21, 2009
In a review of the literature regarding the relationship between
smokeless tobacco use and cancer, a conflict of interest of one of the
article's authors was initially not disclosed (see: Boffetta P, Hecht S, Gray
N, Gupta P, Straif K. Smokeless tobacco and cancer. Lancet Oncology
2008; 9:667-675). The original article was published in July, 2008. That
article stated: "The authors declare no conflicts of interest." After the
editor of the journal was notified by a researcher with knowledge of a
potential conflict of interest of Dr. Stephen Hecht (one of the study
authors), an erratum was published in September 2008, which noted:
"During the immediate months preceding submission of the review SH
was acting in the capacity of an expert witness for the plaintiff in a
future court case against a smokeless tobacco company. SH declares his
participation in this case in no way influenced his writing or involvement
in the review."
http://tobaccoanalysis.blogspot.com/2009/01/conflict-of-interestnot.html
January 16, 2009 — More than one third of new
drug marketing applications approved by the US
Food and Drug Administration (FDA) were
missing information about potential conflicts of
interest for clinical trial investigators, which
could allow bias to creep into the approvals
process, a government report released this week
has found. The FDA has said that it agrees with
most of the report's findings.
http://www.medscape.com/viewarticle/586980
Do collaborations between biotech companies
and academic centers constitute a conflict of
interest?
Biotechnology industry partnerships with
universities and academic centers have been
fruitful for both. So why is there so much
concern about conflict of interest and is that
concern appropriate?
http://www.redorbit.com/news/health/750100/genetic_engineering_news_p
osts_podcast_on_industrialacademic_collaborations_are_these/index.html
Universities are responsible for use of public
funds and therefore must maintain the public
trust.
Identifying and mitigating situations that may
have the potential for conflict maintains the
integrity of the university.
Maintaining integrity allows the university to
do credible academic research.
To provide information on the purpose of the
conflict of interest requirements.
To provide a basic overview of conflicts of
interest
To introduce the disclosure process and the use
of management plans
To provide information on the need for updates
and annual renewals.
Situations where financial considerations
compromise your professional judgment.
“Actual Conflict of Interest”
◦ Not permitted
Situations where an independent observer
might reasonably question whether your
professional actions or decisions are
determined by considerations of personal
gain. “Perceived Conflict of Interest”
◦ Managed
Potential conflicts may be financial or may be
a conflict of time, effort and/or commitment.
Potential conflicts can occur as a result of
administrative, scientific, academic, fiduciary
or familial situations.
They are situations that can be PERCEIVED to
be conflicting, whether a “real” conflict exists
or not.
Ohio University Policy has a mandatory
disclosure policy if you:
Earn over $10,000 in a twelve month period
from your outside activity OR
Have over 5% equity in the entity
Applies to members of your immediate family
(spouse, domestic partner, dependent
children) as well as yourself.
Anything of monetary value, including but not
limited to:
◦
◦
◦
◦
Salary
Payments for services
Equity interests over 5%
Intellectual property rights
Excludes mutual, pension and other
investments over which you have no control
Outside work during regular academic year
should not exceed equivalent of 1 day per
week.
Consulting work must avoid activities that
involve a conflict of interest with assigned
Ohio University activities and programs
Faculty Handbook, section IV-D
Outside interests cannot interfere with
primary loyalty to Ohio University and your
academic role
Use of university resources must have prior
approval of Chair, Dean and VPR.
Your outside interests should not be in
direct competition with university interests
Full time administrative employees are
expected to devote their full-time
professional loyalty, time and energy to their
position.
You must use non-work hours and no
university resources
Federal Agencies
State Law
University Policies
Many Academic Publications
45 CFR Part 50, Subpart F
“Responsibility of Applicants for Promoting
Objectivity in Research for Which PHS Funding
is Sought”
Authority: 42 U.S.C. 216, 289b-1, 299c-3.
Intent is to assure objectivity by establishing
standards that preclude bias in design, conduct, or
reporting of research
Focuses on financial conflicts of interest
(FCOI)
Regulations apply to investigators, including
sub grantees, contractors, and collaborating
investigators.
Does not apply to applications for support
under Phase I of SBIR and STTR programs
An institutional conflict of interest policy should
require that each investigator disclose to a
responsible representative of the institution all
significant financial interests of the investigator
(including those of the investigator’s spouse and
dependent children) (i) that would reasonably
appear to be affected by the research or
educational activities funded or proposed for
funding by NSF; or (ii) in entities whose financial
interests would reasonably appear to be affected
by such activities.
Chapter 1 (Subchapter A) (Part 54)
Financial Disclosure by Clinical Investigators
The Food and Drug Administration (FDA)
regulations state that investigators that
receive compensation in excess of $25,000
from a corporate sponsor of a trial in which
the investigator is engaged must disclose to
the FDA at the time of filing for a new drug
application.
19.058, Conflict of Interest in Research,
Educational, and Public Service Activities
19.059, Employee Participation in Authorized
Private Companies Commercializing Ohio
University Research
“Conflict of Interest in Research, Educational,
and Public Service Activities”
Most conflict disclosures fall within the
parameters of this policy
States that faculty are primarily responsible
for their academic, research and service
obligations
“Employee Participation in Authorized Private
Companies Commercializing Ohio University
Research”
Applies to “employees, faculty, staff and students,
who create intellectual property owned by the Ohio
University and who desire to hold an equity interest
in a firm, corporation, or other association to which
Ohio University has assigned, licensed or
transferred Ohio University’s interests…”
Consulting
Licensing University Technology
Clinical Studies
Procurement
Mentoring
Institutional
A disclosure is filed specific to the funding
application.
If you have a potential conflict for one
proposal, it does not automatically apply to
all of your proposals.
Research conflicts of interest are usually
disclosed using LEO as you apply for funding
by completing the conflict of interest section
of the electronic transmittal
If you are not using LEO, you can download
the appropriate disclosure form from
www.ohio.edu/research/compliance
“A” is selected if you have no conflicts to
disclose
“B” is selected if you have a potential conflict
to disclose relative to the submission.
(Requires a subsequent paper process)
“C” is selected if you have a current disclosure
on file, but it is not relevant to the proposal
you are submitting
Still uses option A, B or C
Requires that you gather signatures on paper
for all options, however
Generally used for personnel not listed on the
grant proposal or “key personnel”
We have revised the COI forms to word forms
This should be easier to complete than the
previous form
PDF versions are also available
Should be on the compliance web site soon,
but we can e-mail them to you until then
Use this form only if you are unable to use
the LEO transmittal form to assure that no
conflict of interest exists. A form must be
completed for each proposal.
I assure that I have read Ohio University
Policy 19.058, “Conflict of Interest in
Research, Educational, and Public Service
Activities” and declare that I have nothing
that is, or could be perceived to be a conflict
of interest with this proposal.
Use this form to disclose a potential conflict
of interest situation.
A separate disclosure form must be used for
each entity with which you conduct business
Conflict includes any member of your
immediate family (spouse, domestic partner
or children)
Require that you complete an option “B”
disclosure statement in addition to
completing the LEO transmittal form.
Require you to obtain signatures from Center
or Institute (if applicable), Chair and Dean on
the additional disclosure statement!!
The B disclosure form is available at
www.ohio.edu/research/compliance
Use this form only if you are unable to use
the LEO transmittal form. Complete this form
if you have a current conflict of interest
disclosure on file with the Office of Research
Compliance, but that disclosure is not
applicable to this proposal.
*New Option for 2008*
A management plan is developed for some
disclosures to mitigate the potential conflict
Management plans are specific to each
disclosure
May require submission of additional pieces,
such as a student employment plan
Reduce or remove the financial interest creating the
conflict
Place safeguards that mitigate the conflict potential,
such having some decisions made by an independent
entity
Limit participation in portions of the proposed
research likely to create a conflict
Require that the researcher disclose his or her
conflicting financial interests to all collaborators and
any proposed trainees;
Disclose the conflict in publications
Work to remove students from being directly advised
or taught by faculty where a conflict exists
Assure publication rights for student participants
Student Use
Nepotism and Cronyism
Intellectual Property
Use of University Resources
Publication provisions
Use of Human Subjects
Oversight Requirements
Reporting and Annual Reviews
You must submit an annual renewal for your
disclosure
◦ If the potential conflict no longer exists you must
notify us
If significant changes occur during the year
you should submit an update to your
disclosure as they occur
Yes. We encourage employees to disclose
potential conflicts that do not meet the
financial threshold, but may still be
problematic, such as student employment.
This allows you to be transparent with
respect to outside interests.
Allowable situations
Situations that require disclosure but may not
need an extensive management plan
Situations that require disclosure and have
problematic elements that will require
mitigation and/or a management plan
Situations that are not permitted
Receipt of royalties or honoraria for
published scholarly works, seminars,
teaching, etc.
Honoraria for serving as a special reviewer
or work on review panels
Royalties under our intellectual property
policies if no other relationship with entity
Clinical income at OUCOM
You participate in research developed in
whole or part by you, and you or your
family receive royalties from an existing
agreement with the business, but have
no other significant financial interest
You assign students, etc. to research
projects where you are entitled to
receive royalties, but have no other
significant financial interest
You assign students, etc. to projects supported
by the business through an SRA, and have a
significant financial interest other than royalty
income
You receive research support from a business in
which you serve on the board of directors, or
other advisory board, even if you are not
compensated.
You hold an executive position in a business
engaged in commercial or research activities
directly related to your Ohio University
responsibilities.
Any situation in which an actual conflict
exists is not permitted.
The only “exceptions” are those handled
under Ohio University Policy and Procedure
19.059 where faculty entrepreneurship is
addressed.
Participation in clinical trials or evaluation
of other research in which you have a
significant financial interest other than
royalty income.
In the context of your position at Ohio
University, you make professional referrals
to a business in which you have a
significant financial interest.
Letter of admonition
Ineligibility to submit grant applications
Withholding of IRB or IACUC approvals
Suspension
Non-Renewal
Loss of Tenure
Consulting
Procurement
Mentoring
Clinical Studies
Avoid consulting relationships that have
the potential to divert time and effort from
your responsibilities to Ohio University.
Do not use students.
Be wary of situations that limit publication.
Do not use university stationary, etc. that
could create an impression the university
is involved with the activities.
Make sure you are devoting sufficient time
to your university obligations.
Be cautious that the potential financial gain
cannot be perceived to influence your
university mentoring relationships.
Disclose any personal or familial financial
interest or equity in a company that is
doing business with Ohio University.
If you make purchases using public funds,
you should not use companies which will
benefit you or your family. If there is no
alternative you must seek and receive
permission prior to purchasing.
Any relationship in which there is a real or
perceived power or influence imbalance has
the potential for conflict. (Faculty:Student)
Isolating these relationships with respect to
areas of personal financial gain is best.
If they cannot be isolated, then safeguards
must be created.
If you have a financial interest, it is best to
isolate yourself from the study.
At a minimum, expect a more intense review
and a robust management plan if you have a
financial interest.
If both the institution and you have financial
interests the clinical study should be
conducted elsewhere.
You have administrative responsibilities on
behalf of Ohio University that is beneficial to
the business in which you have a significant
financial interest
You have administrative responsibilities on
behalf of Ohio University with respect to an
SRA where you have a significant financial
interest
Slide 26
Jo Ellen Sherow
Ohio University
Office of Research Compliance
Researchers’ Financial Disclosures in the
Spotlight
Conflicts of interest, always an emotional topic,
returned to the headlines this week as Sen.
Charles Grassley, a longtime critic of the drug
industry’s potential influence on research,
released new evidence that prominent Harvard
University scientists had failed to disclose much
of their outside income from pharmaceutical
companies over the past eight years.
http://www.insidehighered.com/news/2008/06/12/conflict January 15, 2008
WEDNESDAY, JANUARY 21, 2009
In a review of the literature regarding the relationship between
smokeless tobacco use and cancer, a conflict of interest of one of the
article's authors was initially not disclosed (see: Boffetta P, Hecht S, Gray
N, Gupta P, Straif K. Smokeless tobacco and cancer. Lancet Oncology
2008; 9:667-675). The original article was published in July, 2008. That
article stated: "The authors declare no conflicts of interest." After the
editor of the journal was notified by a researcher with knowledge of a
potential conflict of interest of Dr. Stephen Hecht (one of the study
authors), an erratum was published in September 2008, which noted:
"During the immediate months preceding submission of the review SH
was acting in the capacity of an expert witness for the plaintiff in a
future court case against a smokeless tobacco company. SH declares his
participation in this case in no way influenced his writing or involvement
in the review."
http://tobaccoanalysis.blogspot.com/2009/01/conflict-of-interestnot.html
January 16, 2009 — More than one third of new
drug marketing applications approved by the US
Food and Drug Administration (FDA) were
missing information about potential conflicts of
interest for clinical trial investigators, which
could allow bias to creep into the approvals
process, a government report released this week
has found. The FDA has said that it agrees with
most of the report's findings.
http://www.medscape.com/viewarticle/586980
Do collaborations between biotech companies
and academic centers constitute a conflict of
interest?
Biotechnology industry partnerships with
universities and academic centers have been
fruitful for both. So why is there so much
concern about conflict of interest and is that
concern appropriate?
http://www.redorbit.com/news/health/750100/genetic_engineering_news_p
osts_podcast_on_industrialacademic_collaborations_are_these/index.html
Universities are responsible for use of public
funds and therefore must maintain the public
trust.
Identifying and mitigating situations that may
have the potential for conflict maintains the
integrity of the university.
Maintaining integrity allows the university to
do credible academic research.
To provide information on the purpose of the
conflict of interest requirements.
To provide a basic overview of conflicts of
interest
To introduce the disclosure process and the use
of management plans
To provide information on the need for updates
and annual renewals.
Situations where financial considerations
compromise your professional judgment.
“Actual Conflict of Interest”
◦ Not permitted
Situations where an independent observer
might reasonably question whether your
professional actions or decisions are
determined by considerations of personal
gain. “Perceived Conflict of Interest”
◦ Managed
Potential conflicts may be financial or may be
a conflict of time, effort and/or commitment.
Potential conflicts can occur as a result of
administrative, scientific, academic, fiduciary
or familial situations.
They are situations that can be PERCEIVED to
be conflicting, whether a “real” conflict exists
or not.
Ohio University Policy has a mandatory
disclosure policy if you:
Earn over $10,000 in a twelve month period
from your outside activity OR
Have over 5% equity in the entity
Applies to members of your immediate family
(spouse, domestic partner, dependent
children) as well as yourself.
Anything of monetary value, including but not
limited to:
◦
◦
◦
◦
Salary
Payments for services
Equity interests over 5%
Intellectual property rights
Excludes mutual, pension and other
investments over which you have no control
Outside work during regular academic year
should not exceed equivalent of 1 day per
week.
Consulting work must avoid activities that
involve a conflict of interest with assigned
Ohio University activities and programs
Faculty Handbook, section IV-D
Outside interests cannot interfere with
primary loyalty to Ohio University and your
academic role
Use of university resources must have prior
approval of Chair, Dean and VPR.
Your outside interests should not be in
direct competition with university interests
Full time administrative employees are
expected to devote their full-time
professional loyalty, time and energy to their
position.
You must use non-work hours and no
university resources
Federal Agencies
State Law
University Policies
Many Academic Publications
45 CFR Part 50, Subpart F
“Responsibility of Applicants for Promoting
Objectivity in Research for Which PHS Funding
is Sought”
Authority: 42 U.S.C. 216, 289b-1, 299c-3.
Intent is to assure objectivity by establishing
standards that preclude bias in design, conduct, or
reporting of research
Focuses on financial conflicts of interest
(FCOI)
Regulations apply to investigators, including
sub grantees, contractors, and collaborating
investigators.
Does not apply to applications for support
under Phase I of SBIR and STTR programs
An institutional conflict of interest policy should
require that each investigator disclose to a
responsible representative of the institution all
significant financial interests of the investigator
(including those of the investigator’s spouse and
dependent children) (i) that would reasonably
appear to be affected by the research or
educational activities funded or proposed for
funding by NSF; or (ii) in entities whose financial
interests would reasonably appear to be affected
by such activities.
Chapter 1 (Subchapter A) (Part 54)
Financial Disclosure by Clinical Investigators
The Food and Drug Administration (FDA)
regulations state that investigators that
receive compensation in excess of $25,000
from a corporate sponsor of a trial in which
the investigator is engaged must disclose to
the FDA at the time of filing for a new drug
application.
19.058, Conflict of Interest in Research,
Educational, and Public Service Activities
19.059, Employee Participation in Authorized
Private Companies Commercializing Ohio
University Research
“Conflict of Interest in Research, Educational,
and Public Service Activities”
Most conflict disclosures fall within the
parameters of this policy
States that faculty are primarily responsible
for their academic, research and service
obligations
“Employee Participation in Authorized Private
Companies Commercializing Ohio University
Research”
Applies to “employees, faculty, staff and students,
who create intellectual property owned by the Ohio
University and who desire to hold an equity interest
in a firm, corporation, or other association to which
Ohio University has assigned, licensed or
transferred Ohio University’s interests…”
Consulting
Licensing University Technology
Clinical Studies
Procurement
Mentoring
Institutional
A disclosure is filed specific to the funding
application.
If you have a potential conflict for one
proposal, it does not automatically apply to
all of your proposals.
Research conflicts of interest are usually
disclosed using LEO as you apply for funding
by completing the conflict of interest section
of the electronic transmittal
If you are not using LEO, you can download
the appropriate disclosure form from
www.ohio.edu/research/compliance
“A” is selected if you have no conflicts to
disclose
“B” is selected if you have a potential conflict
to disclose relative to the submission.
(Requires a subsequent paper process)
“C” is selected if you have a current disclosure
on file, but it is not relevant to the proposal
you are submitting
Still uses option A, B or C
Requires that you gather signatures on paper
for all options, however
Generally used for personnel not listed on the
grant proposal or “key personnel”
We have revised the COI forms to word forms
This should be easier to complete than the
previous form
PDF versions are also available
Should be on the compliance web site soon,
but we can e-mail them to you until then
Use this form only if you are unable to use
the LEO transmittal form to assure that no
conflict of interest exists. A form must be
completed for each proposal.
I assure that I have read Ohio University
Policy 19.058, “Conflict of Interest in
Research, Educational, and Public Service
Activities” and declare that I have nothing
that is, or could be perceived to be a conflict
of interest with this proposal.
Use this form to disclose a potential conflict
of interest situation.
A separate disclosure form must be used for
each entity with which you conduct business
Conflict includes any member of your
immediate family (spouse, domestic partner
or children)
Require that you complete an option “B”
disclosure statement in addition to
completing the LEO transmittal form.
Require you to obtain signatures from Center
or Institute (if applicable), Chair and Dean on
the additional disclosure statement!!
The B disclosure form is available at
www.ohio.edu/research/compliance
Use this form only if you are unable to use
the LEO transmittal form. Complete this form
if you have a current conflict of interest
disclosure on file with the Office of Research
Compliance, but that disclosure is not
applicable to this proposal.
*New Option for 2008*
A management plan is developed for some
disclosures to mitigate the potential conflict
Management plans are specific to each
disclosure
May require submission of additional pieces,
such as a student employment plan
Reduce or remove the financial interest creating the
conflict
Place safeguards that mitigate the conflict potential,
such having some decisions made by an independent
entity
Limit participation in portions of the proposed
research likely to create a conflict
Require that the researcher disclose his or her
conflicting financial interests to all collaborators and
any proposed trainees;
Disclose the conflict in publications
Work to remove students from being directly advised
or taught by faculty where a conflict exists
Assure publication rights for student participants
Student Use
Nepotism and Cronyism
Intellectual Property
Use of University Resources
Publication provisions
Use of Human Subjects
Oversight Requirements
Reporting and Annual Reviews
You must submit an annual renewal for your
disclosure
◦ If the potential conflict no longer exists you must
notify us
If significant changes occur during the year
you should submit an update to your
disclosure as they occur
Yes. We encourage employees to disclose
potential conflicts that do not meet the
financial threshold, but may still be
problematic, such as student employment.
This allows you to be transparent with
respect to outside interests.
Allowable situations
Situations that require disclosure but may not
need an extensive management plan
Situations that require disclosure and have
problematic elements that will require
mitigation and/or a management plan
Situations that are not permitted
Receipt of royalties or honoraria for
published scholarly works, seminars,
teaching, etc.
Honoraria for serving as a special reviewer
or work on review panels
Royalties under our intellectual property
policies if no other relationship with entity
Clinical income at OUCOM
You participate in research developed in
whole or part by you, and you or your
family receive royalties from an existing
agreement with the business, but have
no other significant financial interest
You assign students, etc. to research
projects where you are entitled to
receive royalties, but have no other
significant financial interest
You assign students, etc. to projects supported
by the business through an SRA, and have a
significant financial interest other than royalty
income
You receive research support from a business in
which you serve on the board of directors, or
other advisory board, even if you are not
compensated.
You hold an executive position in a business
engaged in commercial or research activities
directly related to your Ohio University
responsibilities.
Any situation in which an actual conflict
exists is not permitted.
The only “exceptions” are those handled
under Ohio University Policy and Procedure
19.059 where faculty entrepreneurship is
addressed.
Participation in clinical trials or evaluation
of other research in which you have a
significant financial interest other than
royalty income.
In the context of your position at Ohio
University, you make professional referrals
to a business in which you have a
significant financial interest.
Letter of admonition
Ineligibility to submit grant applications
Withholding of IRB or IACUC approvals
Suspension
Non-Renewal
Loss of Tenure
Consulting
Procurement
Mentoring
Clinical Studies
Avoid consulting relationships that have
the potential to divert time and effort from
your responsibilities to Ohio University.
Do not use students.
Be wary of situations that limit publication.
Do not use university stationary, etc. that
could create an impression the university
is involved with the activities.
Make sure you are devoting sufficient time
to your university obligations.
Be cautious that the potential financial gain
cannot be perceived to influence your
university mentoring relationships.
Disclose any personal or familial financial
interest or equity in a company that is
doing business with Ohio University.
If you make purchases using public funds,
you should not use companies which will
benefit you or your family. If there is no
alternative you must seek and receive
permission prior to purchasing.
Any relationship in which there is a real or
perceived power or influence imbalance has
the potential for conflict. (Faculty:Student)
Isolating these relationships with respect to
areas of personal financial gain is best.
If they cannot be isolated, then safeguards
must be created.
If you have a financial interest, it is best to
isolate yourself from the study.
At a minimum, expect a more intense review
and a robust management plan if you have a
financial interest.
If both the institution and you have financial
interests the clinical study should be
conducted elsewhere.
You have administrative responsibilities on
behalf of Ohio University that is beneficial to
the business in which you have a significant
financial interest
You have administrative responsibilities on
behalf of Ohio University with respect to an
SRA where you have a significant financial
interest
Slide 27
Jo Ellen Sherow
Ohio University
Office of Research Compliance
Researchers’ Financial Disclosures in the
Spotlight
Conflicts of interest, always an emotional topic,
returned to the headlines this week as Sen.
Charles Grassley, a longtime critic of the drug
industry’s potential influence on research,
released new evidence that prominent Harvard
University scientists had failed to disclose much
of their outside income from pharmaceutical
companies over the past eight years.
http://www.insidehighered.com/news/2008/06/12/conflict January 15, 2008
WEDNESDAY, JANUARY 21, 2009
In a review of the literature regarding the relationship between
smokeless tobacco use and cancer, a conflict of interest of one of the
article's authors was initially not disclosed (see: Boffetta P, Hecht S, Gray
N, Gupta P, Straif K. Smokeless tobacco and cancer. Lancet Oncology
2008; 9:667-675). The original article was published in July, 2008. That
article stated: "The authors declare no conflicts of interest." After the
editor of the journal was notified by a researcher with knowledge of a
potential conflict of interest of Dr. Stephen Hecht (one of the study
authors), an erratum was published in September 2008, which noted:
"During the immediate months preceding submission of the review SH
was acting in the capacity of an expert witness for the plaintiff in a
future court case against a smokeless tobacco company. SH declares his
participation in this case in no way influenced his writing or involvement
in the review."
http://tobaccoanalysis.blogspot.com/2009/01/conflict-of-interestnot.html
January 16, 2009 — More than one third of new
drug marketing applications approved by the US
Food and Drug Administration (FDA) were
missing information about potential conflicts of
interest for clinical trial investigators, which
could allow bias to creep into the approvals
process, a government report released this week
has found. The FDA has said that it agrees with
most of the report's findings.
http://www.medscape.com/viewarticle/586980
Do collaborations between biotech companies
and academic centers constitute a conflict of
interest?
Biotechnology industry partnerships with
universities and academic centers have been
fruitful for both. So why is there so much
concern about conflict of interest and is that
concern appropriate?
http://www.redorbit.com/news/health/750100/genetic_engineering_news_p
osts_podcast_on_industrialacademic_collaborations_are_these/index.html
Universities are responsible for use of public
funds and therefore must maintain the public
trust.
Identifying and mitigating situations that may
have the potential for conflict maintains the
integrity of the university.
Maintaining integrity allows the university to
do credible academic research.
To provide information on the purpose of the
conflict of interest requirements.
To provide a basic overview of conflicts of
interest
To introduce the disclosure process and the use
of management plans
To provide information on the need for updates
and annual renewals.
Situations where financial considerations
compromise your professional judgment.
“Actual Conflict of Interest”
◦ Not permitted
Situations where an independent observer
might reasonably question whether your
professional actions or decisions are
determined by considerations of personal
gain. “Perceived Conflict of Interest”
◦ Managed
Potential conflicts may be financial or may be
a conflict of time, effort and/or commitment.
Potential conflicts can occur as a result of
administrative, scientific, academic, fiduciary
or familial situations.
They are situations that can be PERCEIVED to
be conflicting, whether a “real” conflict exists
or not.
Ohio University Policy has a mandatory
disclosure policy if you:
Earn over $10,000 in a twelve month period
from your outside activity OR
Have over 5% equity in the entity
Applies to members of your immediate family
(spouse, domestic partner, dependent
children) as well as yourself.
Anything of monetary value, including but not
limited to:
◦
◦
◦
◦
Salary
Payments for services
Equity interests over 5%
Intellectual property rights
Excludes mutual, pension and other
investments over which you have no control
Outside work during regular academic year
should not exceed equivalent of 1 day per
week.
Consulting work must avoid activities that
involve a conflict of interest with assigned
Ohio University activities and programs
Faculty Handbook, section IV-D
Outside interests cannot interfere with
primary loyalty to Ohio University and your
academic role
Use of university resources must have prior
approval of Chair, Dean and VPR.
Your outside interests should not be in
direct competition with university interests
Full time administrative employees are
expected to devote their full-time
professional loyalty, time and energy to their
position.
You must use non-work hours and no
university resources
Federal Agencies
State Law
University Policies
Many Academic Publications
45 CFR Part 50, Subpart F
“Responsibility of Applicants for Promoting
Objectivity in Research for Which PHS Funding
is Sought”
Authority: 42 U.S.C. 216, 289b-1, 299c-3.
Intent is to assure objectivity by establishing
standards that preclude bias in design, conduct, or
reporting of research
Focuses on financial conflicts of interest
(FCOI)
Regulations apply to investigators, including
sub grantees, contractors, and collaborating
investigators.
Does not apply to applications for support
under Phase I of SBIR and STTR programs
An institutional conflict of interest policy should
require that each investigator disclose to a
responsible representative of the institution all
significant financial interests of the investigator
(including those of the investigator’s spouse and
dependent children) (i) that would reasonably
appear to be affected by the research or
educational activities funded or proposed for
funding by NSF; or (ii) in entities whose financial
interests would reasonably appear to be affected
by such activities.
Chapter 1 (Subchapter A) (Part 54)
Financial Disclosure by Clinical Investigators
The Food and Drug Administration (FDA)
regulations state that investigators that
receive compensation in excess of $25,000
from a corporate sponsor of a trial in which
the investigator is engaged must disclose to
the FDA at the time of filing for a new drug
application.
19.058, Conflict of Interest in Research,
Educational, and Public Service Activities
19.059, Employee Participation in Authorized
Private Companies Commercializing Ohio
University Research
“Conflict of Interest in Research, Educational,
and Public Service Activities”
Most conflict disclosures fall within the
parameters of this policy
States that faculty are primarily responsible
for their academic, research and service
obligations
“Employee Participation in Authorized Private
Companies Commercializing Ohio University
Research”
Applies to “employees, faculty, staff and students,
who create intellectual property owned by the Ohio
University and who desire to hold an equity interest
in a firm, corporation, or other association to which
Ohio University has assigned, licensed or
transferred Ohio University’s interests…”
Consulting
Licensing University Technology
Clinical Studies
Procurement
Mentoring
Institutional
A disclosure is filed specific to the funding
application.
If you have a potential conflict for one
proposal, it does not automatically apply to
all of your proposals.
Research conflicts of interest are usually
disclosed using LEO as you apply for funding
by completing the conflict of interest section
of the electronic transmittal
If you are not using LEO, you can download
the appropriate disclosure form from
www.ohio.edu/research/compliance
“A” is selected if you have no conflicts to
disclose
“B” is selected if you have a potential conflict
to disclose relative to the submission.
(Requires a subsequent paper process)
“C” is selected if you have a current disclosure
on file, but it is not relevant to the proposal
you are submitting
Still uses option A, B or C
Requires that you gather signatures on paper
for all options, however
Generally used for personnel not listed on the
grant proposal or “key personnel”
We have revised the COI forms to word forms
This should be easier to complete than the
previous form
PDF versions are also available
Should be on the compliance web site soon,
but we can e-mail them to you until then
Use this form only if you are unable to use
the LEO transmittal form to assure that no
conflict of interest exists. A form must be
completed for each proposal.
I assure that I have read Ohio University
Policy 19.058, “Conflict of Interest in
Research, Educational, and Public Service
Activities” and declare that I have nothing
that is, or could be perceived to be a conflict
of interest with this proposal.
Use this form to disclose a potential conflict
of interest situation.
A separate disclosure form must be used for
each entity with which you conduct business
Conflict includes any member of your
immediate family (spouse, domestic partner
or children)
Require that you complete an option “B”
disclosure statement in addition to
completing the LEO transmittal form.
Require you to obtain signatures from Center
or Institute (if applicable), Chair and Dean on
the additional disclosure statement!!
The B disclosure form is available at
www.ohio.edu/research/compliance
Use this form only if you are unable to use
the LEO transmittal form. Complete this form
if you have a current conflict of interest
disclosure on file with the Office of Research
Compliance, but that disclosure is not
applicable to this proposal.
*New Option for 2008*
A management plan is developed for some
disclosures to mitigate the potential conflict
Management plans are specific to each
disclosure
May require submission of additional pieces,
such as a student employment plan
Reduce or remove the financial interest creating the
conflict
Place safeguards that mitigate the conflict potential,
such having some decisions made by an independent
entity
Limit participation in portions of the proposed
research likely to create a conflict
Require that the researcher disclose his or her
conflicting financial interests to all collaborators and
any proposed trainees;
Disclose the conflict in publications
Work to remove students from being directly advised
or taught by faculty where a conflict exists
Assure publication rights for student participants
Student Use
Nepotism and Cronyism
Intellectual Property
Use of University Resources
Publication provisions
Use of Human Subjects
Oversight Requirements
Reporting and Annual Reviews
You must submit an annual renewal for your
disclosure
◦ If the potential conflict no longer exists you must
notify us
If significant changes occur during the year
you should submit an update to your
disclosure as they occur
Yes. We encourage employees to disclose
potential conflicts that do not meet the
financial threshold, but may still be
problematic, such as student employment.
This allows you to be transparent with
respect to outside interests.
Allowable situations
Situations that require disclosure but may not
need an extensive management plan
Situations that require disclosure and have
problematic elements that will require
mitigation and/or a management plan
Situations that are not permitted
Receipt of royalties or honoraria for
published scholarly works, seminars,
teaching, etc.
Honoraria for serving as a special reviewer
or work on review panels
Royalties under our intellectual property
policies if no other relationship with entity
Clinical income at OUCOM
You participate in research developed in
whole or part by you, and you or your
family receive royalties from an existing
agreement with the business, but have
no other significant financial interest
You assign students, etc. to research
projects where you are entitled to
receive royalties, but have no other
significant financial interest
You assign students, etc. to projects supported
by the business through an SRA, and have a
significant financial interest other than royalty
income
You receive research support from a business in
which you serve on the board of directors, or
other advisory board, even if you are not
compensated.
You hold an executive position in a business
engaged in commercial or research activities
directly related to your Ohio University
responsibilities.
Any situation in which an actual conflict
exists is not permitted.
The only “exceptions” are those handled
under Ohio University Policy and Procedure
19.059 where faculty entrepreneurship is
addressed.
Participation in clinical trials or evaluation
of other research in which you have a
significant financial interest other than
royalty income.
In the context of your position at Ohio
University, you make professional referrals
to a business in which you have a
significant financial interest.
Letter of admonition
Ineligibility to submit grant applications
Withholding of IRB or IACUC approvals
Suspension
Non-Renewal
Loss of Tenure
Consulting
Procurement
Mentoring
Clinical Studies
Avoid consulting relationships that have
the potential to divert time and effort from
your responsibilities to Ohio University.
Do not use students.
Be wary of situations that limit publication.
Do not use university stationary, etc. that
could create an impression the university
is involved with the activities.
Make sure you are devoting sufficient time
to your university obligations.
Be cautious that the potential financial gain
cannot be perceived to influence your
university mentoring relationships.
Disclose any personal or familial financial
interest or equity in a company that is
doing business with Ohio University.
If you make purchases using public funds,
you should not use companies which will
benefit you or your family. If there is no
alternative you must seek and receive
permission prior to purchasing.
Any relationship in which there is a real or
perceived power or influence imbalance has
the potential for conflict. (Faculty:Student)
Isolating these relationships with respect to
areas of personal financial gain is best.
If they cannot be isolated, then safeguards
must be created.
If you have a financial interest, it is best to
isolate yourself from the study.
At a minimum, expect a more intense review
and a robust management plan if you have a
financial interest.
If both the institution and you have financial
interests the clinical study should be
conducted elsewhere.
You have administrative responsibilities on
behalf of Ohio University that is beneficial to
the business in which you have a significant
financial interest
You have administrative responsibilities on
behalf of Ohio University with respect to an
SRA where you have a significant financial
interest
Slide 28
Jo Ellen Sherow
Ohio University
Office of Research Compliance
Researchers’ Financial Disclosures in the
Spotlight
Conflicts of interest, always an emotional topic,
returned to the headlines this week as Sen.
Charles Grassley, a longtime critic of the drug
industry’s potential influence on research,
released new evidence that prominent Harvard
University scientists had failed to disclose much
of their outside income from pharmaceutical
companies over the past eight years.
http://www.insidehighered.com/news/2008/06/12/conflict January 15, 2008
WEDNESDAY, JANUARY 21, 2009
In a review of the literature regarding the relationship between
smokeless tobacco use and cancer, a conflict of interest of one of the
article's authors was initially not disclosed (see: Boffetta P, Hecht S, Gray
N, Gupta P, Straif K. Smokeless tobacco and cancer. Lancet Oncology
2008; 9:667-675). The original article was published in July, 2008. That
article stated: "The authors declare no conflicts of interest." After the
editor of the journal was notified by a researcher with knowledge of a
potential conflict of interest of Dr. Stephen Hecht (one of the study
authors), an erratum was published in September 2008, which noted:
"During the immediate months preceding submission of the review SH
was acting in the capacity of an expert witness for the plaintiff in a
future court case against a smokeless tobacco company. SH declares his
participation in this case in no way influenced his writing or involvement
in the review."
http://tobaccoanalysis.blogspot.com/2009/01/conflict-of-interestnot.html
January 16, 2009 — More than one third of new
drug marketing applications approved by the US
Food and Drug Administration (FDA) were
missing information about potential conflicts of
interest for clinical trial investigators, which
could allow bias to creep into the approvals
process, a government report released this week
has found. The FDA has said that it agrees with
most of the report's findings.
http://www.medscape.com/viewarticle/586980
Do collaborations between biotech companies
and academic centers constitute a conflict of
interest?
Biotechnology industry partnerships with
universities and academic centers have been
fruitful for both. So why is there so much
concern about conflict of interest and is that
concern appropriate?
http://www.redorbit.com/news/health/750100/genetic_engineering_news_p
osts_podcast_on_industrialacademic_collaborations_are_these/index.html
Universities are responsible for use of public
funds and therefore must maintain the public
trust.
Identifying and mitigating situations that may
have the potential for conflict maintains the
integrity of the university.
Maintaining integrity allows the university to
do credible academic research.
To provide information on the purpose of the
conflict of interest requirements.
To provide a basic overview of conflicts of
interest
To introduce the disclosure process and the use
of management plans
To provide information on the need for updates
and annual renewals.
Situations where financial considerations
compromise your professional judgment.
“Actual Conflict of Interest”
◦ Not permitted
Situations where an independent observer
might reasonably question whether your
professional actions or decisions are
determined by considerations of personal
gain. “Perceived Conflict of Interest”
◦ Managed
Potential conflicts may be financial or may be
a conflict of time, effort and/or commitment.
Potential conflicts can occur as a result of
administrative, scientific, academic, fiduciary
or familial situations.
They are situations that can be PERCEIVED to
be conflicting, whether a “real” conflict exists
or not.
Ohio University Policy has a mandatory
disclosure policy if you:
Earn over $10,000 in a twelve month period
from your outside activity OR
Have over 5% equity in the entity
Applies to members of your immediate family
(spouse, domestic partner, dependent
children) as well as yourself.
Anything of monetary value, including but not
limited to:
◦
◦
◦
◦
Salary
Payments for services
Equity interests over 5%
Intellectual property rights
Excludes mutual, pension and other
investments over which you have no control
Outside work during regular academic year
should not exceed equivalent of 1 day per
week.
Consulting work must avoid activities that
involve a conflict of interest with assigned
Ohio University activities and programs
Faculty Handbook, section IV-D
Outside interests cannot interfere with
primary loyalty to Ohio University and your
academic role
Use of university resources must have prior
approval of Chair, Dean and VPR.
Your outside interests should not be in
direct competition with university interests
Full time administrative employees are
expected to devote their full-time
professional loyalty, time and energy to their
position.
You must use non-work hours and no
university resources
Federal Agencies
State Law
University Policies
Many Academic Publications
45 CFR Part 50, Subpart F
“Responsibility of Applicants for Promoting
Objectivity in Research for Which PHS Funding
is Sought”
Authority: 42 U.S.C. 216, 289b-1, 299c-3.
Intent is to assure objectivity by establishing
standards that preclude bias in design, conduct, or
reporting of research
Focuses on financial conflicts of interest
(FCOI)
Regulations apply to investigators, including
sub grantees, contractors, and collaborating
investigators.
Does not apply to applications for support
under Phase I of SBIR and STTR programs
An institutional conflict of interest policy should
require that each investigator disclose to a
responsible representative of the institution all
significant financial interests of the investigator
(including those of the investigator’s spouse and
dependent children) (i) that would reasonably
appear to be affected by the research or
educational activities funded or proposed for
funding by NSF; or (ii) in entities whose financial
interests would reasonably appear to be affected
by such activities.
Chapter 1 (Subchapter A) (Part 54)
Financial Disclosure by Clinical Investigators
The Food and Drug Administration (FDA)
regulations state that investigators that
receive compensation in excess of $25,000
from a corporate sponsor of a trial in which
the investigator is engaged must disclose to
the FDA at the time of filing for a new drug
application.
19.058, Conflict of Interest in Research,
Educational, and Public Service Activities
19.059, Employee Participation in Authorized
Private Companies Commercializing Ohio
University Research
“Conflict of Interest in Research, Educational,
and Public Service Activities”
Most conflict disclosures fall within the
parameters of this policy
States that faculty are primarily responsible
for their academic, research and service
obligations
“Employee Participation in Authorized Private
Companies Commercializing Ohio University
Research”
Applies to “employees, faculty, staff and students,
who create intellectual property owned by the Ohio
University and who desire to hold an equity interest
in a firm, corporation, or other association to which
Ohio University has assigned, licensed or
transferred Ohio University’s interests…”
Consulting
Licensing University Technology
Clinical Studies
Procurement
Mentoring
Institutional
A disclosure is filed specific to the funding
application.
If you have a potential conflict for one
proposal, it does not automatically apply to
all of your proposals.
Research conflicts of interest are usually
disclosed using LEO as you apply for funding
by completing the conflict of interest section
of the electronic transmittal
If you are not using LEO, you can download
the appropriate disclosure form from
www.ohio.edu/research/compliance
“A” is selected if you have no conflicts to
disclose
“B” is selected if you have a potential conflict
to disclose relative to the submission.
(Requires a subsequent paper process)
“C” is selected if you have a current disclosure
on file, but it is not relevant to the proposal
you are submitting
Still uses option A, B or C
Requires that you gather signatures on paper
for all options, however
Generally used for personnel not listed on the
grant proposal or “key personnel”
We have revised the COI forms to word forms
This should be easier to complete than the
previous form
PDF versions are also available
Should be on the compliance web site soon,
but we can e-mail them to you until then
Use this form only if you are unable to use
the LEO transmittal form to assure that no
conflict of interest exists. A form must be
completed for each proposal.
I assure that I have read Ohio University
Policy 19.058, “Conflict of Interest in
Research, Educational, and Public Service
Activities” and declare that I have nothing
that is, or could be perceived to be a conflict
of interest with this proposal.
Use this form to disclose a potential conflict
of interest situation.
A separate disclosure form must be used for
each entity with which you conduct business
Conflict includes any member of your
immediate family (spouse, domestic partner
or children)
Require that you complete an option “B”
disclosure statement in addition to
completing the LEO transmittal form.
Require you to obtain signatures from Center
or Institute (if applicable), Chair and Dean on
the additional disclosure statement!!
The B disclosure form is available at
www.ohio.edu/research/compliance
Use this form only if you are unable to use
the LEO transmittal form. Complete this form
if you have a current conflict of interest
disclosure on file with the Office of Research
Compliance, but that disclosure is not
applicable to this proposal.
*New Option for 2008*
A management plan is developed for some
disclosures to mitigate the potential conflict
Management plans are specific to each
disclosure
May require submission of additional pieces,
such as a student employment plan
Reduce or remove the financial interest creating the
conflict
Place safeguards that mitigate the conflict potential,
such having some decisions made by an independent
entity
Limit participation in portions of the proposed
research likely to create a conflict
Require that the researcher disclose his or her
conflicting financial interests to all collaborators and
any proposed trainees;
Disclose the conflict in publications
Work to remove students from being directly advised
or taught by faculty where a conflict exists
Assure publication rights for student participants
Student Use
Nepotism and Cronyism
Intellectual Property
Use of University Resources
Publication provisions
Use of Human Subjects
Oversight Requirements
Reporting and Annual Reviews
You must submit an annual renewal for your
disclosure
◦ If the potential conflict no longer exists you must
notify us
If significant changes occur during the year
you should submit an update to your
disclosure as they occur
Yes. We encourage employees to disclose
potential conflicts that do not meet the
financial threshold, but may still be
problematic, such as student employment.
This allows you to be transparent with
respect to outside interests.
Allowable situations
Situations that require disclosure but may not
need an extensive management plan
Situations that require disclosure and have
problematic elements that will require
mitigation and/or a management plan
Situations that are not permitted
Receipt of royalties or honoraria for
published scholarly works, seminars,
teaching, etc.
Honoraria for serving as a special reviewer
or work on review panels
Royalties under our intellectual property
policies if no other relationship with entity
Clinical income at OUCOM
You participate in research developed in
whole or part by you, and you or your
family receive royalties from an existing
agreement with the business, but have
no other significant financial interest
You assign students, etc. to research
projects where you are entitled to
receive royalties, but have no other
significant financial interest
You assign students, etc. to projects supported
by the business through an SRA, and have a
significant financial interest other than royalty
income
You receive research support from a business in
which you serve on the board of directors, or
other advisory board, even if you are not
compensated.
You hold an executive position in a business
engaged in commercial or research activities
directly related to your Ohio University
responsibilities.
Any situation in which an actual conflict
exists is not permitted.
The only “exceptions” are those handled
under Ohio University Policy and Procedure
19.059 where faculty entrepreneurship is
addressed.
Participation in clinical trials or evaluation
of other research in which you have a
significant financial interest other than
royalty income.
In the context of your position at Ohio
University, you make professional referrals
to a business in which you have a
significant financial interest.
Letter of admonition
Ineligibility to submit grant applications
Withholding of IRB or IACUC approvals
Suspension
Non-Renewal
Loss of Tenure
Consulting
Procurement
Mentoring
Clinical Studies
Avoid consulting relationships that have
the potential to divert time and effort from
your responsibilities to Ohio University.
Do not use students.
Be wary of situations that limit publication.
Do not use university stationary, etc. that
could create an impression the university
is involved with the activities.
Make sure you are devoting sufficient time
to your university obligations.
Be cautious that the potential financial gain
cannot be perceived to influence your
university mentoring relationships.
Disclose any personal or familial financial
interest or equity in a company that is
doing business with Ohio University.
If you make purchases using public funds,
you should not use companies which will
benefit you or your family. If there is no
alternative you must seek and receive
permission prior to purchasing.
Any relationship in which there is a real or
perceived power or influence imbalance has
the potential for conflict. (Faculty:Student)
Isolating these relationships with respect to
areas of personal financial gain is best.
If they cannot be isolated, then safeguards
must be created.
If you have a financial interest, it is best to
isolate yourself from the study.
At a minimum, expect a more intense review
and a robust management plan if you have a
financial interest.
If both the institution and you have financial
interests the clinical study should be
conducted elsewhere.
You have administrative responsibilities on
behalf of Ohio University that is beneficial to
the business in which you have a significant
financial interest
You have administrative responsibilities on
behalf of Ohio University with respect to an
SRA where you have a significant financial
interest
Slide 29
Jo Ellen Sherow
Ohio University
Office of Research Compliance
Researchers’ Financial Disclosures in the
Spotlight
Conflicts of interest, always an emotional topic,
returned to the headlines this week as Sen.
Charles Grassley, a longtime critic of the drug
industry’s potential influence on research,
released new evidence that prominent Harvard
University scientists had failed to disclose much
of their outside income from pharmaceutical
companies over the past eight years.
http://www.insidehighered.com/news/2008/06/12/conflict January 15, 2008
WEDNESDAY, JANUARY 21, 2009
In a review of the literature regarding the relationship between
smokeless tobacco use and cancer, a conflict of interest of one of the
article's authors was initially not disclosed (see: Boffetta P, Hecht S, Gray
N, Gupta P, Straif K. Smokeless tobacco and cancer. Lancet Oncology
2008; 9:667-675). The original article was published in July, 2008. That
article stated: "The authors declare no conflicts of interest." After the
editor of the journal was notified by a researcher with knowledge of a
potential conflict of interest of Dr. Stephen Hecht (one of the study
authors), an erratum was published in September 2008, which noted:
"During the immediate months preceding submission of the review SH
was acting in the capacity of an expert witness for the plaintiff in a
future court case against a smokeless tobacco company. SH declares his
participation in this case in no way influenced his writing or involvement
in the review."
http://tobaccoanalysis.blogspot.com/2009/01/conflict-of-interestnot.html
January 16, 2009 — More than one third of new
drug marketing applications approved by the US
Food and Drug Administration (FDA) were
missing information about potential conflicts of
interest for clinical trial investigators, which
could allow bias to creep into the approvals
process, a government report released this week
has found. The FDA has said that it agrees with
most of the report's findings.
http://www.medscape.com/viewarticle/586980
Do collaborations between biotech companies
and academic centers constitute a conflict of
interest?
Biotechnology industry partnerships with
universities and academic centers have been
fruitful for both. So why is there so much
concern about conflict of interest and is that
concern appropriate?
http://www.redorbit.com/news/health/750100/genetic_engineering_news_p
osts_podcast_on_industrialacademic_collaborations_are_these/index.html
Universities are responsible for use of public
funds and therefore must maintain the public
trust.
Identifying and mitigating situations that may
have the potential for conflict maintains the
integrity of the university.
Maintaining integrity allows the university to
do credible academic research.
To provide information on the purpose of the
conflict of interest requirements.
To provide a basic overview of conflicts of
interest
To introduce the disclosure process and the use
of management plans
To provide information on the need for updates
and annual renewals.
Situations where financial considerations
compromise your professional judgment.
“Actual Conflict of Interest”
◦ Not permitted
Situations where an independent observer
might reasonably question whether your
professional actions or decisions are
determined by considerations of personal
gain. “Perceived Conflict of Interest”
◦ Managed
Potential conflicts may be financial or may be
a conflict of time, effort and/or commitment.
Potential conflicts can occur as a result of
administrative, scientific, academic, fiduciary
or familial situations.
They are situations that can be PERCEIVED to
be conflicting, whether a “real” conflict exists
or not.
Ohio University Policy has a mandatory
disclosure policy if you:
Earn over $10,000 in a twelve month period
from your outside activity OR
Have over 5% equity in the entity
Applies to members of your immediate family
(spouse, domestic partner, dependent
children) as well as yourself.
Anything of monetary value, including but not
limited to:
◦
◦
◦
◦
Salary
Payments for services
Equity interests over 5%
Intellectual property rights
Excludes mutual, pension and other
investments over which you have no control
Outside work during regular academic year
should not exceed equivalent of 1 day per
week.
Consulting work must avoid activities that
involve a conflict of interest with assigned
Ohio University activities and programs
Faculty Handbook, section IV-D
Outside interests cannot interfere with
primary loyalty to Ohio University and your
academic role
Use of university resources must have prior
approval of Chair, Dean and VPR.
Your outside interests should not be in
direct competition with university interests
Full time administrative employees are
expected to devote their full-time
professional loyalty, time and energy to their
position.
You must use non-work hours and no
university resources
Federal Agencies
State Law
University Policies
Many Academic Publications
45 CFR Part 50, Subpart F
“Responsibility of Applicants for Promoting
Objectivity in Research for Which PHS Funding
is Sought”
Authority: 42 U.S.C. 216, 289b-1, 299c-3.
Intent is to assure objectivity by establishing
standards that preclude bias in design, conduct, or
reporting of research
Focuses on financial conflicts of interest
(FCOI)
Regulations apply to investigators, including
sub grantees, contractors, and collaborating
investigators.
Does not apply to applications for support
under Phase I of SBIR and STTR programs
An institutional conflict of interest policy should
require that each investigator disclose to a
responsible representative of the institution all
significant financial interests of the investigator
(including those of the investigator’s spouse and
dependent children) (i) that would reasonably
appear to be affected by the research or
educational activities funded or proposed for
funding by NSF; or (ii) in entities whose financial
interests would reasonably appear to be affected
by such activities.
Chapter 1 (Subchapter A) (Part 54)
Financial Disclosure by Clinical Investigators
The Food and Drug Administration (FDA)
regulations state that investigators that
receive compensation in excess of $25,000
from a corporate sponsor of a trial in which
the investigator is engaged must disclose to
the FDA at the time of filing for a new drug
application.
19.058, Conflict of Interest in Research,
Educational, and Public Service Activities
19.059, Employee Participation in Authorized
Private Companies Commercializing Ohio
University Research
“Conflict of Interest in Research, Educational,
and Public Service Activities”
Most conflict disclosures fall within the
parameters of this policy
States that faculty are primarily responsible
for their academic, research and service
obligations
“Employee Participation in Authorized Private
Companies Commercializing Ohio University
Research”
Applies to “employees, faculty, staff and students,
who create intellectual property owned by the Ohio
University and who desire to hold an equity interest
in a firm, corporation, or other association to which
Ohio University has assigned, licensed or
transferred Ohio University’s interests…”
Consulting
Licensing University Technology
Clinical Studies
Procurement
Mentoring
Institutional
A disclosure is filed specific to the funding
application.
If you have a potential conflict for one
proposal, it does not automatically apply to
all of your proposals.
Research conflicts of interest are usually
disclosed using LEO as you apply for funding
by completing the conflict of interest section
of the electronic transmittal
If you are not using LEO, you can download
the appropriate disclosure form from
www.ohio.edu/research/compliance
“A” is selected if you have no conflicts to
disclose
“B” is selected if you have a potential conflict
to disclose relative to the submission.
(Requires a subsequent paper process)
“C” is selected if you have a current disclosure
on file, but it is not relevant to the proposal
you are submitting
Still uses option A, B or C
Requires that you gather signatures on paper
for all options, however
Generally used for personnel not listed on the
grant proposal or “key personnel”
We have revised the COI forms to word forms
This should be easier to complete than the
previous form
PDF versions are also available
Should be on the compliance web site soon,
but we can e-mail them to you until then
Use this form only if you are unable to use
the LEO transmittal form to assure that no
conflict of interest exists. A form must be
completed for each proposal.
I assure that I have read Ohio University
Policy 19.058, “Conflict of Interest in
Research, Educational, and Public Service
Activities” and declare that I have nothing
that is, or could be perceived to be a conflict
of interest with this proposal.
Use this form to disclose a potential conflict
of interest situation.
A separate disclosure form must be used for
each entity with which you conduct business
Conflict includes any member of your
immediate family (spouse, domestic partner
or children)
Require that you complete an option “B”
disclosure statement in addition to
completing the LEO transmittal form.
Require you to obtain signatures from Center
or Institute (if applicable), Chair and Dean on
the additional disclosure statement!!
The B disclosure form is available at
www.ohio.edu/research/compliance
Use this form only if you are unable to use
the LEO transmittal form. Complete this form
if you have a current conflict of interest
disclosure on file with the Office of Research
Compliance, but that disclosure is not
applicable to this proposal.
*New Option for 2008*
A management plan is developed for some
disclosures to mitigate the potential conflict
Management plans are specific to each
disclosure
May require submission of additional pieces,
such as a student employment plan
Reduce or remove the financial interest creating the
conflict
Place safeguards that mitigate the conflict potential,
such having some decisions made by an independent
entity
Limit participation in portions of the proposed
research likely to create a conflict
Require that the researcher disclose his or her
conflicting financial interests to all collaborators and
any proposed trainees;
Disclose the conflict in publications
Work to remove students from being directly advised
or taught by faculty where a conflict exists
Assure publication rights for student participants
Student Use
Nepotism and Cronyism
Intellectual Property
Use of University Resources
Publication provisions
Use of Human Subjects
Oversight Requirements
Reporting and Annual Reviews
You must submit an annual renewal for your
disclosure
◦ If the potential conflict no longer exists you must
notify us
If significant changes occur during the year
you should submit an update to your
disclosure as they occur
Yes. We encourage employees to disclose
potential conflicts that do not meet the
financial threshold, but may still be
problematic, such as student employment.
This allows you to be transparent with
respect to outside interests.
Allowable situations
Situations that require disclosure but may not
need an extensive management plan
Situations that require disclosure and have
problematic elements that will require
mitigation and/or a management plan
Situations that are not permitted
Receipt of royalties or honoraria for
published scholarly works, seminars,
teaching, etc.
Honoraria for serving as a special reviewer
or work on review panels
Royalties under our intellectual property
policies if no other relationship with entity
Clinical income at OUCOM
You participate in research developed in
whole or part by you, and you or your
family receive royalties from an existing
agreement with the business, but have
no other significant financial interest
You assign students, etc. to research
projects where you are entitled to
receive royalties, but have no other
significant financial interest
You assign students, etc. to projects supported
by the business through an SRA, and have a
significant financial interest other than royalty
income
You receive research support from a business in
which you serve on the board of directors, or
other advisory board, even if you are not
compensated.
You hold an executive position in a business
engaged in commercial or research activities
directly related to your Ohio University
responsibilities.
Any situation in which an actual conflict
exists is not permitted.
The only “exceptions” are those handled
under Ohio University Policy and Procedure
19.059 where faculty entrepreneurship is
addressed.
Participation in clinical trials or evaluation
of other research in which you have a
significant financial interest other than
royalty income.
In the context of your position at Ohio
University, you make professional referrals
to a business in which you have a
significant financial interest.
Letter of admonition
Ineligibility to submit grant applications
Withholding of IRB or IACUC approvals
Suspension
Non-Renewal
Loss of Tenure
Consulting
Procurement
Mentoring
Clinical Studies
Avoid consulting relationships that have
the potential to divert time and effort from
your responsibilities to Ohio University.
Do not use students.
Be wary of situations that limit publication.
Do not use university stationary, etc. that
could create an impression the university
is involved with the activities.
Make sure you are devoting sufficient time
to your university obligations.
Be cautious that the potential financial gain
cannot be perceived to influence your
university mentoring relationships.
Disclose any personal or familial financial
interest or equity in a company that is
doing business with Ohio University.
If you make purchases using public funds,
you should not use companies which will
benefit you or your family. If there is no
alternative you must seek and receive
permission prior to purchasing.
Any relationship in which there is a real or
perceived power or influence imbalance has
the potential for conflict. (Faculty:Student)
Isolating these relationships with respect to
areas of personal financial gain is best.
If they cannot be isolated, then safeguards
must be created.
If you have a financial interest, it is best to
isolate yourself from the study.
At a minimum, expect a more intense review
and a robust management plan if you have a
financial interest.
If both the institution and you have financial
interests the clinical study should be
conducted elsewhere.
You have administrative responsibilities on
behalf of Ohio University that is beneficial to
the business in which you have a significant
financial interest
You have administrative responsibilities on
behalf of Ohio University with respect to an
SRA where you have a significant financial
interest
Slide 30
Jo Ellen Sherow
Ohio University
Office of Research Compliance
Researchers’ Financial Disclosures in the
Spotlight
Conflicts of interest, always an emotional topic,
returned to the headlines this week as Sen.
Charles Grassley, a longtime critic of the drug
industry’s potential influence on research,
released new evidence that prominent Harvard
University scientists had failed to disclose much
of their outside income from pharmaceutical
companies over the past eight years.
http://www.insidehighered.com/news/2008/06/12/conflict January 15, 2008
WEDNESDAY, JANUARY 21, 2009
In a review of the literature regarding the relationship between
smokeless tobacco use and cancer, a conflict of interest of one of the
article's authors was initially not disclosed (see: Boffetta P, Hecht S, Gray
N, Gupta P, Straif K. Smokeless tobacco and cancer. Lancet Oncology
2008; 9:667-675). The original article was published in July, 2008. That
article stated: "The authors declare no conflicts of interest." After the
editor of the journal was notified by a researcher with knowledge of a
potential conflict of interest of Dr. Stephen Hecht (one of the study
authors), an erratum was published in September 2008, which noted:
"During the immediate months preceding submission of the review SH
was acting in the capacity of an expert witness for the plaintiff in a
future court case against a smokeless tobacco company. SH declares his
participation in this case in no way influenced his writing or involvement
in the review."
http://tobaccoanalysis.blogspot.com/2009/01/conflict-of-interestnot.html
January 16, 2009 — More than one third of new
drug marketing applications approved by the US
Food and Drug Administration (FDA) were
missing information about potential conflicts of
interest for clinical trial investigators, which
could allow bias to creep into the approvals
process, a government report released this week
has found. The FDA has said that it agrees with
most of the report's findings.
http://www.medscape.com/viewarticle/586980
Do collaborations between biotech companies
and academic centers constitute a conflict of
interest?
Biotechnology industry partnerships with
universities and academic centers have been
fruitful for both. So why is there so much
concern about conflict of interest and is that
concern appropriate?
http://www.redorbit.com/news/health/750100/genetic_engineering_news_p
osts_podcast_on_industrialacademic_collaborations_are_these/index.html
Universities are responsible for use of public
funds and therefore must maintain the public
trust.
Identifying and mitigating situations that may
have the potential for conflict maintains the
integrity of the university.
Maintaining integrity allows the university to
do credible academic research.
To provide information on the purpose of the
conflict of interest requirements.
To provide a basic overview of conflicts of
interest
To introduce the disclosure process and the use
of management plans
To provide information on the need for updates
and annual renewals.
Situations where financial considerations
compromise your professional judgment.
“Actual Conflict of Interest”
◦ Not permitted
Situations where an independent observer
might reasonably question whether your
professional actions or decisions are
determined by considerations of personal
gain. “Perceived Conflict of Interest”
◦ Managed
Potential conflicts may be financial or may be
a conflict of time, effort and/or commitment.
Potential conflicts can occur as a result of
administrative, scientific, academic, fiduciary
or familial situations.
They are situations that can be PERCEIVED to
be conflicting, whether a “real” conflict exists
or not.
Ohio University Policy has a mandatory
disclosure policy if you:
Earn over $10,000 in a twelve month period
from your outside activity OR
Have over 5% equity in the entity
Applies to members of your immediate family
(spouse, domestic partner, dependent
children) as well as yourself.
Anything of monetary value, including but not
limited to:
◦
◦
◦
◦
Salary
Payments for services
Equity interests over 5%
Intellectual property rights
Excludes mutual, pension and other
investments over which you have no control
Outside work during regular academic year
should not exceed equivalent of 1 day per
week.
Consulting work must avoid activities that
involve a conflict of interest with assigned
Ohio University activities and programs
Faculty Handbook, section IV-D
Outside interests cannot interfere with
primary loyalty to Ohio University and your
academic role
Use of university resources must have prior
approval of Chair, Dean and VPR.
Your outside interests should not be in
direct competition with university interests
Full time administrative employees are
expected to devote their full-time
professional loyalty, time and energy to their
position.
You must use non-work hours and no
university resources
Federal Agencies
State Law
University Policies
Many Academic Publications
45 CFR Part 50, Subpart F
“Responsibility of Applicants for Promoting
Objectivity in Research for Which PHS Funding
is Sought”
Authority: 42 U.S.C. 216, 289b-1, 299c-3.
Intent is to assure objectivity by establishing
standards that preclude bias in design, conduct, or
reporting of research
Focuses on financial conflicts of interest
(FCOI)
Regulations apply to investigators, including
sub grantees, contractors, and collaborating
investigators.
Does not apply to applications for support
under Phase I of SBIR and STTR programs
An institutional conflict of interest policy should
require that each investigator disclose to a
responsible representative of the institution all
significant financial interests of the investigator
(including those of the investigator’s spouse and
dependent children) (i) that would reasonably
appear to be affected by the research or
educational activities funded or proposed for
funding by NSF; or (ii) in entities whose financial
interests would reasonably appear to be affected
by such activities.
Chapter 1 (Subchapter A) (Part 54)
Financial Disclosure by Clinical Investigators
The Food and Drug Administration (FDA)
regulations state that investigators that
receive compensation in excess of $25,000
from a corporate sponsor of a trial in which
the investigator is engaged must disclose to
the FDA at the time of filing for a new drug
application.
19.058, Conflict of Interest in Research,
Educational, and Public Service Activities
19.059, Employee Participation in Authorized
Private Companies Commercializing Ohio
University Research
“Conflict of Interest in Research, Educational,
and Public Service Activities”
Most conflict disclosures fall within the
parameters of this policy
States that faculty are primarily responsible
for their academic, research and service
obligations
“Employee Participation in Authorized Private
Companies Commercializing Ohio University
Research”
Applies to “employees, faculty, staff and students,
who create intellectual property owned by the Ohio
University and who desire to hold an equity interest
in a firm, corporation, or other association to which
Ohio University has assigned, licensed or
transferred Ohio University’s interests…”
Consulting
Licensing University Technology
Clinical Studies
Procurement
Mentoring
Institutional
A disclosure is filed specific to the funding
application.
If you have a potential conflict for one
proposal, it does not automatically apply to
all of your proposals.
Research conflicts of interest are usually
disclosed using LEO as you apply for funding
by completing the conflict of interest section
of the electronic transmittal
If you are not using LEO, you can download
the appropriate disclosure form from
www.ohio.edu/research/compliance
“A” is selected if you have no conflicts to
disclose
“B” is selected if you have a potential conflict
to disclose relative to the submission.
(Requires a subsequent paper process)
“C” is selected if you have a current disclosure
on file, but it is not relevant to the proposal
you are submitting
Still uses option A, B or C
Requires that you gather signatures on paper
for all options, however
Generally used for personnel not listed on the
grant proposal or “key personnel”
We have revised the COI forms to word forms
This should be easier to complete than the
previous form
PDF versions are also available
Should be on the compliance web site soon,
but we can e-mail them to you until then
Use this form only if you are unable to use
the LEO transmittal form to assure that no
conflict of interest exists. A form must be
completed for each proposal.
I assure that I have read Ohio University
Policy 19.058, “Conflict of Interest in
Research, Educational, and Public Service
Activities” and declare that I have nothing
that is, or could be perceived to be a conflict
of interest with this proposal.
Use this form to disclose a potential conflict
of interest situation.
A separate disclosure form must be used for
each entity with which you conduct business
Conflict includes any member of your
immediate family (spouse, domestic partner
or children)
Require that you complete an option “B”
disclosure statement in addition to
completing the LEO transmittal form.
Require you to obtain signatures from Center
or Institute (if applicable), Chair and Dean on
the additional disclosure statement!!
The B disclosure form is available at
www.ohio.edu/research/compliance
Use this form only if you are unable to use
the LEO transmittal form. Complete this form
if you have a current conflict of interest
disclosure on file with the Office of Research
Compliance, but that disclosure is not
applicable to this proposal.
*New Option for 2008*
A management plan is developed for some
disclosures to mitigate the potential conflict
Management plans are specific to each
disclosure
May require submission of additional pieces,
such as a student employment plan
Reduce or remove the financial interest creating the
conflict
Place safeguards that mitigate the conflict potential,
such having some decisions made by an independent
entity
Limit participation in portions of the proposed
research likely to create a conflict
Require that the researcher disclose his or her
conflicting financial interests to all collaborators and
any proposed trainees;
Disclose the conflict in publications
Work to remove students from being directly advised
or taught by faculty where a conflict exists
Assure publication rights for student participants
Student Use
Nepotism and Cronyism
Intellectual Property
Use of University Resources
Publication provisions
Use of Human Subjects
Oversight Requirements
Reporting and Annual Reviews
You must submit an annual renewal for your
disclosure
◦ If the potential conflict no longer exists you must
notify us
If significant changes occur during the year
you should submit an update to your
disclosure as they occur
Yes. We encourage employees to disclose
potential conflicts that do not meet the
financial threshold, but may still be
problematic, such as student employment.
This allows you to be transparent with
respect to outside interests.
Allowable situations
Situations that require disclosure but may not
need an extensive management plan
Situations that require disclosure and have
problematic elements that will require
mitigation and/or a management plan
Situations that are not permitted
Receipt of royalties or honoraria for
published scholarly works, seminars,
teaching, etc.
Honoraria for serving as a special reviewer
or work on review panels
Royalties under our intellectual property
policies if no other relationship with entity
Clinical income at OUCOM
You participate in research developed in
whole or part by you, and you or your
family receive royalties from an existing
agreement with the business, but have
no other significant financial interest
You assign students, etc. to research
projects where you are entitled to
receive royalties, but have no other
significant financial interest
You assign students, etc. to projects supported
by the business through an SRA, and have a
significant financial interest other than royalty
income
You receive research support from a business in
which you serve on the board of directors, or
other advisory board, even if you are not
compensated.
You hold an executive position in a business
engaged in commercial or research activities
directly related to your Ohio University
responsibilities.
Any situation in which an actual conflict
exists is not permitted.
The only “exceptions” are those handled
under Ohio University Policy and Procedure
19.059 where faculty entrepreneurship is
addressed.
Participation in clinical trials or evaluation
of other research in which you have a
significant financial interest other than
royalty income.
In the context of your position at Ohio
University, you make professional referrals
to a business in which you have a
significant financial interest.
Letter of admonition
Ineligibility to submit grant applications
Withholding of IRB or IACUC approvals
Suspension
Non-Renewal
Loss of Tenure
Consulting
Procurement
Mentoring
Clinical Studies
Avoid consulting relationships that have
the potential to divert time and effort from
your responsibilities to Ohio University.
Do not use students.
Be wary of situations that limit publication.
Do not use university stationary, etc. that
could create an impression the university
is involved with the activities.
Make sure you are devoting sufficient time
to your university obligations.
Be cautious that the potential financial gain
cannot be perceived to influence your
university mentoring relationships.
Disclose any personal or familial financial
interest or equity in a company that is
doing business with Ohio University.
If you make purchases using public funds,
you should not use companies which will
benefit you or your family. If there is no
alternative you must seek and receive
permission prior to purchasing.
Any relationship in which there is a real or
perceived power or influence imbalance has
the potential for conflict. (Faculty:Student)
Isolating these relationships with respect to
areas of personal financial gain is best.
If they cannot be isolated, then safeguards
must be created.
If you have a financial interest, it is best to
isolate yourself from the study.
At a minimum, expect a more intense review
and a robust management plan if you have a
financial interest.
If both the institution and you have financial
interests the clinical study should be
conducted elsewhere.
You have administrative responsibilities on
behalf of Ohio University that is beneficial to
the business in which you have a significant
financial interest
You have administrative responsibilities on
behalf of Ohio University with respect to an
SRA where you have a significant financial
interest
Slide 31
Jo Ellen Sherow
Ohio University
Office of Research Compliance
Researchers’ Financial Disclosures in the
Spotlight
Conflicts of interest, always an emotional topic,
returned to the headlines this week as Sen.
Charles Grassley, a longtime critic of the drug
industry’s potential influence on research,
released new evidence that prominent Harvard
University scientists had failed to disclose much
of their outside income from pharmaceutical
companies over the past eight years.
http://www.insidehighered.com/news/2008/06/12/conflict January 15, 2008
WEDNESDAY, JANUARY 21, 2009
In a review of the literature regarding the relationship between
smokeless tobacco use and cancer, a conflict of interest of one of the
article's authors was initially not disclosed (see: Boffetta P, Hecht S, Gray
N, Gupta P, Straif K. Smokeless tobacco and cancer. Lancet Oncology
2008; 9:667-675). The original article was published in July, 2008. That
article stated: "The authors declare no conflicts of interest." After the
editor of the journal was notified by a researcher with knowledge of a
potential conflict of interest of Dr. Stephen Hecht (one of the study
authors), an erratum was published in September 2008, which noted:
"During the immediate months preceding submission of the review SH
was acting in the capacity of an expert witness for the plaintiff in a
future court case against a smokeless tobacco company. SH declares his
participation in this case in no way influenced his writing or involvement
in the review."
http://tobaccoanalysis.blogspot.com/2009/01/conflict-of-interestnot.html
January 16, 2009 — More than one third of new
drug marketing applications approved by the US
Food and Drug Administration (FDA) were
missing information about potential conflicts of
interest for clinical trial investigators, which
could allow bias to creep into the approvals
process, a government report released this week
has found. The FDA has said that it agrees with
most of the report's findings.
http://www.medscape.com/viewarticle/586980
Do collaborations between biotech companies
and academic centers constitute a conflict of
interest?
Biotechnology industry partnerships with
universities and academic centers have been
fruitful for both. So why is there so much
concern about conflict of interest and is that
concern appropriate?
http://www.redorbit.com/news/health/750100/genetic_engineering_news_p
osts_podcast_on_industrialacademic_collaborations_are_these/index.html
Universities are responsible for use of public
funds and therefore must maintain the public
trust.
Identifying and mitigating situations that may
have the potential for conflict maintains the
integrity of the university.
Maintaining integrity allows the university to
do credible academic research.
To provide information on the purpose of the
conflict of interest requirements.
To provide a basic overview of conflicts of
interest
To introduce the disclosure process and the use
of management plans
To provide information on the need for updates
and annual renewals.
Situations where financial considerations
compromise your professional judgment.
“Actual Conflict of Interest”
◦ Not permitted
Situations where an independent observer
might reasonably question whether your
professional actions or decisions are
determined by considerations of personal
gain. “Perceived Conflict of Interest”
◦ Managed
Potential conflicts may be financial or may be
a conflict of time, effort and/or commitment.
Potential conflicts can occur as a result of
administrative, scientific, academic, fiduciary
or familial situations.
They are situations that can be PERCEIVED to
be conflicting, whether a “real” conflict exists
or not.
Ohio University Policy has a mandatory
disclosure policy if you:
Earn over $10,000 in a twelve month period
from your outside activity OR
Have over 5% equity in the entity
Applies to members of your immediate family
(spouse, domestic partner, dependent
children) as well as yourself.
Anything of monetary value, including but not
limited to:
◦
◦
◦
◦
Salary
Payments for services
Equity interests over 5%
Intellectual property rights
Excludes mutual, pension and other
investments over which you have no control
Outside work during regular academic year
should not exceed equivalent of 1 day per
week.
Consulting work must avoid activities that
involve a conflict of interest with assigned
Ohio University activities and programs
Faculty Handbook, section IV-D
Outside interests cannot interfere with
primary loyalty to Ohio University and your
academic role
Use of university resources must have prior
approval of Chair, Dean and VPR.
Your outside interests should not be in
direct competition with university interests
Full time administrative employees are
expected to devote their full-time
professional loyalty, time and energy to their
position.
You must use non-work hours and no
university resources
Federal Agencies
State Law
University Policies
Many Academic Publications
45 CFR Part 50, Subpart F
“Responsibility of Applicants for Promoting
Objectivity in Research for Which PHS Funding
is Sought”
Authority: 42 U.S.C. 216, 289b-1, 299c-3.
Intent is to assure objectivity by establishing
standards that preclude bias in design, conduct, or
reporting of research
Focuses on financial conflicts of interest
(FCOI)
Regulations apply to investigators, including
sub grantees, contractors, and collaborating
investigators.
Does not apply to applications for support
under Phase I of SBIR and STTR programs
An institutional conflict of interest policy should
require that each investigator disclose to a
responsible representative of the institution all
significant financial interests of the investigator
(including those of the investigator’s spouse and
dependent children) (i) that would reasonably
appear to be affected by the research or
educational activities funded or proposed for
funding by NSF; or (ii) in entities whose financial
interests would reasonably appear to be affected
by such activities.
Chapter 1 (Subchapter A) (Part 54)
Financial Disclosure by Clinical Investigators
The Food and Drug Administration (FDA)
regulations state that investigators that
receive compensation in excess of $25,000
from a corporate sponsor of a trial in which
the investigator is engaged must disclose to
the FDA at the time of filing for a new drug
application.
19.058, Conflict of Interest in Research,
Educational, and Public Service Activities
19.059, Employee Participation in Authorized
Private Companies Commercializing Ohio
University Research
“Conflict of Interest in Research, Educational,
and Public Service Activities”
Most conflict disclosures fall within the
parameters of this policy
States that faculty are primarily responsible
for their academic, research and service
obligations
“Employee Participation in Authorized Private
Companies Commercializing Ohio University
Research”
Applies to “employees, faculty, staff and students,
who create intellectual property owned by the Ohio
University and who desire to hold an equity interest
in a firm, corporation, or other association to which
Ohio University has assigned, licensed or
transferred Ohio University’s interests…”
Consulting
Licensing University Technology
Clinical Studies
Procurement
Mentoring
Institutional
A disclosure is filed specific to the funding
application.
If you have a potential conflict for one
proposal, it does not automatically apply to
all of your proposals.
Research conflicts of interest are usually
disclosed using LEO as you apply for funding
by completing the conflict of interest section
of the electronic transmittal
If you are not using LEO, you can download
the appropriate disclosure form from
www.ohio.edu/research/compliance
“A” is selected if you have no conflicts to
disclose
“B” is selected if you have a potential conflict
to disclose relative to the submission.
(Requires a subsequent paper process)
“C” is selected if you have a current disclosure
on file, but it is not relevant to the proposal
you are submitting
Still uses option A, B or C
Requires that you gather signatures on paper
for all options, however
Generally used for personnel not listed on the
grant proposal or “key personnel”
We have revised the COI forms to word forms
This should be easier to complete than the
previous form
PDF versions are also available
Should be on the compliance web site soon,
but we can e-mail them to you until then
Use this form only if you are unable to use
the LEO transmittal form to assure that no
conflict of interest exists. A form must be
completed for each proposal.
I assure that I have read Ohio University
Policy 19.058, “Conflict of Interest in
Research, Educational, and Public Service
Activities” and declare that I have nothing
that is, or could be perceived to be a conflict
of interest with this proposal.
Use this form to disclose a potential conflict
of interest situation.
A separate disclosure form must be used for
each entity with which you conduct business
Conflict includes any member of your
immediate family (spouse, domestic partner
or children)
Require that you complete an option “B”
disclosure statement in addition to
completing the LEO transmittal form.
Require you to obtain signatures from Center
or Institute (if applicable), Chair and Dean on
the additional disclosure statement!!
The B disclosure form is available at
www.ohio.edu/research/compliance
Use this form only if you are unable to use
the LEO transmittal form. Complete this form
if you have a current conflict of interest
disclosure on file with the Office of Research
Compliance, but that disclosure is not
applicable to this proposal.
*New Option for 2008*
A management plan is developed for some
disclosures to mitigate the potential conflict
Management plans are specific to each
disclosure
May require submission of additional pieces,
such as a student employment plan
Reduce or remove the financial interest creating the
conflict
Place safeguards that mitigate the conflict potential,
such having some decisions made by an independent
entity
Limit participation in portions of the proposed
research likely to create a conflict
Require that the researcher disclose his or her
conflicting financial interests to all collaborators and
any proposed trainees;
Disclose the conflict in publications
Work to remove students from being directly advised
or taught by faculty where a conflict exists
Assure publication rights for student participants
Student Use
Nepotism and Cronyism
Intellectual Property
Use of University Resources
Publication provisions
Use of Human Subjects
Oversight Requirements
Reporting and Annual Reviews
You must submit an annual renewal for your
disclosure
◦ If the potential conflict no longer exists you must
notify us
If significant changes occur during the year
you should submit an update to your
disclosure as they occur
Yes. We encourage employees to disclose
potential conflicts that do not meet the
financial threshold, but may still be
problematic, such as student employment.
This allows you to be transparent with
respect to outside interests.
Allowable situations
Situations that require disclosure but may not
need an extensive management plan
Situations that require disclosure and have
problematic elements that will require
mitigation and/or a management plan
Situations that are not permitted
Receipt of royalties or honoraria for
published scholarly works, seminars,
teaching, etc.
Honoraria for serving as a special reviewer
or work on review panels
Royalties under our intellectual property
policies if no other relationship with entity
Clinical income at OUCOM
You participate in research developed in
whole or part by you, and you or your
family receive royalties from an existing
agreement with the business, but have
no other significant financial interest
You assign students, etc. to research
projects where you are entitled to
receive royalties, but have no other
significant financial interest
You assign students, etc. to projects supported
by the business through an SRA, and have a
significant financial interest other than royalty
income
You receive research support from a business in
which you serve on the board of directors, or
other advisory board, even if you are not
compensated.
You hold an executive position in a business
engaged in commercial or research activities
directly related to your Ohio University
responsibilities.
Any situation in which an actual conflict
exists is not permitted.
The only “exceptions” are those handled
under Ohio University Policy and Procedure
19.059 where faculty entrepreneurship is
addressed.
Participation in clinical trials or evaluation
of other research in which you have a
significant financial interest other than
royalty income.
In the context of your position at Ohio
University, you make professional referrals
to a business in which you have a
significant financial interest.
Letter of admonition
Ineligibility to submit grant applications
Withholding of IRB or IACUC approvals
Suspension
Non-Renewal
Loss of Tenure
Consulting
Procurement
Mentoring
Clinical Studies
Avoid consulting relationships that have
the potential to divert time and effort from
your responsibilities to Ohio University.
Do not use students.
Be wary of situations that limit publication.
Do not use university stationary, etc. that
could create an impression the university
is involved with the activities.
Make sure you are devoting sufficient time
to your university obligations.
Be cautious that the potential financial gain
cannot be perceived to influence your
university mentoring relationships.
Disclose any personal or familial financial
interest or equity in a company that is
doing business with Ohio University.
If you make purchases using public funds,
you should not use companies which will
benefit you or your family. If there is no
alternative you must seek and receive
permission prior to purchasing.
Any relationship in which there is a real or
perceived power or influence imbalance has
the potential for conflict. (Faculty:Student)
Isolating these relationships with respect to
areas of personal financial gain is best.
If they cannot be isolated, then safeguards
must be created.
If you have a financial interest, it is best to
isolate yourself from the study.
At a minimum, expect a more intense review
and a robust management plan if you have a
financial interest.
If both the institution and you have financial
interests the clinical study should be
conducted elsewhere.
You have administrative responsibilities on
behalf of Ohio University that is beneficial to
the business in which you have a significant
financial interest
You have administrative responsibilities on
behalf of Ohio University with respect to an
SRA where you have a significant financial
interest
Slide 32
Jo Ellen Sherow
Ohio University
Office of Research Compliance
Researchers’ Financial Disclosures in the
Spotlight
Conflicts of interest, always an emotional topic,
returned to the headlines this week as Sen.
Charles Grassley, a longtime critic of the drug
industry’s potential influence on research,
released new evidence that prominent Harvard
University scientists had failed to disclose much
of their outside income from pharmaceutical
companies over the past eight years.
http://www.insidehighered.com/news/2008/06/12/conflict January 15, 2008
WEDNESDAY, JANUARY 21, 2009
In a review of the literature regarding the relationship between
smokeless tobacco use and cancer, a conflict of interest of one of the
article's authors was initially not disclosed (see: Boffetta P, Hecht S, Gray
N, Gupta P, Straif K. Smokeless tobacco and cancer. Lancet Oncology
2008; 9:667-675). The original article was published in July, 2008. That
article stated: "The authors declare no conflicts of interest." After the
editor of the journal was notified by a researcher with knowledge of a
potential conflict of interest of Dr. Stephen Hecht (one of the study
authors), an erratum was published in September 2008, which noted:
"During the immediate months preceding submission of the review SH
was acting in the capacity of an expert witness for the plaintiff in a
future court case against a smokeless tobacco company. SH declares his
participation in this case in no way influenced his writing or involvement
in the review."
http://tobaccoanalysis.blogspot.com/2009/01/conflict-of-interestnot.html
January 16, 2009 — More than one third of new
drug marketing applications approved by the US
Food and Drug Administration (FDA) were
missing information about potential conflicts of
interest for clinical trial investigators, which
could allow bias to creep into the approvals
process, a government report released this week
has found. The FDA has said that it agrees with
most of the report's findings.
http://www.medscape.com/viewarticle/586980
Do collaborations between biotech companies
and academic centers constitute a conflict of
interest?
Biotechnology industry partnerships with
universities and academic centers have been
fruitful for both. So why is there so much
concern about conflict of interest and is that
concern appropriate?
http://www.redorbit.com/news/health/750100/genetic_engineering_news_p
osts_podcast_on_industrialacademic_collaborations_are_these/index.html
Universities are responsible for use of public
funds and therefore must maintain the public
trust.
Identifying and mitigating situations that may
have the potential for conflict maintains the
integrity of the university.
Maintaining integrity allows the university to
do credible academic research.
To provide information on the purpose of the
conflict of interest requirements.
To provide a basic overview of conflicts of
interest
To introduce the disclosure process and the use
of management plans
To provide information on the need for updates
and annual renewals.
Situations where financial considerations
compromise your professional judgment.
“Actual Conflict of Interest”
◦ Not permitted
Situations where an independent observer
might reasonably question whether your
professional actions or decisions are
determined by considerations of personal
gain. “Perceived Conflict of Interest”
◦ Managed
Potential conflicts may be financial or may be
a conflict of time, effort and/or commitment.
Potential conflicts can occur as a result of
administrative, scientific, academic, fiduciary
or familial situations.
They are situations that can be PERCEIVED to
be conflicting, whether a “real” conflict exists
or not.
Ohio University Policy has a mandatory
disclosure policy if you:
Earn over $10,000 in a twelve month period
from your outside activity OR
Have over 5% equity in the entity
Applies to members of your immediate family
(spouse, domestic partner, dependent
children) as well as yourself.
Anything of monetary value, including but not
limited to:
◦
◦
◦
◦
Salary
Payments for services
Equity interests over 5%
Intellectual property rights
Excludes mutual, pension and other
investments over which you have no control
Outside work during regular academic year
should not exceed equivalent of 1 day per
week.
Consulting work must avoid activities that
involve a conflict of interest with assigned
Ohio University activities and programs
Faculty Handbook, section IV-D
Outside interests cannot interfere with
primary loyalty to Ohio University and your
academic role
Use of university resources must have prior
approval of Chair, Dean and VPR.
Your outside interests should not be in
direct competition with university interests
Full time administrative employees are
expected to devote their full-time
professional loyalty, time and energy to their
position.
You must use non-work hours and no
university resources
Federal Agencies
State Law
University Policies
Many Academic Publications
45 CFR Part 50, Subpart F
“Responsibility of Applicants for Promoting
Objectivity in Research for Which PHS Funding
is Sought”
Authority: 42 U.S.C. 216, 289b-1, 299c-3.
Intent is to assure objectivity by establishing
standards that preclude bias in design, conduct, or
reporting of research
Focuses on financial conflicts of interest
(FCOI)
Regulations apply to investigators, including
sub grantees, contractors, and collaborating
investigators.
Does not apply to applications for support
under Phase I of SBIR and STTR programs
An institutional conflict of interest policy should
require that each investigator disclose to a
responsible representative of the institution all
significant financial interests of the investigator
(including those of the investigator’s spouse and
dependent children) (i) that would reasonably
appear to be affected by the research or
educational activities funded or proposed for
funding by NSF; or (ii) in entities whose financial
interests would reasonably appear to be affected
by such activities.
Chapter 1 (Subchapter A) (Part 54)
Financial Disclosure by Clinical Investigators
The Food and Drug Administration (FDA)
regulations state that investigators that
receive compensation in excess of $25,000
from a corporate sponsor of a trial in which
the investigator is engaged must disclose to
the FDA at the time of filing for a new drug
application.
19.058, Conflict of Interest in Research,
Educational, and Public Service Activities
19.059, Employee Participation in Authorized
Private Companies Commercializing Ohio
University Research
“Conflict of Interest in Research, Educational,
and Public Service Activities”
Most conflict disclosures fall within the
parameters of this policy
States that faculty are primarily responsible
for their academic, research and service
obligations
“Employee Participation in Authorized Private
Companies Commercializing Ohio University
Research”
Applies to “employees, faculty, staff and students,
who create intellectual property owned by the Ohio
University and who desire to hold an equity interest
in a firm, corporation, or other association to which
Ohio University has assigned, licensed or
transferred Ohio University’s interests…”
Consulting
Licensing University Technology
Clinical Studies
Procurement
Mentoring
Institutional
A disclosure is filed specific to the funding
application.
If you have a potential conflict for one
proposal, it does not automatically apply to
all of your proposals.
Research conflicts of interest are usually
disclosed using LEO as you apply for funding
by completing the conflict of interest section
of the electronic transmittal
If you are not using LEO, you can download
the appropriate disclosure form from
www.ohio.edu/research/compliance
“A” is selected if you have no conflicts to
disclose
“B” is selected if you have a potential conflict
to disclose relative to the submission.
(Requires a subsequent paper process)
“C” is selected if you have a current disclosure
on file, but it is not relevant to the proposal
you are submitting
Still uses option A, B or C
Requires that you gather signatures on paper
for all options, however
Generally used for personnel not listed on the
grant proposal or “key personnel”
We have revised the COI forms to word forms
This should be easier to complete than the
previous form
PDF versions are also available
Should be on the compliance web site soon,
but we can e-mail them to you until then
Use this form only if you are unable to use
the LEO transmittal form to assure that no
conflict of interest exists. A form must be
completed for each proposal.
I assure that I have read Ohio University
Policy 19.058, “Conflict of Interest in
Research, Educational, and Public Service
Activities” and declare that I have nothing
that is, or could be perceived to be a conflict
of interest with this proposal.
Use this form to disclose a potential conflict
of interest situation.
A separate disclosure form must be used for
each entity with which you conduct business
Conflict includes any member of your
immediate family (spouse, domestic partner
or children)
Require that you complete an option “B”
disclosure statement in addition to
completing the LEO transmittal form.
Require you to obtain signatures from Center
or Institute (if applicable), Chair and Dean on
the additional disclosure statement!!
The B disclosure form is available at
www.ohio.edu/research/compliance
Use this form only if you are unable to use
the LEO transmittal form. Complete this form
if you have a current conflict of interest
disclosure on file with the Office of Research
Compliance, but that disclosure is not
applicable to this proposal.
*New Option for 2008*
A management plan is developed for some
disclosures to mitigate the potential conflict
Management plans are specific to each
disclosure
May require submission of additional pieces,
such as a student employment plan
Reduce or remove the financial interest creating the
conflict
Place safeguards that mitigate the conflict potential,
such having some decisions made by an independent
entity
Limit participation in portions of the proposed
research likely to create a conflict
Require that the researcher disclose his or her
conflicting financial interests to all collaborators and
any proposed trainees;
Disclose the conflict in publications
Work to remove students from being directly advised
or taught by faculty where a conflict exists
Assure publication rights for student participants
Student Use
Nepotism and Cronyism
Intellectual Property
Use of University Resources
Publication provisions
Use of Human Subjects
Oversight Requirements
Reporting and Annual Reviews
You must submit an annual renewal for your
disclosure
◦ If the potential conflict no longer exists you must
notify us
If significant changes occur during the year
you should submit an update to your
disclosure as they occur
Yes. We encourage employees to disclose
potential conflicts that do not meet the
financial threshold, but may still be
problematic, such as student employment.
This allows you to be transparent with
respect to outside interests.
Allowable situations
Situations that require disclosure but may not
need an extensive management plan
Situations that require disclosure and have
problematic elements that will require
mitigation and/or a management plan
Situations that are not permitted
Receipt of royalties or honoraria for
published scholarly works, seminars,
teaching, etc.
Honoraria for serving as a special reviewer
or work on review panels
Royalties under our intellectual property
policies if no other relationship with entity
Clinical income at OUCOM
You participate in research developed in
whole or part by you, and you or your
family receive royalties from an existing
agreement with the business, but have
no other significant financial interest
You assign students, etc. to research
projects where you are entitled to
receive royalties, but have no other
significant financial interest
You assign students, etc. to projects supported
by the business through an SRA, and have a
significant financial interest other than royalty
income
You receive research support from a business in
which you serve on the board of directors, or
other advisory board, even if you are not
compensated.
You hold an executive position in a business
engaged in commercial or research activities
directly related to your Ohio University
responsibilities.
Any situation in which an actual conflict
exists is not permitted.
The only “exceptions” are those handled
under Ohio University Policy and Procedure
19.059 where faculty entrepreneurship is
addressed.
Participation in clinical trials or evaluation
of other research in which you have a
significant financial interest other than
royalty income.
In the context of your position at Ohio
University, you make professional referrals
to a business in which you have a
significant financial interest.
Letter of admonition
Ineligibility to submit grant applications
Withholding of IRB or IACUC approvals
Suspension
Non-Renewal
Loss of Tenure
Consulting
Procurement
Mentoring
Clinical Studies
Avoid consulting relationships that have
the potential to divert time and effort from
your responsibilities to Ohio University.
Do not use students.
Be wary of situations that limit publication.
Do not use university stationary, etc. that
could create an impression the university
is involved with the activities.
Make sure you are devoting sufficient time
to your university obligations.
Be cautious that the potential financial gain
cannot be perceived to influence your
university mentoring relationships.
Disclose any personal or familial financial
interest or equity in a company that is
doing business with Ohio University.
If you make purchases using public funds,
you should not use companies which will
benefit you or your family. If there is no
alternative you must seek and receive
permission prior to purchasing.
Any relationship in which there is a real or
perceived power or influence imbalance has
the potential for conflict. (Faculty:Student)
Isolating these relationships with respect to
areas of personal financial gain is best.
If they cannot be isolated, then safeguards
must be created.
If you have a financial interest, it is best to
isolate yourself from the study.
At a minimum, expect a more intense review
and a robust management plan if you have a
financial interest.
If both the institution and you have financial
interests the clinical study should be
conducted elsewhere.
You have administrative responsibilities on
behalf of Ohio University that is beneficial to
the business in which you have a significant
financial interest
You have administrative responsibilities on
behalf of Ohio University with respect to an
SRA where you have a significant financial
interest
Slide 33
Jo Ellen Sherow
Ohio University
Office of Research Compliance
Researchers’ Financial Disclosures in the
Spotlight
Conflicts of interest, always an emotional topic,
returned to the headlines this week as Sen.
Charles Grassley, a longtime critic of the drug
industry’s potential influence on research,
released new evidence that prominent Harvard
University scientists had failed to disclose much
of their outside income from pharmaceutical
companies over the past eight years.
http://www.insidehighered.com/news/2008/06/12/conflict January 15, 2008
WEDNESDAY, JANUARY 21, 2009
In a review of the literature regarding the relationship between
smokeless tobacco use and cancer, a conflict of interest of one of the
article's authors was initially not disclosed (see: Boffetta P, Hecht S, Gray
N, Gupta P, Straif K. Smokeless tobacco and cancer. Lancet Oncology
2008; 9:667-675). The original article was published in July, 2008. That
article stated: "The authors declare no conflicts of interest." After the
editor of the journal was notified by a researcher with knowledge of a
potential conflict of interest of Dr. Stephen Hecht (one of the study
authors), an erratum was published in September 2008, which noted:
"During the immediate months preceding submission of the review SH
was acting in the capacity of an expert witness for the plaintiff in a
future court case against a smokeless tobacco company. SH declares his
participation in this case in no way influenced his writing or involvement
in the review."
http://tobaccoanalysis.blogspot.com/2009/01/conflict-of-interestnot.html
January 16, 2009 — More than one third of new
drug marketing applications approved by the US
Food and Drug Administration (FDA) were
missing information about potential conflicts of
interest for clinical trial investigators, which
could allow bias to creep into the approvals
process, a government report released this week
has found. The FDA has said that it agrees with
most of the report's findings.
http://www.medscape.com/viewarticle/586980
Do collaborations between biotech companies
and academic centers constitute a conflict of
interest?
Biotechnology industry partnerships with
universities and academic centers have been
fruitful for both. So why is there so much
concern about conflict of interest and is that
concern appropriate?
http://www.redorbit.com/news/health/750100/genetic_engineering_news_p
osts_podcast_on_industrialacademic_collaborations_are_these/index.html
Universities are responsible for use of public
funds and therefore must maintain the public
trust.
Identifying and mitigating situations that may
have the potential for conflict maintains the
integrity of the university.
Maintaining integrity allows the university to
do credible academic research.
To provide information on the purpose of the
conflict of interest requirements.
To provide a basic overview of conflicts of
interest
To introduce the disclosure process and the use
of management plans
To provide information on the need for updates
and annual renewals.
Situations where financial considerations
compromise your professional judgment.
“Actual Conflict of Interest”
◦ Not permitted
Situations where an independent observer
might reasonably question whether your
professional actions or decisions are
determined by considerations of personal
gain. “Perceived Conflict of Interest”
◦ Managed
Potential conflicts may be financial or may be
a conflict of time, effort and/or commitment.
Potential conflicts can occur as a result of
administrative, scientific, academic, fiduciary
or familial situations.
They are situations that can be PERCEIVED to
be conflicting, whether a “real” conflict exists
or not.
Ohio University Policy has a mandatory
disclosure policy if you:
Earn over $10,000 in a twelve month period
from your outside activity OR
Have over 5% equity in the entity
Applies to members of your immediate family
(spouse, domestic partner, dependent
children) as well as yourself.
Anything of monetary value, including but not
limited to:
◦
◦
◦
◦
Salary
Payments for services
Equity interests over 5%
Intellectual property rights
Excludes mutual, pension and other
investments over which you have no control
Outside work during regular academic year
should not exceed equivalent of 1 day per
week.
Consulting work must avoid activities that
involve a conflict of interest with assigned
Ohio University activities and programs
Faculty Handbook, section IV-D
Outside interests cannot interfere with
primary loyalty to Ohio University and your
academic role
Use of university resources must have prior
approval of Chair, Dean and VPR.
Your outside interests should not be in
direct competition with university interests
Full time administrative employees are
expected to devote their full-time
professional loyalty, time and energy to their
position.
You must use non-work hours and no
university resources
Federal Agencies
State Law
University Policies
Many Academic Publications
45 CFR Part 50, Subpart F
“Responsibility of Applicants for Promoting
Objectivity in Research for Which PHS Funding
is Sought”
Authority: 42 U.S.C. 216, 289b-1, 299c-3.
Intent is to assure objectivity by establishing
standards that preclude bias in design, conduct, or
reporting of research
Focuses on financial conflicts of interest
(FCOI)
Regulations apply to investigators, including
sub grantees, contractors, and collaborating
investigators.
Does not apply to applications for support
under Phase I of SBIR and STTR programs
An institutional conflict of interest policy should
require that each investigator disclose to a
responsible representative of the institution all
significant financial interests of the investigator
(including those of the investigator’s spouse and
dependent children) (i) that would reasonably
appear to be affected by the research or
educational activities funded or proposed for
funding by NSF; or (ii) in entities whose financial
interests would reasonably appear to be affected
by such activities.
Chapter 1 (Subchapter A) (Part 54)
Financial Disclosure by Clinical Investigators
The Food and Drug Administration (FDA)
regulations state that investigators that
receive compensation in excess of $25,000
from a corporate sponsor of a trial in which
the investigator is engaged must disclose to
the FDA at the time of filing for a new drug
application.
19.058, Conflict of Interest in Research,
Educational, and Public Service Activities
19.059, Employee Participation in Authorized
Private Companies Commercializing Ohio
University Research
“Conflict of Interest in Research, Educational,
and Public Service Activities”
Most conflict disclosures fall within the
parameters of this policy
States that faculty are primarily responsible
for their academic, research and service
obligations
“Employee Participation in Authorized Private
Companies Commercializing Ohio University
Research”
Applies to “employees, faculty, staff and students,
who create intellectual property owned by the Ohio
University and who desire to hold an equity interest
in a firm, corporation, or other association to which
Ohio University has assigned, licensed or
transferred Ohio University’s interests…”
Consulting
Licensing University Technology
Clinical Studies
Procurement
Mentoring
Institutional
A disclosure is filed specific to the funding
application.
If you have a potential conflict for one
proposal, it does not automatically apply to
all of your proposals.
Research conflicts of interest are usually
disclosed using LEO as you apply for funding
by completing the conflict of interest section
of the electronic transmittal
If you are not using LEO, you can download
the appropriate disclosure form from
www.ohio.edu/research/compliance
“A” is selected if you have no conflicts to
disclose
“B” is selected if you have a potential conflict
to disclose relative to the submission.
(Requires a subsequent paper process)
“C” is selected if you have a current disclosure
on file, but it is not relevant to the proposal
you are submitting
Still uses option A, B or C
Requires that you gather signatures on paper
for all options, however
Generally used for personnel not listed on the
grant proposal or “key personnel”
We have revised the COI forms to word forms
This should be easier to complete than the
previous form
PDF versions are also available
Should be on the compliance web site soon,
but we can e-mail them to you until then
Use this form only if you are unable to use
the LEO transmittal form to assure that no
conflict of interest exists. A form must be
completed for each proposal.
I assure that I have read Ohio University
Policy 19.058, “Conflict of Interest in
Research, Educational, and Public Service
Activities” and declare that I have nothing
that is, or could be perceived to be a conflict
of interest with this proposal.
Use this form to disclose a potential conflict
of interest situation.
A separate disclosure form must be used for
each entity with which you conduct business
Conflict includes any member of your
immediate family (spouse, domestic partner
or children)
Require that you complete an option “B”
disclosure statement in addition to
completing the LEO transmittal form.
Require you to obtain signatures from Center
or Institute (if applicable), Chair and Dean on
the additional disclosure statement!!
The B disclosure form is available at
www.ohio.edu/research/compliance
Use this form only if you are unable to use
the LEO transmittal form. Complete this form
if you have a current conflict of interest
disclosure on file with the Office of Research
Compliance, but that disclosure is not
applicable to this proposal.
*New Option for 2008*
A management plan is developed for some
disclosures to mitigate the potential conflict
Management plans are specific to each
disclosure
May require submission of additional pieces,
such as a student employment plan
Reduce or remove the financial interest creating the
conflict
Place safeguards that mitigate the conflict potential,
such having some decisions made by an independent
entity
Limit participation in portions of the proposed
research likely to create a conflict
Require that the researcher disclose his or her
conflicting financial interests to all collaborators and
any proposed trainees;
Disclose the conflict in publications
Work to remove students from being directly advised
or taught by faculty where a conflict exists
Assure publication rights for student participants
Student Use
Nepotism and Cronyism
Intellectual Property
Use of University Resources
Publication provisions
Use of Human Subjects
Oversight Requirements
Reporting and Annual Reviews
You must submit an annual renewal for your
disclosure
◦ If the potential conflict no longer exists you must
notify us
If significant changes occur during the year
you should submit an update to your
disclosure as they occur
Yes. We encourage employees to disclose
potential conflicts that do not meet the
financial threshold, but may still be
problematic, such as student employment.
This allows you to be transparent with
respect to outside interests.
Allowable situations
Situations that require disclosure but may not
need an extensive management plan
Situations that require disclosure and have
problematic elements that will require
mitigation and/or a management plan
Situations that are not permitted
Receipt of royalties or honoraria for
published scholarly works, seminars,
teaching, etc.
Honoraria for serving as a special reviewer
or work on review panels
Royalties under our intellectual property
policies if no other relationship with entity
Clinical income at OUCOM
You participate in research developed in
whole or part by you, and you or your
family receive royalties from an existing
agreement with the business, but have
no other significant financial interest
You assign students, etc. to research
projects where you are entitled to
receive royalties, but have no other
significant financial interest
You assign students, etc. to projects supported
by the business through an SRA, and have a
significant financial interest other than royalty
income
You receive research support from a business in
which you serve on the board of directors, or
other advisory board, even if you are not
compensated.
You hold an executive position in a business
engaged in commercial or research activities
directly related to your Ohio University
responsibilities.
Any situation in which an actual conflict
exists is not permitted.
The only “exceptions” are those handled
under Ohio University Policy and Procedure
19.059 where faculty entrepreneurship is
addressed.
Participation in clinical trials or evaluation
of other research in which you have a
significant financial interest other than
royalty income.
In the context of your position at Ohio
University, you make professional referrals
to a business in which you have a
significant financial interest.
Letter of admonition
Ineligibility to submit grant applications
Withholding of IRB or IACUC approvals
Suspension
Non-Renewal
Loss of Tenure
Consulting
Procurement
Mentoring
Clinical Studies
Avoid consulting relationships that have
the potential to divert time and effort from
your responsibilities to Ohio University.
Do not use students.
Be wary of situations that limit publication.
Do not use university stationary, etc. that
could create an impression the university
is involved with the activities.
Make sure you are devoting sufficient time
to your university obligations.
Be cautious that the potential financial gain
cannot be perceived to influence your
university mentoring relationships.
Disclose any personal or familial financial
interest or equity in a company that is
doing business with Ohio University.
If you make purchases using public funds,
you should not use companies which will
benefit you or your family. If there is no
alternative you must seek and receive
permission prior to purchasing.
Any relationship in which there is a real or
perceived power or influence imbalance has
the potential for conflict. (Faculty:Student)
Isolating these relationships with respect to
areas of personal financial gain is best.
If they cannot be isolated, then safeguards
must be created.
If you have a financial interest, it is best to
isolate yourself from the study.
At a minimum, expect a more intense review
and a robust management plan if you have a
financial interest.
If both the institution and you have financial
interests the clinical study should be
conducted elsewhere.
You have administrative responsibilities on
behalf of Ohio University that is beneficial to
the business in which you have a significant
financial interest
You have administrative responsibilities on
behalf of Ohio University with respect to an
SRA where you have a significant financial
interest
Slide 34
Jo Ellen Sherow
Ohio University
Office of Research Compliance
Researchers’ Financial Disclosures in the
Spotlight
Conflicts of interest, always an emotional topic,
returned to the headlines this week as Sen.
Charles Grassley, a longtime critic of the drug
industry’s potential influence on research,
released new evidence that prominent Harvard
University scientists had failed to disclose much
of their outside income from pharmaceutical
companies over the past eight years.
http://www.insidehighered.com/news/2008/06/12/conflict January 15, 2008
WEDNESDAY, JANUARY 21, 2009
In a review of the literature regarding the relationship between
smokeless tobacco use and cancer, a conflict of interest of one of the
article's authors was initially not disclosed (see: Boffetta P, Hecht S, Gray
N, Gupta P, Straif K. Smokeless tobacco and cancer. Lancet Oncology
2008; 9:667-675). The original article was published in July, 2008. That
article stated: "The authors declare no conflicts of interest." After the
editor of the journal was notified by a researcher with knowledge of a
potential conflict of interest of Dr. Stephen Hecht (one of the study
authors), an erratum was published in September 2008, which noted:
"During the immediate months preceding submission of the review SH
was acting in the capacity of an expert witness for the plaintiff in a
future court case against a smokeless tobacco company. SH declares his
participation in this case in no way influenced his writing or involvement
in the review."
http://tobaccoanalysis.blogspot.com/2009/01/conflict-of-interestnot.html
January 16, 2009 — More than one third of new
drug marketing applications approved by the US
Food and Drug Administration (FDA) were
missing information about potential conflicts of
interest for clinical trial investigators, which
could allow bias to creep into the approvals
process, a government report released this week
has found. The FDA has said that it agrees with
most of the report's findings.
http://www.medscape.com/viewarticle/586980
Do collaborations between biotech companies
and academic centers constitute a conflict of
interest?
Biotechnology industry partnerships with
universities and academic centers have been
fruitful for both. So why is there so much
concern about conflict of interest and is that
concern appropriate?
http://www.redorbit.com/news/health/750100/genetic_engineering_news_p
osts_podcast_on_industrialacademic_collaborations_are_these/index.html
Universities are responsible for use of public
funds and therefore must maintain the public
trust.
Identifying and mitigating situations that may
have the potential for conflict maintains the
integrity of the university.
Maintaining integrity allows the university to
do credible academic research.
To provide information on the purpose of the
conflict of interest requirements.
To provide a basic overview of conflicts of
interest
To introduce the disclosure process and the use
of management plans
To provide information on the need for updates
and annual renewals.
Situations where financial considerations
compromise your professional judgment.
“Actual Conflict of Interest”
◦ Not permitted
Situations where an independent observer
might reasonably question whether your
professional actions or decisions are
determined by considerations of personal
gain. “Perceived Conflict of Interest”
◦ Managed
Potential conflicts may be financial or may be
a conflict of time, effort and/or commitment.
Potential conflicts can occur as a result of
administrative, scientific, academic, fiduciary
or familial situations.
They are situations that can be PERCEIVED to
be conflicting, whether a “real” conflict exists
or not.
Ohio University Policy has a mandatory
disclosure policy if you:
Earn over $10,000 in a twelve month period
from your outside activity OR
Have over 5% equity in the entity
Applies to members of your immediate family
(spouse, domestic partner, dependent
children) as well as yourself.
Anything of monetary value, including but not
limited to:
◦
◦
◦
◦
Salary
Payments for services
Equity interests over 5%
Intellectual property rights
Excludes mutual, pension and other
investments over which you have no control
Outside work during regular academic year
should not exceed equivalent of 1 day per
week.
Consulting work must avoid activities that
involve a conflict of interest with assigned
Ohio University activities and programs
Faculty Handbook, section IV-D
Outside interests cannot interfere with
primary loyalty to Ohio University and your
academic role
Use of university resources must have prior
approval of Chair, Dean and VPR.
Your outside interests should not be in
direct competition with university interests
Full time administrative employees are
expected to devote their full-time
professional loyalty, time and energy to their
position.
You must use non-work hours and no
university resources
Federal Agencies
State Law
University Policies
Many Academic Publications
45 CFR Part 50, Subpart F
“Responsibility of Applicants for Promoting
Objectivity in Research for Which PHS Funding
is Sought”
Authority: 42 U.S.C. 216, 289b-1, 299c-3.
Intent is to assure objectivity by establishing
standards that preclude bias in design, conduct, or
reporting of research
Focuses on financial conflicts of interest
(FCOI)
Regulations apply to investigators, including
sub grantees, contractors, and collaborating
investigators.
Does not apply to applications for support
under Phase I of SBIR and STTR programs
An institutional conflict of interest policy should
require that each investigator disclose to a
responsible representative of the institution all
significant financial interests of the investigator
(including those of the investigator’s spouse and
dependent children) (i) that would reasonably
appear to be affected by the research or
educational activities funded or proposed for
funding by NSF; or (ii) in entities whose financial
interests would reasonably appear to be affected
by such activities.
Chapter 1 (Subchapter A) (Part 54)
Financial Disclosure by Clinical Investigators
The Food and Drug Administration (FDA)
regulations state that investigators that
receive compensation in excess of $25,000
from a corporate sponsor of a trial in which
the investigator is engaged must disclose to
the FDA at the time of filing for a new drug
application.
19.058, Conflict of Interest in Research,
Educational, and Public Service Activities
19.059, Employee Participation in Authorized
Private Companies Commercializing Ohio
University Research
“Conflict of Interest in Research, Educational,
and Public Service Activities”
Most conflict disclosures fall within the
parameters of this policy
States that faculty are primarily responsible
for their academic, research and service
obligations
“Employee Participation in Authorized Private
Companies Commercializing Ohio University
Research”
Applies to “employees, faculty, staff and students,
who create intellectual property owned by the Ohio
University and who desire to hold an equity interest
in a firm, corporation, or other association to which
Ohio University has assigned, licensed or
transferred Ohio University’s interests…”
Consulting
Licensing University Technology
Clinical Studies
Procurement
Mentoring
Institutional
A disclosure is filed specific to the funding
application.
If you have a potential conflict for one
proposal, it does not automatically apply to
all of your proposals.
Research conflicts of interest are usually
disclosed using LEO as you apply for funding
by completing the conflict of interest section
of the electronic transmittal
If you are not using LEO, you can download
the appropriate disclosure form from
www.ohio.edu/research/compliance
“A” is selected if you have no conflicts to
disclose
“B” is selected if you have a potential conflict
to disclose relative to the submission.
(Requires a subsequent paper process)
“C” is selected if you have a current disclosure
on file, but it is not relevant to the proposal
you are submitting
Still uses option A, B or C
Requires that you gather signatures on paper
for all options, however
Generally used for personnel not listed on the
grant proposal or “key personnel”
We have revised the COI forms to word forms
This should be easier to complete than the
previous form
PDF versions are also available
Should be on the compliance web site soon,
but we can e-mail them to you until then
Use this form only if you are unable to use
the LEO transmittal form to assure that no
conflict of interest exists. A form must be
completed for each proposal.
I assure that I have read Ohio University
Policy 19.058, “Conflict of Interest in
Research, Educational, and Public Service
Activities” and declare that I have nothing
that is, or could be perceived to be a conflict
of interest with this proposal.
Use this form to disclose a potential conflict
of interest situation.
A separate disclosure form must be used for
each entity with which you conduct business
Conflict includes any member of your
immediate family (spouse, domestic partner
or children)
Require that you complete an option “B”
disclosure statement in addition to
completing the LEO transmittal form.
Require you to obtain signatures from Center
or Institute (if applicable), Chair and Dean on
the additional disclosure statement!!
The B disclosure form is available at
www.ohio.edu/research/compliance
Use this form only if you are unable to use
the LEO transmittal form. Complete this form
if you have a current conflict of interest
disclosure on file with the Office of Research
Compliance, but that disclosure is not
applicable to this proposal.
*New Option for 2008*
A management plan is developed for some
disclosures to mitigate the potential conflict
Management plans are specific to each
disclosure
May require submission of additional pieces,
such as a student employment plan
Reduce or remove the financial interest creating the
conflict
Place safeguards that mitigate the conflict potential,
such having some decisions made by an independent
entity
Limit participation in portions of the proposed
research likely to create a conflict
Require that the researcher disclose his or her
conflicting financial interests to all collaborators and
any proposed trainees;
Disclose the conflict in publications
Work to remove students from being directly advised
or taught by faculty where a conflict exists
Assure publication rights for student participants
Student Use
Nepotism and Cronyism
Intellectual Property
Use of University Resources
Publication provisions
Use of Human Subjects
Oversight Requirements
Reporting and Annual Reviews
You must submit an annual renewal for your
disclosure
◦ If the potential conflict no longer exists you must
notify us
If significant changes occur during the year
you should submit an update to your
disclosure as they occur
Yes. We encourage employees to disclose
potential conflicts that do not meet the
financial threshold, but may still be
problematic, such as student employment.
This allows you to be transparent with
respect to outside interests.
Allowable situations
Situations that require disclosure but may not
need an extensive management plan
Situations that require disclosure and have
problematic elements that will require
mitigation and/or a management plan
Situations that are not permitted
Receipt of royalties or honoraria for
published scholarly works, seminars,
teaching, etc.
Honoraria for serving as a special reviewer
or work on review panels
Royalties under our intellectual property
policies if no other relationship with entity
Clinical income at OUCOM
You participate in research developed in
whole or part by you, and you or your
family receive royalties from an existing
agreement with the business, but have
no other significant financial interest
You assign students, etc. to research
projects where you are entitled to
receive royalties, but have no other
significant financial interest
You assign students, etc. to projects supported
by the business through an SRA, and have a
significant financial interest other than royalty
income
You receive research support from a business in
which you serve on the board of directors, or
other advisory board, even if you are not
compensated.
You hold an executive position in a business
engaged in commercial or research activities
directly related to your Ohio University
responsibilities.
Any situation in which an actual conflict
exists is not permitted.
The only “exceptions” are those handled
under Ohio University Policy and Procedure
19.059 where faculty entrepreneurship is
addressed.
Participation in clinical trials or evaluation
of other research in which you have a
significant financial interest other than
royalty income.
In the context of your position at Ohio
University, you make professional referrals
to a business in which you have a
significant financial interest.
Letter of admonition
Ineligibility to submit grant applications
Withholding of IRB or IACUC approvals
Suspension
Non-Renewal
Loss of Tenure
Consulting
Procurement
Mentoring
Clinical Studies
Avoid consulting relationships that have
the potential to divert time and effort from
your responsibilities to Ohio University.
Do not use students.
Be wary of situations that limit publication.
Do not use university stationary, etc. that
could create an impression the university
is involved with the activities.
Make sure you are devoting sufficient time
to your university obligations.
Be cautious that the potential financial gain
cannot be perceived to influence your
university mentoring relationships.
Disclose any personal or familial financial
interest or equity in a company that is
doing business with Ohio University.
If you make purchases using public funds,
you should not use companies which will
benefit you or your family. If there is no
alternative you must seek and receive
permission prior to purchasing.
Any relationship in which there is a real or
perceived power or influence imbalance has
the potential for conflict. (Faculty:Student)
Isolating these relationships with respect to
areas of personal financial gain is best.
If they cannot be isolated, then safeguards
must be created.
If you have a financial interest, it is best to
isolate yourself from the study.
At a minimum, expect a more intense review
and a robust management plan if you have a
financial interest.
If both the institution and you have financial
interests the clinical study should be
conducted elsewhere.
You have administrative responsibilities on
behalf of Ohio University that is beneficial to
the business in which you have a significant
financial interest
You have administrative responsibilities on
behalf of Ohio University with respect to an
SRA where you have a significant financial
interest
Slide 35
Jo Ellen Sherow
Ohio University
Office of Research Compliance
Researchers’ Financial Disclosures in the
Spotlight
Conflicts of interest, always an emotional topic,
returned to the headlines this week as Sen.
Charles Grassley, a longtime critic of the drug
industry’s potential influence on research,
released new evidence that prominent Harvard
University scientists had failed to disclose much
of their outside income from pharmaceutical
companies over the past eight years.
http://www.insidehighered.com/news/2008/06/12/conflict January 15, 2008
WEDNESDAY, JANUARY 21, 2009
In a review of the literature regarding the relationship between
smokeless tobacco use and cancer, a conflict of interest of one of the
article's authors was initially not disclosed (see: Boffetta P, Hecht S, Gray
N, Gupta P, Straif K. Smokeless tobacco and cancer. Lancet Oncology
2008; 9:667-675). The original article was published in July, 2008. That
article stated: "The authors declare no conflicts of interest." After the
editor of the journal was notified by a researcher with knowledge of a
potential conflict of interest of Dr. Stephen Hecht (one of the study
authors), an erratum was published in September 2008, which noted:
"During the immediate months preceding submission of the review SH
was acting in the capacity of an expert witness for the plaintiff in a
future court case against a smokeless tobacco company. SH declares his
participation in this case in no way influenced his writing or involvement
in the review."
http://tobaccoanalysis.blogspot.com/2009/01/conflict-of-interestnot.html
January 16, 2009 — More than one third of new
drug marketing applications approved by the US
Food and Drug Administration (FDA) were
missing information about potential conflicts of
interest for clinical trial investigators, which
could allow bias to creep into the approvals
process, a government report released this week
has found. The FDA has said that it agrees with
most of the report's findings.
http://www.medscape.com/viewarticle/586980
Do collaborations between biotech companies
and academic centers constitute a conflict of
interest?
Biotechnology industry partnerships with
universities and academic centers have been
fruitful for both. So why is there so much
concern about conflict of interest and is that
concern appropriate?
http://www.redorbit.com/news/health/750100/genetic_engineering_news_p
osts_podcast_on_industrialacademic_collaborations_are_these/index.html
Universities are responsible for use of public
funds and therefore must maintain the public
trust.
Identifying and mitigating situations that may
have the potential for conflict maintains the
integrity of the university.
Maintaining integrity allows the university to
do credible academic research.
To provide information on the purpose of the
conflict of interest requirements.
To provide a basic overview of conflicts of
interest
To introduce the disclosure process and the use
of management plans
To provide information on the need for updates
and annual renewals.
Situations where financial considerations
compromise your professional judgment.
“Actual Conflict of Interest”
◦ Not permitted
Situations where an independent observer
might reasonably question whether your
professional actions or decisions are
determined by considerations of personal
gain. “Perceived Conflict of Interest”
◦ Managed
Potential conflicts may be financial or may be
a conflict of time, effort and/or commitment.
Potential conflicts can occur as a result of
administrative, scientific, academic, fiduciary
or familial situations.
They are situations that can be PERCEIVED to
be conflicting, whether a “real” conflict exists
or not.
Ohio University Policy has a mandatory
disclosure policy if you:
Earn over $10,000 in a twelve month period
from your outside activity OR
Have over 5% equity in the entity
Applies to members of your immediate family
(spouse, domestic partner, dependent
children) as well as yourself.
Anything of monetary value, including but not
limited to:
◦
◦
◦
◦
Salary
Payments for services
Equity interests over 5%
Intellectual property rights
Excludes mutual, pension and other
investments over which you have no control
Outside work during regular academic year
should not exceed equivalent of 1 day per
week.
Consulting work must avoid activities that
involve a conflict of interest with assigned
Ohio University activities and programs
Faculty Handbook, section IV-D
Outside interests cannot interfere with
primary loyalty to Ohio University and your
academic role
Use of university resources must have prior
approval of Chair, Dean and VPR.
Your outside interests should not be in
direct competition with university interests
Full time administrative employees are
expected to devote their full-time
professional loyalty, time and energy to their
position.
You must use non-work hours and no
university resources
Federal Agencies
State Law
University Policies
Many Academic Publications
45 CFR Part 50, Subpart F
“Responsibility of Applicants for Promoting
Objectivity in Research for Which PHS Funding
is Sought”
Authority: 42 U.S.C. 216, 289b-1, 299c-3.
Intent is to assure objectivity by establishing
standards that preclude bias in design, conduct, or
reporting of research
Focuses on financial conflicts of interest
(FCOI)
Regulations apply to investigators, including
sub grantees, contractors, and collaborating
investigators.
Does not apply to applications for support
under Phase I of SBIR and STTR programs
An institutional conflict of interest policy should
require that each investigator disclose to a
responsible representative of the institution all
significant financial interests of the investigator
(including those of the investigator’s spouse and
dependent children) (i) that would reasonably
appear to be affected by the research or
educational activities funded or proposed for
funding by NSF; or (ii) in entities whose financial
interests would reasonably appear to be affected
by such activities.
Chapter 1 (Subchapter A) (Part 54)
Financial Disclosure by Clinical Investigators
The Food and Drug Administration (FDA)
regulations state that investigators that
receive compensation in excess of $25,000
from a corporate sponsor of a trial in which
the investigator is engaged must disclose to
the FDA at the time of filing for a new drug
application.
19.058, Conflict of Interest in Research,
Educational, and Public Service Activities
19.059, Employee Participation in Authorized
Private Companies Commercializing Ohio
University Research
“Conflict of Interest in Research, Educational,
and Public Service Activities”
Most conflict disclosures fall within the
parameters of this policy
States that faculty are primarily responsible
for their academic, research and service
obligations
“Employee Participation in Authorized Private
Companies Commercializing Ohio University
Research”
Applies to “employees, faculty, staff and students,
who create intellectual property owned by the Ohio
University and who desire to hold an equity interest
in a firm, corporation, or other association to which
Ohio University has assigned, licensed or
transferred Ohio University’s interests…”
Consulting
Licensing University Technology
Clinical Studies
Procurement
Mentoring
Institutional
A disclosure is filed specific to the funding
application.
If you have a potential conflict for one
proposal, it does not automatically apply to
all of your proposals.
Research conflicts of interest are usually
disclosed using LEO as you apply for funding
by completing the conflict of interest section
of the electronic transmittal
If you are not using LEO, you can download
the appropriate disclosure form from
www.ohio.edu/research/compliance
“A” is selected if you have no conflicts to
disclose
“B” is selected if you have a potential conflict
to disclose relative to the submission.
(Requires a subsequent paper process)
“C” is selected if you have a current disclosure
on file, but it is not relevant to the proposal
you are submitting
Still uses option A, B or C
Requires that you gather signatures on paper
for all options, however
Generally used for personnel not listed on the
grant proposal or “key personnel”
We have revised the COI forms to word forms
This should be easier to complete than the
previous form
PDF versions are also available
Should be on the compliance web site soon,
but we can e-mail them to you until then
Use this form only if you are unable to use
the LEO transmittal form to assure that no
conflict of interest exists. A form must be
completed for each proposal.
I assure that I have read Ohio University
Policy 19.058, “Conflict of Interest in
Research, Educational, and Public Service
Activities” and declare that I have nothing
that is, or could be perceived to be a conflict
of interest with this proposal.
Use this form to disclose a potential conflict
of interest situation.
A separate disclosure form must be used for
each entity with which you conduct business
Conflict includes any member of your
immediate family (spouse, domestic partner
or children)
Require that you complete an option “B”
disclosure statement in addition to
completing the LEO transmittal form.
Require you to obtain signatures from Center
or Institute (if applicable), Chair and Dean on
the additional disclosure statement!!
The B disclosure form is available at
www.ohio.edu/research/compliance
Use this form only if you are unable to use
the LEO transmittal form. Complete this form
if you have a current conflict of interest
disclosure on file with the Office of Research
Compliance, but that disclosure is not
applicable to this proposal.
*New Option for 2008*
A management plan is developed for some
disclosures to mitigate the potential conflict
Management plans are specific to each
disclosure
May require submission of additional pieces,
such as a student employment plan
Reduce or remove the financial interest creating the
conflict
Place safeguards that mitigate the conflict potential,
such having some decisions made by an independent
entity
Limit participation in portions of the proposed
research likely to create a conflict
Require that the researcher disclose his or her
conflicting financial interests to all collaborators and
any proposed trainees;
Disclose the conflict in publications
Work to remove students from being directly advised
or taught by faculty where a conflict exists
Assure publication rights for student participants
Student Use
Nepotism and Cronyism
Intellectual Property
Use of University Resources
Publication provisions
Use of Human Subjects
Oversight Requirements
Reporting and Annual Reviews
You must submit an annual renewal for your
disclosure
◦ If the potential conflict no longer exists you must
notify us
If significant changes occur during the year
you should submit an update to your
disclosure as they occur
Yes. We encourage employees to disclose
potential conflicts that do not meet the
financial threshold, but may still be
problematic, such as student employment.
This allows you to be transparent with
respect to outside interests.
Allowable situations
Situations that require disclosure but may not
need an extensive management plan
Situations that require disclosure and have
problematic elements that will require
mitigation and/or a management plan
Situations that are not permitted
Receipt of royalties or honoraria for
published scholarly works, seminars,
teaching, etc.
Honoraria for serving as a special reviewer
or work on review panels
Royalties under our intellectual property
policies if no other relationship with entity
Clinical income at OUCOM
You participate in research developed in
whole or part by you, and you or your
family receive royalties from an existing
agreement with the business, but have
no other significant financial interest
You assign students, etc. to research
projects where you are entitled to
receive royalties, but have no other
significant financial interest
You assign students, etc. to projects supported
by the business through an SRA, and have a
significant financial interest other than royalty
income
You receive research support from a business in
which you serve on the board of directors, or
other advisory board, even if you are not
compensated.
You hold an executive position in a business
engaged in commercial or research activities
directly related to your Ohio University
responsibilities.
Any situation in which an actual conflict
exists is not permitted.
The only “exceptions” are those handled
under Ohio University Policy and Procedure
19.059 where faculty entrepreneurship is
addressed.
Participation in clinical trials or evaluation
of other research in which you have a
significant financial interest other than
royalty income.
In the context of your position at Ohio
University, you make professional referrals
to a business in which you have a
significant financial interest.
Letter of admonition
Ineligibility to submit grant applications
Withholding of IRB or IACUC approvals
Suspension
Non-Renewal
Loss of Tenure
Consulting
Procurement
Mentoring
Clinical Studies
Avoid consulting relationships that have
the potential to divert time and effort from
your responsibilities to Ohio University.
Do not use students.
Be wary of situations that limit publication.
Do not use university stationary, etc. that
could create an impression the university
is involved with the activities.
Make sure you are devoting sufficient time
to your university obligations.
Be cautious that the potential financial gain
cannot be perceived to influence your
university mentoring relationships.
Disclose any personal or familial financial
interest or equity in a company that is
doing business with Ohio University.
If you make purchases using public funds,
you should not use companies which will
benefit you or your family. If there is no
alternative you must seek and receive
permission prior to purchasing.
Any relationship in which there is a real or
perceived power or influence imbalance has
the potential for conflict. (Faculty:Student)
Isolating these relationships with respect to
areas of personal financial gain is best.
If they cannot be isolated, then safeguards
must be created.
If you have a financial interest, it is best to
isolate yourself from the study.
At a minimum, expect a more intense review
and a robust management plan if you have a
financial interest.
If both the institution and you have financial
interests the clinical study should be
conducted elsewhere.
You have administrative responsibilities on
behalf of Ohio University that is beneficial to
the business in which you have a significant
financial interest
You have administrative responsibilities on
behalf of Ohio University with respect to an
SRA where you have a significant financial
interest
Slide 36
Jo Ellen Sherow
Ohio University
Office of Research Compliance
Researchers’ Financial Disclosures in the
Spotlight
Conflicts of interest, always an emotional topic,
returned to the headlines this week as Sen.
Charles Grassley, a longtime critic of the drug
industry’s potential influence on research,
released new evidence that prominent Harvard
University scientists had failed to disclose much
of their outside income from pharmaceutical
companies over the past eight years.
http://www.insidehighered.com/news/2008/06/12/conflict January 15, 2008
WEDNESDAY, JANUARY 21, 2009
In a review of the literature regarding the relationship between
smokeless tobacco use and cancer, a conflict of interest of one of the
article's authors was initially not disclosed (see: Boffetta P, Hecht S, Gray
N, Gupta P, Straif K. Smokeless tobacco and cancer. Lancet Oncology
2008; 9:667-675). The original article was published in July, 2008. That
article stated: "The authors declare no conflicts of interest." After the
editor of the journal was notified by a researcher with knowledge of a
potential conflict of interest of Dr. Stephen Hecht (one of the study
authors), an erratum was published in September 2008, which noted:
"During the immediate months preceding submission of the review SH
was acting in the capacity of an expert witness for the plaintiff in a
future court case against a smokeless tobacco company. SH declares his
participation in this case in no way influenced his writing or involvement
in the review."
http://tobaccoanalysis.blogspot.com/2009/01/conflict-of-interestnot.html
January 16, 2009 — More than one third of new
drug marketing applications approved by the US
Food and Drug Administration (FDA) were
missing information about potential conflicts of
interest for clinical trial investigators, which
could allow bias to creep into the approvals
process, a government report released this week
has found. The FDA has said that it agrees with
most of the report's findings.
http://www.medscape.com/viewarticle/586980
Do collaborations between biotech companies
and academic centers constitute a conflict of
interest?
Biotechnology industry partnerships with
universities and academic centers have been
fruitful for both. So why is there so much
concern about conflict of interest and is that
concern appropriate?
http://www.redorbit.com/news/health/750100/genetic_engineering_news_p
osts_podcast_on_industrialacademic_collaborations_are_these/index.html
Universities are responsible for use of public
funds and therefore must maintain the public
trust.
Identifying and mitigating situations that may
have the potential for conflict maintains the
integrity of the university.
Maintaining integrity allows the university to
do credible academic research.
To provide information on the purpose of the
conflict of interest requirements.
To provide a basic overview of conflicts of
interest
To introduce the disclosure process and the use
of management plans
To provide information on the need for updates
and annual renewals.
Situations where financial considerations
compromise your professional judgment.
“Actual Conflict of Interest”
◦ Not permitted
Situations where an independent observer
might reasonably question whether your
professional actions or decisions are
determined by considerations of personal
gain. “Perceived Conflict of Interest”
◦ Managed
Potential conflicts may be financial or may be
a conflict of time, effort and/or commitment.
Potential conflicts can occur as a result of
administrative, scientific, academic, fiduciary
or familial situations.
They are situations that can be PERCEIVED to
be conflicting, whether a “real” conflict exists
or not.
Ohio University Policy has a mandatory
disclosure policy if you:
Earn over $10,000 in a twelve month period
from your outside activity OR
Have over 5% equity in the entity
Applies to members of your immediate family
(spouse, domestic partner, dependent
children) as well as yourself.
Anything of monetary value, including but not
limited to:
◦
◦
◦
◦
Salary
Payments for services
Equity interests over 5%
Intellectual property rights
Excludes mutual, pension and other
investments over which you have no control
Outside work during regular academic year
should not exceed equivalent of 1 day per
week.
Consulting work must avoid activities that
involve a conflict of interest with assigned
Ohio University activities and programs
Faculty Handbook, section IV-D
Outside interests cannot interfere with
primary loyalty to Ohio University and your
academic role
Use of university resources must have prior
approval of Chair, Dean and VPR.
Your outside interests should not be in
direct competition with university interests
Full time administrative employees are
expected to devote their full-time
professional loyalty, time and energy to their
position.
You must use non-work hours and no
university resources
Federal Agencies
State Law
University Policies
Many Academic Publications
45 CFR Part 50, Subpart F
“Responsibility of Applicants for Promoting
Objectivity in Research for Which PHS Funding
is Sought”
Authority: 42 U.S.C. 216, 289b-1, 299c-3.
Intent is to assure objectivity by establishing
standards that preclude bias in design, conduct, or
reporting of research
Focuses on financial conflicts of interest
(FCOI)
Regulations apply to investigators, including
sub grantees, contractors, and collaborating
investigators.
Does not apply to applications for support
under Phase I of SBIR and STTR programs
An institutional conflict of interest policy should
require that each investigator disclose to a
responsible representative of the institution all
significant financial interests of the investigator
(including those of the investigator’s spouse and
dependent children) (i) that would reasonably
appear to be affected by the research or
educational activities funded or proposed for
funding by NSF; or (ii) in entities whose financial
interests would reasonably appear to be affected
by such activities.
Chapter 1 (Subchapter A) (Part 54)
Financial Disclosure by Clinical Investigators
The Food and Drug Administration (FDA)
regulations state that investigators that
receive compensation in excess of $25,000
from a corporate sponsor of a trial in which
the investigator is engaged must disclose to
the FDA at the time of filing for a new drug
application.
19.058, Conflict of Interest in Research,
Educational, and Public Service Activities
19.059, Employee Participation in Authorized
Private Companies Commercializing Ohio
University Research
“Conflict of Interest in Research, Educational,
and Public Service Activities”
Most conflict disclosures fall within the
parameters of this policy
States that faculty are primarily responsible
for their academic, research and service
obligations
“Employee Participation in Authorized Private
Companies Commercializing Ohio University
Research”
Applies to “employees, faculty, staff and students,
who create intellectual property owned by the Ohio
University and who desire to hold an equity interest
in a firm, corporation, or other association to which
Ohio University has assigned, licensed or
transferred Ohio University’s interests…”
Consulting
Licensing University Technology
Clinical Studies
Procurement
Mentoring
Institutional
A disclosure is filed specific to the funding
application.
If you have a potential conflict for one
proposal, it does not automatically apply to
all of your proposals.
Research conflicts of interest are usually
disclosed using LEO as you apply for funding
by completing the conflict of interest section
of the electronic transmittal
If you are not using LEO, you can download
the appropriate disclosure form from
www.ohio.edu/research/compliance
“A” is selected if you have no conflicts to
disclose
“B” is selected if you have a potential conflict
to disclose relative to the submission.
(Requires a subsequent paper process)
“C” is selected if you have a current disclosure
on file, but it is not relevant to the proposal
you are submitting
Still uses option A, B or C
Requires that you gather signatures on paper
for all options, however
Generally used for personnel not listed on the
grant proposal or “key personnel”
We have revised the COI forms to word forms
This should be easier to complete than the
previous form
PDF versions are also available
Should be on the compliance web site soon,
but we can e-mail them to you until then
Use this form only if you are unable to use
the LEO transmittal form to assure that no
conflict of interest exists. A form must be
completed for each proposal.
I assure that I have read Ohio University
Policy 19.058, “Conflict of Interest in
Research, Educational, and Public Service
Activities” and declare that I have nothing
that is, or could be perceived to be a conflict
of interest with this proposal.
Use this form to disclose a potential conflict
of interest situation.
A separate disclosure form must be used for
each entity with which you conduct business
Conflict includes any member of your
immediate family (spouse, domestic partner
or children)
Require that you complete an option “B”
disclosure statement in addition to
completing the LEO transmittal form.
Require you to obtain signatures from Center
or Institute (if applicable), Chair and Dean on
the additional disclosure statement!!
The B disclosure form is available at
www.ohio.edu/research/compliance
Use this form only if you are unable to use
the LEO transmittal form. Complete this form
if you have a current conflict of interest
disclosure on file with the Office of Research
Compliance, but that disclosure is not
applicable to this proposal.
*New Option for 2008*
A management plan is developed for some
disclosures to mitigate the potential conflict
Management plans are specific to each
disclosure
May require submission of additional pieces,
such as a student employment plan
Reduce or remove the financial interest creating the
conflict
Place safeguards that mitigate the conflict potential,
such having some decisions made by an independent
entity
Limit participation in portions of the proposed
research likely to create a conflict
Require that the researcher disclose his or her
conflicting financial interests to all collaborators and
any proposed trainees;
Disclose the conflict in publications
Work to remove students from being directly advised
or taught by faculty where a conflict exists
Assure publication rights for student participants
Student Use
Nepotism and Cronyism
Intellectual Property
Use of University Resources
Publication provisions
Use of Human Subjects
Oversight Requirements
Reporting and Annual Reviews
You must submit an annual renewal for your
disclosure
◦ If the potential conflict no longer exists you must
notify us
If significant changes occur during the year
you should submit an update to your
disclosure as they occur
Yes. We encourage employees to disclose
potential conflicts that do not meet the
financial threshold, but may still be
problematic, such as student employment.
This allows you to be transparent with
respect to outside interests.
Allowable situations
Situations that require disclosure but may not
need an extensive management plan
Situations that require disclosure and have
problematic elements that will require
mitigation and/or a management plan
Situations that are not permitted
Receipt of royalties or honoraria for
published scholarly works, seminars,
teaching, etc.
Honoraria for serving as a special reviewer
or work on review panels
Royalties under our intellectual property
policies if no other relationship with entity
Clinical income at OUCOM
You participate in research developed in
whole or part by you, and you or your
family receive royalties from an existing
agreement with the business, but have
no other significant financial interest
You assign students, etc. to research
projects where you are entitled to
receive royalties, but have no other
significant financial interest
You assign students, etc. to projects supported
by the business through an SRA, and have a
significant financial interest other than royalty
income
You receive research support from a business in
which you serve on the board of directors, or
other advisory board, even if you are not
compensated.
You hold an executive position in a business
engaged in commercial or research activities
directly related to your Ohio University
responsibilities.
Any situation in which an actual conflict
exists is not permitted.
The only “exceptions” are those handled
under Ohio University Policy and Procedure
19.059 where faculty entrepreneurship is
addressed.
Participation in clinical trials or evaluation
of other research in which you have a
significant financial interest other than
royalty income.
In the context of your position at Ohio
University, you make professional referrals
to a business in which you have a
significant financial interest.
Letter of admonition
Ineligibility to submit grant applications
Withholding of IRB or IACUC approvals
Suspension
Non-Renewal
Loss of Tenure
Consulting
Procurement
Mentoring
Clinical Studies
Avoid consulting relationships that have
the potential to divert time and effort from
your responsibilities to Ohio University.
Do not use students.
Be wary of situations that limit publication.
Do not use university stationary, etc. that
could create an impression the university
is involved with the activities.
Make sure you are devoting sufficient time
to your university obligations.
Be cautious that the potential financial gain
cannot be perceived to influence your
university mentoring relationships.
Disclose any personal or familial financial
interest or equity in a company that is
doing business with Ohio University.
If you make purchases using public funds,
you should not use companies which will
benefit you or your family. If there is no
alternative you must seek and receive
permission prior to purchasing.
Any relationship in which there is a real or
perceived power or influence imbalance has
the potential for conflict. (Faculty:Student)
Isolating these relationships with respect to
areas of personal financial gain is best.
If they cannot be isolated, then safeguards
must be created.
If you have a financial interest, it is best to
isolate yourself from the study.
At a minimum, expect a more intense review
and a robust management plan if you have a
financial interest.
If both the institution and you have financial
interests the clinical study should be
conducted elsewhere.
You have administrative responsibilities on
behalf of Ohio University that is beneficial to
the business in which you have a significant
financial interest
You have administrative responsibilities on
behalf of Ohio University with respect to an
SRA where you have a significant financial
interest
Slide 37
Jo Ellen Sherow
Ohio University
Office of Research Compliance
Researchers’ Financial Disclosures in the
Spotlight
Conflicts of interest, always an emotional topic,
returned to the headlines this week as Sen.
Charles Grassley, a longtime critic of the drug
industry’s potential influence on research,
released new evidence that prominent Harvard
University scientists had failed to disclose much
of their outside income from pharmaceutical
companies over the past eight years.
http://www.insidehighered.com/news/2008/06/12/conflict January 15, 2008
WEDNESDAY, JANUARY 21, 2009
In a review of the literature regarding the relationship between
smokeless tobacco use and cancer, a conflict of interest of one of the
article's authors was initially not disclosed (see: Boffetta P, Hecht S, Gray
N, Gupta P, Straif K. Smokeless tobacco and cancer. Lancet Oncology
2008; 9:667-675). The original article was published in July, 2008. That
article stated: "The authors declare no conflicts of interest." After the
editor of the journal was notified by a researcher with knowledge of a
potential conflict of interest of Dr. Stephen Hecht (one of the study
authors), an erratum was published in September 2008, which noted:
"During the immediate months preceding submission of the review SH
was acting in the capacity of an expert witness for the plaintiff in a
future court case against a smokeless tobacco company. SH declares his
participation in this case in no way influenced his writing or involvement
in the review."
http://tobaccoanalysis.blogspot.com/2009/01/conflict-of-interestnot.html
January 16, 2009 — More than one third of new
drug marketing applications approved by the US
Food and Drug Administration (FDA) were
missing information about potential conflicts of
interest for clinical trial investigators, which
could allow bias to creep into the approvals
process, a government report released this week
has found. The FDA has said that it agrees with
most of the report's findings.
http://www.medscape.com/viewarticle/586980
Do collaborations between biotech companies
and academic centers constitute a conflict of
interest?
Biotechnology industry partnerships with
universities and academic centers have been
fruitful for both. So why is there so much
concern about conflict of interest and is that
concern appropriate?
http://www.redorbit.com/news/health/750100/genetic_engineering_news_p
osts_podcast_on_industrialacademic_collaborations_are_these/index.html
Universities are responsible for use of public
funds and therefore must maintain the public
trust.
Identifying and mitigating situations that may
have the potential for conflict maintains the
integrity of the university.
Maintaining integrity allows the university to
do credible academic research.
To provide information on the purpose of the
conflict of interest requirements.
To provide a basic overview of conflicts of
interest
To introduce the disclosure process and the use
of management plans
To provide information on the need for updates
and annual renewals.
Situations where financial considerations
compromise your professional judgment.
“Actual Conflict of Interest”
◦ Not permitted
Situations where an independent observer
might reasonably question whether your
professional actions or decisions are
determined by considerations of personal
gain. “Perceived Conflict of Interest”
◦ Managed
Potential conflicts may be financial or may be
a conflict of time, effort and/or commitment.
Potential conflicts can occur as a result of
administrative, scientific, academic, fiduciary
or familial situations.
They are situations that can be PERCEIVED to
be conflicting, whether a “real” conflict exists
or not.
Ohio University Policy has a mandatory
disclosure policy if you:
Earn over $10,000 in a twelve month period
from your outside activity OR
Have over 5% equity in the entity
Applies to members of your immediate family
(spouse, domestic partner, dependent
children) as well as yourself.
Anything of monetary value, including but not
limited to:
◦
◦
◦
◦
Salary
Payments for services
Equity interests over 5%
Intellectual property rights
Excludes mutual, pension and other
investments over which you have no control
Outside work during regular academic year
should not exceed equivalent of 1 day per
week.
Consulting work must avoid activities that
involve a conflict of interest with assigned
Ohio University activities and programs
Faculty Handbook, section IV-D
Outside interests cannot interfere with
primary loyalty to Ohio University and your
academic role
Use of university resources must have prior
approval of Chair, Dean and VPR.
Your outside interests should not be in
direct competition with university interests
Full time administrative employees are
expected to devote their full-time
professional loyalty, time and energy to their
position.
You must use non-work hours and no
university resources
Federal Agencies
State Law
University Policies
Many Academic Publications
45 CFR Part 50, Subpart F
“Responsibility of Applicants for Promoting
Objectivity in Research for Which PHS Funding
is Sought”
Authority: 42 U.S.C. 216, 289b-1, 299c-3.
Intent is to assure objectivity by establishing
standards that preclude bias in design, conduct, or
reporting of research
Focuses on financial conflicts of interest
(FCOI)
Regulations apply to investigators, including
sub grantees, contractors, and collaborating
investigators.
Does not apply to applications for support
under Phase I of SBIR and STTR programs
An institutional conflict of interest policy should
require that each investigator disclose to a
responsible representative of the institution all
significant financial interests of the investigator
(including those of the investigator’s spouse and
dependent children) (i) that would reasonably
appear to be affected by the research or
educational activities funded or proposed for
funding by NSF; or (ii) in entities whose financial
interests would reasonably appear to be affected
by such activities.
Chapter 1 (Subchapter A) (Part 54)
Financial Disclosure by Clinical Investigators
The Food and Drug Administration (FDA)
regulations state that investigators that
receive compensation in excess of $25,000
from a corporate sponsor of a trial in which
the investigator is engaged must disclose to
the FDA at the time of filing for a new drug
application.
19.058, Conflict of Interest in Research,
Educational, and Public Service Activities
19.059, Employee Participation in Authorized
Private Companies Commercializing Ohio
University Research
“Conflict of Interest in Research, Educational,
and Public Service Activities”
Most conflict disclosures fall within the
parameters of this policy
States that faculty are primarily responsible
for their academic, research and service
obligations
“Employee Participation in Authorized Private
Companies Commercializing Ohio University
Research”
Applies to “employees, faculty, staff and students,
who create intellectual property owned by the Ohio
University and who desire to hold an equity interest
in a firm, corporation, or other association to which
Ohio University has assigned, licensed or
transferred Ohio University’s interests…”
Consulting
Licensing University Technology
Clinical Studies
Procurement
Mentoring
Institutional
A disclosure is filed specific to the funding
application.
If you have a potential conflict for one
proposal, it does not automatically apply to
all of your proposals.
Research conflicts of interest are usually
disclosed using LEO as you apply for funding
by completing the conflict of interest section
of the electronic transmittal
If you are not using LEO, you can download
the appropriate disclosure form from
www.ohio.edu/research/compliance
“A” is selected if you have no conflicts to
disclose
“B” is selected if you have a potential conflict
to disclose relative to the submission.
(Requires a subsequent paper process)
“C” is selected if you have a current disclosure
on file, but it is not relevant to the proposal
you are submitting
Still uses option A, B or C
Requires that you gather signatures on paper
for all options, however
Generally used for personnel not listed on the
grant proposal or “key personnel”
We have revised the COI forms to word forms
This should be easier to complete than the
previous form
PDF versions are also available
Should be on the compliance web site soon,
but we can e-mail them to you until then
Use this form only if you are unable to use
the LEO transmittal form to assure that no
conflict of interest exists. A form must be
completed for each proposal.
I assure that I have read Ohio University
Policy 19.058, “Conflict of Interest in
Research, Educational, and Public Service
Activities” and declare that I have nothing
that is, or could be perceived to be a conflict
of interest with this proposal.
Use this form to disclose a potential conflict
of interest situation.
A separate disclosure form must be used for
each entity with which you conduct business
Conflict includes any member of your
immediate family (spouse, domestic partner
or children)
Require that you complete an option “B”
disclosure statement in addition to
completing the LEO transmittal form.
Require you to obtain signatures from Center
or Institute (if applicable), Chair and Dean on
the additional disclosure statement!!
The B disclosure form is available at
www.ohio.edu/research/compliance
Use this form only if you are unable to use
the LEO transmittal form. Complete this form
if you have a current conflict of interest
disclosure on file with the Office of Research
Compliance, but that disclosure is not
applicable to this proposal.
*New Option for 2008*
A management plan is developed for some
disclosures to mitigate the potential conflict
Management plans are specific to each
disclosure
May require submission of additional pieces,
such as a student employment plan
Reduce or remove the financial interest creating the
conflict
Place safeguards that mitigate the conflict potential,
such having some decisions made by an independent
entity
Limit participation in portions of the proposed
research likely to create a conflict
Require that the researcher disclose his or her
conflicting financial interests to all collaborators and
any proposed trainees;
Disclose the conflict in publications
Work to remove students from being directly advised
or taught by faculty where a conflict exists
Assure publication rights for student participants
Student Use
Nepotism and Cronyism
Intellectual Property
Use of University Resources
Publication provisions
Use of Human Subjects
Oversight Requirements
Reporting and Annual Reviews
You must submit an annual renewal for your
disclosure
◦ If the potential conflict no longer exists you must
notify us
If significant changes occur during the year
you should submit an update to your
disclosure as they occur
Yes. We encourage employees to disclose
potential conflicts that do not meet the
financial threshold, but may still be
problematic, such as student employment.
This allows you to be transparent with
respect to outside interests.
Allowable situations
Situations that require disclosure but may not
need an extensive management plan
Situations that require disclosure and have
problematic elements that will require
mitigation and/or a management plan
Situations that are not permitted
Receipt of royalties or honoraria for
published scholarly works, seminars,
teaching, etc.
Honoraria for serving as a special reviewer
or work on review panels
Royalties under our intellectual property
policies if no other relationship with entity
Clinical income at OUCOM
You participate in research developed in
whole or part by you, and you or your
family receive royalties from an existing
agreement with the business, but have
no other significant financial interest
You assign students, etc. to research
projects where you are entitled to
receive royalties, but have no other
significant financial interest
You assign students, etc. to projects supported
by the business through an SRA, and have a
significant financial interest other than royalty
income
You receive research support from a business in
which you serve on the board of directors, or
other advisory board, even if you are not
compensated.
You hold an executive position in a business
engaged in commercial or research activities
directly related to your Ohio University
responsibilities.
Any situation in which an actual conflict
exists is not permitted.
The only “exceptions” are those handled
under Ohio University Policy and Procedure
19.059 where faculty entrepreneurship is
addressed.
Participation in clinical trials or evaluation
of other research in which you have a
significant financial interest other than
royalty income.
In the context of your position at Ohio
University, you make professional referrals
to a business in which you have a
significant financial interest.
Letter of admonition
Ineligibility to submit grant applications
Withholding of IRB or IACUC approvals
Suspension
Non-Renewal
Loss of Tenure
Consulting
Procurement
Mentoring
Clinical Studies
Avoid consulting relationships that have
the potential to divert time and effort from
your responsibilities to Ohio University.
Do not use students.
Be wary of situations that limit publication.
Do not use university stationary, etc. that
could create an impression the university
is involved with the activities.
Make sure you are devoting sufficient time
to your university obligations.
Be cautious that the potential financial gain
cannot be perceived to influence your
university mentoring relationships.
Disclose any personal or familial financial
interest or equity in a company that is
doing business with Ohio University.
If you make purchases using public funds,
you should not use companies which will
benefit you or your family. If there is no
alternative you must seek and receive
permission prior to purchasing.
Any relationship in which there is a real or
perceived power or influence imbalance has
the potential for conflict. (Faculty:Student)
Isolating these relationships with respect to
areas of personal financial gain is best.
If they cannot be isolated, then safeguards
must be created.
If you have a financial interest, it is best to
isolate yourself from the study.
At a minimum, expect a more intense review
and a robust management plan if you have a
financial interest.
If both the institution and you have financial
interests the clinical study should be
conducted elsewhere.
You have administrative responsibilities on
behalf of Ohio University that is beneficial to
the business in which you have a significant
financial interest
You have administrative responsibilities on
behalf of Ohio University with respect to an
SRA where you have a significant financial
interest
Slide 38
Jo Ellen Sherow
Ohio University
Office of Research Compliance
Researchers’ Financial Disclosures in the
Spotlight
Conflicts of interest, always an emotional topic,
returned to the headlines this week as Sen.
Charles Grassley, a longtime critic of the drug
industry’s potential influence on research,
released new evidence that prominent Harvard
University scientists had failed to disclose much
of their outside income from pharmaceutical
companies over the past eight years.
http://www.insidehighered.com/news/2008/06/12/conflict January 15, 2008
WEDNESDAY, JANUARY 21, 2009
In a review of the literature regarding the relationship between
smokeless tobacco use and cancer, a conflict of interest of one of the
article's authors was initially not disclosed (see: Boffetta P, Hecht S, Gray
N, Gupta P, Straif K. Smokeless tobacco and cancer. Lancet Oncology
2008; 9:667-675). The original article was published in July, 2008. That
article stated: "The authors declare no conflicts of interest." After the
editor of the journal was notified by a researcher with knowledge of a
potential conflict of interest of Dr. Stephen Hecht (one of the study
authors), an erratum was published in September 2008, which noted:
"During the immediate months preceding submission of the review SH
was acting in the capacity of an expert witness for the plaintiff in a
future court case against a smokeless tobacco company. SH declares his
participation in this case in no way influenced his writing or involvement
in the review."
http://tobaccoanalysis.blogspot.com/2009/01/conflict-of-interestnot.html
January 16, 2009 — More than one third of new
drug marketing applications approved by the US
Food and Drug Administration (FDA) were
missing information about potential conflicts of
interest for clinical trial investigators, which
could allow bias to creep into the approvals
process, a government report released this week
has found. The FDA has said that it agrees with
most of the report's findings.
http://www.medscape.com/viewarticle/586980
Do collaborations between biotech companies
and academic centers constitute a conflict of
interest?
Biotechnology industry partnerships with
universities and academic centers have been
fruitful for both. So why is there so much
concern about conflict of interest and is that
concern appropriate?
http://www.redorbit.com/news/health/750100/genetic_engineering_news_p
osts_podcast_on_industrialacademic_collaborations_are_these/index.html
Universities are responsible for use of public
funds and therefore must maintain the public
trust.
Identifying and mitigating situations that may
have the potential for conflict maintains the
integrity of the university.
Maintaining integrity allows the university to
do credible academic research.
To provide information on the purpose of the
conflict of interest requirements.
To provide a basic overview of conflicts of
interest
To introduce the disclosure process and the use
of management plans
To provide information on the need for updates
and annual renewals.
Situations where financial considerations
compromise your professional judgment.
“Actual Conflict of Interest”
◦ Not permitted
Situations where an independent observer
might reasonably question whether your
professional actions or decisions are
determined by considerations of personal
gain. “Perceived Conflict of Interest”
◦ Managed
Potential conflicts may be financial or may be
a conflict of time, effort and/or commitment.
Potential conflicts can occur as a result of
administrative, scientific, academic, fiduciary
or familial situations.
They are situations that can be PERCEIVED to
be conflicting, whether a “real” conflict exists
or not.
Ohio University Policy has a mandatory
disclosure policy if you:
Earn over $10,000 in a twelve month period
from your outside activity OR
Have over 5% equity in the entity
Applies to members of your immediate family
(spouse, domestic partner, dependent
children) as well as yourself.
Anything of monetary value, including but not
limited to:
◦
◦
◦
◦
Salary
Payments for services
Equity interests over 5%
Intellectual property rights
Excludes mutual, pension and other
investments over which you have no control
Outside work during regular academic year
should not exceed equivalent of 1 day per
week.
Consulting work must avoid activities that
involve a conflict of interest with assigned
Ohio University activities and programs
Faculty Handbook, section IV-D
Outside interests cannot interfere with
primary loyalty to Ohio University and your
academic role
Use of university resources must have prior
approval of Chair, Dean and VPR.
Your outside interests should not be in
direct competition with university interests
Full time administrative employees are
expected to devote their full-time
professional loyalty, time and energy to their
position.
You must use non-work hours and no
university resources
Federal Agencies
State Law
University Policies
Many Academic Publications
45 CFR Part 50, Subpart F
“Responsibility of Applicants for Promoting
Objectivity in Research for Which PHS Funding
is Sought”
Authority: 42 U.S.C. 216, 289b-1, 299c-3.
Intent is to assure objectivity by establishing
standards that preclude bias in design, conduct, or
reporting of research
Focuses on financial conflicts of interest
(FCOI)
Regulations apply to investigators, including
sub grantees, contractors, and collaborating
investigators.
Does not apply to applications for support
under Phase I of SBIR and STTR programs
An institutional conflict of interest policy should
require that each investigator disclose to a
responsible representative of the institution all
significant financial interests of the investigator
(including those of the investigator’s spouse and
dependent children) (i) that would reasonably
appear to be affected by the research or
educational activities funded or proposed for
funding by NSF; or (ii) in entities whose financial
interests would reasonably appear to be affected
by such activities.
Chapter 1 (Subchapter A) (Part 54)
Financial Disclosure by Clinical Investigators
The Food and Drug Administration (FDA)
regulations state that investigators that
receive compensation in excess of $25,000
from a corporate sponsor of a trial in which
the investigator is engaged must disclose to
the FDA at the time of filing for a new drug
application.
19.058, Conflict of Interest in Research,
Educational, and Public Service Activities
19.059, Employee Participation in Authorized
Private Companies Commercializing Ohio
University Research
“Conflict of Interest in Research, Educational,
and Public Service Activities”
Most conflict disclosures fall within the
parameters of this policy
States that faculty are primarily responsible
for their academic, research and service
obligations
“Employee Participation in Authorized Private
Companies Commercializing Ohio University
Research”
Applies to “employees, faculty, staff and students,
who create intellectual property owned by the Ohio
University and who desire to hold an equity interest
in a firm, corporation, or other association to which
Ohio University has assigned, licensed or
transferred Ohio University’s interests…”
Consulting
Licensing University Technology
Clinical Studies
Procurement
Mentoring
Institutional
A disclosure is filed specific to the funding
application.
If you have a potential conflict for one
proposal, it does not automatically apply to
all of your proposals.
Research conflicts of interest are usually
disclosed using LEO as you apply for funding
by completing the conflict of interest section
of the electronic transmittal
If you are not using LEO, you can download
the appropriate disclosure form from
www.ohio.edu/research/compliance
“A” is selected if you have no conflicts to
disclose
“B” is selected if you have a potential conflict
to disclose relative to the submission.
(Requires a subsequent paper process)
“C” is selected if you have a current disclosure
on file, but it is not relevant to the proposal
you are submitting
Still uses option A, B or C
Requires that you gather signatures on paper
for all options, however
Generally used for personnel not listed on the
grant proposal or “key personnel”
We have revised the COI forms to word forms
This should be easier to complete than the
previous form
PDF versions are also available
Should be on the compliance web site soon,
but we can e-mail them to you until then
Use this form only if you are unable to use
the LEO transmittal form to assure that no
conflict of interest exists. A form must be
completed for each proposal.
I assure that I have read Ohio University
Policy 19.058, “Conflict of Interest in
Research, Educational, and Public Service
Activities” and declare that I have nothing
that is, or could be perceived to be a conflict
of interest with this proposal.
Use this form to disclose a potential conflict
of interest situation.
A separate disclosure form must be used for
each entity with which you conduct business
Conflict includes any member of your
immediate family (spouse, domestic partner
or children)
Require that you complete an option “B”
disclosure statement in addition to
completing the LEO transmittal form.
Require you to obtain signatures from Center
or Institute (if applicable), Chair and Dean on
the additional disclosure statement!!
The B disclosure form is available at
www.ohio.edu/research/compliance
Use this form only if you are unable to use
the LEO transmittal form. Complete this form
if you have a current conflict of interest
disclosure on file with the Office of Research
Compliance, but that disclosure is not
applicable to this proposal.
*New Option for 2008*
A management plan is developed for some
disclosures to mitigate the potential conflict
Management plans are specific to each
disclosure
May require submission of additional pieces,
such as a student employment plan
Reduce or remove the financial interest creating the
conflict
Place safeguards that mitigate the conflict potential,
such having some decisions made by an independent
entity
Limit participation in portions of the proposed
research likely to create a conflict
Require that the researcher disclose his or her
conflicting financial interests to all collaborators and
any proposed trainees;
Disclose the conflict in publications
Work to remove students from being directly advised
or taught by faculty where a conflict exists
Assure publication rights for student participants
Student Use
Nepotism and Cronyism
Intellectual Property
Use of University Resources
Publication provisions
Use of Human Subjects
Oversight Requirements
Reporting and Annual Reviews
You must submit an annual renewal for your
disclosure
◦ If the potential conflict no longer exists you must
notify us
If significant changes occur during the year
you should submit an update to your
disclosure as they occur
Yes. We encourage employees to disclose
potential conflicts that do not meet the
financial threshold, but may still be
problematic, such as student employment.
This allows you to be transparent with
respect to outside interests.
Allowable situations
Situations that require disclosure but may not
need an extensive management plan
Situations that require disclosure and have
problematic elements that will require
mitigation and/or a management plan
Situations that are not permitted
Receipt of royalties or honoraria for
published scholarly works, seminars,
teaching, etc.
Honoraria for serving as a special reviewer
or work on review panels
Royalties under our intellectual property
policies if no other relationship with entity
Clinical income at OUCOM
You participate in research developed in
whole or part by you, and you or your
family receive royalties from an existing
agreement with the business, but have
no other significant financial interest
You assign students, etc. to research
projects where you are entitled to
receive royalties, but have no other
significant financial interest
You assign students, etc. to projects supported
by the business through an SRA, and have a
significant financial interest other than royalty
income
You receive research support from a business in
which you serve on the board of directors, or
other advisory board, even if you are not
compensated.
You hold an executive position in a business
engaged in commercial or research activities
directly related to your Ohio University
responsibilities.
Any situation in which an actual conflict
exists is not permitted.
The only “exceptions” are those handled
under Ohio University Policy and Procedure
19.059 where faculty entrepreneurship is
addressed.
Participation in clinical trials or evaluation
of other research in which you have a
significant financial interest other than
royalty income.
In the context of your position at Ohio
University, you make professional referrals
to a business in which you have a
significant financial interest.
Letter of admonition
Ineligibility to submit grant applications
Withholding of IRB or IACUC approvals
Suspension
Non-Renewal
Loss of Tenure
Consulting
Procurement
Mentoring
Clinical Studies
Avoid consulting relationships that have
the potential to divert time and effort from
your responsibilities to Ohio University.
Do not use students.
Be wary of situations that limit publication.
Do not use university stationary, etc. that
could create an impression the university
is involved with the activities.
Make sure you are devoting sufficient time
to your university obligations.
Be cautious that the potential financial gain
cannot be perceived to influence your
university mentoring relationships.
Disclose any personal or familial financial
interest or equity in a company that is
doing business with Ohio University.
If you make purchases using public funds,
you should not use companies which will
benefit you or your family. If there is no
alternative you must seek and receive
permission prior to purchasing.
Any relationship in which there is a real or
perceived power or influence imbalance has
the potential for conflict. (Faculty:Student)
Isolating these relationships with respect to
areas of personal financial gain is best.
If they cannot be isolated, then safeguards
must be created.
If you have a financial interest, it is best to
isolate yourself from the study.
At a minimum, expect a more intense review
and a robust management plan if you have a
financial interest.
If both the institution and you have financial
interests the clinical study should be
conducted elsewhere.
You have administrative responsibilities on
behalf of Ohio University that is beneficial to
the business in which you have a significant
financial interest
You have administrative responsibilities on
behalf of Ohio University with respect to an
SRA where you have a significant financial
interest
Slide 39
Jo Ellen Sherow
Ohio University
Office of Research Compliance
Researchers’ Financial Disclosures in the
Spotlight
Conflicts of interest, always an emotional topic,
returned to the headlines this week as Sen.
Charles Grassley, a longtime critic of the drug
industry’s potential influence on research,
released new evidence that prominent Harvard
University scientists had failed to disclose much
of their outside income from pharmaceutical
companies over the past eight years.
http://www.insidehighered.com/news/2008/06/12/conflict January 15, 2008
WEDNESDAY, JANUARY 21, 2009
In a review of the literature regarding the relationship between
smokeless tobacco use and cancer, a conflict of interest of one of the
article's authors was initially not disclosed (see: Boffetta P, Hecht S, Gray
N, Gupta P, Straif K. Smokeless tobacco and cancer. Lancet Oncology
2008; 9:667-675). The original article was published in July, 2008. That
article stated: "The authors declare no conflicts of interest." After the
editor of the journal was notified by a researcher with knowledge of a
potential conflict of interest of Dr. Stephen Hecht (one of the study
authors), an erratum was published in September 2008, which noted:
"During the immediate months preceding submission of the review SH
was acting in the capacity of an expert witness for the plaintiff in a
future court case against a smokeless tobacco company. SH declares his
participation in this case in no way influenced his writing or involvement
in the review."
http://tobaccoanalysis.blogspot.com/2009/01/conflict-of-interestnot.html
January 16, 2009 — More than one third of new
drug marketing applications approved by the US
Food and Drug Administration (FDA) were
missing information about potential conflicts of
interest for clinical trial investigators, which
could allow bias to creep into the approvals
process, a government report released this week
has found. The FDA has said that it agrees with
most of the report's findings.
http://www.medscape.com/viewarticle/586980
Do collaborations between biotech companies
and academic centers constitute a conflict of
interest?
Biotechnology industry partnerships with
universities and academic centers have been
fruitful for both. So why is there so much
concern about conflict of interest and is that
concern appropriate?
http://www.redorbit.com/news/health/750100/genetic_engineering_news_p
osts_podcast_on_industrialacademic_collaborations_are_these/index.html
Universities are responsible for use of public
funds and therefore must maintain the public
trust.
Identifying and mitigating situations that may
have the potential for conflict maintains the
integrity of the university.
Maintaining integrity allows the university to
do credible academic research.
To provide information on the purpose of the
conflict of interest requirements.
To provide a basic overview of conflicts of
interest
To introduce the disclosure process and the use
of management plans
To provide information on the need for updates
and annual renewals.
Situations where financial considerations
compromise your professional judgment.
“Actual Conflict of Interest”
◦ Not permitted
Situations where an independent observer
might reasonably question whether your
professional actions or decisions are
determined by considerations of personal
gain. “Perceived Conflict of Interest”
◦ Managed
Potential conflicts may be financial or may be
a conflict of time, effort and/or commitment.
Potential conflicts can occur as a result of
administrative, scientific, academic, fiduciary
or familial situations.
They are situations that can be PERCEIVED to
be conflicting, whether a “real” conflict exists
or not.
Ohio University Policy has a mandatory
disclosure policy if you:
Earn over $10,000 in a twelve month period
from your outside activity OR
Have over 5% equity in the entity
Applies to members of your immediate family
(spouse, domestic partner, dependent
children) as well as yourself.
Anything of monetary value, including but not
limited to:
◦
◦
◦
◦
Salary
Payments for services
Equity interests over 5%
Intellectual property rights
Excludes mutual, pension and other
investments over which you have no control
Outside work during regular academic year
should not exceed equivalent of 1 day per
week.
Consulting work must avoid activities that
involve a conflict of interest with assigned
Ohio University activities and programs
Faculty Handbook, section IV-D
Outside interests cannot interfere with
primary loyalty to Ohio University and your
academic role
Use of university resources must have prior
approval of Chair, Dean and VPR.
Your outside interests should not be in
direct competition with university interests
Full time administrative employees are
expected to devote their full-time
professional loyalty, time and energy to their
position.
You must use non-work hours and no
university resources
Federal Agencies
State Law
University Policies
Many Academic Publications
45 CFR Part 50, Subpart F
“Responsibility of Applicants for Promoting
Objectivity in Research for Which PHS Funding
is Sought”
Authority: 42 U.S.C. 216, 289b-1, 299c-3.
Intent is to assure objectivity by establishing
standards that preclude bias in design, conduct, or
reporting of research
Focuses on financial conflicts of interest
(FCOI)
Regulations apply to investigators, including
sub grantees, contractors, and collaborating
investigators.
Does not apply to applications for support
under Phase I of SBIR and STTR programs
An institutional conflict of interest policy should
require that each investigator disclose to a
responsible representative of the institution all
significant financial interests of the investigator
(including those of the investigator’s spouse and
dependent children) (i) that would reasonably
appear to be affected by the research or
educational activities funded or proposed for
funding by NSF; or (ii) in entities whose financial
interests would reasonably appear to be affected
by such activities.
Chapter 1 (Subchapter A) (Part 54)
Financial Disclosure by Clinical Investigators
The Food and Drug Administration (FDA)
regulations state that investigators that
receive compensation in excess of $25,000
from a corporate sponsor of a trial in which
the investigator is engaged must disclose to
the FDA at the time of filing for a new drug
application.
19.058, Conflict of Interest in Research,
Educational, and Public Service Activities
19.059, Employee Participation in Authorized
Private Companies Commercializing Ohio
University Research
“Conflict of Interest in Research, Educational,
and Public Service Activities”
Most conflict disclosures fall within the
parameters of this policy
States that faculty are primarily responsible
for their academic, research and service
obligations
“Employee Participation in Authorized Private
Companies Commercializing Ohio University
Research”
Applies to “employees, faculty, staff and students,
who create intellectual property owned by the Ohio
University and who desire to hold an equity interest
in a firm, corporation, or other association to which
Ohio University has assigned, licensed or
transferred Ohio University’s interests…”
Consulting
Licensing University Technology
Clinical Studies
Procurement
Mentoring
Institutional
A disclosure is filed specific to the funding
application.
If you have a potential conflict for one
proposal, it does not automatically apply to
all of your proposals.
Research conflicts of interest are usually
disclosed using LEO as you apply for funding
by completing the conflict of interest section
of the electronic transmittal
If you are not using LEO, you can download
the appropriate disclosure form from
www.ohio.edu/research/compliance
“A” is selected if you have no conflicts to
disclose
“B” is selected if you have a potential conflict
to disclose relative to the submission.
(Requires a subsequent paper process)
“C” is selected if you have a current disclosure
on file, but it is not relevant to the proposal
you are submitting
Still uses option A, B or C
Requires that you gather signatures on paper
for all options, however
Generally used for personnel not listed on the
grant proposal or “key personnel”
We have revised the COI forms to word forms
This should be easier to complete than the
previous form
PDF versions are also available
Should be on the compliance web site soon,
but we can e-mail them to you until then
Use this form only if you are unable to use
the LEO transmittal form to assure that no
conflict of interest exists. A form must be
completed for each proposal.
I assure that I have read Ohio University
Policy 19.058, “Conflict of Interest in
Research, Educational, and Public Service
Activities” and declare that I have nothing
that is, or could be perceived to be a conflict
of interest with this proposal.
Use this form to disclose a potential conflict
of interest situation.
A separate disclosure form must be used for
each entity with which you conduct business
Conflict includes any member of your
immediate family (spouse, domestic partner
or children)
Require that you complete an option “B”
disclosure statement in addition to
completing the LEO transmittal form.
Require you to obtain signatures from Center
or Institute (if applicable), Chair and Dean on
the additional disclosure statement!!
The B disclosure form is available at
www.ohio.edu/research/compliance
Use this form only if you are unable to use
the LEO transmittal form. Complete this form
if you have a current conflict of interest
disclosure on file with the Office of Research
Compliance, but that disclosure is not
applicable to this proposal.
*New Option for 2008*
A management plan is developed for some
disclosures to mitigate the potential conflict
Management plans are specific to each
disclosure
May require submission of additional pieces,
such as a student employment plan
Reduce or remove the financial interest creating the
conflict
Place safeguards that mitigate the conflict potential,
such having some decisions made by an independent
entity
Limit participation in portions of the proposed
research likely to create a conflict
Require that the researcher disclose his or her
conflicting financial interests to all collaborators and
any proposed trainees;
Disclose the conflict in publications
Work to remove students from being directly advised
or taught by faculty where a conflict exists
Assure publication rights for student participants
Student Use
Nepotism and Cronyism
Intellectual Property
Use of University Resources
Publication provisions
Use of Human Subjects
Oversight Requirements
Reporting and Annual Reviews
You must submit an annual renewal for your
disclosure
◦ If the potential conflict no longer exists you must
notify us
If significant changes occur during the year
you should submit an update to your
disclosure as they occur
Yes. We encourage employees to disclose
potential conflicts that do not meet the
financial threshold, but may still be
problematic, such as student employment.
This allows you to be transparent with
respect to outside interests.
Allowable situations
Situations that require disclosure but may not
need an extensive management plan
Situations that require disclosure and have
problematic elements that will require
mitigation and/or a management plan
Situations that are not permitted
Receipt of royalties or honoraria for
published scholarly works, seminars,
teaching, etc.
Honoraria for serving as a special reviewer
or work on review panels
Royalties under our intellectual property
policies if no other relationship with entity
Clinical income at OUCOM
You participate in research developed in
whole or part by you, and you or your
family receive royalties from an existing
agreement with the business, but have
no other significant financial interest
You assign students, etc. to research
projects where you are entitled to
receive royalties, but have no other
significant financial interest
You assign students, etc. to projects supported
by the business through an SRA, and have a
significant financial interest other than royalty
income
You receive research support from a business in
which you serve on the board of directors, or
other advisory board, even if you are not
compensated.
You hold an executive position in a business
engaged in commercial or research activities
directly related to your Ohio University
responsibilities.
Any situation in which an actual conflict
exists is not permitted.
The only “exceptions” are those handled
under Ohio University Policy and Procedure
19.059 where faculty entrepreneurship is
addressed.
Participation in clinical trials or evaluation
of other research in which you have a
significant financial interest other than
royalty income.
In the context of your position at Ohio
University, you make professional referrals
to a business in which you have a
significant financial interest.
Letter of admonition
Ineligibility to submit grant applications
Withholding of IRB or IACUC approvals
Suspension
Non-Renewal
Loss of Tenure
Consulting
Procurement
Mentoring
Clinical Studies
Avoid consulting relationships that have
the potential to divert time and effort from
your responsibilities to Ohio University.
Do not use students.
Be wary of situations that limit publication.
Do not use university stationary, etc. that
could create an impression the university
is involved with the activities.
Make sure you are devoting sufficient time
to your university obligations.
Be cautious that the potential financial gain
cannot be perceived to influence your
university mentoring relationships.
Disclose any personal or familial financial
interest or equity in a company that is
doing business with Ohio University.
If you make purchases using public funds,
you should not use companies which will
benefit you or your family. If there is no
alternative you must seek and receive
permission prior to purchasing.
Any relationship in which there is a real or
perceived power or influence imbalance has
the potential for conflict. (Faculty:Student)
Isolating these relationships with respect to
areas of personal financial gain is best.
If they cannot be isolated, then safeguards
must be created.
If you have a financial interest, it is best to
isolate yourself from the study.
At a minimum, expect a more intense review
and a robust management plan if you have a
financial interest.
If both the institution and you have financial
interests the clinical study should be
conducted elsewhere.
You have administrative responsibilities on
behalf of Ohio University that is beneficial to
the business in which you have a significant
financial interest
You have administrative responsibilities on
behalf of Ohio University with respect to an
SRA where you have a significant financial
interest
Slide 40
Jo Ellen Sherow
Ohio University
Office of Research Compliance
Researchers’ Financial Disclosures in the
Spotlight
Conflicts of interest, always an emotional topic,
returned to the headlines this week as Sen.
Charles Grassley, a longtime critic of the drug
industry’s potential influence on research,
released new evidence that prominent Harvard
University scientists had failed to disclose much
of their outside income from pharmaceutical
companies over the past eight years.
http://www.insidehighered.com/news/2008/06/12/conflict January 15, 2008
WEDNESDAY, JANUARY 21, 2009
In a review of the literature regarding the relationship between
smokeless tobacco use and cancer, a conflict of interest of one of the
article's authors was initially not disclosed (see: Boffetta P, Hecht S, Gray
N, Gupta P, Straif K. Smokeless tobacco and cancer. Lancet Oncology
2008; 9:667-675). The original article was published in July, 2008. That
article stated: "The authors declare no conflicts of interest." After the
editor of the journal was notified by a researcher with knowledge of a
potential conflict of interest of Dr. Stephen Hecht (one of the study
authors), an erratum was published in September 2008, which noted:
"During the immediate months preceding submission of the review SH
was acting in the capacity of an expert witness for the plaintiff in a
future court case against a smokeless tobacco company. SH declares his
participation in this case in no way influenced his writing or involvement
in the review."
http://tobaccoanalysis.blogspot.com/2009/01/conflict-of-interestnot.html
January 16, 2009 — More than one third of new
drug marketing applications approved by the US
Food and Drug Administration (FDA) were
missing information about potential conflicts of
interest for clinical trial investigators, which
could allow bias to creep into the approvals
process, a government report released this week
has found. The FDA has said that it agrees with
most of the report's findings.
http://www.medscape.com/viewarticle/586980
Do collaborations between biotech companies
and academic centers constitute a conflict of
interest?
Biotechnology industry partnerships with
universities and academic centers have been
fruitful for both. So why is there so much
concern about conflict of interest and is that
concern appropriate?
http://www.redorbit.com/news/health/750100/genetic_engineering_news_p
osts_podcast_on_industrialacademic_collaborations_are_these/index.html
Universities are responsible for use of public
funds and therefore must maintain the public
trust.
Identifying and mitigating situations that may
have the potential for conflict maintains the
integrity of the university.
Maintaining integrity allows the university to
do credible academic research.
To provide information on the purpose of the
conflict of interest requirements.
To provide a basic overview of conflicts of
interest
To introduce the disclosure process and the use
of management plans
To provide information on the need for updates
and annual renewals.
Situations where financial considerations
compromise your professional judgment.
“Actual Conflict of Interest”
◦ Not permitted
Situations where an independent observer
might reasonably question whether your
professional actions or decisions are
determined by considerations of personal
gain. “Perceived Conflict of Interest”
◦ Managed
Potential conflicts may be financial or may be
a conflict of time, effort and/or commitment.
Potential conflicts can occur as a result of
administrative, scientific, academic, fiduciary
or familial situations.
They are situations that can be PERCEIVED to
be conflicting, whether a “real” conflict exists
or not.
Ohio University Policy has a mandatory
disclosure policy if you:
Earn over $10,000 in a twelve month period
from your outside activity OR
Have over 5% equity in the entity
Applies to members of your immediate family
(spouse, domestic partner, dependent
children) as well as yourself.
Anything of monetary value, including but not
limited to:
◦
◦
◦
◦
Salary
Payments for services
Equity interests over 5%
Intellectual property rights
Excludes mutual, pension and other
investments over which you have no control
Outside work during regular academic year
should not exceed equivalent of 1 day per
week.
Consulting work must avoid activities that
involve a conflict of interest with assigned
Ohio University activities and programs
Faculty Handbook, section IV-D
Outside interests cannot interfere with
primary loyalty to Ohio University and your
academic role
Use of university resources must have prior
approval of Chair, Dean and VPR.
Your outside interests should not be in
direct competition with university interests
Full time administrative employees are
expected to devote their full-time
professional loyalty, time and energy to their
position.
You must use non-work hours and no
university resources
Federal Agencies
State Law
University Policies
Many Academic Publications
45 CFR Part 50, Subpart F
“Responsibility of Applicants for Promoting
Objectivity in Research for Which PHS Funding
is Sought”
Authority: 42 U.S.C. 216, 289b-1, 299c-3.
Intent is to assure objectivity by establishing
standards that preclude bias in design, conduct, or
reporting of research
Focuses on financial conflicts of interest
(FCOI)
Regulations apply to investigators, including
sub grantees, contractors, and collaborating
investigators.
Does not apply to applications for support
under Phase I of SBIR and STTR programs
An institutional conflict of interest policy should
require that each investigator disclose to a
responsible representative of the institution all
significant financial interests of the investigator
(including those of the investigator’s spouse and
dependent children) (i) that would reasonably
appear to be affected by the research or
educational activities funded or proposed for
funding by NSF; or (ii) in entities whose financial
interests would reasonably appear to be affected
by such activities.
Chapter 1 (Subchapter A) (Part 54)
Financial Disclosure by Clinical Investigators
The Food and Drug Administration (FDA)
regulations state that investigators that
receive compensation in excess of $25,000
from a corporate sponsor of a trial in which
the investigator is engaged must disclose to
the FDA at the time of filing for a new drug
application.
19.058, Conflict of Interest in Research,
Educational, and Public Service Activities
19.059, Employee Participation in Authorized
Private Companies Commercializing Ohio
University Research
“Conflict of Interest in Research, Educational,
and Public Service Activities”
Most conflict disclosures fall within the
parameters of this policy
States that faculty are primarily responsible
for their academic, research and service
obligations
“Employee Participation in Authorized Private
Companies Commercializing Ohio University
Research”
Applies to “employees, faculty, staff and students,
who create intellectual property owned by the Ohio
University and who desire to hold an equity interest
in a firm, corporation, or other association to which
Ohio University has assigned, licensed or
transferred Ohio University’s interests…”
Consulting
Licensing University Technology
Clinical Studies
Procurement
Mentoring
Institutional
A disclosure is filed specific to the funding
application.
If you have a potential conflict for one
proposal, it does not automatically apply to
all of your proposals.
Research conflicts of interest are usually
disclosed using LEO as you apply for funding
by completing the conflict of interest section
of the electronic transmittal
If you are not using LEO, you can download
the appropriate disclosure form from
www.ohio.edu/research/compliance
“A” is selected if you have no conflicts to
disclose
“B” is selected if you have a potential conflict
to disclose relative to the submission.
(Requires a subsequent paper process)
“C” is selected if you have a current disclosure
on file, but it is not relevant to the proposal
you are submitting
Still uses option A, B or C
Requires that you gather signatures on paper
for all options, however
Generally used for personnel not listed on the
grant proposal or “key personnel”
We have revised the COI forms to word forms
This should be easier to complete than the
previous form
PDF versions are also available
Should be on the compliance web site soon,
but we can e-mail them to you until then
Use this form only if you are unable to use
the LEO transmittal form to assure that no
conflict of interest exists. A form must be
completed for each proposal.
I assure that I have read Ohio University
Policy 19.058, “Conflict of Interest in
Research, Educational, and Public Service
Activities” and declare that I have nothing
that is, or could be perceived to be a conflict
of interest with this proposal.
Use this form to disclose a potential conflict
of interest situation.
A separate disclosure form must be used for
each entity with which you conduct business
Conflict includes any member of your
immediate family (spouse, domestic partner
or children)
Require that you complete an option “B”
disclosure statement in addition to
completing the LEO transmittal form.
Require you to obtain signatures from Center
or Institute (if applicable), Chair and Dean on
the additional disclosure statement!!
The B disclosure form is available at
www.ohio.edu/research/compliance
Use this form only if you are unable to use
the LEO transmittal form. Complete this form
if you have a current conflict of interest
disclosure on file with the Office of Research
Compliance, but that disclosure is not
applicable to this proposal.
*New Option for 2008*
A management plan is developed for some
disclosures to mitigate the potential conflict
Management plans are specific to each
disclosure
May require submission of additional pieces,
such as a student employment plan
Reduce or remove the financial interest creating the
conflict
Place safeguards that mitigate the conflict potential,
such having some decisions made by an independent
entity
Limit participation in portions of the proposed
research likely to create a conflict
Require that the researcher disclose his or her
conflicting financial interests to all collaborators and
any proposed trainees;
Disclose the conflict in publications
Work to remove students from being directly advised
or taught by faculty where a conflict exists
Assure publication rights for student participants
Student Use
Nepotism and Cronyism
Intellectual Property
Use of University Resources
Publication provisions
Use of Human Subjects
Oversight Requirements
Reporting and Annual Reviews
You must submit an annual renewal for your
disclosure
◦ If the potential conflict no longer exists you must
notify us
If significant changes occur during the year
you should submit an update to your
disclosure as they occur
Yes. We encourage employees to disclose
potential conflicts that do not meet the
financial threshold, but may still be
problematic, such as student employment.
This allows you to be transparent with
respect to outside interests.
Allowable situations
Situations that require disclosure but may not
need an extensive management plan
Situations that require disclosure and have
problematic elements that will require
mitigation and/or a management plan
Situations that are not permitted
Receipt of royalties or honoraria for
published scholarly works, seminars,
teaching, etc.
Honoraria for serving as a special reviewer
or work on review panels
Royalties under our intellectual property
policies if no other relationship with entity
Clinical income at OUCOM
You participate in research developed in
whole or part by you, and you or your
family receive royalties from an existing
agreement with the business, but have
no other significant financial interest
You assign students, etc. to research
projects where you are entitled to
receive royalties, but have no other
significant financial interest
You assign students, etc. to projects supported
by the business through an SRA, and have a
significant financial interest other than royalty
income
You receive research support from a business in
which you serve on the board of directors, or
other advisory board, even if you are not
compensated.
You hold an executive position in a business
engaged in commercial or research activities
directly related to your Ohio University
responsibilities.
Any situation in which an actual conflict
exists is not permitted.
The only “exceptions” are those handled
under Ohio University Policy and Procedure
19.059 where faculty entrepreneurship is
addressed.
Participation in clinical trials or evaluation
of other research in which you have a
significant financial interest other than
royalty income.
In the context of your position at Ohio
University, you make professional referrals
to a business in which you have a
significant financial interest.
Letter of admonition
Ineligibility to submit grant applications
Withholding of IRB or IACUC approvals
Suspension
Non-Renewal
Loss of Tenure
Consulting
Procurement
Mentoring
Clinical Studies
Avoid consulting relationships that have
the potential to divert time and effort from
your responsibilities to Ohio University.
Do not use students.
Be wary of situations that limit publication.
Do not use university stationary, etc. that
could create an impression the university
is involved with the activities.
Make sure you are devoting sufficient time
to your university obligations.
Be cautious that the potential financial gain
cannot be perceived to influence your
university mentoring relationships.
Disclose any personal or familial financial
interest or equity in a company that is
doing business with Ohio University.
If you make purchases using public funds,
you should not use companies which will
benefit you or your family. If there is no
alternative you must seek and receive
permission prior to purchasing.
Any relationship in which there is a real or
perceived power or influence imbalance has
the potential for conflict. (Faculty:Student)
Isolating these relationships with respect to
areas of personal financial gain is best.
If they cannot be isolated, then safeguards
must be created.
If you have a financial interest, it is best to
isolate yourself from the study.
At a minimum, expect a more intense review
and a robust management plan if you have a
financial interest.
If both the institution and you have financial
interests the clinical study should be
conducted elsewhere.
You have administrative responsibilities on
behalf of Ohio University that is beneficial to
the business in which you have a significant
financial interest
You have administrative responsibilities on
behalf of Ohio University with respect to an
SRA where you have a significant financial
interest
Slide 41
Jo Ellen Sherow
Ohio University
Office of Research Compliance
Researchers’ Financial Disclosures in the
Spotlight
Conflicts of interest, always an emotional topic,
returned to the headlines this week as Sen.
Charles Grassley, a longtime critic of the drug
industry’s potential influence on research,
released new evidence that prominent Harvard
University scientists had failed to disclose much
of their outside income from pharmaceutical
companies over the past eight years.
http://www.insidehighered.com/news/2008/06/12/conflict January 15, 2008
WEDNESDAY, JANUARY 21, 2009
In a review of the literature regarding the relationship between
smokeless tobacco use and cancer, a conflict of interest of one of the
article's authors was initially not disclosed (see: Boffetta P, Hecht S, Gray
N, Gupta P, Straif K. Smokeless tobacco and cancer. Lancet Oncology
2008; 9:667-675). The original article was published in July, 2008. That
article stated: "The authors declare no conflicts of interest." After the
editor of the journal was notified by a researcher with knowledge of a
potential conflict of interest of Dr. Stephen Hecht (one of the study
authors), an erratum was published in September 2008, which noted:
"During the immediate months preceding submission of the review SH
was acting in the capacity of an expert witness for the plaintiff in a
future court case against a smokeless tobacco company. SH declares his
participation in this case in no way influenced his writing or involvement
in the review."
http://tobaccoanalysis.blogspot.com/2009/01/conflict-of-interestnot.html
January 16, 2009 — More than one third of new
drug marketing applications approved by the US
Food and Drug Administration (FDA) were
missing information about potential conflicts of
interest for clinical trial investigators, which
could allow bias to creep into the approvals
process, a government report released this week
has found. The FDA has said that it agrees with
most of the report's findings.
http://www.medscape.com/viewarticle/586980
Do collaborations between biotech companies
and academic centers constitute a conflict of
interest?
Biotechnology industry partnerships with
universities and academic centers have been
fruitful for both. So why is there so much
concern about conflict of interest and is that
concern appropriate?
http://www.redorbit.com/news/health/750100/genetic_engineering_news_p
osts_podcast_on_industrialacademic_collaborations_are_these/index.html
Universities are responsible for use of public
funds and therefore must maintain the public
trust.
Identifying and mitigating situations that may
have the potential for conflict maintains the
integrity of the university.
Maintaining integrity allows the university to
do credible academic research.
To provide information on the purpose of the
conflict of interest requirements.
To provide a basic overview of conflicts of
interest
To introduce the disclosure process and the use
of management plans
To provide information on the need for updates
and annual renewals.
Situations where financial considerations
compromise your professional judgment.
“Actual Conflict of Interest”
◦ Not permitted
Situations where an independent observer
might reasonably question whether your
professional actions or decisions are
determined by considerations of personal
gain. “Perceived Conflict of Interest”
◦ Managed
Potential conflicts may be financial or may be
a conflict of time, effort and/or commitment.
Potential conflicts can occur as a result of
administrative, scientific, academic, fiduciary
or familial situations.
They are situations that can be PERCEIVED to
be conflicting, whether a “real” conflict exists
or not.
Ohio University Policy has a mandatory
disclosure policy if you:
Earn over $10,000 in a twelve month period
from your outside activity OR
Have over 5% equity in the entity
Applies to members of your immediate family
(spouse, domestic partner, dependent
children) as well as yourself.
Anything of monetary value, including but not
limited to:
◦
◦
◦
◦
Salary
Payments for services
Equity interests over 5%
Intellectual property rights
Excludes mutual, pension and other
investments over which you have no control
Outside work during regular academic year
should not exceed equivalent of 1 day per
week.
Consulting work must avoid activities that
involve a conflict of interest with assigned
Ohio University activities and programs
Faculty Handbook, section IV-D
Outside interests cannot interfere with
primary loyalty to Ohio University and your
academic role
Use of university resources must have prior
approval of Chair, Dean and VPR.
Your outside interests should not be in
direct competition with university interests
Full time administrative employees are
expected to devote their full-time
professional loyalty, time and energy to their
position.
You must use non-work hours and no
university resources
Federal Agencies
State Law
University Policies
Many Academic Publications
45 CFR Part 50, Subpart F
“Responsibility of Applicants for Promoting
Objectivity in Research for Which PHS Funding
is Sought”
Authority: 42 U.S.C. 216, 289b-1, 299c-3.
Intent is to assure objectivity by establishing
standards that preclude bias in design, conduct, or
reporting of research
Focuses on financial conflicts of interest
(FCOI)
Regulations apply to investigators, including
sub grantees, contractors, and collaborating
investigators.
Does not apply to applications for support
under Phase I of SBIR and STTR programs
An institutional conflict of interest policy should
require that each investigator disclose to a
responsible representative of the institution all
significant financial interests of the investigator
(including those of the investigator’s spouse and
dependent children) (i) that would reasonably
appear to be affected by the research or
educational activities funded or proposed for
funding by NSF; or (ii) in entities whose financial
interests would reasonably appear to be affected
by such activities.
Chapter 1 (Subchapter A) (Part 54)
Financial Disclosure by Clinical Investigators
The Food and Drug Administration (FDA)
regulations state that investigators that
receive compensation in excess of $25,000
from a corporate sponsor of a trial in which
the investigator is engaged must disclose to
the FDA at the time of filing for a new drug
application.
19.058, Conflict of Interest in Research,
Educational, and Public Service Activities
19.059, Employee Participation in Authorized
Private Companies Commercializing Ohio
University Research
“Conflict of Interest in Research, Educational,
and Public Service Activities”
Most conflict disclosures fall within the
parameters of this policy
States that faculty are primarily responsible
for their academic, research and service
obligations
“Employee Participation in Authorized Private
Companies Commercializing Ohio University
Research”
Applies to “employees, faculty, staff and students,
who create intellectual property owned by the Ohio
University and who desire to hold an equity interest
in a firm, corporation, or other association to which
Ohio University has assigned, licensed or
transferred Ohio University’s interests…”
Consulting
Licensing University Technology
Clinical Studies
Procurement
Mentoring
Institutional
A disclosure is filed specific to the funding
application.
If you have a potential conflict for one
proposal, it does not automatically apply to
all of your proposals.
Research conflicts of interest are usually
disclosed using LEO as you apply for funding
by completing the conflict of interest section
of the electronic transmittal
If you are not using LEO, you can download
the appropriate disclosure form from
www.ohio.edu/research/compliance
“A” is selected if you have no conflicts to
disclose
“B” is selected if you have a potential conflict
to disclose relative to the submission.
(Requires a subsequent paper process)
“C” is selected if you have a current disclosure
on file, but it is not relevant to the proposal
you are submitting
Still uses option A, B or C
Requires that you gather signatures on paper
for all options, however
Generally used for personnel not listed on the
grant proposal or “key personnel”
We have revised the COI forms to word forms
This should be easier to complete than the
previous form
PDF versions are also available
Should be on the compliance web site soon,
but we can e-mail them to you until then
Use this form only if you are unable to use
the LEO transmittal form to assure that no
conflict of interest exists. A form must be
completed for each proposal.
I assure that I have read Ohio University
Policy 19.058, “Conflict of Interest in
Research, Educational, and Public Service
Activities” and declare that I have nothing
that is, or could be perceived to be a conflict
of interest with this proposal.
Use this form to disclose a potential conflict
of interest situation.
A separate disclosure form must be used for
each entity with which you conduct business
Conflict includes any member of your
immediate family (spouse, domestic partner
or children)
Require that you complete an option “B”
disclosure statement in addition to
completing the LEO transmittal form.
Require you to obtain signatures from Center
or Institute (if applicable), Chair and Dean on
the additional disclosure statement!!
The B disclosure form is available at
www.ohio.edu/research/compliance
Use this form only if you are unable to use
the LEO transmittal form. Complete this form
if you have a current conflict of interest
disclosure on file with the Office of Research
Compliance, but that disclosure is not
applicable to this proposal.
*New Option for 2008*
A management plan is developed for some
disclosures to mitigate the potential conflict
Management plans are specific to each
disclosure
May require submission of additional pieces,
such as a student employment plan
Reduce or remove the financial interest creating the
conflict
Place safeguards that mitigate the conflict potential,
such having some decisions made by an independent
entity
Limit participation in portions of the proposed
research likely to create a conflict
Require that the researcher disclose his or her
conflicting financial interests to all collaborators and
any proposed trainees;
Disclose the conflict in publications
Work to remove students from being directly advised
or taught by faculty where a conflict exists
Assure publication rights for student participants
Student Use
Nepotism and Cronyism
Intellectual Property
Use of University Resources
Publication provisions
Use of Human Subjects
Oversight Requirements
Reporting and Annual Reviews
You must submit an annual renewal for your
disclosure
◦ If the potential conflict no longer exists you must
notify us
If significant changes occur during the year
you should submit an update to your
disclosure as they occur
Yes. We encourage employees to disclose
potential conflicts that do not meet the
financial threshold, but may still be
problematic, such as student employment.
This allows you to be transparent with
respect to outside interests.
Allowable situations
Situations that require disclosure but may not
need an extensive management plan
Situations that require disclosure and have
problematic elements that will require
mitigation and/or a management plan
Situations that are not permitted
Receipt of royalties or honoraria for
published scholarly works, seminars,
teaching, etc.
Honoraria for serving as a special reviewer
or work on review panels
Royalties under our intellectual property
policies if no other relationship with entity
Clinical income at OUCOM
You participate in research developed in
whole or part by you, and you or your
family receive royalties from an existing
agreement with the business, but have
no other significant financial interest
You assign students, etc. to research
projects where you are entitled to
receive royalties, but have no other
significant financial interest
You assign students, etc. to projects supported
by the business through an SRA, and have a
significant financial interest other than royalty
income
You receive research support from a business in
which you serve on the board of directors, or
other advisory board, even if you are not
compensated.
You hold an executive position in a business
engaged in commercial or research activities
directly related to your Ohio University
responsibilities.
Any situation in which an actual conflict
exists is not permitted.
The only “exceptions” are those handled
under Ohio University Policy and Procedure
19.059 where faculty entrepreneurship is
addressed.
Participation in clinical trials or evaluation
of other research in which you have a
significant financial interest other than
royalty income.
In the context of your position at Ohio
University, you make professional referrals
to a business in which you have a
significant financial interest.
Letter of admonition
Ineligibility to submit grant applications
Withholding of IRB or IACUC approvals
Suspension
Non-Renewal
Loss of Tenure
Consulting
Procurement
Mentoring
Clinical Studies
Avoid consulting relationships that have
the potential to divert time and effort from
your responsibilities to Ohio University.
Do not use students.
Be wary of situations that limit publication.
Do not use university stationary, etc. that
could create an impression the university
is involved with the activities.
Make sure you are devoting sufficient time
to your university obligations.
Be cautious that the potential financial gain
cannot be perceived to influence your
university mentoring relationships.
Disclose any personal or familial financial
interest or equity in a company that is
doing business with Ohio University.
If you make purchases using public funds,
you should not use companies which will
benefit you or your family. If there is no
alternative you must seek and receive
permission prior to purchasing.
Any relationship in which there is a real or
perceived power or influence imbalance has
the potential for conflict. (Faculty:Student)
Isolating these relationships with respect to
areas of personal financial gain is best.
If they cannot be isolated, then safeguards
must be created.
If you have a financial interest, it is best to
isolate yourself from the study.
At a minimum, expect a more intense review
and a robust management plan if you have a
financial interest.
If both the institution and you have financial
interests the clinical study should be
conducted elsewhere.
You have administrative responsibilities on
behalf of Ohio University that is beneficial to
the business in which you have a significant
financial interest
You have administrative responsibilities on
behalf of Ohio University with respect to an
SRA where you have a significant financial
interest
Slide 42
Jo Ellen Sherow
Ohio University
Office of Research Compliance
Researchers’ Financial Disclosures in the
Spotlight
Conflicts of interest, always an emotional topic,
returned to the headlines this week as Sen.
Charles Grassley, a longtime critic of the drug
industry’s potential influence on research,
released new evidence that prominent Harvard
University scientists had failed to disclose much
of their outside income from pharmaceutical
companies over the past eight years.
http://www.insidehighered.com/news/2008/06/12/conflict January 15, 2008
WEDNESDAY, JANUARY 21, 2009
In a review of the literature regarding the relationship between
smokeless tobacco use and cancer, a conflict of interest of one of the
article's authors was initially not disclosed (see: Boffetta P, Hecht S, Gray
N, Gupta P, Straif K. Smokeless tobacco and cancer. Lancet Oncology
2008; 9:667-675). The original article was published in July, 2008. That
article stated: "The authors declare no conflicts of interest." After the
editor of the journal was notified by a researcher with knowledge of a
potential conflict of interest of Dr. Stephen Hecht (one of the study
authors), an erratum was published in September 2008, which noted:
"During the immediate months preceding submission of the review SH
was acting in the capacity of an expert witness for the plaintiff in a
future court case against a smokeless tobacco company. SH declares his
participation in this case in no way influenced his writing or involvement
in the review."
http://tobaccoanalysis.blogspot.com/2009/01/conflict-of-interestnot.html
January 16, 2009 — More than one third of new
drug marketing applications approved by the US
Food and Drug Administration (FDA) were
missing information about potential conflicts of
interest for clinical trial investigators, which
could allow bias to creep into the approvals
process, a government report released this week
has found. The FDA has said that it agrees with
most of the report's findings.
http://www.medscape.com/viewarticle/586980
Do collaborations between biotech companies
and academic centers constitute a conflict of
interest?
Biotechnology industry partnerships with
universities and academic centers have been
fruitful for both. So why is there so much
concern about conflict of interest and is that
concern appropriate?
http://www.redorbit.com/news/health/750100/genetic_engineering_news_p
osts_podcast_on_industrialacademic_collaborations_are_these/index.html
Universities are responsible for use of public
funds and therefore must maintain the public
trust.
Identifying and mitigating situations that may
have the potential for conflict maintains the
integrity of the university.
Maintaining integrity allows the university to
do credible academic research.
To provide information on the purpose of the
conflict of interest requirements.
To provide a basic overview of conflicts of
interest
To introduce the disclosure process and the use
of management plans
To provide information on the need for updates
and annual renewals.
Situations where financial considerations
compromise your professional judgment.
“Actual Conflict of Interest”
◦ Not permitted
Situations where an independent observer
might reasonably question whether your
professional actions or decisions are
determined by considerations of personal
gain. “Perceived Conflict of Interest”
◦ Managed
Potential conflicts may be financial or may be
a conflict of time, effort and/or commitment.
Potential conflicts can occur as a result of
administrative, scientific, academic, fiduciary
or familial situations.
They are situations that can be PERCEIVED to
be conflicting, whether a “real” conflict exists
or not.
Ohio University Policy has a mandatory
disclosure policy if you:
Earn over $10,000 in a twelve month period
from your outside activity OR
Have over 5% equity in the entity
Applies to members of your immediate family
(spouse, domestic partner, dependent
children) as well as yourself.
Anything of monetary value, including but not
limited to:
◦
◦
◦
◦
Salary
Payments for services
Equity interests over 5%
Intellectual property rights
Excludes mutual, pension and other
investments over which you have no control
Outside work during regular academic year
should not exceed equivalent of 1 day per
week.
Consulting work must avoid activities that
involve a conflict of interest with assigned
Ohio University activities and programs
Faculty Handbook, section IV-D
Outside interests cannot interfere with
primary loyalty to Ohio University and your
academic role
Use of university resources must have prior
approval of Chair, Dean and VPR.
Your outside interests should not be in
direct competition with university interests
Full time administrative employees are
expected to devote their full-time
professional loyalty, time and energy to their
position.
You must use non-work hours and no
university resources
Federal Agencies
State Law
University Policies
Many Academic Publications
45 CFR Part 50, Subpart F
“Responsibility of Applicants for Promoting
Objectivity in Research for Which PHS Funding
is Sought”
Authority: 42 U.S.C. 216, 289b-1, 299c-3.
Intent is to assure objectivity by establishing
standards that preclude bias in design, conduct, or
reporting of research
Focuses on financial conflicts of interest
(FCOI)
Regulations apply to investigators, including
sub grantees, contractors, and collaborating
investigators.
Does not apply to applications for support
under Phase I of SBIR and STTR programs
An institutional conflict of interest policy should
require that each investigator disclose to a
responsible representative of the institution all
significant financial interests of the investigator
(including those of the investigator’s spouse and
dependent children) (i) that would reasonably
appear to be affected by the research or
educational activities funded or proposed for
funding by NSF; or (ii) in entities whose financial
interests would reasonably appear to be affected
by such activities.
Chapter 1 (Subchapter A) (Part 54)
Financial Disclosure by Clinical Investigators
The Food and Drug Administration (FDA)
regulations state that investigators that
receive compensation in excess of $25,000
from a corporate sponsor of a trial in which
the investigator is engaged must disclose to
the FDA at the time of filing for a new drug
application.
19.058, Conflict of Interest in Research,
Educational, and Public Service Activities
19.059, Employee Participation in Authorized
Private Companies Commercializing Ohio
University Research
“Conflict of Interest in Research, Educational,
and Public Service Activities”
Most conflict disclosures fall within the
parameters of this policy
States that faculty are primarily responsible
for their academic, research and service
obligations
“Employee Participation in Authorized Private
Companies Commercializing Ohio University
Research”
Applies to “employees, faculty, staff and students,
who create intellectual property owned by the Ohio
University and who desire to hold an equity interest
in a firm, corporation, or other association to which
Ohio University has assigned, licensed or
transferred Ohio University’s interests…”
Consulting
Licensing University Technology
Clinical Studies
Procurement
Mentoring
Institutional
A disclosure is filed specific to the funding
application.
If you have a potential conflict for one
proposal, it does not automatically apply to
all of your proposals.
Research conflicts of interest are usually
disclosed using LEO as you apply for funding
by completing the conflict of interest section
of the electronic transmittal
If you are not using LEO, you can download
the appropriate disclosure form from
www.ohio.edu/research/compliance
“A” is selected if you have no conflicts to
disclose
“B” is selected if you have a potential conflict
to disclose relative to the submission.
(Requires a subsequent paper process)
“C” is selected if you have a current disclosure
on file, but it is not relevant to the proposal
you are submitting
Still uses option A, B or C
Requires that you gather signatures on paper
for all options, however
Generally used for personnel not listed on the
grant proposal or “key personnel”
We have revised the COI forms to word forms
This should be easier to complete than the
previous form
PDF versions are also available
Should be on the compliance web site soon,
but we can e-mail them to you until then
Use this form only if you are unable to use
the LEO transmittal form to assure that no
conflict of interest exists. A form must be
completed for each proposal.
I assure that I have read Ohio University
Policy 19.058, “Conflict of Interest in
Research, Educational, and Public Service
Activities” and declare that I have nothing
that is, or could be perceived to be a conflict
of interest with this proposal.
Use this form to disclose a potential conflict
of interest situation.
A separate disclosure form must be used for
each entity with which you conduct business
Conflict includes any member of your
immediate family (spouse, domestic partner
or children)
Require that you complete an option “B”
disclosure statement in addition to
completing the LEO transmittal form.
Require you to obtain signatures from Center
or Institute (if applicable), Chair and Dean on
the additional disclosure statement!!
The B disclosure form is available at
www.ohio.edu/research/compliance
Use this form only if you are unable to use
the LEO transmittal form. Complete this form
if you have a current conflict of interest
disclosure on file with the Office of Research
Compliance, but that disclosure is not
applicable to this proposal.
*New Option for 2008*
A management plan is developed for some
disclosures to mitigate the potential conflict
Management plans are specific to each
disclosure
May require submission of additional pieces,
such as a student employment plan
Reduce or remove the financial interest creating the
conflict
Place safeguards that mitigate the conflict potential,
such having some decisions made by an independent
entity
Limit participation in portions of the proposed
research likely to create a conflict
Require that the researcher disclose his or her
conflicting financial interests to all collaborators and
any proposed trainees;
Disclose the conflict in publications
Work to remove students from being directly advised
or taught by faculty where a conflict exists
Assure publication rights for student participants
Student Use
Nepotism and Cronyism
Intellectual Property
Use of University Resources
Publication provisions
Use of Human Subjects
Oversight Requirements
Reporting and Annual Reviews
You must submit an annual renewal for your
disclosure
◦ If the potential conflict no longer exists you must
notify us
If significant changes occur during the year
you should submit an update to your
disclosure as they occur
Yes. We encourage employees to disclose
potential conflicts that do not meet the
financial threshold, but may still be
problematic, such as student employment.
This allows you to be transparent with
respect to outside interests.
Allowable situations
Situations that require disclosure but may not
need an extensive management plan
Situations that require disclosure and have
problematic elements that will require
mitigation and/or a management plan
Situations that are not permitted
Receipt of royalties or honoraria for
published scholarly works, seminars,
teaching, etc.
Honoraria for serving as a special reviewer
or work on review panels
Royalties under our intellectual property
policies if no other relationship with entity
Clinical income at OUCOM
You participate in research developed in
whole or part by you, and you or your
family receive royalties from an existing
agreement with the business, but have
no other significant financial interest
You assign students, etc. to research
projects where you are entitled to
receive royalties, but have no other
significant financial interest
You assign students, etc. to projects supported
by the business through an SRA, and have a
significant financial interest other than royalty
income
You receive research support from a business in
which you serve on the board of directors, or
other advisory board, even if you are not
compensated.
You hold an executive position in a business
engaged in commercial or research activities
directly related to your Ohio University
responsibilities.
Any situation in which an actual conflict
exists is not permitted.
The only “exceptions” are those handled
under Ohio University Policy and Procedure
19.059 where faculty entrepreneurship is
addressed.
Participation in clinical trials or evaluation
of other research in which you have a
significant financial interest other than
royalty income.
In the context of your position at Ohio
University, you make professional referrals
to a business in which you have a
significant financial interest.
Letter of admonition
Ineligibility to submit grant applications
Withholding of IRB or IACUC approvals
Suspension
Non-Renewal
Loss of Tenure
Consulting
Procurement
Mentoring
Clinical Studies
Avoid consulting relationships that have
the potential to divert time and effort from
your responsibilities to Ohio University.
Do not use students.
Be wary of situations that limit publication.
Do not use university stationary, etc. that
could create an impression the university
is involved with the activities.
Make sure you are devoting sufficient time
to your university obligations.
Be cautious that the potential financial gain
cannot be perceived to influence your
university mentoring relationships.
Disclose any personal or familial financial
interest or equity in a company that is
doing business with Ohio University.
If you make purchases using public funds,
you should not use companies which will
benefit you or your family. If there is no
alternative you must seek and receive
permission prior to purchasing.
Any relationship in which there is a real or
perceived power or influence imbalance has
the potential for conflict. (Faculty:Student)
Isolating these relationships with respect to
areas of personal financial gain is best.
If they cannot be isolated, then safeguards
must be created.
If you have a financial interest, it is best to
isolate yourself from the study.
At a minimum, expect a more intense review
and a robust management plan if you have a
financial interest.
If both the institution and you have financial
interests the clinical study should be
conducted elsewhere.
You have administrative responsibilities on
behalf of Ohio University that is beneficial to
the business in which you have a significant
financial interest
You have administrative responsibilities on
behalf of Ohio University with respect to an
SRA where you have a significant financial
interest
Slide 43
Jo Ellen Sherow
Ohio University
Office of Research Compliance
Researchers’ Financial Disclosures in the
Spotlight
Conflicts of interest, always an emotional topic,
returned to the headlines this week as Sen.
Charles Grassley, a longtime critic of the drug
industry’s potential influence on research,
released new evidence that prominent Harvard
University scientists had failed to disclose much
of their outside income from pharmaceutical
companies over the past eight years.
http://www.insidehighered.com/news/2008/06/12/conflict January 15, 2008
WEDNESDAY, JANUARY 21, 2009
In a review of the literature regarding the relationship between
smokeless tobacco use and cancer, a conflict of interest of one of the
article's authors was initially not disclosed (see: Boffetta P, Hecht S, Gray
N, Gupta P, Straif K. Smokeless tobacco and cancer. Lancet Oncology
2008; 9:667-675). The original article was published in July, 2008. That
article stated: "The authors declare no conflicts of interest." After the
editor of the journal was notified by a researcher with knowledge of a
potential conflict of interest of Dr. Stephen Hecht (one of the study
authors), an erratum was published in September 2008, which noted:
"During the immediate months preceding submission of the review SH
was acting in the capacity of an expert witness for the plaintiff in a
future court case against a smokeless tobacco company. SH declares his
participation in this case in no way influenced his writing or involvement
in the review."
http://tobaccoanalysis.blogspot.com/2009/01/conflict-of-interestnot.html
January 16, 2009 — More than one third of new
drug marketing applications approved by the US
Food and Drug Administration (FDA) were
missing information about potential conflicts of
interest for clinical trial investigators, which
could allow bias to creep into the approvals
process, a government report released this week
has found. The FDA has said that it agrees with
most of the report's findings.
http://www.medscape.com/viewarticle/586980
Do collaborations between biotech companies
and academic centers constitute a conflict of
interest?
Biotechnology industry partnerships with
universities and academic centers have been
fruitful for both. So why is there so much
concern about conflict of interest and is that
concern appropriate?
http://www.redorbit.com/news/health/750100/genetic_engineering_news_p
osts_podcast_on_industrialacademic_collaborations_are_these/index.html
Universities are responsible for use of public
funds and therefore must maintain the public
trust.
Identifying and mitigating situations that may
have the potential for conflict maintains the
integrity of the university.
Maintaining integrity allows the university to
do credible academic research.
To provide information on the purpose of the
conflict of interest requirements.
To provide a basic overview of conflicts of
interest
To introduce the disclosure process and the use
of management plans
To provide information on the need for updates
and annual renewals.
Situations where financial considerations
compromise your professional judgment.
“Actual Conflict of Interest”
◦ Not permitted
Situations where an independent observer
might reasonably question whether your
professional actions or decisions are
determined by considerations of personal
gain. “Perceived Conflict of Interest”
◦ Managed
Potential conflicts may be financial or may be
a conflict of time, effort and/or commitment.
Potential conflicts can occur as a result of
administrative, scientific, academic, fiduciary
or familial situations.
They are situations that can be PERCEIVED to
be conflicting, whether a “real” conflict exists
or not.
Ohio University Policy has a mandatory
disclosure policy if you:
Earn over $10,000 in a twelve month period
from your outside activity OR
Have over 5% equity in the entity
Applies to members of your immediate family
(spouse, domestic partner, dependent
children) as well as yourself.
Anything of monetary value, including but not
limited to:
◦
◦
◦
◦
Salary
Payments for services
Equity interests over 5%
Intellectual property rights
Excludes mutual, pension and other
investments over which you have no control
Outside work during regular academic year
should not exceed equivalent of 1 day per
week.
Consulting work must avoid activities that
involve a conflict of interest with assigned
Ohio University activities and programs
Faculty Handbook, section IV-D
Outside interests cannot interfere with
primary loyalty to Ohio University and your
academic role
Use of university resources must have prior
approval of Chair, Dean and VPR.
Your outside interests should not be in
direct competition with university interests
Full time administrative employees are
expected to devote their full-time
professional loyalty, time and energy to their
position.
You must use non-work hours and no
university resources
Federal Agencies
State Law
University Policies
Many Academic Publications
45 CFR Part 50, Subpart F
“Responsibility of Applicants for Promoting
Objectivity in Research for Which PHS Funding
is Sought”
Authority: 42 U.S.C. 216, 289b-1, 299c-3.
Intent is to assure objectivity by establishing
standards that preclude bias in design, conduct, or
reporting of research
Focuses on financial conflicts of interest
(FCOI)
Regulations apply to investigators, including
sub grantees, contractors, and collaborating
investigators.
Does not apply to applications for support
under Phase I of SBIR and STTR programs
An institutional conflict of interest policy should
require that each investigator disclose to a
responsible representative of the institution all
significant financial interests of the investigator
(including those of the investigator’s spouse and
dependent children) (i) that would reasonably
appear to be affected by the research or
educational activities funded or proposed for
funding by NSF; or (ii) in entities whose financial
interests would reasonably appear to be affected
by such activities.
Chapter 1 (Subchapter A) (Part 54)
Financial Disclosure by Clinical Investigators
The Food and Drug Administration (FDA)
regulations state that investigators that
receive compensation in excess of $25,000
from a corporate sponsor of a trial in which
the investigator is engaged must disclose to
the FDA at the time of filing for a new drug
application.
19.058, Conflict of Interest in Research,
Educational, and Public Service Activities
19.059, Employee Participation in Authorized
Private Companies Commercializing Ohio
University Research
“Conflict of Interest in Research, Educational,
and Public Service Activities”
Most conflict disclosures fall within the
parameters of this policy
States that faculty are primarily responsible
for their academic, research and service
obligations
“Employee Participation in Authorized Private
Companies Commercializing Ohio University
Research”
Applies to “employees, faculty, staff and students,
who create intellectual property owned by the Ohio
University and who desire to hold an equity interest
in a firm, corporation, or other association to which
Ohio University has assigned, licensed or
transferred Ohio University’s interests…”
Consulting
Licensing University Technology
Clinical Studies
Procurement
Mentoring
Institutional
A disclosure is filed specific to the funding
application.
If you have a potential conflict for one
proposal, it does not automatically apply to
all of your proposals.
Research conflicts of interest are usually
disclosed using LEO as you apply for funding
by completing the conflict of interest section
of the electronic transmittal
If you are not using LEO, you can download
the appropriate disclosure form from
www.ohio.edu/research/compliance
“A” is selected if you have no conflicts to
disclose
“B” is selected if you have a potential conflict
to disclose relative to the submission.
(Requires a subsequent paper process)
“C” is selected if you have a current disclosure
on file, but it is not relevant to the proposal
you are submitting
Still uses option A, B or C
Requires that you gather signatures on paper
for all options, however
Generally used for personnel not listed on the
grant proposal or “key personnel”
We have revised the COI forms to word forms
This should be easier to complete than the
previous form
PDF versions are also available
Should be on the compliance web site soon,
but we can e-mail them to you until then
Use this form only if you are unable to use
the LEO transmittal form to assure that no
conflict of interest exists. A form must be
completed for each proposal.
I assure that I have read Ohio University
Policy 19.058, “Conflict of Interest in
Research, Educational, and Public Service
Activities” and declare that I have nothing
that is, or could be perceived to be a conflict
of interest with this proposal.
Use this form to disclose a potential conflict
of interest situation.
A separate disclosure form must be used for
each entity with which you conduct business
Conflict includes any member of your
immediate family (spouse, domestic partner
or children)
Require that you complete an option “B”
disclosure statement in addition to
completing the LEO transmittal form.
Require you to obtain signatures from Center
or Institute (if applicable), Chair and Dean on
the additional disclosure statement!!
The B disclosure form is available at
www.ohio.edu/research/compliance
Use this form only if you are unable to use
the LEO transmittal form. Complete this form
if you have a current conflict of interest
disclosure on file with the Office of Research
Compliance, but that disclosure is not
applicable to this proposal.
*New Option for 2008*
A management plan is developed for some
disclosures to mitigate the potential conflict
Management plans are specific to each
disclosure
May require submission of additional pieces,
such as a student employment plan
Reduce or remove the financial interest creating the
conflict
Place safeguards that mitigate the conflict potential,
such having some decisions made by an independent
entity
Limit participation in portions of the proposed
research likely to create a conflict
Require that the researcher disclose his or her
conflicting financial interests to all collaborators and
any proposed trainees;
Disclose the conflict in publications
Work to remove students from being directly advised
or taught by faculty where a conflict exists
Assure publication rights for student participants
Student Use
Nepotism and Cronyism
Intellectual Property
Use of University Resources
Publication provisions
Use of Human Subjects
Oversight Requirements
Reporting and Annual Reviews
You must submit an annual renewal for your
disclosure
◦ If the potential conflict no longer exists you must
notify us
If significant changes occur during the year
you should submit an update to your
disclosure as they occur
Yes. We encourage employees to disclose
potential conflicts that do not meet the
financial threshold, but may still be
problematic, such as student employment.
This allows you to be transparent with
respect to outside interests.
Allowable situations
Situations that require disclosure but may not
need an extensive management plan
Situations that require disclosure and have
problematic elements that will require
mitigation and/or a management plan
Situations that are not permitted
Receipt of royalties or honoraria for
published scholarly works, seminars,
teaching, etc.
Honoraria for serving as a special reviewer
or work on review panels
Royalties under our intellectual property
policies if no other relationship with entity
Clinical income at OUCOM
You participate in research developed in
whole or part by you, and you or your
family receive royalties from an existing
agreement with the business, but have
no other significant financial interest
You assign students, etc. to research
projects where you are entitled to
receive royalties, but have no other
significant financial interest
You assign students, etc. to projects supported
by the business through an SRA, and have a
significant financial interest other than royalty
income
You receive research support from a business in
which you serve on the board of directors, or
other advisory board, even if you are not
compensated.
You hold an executive position in a business
engaged in commercial or research activities
directly related to your Ohio University
responsibilities.
Any situation in which an actual conflict
exists is not permitted.
The only “exceptions” are those handled
under Ohio University Policy and Procedure
19.059 where faculty entrepreneurship is
addressed.
Participation in clinical trials or evaluation
of other research in which you have a
significant financial interest other than
royalty income.
In the context of your position at Ohio
University, you make professional referrals
to a business in which you have a
significant financial interest.
Letter of admonition
Ineligibility to submit grant applications
Withholding of IRB or IACUC approvals
Suspension
Non-Renewal
Loss of Tenure
Consulting
Procurement
Mentoring
Clinical Studies
Avoid consulting relationships that have
the potential to divert time and effort from
your responsibilities to Ohio University.
Do not use students.
Be wary of situations that limit publication.
Do not use university stationary, etc. that
could create an impression the university
is involved with the activities.
Make sure you are devoting sufficient time
to your university obligations.
Be cautious that the potential financial gain
cannot be perceived to influence your
university mentoring relationships.
Disclose any personal or familial financial
interest or equity in a company that is
doing business with Ohio University.
If you make purchases using public funds,
you should not use companies which will
benefit you or your family. If there is no
alternative you must seek and receive
permission prior to purchasing.
Any relationship in which there is a real or
perceived power or influence imbalance has
the potential for conflict. (Faculty:Student)
Isolating these relationships with respect to
areas of personal financial gain is best.
If they cannot be isolated, then safeguards
must be created.
If you have a financial interest, it is best to
isolate yourself from the study.
At a minimum, expect a more intense review
and a robust management plan if you have a
financial interest.
If both the institution and you have financial
interests the clinical study should be
conducted elsewhere.
You have administrative responsibilities on
behalf of Ohio University that is beneficial to
the business in which you have a significant
financial interest
You have administrative responsibilities on
behalf of Ohio University with respect to an
SRA where you have a significant financial
interest
Slide 44
Jo Ellen Sherow
Ohio University
Office of Research Compliance
Researchers’ Financial Disclosures in the
Spotlight
Conflicts of interest, always an emotional topic,
returned to the headlines this week as Sen.
Charles Grassley, a longtime critic of the drug
industry’s potential influence on research,
released new evidence that prominent Harvard
University scientists had failed to disclose much
of their outside income from pharmaceutical
companies over the past eight years.
http://www.insidehighered.com/news/2008/06/12/conflict January 15, 2008
WEDNESDAY, JANUARY 21, 2009
In a review of the literature regarding the relationship between
smokeless tobacco use and cancer, a conflict of interest of one of the
article's authors was initially not disclosed (see: Boffetta P, Hecht S, Gray
N, Gupta P, Straif K. Smokeless tobacco and cancer. Lancet Oncology
2008; 9:667-675). The original article was published in July, 2008. That
article stated: "The authors declare no conflicts of interest." After the
editor of the journal was notified by a researcher with knowledge of a
potential conflict of interest of Dr. Stephen Hecht (one of the study
authors), an erratum was published in September 2008, which noted:
"During the immediate months preceding submission of the review SH
was acting in the capacity of an expert witness for the plaintiff in a
future court case against a smokeless tobacco company. SH declares his
participation in this case in no way influenced his writing or involvement
in the review."
http://tobaccoanalysis.blogspot.com/2009/01/conflict-of-interestnot.html
January 16, 2009 — More than one third of new
drug marketing applications approved by the US
Food and Drug Administration (FDA) were
missing information about potential conflicts of
interest for clinical trial investigators, which
could allow bias to creep into the approvals
process, a government report released this week
has found. The FDA has said that it agrees with
most of the report's findings.
http://www.medscape.com/viewarticle/586980
Do collaborations between biotech companies
and academic centers constitute a conflict of
interest?
Biotechnology industry partnerships with
universities and academic centers have been
fruitful for both. So why is there so much
concern about conflict of interest and is that
concern appropriate?
http://www.redorbit.com/news/health/750100/genetic_engineering_news_p
osts_podcast_on_industrialacademic_collaborations_are_these/index.html
Universities are responsible for use of public
funds and therefore must maintain the public
trust.
Identifying and mitigating situations that may
have the potential for conflict maintains the
integrity of the university.
Maintaining integrity allows the university to
do credible academic research.
To provide information on the purpose of the
conflict of interest requirements.
To provide a basic overview of conflicts of
interest
To introduce the disclosure process and the use
of management plans
To provide information on the need for updates
and annual renewals.
Situations where financial considerations
compromise your professional judgment.
“Actual Conflict of Interest”
◦ Not permitted
Situations where an independent observer
might reasonably question whether your
professional actions or decisions are
determined by considerations of personal
gain. “Perceived Conflict of Interest”
◦ Managed
Potential conflicts may be financial or may be
a conflict of time, effort and/or commitment.
Potential conflicts can occur as a result of
administrative, scientific, academic, fiduciary
or familial situations.
They are situations that can be PERCEIVED to
be conflicting, whether a “real” conflict exists
or not.
Ohio University Policy has a mandatory
disclosure policy if you:
Earn over $10,000 in a twelve month period
from your outside activity OR
Have over 5% equity in the entity
Applies to members of your immediate family
(spouse, domestic partner, dependent
children) as well as yourself.
Anything of monetary value, including but not
limited to:
◦
◦
◦
◦
Salary
Payments for services
Equity interests over 5%
Intellectual property rights
Excludes mutual, pension and other
investments over which you have no control
Outside work during regular academic year
should not exceed equivalent of 1 day per
week.
Consulting work must avoid activities that
involve a conflict of interest with assigned
Ohio University activities and programs
Faculty Handbook, section IV-D
Outside interests cannot interfere with
primary loyalty to Ohio University and your
academic role
Use of university resources must have prior
approval of Chair, Dean and VPR.
Your outside interests should not be in
direct competition with university interests
Full time administrative employees are
expected to devote their full-time
professional loyalty, time and energy to their
position.
You must use non-work hours and no
university resources
Federal Agencies
State Law
University Policies
Many Academic Publications
45 CFR Part 50, Subpart F
“Responsibility of Applicants for Promoting
Objectivity in Research for Which PHS Funding
is Sought”
Authority: 42 U.S.C. 216, 289b-1, 299c-3.
Intent is to assure objectivity by establishing
standards that preclude bias in design, conduct, or
reporting of research
Focuses on financial conflicts of interest
(FCOI)
Regulations apply to investigators, including
sub grantees, contractors, and collaborating
investigators.
Does not apply to applications for support
under Phase I of SBIR and STTR programs
An institutional conflict of interest policy should
require that each investigator disclose to a
responsible representative of the institution all
significant financial interests of the investigator
(including those of the investigator’s spouse and
dependent children) (i) that would reasonably
appear to be affected by the research or
educational activities funded or proposed for
funding by NSF; or (ii) in entities whose financial
interests would reasonably appear to be affected
by such activities.
Chapter 1 (Subchapter A) (Part 54)
Financial Disclosure by Clinical Investigators
The Food and Drug Administration (FDA)
regulations state that investigators that
receive compensation in excess of $25,000
from a corporate sponsor of a trial in which
the investigator is engaged must disclose to
the FDA at the time of filing for a new drug
application.
19.058, Conflict of Interest in Research,
Educational, and Public Service Activities
19.059, Employee Participation in Authorized
Private Companies Commercializing Ohio
University Research
“Conflict of Interest in Research, Educational,
and Public Service Activities”
Most conflict disclosures fall within the
parameters of this policy
States that faculty are primarily responsible
for their academic, research and service
obligations
“Employee Participation in Authorized Private
Companies Commercializing Ohio University
Research”
Applies to “employees, faculty, staff and students,
who create intellectual property owned by the Ohio
University and who desire to hold an equity interest
in a firm, corporation, or other association to which
Ohio University has assigned, licensed or
transferred Ohio University’s interests…”
Consulting
Licensing University Technology
Clinical Studies
Procurement
Mentoring
Institutional
A disclosure is filed specific to the funding
application.
If you have a potential conflict for one
proposal, it does not automatically apply to
all of your proposals.
Research conflicts of interest are usually
disclosed using LEO as you apply for funding
by completing the conflict of interest section
of the electronic transmittal
If you are not using LEO, you can download
the appropriate disclosure form from
www.ohio.edu/research/compliance
“A” is selected if you have no conflicts to
disclose
“B” is selected if you have a potential conflict
to disclose relative to the submission.
(Requires a subsequent paper process)
“C” is selected if you have a current disclosure
on file, but it is not relevant to the proposal
you are submitting
Still uses option A, B or C
Requires that you gather signatures on paper
for all options, however
Generally used for personnel not listed on the
grant proposal or “key personnel”
We have revised the COI forms to word forms
This should be easier to complete than the
previous form
PDF versions are also available
Should be on the compliance web site soon,
but we can e-mail them to you until then
Use this form only if you are unable to use
the LEO transmittal form to assure that no
conflict of interest exists. A form must be
completed for each proposal.
I assure that I have read Ohio University
Policy 19.058, “Conflict of Interest in
Research, Educational, and Public Service
Activities” and declare that I have nothing
that is, or could be perceived to be a conflict
of interest with this proposal.
Use this form to disclose a potential conflict
of interest situation.
A separate disclosure form must be used for
each entity with which you conduct business
Conflict includes any member of your
immediate family (spouse, domestic partner
or children)
Require that you complete an option “B”
disclosure statement in addition to
completing the LEO transmittal form.
Require you to obtain signatures from Center
or Institute (if applicable), Chair and Dean on
the additional disclosure statement!!
The B disclosure form is available at
www.ohio.edu/research/compliance
Use this form only if you are unable to use
the LEO transmittal form. Complete this form
if you have a current conflict of interest
disclosure on file with the Office of Research
Compliance, but that disclosure is not
applicable to this proposal.
*New Option for 2008*
A management plan is developed for some
disclosures to mitigate the potential conflict
Management plans are specific to each
disclosure
May require submission of additional pieces,
such as a student employment plan
Reduce or remove the financial interest creating the
conflict
Place safeguards that mitigate the conflict potential,
such having some decisions made by an independent
entity
Limit participation in portions of the proposed
research likely to create a conflict
Require that the researcher disclose his or her
conflicting financial interests to all collaborators and
any proposed trainees;
Disclose the conflict in publications
Work to remove students from being directly advised
or taught by faculty where a conflict exists
Assure publication rights for student participants
Student Use
Nepotism and Cronyism
Intellectual Property
Use of University Resources
Publication provisions
Use of Human Subjects
Oversight Requirements
Reporting and Annual Reviews
You must submit an annual renewal for your
disclosure
◦ If the potential conflict no longer exists you must
notify us
If significant changes occur during the year
you should submit an update to your
disclosure as they occur
Yes. We encourage employees to disclose
potential conflicts that do not meet the
financial threshold, but may still be
problematic, such as student employment.
This allows you to be transparent with
respect to outside interests.
Allowable situations
Situations that require disclosure but may not
need an extensive management plan
Situations that require disclosure and have
problematic elements that will require
mitigation and/or a management plan
Situations that are not permitted
Receipt of royalties or honoraria for
published scholarly works, seminars,
teaching, etc.
Honoraria for serving as a special reviewer
or work on review panels
Royalties under our intellectual property
policies if no other relationship with entity
Clinical income at OUCOM
You participate in research developed in
whole or part by you, and you or your
family receive royalties from an existing
agreement with the business, but have
no other significant financial interest
You assign students, etc. to research
projects where you are entitled to
receive royalties, but have no other
significant financial interest
You assign students, etc. to projects supported
by the business through an SRA, and have a
significant financial interest other than royalty
income
You receive research support from a business in
which you serve on the board of directors, or
other advisory board, even if you are not
compensated.
You hold an executive position in a business
engaged in commercial or research activities
directly related to your Ohio University
responsibilities.
Any situation in which an actual conflict
exists is not permitted.
The only “exceptions” are those handled
under Ohio University Policy and Procedure
19.059 where faculty entrepreneurship is
addressed.
Participation in clinical trials or evaluation
of other research in which you have a
significant financial interest other than
royalty income.
In the context of your position at Ohio
University, you make professional referrals
to a business in which you have a
significant financial interest.
Letter of admonition
Ineligibility to submit grant applications
Withholding of IRB or IACUC approvals
Suspension
Non-Renewal
Loss of Tenure
Consulting
Procurement
Mentoring
Clinical Studies
Avoid consulting relationships that have
the potential to divert time and effort from
your responsibilities to Ohio University.
Do not use students.
Be wary of situations that limit publication.
Do not use university stationary, etc. that
could create an impression the university
is involved with the activities.
Make sure you are devoting sufficient time
to your university obligations.
Be cautious that the potential financial gain
cannot be perceived to influence your
university mentoring relationships.
Disclose any personal or familial financial
interest or equity in a company that is
doing business with Ohio University.
If you make purchases using public funds,
you should not use companies which will
benefit you or your family. If there is no
alternative you must seek and receive
permission prior to purchasing.
Any relationship in which there is a real or
perceived power or influence imbalance has
the potential for conflict. (Faculty:Student)
Isolating these relationships with respect to
areas of personal financial gain is best.
If they cannot be isolated, then safeguards
must be created.
If you have a financial interest, it is best to
isolate yourself from the study.
At a minimum, expect a more intense review
and a robust management plan if you have a
financial interest.
If both the institution and you have financial
interests the clinical study should be
conducted elsewhere.
You have administrative responsibilities on
behalf of Ohio University that is beneficial to
the business in which you have a significant
financial interest
You have administrative responsibilities on
behalf of Ohio University with respect to an
SRA where you have a significant financial
interest
Slide 45
Jo Ellen Sherow
Ohio University
Office of Research Compliance
Researchers’ Financial Disclosures in the
Spotlight
Conflicts of interest, always an emotional topic,
returned to the headlines this week as Sen.
Charles Grassley, a longtime critic of the drug
industry’s potential influence on research,
released new evidence that prominent Harvard
University scientists had failed to disclose much
of their outside income from pharmaceutical
companies over the past eight years.
http://www.insidehighered.com/news/2008/06/12/conflict January 15, 2008
WEDNESDAY, JANUARY 21, 2009
In a review of the literature regarding the relationship between
smokeless tobacco use and cancer, a conflict of interest of one of the
article's authors was initially not disclosed (see: Boffetta P, Hecht S, Gray
N, Gupta P, Straif K. Smokeless tobacco and cancer. Lancet Oncology
2008; 9:667-675). The original article was published in July, 2008. That
article stated: "The authors declare no conflicts of interest." After the
editor of the journal was notified by a researcher with knowledge of a
potential conflict of interest of Dr. Stephen Hecht (one of the study
authors), an erratum was published in September 2008, which noted:
"During the immediate months preceding submission of the review SH
was acting in the capacity of an expert witness for the plaintiff in a
future court case against a smokeless tobacco company. SH declares his
participation in this case in no way influenced his writing or involvement
in the review."
http://tobaccoanalysis.blogspot.com/2009/01/conflict-of-interestnot.html
January 16, 2009 — More than one third of new
drug marketing applications approved by the US
Food and Drug Administration (FDA) were
missing information about potential conflicts of
interest for clinical trial investigators, which
could allow bias to creep into the approvals
process, a government report released this week
has found. The FDA has said that it agrees with
most of the report's findings.
http://www.medscape.com/viewarticle/586980
Do collaborations between biotech companies
and academic centers constitute a conflict of
interest?
Biotechnology industry partnerships with
universities and academic centers have been
fruitful for both. So why is there so much
concern about conflict of interest and is that
concern appropriate?
http://www.redorbit.com/news/health/750100/genetic_engineering_news_p
osts_podcast_on_industrialacademic_collaborations_are_these/index.html
Universities are responsible for use of public
funds and therefore must maintain the public
trust.
Identifying and mitigating situations that may
have the potential for conflict maintains the
integrity of the university.
Maintaining integrity allows the university to
do credible academic research.
To provide information on the purpose of the
conflict of interest requirements.
To provide a basic overview of conflicts of
interest
To introduce the disclosure process and the use
of management plans
To provide information on the need for updates
and annual renewals.
Situations where financial considerations
compromise your professional judgment.
“Actual Conflict of Interest”
◦ Not permitted
Situations where an independent observer
might reasonably question whether your
professional actions or decisions are
determined by considerations of personal
gain. “Perceived Conflict of Interest”
◦ Managed
Potential conflicts may be financial or may be
a conflict of time, effort and/or commitment.
Potential conflicts can occur as a result of
administrative, scientific, academic, fiduciary
or familial situations.
They are situations that can be PERCEIVED to
be conflicting, whether a “real” conflict exists
or not.
Ohio University Policy has a mandatory
disclosure policy if you:
Earn over $10,000 in a twelve month period
from your outside activity OR
Have over 5% equity in the entity
Applies to members of your immediate family
(spouse, domestic partner, dependent
children) as well as yourself.
Anything of monetary value, including but not
limited to:
◦
◦
◦
◦
Salary
Payments for services
Equity interests over 5%
Intellectual property rights
Excludes mutual, pension and other
investments over which you have no control
Outside work during regular academic year
should not exceed equivalent of 1 day per
week.
Consulting work must avoid activities that
involve a conflict of interest with assigned
Ohio University activities and programs
Faculty Handbook, section IV-D
Outside interests cannot interfere with
primary loyalty to Ohio University and your
academic role
Use of university resources must have prior
approval of Chair, Dean and VPR.
Your outside interests should not be in
direct competition with university interests
Full time administrative employees are
expected to devote their full-time
professional loyalty, time and energy to their
position.
You must use non-work hours and no
university resources
Federal Agencies
State Law
University Policies
Many Academic Publications
45 CFR Part 50, Subpart F
“Responsibility of Applicants for Promoting
Objectivity in Research for Which PHS Funding
is Sought”
Authority: 42 U.S.C. 216, 289b-1, 299c-3.
Intent is to assure objectivity by establishing
standards that preclude bias in design, conduct, or
reporting of research
Focuses on financial conflicts of interest
(FCOI)
Regulations apply to investigators, including
sub grantees, contractors, and collaborating
investigators.
Does not apply to applications for support
under Phase I of SBIR and STTR programs
An institutional conflict of interest policy should
require that each investigator disclose to a
responsible representative of the institution all
significant financial interests of the investigator
(including those of the investigator’s spouse and
dependent children) (i) that would reasonably
appear to be affected by the research or
educational activities funded or proposed for
funding by NSF; or (ii) in entities whose financial
interests would reasonably appear to be affected
by such activities.
Chapter 1 (Subchapter A) (Part 54)
Financial Disclosure by Clinical Investigators
The Food and Drug Administration (FDA)
regulations state that investigators that
receive compensation in excess of $25,000
from a corporate sponsor of a trial in which
the investigator is engaged must disclose to
the FDA at the time of filing for a new drug
application.
19.058, Conflict of Interest in Research,
Educational, and Public Service Activities
19.059, Employee Participation in Authorized
Private Companies Commercializing Ohio
University Research
“Conflict of Interest in Research, Educational,
and Public Service Activities”
Most conflict disclosures fall within the
parameters of this policy
States that faculty are primarily responsible
for their academic, research and service
obligations
“Employee Participation in Authorized Private
Companies Commercializing Ohio University
Research”
Applies to “employees, faculty, staff and students,
who create intellectual property owned by the Ohio
University and who desire to hold an equity interest
in a firm, corporation, or other association to which
Ohio University has assigned, licensed or
transferred Ohio University’s interests…”
Consulting
Licensing University Technology
Clinical Studies
Procurement
Mentoring
Institutional
A disclosure is filed specific to the funding
application.
If you have a potential conflict for one
proposal, it does not automatically apply to
all of your proposals.
Research conflicts of interest are usually
disclosed using LEO as you apply for funding
by completing the conflict of interest section
of the electronic transmittal
If you are not using LEO, you can download
the appropriate disclosure form from
www.ohio.edu/research/compliance
“A” is selected if you have no conflicts to
disclose
“B” is selected if you have a potential conflict
to disclose relative to the submission.
(Requires a subsequent paper process)
“C” is selected if you have a current disclosure
on file, but it is not relevant to the proposal
you are submitting
Still uses option A, B or C
Requires that you gather signatures on paper
for all options, however
Generally used for personnel not listed on the
grant proposal or “key personnel”
We have revised the COI forms to word forms
This should be easier to complete than the
previous form
PDF versions are also available
Should be on the compliance web site soon,
but we can e-mail them to you until then
Use this form only if you are unable to use
the LEO transmittal form to assure that no
conflict of interest exists. A form must be
completed for each proposal.
I assure that I have read Ohio University
Policy 19.058, “Conflict of Interest in
Research, Educational, and Public Service
Activities” and declare that I have nothing
that is, or could be perceived to be a conflict
of interest with this proposal.
Use this form to disclose a potential conflict
of interest situation.
A separate disclosure form must be used for
each entity with which you conduct business
Conflict includes any member of your
immediate family (spouse, domestic partner
or children)
Require that you complete an option “B”
disclosure statement in addition to
completing the LEO transmittal form.
Require you to obtain signatures from Center
or Institute (if applicable), Chair and Dean on
the additional disclosure statement!!
The B disclosure form is available at
www.ohio.edu/research/compliance
Use this form only if you are unable to use
the LEO transmittal form. Complete this form
if you have a current conflict of interest
disclosure on file with the Office of Research
Compliance, but that disclosure is not
applicable to this proposal.
*New Option for 2008*
A management plan is developed for some
disclosures to mitigate the potential conflict
Management plans are specific to each
disclosure
May require submission of additional pieces,
such as a student employment plan
Reduce or remove the financial interest creating the
conflict
Place safeguards that mitigate the conflict potential,
such having some decisions made by an independent
entity
Limit participation in portions of the proposed
research likely to create a conflict
Require that the researcher disclose his or her
conflicting financial interests to all collaborators and
any proposed trainees;
Disclose the conflict in publications
Work to remove students from being directly advised
or taught by faculty where a conflict exists
Assure publication rights for student participants
Student Use
Nepotism and Cronyism
Intellectual Property
Use of University Resources
Publication provisions
Use of Human Subjects
Oversight Requirements
Reporting and Annual Reviews
You must submit an annual renewal for your
disclosure
◦ If the potential conflict no longer exists you must
notify us
If significant changes occur during the year
you should submit an update to your
disclosure as they occur
Yes. We encourage employees to disclose
potential conflicts that do not meet the
financial threshold, but may still be
problematic, such as student employment.
This allows you to be transparent with
respect to outside interests.
Allowable situations
Situations that require disclosure but may not
need an extensive management plan
Situations that require disclosure and have
problematic elements that will require
mitigation and/or a management plan
Situations that are not permitted
Receipt of royalties or honoraria for
published scholarly works, seminars,
teaching, etc.
Honoraria for serving as a special reviewer
or work on review panels
Royalties under our intellectual property
policies if no other relationship with entity
Clinical income at OUCOM
You participate in research developed in
whole or part by you, and you or your
family receive royalties from an existing
agreement with the business, but have
no other significant financial interest
You assign students, etc. to research
projects where you are entitled to
receive royalties, but have no other
significant financial interest
You assign students, etc. to projects supported
by the business through an SRA, and have a
significant financial interest other than royalty
income
You receive research support from a business in
which you serve on the board of directors, or
other advisory board, even if you are not
compensated.
You hold an executive position in a business
engaged in commercial or research activities
directly related to your Ohio University
responsibilities.
Any situation in which an actual conflict
exists is not permitted.
The only “exceptions” are those handled
under Ohio University Policy and Procedure
19.059 where faculty entrepreneurship is
addressed.
Participation in clinical trials or evaluation
of other research in which you have a
significant financial interest other than
royalty income.
In the context of your position at Ohio
University, you make professional referrals
to a business in which you have a
significant financial interest.
Letter of admonition
Ineligibility to submit grant applications
Withholding of IRB or IACUC approvals
Suspension
Non-Renewal
Loss of Tenure
Consulting
Procurement
Mentoring
Clinical Studies
Avoid consulting relationships that have
the potential to divert time and effort from
your responsibilities to Ohio University.
Do not use students.
Be wary of situations that limit publication.
Do not use university stationary, etc. that
could create an impression the university
is involved with the activities.
Make sure you are devoting sufficient time
to your university obligations.
Be cautious that the potential financial gain
cannot be perceived to influence your
university mentoring relationships.
Disclose any personal or familial financial
interest or equity in a company that is
doing business with Ohio University.
If you make purchases using public funds,
you should not use companies which will
benefit you or your family. If there is no
alternative you must seek and receive
permission prior to purchasing.
Any relationship in which there is a real or
perceived power or influence imbalance has
the potential for conflict. (Faculty:Student)
Isolating these relationships with respect to
areas of personal financial gain is best.
If they cannot be isolated, then safeguards
must be created.
If you have a financial interest, it is best to
isolate yourself from the study.
At a minimum, expect a more intense review
and a robust management plan if you have a
financial interest.
If both the institution and you have financial
interests the clinical study should be
conducted elsewhere.
You have administrative responsibilities on
behalf of Ohio University that is beneficial to
the business in which you have a significant
financial interest
You have administrative responsibilities on
behalf of Ohio University with respect to an
SRA where you have a significant financial
interest
Slide 46
Jo Ellen Sherow
Ohio University
Office of Research Compliance
Researchers’ Financial Disclosures in the
Spotlight
Conflicts of interest, always an emotional topic,
returned to the headlines this week as Sen.
Charles Grassley, a longtime critic of the drug
industry’s potential influence on research,
released new evidence that prominent Harvard
University scientists had failed to disclose much
of their outside income from pharmaceutical
companies over the past eight years.
http://www.insidehighered.com/news/2008/06/12/conflict January 15, 2008
WEDNESDAY, JANUARY 21, 2009
In a review of the literature regarding the relationship between
smokeless tobacco use and cancer, a conflict of interest of one of the
article's authors was initially not disclosed (see: Boffetta P, Hecht S, Gray
N, Gupta P, Straif K. Smokeless tobacco and cancer. Lancet Oncology
2008; 9:667-675). The original article was published in July, 2008. That
article stated: "The authors declare no conflicts of interest." After the
editor of the journal was notified by a researcher with knowledge of a
potential conflict of interest of Dr. Stephen Hecht (one of the study
authors), an erratum was published in September 2008, which noted:
"During the immediate months preceding submission of the review SH
was acting in the capacity of an expert witness for the plaintiff in a
future court case against a smokeless tobacco company. SH declares his
participation in this case in no way influenced his writing or involvement
in the review."
http://tobaccoanalysis.blogspot.com/2009/01/conflict-of-interestnot.html
January 16, 2009 — More than one third of new
drug marketing applications approved by the US
Food and Drug Administration (FDA) were
missing information about potential conflicts of
interest for clinical trial investigators, which
could allow bias to creep into the approvals
process, a government report released this week
has found. The FDA has said that it agrees with
most of the report's findings.
http://www.medscape.com/viewarticle/586980
Do collaborations between biotech companies
and academic centers constitute a conflict of
interest?
Biotechnology industry partnerships with
universities and academic centers have been
fruitful for both. So why is there so much
concern about conflict of interest and is that
concern appropriate?
http://www.redorbit.com/news/health/750100/genetic_engineering_news_p
osts_podcast_on_industrialacademic_collaborations_are_these/index.html
Universities are responsible for use of public
funds and therefore must maintain the public
trust.
Identifying and mitigating situations that may
have the potential for conflict maintains the
integrity of the university.
Maintaining integrity allows the university to
do credible academic research.
To provide information on the purpose of the
conflict of interest requirements.
To provide a basic overview of conflicts of
interest
To introduce the disclosure process and the use
of management plans
To provide information on the need for updates
and annual renewals.
Situations where financial considerations
compromise your professional judgment.
“Actual Conflict of Interest”
◦ Not permitted
Situations where an independent observer
might reasonably question whether your
professional actions or decisions are
determined by considerations of personal
gain. “Perceived Conflict of Interest”
◦ Managed
Potential conflicts may be financial or may be
a conflict of time, effort and/or commitment.
Potential conflicts can occur as a result of
administrative, scientific, academic, fiduciary
or familial situations.
They are situations that can be PERCEIVED to
be conflicting, whether a “real” conflict exists
or not.
Ohio University Policy has a mandatory
disclosure policy if you:
Earn over $10,000 in a twelve month period
from your outside activity OR
Have over 5% equity in the entity
Applies to members of your immediate family
(spouse, domestic partner, dependent
children) as well as yourself.
Anything of monetary value, including but not
limited to:
◦
◦
◦
◦
Salary
Payments for services
Equity interests over 5%
Intellectual property rights
Excludes mutual, pension and other
investments over which you have no control
Outside work during regular academic year
should not exceed equivalent of 1 day per
week.
Consulting work must avoid activities that
involve a conflict of interest with assigned
Ohio University activities and programs
Faculty Handbook, section IV-D
Outside interests cannot interfere with
primary loyalty to Ohio University and your
academic role
Use of university resources must have prior
approval of Chair, Dean and VPR.
Your outside interests should not be in
direct competition with university interests
Full time administrative employees are
expected to devote their full-time
professional loyalty, time and energy to their
position.
You must use non-work hours and no
university resources
Federal Agencies
State Law
University Policies
Many Academic Publications
45 CFR Part 50, Subpart F
“Responsibility of Applicants for Promoting
Objectivity in Research for Which PHS Funding
is Sought”
Authority: 42 U.S.C. 216, 289b-1, 299c-3.
Intent is to assure objectivity by establishing
standards that preclude bias in design, conduct, or
reporting of research
Focuses on financial conflicts of interest
(FCOI)
Regulations apply to investigators, including
sub grantees, contractors, and collaborating
investigators.
Does not apply to applications for support
under Phase I of SBIR and STTR programs
An institutional conflict of interest policy should
require that each investigator disclose to a
responsible representative of the institution all
significant financial interests of the investigator
(including those of the investigator’s spouse and
dependent children) (i) that would reasonably
appear to be affected by the research or
educational activities funded or proposed for
funding by NSF; or (ii) in entities whose financial
interests would reasonably appear to be affected
by such activities.
Chapter 1 (Subchapter A) (Part 54)
Financial Disclosure by Clinical Investigators
The Food and Drug Administration (FDA)
regulations state that investigators that
receive compensation in excess of $25,000
from a corporate sponsor of a trial in which
the investigator is engaged must disclose to
the FDA at the time of filing for a new drug
application.
19.058, Conflict of Interest in Research,
Educational, and Public Service Activities
19.059, Employee Participation in Authorized
Private Companies Commercializing Ohio
University Research
“Conflict of Interest in Research, Educational,
and Public Service Activities”
Most conflict disclosures fall within the
parameters of this policy
States that faculty are primarily responsible
for their academic, research and service
obligations
“Employee Participation in Authorized Private
Companies Commercializing Ohio University
Research”
Applies to “employees, faculty, staff and students,
who create intellectual property owned by the Ohio
University and who desire to hold an equity interest
in a firm, corporation, or other association to which
Ohio University has assigned, licensed or
transferred Ohio University’s interests…”
Consulting
Licensing University Technology
Clinical Studies
Procurement
Mentoring
Institutional
A disclosure is filed specific to the funding
application.
If you have a potential conflict for one
proposal, it does not automatically apply to
all of your proposals.
Research conflicts of interest are usually
disclosed using LEO as you apply for funding
by completing the conflict of interest section
of the electronic transmittal
If you are not using LEO, you can download
the appropriate disclosure form from
www.ohio.edu/research/compliance
“A” is selected if you have no conflicts to
disclose
“B” is selected if you have a potential conflict
to disclose relative to the submission.
(Requires a subsequent paper process)
“C” is selected if you have a current disclosure
on file, but it is not relevant to the proposal
you are submitting
Still uses option A, B or C
Requires that you gather signatures on paper
for all options, however
Generally used for personnel not listed on the
grant proposal or “key personnel”
We have revised the COI forms to word forms
This should be easier to complete than the
previous form
PDF versions are also available
Should be on the compliance web site soon,
but we can e-mail them to you until then
Use this form only if you are unable to use
the LEO transmittal form to assure that no
conflict of interest exists. A form must be
completed for each proposal.
I assure that I have read Ohio University
Policy 19.058, “Conflict of Interest in
Research, Educational, and Public Service
Activities” and declare that I have nothing
that is, or could be perceived to be a conflict
of interest with this proposal.
Use this form to disclose a potential conflict
of interest situation.
A separate disclosure form must be used for
each entity with which you conduct business
Conflict includes any member of your
immediate family (spouse, domestic partner
or children)
Require that you complete an option “B”
disclosure statement in addition to
completing the LEO transmittal form.
Require you to obtain signatures from Center
or Institute (if applicable), Chair and Dean on
the additional disclosure statement!!
The B disclosure form is available at
www.ohio.edu/research/compliance
Use this form only if you are unable to use
the LEO transmittal form. Complete this form
if you have a current conflict of interest
disclosure on file with the Office of Research
Compliance, but that disclosure is not
applicable to this proposal.
*New Option for 2008*
A management plan is developed for some
disclosures to mitigate the potential conflict
Management plans are specific to each
disclosure
May require submission of additional pieces,
such as a student employment plan
Reduce or remove the financial interest creating the
conflict
Place safeguards that mitigate the conflict potential,
such having some decisions made by an independent
entity
Limit participation in portions of the proposed
research likely to create a conflict
Require that the researcher disclose his or her
conflicting financial interests to all collaborators and
any proposed trainees;
Disclose the conflict in publications
Work to remove students from being directly advised
or taught by faculty where a conflict exists
Assure publication rights for student participants
Student Use
Nepotism and Cronyism
Intellectual Property
Use of University Resources
Publication provisions
Use of Human Subjects
Oversight Requirements
Reporting and Annual Reviews
You must submit an annual renewal for your
disclosure
◦ If the potential conflict no longer exists you must
notify us
If significant changes occur during the year
you should submit an update to your
disclosure as they occur
Yes. We encourage employees to disclose
potential conflicts that do not meet the
financial threshold, but may still be
problematic, such as student employment.
This allows you to be transparent with
respect to outside interests.
Allowable situations
Situations that require disclosure but may not
need an extensive management plan
Situations that require disclosure and have
problematic elements that will require
mitigation and/or a management plan
Situations that are not permitted
Receipt of royalties or honoraria for
published scholarly works, seminars,
teaching, etc.
Honoraria for serving as a special reviewer
or work on review panels
Royalties under our intellectual property
policies if no other relationship with entity
Clinical income at OUCOM
You participate in research developed in
whole or part by you, and you or your
family receive royalties from an existing
agreement with the business, but have
no other significant financial interest
You assign students, etc. to research
projects where you are entitled to
receive royalties, but have no other
significant financial interest
You assign students, etc. to projects supported
by the business through an SRA, and have a
significant financial interest other than royalty
income
You receive research support from a business in
which you serve on the board of directors, or
other advisory board, even if you are not
compensated.
You hold an executive position in a business
engaged in commercial or research activities
directly related to your Ohio University
responsibilities.
Any situation in which an actual conflict
exists is not permitted.
The only “exceptions” are those handled
under Ohio University Policy and Procedure
19.059 where faculty entrepreneurship is
addressed.
Participation in clinical trials or evaluation
of other research in which you have a
significant financial interest other than
royalty income.
In the context of your position at Ohio
University, you make professional referrals
to a business in which you have a
significant financial interest.
Letter of admonition
Ineligibility to submit grant applications
Withholding of IRB or IACUC approvals
Suspension
Non-Renewal
Loss of Tenure
Consulting
Procurement
Mentoring
Clinical Studies
Avoid consulting relationships that have
the potential to divert time and effort from
your responsibilities to Ohio University.
Do not use students.
Be wary of situations that limit publication.
Do not use university stationary, etc. that
could create an impression the university
is involved with the activities.
Make sure you are devoting sufficient time
to your university obligations.
Be cautious that the potential financial gain
cannot be perceived to influence your
university mentoring relationships.
Disclose any personal or familial financial
interest or equity in a company that is
doing business with Ohio University.
If you make purchases using public funds,
you should not use companies which will
benefit you or your family. If there is no
alternative you must seek and receive
permission prior to purchasing.
Any relationship in which there is a real or
perceived power or influence imbalance has
the potential for conflict. (Faculty:Student)
Isolating these relationships with respect to
areas of personal financial gain is best.
If they cannot be isolated, then safeguards
must be created.
If you have a financial interest, it is best to
isolate yourself from the study.
At a minimum, expect a more intense review
and a robust management plan if you have a
financial interest.
If both the institution and you have financial
interests the clinical study should be
conducted elsewhere.
You have administrative responsibilities on
behalf of Ohio University that is beneficial to
the business in which you have a significant
financial interest
You have administrative responsibilities on
behalf of Ohio University with respect to an
SRA where you have a significant financial
interest
Slide 47
Jo Ellen Sherow
Ohio University
Office of Research Compliance
Researchers’ Financial Disclosures in the
Spotlight
Conflicts of interest, always an emotional topic,
returned to the headlines this week as Sen.
Charles Grassley, a longtime critic of the drug
industry’s potential influence on research,
released new evidence that prominent Harvard
University scientists had failed to disclose much
of their outside income from pharmaceutical
companies over the past eight years.
http://www.insidehighered.com/news/2008/06/12/conflict January 15, 2008
WEDNESDAY, JANUARY 21, 2009
In a review of the literature regarding the relationship between
smokeless tobacco use and cancer, a conflict of interest of one of the
article's authors was initially not disclosed (see: Boffetta P, Hecht S, Gray
N, Gupta P, Straif K. Smokeless tobacco and cancer. Lancet Oncology
2008; 9:667-675). The original article was published in July, 2008. That
article stated: "The authors declare no conflicts of interest." After the
editor of the journal was notified by a researcher with knowledge of a
potential conflict of interest of Dr. Stephen Hecht (one of the study
authors), an erratum was published in September 2008, which noted:
"During the immediate months preceding submission of the review SH
was acting in the capacity of an expert witness for the plaintiff in a
future court case against a smokeless tobacco company. SH declares his
participation in this case in no way influenced his writing or involvement
in the review."
http://tobaccoanalysis.blogspot.com/2009/01/conflict-of-interestnot.html
January 16, 2009 — More than one third of new
drug marketing applications approved by the US
Food and Drug Administration (FDA) were
missing information about potential conflicts of
interest for clinical trial investigators, which
could allow bias to creep into the approvals
process, a government report released this week
has found. The FDA has said that it agrees with
most of the report's findings.
http://www.medscape.com/viewarticle/586980
Do collaborations between biotech companies
and academic centers constitute a conflict of
interest?
Biotechnology industry partnerships with
universities and academic centers have been
fruitful for both. So why is there so much
concern about conflict of interest and is that
concern appropriate?
http://www.redorbit.com/news/health/750100/genetic_engineering_news_p
osts_podcast_on_industrialacademic_collaborations_are_these/index.html
Universities are responsible for use of public
funds and therefore must maintain the public
trust.
Identifying and mitigating situations that may
have the potential for conflict maintains the
integrity of the university.
Maintaining integrity allows the university to
do credible academic research.
To provide information on the purpose of the
conflict of interest requirements.
To provide a basic overview of conflicts of
interest
To introduce the disclosure process and the use
of management plans
To provide information on the need for updates
and annual renewals.
Situations where financial considerations
compromise your professional judgment.
“Actual Conflict of Interest”
◦ Not permitted
Situations where an independent observer
might reasonably question whether your
professional actions or decisions are
determined by considerations of personal
gain. “Perceived Conflict of Interest”
◦ Managed
Potential conflicts may be financial or may be
a conflict of time, effort and/or commitment.
Potential conflicts can occur as a result of
administrative, scientific, academic, fiduciary
or familial situations.
They are situations that can be PERCEIVED to
be conflicting, whether a “real” conflict exists
or not.
Ohio University Policy has a mandatory
disclosure policy if you:
Earn over $10,000 in a twelve month period
from your outside activity OR
Have over 5% equity in the entity
Applies to members of your immediate family
(spouse, domestic partner, dependent
children) as well as yourself.
Anything of monetary value, including but not
limited to:
◦
◦
◦
◦
Salary
Payments for services
Equity interests over 5%
Intellectual property rights
Excludes mutual, pension and other
investments over which you have no control
Outside work during regular academic year
should not exceed equivalent of 1 day per
week.
Consulting work must avoid activities that
involve a conflict of interest with assigned
Ohio University activities and programs
Faculty Handbook, section IV-D
Outside interests cannot interfere with
primary loyalty to Ohio University and your
academic role
Use of university resources must have prior
approval of Chair, Dean and VPR.
Your outside interests should not be in
direct competition with university interests
Full time administrative employees are
expected to devote their full-time
professional loyalty, time and energy to their
position.
You must use non-work hours and no
university resources
Federal Agencies
State Law
University Policies
Many Academic Publications
45 CFR Part 50, Subpart F
“Responsibility of Applicants for Promoting
Objectivity in Research for Which PHS Funding
is Sought”
Authority: 42 U.S.C. 216, 289b-1, 299c-3.
Intent is to assure objectivity by establishing
standards that preclude bias in design, conduct, or
reporting of research
Focuses on financial conflicts of interest
(FCOI)
Regulations apply to investigators, including
sub grantees, contractors, and collaborating
investigators.
Does not apply to applications for support
under Phase I of SBIR and STTR programs
An institutional conflict of interest policy should
require that each investigator disclose to a
responsible representative of the institution all
significant financial interests of the investigator
(including those of the investigator’s spouse and
dependent children) (i) that would reasonably
appear to be affected by the research or
educational activities funded or proposed for
funding by NSF; or (ii) in entities whose financial
interests would reasonably appear to be affected
by such activities.
Chapter 1 (Subchapter A) (Part 54)
Financial Disclosure by Clinical Investigators
The Food and Drug Administration (FDA)
regulations state that investigators that
receive compensation in excess of $25,000
from a corporate sponsor of a trial in which
the investigator is engaged must disclose to
the FDA at the time of filing for a new drug
application.
19.058, Conflict of Interest in Research,
Educational, and Public Service Activities
19.059, Employee Participation in Authorized
Private Companies Commercializing Ohio
University Research
“Conflict of Interest in Research, Educational,
and Public Service Activities”
Most conflict disclosures fall within the
parameters of this policy
States that faculty are primarily responsible
for their academic, research and service
obligations
“Employee Participation in Authorized Private
Companies Commercializing Ohio University
Research”
Applies to “employees, faculty, staff and students,
who create intellectual property owned by the Ohio
University and who desire to hold an equity interest
in a firm, corporation, or other association to which
Ohio University has assigned, licensed or
transferred Ohio University’s interests…”
Consulting
Licensing University Technology
Clinical Studies
Procurement
Mentoring
Institutional
A disclosure is filed specific to the funding
application.
If you have a potential conflict for one
proposal, it does not automatically apply to
all of your proposals.
Research conflicts of interest are usually
disclosed using LEO as you apply for funding
by completing the conflict of interest section
of the electronic transmittal
If you are not using LEO, you can download
the appropriate disclosure form from
www.ohio.edu/research/compliance
“A” is selected if you have no conflicts to
disclose
“B” is selected if you have a potential conflict
to disclose relative to the submission.
(Requires a subsequent paper process)
“C” is selected if you have a current disclosure
on file, but it is not relevant to the proposal
you are submitting
Still uses option A, B or C
Requires that you gather signatures on paper
for all options, however
Generally used for personnel not listed on the
grant proposal or “key personnel”
We have revised the COI forms to word forms
This should be easier to complete than the
previous form
PDF versions are also available
Should be on the compliance web site soon,
but we can e-mail them to you until then
Use this form only if you are unable to use
the LEO transmittal form to assure that no
conflict of interest exists. A form must be
completed for each proposal.
I assure that I have read Ohio University
Policy 19.058, “Conflict of Interest in
Research, Educational, and Public Service
Activities” and declare that I have nothing
that is, or could be perceived to be a conflict
of interest with this proposal.
Use this form to disclose a potential conflict
of interest situation.
A separate disclosure form must be used for
each entity with which you conduct business
Conflict includes any member of your
immediate family (spouse, domestic partner
or children)
Require that you complete an option “B”
disclosure statement in addition to
completing the LEO transmittal form.
Require you to obtain signatures from Center
or Institute (if applicable), Chair and Dean on
the additional disclosure statement!!
The B disclosure form is available at
www.ohio.edu/research/compliance
Use this form only if you are unable to use
the LEO transmittal form. Complete this form
if you have a current conflict of interest
disclosure on file with the Office of Research
Compliance, but that disclosure is not
applicable to this proposal.
*New Option for 2008*
A management plan is developed for some
disclosures to mitigate the potential conflict
Management plans are specific to each
disclosure
May require submission of additional pieces,
such as a student employment plan
Reduce or remove the financial interest creating the
conflict
Place safeguards that mitigate the conflict potential,
such having some decisions made by an independent
entity
Limit participation in portions of the proposed
research likely to create a conflict
Require that the researcher disclose his or her
conflicting financial interests to all collaborators and
any proposed trainees;
Disclose the conflict in publications
Work to remove students from being directly advised
or taught by faculty where a conflict exists
Assure publication rights for student participants
Student Use
Nepotism and Cronyism
Intellectual Property
Use of University Resources
Publication provisions
Use of Human Subjects
Oversight Requirements
Reporting and Annual Reviews
You must submit an annual renewal for your
disclosure
◦ If the potential conflict no longer exists you must
notify us
If significant changes occur during the year
you should submit an update to your
disclosure as they occur
Yes. We encourage employees to disclose
potential conflicts that do not meet the
financial threshold, but may still be
problematic, such as student employment.
This allows you to be transparent with
respect to outside interests.
Allowable situations
Situations that require disclosure but may not
need an extensive management plan
Situations that require disclosure and have
problematic elements that will require
mitigation and/or a management plan
Situations that are not permitted
Receipt of royalties or honoraria for
published scholarly works, seminars,
teaching, etc.
Honoraria for serving as a special reviewer
or work on review panels
Royalties under our intellectual property
policies if no other relationship with entity
Clinical income at OUCOM
You participate in research developed in
whole or part by you, and you or your
family receive royalties from an existing
agreement with the business, but have
no other significant financial interest
You assign students, etc. to research
projects where you are entitled to
receive royalties, but have no other
significant financial interest
You assign students, etc. to projects supported
by the business through an SRA, and have a
significant financial interest other than royalty
income
You receive research support from a business in
which you serve on the board of directors, or
other advisory board, even if you are not
compensated.
You hold an executive position in a business
engaged in commercial or research activities
directly related to your Ohio University
responsibilities.
Any situation in which an actual conflict
exists is not permitted.
The only “exceptions” are those handled
under Ohio University Policy and Procedure
19.059 where faculty entrepreneurship is
addressed.
Participation in clinical trials or evaluation
of other research in which you have a
significant financial interest other than
royalty income.
In the context of your position at Ohio
University, you make professional referrals
to a business in which you have a
significant financial interest.
Letter of admonition
Ineligibility to submit grant applications
Withholding of IRB or IACUC approvals
Suspension
Non-Renewal
Loss of Tenure
Consulting
Procurement
Mentoring
Clinical Studies
Avoid consulting relationships that have
the potential to divert time and effort from
your responsibilities to Ohio University.
Do not use students.
Be wary of situations that limit publication.
Do not use university stationary, etc. that
could create an impression the university
is involved with the activities.
Make sure you are devoting sufficient time
to your university obligations.
Be cautious that the potential financial gain
cannot be perceived to influence your
university mentoring relationships.
Disclose any personal or familial financial
interest or equity in a company that is
doing business with Ohio University.
If you make purchases using public funds,
you should not use companies which will
benefit you or your family. If there is no
alternative you must seek and receive
permission prior to purchasing.
Any relationship in which there is a real or
perceived power or influence imbalance has
the potential for conflict. (Faculty:Student)
Isolating these relationships with respect to
areas of personal financial gain is best.
If they cannot be isolated, then safeguards
must be created.
If you have a financial interest, it is best to
isolate yourself from the study.
At a minimum, expect a more intense review
and a robust management plan if you have a
financial interest.
If both the institution and you have financial
interests the clinical study should be
conducted elsewhere.
You have administrative responsibilities on
behalf of Ohio University that is beneficial to
the business in which you have a significant
financial interest
You have administrative responsibilities on
behalf of Ohio University with respect to an
SRA where you have a significant financial
interest
Slide 48
Jo Ellen Sherow
Ohio University
Office of Research Compliance
Researchers’ Financial Disclosures in the
Spotlight
Conflicts of interest, always an emotional topic,
returned to the headlines this week as Sen.
Charles Grassley, a longtime critic of the drug
industry’s potential influence on research,
released new evidence that prominent Harvard
University scientists had failed to disclose much
of their outside income from pharmaceutical
companies over the past eight years.
http://www.insidehighered.com/news/2008/06/12/conflict January 15, 2008
WEDNESDAY, JANUARY 21, 2009
In a review of the literature regarding the relationship between
smokeless tobacco use and cancer, a conflict of interest of one of the
article's authors was initially not disclosed (see: Boffetta P, Hecht S, Gray
N, Gupta P, Straif K. Smokeless tobacco and cancer. Lancet Oncology
2008; 9:667-675). The original article was published in July, 2008. That
article stated: "The authors declare no conflicts of interest." After the
editor of the journal was notified by a researcher with knowledge of a
potential conflict of interest of Dr. Stephen Hecht (one of the study
authors), an erratum was published in September 2008, which noted:
"During the immediate months preceding submission of the review SH
was acting in the capacity of an expert witness for the plaintiff in a
future court case against a smokeless tobacco company. SH declares his
participation in this case in no way influenced his writing or involvement
in the review."
http://tobaccoanalysis.blogspot.com/2009/01/conflict-of-interestnot.html
January 16, 2009 — More than one third of new
drug marketing applications approved by the US
Food and Drug Administration (FDA) were
missing information about potential conflicts of
interest for clinical trial investigators, which
could allow bias to creep into the approvals
process, a government report released this week
has found. The FDA has said that it agrees with
most of the report's findings.
http://www.medscape.com/viewarticle/586980
Do collaborations between biotech companies
and academic centers constitute a conflict of
interest?
Biotechnology industry partnerships with
universities and academic centers have been
fruitful for both. So why is there so much
concern about conflict of interest and is that
concern appropriate?
http://www.redorbit.com/news/health/750100/genetic_engineering_news_p
osts_podcast_on_industrialacademic_collaborations_are_these/index.html
Universities are responsible for use of public
funds and therefore must maintain the public
trust.
Identifying and mitigating situations that may
have the potential for conflict maintains the
integrity of the university.
Maintaining integrity allows the university to
do credible academic research.
To provide information on the purpose of the
conflict of interest requirements.
To provide a basic overview of conflicts of
interest
To introduce the disclosure process and the use
of management plans
To provide information on the need for updates
and annual renewals.
Situations where financial considerations
compromise your professional judgment.
“Actual Conflict of Interest”
◦ Not permitted
Situations where an independent observer
might reasonably question whether your
professional actions or decisions are
determined by considerations of personal
gain. “Perceived Conflict of Interest”
◦ Managed
Potential conflicts may be financial or may be
a conflict of time, effort and/or commitment.
Potential conflicts can occur as a result of
administrative, scientific, academic, fiduciary
or familial situations.
They are situations that can be PERCEIVED to
be conflicting, whether a “real” conflict exists
or not.
Ohio University Policy has a mandatory
disclosure policy if you:
Earn over $10,000 in a twelve month period
from your outside activity OR
Have over 5% equity in the entity
Applies to members of your immediate family
(spouse, domestic partner, dependent
children) as well as yourself.
Anything of monetary value, including but not
limited to:
◦
◦
◦
◦
Salary
Payments for services
Equity interests over 5%
Intellectual property rights
Excludes mutual, pension and other
investments over which you have no control
Outside work during regular academic year
should not exceed equivalent of 1 day per
week.
Consulting work must avoid activities that
involve a conflict of interest with assigned
Ohio University activities and programs
Faculty Handbook, section IV-D
Outside interests cannot interfere with
primary loyalty to Ohio University and your
academic role
Use of university resources must have prior
approval of Chair, Dean and VPR.
Your outside interests should not be in
direct competition with university interests
Full time administrative employees are
expected to devote their full-time
professional loyalty, time and energy to their
position.
You must use non-work hours and no
university resources
Federal Agencies
State Law
University Policies
Many Academic Publications
45 CFR Part 50, Subpart F
“Responsibility of Applicants for Promoting
Objectivity in Research for Which PHS Funding
is Sought”
Authority: 42 U.S.C. 216, 289b-1, 299c-3.
Intent is to assure objectivity by establishing
standards that preclude bias in design, conduct, or
reporting of research
Focuses on financial conflicts of interest
(FCOI)
Regulations apply to investigators, including
sub grantees, contractors, and collaborating
investigators.
Does not apply to applications for support
under Phase I of SBIR and STTR programs
An institutional conflict of interest policy should
require that each investigator disclose to a
responsible representative of the institution all
significant financial interests of the investigator
(including those of the investigator’s spouse and
dependent children) (i) that would reasonably
appear to be affected by the research or
educational activities funded or proposed for
funding by NSF; or (ii) in entities whose financial
interests would reasonably appear to be affected
by such activities.
Chapter 1 (Subchapter A) (Part 54)
Financial Disclosure by Clinical Investigators
The Food and Drug Administration (FDA)
regulations state that investigators that
receive compensation in excess of $25,000
from a corporate sponsor of a trial in which
the investigator is engaged must disclose to
the FDA at the time of filing for a new drug
application.
19.058, Conflict of Interest in Research,
Educational, and Public Service Activities
19.059, Employee Participation in Authorized
Private Companies Commercializing Ohio
University Research
“Conflict of Interest in Research, Educational,
and Public Service Activities”
Most conflict disclosures fall within the
parameters of this policy
States that faculty are primarily responsible
for their academic, research and service
obligations
“Employee Participation in Authorized Private
Companies Commercializing Ohio University
Research”
Applies to “employees, faculty, staff and students,
who create intellectual property owned by the Ohio
University and who desire to hold an equity interest
in a firm, corporation, or other association to which
Ohio University has assigned, licensed or
transferred Ohio University’s interests…”
Consulting
Licensing University Technology
Clinical Studies
Procurement
Mentoring
Institutional
A disclosure is filed specific to the funding
application.
If you have a potential conflict for one
proposal, it does not automatically apply to
all of your proposals.
Research conflicts of interest are usually
disclosed using LEO as you apply for funding
by completing the conflict of interest section
of the electronic transmittal
If you are not using LEO, you can download
the appropriate disclosure form from
www.ohio.edu/research/compliance
“A” is selected if you have no conflicts to
disclose
“B” is selected if you have a potential conflict
to disclose relative to the submission.
(Requires a subsequent paper process)
“C” is selected if you have a current disclosure
on file, but it is not relevant to the proposal
you are submitting
Still uses option A, B or C
Requires that you gather signatures on paper
for all options, however
Generally used for personnel not listed on the
grant proposal or “key personnel”
We have revised the COI forms to word forms
This should be easier to complete than the
previous form
PDF versions are also available
Should be on the compliance web site soon,
but we can e-mail them to you until then
Use this form only if you are unable to use
the LEO transmittal form to assure that no
conflict of interest exists. A form must be
completed for each proposal.
I assure that I have read Ohio University
Policy 19.058, “Conflict of Interest in
Research, Educational, and Public Service
Activities” and declare that I have nothing
that is, or could be perceived to be a conflict
of interest with this proposal.
Use this form to disclose a potential conflict
of interest situation.
A separate disclosure form must be used for
each entity with which you conduct business
Conflict includes any member of your
immediate family (spouse, domestic partner
or children)
Require that you complete an option “B”
disclosure statement in addition to
completing the LEO transmittal form.
Require you to obtain signatures from Center
or Institute (if applicable), Chair and Dean on
the additional disclosure statement!!
The B disclosure form is available at
www.ohio.edu/research/compliance
Use this form only if you are unable to use
the LEO transmittal form. Complete this form
if you have a current conflict of interest
disclosure on file with the Office of Research
Compliance, but that disclosure is not
applicable to this proposal.
*New Option for 2008*
A management plan is developed for some
disclosures to mitigate the potential conflict
Management plans are specific to each
disclosure
May require submission of additional pieces,
such as a student employment plan
Reduce or remove the financial interest creating the
conflict
Place safeguards that mitigate the conflict potential,
such having some decisions made by an independent
entity
Limit participation in portions of the proposed
research likely to create a conflict
Require that the researcher disclose his or her
conflicting financial interests to all collaborators and
any proposed trainees;
Disclose the conflict in publications
Work to remove students from being directly advised
or taught by faculty where a conflict exists
Assure publication rights for student participants
Student Use
Nepotism and Cronyism
Intellectual Property
Use of University Resources
Publication provisions
Use of Human Subjects
Oversight Requirements
Reporting and Annual Reviews
You must submit an annual renewal for your
disclosure
◦ If the potential conflict no longer exists you must
notify us
If significant changes occur during the year
you should submit an update to your
disclosure as they occur
Yes. We encourage employees to disclose
potential conflicts that do not meet the
financial threshold, but may still be
problematic, such as student employment.
This allows you to be transparent with
respect to outside interests.
Allowable situations
Situations that require disclosure but may not
need an extensive management plan
Situations that require disclosure and have
problematic elements that will require
mitigation and/or a management plan
Situations that are not permitted
Receipt of royalties or honoraria for
published scholarly works, seminars,
teaching, etc.
Honoraria for serving as a special reviewer
or work on review panels
Royalties under our intellectual property
policies if no other relationship with entity
Clinical income at OUCOM
You participate in research developed in
whole or part by you, and you or your
family receive royalties from an existing
agreement with the business, but have
no other significant financial interest
You assign students, etc. to research
projects where you are entitled to
receive royalties, but have no other
significant financial interest
You assign students, etc. to projects supported
by the business through an SRA, and have a
significant financial interest other than royalty
income
You receive research support from a business in
which you serve on the board of directors, or
other advisory board, even if you are not
compensated.
You hold an executive position in a business
engaged in commercial or research activities
directly related to your Ohio University
responsibilities.
Any situation in which an actual conflict
exists is not permitted.
The only “exceptions” are those handled
under Ohio University Policy and Procedure
19.059 where faculty entrepreneurship is
addressed.
Participation in clinical trials or evaluation
of other research in which you have a
significant financial interest other than
royalty income.
In the context of your position at Ohio
University, you make professional referrals
to a business in which you have a
significant financial interest.
Letter of admonition
Ineligibility to submit grant applications
Withholding of IRB or IACUC approvals
Suspension
Non-Renewal
Loss of Tenure
Consulting
Procurement
Mentoring
Clinical Studies
Avoid consulting relationships that have
the potential to divert time and effort from
your responsibilities to Ohio University.
Do not use students.
Be wary of situations that limit publication.
Do not use university stationary, etc. that
could create an impression the university
is involved with the activities.
Make sure you are devoting sufficient time
to your university obligations.
Be cautious that the potential financial gain
cannot be perceived to influence your
university mentoring relationships.
Disclose any personal or familial financial
interest or equity in a company that is
doing business with Ohio University.
If you make purchases using public funds,
you should not use companies which will
benefit you or your family. If there is no
alternative you must seek and receive
permission prior to purchasing.
Any relationship in which there is a real or
perceived power or influence imbalance has
the potential for conflict. (Faculty:Student)
Isolating these relationships with respect to
areas of personal financial gain is best.
If they cannot be isolated, then safeguards
must be created.
If you have a financial interest, it is best to
isolate yourself from the study.
At a minimum, expect a more intense review
and a robust management plan if you have a
financial interest.
If both the institution and you have financial
interests the clinical study should be
conducted elsewhere.
You have administrative responsibilities on
behalf of Ohio University that is beneficial to
the business in which you have a significant
financial interest
You have administrative responsibilities on
behalf of Ohio University with respect to an
SRA where you have a significant financial
interest
Slide 49
Jo Ellen Sherow
Ohio University
Office of Research Compliance
Researchers’ Financial Disclosures in the
Spotlight
Conflicts of interest, always an emotional topic,
returned to the headlines this week as Sen.
Charles Grassley, a longtime critic of the drug
industry’s potential influence on research,
released new evidence that prominent Harvard
University scientists had failed to disclose much
of their outside income from pharmaceutical
companies over the past eight years.
http://www.insidehighered.com/news/2008/06/12/conflict January 15, 2008
WEDNESDAY, JANUARY 21, 2009
In a review of the literature regarding the relationship between
smokeless tobacco use and cancer, a conflict of interest of one of the
article's authors was initially not disclosed (see: Boffetta P, Hecht S, Gray
N, Gupta P, Straif K. Smokeless tobacco and cancer. Lancet Oncology
2008; 9:667-675). The original article was published in July, 2008. That
article stated: "The authors declare no conflicts of interest." After the
editor of the journal was notified by a researcher with knowledge of a
potential conflict of interest of Dr. Stephen Hecht (one of the study
authors), an erratum was published in September 2008, which noted:
"During the immediate months preceding submission of the review SH
was acting in the capacity of an expert witness for the plaintiff in a
future court case against a smokeless tobacco company. SH declares his
participation in this case in no way influenced his writing or involvement
in the review."
http://tobaccoanalysis.blogspot.com/2009/01/conflict-of-interestnot.html
January 16, 2009 — More than one third of new
drug marketing applications approved by the US
Food and Drug Administration (FDA) were
missing information about potential conflicts of
interest for clinical trial investigators, which
could allow bias to creep into the approvals
process, a government report released this week
has found. The FDA has said that it agrees with
most of the report's findings.
http://www.medscape.com/viewarticle/586980
Do collaborations between biotech companies
and academic centers constitute a conflict of
interest?
Biotechnology industry partnerships with
universities and academic centers have been
fruitful for both. So why is there so much
concern about conflict of interest and is that
concern appropriate?
http://www.redorbit.com/news/health/750100/genetic_engineering_news_p
osts_podcast_on_industrialacademic_collaborations_are_these/index.html
Universities are responsible for use of public
funds and therefore must maintain the public
trust.
Identifying and mitigating situations that may
have the potential for conflict maintains the
integrity of the university.
Maintaining integrity allows the university to
do credible academic research.
To provide information on the purpose of the
conflict of interest requirements.
To provide a basic overview of conflicts of
interest
To introduce the disclosure process and the use
of management plans
To provide information on the need for updates
and annual renewals.
Situations where financial considerations
compromise your professional judgment.
“Actual Conflict of Interest”
◦ Not permitted
Situations where an independent observer
might reasonably question whether your
professional actions or decisions are
determined by considerations of personal
gain. “Perceived Conflict of Interest”
◦ Managed
Potential conflicts may be financial or may be
a conflict of time, effort and/or commitment.
Potential conflicts can occur as a result of
administrative, scientific, academic, fiduciary
or familial situations.
They are situations that can be PERCEIVED to
be conflicting, whether a “real” conflict exists
or not.
Ohio University Policy has a mandatory
disclosure policy if you:
Earn over $10,000 in a twelve month period
from your outside activity OR
Have over 5% equity in the entity
Applies to members of your immediate family
(spouse, domestic partner, dependent
children) as well as yourself.
Anything of monetary value, including but not
limited to:
◦
◦
◦
◦
Salary
Payments for services
Equity interests over 5%
Intellectual property rights
Excludes mutual, pension and other
investments over which you have no control
Outside work during regular academic year
should not exceed equivalent of 1 day per
week.
Consulting work must avoid activities that
involve a conflict of interest with assigned
Ohio University activities and programs
Faculty Handbook, section IV-D
Outside interests cannot interfere with
primary loyalty to Ohio University and your
academic role
Use of university resources must have prior
approval of Chair, Dean and VPR.
Your outside interests should not be in
direct competition with university interests
Full time administrative employees are
expected to devote their full-time
professional loyalty, time and energy to their
position.
You must use non-work hours and no
university resources
Federal Agencies
State Law
University Policies
Many Academic Publications
45 CFR Part 50, Subpart F
“Responsibility of Applicants for Promoting
Objectivity in Research for Which PHS Funding
is Sought”
Authority: 42 U.S.C. 216, 289b-1, 299c-3.
Intent is to assure objectivity by establishing
standards that preclude bias in design, conduct, or
reporting of research
Focuses on financial conflicts of interest
(FCOI)
Regulations apply to investigators, including
sub grantees, contractors, and collaborating
investigators.
Does not apply to applications for support
under Phase I of SBIR and STTR programs
An institutional conflict of interest policy should
require that each investigator disclose to a
responsible representative of the institution all
significant financial interests of the investigator
(including those of the investigator’s spouse and
dependent children) (i) that would reasonably
appear to be affected by the research or
educational activities funded or proposed for
funding by NSF; or (ii) in entities whose financial
interests would reasonably appear to be affected
by such activities.
Chapter 1 (Subchapter A) (Part 54)
Financial Disclosure by Clinical Investigators
The Food and Drug Administration (FDA)
regulations state that investigators that
receive compensation in excess of $25,000
from a corporate sponsor of a trial in which
the investigator is engaged must disclose to
the FDA at the time of filing for a new drug
application.
19.058, Conflict of Interest in Research,
Educational, and Public Service Activities
19.059, Employee Participation in Authorized
Private Companies Commercializing Ohio
University Research
“Conflict of Interest in Research, Educational,
and Public Service Activities”
Most conflict disclosures fall within the
parameters of this policy
States that faculty are primarily responsible
for their academic, research and service
obligations
“Employee Participation in Authorized Private
Companies Commercializing Ohio University
Research”
Applies to “employees, faculty, staff and students,
who create intellectual property owned by the Ohio
University and who desire to hold an equity interest
in a firm, corporation, or other association to which
Ohio University has assigned, licensed or
transferred Ohio University’s interests…”
Consulting
Licensing University Technology
Clinical Studies
Procurement
Mentoring
Institutional
A disclosure is filed specific to the funding
application.
If you have a potential conflict for one
proposal, it does not automatically apply to
all of your proposals.
Research conflicts of interest are usually
disclosed using LEO as you apply for funding
by completing the conflict of interest section
of the electronic transmittal
If you are not using LEO, you can download
the appropriate disclosure form from
www.ohio.edu/research/compliance
“A” is selected if you have no conflicts to
disclose
“B” is selected if you have a potential conflict
to disclose relative to the submission.
(Requires a subsequent paper process)
“C” is selected if you have a current disclosure
on file, but it is not relevant to the proposal
you are submitting
Still uses option A, B or C
Requires that you gather signatures on paper
for all options, however
Generally used for personnel not listed on the
grant proposal or “key personnel”
We have revised the COI forms to word forms
This should be easier to complete than the
previous form
PDF versions are also available
Should be on the compliance web site soon,
but we can e-mail them to you until then
Use this form only if you are unable to use
the LEO transmittal form to assure that no
conflict of interest exists. A form must be
completed for each proposal.
I assure that I have read Ohio University
Policy 19.058, “Conflict of Interest in
Research, Educational, and Public Service
Activities” and declare that I have nothing
that is, or could be perceived to be a conflict
of interest with this proposal.
Use this form to disclose a potential conflict
of interest situation.
A separate disclosure form must be used for
each entity with which you conduct business
Conflict includes any member of your
immediate family (spouse, domestic partner
or children)
Require that you complete an option “B”
disclosure statement in addition to
completing the LEO transmittal form.
Require you to obtain signatures from Center
or Institute (if applicable), Chair and Dean on
the additional disclosure statement!!
The B disclosure form is available at
www.ohio.edu/research/compliance
Use this form only if you are unable to use
the LEO transmittal form. Complete this form
if you have a current conflict of interest
disclosure on file with the Office of Research
Compliance, but that disclosure is not
applicable to this proposal.
*New Option for 2008*
A management plan is developed for some
disclosures to mitigate the potential conflict
Management plans are specific to each
disclosure
May require submission of additional pieces,
such as a student employment plan
Reduce or remove the financial interest creating the
conflict
Place safeguards that mitigate the conflict potential,
such having some decisions made by an independent
entity
Limit participation in portions of the proposed
research likely to create a conflict
Require that the researcher disclose his or her
conflicting financial interests to all collaborators and
any proposed trainees;
Disclose the conflict in publications
Work to remove students from being directly advised
or taught by faculty where a conflict exists
Assure publication rights for student participants
Student Use
Nepotism and Cronyism
Intellectual Property
Use of University Resources
Publication provisions
Use of Human Subjects
Oversight Requirements
Reporting and Annual Reviews
You must submit an annual renewal for your
disclosure
◦ If the potential conflict no longer exists you must
notify us
If significant changes occur during the year
you should submit an update to your
disclosure as they occur
Yes. We encourage employees to disclose
potential conflicts that do not meet the
financial threshold, but may still be
problematic, such as student employment.
This allows you to be transparent with
respect to outside interests.
Allowable situations
Situations that require disclosure but may not
need an extensive management plan
Situations that require disclosure and have
problematic elements that will require
mitigation and/or a management plan
Situations that are not permitted
Receipt of royalties or honoraria for
published scholarly works, seminars,
teaching, etc.
Honoraria for serving as a special reviewer
or work on review panels
Royalties under our intellectual property
policies if no other relationship with entity
Clinical income at OUCOM
You participate in research developed in
whole or part by you, and you or your
family receive royalties from an existing
agreement with the business, but have
no other significant financial interest
You assign students, etc. to research
projects where you are entitled to
receive royalties, but have no other
significant financial interest
You assign students, etc. to projects supported
by the business through an SRA, and have a
significant financial interest other than royalty
income
You receive research support from a business in
which you serve on the board of directors, or
other advisory board, even if you are not
compensated.
You hold an executive position in a business
engaged in commercial or research activities
directly related to your Ohio University
responsibilities.
Any situation in which an actual conflict
exists is not permitted.
The only “exceptions” are those handled
under Ohio University Policy and Procedure
19.059 where faculty entrepreneurship is
addressed.
Participation in clinical trials or evaluation
of other research in which you have a
significant financial interest other than
royalty income.
In the context of your position at Ohio
University, you make professional referrals
to a business in which you have a
significant financial interest.
Letter of admonition
Ineligibility to submit grant applications
Withholding of IRB or IACUC approvals
Suspension
Non-Renewal
Loss of Tenure
Consulting
Procurement
Mentoring
Clinical Studies
Avoid consulting relationships that have
the potential to divert time and effort from
your responsibilities to Ohio University.
Do not use students.
Be wary of situations that limit publication.
Do not use university stationary, etc. that
could create an impression the university
is involved with the activities.
Make sure you are devoting sufficient time
to your university obligations.
Be cautious that the potential financial gain
cannot be perceived to influence your
university mentoring relationships.
Disclose any personal or familial financial
interest or equity in a company that is
doing business with Ohio University.
If you make purchases using public funds,
you should not use companies which will
benefit you or your family. If there is no
alternative you must seek and receive
permission prior to purchasing.
Any relationship in which there is a real or
perceived power or influence imbalance has
the potential for conflict. (Faculty:Student)
Isolating these relationships with respect to
areas of personal financial gain is best.
If they cannot be isolated, then safeguards
must be created.
If you have a financial interest, it is best to
isolate yourself from the study.
At a minimum, expect a more intense review
and a robust management plan if you have a
financial interest.
If both the institution and you have financial
interests the clinical study should be
conducted elsewhere.
You have administrative responsibilities on
behalf of Ohio University that is beneficial to
the business in which you have a significant
financial interest
You have administrative responsibilities on
behalf of Ohio University with respect to an
SRA where you have a significant financial
interest
Slide 50
Jo Ellen Sherow
Ohio University
Office of Research Compliance
Researchers’ Financial Disclosures in the
Spotlight
Conflicts of interest, always an emotional topic,
returned to the headlines this week as Sen.
Charles Grassley, a longtime critic of the drug
industry’s potential influence on research,
released new evidence that prominent Harvard
University scientists had failed to disclose much
of their outside income from pharmaceutical
companies over the past eight years.
http://www.insidehighered.com/news/2008/06/12/conflict January 15, 2008
WEDNESDAY, JANUARY 21, 2009
In a review of the literature regarding the relationship between
smokeless tobacco use and cancer, a conflict of interest of one of the
article's authors was initially not disclosed (see: Boffetta P, Hecht S, Gray
N, Gupta P, Straif K. Smokeless tobacco and cancer. Lancet Oncology
2008; 9:667-675). The original article was published in July, 2008. That
article stated: "The authors declare no conflicts of interest." After the
editor of the journal was notified by a researcher with knowledge of a
potential conflict of interest of Dr. Stephen Hecht (one of the study
authors), an erratum was published in September 2008, which noted:
"During the immediate months preceding submission of the review SH
was acting in the capacity of an expert witness for the plaintiff in a
future court case against a smokeless tobacco company. SH declares his
participation in this case in no way influenced his writing or involvement
in the review."
http://tobaccoanalysis.blogspot.com/2009/01/conflict-of-interestnot.html
January 16, 2009 — More than one third of new
drug marketing applications approved by the US
Food and Drug Administration (FDA) were
missing information about potential conflicts of
interest for clinical trial investigators, which
could allow bias to creep into the approvals
process, a government report released this week
has found. The FDA has said that it agrees with
most of the report's findings.
http://www.medscape.com/viewarticle/586980
Do collaborations between biotech companies
and academic centers constitute a conflict of
interest?
Biotechnology industry partnerships with
universities and academic centers have been
fruitful for both. So why is there so much
concern about conflict of interest and is that
concern appropriate?
http://www.redorbit.com/news/health/750100/genetic_engineering_news_p
osts_podcast_on_industrialacademic_collaborations_are_these/index.html
Universities are responsible for use of public
funds and therefore must maintain the public
trust.
Identifying and mitigating situations that may
have the potential for conflict maintains the
integrity of the university.
Maintaining integrity allows the university to
do credible academic research.
To provide information on the purpose of the
conflict of interest requirements.
To provide a basic overview of conflicts of
interest
To introduce the disclosure process and the use
of management plans
To provide information on the need for updates
and annual renewals.
Situations where financial considerations
compromise your professional judgment.
“Actual Conflict of Interest”
◦ Not permitted
Situations where an independent observer
might reasonably question whether your
professional actions or decisions are
determined by considerations of personal
gain. “Perceived Conflict of Interest”
◦ Managed
Potential conflicts may be financial or may be
a conflict of time, effort and/or commitment.
Potential conflicts can occur as a result of
administrative, scientific, academic, fiduciary
or familial situations.
They are situations that can be PERCEIVED to
be conflicting, whether a “real” conflict exists
or not.
Ohio University Policy has a mandatory
disclosure policy if you:
Earn over $10,000 in a twelve month period
from your outside activity OR
Have over 5% equity in the entity
Applies to members of your immediate family
(spouse, domestic partner, dependent
children) as well as yourself.
Anything of monetary value, including but not
limited to:
◦
◦
◦
◦
Salary
Payments for services
Equity interests over 5%
Intellectual property rights
Excludes mutual, pension and other
investments over which you have no control
Outside work during regular academic year
should not exceed equivalent of 1 day per
week.
Consulting work must avoid activities that
involve a conflict of interest with assigned
Ohio University activities and programs
Faculty Handbook, section IV-D
Outside interests cannot interfere with
primary loyalty to Ohio University and your
academic role
Use of university resources must have prior
approval of Chair, Dean and VPR.
Your outside interests should not be in
direct competition with university interests
Full time administrative employees are
expected to devote their full-time
professional loyalty, time and energy to their
position.
You must use non-work hours and no
university resources
Federal Agencies
State Law
University Policies
Many Academic Publications
45 CFR Part 50, Subpart F
“Responsibility of Applicants for Promoting
Objectivity in Research for Which PHS Funding
is Sought”
Authority: 42 U.S.C. 216, 289b-1, 299c-3.
Intent is to assure objectivity by establishing
standards that preclude bias in design, conduct, or
reporting of research
Focuses on financial conflicts of interest
(FCOI)
Regulations apply to investigators, including
sub grantees, contractors, and collaborating
investigators.
Does not apply to applications for support
under Phase I of SBIR and STTR programs
An institutional conflict of interest policy should
require that each investigator disclose to a
responsible representative of the institution all
significant financial interests of the investigator
(including those of the investigator’s spouse and
dependent children) (i) that would reasonably
appear to be affected by the research or
educational activities funded or proposed for
funding by NSF; or (ii) in entities whose financial
interests would reasonably appear to be affected
by such activities.
Chapter 1 (Subchapter A) (Part 54)
Financial Disclosure by Clinical Investigators
The Food and Drug Administration (FDA)
regulations state that investigators that
receive compensation in excess of $25,000
from a corporate sponsor of a trial in which
the investigator is engaged must disclose to
the FDA at the time of filing for a new drug
application.
19.058, Conflict of Interest in Research,
Educational, and Public Service Activities
19.059, Employee Participation in Authorized
Private Companies Commercializing Ohio
University Research
“Conflict of Interest in Research, Educational,
and Public Service Activities”
Most conflict disclosures fall within the
parameters of this policy
States that faculty are primarily responsible
for their academic, research and service
obligations
“Employee Participation in Authorized Private
Companies Commercializing Ohio University
Research”
Applies to “employees, faculty, staff and students,
who create intellectual property owned by the Ohio
University and who desire to hold an equity interest
in a firm, corporation, or other association to which
Ohio University has assigned, licensed or
transferred Ohio University’s interests…”
Consulting
Licensing University Technology
Clinical Studies
Procurement
Mentoring
Institutional
A disclosure is filed specific to the funding
application.
If you have a potential conflict for one
proposal, it does not automatically apply to
all of your proposals.
Research conflicts of interest are usually
disclosed using LEO as you apply for funding
by completing the conflict of interest section
of the electronic transmittal
If you are not using LEO, you can download
the appropriate disclosure form from
www.ohio.edu/research/compliance
“A” is selected if you have no conflicts to
disclose
“B” is selected if you have a potential conflict
to disclose relative to the submission.
(Requires a subsequent paper process)
“C” is selected if you have a current disclosure
on file, but it is not relevant to the proposal
you are submitting
Still uses option A, B or C
Requires that you gather signatures on paper
for all options, however
Generally used for personnel not listed on the
grant proposal or “key personnel”
We have revised the COI forms to word forms
This should be easier to complete than the
previous form
PDF versions are also available
Should be on the compliance web site soon,
but we can e-mail them to you until then
Use this form only if you are unable to use
the LEO transmittal form to assure that no
conflict of interest exists. A form must be
completed for each proposal.
I assure that I have read Ohio University
Policy 19.058, “Conflict of Interest in
Research, Educational, and Public Service
Activities” and declare that I have nothing
that is, or could be perceived to be a conflict
of interest with this proposal.
Use this form to disclose a potential conflict
of interest situation.
A separate disclosure form must be used for
each entity with which you conduct business
Conflict includes any member of your
immediate family (spouse, domestic partner
or children)
Require that you complete an option “B”
disclosure statement in addition to
completing the LEO transmittal form.
Require you to obtain signatures from Center
or Institute (if applicable), Chair and Dean on
the additional disclosure statement!!
The B disclosure form is available at
www.ohio.edu/research/compliance
Use this form only if you are unable to use
the LEO transmittal form. Complete this form
if you have a current conflict of interest
disclosure on file with the Office of Research
Compliance, but that disclosure is not
applicable to this proposal.
*New Option for 2008*
A management plan is developed for some
disclosures to mitigate the potential conflict
Management plans are specific to each
disclosure
May require submission of additional pieces,
such as a student employment plan
Reduce or remove the financial interest creating the
conflict
Place safeguards that mitigate the conflict potential,
such having some decisions made by an independent
entity
Limit participation in portions of the proposed
research likely to create a conflict
Require that the researcher disclose his or her
conflicting financial interests to all collaborators and
any proposed trainees;
Disclose the conflict in publications
Work to remove students from being directly advised
or taught by faculty where a conflict exists
Assure publication rights for student participants
Student Use
Nepotism and Cronyism
Intellectual Property
Use of University Resources
Publication provisions
Use of Human Subjects
Oversight Requirements
Reporting and Annual Reviews
You must submit an annual renewal for your
disclosure
◦ If the potential conflict no longer exists you must
notify us
If significant changes occur during the year
you should submit an update to your
disclosure as they occur
Yes. We encourage employees to disclose
potential conflicts that do not meet the
financial threshold, but may still be
problematic, such as student employment.
This allows you to be transparent with
respect to outside interests.
Allowable situations
Situations that require disclosure but may not
need an extensive management plan
Situations that require disclosure and have
problematic elements that will require
mitigation and/or a management plan
Situations that are not permitted
Receipt of royalties or honoraria for
published scholarly works, seminars,
teaching, etc.
Honoraria for serving as a special reviewer
or work on review panels
Royalties under our intellectual property
policies if no other relationship with entity
Clinical income at OUCOM
You participate in research developed in
whole or part by you, and you or your
family receive royalties from an existing
agreement with the business, but have
no other significant financial interest
You assign students, etc. to research
projects where you are entitled to
receive royalties, but have no other
significant financial interest
You assign students, etc. to projects supported
by the business through an SRA, and have a
significant financial interest other than royalty
income
You receive research support from a business in
which you serve on the board of directors, or
other advisory board, even if you are not
compensated.
You hold an executive position in a business
engaged in commercial or research activities
directly related to your Ohio University
responsibilities.
Any situation in which an actual conflict
exists is not permitted.
The only “exceptions” are those handled
under Ohio University Policy and Procedure
19.059 where faculty entrepreneurship is
addressed.
Participation in clinical trials or evaluation
of other research in which you have a
significant financial interest other than
royalty income.
In the context of your position at Ohio
University, you make professional referrals
to a business in which you have a
significant financial interest.
Letter of admonition
Ineligibility to submit grant applications
Withholding of IRB or IACUC approvals
Suspension
Non-Renewal
Loss of Tenure
Consulting
Procurement
Mentoring
Clinical Studies
Avoid consulting relationships that have
the potential to divert time and effort from
your responsibilities to Ohio University.
Do not use students.
Be wary of situations that limit publication.
Do not use university stationary, etc. that
could create an impression the university
is involved with the activities.
Make sure you are devoting sufficient time
to your university obligations.
Be cautious that the potential financial gain
cannot be perceived to influence your
university mentoring relationships.
Disclose any personal or familial financial
interest or equity in a company that is
doing business with Ohio University.
If you make purchases using public funds,
you should not use companies which will
benefit you or your family. If there is no
alternative you must seek and receive
permission prior to purchasing.
Any relationship in which there is a real or
perceived power or influence imbalance has
the potential for conflict. (Faculty:Student)
Isolating these relationships with respect to
areas of personal financial gain is best.
If they cannot be isolated, then safeguards
must be created.
If you have a financial interest, it is best to
isolate yourself from the study.
At a minimum, expect a more intense review
and a robust management plan if you have a
financial interest.
If both the institution and you have financial
interests the clinical study should be
conducted elsewhere.
You have administrative responsibilities on
behalf of Ohio University that is beneficial to
the business in which you have a significant
financial interest
You have administrative responsibilities on
behalf of Ohio University with respect to an
SRA where you have a significant financial
interest
Slide 51
Jo Ellen Sherow
Ohio University
Office of Research Compliance
Researchers’ Financial Disclosures in the
Spotlight
Conflicts of interest, always an emotional topic,
returned to the headlines this week as Sen.
Charles Grassley, a longtime critic of the drug
industry’s potential influence on research,
released new evidence that prominent Harvard
University scientists had failed to disclose much
of their outside income from pharmaceutical
companies over the past eight years.
http://www.insidehighered.com/news/2008/06/12/conflict January 15, 2008
WEDNESDAY, JANUARY 21, 2009
In a review of the literature regarding the relationship between
smokeless tobacco use and cancer, a conflict of interest of one of the
article's authors was initially not disclosed (see: Boffetta P, Hecht S, Gray
N, Gupta P, Straif K. Smokeless tobacco and cancer. Lancet Oncology
2008; 9:667-675). The original article was published in July, 2008. That
article stated: "The authors declare no conflicts of interest." After the
editor of the journal was notified by a researcher with knowledge of a
potential conflict of interest of Dr. Stephen Hecht (one of the study
authors), an erratum was published in September 2008, which noted:
"During the immediate months preceding submission of the review SH
was acting in the capacity of an expert witness for the plaintiff in a
future court case against a smokeless tobacco company. SH declares his
participation in this case in no way influenced his writing or involvement
in the review."
http://tobaccoanalysis.blogspot.com/2009/01/conflict-of-interestnot.html
January 16, 2009 — More than one third of new
drug marketing applications approved by the US
Food and Drug Administration (FDA) were
missing information about potential conflicts of
interest for clinical trial investigators, which
could allow bias to creep into the approvals
process, a government report released this week
has found. The FDA has said that it agrees with
most of the report's findings.
http://www.medscape.com/viewarticle/586980
Do collaborations between biotech companies
and academic centers constitute a conflict of
interest?
Biotechnology industry partnerships with
universities and academic centers have been
fruitful for both. So why is there so much
concern about conflict of interest and is that
concern appropriate?
http://www.redorbit.com/news/health/750100/genetic_engineering_news_p
osts_podcast_on_industrialacademic_collaborations_are_these/index.html
Universities are responsible for use of public
funds and therefore must maintain the public
trust.
Identifying and mitigating situations that may
have the potential for conflict maintains the
integrity of the university.
Maintaining integrity allows the university to
do credible academic research.
To provide information on the purpose of the
conflict of interest requirements.
To provide a basic overview of conflicts of
interest
To introduce the disclosure process and the use
of management plans
To provide information on the need for updates
and annual renewals.
Situations where financial considerations
compromise your professional judgment.
“Actual Conflict of Interest”
◦ Not permitted
Situations where an independent observer
might reasonably question whether your
professional actions or decisions are
determined by considerations of personal
gain. “Perceived Conflict of Interest”
◦ Managed
Potential conflicts may be financial or may be
a conflict of time, effort and/or commitment.
Potential conflicts can occur as a result of
administrative, scientific, academic, fiduciary
or familial situations.
They are situations that can be PERCEIVED to
be conflicting, whether a “real” conflict exists
or not.
Ohio University Policy has a mandatory
disclosure policy if you:
Earn over $10,000 in a twelve month period
from your outside activity OR
Have over 5% equity in the entity
Applies to members of your immediate family
(spouse, domestic partner, dependent
children) as well as yourself.
Anything of monetary value, including but not
limited to:
◦
◦
◦
◦
Salary
Payments for services
Equity interests over 5%
Intellectual property rights
Excludes mutual, pension and other
investments over which you have no control
Outside work during regular academic year
should not exceed equivalent of 1 day per
week.
Consulting work must avoid activities that
involve a conflict of interest with assigned
Ohio University activities and programs
Faculty Handbook, section IV-D
Outside interests cannot interfere with
primary loyalty to Ohio University and your
academic role
Use of university resources must have prior
approval of Chair, Dean and VPR.
Your outside interests should not be in
direct competition with university interests
Full time administrative employees are
expected to devote their full-time
professional loyalty, time and energy to their
position.
You must use non-work hours and no
university resources
Federal Agencies
State Law
University Policies
Many Academic Publications
45 CFR Part 50, Subpart F
“Responsibility of Applicants for Promoting
Objectivity in Research for Which PHS Funding
is Sought”
Authority: 42 U.S.C. 216, 289b-1, 299c-3.
Intent is to assure objectivity by establishing
standards that preclude bias in design, conduct, or
reporting of research
Focuses on financial conflicts of interest
(FCOI)
Regulations apply to investigators, including
sub grantees, contractors, and collaborating
investigators.
Does not apply to applications for support
under Phase I of SBIR and STTR programs
An institutional conflict of interest policy should
require that each investigator disclose to a
responsible representative of the institution all
significant financial interests of the investigator
(including those of the investigator’s spouse and
dependent children) (i) that would reasonably
appear to be affected by the research or
educational activities funded or proposed for
funding by NSF; or (ii) in entities whose financial
interests would reasonably appear to be affected
by such activities.
Chapter 1 (Subchapter A) (Part 54)
Financial Disclosure by Clinical Investigators
The Food and Drug Administration (FDA)
regulations state that investigators that
receive compensation in excess of $25,000
from a corporate sponsor of a trial in which
the investigator is engaged must disclose to
the FDA at the time of filing for a new drug
application.
19.058, Conflict of Interest in Research,
Educational, and Public Service Activities
19.059, Employee Participation in Authorized
Private Companies Commercializing Ohio
University Research
“Conflict of Interest in Research, Educational,
and Public Service Activities”
Most conflict disclosures fall within the
parameters of this policy
States that faculty are primarily responsible
for their academic, research and service
obligations
“Employee Participation in Authorized Private
Companies Commercializing Ohio University
Research”
Applies to “employees, faculty, staff and students,
who create intellectual property owned by the Ohio
University and who desire to hold an equity interest
in a firm, corporation, or other association to which
Ohio University has assigned, licensed or
transferred Ohio University’s interests…”
Consulting
Licensing University Technology
Clinical Studies
Procurement
Mentoring
Institutional
A disclosure is filed specific to the funding
application.
If you have a potential conflict for one
proposal, it does not automatically apply to
all of your proposals.
Research conflicts of interest are usually
disclosed using LEO as you apply for funding
by completing the conflict of interest section
of the electronic transmittal
If you are not using LEO, you can download
the appropriate disclosure form from
www.ohio.edu/research/compliance
“A” is selected if you have no conflicts to
disclose
“B” is selected if you have a potential conflict
to disclose relative to the submission.
(Requires a subsequent paper process)
“C” is selected if you have a current disclosure
on file, but it is not relevant to the proposal
you are submitting
Still uses option A, B or C
Requires that you gather signatures on paper
for all options, however
Generally used for personnel not listed on the
grant proposal or “key personnel”
We have revised the COI forms to word forms
This should be easier to complete than the
previous form
PDF versions are also available
Should be on the compliance web site soon,
but we can e-mail them to you until then
Use this form only if you are unable to use
the LEO transmittal form to assure that no
conflict of interest exists. A form must be
completed for each proposal.
I assure that I have read Ohio University
Policy 19.058, “Conflict of Interest in
Research, Educational, and Public Service
Activities” and declare that I have nothing
that is, or could be perceived to be a conflict
of interest with this proposal.
Use this form to disclose a potential conflict
of interest situation.
A separate disclosure form must be used for
each entity with which you conduct business
Conflict includes any member of your
immediate family (spouse, domestic partner
or children)
Require that you complete an option “B”
disclosure statement in addition to
completing the LEO transmittal form.
Require you to obtain signatures from Center
or Institute (if applicable), Chair and Dean on
the additional disclosure statement!!
The B disclosure form is available at
www.ohio.edu/research/compliance
Use this form only if you are unable to use
the LEO transmittal form. Complete this form
if you have a current conflict of interest
disclosure on file with the Office of Research
Compliance, but that disclosure is not
applicable to this proposal.
*New Option for 2008*
A management plan is developed for some
disclosures to mitigate the potential conflict
Management plans are specific to each
disclosure
May require submission of additional pieces,
such as a student employment plan
Reduce or remove the financial interest creating the
conflict
Place safeguards that mitigate the conflict potential,
such having some decisions made by an independent
entity
Limit participation in portions of the proposed
research likely to create a conflict
Require that the researcher disclose his or her
conflicting financial interests to all collaborators and
any proposed trainees;
Disclose the conflict in publications
Work to remove students from being directly advised
or taught by faculty where a conflict exists
Assure publication rights for student participants
Student Use
Nepotism and Cronyism
Intellectual Property
Use of University Resources
Publication provisions
Use of Human Subjects
Oversight Requirements
Reporting and Annual Reviews
You must submit an annual renewal for your
disclosure
◦ If the potential conflict no longer exists you must
notify us
If significant changes occur during the year
you should submit an update to your
disclosure as they occur
Yes. We encourage employees to disclose
potential conflicts that do not meet the
financial threshold, but may still be
problematic, such as student employment.
This allows you to be transparent with
respect to outside interests.
Allowable situations
Situations that require disclosure but may not
need an extensive management plan
Situations that require disclosure and have
problematic elements that will require
mitigation and/or a management plan
Situations that are not permitted
Receipt of royalties or honoraria for
published scholarly works, seminars,
teaching, etc.
Honoraria for serving as a special reviewer
or work on review panels
Royalties under our intellectual property
policies if no other relationship with entity
Clinical income at OUCOM
You participate in research developed in
whole or part by you, and you or your
family receive royalties from an existing
agreement with the business, but have
no other significant financial interest
You assign students, etc. to research
projects where you are entitled to
receive royalties, but have no other
significant financial interest
You assign students, etc. to projects supported
by the business through an SRA, and have a
significant financial interest other than royalty
income
You receive research support from a business in
which you serve on the board of directors, or
other advisory board, even if you are not
compensated.
You hold an executive position in a business
engaged in commercial or research activities
directly related to your Ohio University
responsibilities.
Any situation in which an actual conflict
exists is not permitted.
The only “exceptions” are those handled
under Ohio University Policy and Procedure
19.059 where faculty entrepreneurship is
addressed.
Participation in clinical trials or evaluation
of other research in which you have a
significant financial interest other than
royalty income.
In the context of your position at Ohio
University, you make professional referrals
to a business in which you have a
significant financial interest.
Letter of admonition
Ineligibility to submit grant applications
Withholding of IRB or IACUC approvals
Suspension
Non-Renewal
Loss of Tenure
Consulting
Procurement
Mentoring
Clinical Studies
Avoid consulting relationships that have
the potential to divert time and effort from
your responsibilities to Ohio University.
Do not use students.
Be wary of situations that limit publication.
Do not use university stationary, etc. that
could create an impression the university
is involved with the activities.
Make sure you are devoting sufficient time
to your university obligations.
Be cautious that the potential financial gain
cannot be perceived to influence your
university mentoring relationships.
Disclose any personal or familial financial
interest or equity in a company that is
doing business with Ohio University.
If you make purchases using public funds,
you should not use companies which will
benefit you or your family. If there is no
alternative you must seek and receive
permission prior to purchasing.
Any relationship in which there is a real or
perceived power or influence imbalance has
the potential for conflict. (Faculty:Student)
Isolating these relationships with respect to
areas of personal financial gain is best.
If they cannot be isolated, then safeguards
must be created.
If you have a financial interest, it is best to
isolate yourself from the study.
At a minimum, expect a more intense review
and a robust management plan if you have a
financial interest.
If both the institution and you have financial
interests the clinical study should be
conducted elsewhere.
You have administrative responsibilities on
behalf of Ohio University that is beneficial to
the business in which you have a significant
financial interest
You have administrative responsibilities on
behalf of Ohio University with respect to an
SRA where you have a significant financial
interest
Jo Ellen Sherow
Ohio University
Office of Research Compliance
Researchers’ Financial Disclosures in the
Spotlight
Conflicts of interest, always an emotional topic,
returned to the headlines this week as Sen.
Charles Grassley, a longtime critic of the drug
industry’s potential influence on research,
released new evidence that prominent Harvard
University scientists had failed to disclose much
of their outside income from pharmaceutical
companies over the past eight years.
http://www.insidehighered.com/news/2008/06/12/conflict January 15, 2008
WEDNESDAY, JANUARY 21, 2009
In a review of the literature regarding the relationship between
smokeless tobacco use and cancer, a conflict of interest of one of the
article's authors was initially not disclosed (see: Boffetta P, Hecht S, Gray
N, Gupta P, Straif K. Smokeless tobacco and cancer. Lancet Oncology
2008; 9:667-675). The original article was published in July, 2008. That
article stated: "The authors declare no conflicts of interest." After the
editor of the journal was notified by a researcher with knowledge of a
potential conflict of interest of Dr. Stephen Hecht (one of the study
authors), an erratum was published in September 2008, which noted:
"During the immediate months preceding submission of the review SH
was acting in the capacity of an expert witness for the plaintiff in a
future court case against a smokeless tobacco company. SH declares his
participation in this case in no way influenced his writing or involvement
in the review."
http://tobaccoanalysis.blogspot.com/2009/01/conflict-of-interestnot.html
January 16, 2009 — More than one third of new
drug marketing applications approved by the US
Food and Drug Administration (FDA) were
missing information about potential conflicts of
interest for clinical trial investigators, which
could allow bias to creep into the approvals
process, a government report released this week
has found. The FDA has said that it agrees with
most of the report's findings.
http://www.medscape.com/viewarticle/586980
Do collaborations between biotech companies
and academic centers constitute a conflict of
interest?
Biotechnology industry partnerships with
universities and academic centers have been
fruitful for both. So why is there so much
concern about conflict of interest and is that
concern appropriate?
http://www.redorbit.com/news/health/750100/genetic_engineering_news_p
osts_podcast_on_industrialacademic_collaborations_are_these/index.html
Universities are responsible for use of public
funds and therefore must maintain the public
trust.
Identifying and mitigating situations that may
have the potential for conflict maintains the
integrity of the university.
Maintaining integrity allows the university to
do credible academic research.
To provide information on the purpose of the
conflict of interest requirements.
To provide a basic overview of conflicts of
interest
To introduce the disclosure process and the use
of management plans
To provide information on the need for updates
and annual renewals.
Situations where financial considerations
compromise your professional judgment.
“Actual Conflict of Interest”
◦ Not permitted
Situations where an independent observer
might reasonably question whether your
professional actions or decisions are
determined by considerations of personal
gain. “Perceived Conflict of Interest”
◦ Managed
Potential conflicts may be financial or may be
a conflict of time, effort and/or commitment.
Potential conflicts can occur as a result of
administrative, scientific, academic, fiduciary
or familial situations.
They are situations that can be PERCEIVED to
be conflicting, whether a “real” conflict exists
or not.
Ohio University Policy has a mandatory
disclosure policy if you:
Earn over $10,000 in a twelve month period
from your outside activity OR
Have over 5% equity in the entity
Applies to members of your immediate family
(spouse, domestic partner, dependent
children) as well as yourself.
Anything of monetary value, including but not
limited to:
◦
◦
◦
◦
Salary
Payments for services
Equity interests over 5%
Intellectual property rights
Excludes mutual, pension and other
investments over which you have no control
Outside work during regular academic year
should not exceed equivalent of 1 day per
week.
Consulting work must avoid activities that
involve a conflict of interest with assigned
Ohio University activities and programs
Faculty Handbook, section IV-D
Outside interests cannot interfere with
primary loyalty to Ohio University and your
academic role
Use of university resources must have prior
approval of Chair, Dean and VPR.
Your outside interests should not be in
direct competition with university interests
Full time administrative employees are
expected to devote their full-time
professional loyalty, time and energy to their
position.
You must use non-work hours and no
university resources
Federal Agencies
State Law
University Policies
Many Academic Publications
45 CFR Part 50, Subpart F
“Responsibility of Applicants for Promoting
Objectivity in Research for Which PHS Funding
is Sought”
Authority: 42 U.S.C. 216, 289b-1, 299c-3.
Intent is to assure objectivity by establishing
standards that preclude bias in design, conduct, or
reporting of research
Focuses on financial conflicts of interest
(FCOI)
Regulations apply to investigators, including
sub grantees, contractors, and collaborating
investigators.
Does not apply to applications for support
under Phase I of SBIR and STTR programs
An institutional conflict of interest policy should
require that each investigator disclose to a
responsible representative of the institution all
significant financial interests of the investigator
(including those of the investigator’s spouse and
dependent children) (i) that would reasonably
appear to be affected by the research or
educational activities funded or proposed for
funding by NSF; or (ii) in entities whose financial
interests would reasonably appear to be affected
by such activities.
Chapter 1 (Subchapter A) (Part 54)
Financial Disclosure by Clinical Investigators
The Food and Drug Administration (FDA)
regulations state that investigators that
receive compensation in excess of $25,000
from a corporate sponsor of a trial in which
the investigator is engaged must disclose to
the FDA at the time of filing for a new drug
application.
19.058, Conflict of Interest in Research,
Educational, and Public Service Activities
19.059, Employee Participation in Authorized
Private Companies Commercializing Ohio
University Research
“Conflict of Interest in Research, Educational,
and Public Service Activities”
Most conflict disclosures fall within the
parameters of this policy
States that faculty are primarily responsible
for their academic, research and service
obligations
“Employee Participation in Authorized Private
Companies Commercializing Ohio University
Research”
Applies to “employees, faculty, staff and students,
who create intellectual property owned by the Ohio
University and who desire to hold an equity interest
in a firm, corporation, or other association to which
Ohio University has assigned, licensed or
transferred Ohio University’s interests…”
Consulting
Licensing University Technology
Clinical Studies
Procurement
Mentoring
Institutional
A disclosure is filed specific to the funding
application.
If you have a potential conflict for one
proposal, it does not automatically apply to
all of your proposals.
Research conflicts of interest are usually
disclosed using LEO as you apply for funding
by completing the conflict of interest section
of the electronic transmittal
If you are not using LEO, you can download
the appropriate disclosure form from
www.ohio.edu/research/compliance
“A” is selected if you have no conflicts to
disclose
“B” is selected if you have a potential conflict
to disclose relative to the submission.
(Requires a subsequent paper process)
“C” is selected if you have a current disclosure
on file, but it is not relevant to the proposal
you are submitting
Still uses option A, B or C
Requires that you gather signatures on paper
for all options, however
Generally used for personnel not listed on the
grant proposal or “key personnel”
We have revised the COI forms to word forms
This should be easier to complete than the
previous form
PDF versions are also available
Should be on the compliance web site soon,
but we can e-mail them to you until then
Use this form only if you are unable to use
the LEO transmittal form to assure that no
conflict of interest exists. A form must be
completed for each proposal.
I assure that I have read Ohio University
Policy 19.058, “Conflict of Interest in
Research, Educational, and Public Service
Activities” and declare that I have nothing
that is, or could be perceived to be a conflict
of interest with this proposal.
Use this form to disclose a potential conflict
of interest situation.
A separate disclosure form must be used for
each entity with which you conduct business
Conflict includes any member of your
immediate family (spouse, domestic partner
or children)
Require that you complete an option “B”
disclosure statement in addition to
completing the LEO transmittal form.
Require you to obtain signatures from Center
or Institute (if applicable), Chair and Dean on
the additional disclosure statement!!
The B disclosure form is available at
www.ohio.edu/research/compliance
Use this form only if you are unable to use
the LEO transmittal form. Complete this form
if you have a current conflict of interest
disclosure on file with the Office of Research
Compliance, but that disclosure is not
applicable to this proposal.
*New Option for 2008*
A management plan is developed for some
disclosures to mitigate the potential conflict
Management plans are specific to each
disclosure
May require submission of additional pieces,
such as a student employment plan
Reduce or remove the financial interest creating the
conflict
Place safeguards that mitigate the conflict potential,
such having some decisions made by an independent
entity
Limit participation in portions of the proposed
research likely to create a conflict
Require that the researcher disclose his or her
conflicting financial interests to all collaborators and
any proposed trainees;
Disclose the conflict in publications
Work to remove students from being directly advised
or taught by faculty where a conflict exists
Assure publication rights for student participants
Student Use
Nepotism and Cronyism
Intellectual Property
Use of University Resources
Publication provisions
Use of Human Subjects
Oversight Requirements
Reporting and Annual Reviews
You must submit an annual renewal for your
disclosure
◦ If the potential conflict no longer exists you must
notify us
If significant changes occur during the year
you should submit an update to your
disclosure as they occur
Yes. We encourage employees to disclose
potential conflicts that do not meet the
financial threshold, but may still be
problematic, such as student employment.
This allows you to be transparent with
respect to outside interests.
Allowable situations
Situations that require disclosure but may not
need an extensive management plan
Situations that require disclosure and have
problematic elements that will require
mitigation and/or a management plan
Situations that are not permitted
Receipt of royalties or honoraria for
published scholarly works, seminars,
teaching, etc.
Honoraria for serving as a special reviewer
or work on review panels
Royalties under our intellectual property
policies if no other relationship with entity
Clinical income at OUCOM
You participate in research developed in
whole or part by you, and you or your
family receive royalties from an existing
agreement with the business, but have
no other significant financial interest
You assign students, etc. to research
projects where you are entitled to
receive royalties, but have no other
significant financial interest
You assign students, etc. to projects supported
by the business through an SRA, and have a
significant financial interest other than royalty
income
You receive research support from a business in
which you serve on the board of directors, or
other advisory board, even if you are not
compensated.
You hold an executive position in a business
engaged in commercial or research activities
directly related to your Ohio University
responsibilities.
Any situation in which an actual conflict
exists is not permitted.
The only “exceptions” are those handled
under Ohio University Policy and Procedure
19.059 where faculty entrepreneurship is
addressed.
Participation in clinical trials or evaluation
of other research in which you have a
significant financial interest other than
royalty income.
In the context of your position at Ohio
University, you make professional referrals
to a business in which you have a
significant financial interest.
Letter of admonition
Ineligibility to submit grant applications
Withholding of IRB or IACUC approvals
Suspension
Non-Renewal
Loss of Tenure
Consulting
Procurement
Mentoring
Clinical Studies
Avoid consulting relationships that have
the potential to divert time and effort from
your responsibilities to Ohio University.
Do not use students.
Be wary of situations that limit publication.
Do not use university stationary, etc. that
could create an impression the university
is involved with the activities.
Make sure you are devoting sufficient time
to your university obligations.
Be cautious that the potential financial gain
cannot be perceived to influence your
university mentoring relationships.
Disclose any personal or familial financial
interest or equity in a company that is
doing business with Ohio University.
If you make purchases using public funds,
you should not use companies which will
benefit you or your family. If there is no
alternative you must seek and receive
permission prior to purchasing.
Any relationship in which there is a real or
perceived power or influence imbalance has
the potential for conflict. (Faculty:Student)
Isolating these relationships with respect to
areas of personal financial gain is best.
If they cannot be isolated, then safeguards
must be created.
If you have a financial interest, it is best to
isolate yourself from the study.
At a minimum, expect a more intense review
and a robust management plan if you have a
financial interest.
If both the institution and you have financial
interests the clinical study should be
conducted elsewhere.
You have administrative responsibilities on
behalf of Ohio University that is beneficial to
the business in which you have a significant
financial interest
You have administrative responsibilities on
behalf of Ohio University with respect to an
SRA where you have a significant financial
interest
Slide 2
Jo Ellen Sherow
Ohio University
Office of Research Compliance
Researchers’ Financial Disclosures in the
Spotlight
Conflicts of interest, always an emotional topic,
returned to the headlines this week as Sen.
Charles Grassley, a longtime critic of the drug
industry’s potential influence on research,
released new evidence that prominent Harvard
University scientists had failed to disclose much
of their outside income from pharmaceutical
companies over the past eight years.
http://www.insidehighered.com/news/2008/06/12/conflict January 15, 2008
WEDNESDAY, JANUARY 21, 2009
In a review of the literature regarding the relationship between
smokeless tobacco use and cancer, a conflict of interest of one of the
article's authors was initially not disclosed (see: Boffetta P, Hecht S, Gray
N, Gupta P, Straif K. Smokeless tobacco and cancer. Lancet Oncology
2008; 9:667-675). The original article was published in July, 2008. That
article stated: "The authors declare no conflicts of interest." After the
editor of the journal was notified by a researcher with knowledge of a
potential conflict of interest of Dr. Stephen Hecht (one of the study
authors), an erratum was published in September 2008, which noted:
"During the immediate months preceding submission of the review SH
was acting in the capacity of an expert witness for the plaintiff in a
future court case against a smokeless tobacco company. SH declares his
participation in this case in no way influenced his writing or involvement
in the review."
http://tobaccoanalysis.blogspot.com/2009/01/conflict-of-interestnot.html
January 16, 2009 — More than one third of new
drug marketing applications approved by the US
Food and Drug Administration (FDA) were
missing information about potential conflicts of
interest for clinical trial investigators, which
could allow bias to creep into the approvals
process, a government report released this week
has found. The FDA has said that it agrees with
most of the report's findings.
http://www.medscape.com/viewarticle/586980
Do collaborations between biotech companies
and academic centers constitute a conflict of
interest?
Biotechnology industry partnerships with
universities and academic centers have been
fruitful for both. So why is there so much
concern about conflict of interest and is that
concern appropriate?
http://www.redorbit.com/news/health/750100/genetic_engineering_news_p
osts_podcast_on_industrialacademic_collaborations_are_these/index.html
Universities are responsible for use of public
funds and therefore must maintain the public
trust.
Identifying and mitigating situations that may
have the potential for conflict maintains the
integrity of the university.
Maintaining integrity allows the university to
do credible academic research.
To provide information on the purpose of the
conflict of interest requirements.
To provide a basic overview of conflicts of
interest
To introduce the disclosure process and the use
of management plans
To provide information on the need for updates
and annual renewals.
Situations where financial considerations
compromise your professional judgment.
“Actual Conflict of Interest”
◦ Not permitted
Situations where an independent observer
might reasonably question whether your
professional actions or decisions are
determined by considerations of personal
gain. “Perceived Conflict of Interest”
◦ Managed
Potential conflicts may be financial or may be
a conflict of time, effort and/or commitment.
Potential conflicts can occur as a result of
administrative, scientific, academic, fiduciary
or familial situations.
They are situations that can be PERCEIVED to
be conflicting, whether a “real” conflict exists
or not.
Ohio University Policy has a mandatory
disclosure policy if you:
Earn over $10,000 in a twelve month period
from your outside activity OR
Have over 5% equity in the entity
Applies to members of your immediate family
(spouse, domestic partner, dependent
children) as well as yourself.
Anything of monetary value, including but not
limited to:
◦
◦
◦
◦
Salary
Payments for services
Equity interests over 5%
Intellectual property rights
Excludes mutual, pension and other
investments over which you have no control
Outside work during regular academic year
should not exceed equivalent of 1 day per
week.
Consulting work must avoid activities that
involve a conflict of interest with assigned
Ohio University activities and programs
Faculty Handbook, section IV-D
Outside interests cannot interfere with
primary loyalty to Ohio University and your
academic role
Use of university resources must have prior
approval of Chair, Dean and VPR.
Your outside interests should not be in
direct competition with university interests
Full time administrative employees are
expected to devote their full-time
professional loyalty, time and energy to their
position.
You must use non-work hours and no
university resources
Federal Agencies
State Law
University Policies
Many Academic Publications
45 CFR Part 50, Subpart F
“Responsibility of Applicants for Promoting
Objectivity in Research for Which PHS Funding
is Sought”
Authority: 42 U.S.C. 216, 289b-1, 299c-3.
Intent is to assure objectivity by establishing
standards that preclude bias in design, conduct, or
reporting of research
Focuses on financial conflicts of interest
(FCOI)
Regulations apply to investigators, including
sub grantees, contractors, and collaborating
investigators.
Does not apply to applications for support
under Phase I of SBIR and STTR programs
An institutional conflict of interest policy should
require that each investigator disclose to a
responsible representative of the institution all
significant financial interests of the investigator
(including those of the investigator’s spouse and
dependent children) (i) that would reasonably
appear to be affected by the research or
educational activities funded or proposed for
funding by NSF; or (ii) in entities whose financial
interests would reasonably appear to be affected
by such activities.
Chapter 1 (Subchapter A) (Part 54)
Financial Disclosure by Clinical Investigators
The Food and Drug Administration (FDA)
regulations state that investigators that
receive compensation in excess of $25,000
from a corporate sponsor of a trial in which
the investigator is engaged must disclose to
the FDA at the time of filing for a new drug
application.
19.058, Conflict of Interest in Research,
Educational, and Public Service Activities
19.059, Employee Participation in Authorized
Private Companies Commercializing Ohio
University Research
“Conflict of Interest in Research, Educational,
and Public Service Activities”
Most conflict disclosures fall within the
parameters of this policy
States that faculty are primarily responsible
for their academic, research and service
obligations
“Employee Participation in Authorized Private
Companies Commercializing Ohio University
Research”
Applies to “employees, faculty, staff and students,
who create intellectual property owned by the Ohio
University and who desire to hold an equity interest
in a firm, corporation, or other association to which
Ohio University has assigned, licensed or
transferred Ohio University’s interests…”
Consulting
Licensing University Technology
Clinical Studies
Procurement
Mentoring
Institutional
A disclosure is filed specific to the funding
application.
If you have a potential conflict for one
proposal, it does not automatically apply to
all of your proposals.
Research conflicts of interest are usually
disclosed using LEO as you apply for funding
by completing the conflict of interest section
of the electronic transmittal
If you are not using LEO, you can download
the appropriate disclosure form from
www.ohio.edu/research/compliance
“A” is selected if you have no conflicts to
disclose
“B” is selected if you have a potential conflict
to disclose relative to the submission.
(Requires a subsequent paper process)
“C” is selected if you have a current disclosure
on file, but it is not relevant to the proposal
you are submitting
Still uses option A, B or C
Requires that you gather signatures on paper
for all options, however
Generally used for personnel not listed on the
grant proposal or “key personnel”
We have revised the COI forms to word forms
This should be easier to complete than the
previous form
PDF versions are also available
Should be on the compliance web site soon,
but we can e-mail them to you until then
Use this form only if you are unable to use
the LEO transmittal form to assure that no
conflict of interest exists. A form must be
completed for each proposal.
I assure that I have read Ohio University
Policy 19.058, “Conflict of Interest in
Research, Educational, and Public Service
Activities” and declare that I have nothing
that is, or could be perceived to be a conflict
of interest with this proposal.
Use this form to disclose a potential conflict
of interest situation.
A separate disclosure form must be used for
each entity with which you conduct business
Conflict includes any member of your
immediate family (spouse, domestic partner
or children)
Require that you complete an option “B”
disclosure statement in addition to
completing the LEO transmittal form.
Require you to obtain signatures from Center
or Institute (if applicable), Chair and Dean on
the additional disclosure statement!!
The B disclosure form is available at
www.ohio.edu/research/compliance
Use this form only if you are unable to use
the LEO transmittal form. Complete this form
if you have a current conflict of interest
disclosure on file with the Office of Research
Compliance, but that disclosure is not
applicable to this proposal.
*New Option for 2008*
A management plan is developed for some
disclosures to mitigate the potential conflict
Management plans are specific to each
disclosure
May require submission of additional pieces,
such as a student employment plan
Reduce or remove the financial interest creating the
conflict
Place safeguards that mitigate the conflict potential,
such having some decisions made by an independent
entity
Limit participation in portions of the proposed
research likely to create a conflict
Require that the researcher disclose his or her
conflicting financial interests to all collaborators and
any proposed trainees;
Disclose the conflict in publications
Work to remove students from being directly advised
or taught by faculty where a conflict exists
Assure publication rights for student participants
Student Use
Nepotism and Cronyism
Intellectual Property
Use of University Resources
Publication provisions
Use of Human Subjects
Oversight Requirements
Reporting and Annual Reviews
You must submit an annual renewal for your
disclosure
◦ If the potential conflict no longer exists you must
notify us
If significant changes occur during the year
you should submit an update to your
disclosure as they occur
Yes. We encourage employees to disclose
potential conflicts that do not meet the
financial threshold, but may still be
problematic, such as student employment.
This allows you to be transparent with
respect to outside interests.
Allowable situations
Situations that require disclosure but may not
need an extensive management plan
Situations that require disclosure and have
problematic elements that will require
mitigation and/or a management plan
Situations that are not permitted
Receipt of royalties or honoraria for
published scholarly works, seminars,
teaching, etc.
Honoraria for serving as a special reviewer
or work on review panels
Royalties under our intellectual property
policies if no other relationship with entity
Clinical income at OUCOM
You participate in research developed in
whole or part by you, and you or your
family receive royalties from an existing
agreement with the business, but have
no other significant financial interest
You assign students, etc. to research
projects where you are entitled to
receive royalties, but have no other
significant financial interest
You assign students, etc. to projects supported
by the business through an SRA, and have a
significant financial interest other than royalty
income
You receive research support from a business in
which you serve on the board of directors, or
other advisory board, even if you are not
compensated.
You hold an executive position in a business
engaged in commercial or research activities
directly related to your Ohio University
responsibilities.
Any situation in which an actual conflict
exists is not permitted.
The only “exceptions” are those handled
under Ohio University Policy and Procedure
19.059 where faculty entrepreneurship is
addressed.
Participation in clinical trials or evaluation
of other research in which you have a
significant financial interest other than
royalty income.
In the context of your position at Ohio
University, you make professional referrals
to a business in which you have a
significant financial interest.
Letter of admonition
Ineligibility to submit grant applications
Withholding of IRB or IACUC approvals
Suspension
Non-Renewal
Loss of Tenure
Consulting
Procurement
Mentoring
Clinical Studies
Avoid consulting relationships that have
the potential to divert time and effort from
your responsibilities to Ohio University.
Do not use students.
Be wary of situations that limit publication.
Do not use university stationary, etc. that
could create an impression the university
is involved with the activities.
Make sure you are devoting sufficient time
to your university obligations.
Be cautious that the potential financial gain
cannot be perceived to influence your
university mentoring relationships.
Disclose any personal or familial financial
interest or equity in a company that is
doing business with Ohio University.
If you make purchases using public funds,
you should not use companies which will
benefit you or your family. If there is no
alternative you must seek and receive
permission prior to purchasing.
Any relationship in which there is a real or
perceived power or influence imbalance has
the potential for conflict. (Faculty:Student)
Isolating these relationships with respect to
areas of personal financial gain is best.
If they cannot be isolated, then safeguards
must be created.
If you have a financial interest, it is best to
isolate yourself from the study.
At a minimum, expect a more intense review
and a robust management plan if you have a
financial interest.
If both the institution and you have financial
interests the clinical study should be
conducted elsewhere.
You have administrative responsibilities on
behalf of Ohio University that is beneficial to
the business in which you have a significant
financial interest
You have administrative responsibilities on
behalf of Ohio University with respect to an
SRA where you have a significant financial
interest
Slide 3
Jo Ellen Sherow
Ohio University
Office of Research Compliance
Researchers’ Financial Disclosures in the
Spotlight
Conflicts of interest, always an emotional topic,
returned to the headlines this week as Sen.
Charles Grassley, a longtime critic of the drug
industry’s potential influence on research,
released new evidence that prominent Harvard
University scientists had failed to disclose much
of their outside income from pharmaceutical
companies over the past eight years.
http://www.insidehighered.com/news/2008/06/12/conflict January 15, 2008
WEDNESDAY, JANUARY 21, 2009
In a review of the literature regarding the relationship between
smokeless tobacco use and cancer, a conflict of interest of one of the
article's authors was initially not disclosed (see: Boffetta P, Hecht S, Gray
N, Gupta P, Straif K. Smokeless tobacco and cancer. Lancet Oncology
2008; 9:667-675). The original article was published in July, 2008. That
article stated: "The authors declare no conflicts of interest." After the
editor of the journal was notified by a researcher with knowledge of a
potential conflict of interest of Dr. Stephen Hecht (one of the study
authors), an erratum was published in September 2008, which noted:
"During the immediate months preceding submission of the review SH
was acting in the capacity of an expert witness for the plaintiff in a
future court case against a smokeless tobacco company. SH declares his
participation in this case in no way influenced his writing or involvement
in the review."
http://tobaccoanalysis.blogspot.com/2009/01/conflict-of-interestnot.html
January 16, 2009 — More than one third of new
drug marketing applications approved by the US
Food and Drug Administration (FDA) were
missing information about potential conflicts of
interest for clinical trial investigators, which
could allow bias to creep into the approvals
process, a government report released this week
has found. The FDA has said that it agrees with
most of the report's findings.
http://www.medscape.com/viewarticle/586980
Do collaborations between biotech companies
and academic centers constitute a conflict of
interest?
Biotechnology industry partnerships with
universities and academic centers have been
fruitful for both. So why is there so much
concern about conflict of interest and is that
concern appropriate?
http://www.redorbit.com/news/health/750100/genetic_engineering_news_p
osts_podcast_on_industrialacademic_collaborations_are_these/index.html
Universities are responsible for use of public
funds and therefore must maintain the public
trust.
Identifying and mitigating situations that may
have the potential for conflict maintains the
integrity of the university.
Maintaining integrity allows the university to
do credible academic research.
To provide information on the purpose of the
conflict of interest requirements.
To provide a basic overview of conflicts of
interest
To introduce the disclosure process and the use
of management plans
To provide information on the need for updates
and annual renewals.
Situations where financial considerations
compromise your professional judgment.
“Actual Conflict of Interest”
◦ Not permitted
Situations where an independent observer
might reasonably question whether your
professional actions or decisions are
determined by considerations of personal
gain. “Perceived Conflict of Interest”
◦ Managed
Potential conflicts may be financial or may be
a conflict of time, effort and/or commitment.
Potential conflicts can occur as a result of
administrative, scientific, academic, fiduciary
or familial situations.
They are situations that can be PERCEIVED to
be conflicting, whether a “real” conflict exists
or not.
Ohio University Policy has a mandatory
disclosure policy if you:
Earn over $10,000 in a twelve month period
from your outside activity OR
Have over 5% equity in the entity
Applies to members of your immediate family
(spouse, domestic partner, dependent
children) as well as yourself.
Anything of monetary value, including but not
limited to:
◦
◦
◦
◦
Salary
Payments for services
Equity interests over 5%
Intellectual property rights
Excludes mutual, pension and other
investments over which you have no control
Outside work during regular academic year
should not exceed equivalent of 1 day per
week.
Consulting work must avoid activities that
involve a conflict of interest with assigned
Ohio University activities and programs
Faculty Handbook, section IV-D
Outside interests cannot interfere with
primary loyalty to Ohio University and your
academic role
Use of university resources must have prior
approval of Chair, Dean and VPR.
Your outside interests should not be in
direct competition with university interests
Full time administrative employees are
expected to devote their full-time
professional loyalty, time and energy to their
position.
You must use non-work hours and no
university resources
Federal Agencies
State Law
University Policies
Many Academic Publications
45 CFR Part 50, Subpart F
“Responsibility of Applicants for Promoting
Objectivity in Research for Which PHS Funding
is Sought”
Authority: 42 U.S.C. 216, 289b-1, 299c-3.
Intent is to assure objectivity by establishing
standards that preclude bias in design, conduct, or
reporting of research
Focuses on financial conflicts of interest
(FCOI)
Regulations apply to investigators, including
sub grantees, contractors, and collaborating
investigators.
Does not apply to applications for support
under Phase I of SBIR and STTR programs
An institutional conflict of interest policy should
require that each investigator disclose to a
responsible representative of the institution all
significant financial interests of the investigator
(including those of the investigator’s spouse and
dependent children) (i) that would reasonably
appear to be affected by the research or
educational activities funded or proposed for
funding by NSF; or (ii) in entities whose financial
interests would reasonably appear to be affected
by such activities.
Chapter 1 (Subchapter A) (Part 54)
Financial Disclosure by Clinical Investigators
The Food and Drug Administration (FDA)
regulations state that investigators that
receive compensation in excess of $25,000
from a corporate sponsor of a trial in which
the investigator is engaged must disclose to
the FDA at the time of filing for a new drug
application.
19.058, Conflict of Interest in Research,
Educational, and Public Service Activities
19.059, Employee Participation in Authorized
Private Companies Commercializing Ohio
University Research
“Conflict of Interest in Research, Educational,
and Public Service Activities”
Most conflict disclosures fall within the
parameters of this policy
States that faculty are primarily responsible
for their academic, research and service
obligations
“Employee Participation in Authorized Private
Companies Commercializing Ohio University
Research”
Applies to “employees, faculty, staff and students,
who create intellectual property owned by the Ohio
University and who desire to hold an equity interest
in a firm, corporation, or other association to which
Ohio University has assigned, licensed or
transferred Ohio University’s interests…”
Consulting
Licensing University Technology
Clinical Studies
Procurement
Mentoring
Institutional
A disclosure is filed specific to the funding
application.
If you have a potential conflict for one
proposal, it does not automatically apply to
all of your proposals.
Research conflicts of interest are usually
disclosed using LEO as you apply for funding
by completing the conflict of interest section
of the electronic transmittal
If you are not using LEO, you can download
the appropriate disclosure form from
www.ohio.edu/research/compliance
“A” is selected if you have no conflicts to
disclose
“B” is selected if you have a potential conflict
to disclose relative to the submission.
(Requires a subsequent paper process)
“C” is selected if you have a current disclosure
on file, but it is not relevant to the proposal
you are submitting
Still uses option A, B or C
Requires that you gather signatures on paper
for all options, however
Generally used for personnel not listed on the
grant proposal or “key personnel”
We have revised the COI forms to word forms
This should be easier to complete than the
previous form
PDF versions are also available
Should be on the compliance web site soon,
but we can e-mail them to you until then
Use this form only if you are unable to use
the LEO transmittal form to assure that no
conflict of interest exists. A form must be
completed for each proposal.
I assure that I have read Ohio University
Policy 19.058, “Conflict of Interest in
Research, Educational, and Public Service
Activities” and declare that I have nothing
that is, or could be perceived to be a conflict
of interest with this proposal.
Use this form to disclose a potential conflict
of interest situation.
A separate disclosure form must be used for
each entity with which you conduct business
Conflict includes any member of your
immediate family (spouse, domestic partner
or children)
Require that you complete an option “B”
disclosure statement in addition to
completing the LEO transmittal form.
Require you to obtain signatures from Center
or Institute (if applicable), Chair and Dean on
the additional disclosure statement!!
The B disclosure form is available at
www.ohio.edu/research/compliance
Use this form only if you are unable to use
the LEO transmittal form. Complete this form
if you have a current conflict of interest
disclosure on file with the Office of Research
Compliance, but that disclosure is not
applicable to this proposal.
*New Option for 2008*
A management plan is developed for some
disclosures to mitigate the potential conflict
Management plans are specific to each
disclosure
May require submission of additional pieces,
such as a student employment plan
Reduce or remove the financial interest creating the
conflict
Place safeguards that mitigate the conflict potential,
such having some decisions made by an independent
entity
Limit participation in portions of the proposed
research likely to create a conflict
Require that the researcher disclose his or her
conflicting financial interests to all collaborators and
any proposed trainees;
Disclose the conflict in publications
Work to remove students from being directly advised
or taught by faculty where a conflict exists
Assure publication rights for student participants
Student Use
Nepotism and Cronyism
Intellectual Property
Use of University Resources
Publication provisions
Use of Human Subjects
Oversight Requirements
Reporting and Annual Reviews
You must submit an annual renewal for your
disclosure
◦ If the potential conflict no longer exists you must
notify us
If significant changes occur during the year
you should submit an update to your
disclosure as they occur
Yes. We encourage employees to disclose
potential conflicts that do not meet the
financial threshold, but may still be
problematic, such as student employment.
This allows you to be transparent with
respect to outside interests.
Allowable situations
Situations that require disclosure but may not
need an extensive management plan
Situations that require disclosure and have
problematic elements that will require
mitigation and/or a management plan
Situations that are not permitted
Receipt of royalties or honoraria for
published scholarly works, seminars,
teaching, etc.
Honoraria for serving as a special reviewer
or work on review panels
Royalties under our intellectual property
policies if no other relationship with entity
Clinical income at OUCOM
You participate in research developed in
whole or part by you, and you or your
family receive royalties from an existing
agreement with the business, but have
no other significant financial interest
You assign students, etc. to research
projects where you are entitled to
receive royalties, but have no other
significant financial interest
You assign students, etc. to projects supported
by the business through an SRA, and have a
significant financial interest other than royalty
income
You receive research support from a business in
which you serve on the board of directors, or
other advisory board, even if you are not
compensated.
You hold an executive position in a business
engaged in commercial or research activities
directly related to your Ohio University
responsibilities.
Any situation in which an actual conflict
exists is not permitted.
The only “exceptions” are those handled
under Ohio University Policy and Procedure
19.059 where faculty entrepreneurship is
addressed.
Participation in clinical trials or evaluation
of other research in which you have a
significant financial interest other than
royalty income.
In the context of your position at Ohio
University, you make professional referrals
to a business in which you have a
significant financial interest.
Letter of admonition
Ineligibility to submit grant applications
Withholding of IRB or IACUC approvals
Suspension
Non-Renewal
Loss of Tenure
Consulting
Procurement
Mentoring
Clinical Studies
Avoid consulting relationships that have
the potential to divert time and effort from
your responsibilities to Ohio University.
Do not use students.
Be wary of situations that limit publication.
Do not use university stationary, etc. that
could create an impression the university
is involved with the activities.
Make sure you are devoting sufficient time
to your university obligations.
Be cautious that the potential financial gain
cannot be perceived to influence your
university mentoring relationships.
Disclose any personal or familial financial
interest or equity in a company that is
doing business with Ohio University.
If you make purchases using public funds,
you should not use companies which will
benefit you or your family. If there is no
alternative you must seek and receive
permission prior to purchasing.
Any relationship in which there is a real or
perceived power or influence imbalance has
the potential for conflict. (Faculty:Student)
Isolating these relationships with respect to
areas of personal financial gain is best.
If they cannot be isolated, then safeguards
must be created.
If you have a financial interest, it is best to
isolate yourself from the study.
At a minimum, expect a more intense review
and a robust management plan if you have a
financial interest.
If both the institution and you have financial
interests the clinical study should be
conducted elsewhere.
You have administrative responsibilities on
behalf of Ohio University that is beneficial to
the business in which you have a significant
financial interest
You have administrative responsibilities on
behalf of Ohio University with respect to an
SRA where you have a significant financial
interest
Slide 4
Jo Ellen Sherow
Ohio University
Office of Research Compliance
Researchers’ Financial Disclosures in the
Spotlight
Conflicts of interest, always an emotional topic,
returned to the headlines this week as Sen.
Charles Grassley, a longtime critic of the drug
industry’s potential influence on research,
released new evidence that prominent Harvard
University scientists had failed to disclose much
of their outside income from pharmaceutical
companies over the past eight years.
http://www.insidehighered.com/news/2008/06/12/conflict January 15, 2008
WEDNESDAY, JANUARY 21, 2009
In a review of the literature regarding the relationship between
smokeless tobacco use and cancer, a conflict of interest of one of the
article's authors was initially not disclosed (see: Boffetta P, Hecht S, Gray
N, Gupta P, Straif K. Smokeless tobacco and cancer. Lancet Oncology
2008; 9:667-675). The original article was published in July, 2008. That
article stated: "The authors declare no conflicts of interest." After the
editor of the journal was notified by a researcher with knowledge of a
potential conflict of interest of Dr. Stephen Hecht (one of the study
authors), an erratum was published in September 2008, which noted:
"During the immediate months preceding submission of the review SH
was acting in the capacity of an expert witness for the plaintiff in a
future court case against a smokeless tobacco company. SH declares his
participation in this case in no way influenced his writing or involvement
in the review."
http://tobaccoanalysis.blogspot.com/2009/01/conflict-of-interestnot.html
January 16, 2009 — More than one third of new
drug marketing applications approved by the US
Food and Drug Administration (FDA) were
missing information about potential conflicts of
interest for clinical trial investigators, which
could allow bias to creep into the approvals
process, a government report released this week
has found. The FDA has said that it agrees with
most of the report's findings.
http://www.medscape.com/viewarticle/586980
Do collaborations between biotech companies
and academic centers constitute a conflict of
interest?
Biotechnology industry partnerships with
universities and academic centers have been
fruitful for both. So why is there so much
concern about conflict of interest and is that
concern appropriate?
http://www.redorbit.com/news/health/750100/genetic_engineering_news_p
osts_podcast_on_industrialacademic_collaborations_are_these/index.html
Universities are responsible for use of public
funds and therefore must maintain the public
trust.
Identifying and mitigating situations that may
have the potential for conflict maintains the
integrity of the university.
Maintaining integrity allows the university to
do credible academic research.
To provide information on the purpose of the
conflict of interest requirements.
To provide a basic overview of conflicts of
interest
To introduce the disclosure process and the use
of management plans
To provide information on the need for updates
and annual renewals.
Situations where financial considerations
compromise your professional judgment.
“Actual Conflict of Interest”
◦ Not permitted
Situations where an independent observer
might reasonably question whether your
professional actions or decisions are
determined by considerations of personal
gain. “Perceived Conflict of Interest”
◦ Managed
Potential conflicts may be financial or may be
a conflict of time, effort and/or commitment.
Potential conflicts can occur as a result of
administrative, scientific, academic, fiduciary
or familial situations.
They are situations that can be PERCEIVED to
be conflicting, whether a “real” conflict exists
or not.
Ohio University Policy has a mandatory
disclosure policy if you:
Earn over $10,000 in a twelve month period
from your outside activity OR
Have over 5% equity in the entity
Applies to members of your immediate family
(spouse, domestic partner, dependent
children) as well as yourself.
Anything of monetary value, including but not
limited to:
◦
◦
◦
◦
Salary
Payments for services
Equity interests over 5%
Intellectual property rights
Excludes mutual, pension and other
investments over which you have no control
Outside work during regular academic year
should not exceed equivalent of 1 day per
week.
Consulting work must avoid activities that
involve a conflict of interest with assigned
Ohio University activities and programs
Faculty Handbook, section IV-D
Outside interests cannot interfere with
primary loyalty to Ohio University and your
academic role
Use of university resources must have prior
approval of Chair, Dean and VPR.
Your outside interests should not be in
direct competition with university interests
Full time administrative employees are
expected to devote their full-time
professional loyalty, time and energy to their
position.
You must use non-work hours and no
university resources
Federal Agencies
State Law
University Policies
Many Academic Publications
45 CFR Part 50, Subpart F
“Responsibility of Applicants for Promoting
Objectivity in Research for Which PHS Funding
is Sought”
Authority: 42 U.S.C. 216, 289b-1, 299c-3.
Intent is to assure objectivity by establishing
standards that preclude bias in design, conduct, or
reporting of research
Focuses on financial conflicts of interest
(FCOI)
Regulations apply to investigators, including
sub grantees, contractors, and collaborating
investigators.
Does not apply to applications for support
under Phase I of SBIR and STTR programs
An institutional conflict of interest policy should
require that each investigator disclose to a
responsible representative of the institution all
significant financial interests of the investigator
(including those of the investigator’s spouse and
dependent children) (i) that would reasonably
appear to be affected by the research or
educational activities funded or proposed for
funding by NSF; or (ii) in entities whose financial
interests would reasonably appear to be affected
by such activities.
Chapter 1 (Subchapter A) (Part 54)
Financial Disclosure by Clinical Investigators
The Food and Drug Administration (FDA)
regulations state that investigators that
receive compensation in excess of $25,000
from a corporate sponsor of a trial in which
the investigator is engaged must disclose to
the FDA at the time of filing for a new drug
application.
19.058, Conflict of Interest in Research,
Educational, and Public Service Activities
19.059, Employee Participation in Authorized
Private Companies Commercializing Ohio
University Research
“Conflict of Interest in Research, Educational,
and Public Service Activities”
Most conflict disclosures fall within the
parameters of this policy
States that faculty are primarily responsible
for their academic, research and service
obligations
“Employee Participation in Authorized Private
Companies Commercializing Ohio University
Research”
Applies to “employees, faculty, staff and students,
who create intellectual property owned by the Ohio
University and who desire to hold an equity interest
in a firm, corporation, or other association to which
Ohio University has assigned, licensed or
transferred Ohio University’s interests…”
Consulting
Licensing University Technology
Clinical Studies
Procurement
Mentoring
Institutional
A disclosure is filed specific to the funding
application.
If you have a potential conflict for one
proposal, it does not automatically apply to
all of your proposals.
Research conflicts of interest are usually
disclosed using LEO as you apply for funding
by completing the conflict of interest section
of the electronic transmittal
If you are not using LEO, you can download
the appropriate disclosure form from
www.ohio.edu/research/compliance
“A” is selected if you have no conflicts to
disclose
“B” is selected if you have a potential conflict
to disclose relative to the submission.
(Requires a subsequent paper process)
“C” is selected if you have a current disclosure
on file, but it is not relevant to the proposal
you are submitting
Still uses option A, B or C
Requires that you gather signatures on paper
for all options, however
Generally used for personnel not listed on the
grant proposal or “key personnel”
We have revised the COI forms to word forms
This should be easier to complete than the
previous form
PDF versions are also available
Should be on the compliance web site soon,
but we can e-mail them to you until then
Use this form only if you are unable to use
the LEO transmittal form to assure that no
conflict of interest exists. A form must be
completed for each proposal.
I assure that I have read Ohio University
Policy 19.058, “Conflict of Interest in
Research, Educational, and Public Service
Activities” and declare that I have nothing
that is, or could be perceived to be a conflict
of interest with this proposal.
Use this form to disclose a potential conflict
of interest situation.
A separate disclosure form must be used for
each entity with which you conduct business
Conflict includes any member of your
immediate family (spouse, domestic partner
or children)
Require that you complete an option “B”
disclosure statement in addition to
completing the LEO transmittal form.
Require you to obtain signatures from Center
or Institute (if applicable), Chair and Dean on
the additional disclosure statement!!
The B disclosure form is available at
www.ohio.edu/research/compliance
Use this form only if you are unable to use
the LEO transmittal form. Complete this form
if you have a current conflict of interest
disclosure on file with the Office of Research
Compliance, but that disclosure is not
applicable to this proposal.
*New Option for 2008*
A management plan is developed for some
disclosures to mitigate the potential conflict
Management plans are specific to each
disclosure
May require submission of additional pieces,
such as a student employment plan
Reduce or remove the financial interest creating the
conflict
Place safeguards that mitigate the conflict potential,
such having some decisions made by an independent
entity
Limit participation in portions of the proposed
research likely to create a conflict
Require that the researcher disclose his or her
conflicting financial interests to all collaborators and
any proposed trainees;
Disclose the conflict in publications
Work to remove students from being directly advised
or taught by faculty where a conflict exists
Assure publication rights for student participants
Student Use
Nepotism and Cronyism
Intellectual Property
Use of University Resources
Publication provisions
Use of Human Subjects
Oversight Requirements
Reporting and Annual Reviews
You must submit an annual renewal for your
disclosure
◦ If the potential conflict no longer exists you must
notify us
If significant changes occur during the year
you should submit an update to your
disclosure as they occur
Yes. We encourage employees to disclose
potential conflicts that do not meet the
financial threshold, but may still be
problematic, such as student employment.
This allows you to be transparent with
respect to outside interests.
Allowable situations
Situations that require disclosure but may not
need an extensive management plan
Situations that require disclosure and have
problematic elements that will require
mitigation and/or a management plan
Situations that are not permitted
Receipt of royalties or honoraria for
published scholarly works, seminars,
teaching, etc.
Honoraria for serving as a special reviewer
or work on review panels
Royalties under our intellectual property
policies if no other relationship with entity
Clinical income at OUCOM
You participate in research developed in
whole or part by you, and you or your
family receive royalties from an existing
agreement with the business, but have
no other significant financial interest
You assign students, etc. to research
projects where you are entitled to
receive royalties, but have no other
significant financial interest
You assign students, etc. to projects supported
by the business through an SRA, and have a
significant financial interest other than royalty
income
You receive research support from a business in
which you serve on the board of directors, or
other advisory board, even if you are not
compensated.
You hold an executive position in a business
engaged in commercial or research activities
directly related to your Ohio University
responsibilities.
Any situation in which an actual conflict
exists is not permitted.
The only “exceptions” are those handled
under Ohio University Policy and Procedure
19.059 where faculty entrepreneurship is
addressed.
Participation in clinical trials or evaluation
of other research in which you have a
significant financial interest other than
royalty income.
In the context of your position at Ohio
University, you make professional referrals
to a business in which you have a
significant financial interest.
Letter of admonition
Ineligibility to submit grant applications
Withholding of IRB or IACUC approvals
Suspension
Non-Renewal
Loss of Tenure
Consulting
Procurement
Mentoring
Clinical Studies
Avoid consulting relationships that have
the potential to divert time and effort from
your responsibilities to Ohio University.
Do not use students.
Be wary of situations that limit publication.
Do not use university stationary, etc. that
could create an impression the university
is involved with the activities.
Make sure you are devoting sufficient time
to your university obligations.
Be cautious that the potential financial gain
cannot be perceived to influence your
university mentoring relationships.
Disclose any personal or familial financial
interest or equity in a company that is
doing business with Ohio University.
If you make purchases using public funds,
you should not use companies which will
benefit you or your family. If there is no
alternative you must seek and receive
permission prior to purchasing.
Any relationship in which there is a real or
perceived power or influence imbalance has
the potential for conflict. (Faculty:Student)
Isolating these relationships with respect to
areas of personal financial gain is best.
If they cannot be isolated, then safeguards
must be created.
If you have a financial interest, it is best to
isolate yourself from the study.
At a minimum, expect a more intense review
and a robust management plan if you have a
financial interest.
If both the institution and you have financial
interests the clinical study should be
conducted elsewhere.
You have administrative responsibilities on
behalf of Ohio University that is beneficial to
the business in which you have a significant
financial interest
You have administrative responsibilities on
behalf of Ohio University with respect to an
SRA where you have a significant financial
interest
Slide 5
Jo Ellen Sherow
Ohio University
Office of Research Compliance
Researchers’ Financial Disclosures in the
Spotlight
Conflicts of interest, always an emotional topic,
returned to the headlines this week as Sen.
Charles Grassley, a longtime critic of the drug
industry’s potential influence on research,
released new evidence that prominent Harvard
University scientists had failed to disclose much
of their outside income from pharmaceutical
companies over the past eight years.
http://www.insidehighered.com/news/2008/06/12/conflict January 15, 2008
WEDNESDAY, JANUARY 21, 2009
In a review of the literature regarding the relationship between
smokeless tobacco use and cancer, a conflict of interest of one of the
article's authors was initially not disclosed (see: Boffetta P, Hecht S, Gray
N, Gupta P, Straif K. Smokeless tobacco and cancer. Lancet Oncology
2008; 9:667-675). The original article was published in July, 2008. That
article stated: "The authors declare no conflicts of interest." After the
editor of the journal was notified by a researcher with knowledge of a
potential conflict of interest of Dr. Stephen Hecht (one of the study
authors), an erratum was published in September 2008, which noted:
"During the immediate months preceding submission of the review SH
was acting in the capacity of an expert witness for the plaintiff in a
future court case against a smokeless tobacco company. SH declares his
participation in this case in no way influenced his writing or involvement
in the review."
http://tobaccoanalysis.blogspot.com/2009/01/conflict-of-interestnot.html
January 16, 2009 — More than one third of new
drug marketing applications approved by the US
Food and Drug Administration (FDA) were
missing information about potential conflicts of
interest for clinical trial investigators, which
could allow bias to creep into the approvals
process, a government report released this week
has found. The FDA has said that it agrees with
most of the report's findings.
http://www.medscape.com/viewarticle/586980
Do collaborations between biotech companies
and academic centers constitute a conflict of
interest?
Biotechnology industry partnerships with
universities and academic centers have been
fruitful for both. So why is there so much
concern about conflict of interest and is that
concern appropriate?
http://www.redorbit.com/news/health/750100/genetic_engineering_news_p
osts_podcast_on_industrialacademic_collaborations_are_these/index.html
Universities are responsible for use of public
funds and therefore must maintain the public
trust.
Identifying and mitigating situations that may
have the potential for conflict maintains the
integrity of the university.
Maintaining integrity allows the university to
do credible academic research.
To provide information on the purpose of the
conflict of interest requirements.
To provide a basic overview of conflicts of
interest
To introduce the disclosure process and the use
of management plans
To provide information on the need for updates
and annual renewals.
Situations where financial considerations
compromise your professional judgment.
“Actual Conflict of Interest”
◦ Not permitted
Situations where an independent observer
might reasonably question whether your
professional actions or decisions are
determined by considerations of personal
gain. “Perceived Conflict of Interest”
◦ Managed
Potential conflicts may be financial or may be
a conflict of time, effort and/or commitment.
Potential conflicts can occur as a result of
administrative, scientific, academic, fiduciary
or familial situations.
They are situations that can be PERCEIVED to
be conflicting, whether a “real” conflict exists
or not.
Ohio University Policy has a mandatory
disclosure policy if you:
Earn over $10,000 in a twelve month period
from your outside activity OR
Have over 5% equity in the entity
Applies to members of your immediate family
(spouse, domestic partner, dependent
children) as well as yourself.
Anything of monetary value, including but not
limited to:
◦
◦
◦
◦
Salary
Payments for services
Equity interests over 5%
Intellectual property rights
Excludes mutual, pension and other
investments over which you have no control
Outside work during regular academic year
should not exceed equivalent of 1 day per
week.
Consulting work must avoid activities that
involve a conflict of interest with assigned
Ohio University activities and programs
Faculty Handbook, section IV-D
Outside interests cannot interfere with
primary loyalty to Ohio University and your
academic role
Use of university resources must have prior
approval of Chair, Dean and VPR.
Your outside interests should not be in
direct competition with university interests
Full time administrative employees are
expected to devote their full-time
professional loyalty, time and energy to their
position.
You must use non-work hours and no
university resources
Federal Agencies
State Law
University Policies
Many Academic Publications
45 CFR Part 50, Subpart F
“Responsibility of Applicants for Promoting
Objectivity in Research for Which PHS Funding
is Sought”
Authority: 42 U.S.C. 216, 289b-1, 299c-3.
Intent is to assure objectivity by establishing
standards that preclude bias in design, conduct, or
reporting of research
Focuses on financial conflicts of interest
(FCOI)
Regulations apply to investigators, including
sub grantees, contractors, and collaborating
investigators.
Does not apply to applications for support
under Phase I of SBIR and STTR programs
An institutional conflict of interest policy should
require that each investigator disclose to a
responsible representative of the institution all
significant financial interests of the investigator
(including those of the investigator’s spouse and
dependent children) (i) that would reasonably
appear to be affected by the research or
educational activities funded or proposed for
funding by NSF; or (ii) in entities whose financial
interests would reasonably appear to be affected
by such activities.
Chapter 1 (Subchapter A) (Part 54)
Financial Disclosure by Clinical Investigators
The Food and Drug Administration (FDA)
regulations state that investigators that
receive compensation in excess of $25,000
from a corporate sponsor of a trial in which
the investigator is engaged must disclose to
the FDA at the time of filing for a new drug
application.
19.058, Conflict of Interest in Research,
Educational, and Public Service Activities
19.059, Employee Participation in Authorized
Private Companies Commercializing Ohio
University Research
“Conflict of Interest in Research, Educational,
and Public Service Activities”
Most conflict disclosures fall within the
parameters of this policy
States that faculty are primarily responsible
for their academic, research and service
obligations
“Employee Participation in Authorized Private
Companies Commercializing Ohio University
Research”
Applies to “employees, faculty, staff and students,
who create intellectual property owned by the Ohio
University and who desire to hold an equity interest
in a firm, corporation, or other association to which
Ohio University has assigned, licensed or
transferred Ohio University’s interests…”
Consulting
Licensing University Technology
Clinical Studies
Procurement
Mentoring
Institutional
A disclosure is filed specific to the funding
application.
If you have a potential conflict for one
proposal, it does not automatically apply to
all of your proposals.
Research conflicts of interest are usually
disclosed using LEO as you apply for funding
by completing the conflict of interest section
of the electronic transmittal
If you are not using LEO, you can download
the appropriate disclosure form from
www.ohio.edu/research/compliance
“A” is selected if you have no conflicts to
disclose
“B” is selected if you have a potential conflict
to disclose relative to the submission.
(Requires a subsequent paper process)
“C” is selected if you have a current disclosure
on file, but it is not relevant to the proposal
you are submitting
Still uses option A, B or C
Requires that you gather signatures on paper
for all options, however
Generally used for personnel not listed on the
grant proposal or “key personnel”
We have revised the COI forms to word forms
This should be easier to complete than the
previous form
PDF versions are also available
Should be on the compliance web site soon,
but we can e-mail them to you until then
Use this form only if you are unable to use
the LEO transmittal form to assure that no
conflict of interest exists. A form must be
completed for each proposal.
I assure that I have read Ohio University
Policy 19.058, “Conflict of Interest in
Research, Educational, and Public Service
Activities” and declare that I have nothing
that is, or could be perceived to be a conflict
of interest with this proposal.
Use this form to disclose a potential conflict
of interest situation.
A separate disclosure form must be used for
each entity with which you conduct business
Conflict includes any member of your
immediate family (spouse, domestic partner
or children)
Require that you complete an option “B”
disclosure statement in addition to
completing the LEO transmittal form.
Require you to obtain signatures from Center
or Institute (if applicable), Chair and Dean on
the additional disclosure statement!!
The B disclosure form is available at
www.ohio.edu/research/compliance
Use this form only if you are unable to use
the LEO transmittal form. Complete this form
if you have a current conflict of interest
disclosure on file with the Office of Research
Compliance, but that disclosure is not
applicable to this proposal.
*New Option for 2008*
A management plan is developed for some
disclosures to mitigate the potential conflict
Management plans are specific to each
disclosure
May require submission of additional pieces,
such as a student employment plan
Reduce or remove the financial interest creating the
conflict
Place safeguards that mitigate the conflict potential,
such having some decisions made by an independent
entity
Limit participation in portions of the proposed
research likely to create a conflict
Require that the researcher disclose his or her
conflicting financial interests to all collaborators and
any proposed trainees;
Disclose the conflict in publications
Work to remove students from being directly advised
or taught by faculty where a conflict exists
Assure publication rights for student participants
Student Use
Nepotism and Cronyism
Intellectual Property
Use of University Resources
Publication provisions
Use of Human Subjects
Oversight Requirements
Reporting and Annual Reviews
You must submit an annual renewal for your
disclosure
◦ If the potential conflict no longer exists you must
notify us
If significant changes occur during the year
you should submit an update to your
disclosure as they occur
Yes. We encourage employees to disclose
potential conflicts that do not meet the
financial threshold, but may still be
problematic, such as student employment.
This allows you to be transparent with
respect to outside interests.
Allowable situations
Situations that require disclosure but may not
need an extensive management plan
Situations that require disclosure and have
problematic elements that will require
mitigation and/or a management plan
Situations that are not permitted
Receipt of royalties or honoraria for
published scholarly works, seminars,
teaching, etc.
Honoraria for serving as a special reviewer
or work on review panels
Royalties under our intellectual property
policies if no other relationship with entity
Clinical income at OUCOM
You participate in research developed in
whole or part by you, and you or your
family receive royalties from an existing
agreement with the business, but have
no other significant financial interest
You assign students, etc. to research
projects where you are entitled to
receive royalties, but have no other
significant financial interest
You assign students, etc. to projects supported
by the business through an SRA, and have a
significant financial interest other than royalty
income
You receive research support from a business in
which you serve on the board of directors, or
other advisory board, even if you are not
compensated.
You hold an executive position in a business
engaged in commercial or research activities
directly related to your Ohio University
responsibilities.
Any situation in which an actual conflict
exists is not permitted.
The only “exceptions” are those handled
under Ohio University Policy and Procedure
19.059 where faculty entrepreneurship is
addressed.
Participation in clinical trials or evaluation
of other research in which you have a
significant financial interest other than
royalty income.
In the context of your position at Ohio
University, you make professional referrals
to a business in which you have a
significant financial interest.
Letter of admonition
Ineligibility to submit grant applications
Withholding of IRB or IACUC approvals
Suspension
Non-Renewal
Loss of Tenure
Consulting
Procurement
Mentoring
Clinical Studies
Avoid consulting relationships that have
the potential to divert time and effort from
your responsibilities to Ohio University.
Do not use students.
Be wary of situations that limit publication.
Do not use university stationary, etc. that
could create an impression the university
is involved with the activities.
Make sure you are devoting sufficient time
to your university obligations.
Be cautious that the potential financial gain
cannot be perceived to influence your
university mentoring relationships.
Disclose any personal or familial financial
interest or equity in a company that is
doing business with Ohio University.
If you make purchases using public funds,
you should not use companies which will
benefit you or your family. If there is no
alternative you must seek and receive
permission prior to purchasing.
Any relationship in which there is a real or
perceived power or influence imbalance has
the potential for conflict. (Faculty:Student)
Isolating these relationships with respect to
areas of personal financial gain is best.
If they cannot be isolated, then safeguards
must be created.
If you have a financial interest, it is best to
isolate yourself from the study.
At a minimum, expect a more intense review
and a robust management plan if you have a
financial interest.
If both the institution and you have financial
interests the clinical study should be
conducted elsewhere.
You have administrative responsibilities on
behalf of Ohio University that is beneficial to
the business in which you have a significant
financial interest
You have administrative responsibilities on
behalf of Ohio University with respect to an
SRA where you have a significant financial
interest
Slide 6
Jo Ellen Sherow
Ohio University
Office of Research Compliance
Researchers’ Financial Disclosures in the
Spotlight
Conflicts of interest, always an emotional topic,
returned to the headlines this week as Sen.
Charles Grassley, a longtime critic of the drug
industry’s potential influence on research,
released new evidence that prominent Harvard
University scientists had failed to disclose much
of their outside income from pharmaceutical
companies over the past eight years.
http://www.insidehighered.com/news/2008/06/12/conflict January 15, 2008
WEDNESDAY, JANUARY 21, 2009
In a review of the literature regarding the relationship between
smokeless tobacco use and cancer, a conflict of interest of one of the
article's authors was initially not disclosed (see: Boffetta P, Hecht S, Gray
N, Gupta P, Straif K. Smokeless tobacco and cancer. Lancet Oncology
2008; 9:667-675). The original article was published in July, 2008. That
article stated: "The authors declare no conflicts of interest." After the
editor of the journal was notified by a researcher with knowledge of a
potential conflict of interest of Dr. Stephen Hecht (one of the study
authors), an erratum was published in September 2008, which noted:
"During the immediate months preceding submission of the review SH
was acting in the capacity of an expert witness for the plaintiff in a
future court case against a smokeless tobacco company. SH declares his
participation in this case in no way influenced his writing or involvement
in the review."
http://tobaccoanalysis.blogspot.com/2009/01/conflict-of-interestnot.html
January 16, 2009 — More than one third of new
drug marketing applications approved by the US
Food and Drug Administration (FDA) were
missing information about potential conflicts of
interest for clinical trial investigators, which
could allow bias to creep into the approvals
process, a government report released this week
has found. The FDA has said that it agrees with
most of the report's findings.
http://www.medscape.com/viewarticle/586980
Do collaborations between biotech companies
and academic centers constitute a conflict of
interest?
Biotechnology industry partnerships with
universities and academic centers have been
fruitful for both. So why is there so much
concern about conflict of interest and is that
concern appropriate?
http://www.redorbit.com/news/health/750100/genetic_engineering_news_p
osts_podcast_on_industrialacademic_collaborations_are_these/index.html
Universities are responsible for use of public
funds and therefore must maintain the public
trust.
Identifying and mitigating situations that may
have the potential for conflict maintains the
integrity of the university.
Maintaining integrity allows the university to
do credible academic research.
To provide information on the purpose of the
conflict of interest requirements.
To provide a basic overview of conflicts of
interest
To introduce the disclosure process and the use
of management plans
To provide information on the need for updates
and annual renewals.
Situations where financial considerations
compromise your professional judgment.
“Actual Conflict of Interest”
◦ Not permitted
Situations where an independent observer
might reasonably question whether your
professional actions or decisions are
determined by considerations of personal
gain. “Perceived Conflict of Interest”
◦ Managed
Potential conflicts may be financial or may be
a conflict of time, effort and/or commitment.
Potential conflicts can occur as a result of
administrative, scientific, academic, fiduciary
or familial situations.
They are situations that can be PERCEIVED to
be conflicting, whether a “real” conflict exists
or not.
Ohio University Policy has a mandatory
disclosure policy if you:
Earn over $10,000 in a twelve month period
from your outside activity OR
Have over 5% equity in the entity
Applies to members of your immediate family
(spouse, domestic partner, dependent
children) as well as yourself.
Anything of monetary value, including but not
limited to:
◦
◦
◦
◦
Salary
Payments for services
Equity interests over 5%
Intellectual property rights
Excludes mutual, pension and other
investments over which you have no control
Outside work during regular academic year
should not exceed equivalent of 1 day per
week.
Consulting work must avoid activities that
involve a conflict of interest with assigned
Ohio University activities and programs
Faculty Handbook, section IV-D
Outside interests cannot interfere with
primary loyalty to Ohio University and your
academic role
Use of university resources must have prior
approval of Chair, Dean and VPR.
Your outside interests should not be in
direct competition with university interests
Full time administrative employees are
expected to devote their full-time
professional loyalty, time and energy to their
position.
You must use non-work hours and no
university resources
Federal Agencies
State Law
University Policies
Many Academic Publications
45 CFR Part 50, Subpart F
“Responsibility of Applicants for Promoting
Objectivity in Research for Which PHS Funding
is Sought”
Authority: 42 U.S.C. 216, 289b-1, 299c-3.
Intent is to assure objectivity by establishing
standards that preclude bias in design, conduct, or
reporting of research
Focuses on financial conflicts of interest
(FCOI)
Regulations apply to investigators, including
sub grantees, contractors, and collaborating
investigators.
Does not apply to applications for support
under Phase I of SBIR and STTR programs
An institutional conflict of interest policy should
require that each investigator disclose to a
responsible representative of the institution all
significant financial interests of the investigator
(including those of the investigator’s spouse and
dependent children) (i) that would reasonably
appear to be affected by the research or
educational activities funded or proposed for
funding by NSF; or (ii) in entities whose financial
interests would reasonably appear to be affected
by such activities.
Chapter 1 (Subchapter A) (Part 54)
Financial Disclosure by Clinical Investigators
The Food and Drug Administration (FDA)
regulations state that investigators that
receive compensation in excess of $25,000
from a corporate sponsor of a trial in which
the investigator is engaged must disclose to
the FDA at the time of filing for a new drug
application.
19.058, Conflict of Interest in Research,
Educational, and Public Service Activities
19.059, Employee Participation in Authorized
Private Companies Commercializing Ohio
University Research
“Conflict of Interest in Research, Educational,
and Public Service Activities”
Most conflict disclosures fall within the
parameters of this policy
States that faculty are primarily responsible
for their academic, research and service
obligations
“Employee Participation in Authorized Private
Companies Commercializing Ohio University
Research”
Applies to “employees, faculty, staff and students,
who create intellectual property owned by the Ohio
University and who desire to hold an equity interest
in a firm, corporation, or other association to which
Ohio University has assigned, licensed or
transferred Ohio University’s interests…”
Consulting
Licensing University Technology
Clinical Studies
Procurement
Mentoring
Institutional
A disclosure is filed specific to the funding
application.
If you have a potential conflict for one
proposal, it does not automatically apply to
all of your proposals.
Research conflicts of interest are usually
disclosed using LEO as you apply for funding
by completing the conflict of interest section
of the electronic transmittal
If you are not using LEO, you can download
the appropriate disclosure form from
www.ohio.edu/research/compliance
“A” is selected if you have no conflicts to
disclose
“B” is selected if you have a potential conflict
to disclose relative to the submission.
(Requires a subsequent paper process)
“C” is selected if you have a current disclosure
on file, but it is not relevant to the proposal
you are submitting
Still uses option A, B or C
Requires that you gather signatures on paper
for all options, however
Generally used for personnel not listed on the
grant proposal or “key personnel”
We have revised the COI forms to word forms
This should be easier to complete than the
previous form
PDF versions are also available
Should be on the compliance web site soon,
but we can e-mail them to you until then
Use this form only if you are unable to use
the LEO transmittal form to assure that no
conflict of interest exists. A form must be
completed for each proposal.
I assure that I have read Ohio University
Policy 19.058, “Conflict of Interest in
Research, Educational, and Public Service
Activities” and declare that I have nothing
that is, or could be perceived to be a conflict
of interest with this proposal.
Use this form to disclose a potential conflict
of interest situation.
A separate disclosure form must be used for
each entity with which you conduct business
Conflict includes any member of your
immediate family (spouse, domestic partner
or children)
Require that you complete an option “B”
disclosure statement in addition to
completing the LEO transmittal form.
Require you to obtain signatures from Center
or Institute (if applicable), Chair and Dean on
the additional disclosure statement!!
The B disclosure form is available at
www.ohio.edu/research/compliance
Use this form only if you are unable to use
the LEO transmittal form. Complete this form
if you have a current conflict of interest
disclosure on file with the Office of Research
Compliance, but that disclosure is not
applicable to this proposal.
*New Option for 2008*
A management plan is developed for some
disclosures to mitigate the potential conflict
Management plans are specific to each
disclosure
May require submission of additional pieces,
such as a student employment plan
Reduce or remove the financial interest creating the
conflict
Place safeguards that mitigate the conflict potential,
such having some decisions made by an independent
entity
Limit participation in portions of the proposed
research likely to create a conflict
Require that the researcher disclose his or her
conflicting financial interests to all collaborators and
any proposed trainees;
Disclose the conflict in publications
Work to remove students from being directly advised
or taught by faculty where a conflict exists
Assure publication rights for student participants
Student Use
Nepotism and Cronyism
Intellectual Property
Use of University Resources
Publication provisions
Use of Human Subjects
Oversight Requirements
Reporting and Annual Reviews
You must submit an annual renewal for your
disclosure
◦ If the potential conflict no longer exists you must
notify us
If significant changes occur during the year
you should submit an update to your
disclosure as they occur
Yes. We encourage employees to disclose
potential conflicts that do not meet the
financial threshold, but may still be
problematic, such as student employment.
This allows you to be transparent with
respect to outside interests.
Allowable situations
Situations that require disclosure but may not
need an extensive management plan
Situations that require disclosure and have
problematic elements that will require
mitigation and/or a management plan
Situations that are not permitted
Receipt of royalties or honoraria for
published scholarly works, seminars,
teaching, etc.
Honoraria for serving as a special reviewer
or work on review panels
Royalties under our intellectual property
policies if no other relationship with entity
Clinical income at OUCOM
You participate in research developed in
whole or part by you, and you or your
family receive royalties from an existing
agreement with the business, but have
no other significant financial interest
You assign students, etc. to research
projects where you are entitled to
receive royalties, but have no other
significant financial interest
You assign students, etc. to projects supported
by the business through an SRA, and have a
significant financial interest other than royalty
income
You receive research support from a business in
which you serve on the board of directors, or
other advisory board, even if you are not
compensated.
You hold an executive position in a business
engaged in commercial or research activities
directly related to your Ohio University
responsibilities.
Any situation in which an actual conflict
exists is not permitted.
The only “exceptions” are those handled
under Ohio University Policy and Procedure
19.059 where faculty entrepreneurship is
addressed.
Participation in clinical trials or evaluation
of other research in which you have a
significant financial interest other than
royalty income.
In the context of your position at Ohio
University, you make professional referrals
to a business in which you have a
significant financial interest.
Letter of admonition
Ineligibility to submit grant applications
Withholding of IRB or IACUC approvals
Suspension
Non-Renewal
Loss of Tenure
Consulting
Procurement
Mentoring
Clinical Studies
Avoid consulting relationships that have
the potential to divert time and effort from
your responsibilities to Ohio University.
Do not use students.
Be wary of situations that limit publication.
Do not use university stationary, etc. that
could create an impression the university
is involved with the activities.
Make sure you are devoting sufficient time
to your university obligations.
Be cautious that the potential financial gain
cannot be perceived to influence your
university mentoring relationships.
Disclose any personal or familial financial
interest or equity in a company that is
doing business with Ohio University.
If you make purchases using public funds,
you should not use companies which will
benefit you or your family. If there is no
alternative you must seek and receive
permission prior to purchasing.
Any relationship in which there is a real or
perceived power or influence imbalance has
the potential for conflict. (Faculty:Student)
Isolating these relationships with respect to
areas of personal financial gain is best.
If they cannot be isolated, then safeguards
must be created.
If you have a financial interest, it is best to
isolate yourself from the study.
At a minimum, expect a more intense review
and a robust management plan if you have a
financial interest.
If both the institution and you have financial
interests the clinical study should be
conducted elsewhere.
You have administrative responsibilities on
behalf of Ohio University that is beneficial to
the business in which you have a significant
financial interest
You have administrative responsibilities on
behalf of Ohio University with respect to an
SRA where you have a significant financial
interest
Slide 7
Jo Ellen Sherow
Ohio University
Office of Research Compliance
Researchers’ Financial Disclosures in the
Spotlight
Conflicts of interest, always an emotional topic,
returned to the headlines this week as Sen.
Charles Grassley, a longtime critic of the drug
industry’s potential influence on research,
released new evidence that prominent Harvard
University scientists had failed to disclose much
of their outside income from pharmaceutical
companies over the past eight years.
http://www.insidehighered.com/news/2008/06/12/conflict January 15, 2008
WEDNESDAY, JANUARY 21, 2009
In a review of the literature regarding the relationship between
smokeless tobacco use and cancer, a conflict of interest of one of the
article's authors was initially not disclosed (see: Boffetta P, Hecht S, Gray
N, Gupta P, Straif K. Smokeless tobacco and cancer. Lancet Oncology
2008; 9:667-675). The original article was published in July, 2008. That
article stated: "The authors declare no conflicts of interest." After the
editor of the journal was notified by a researcher with knowledge of a
potential conflict of interest of Dr. Stephen Hecht (one of the study
authors), an erratum was published in September 2008, which noted:
"During the immediate months preceding submission of the review SH
was acting in the capacity of an expert witness for the plaintiff in a
future court case against a smokeless tobacco company. SH declares his
participation in this case in no way influenced his writing or involvement
in the review."
http://tobaccoanalysis.blogspot.com/2009/01/conflict-of-interestnot.html
January 16, 2009 — More than one third of new
drug marketing applications approved by the US
Food and Drug Administration (FDA) were
missing information about potential conflicts of
interest for clinical trial investigators, which
could allow bias to creep into the approvals
process, a government report released this week
has found. The FDA has said that it agrees with
most of the report's findings.
http://www.medscape.com/viewarticle/586980
Do collaborations between biotech companies
and academic centers constitute a conflict of
interest?
Biotechnology industry partnerships with
universities and academic centers have been
fruitful for both. So why is there so much
concern about conflict of interest and is that
concern appropriate?
http://www.redorbit.com/news/health/750100/genetic_engineering_news_p
osts_podcast_on_industrialacademic_collaborations_are_these/index.html
Universities are responsible for use of public
funds and therefore must maintain the public
trust.
Identifying and mitigating situations that may
have the potential for conflict maintains the
integrity of the university.
Maintaining integrity allows the university to
do credible academic research.
To provide information on the purpose of the
conflict of interest requirements.
To provide a basic overview of conflicts of
interest
To introduce the disclosure process and the use
of management plans
To provide information on the need for updates
and annual renewals.
Situations where financial considerations
compromise your professional judgment.
“Actual Conflict of Interest”
◦ Not permitted
Situations where an independent observer
might reasonably question whether your
professional actions or decisions are
determined by considerations of personal
gain. “Perceived Conflict of Interest”
◦ Managed
Potential conflicts may be financial or may be
a conflict of time, effort and/or commitment.
Potential conflicts can occur as a result of
administrative, scientific, academic, fiduciary
or familial situations.
They are situations that can be PERCEIVED to
be conflicting, whether a “real” conflict exists
or not.
Ohio University Policy has a mandatory
disclosure policy if you:
Earn over $10,000 in a twelve month period
from your outside activity OR
Have over 5% equity in the entity
Applies to members of your immediate family
(spouse, domestic partner, dependent
children) as well as yourself.
Anything of monetary value, including but not
limited to:
◦
◦
◦
◦
Salary
Payments for services
Equity interests over 5%
Intellectual property rights
Excludes mutual, pension and other
investments over which you have no control
Outside work during regular academic year
should not exceed equivalent of 1 day per
week.
Consulting work must avoid activities that
involve a conflict of interest with assigned
Ohio University activities and programs
Faculty Handbook, section IV-D
Outside interests cannot interfere with
primary loyalty to Ohio University and your
academic role
Use of university resources must have prior
approval of Chair, Dean and VPR.
Your outside interests should not be in
direct competition with university interests
Full time administrative employees are
expected to devote their full-time
professional loyalty, time and energy to their
position.
You must use non-work hours and no
university resources
Federal Agencies
State Law
University Policies
Many Academic Publications
45 CFR Part 50, Subpart F
“Responsibility of Applicants for Promoting
Objectivity in Research for Which PHS Funding
is Sought”
Authority: 42 U.S.C. 216, 289b-1, 299c-3.
Intent is to assure objectivity by establishing
standards that preclude bias in design, conduct, or
reporting of research
Focuses on financial conflicts of interest
(FCOI)
Regulations apply to investigators, including
sub grantees, contractors, and collaborating
investigators.
Does not apply to applications for support
under Phase I of SBIR and STTR programs
An institutional conflict of interest policy should
require that each investigator disclose to a
responsible representative of the institution all
significant financial interests of the investigator
(including those of the investigator’s spouse and
dependent children) (i) that would reasonably
appear to be affected by the research or
educational activities funded or proposed for
funding by NSF; or (ii) in entities whose financial
interests would reasonably appear to be affected
by such activities.
Chapter 1 (Subchapter A) (Part 54)
Financial Disclosure by Clinical Investigators
The Food and Drug Administration (FDA)
regulations state that investigators that
receive compensation in excess of $25,000
from a corporate sponsor of a trial in which
the investigator is engaged must disclose to
the FDA at the time of filing for a new drug
application.
19.058, Conflict of Interest in Research,
Educational, and Public Service Activities
19.059, Employee Participation in Authorized
Private Companies Commercializing Ohio
University Research
“Conflict of Interest in Research, Educational,
and Public Service Activities”
Most conflict disclosures fall within the
parameters of this policy
States that faculty are primarily responsible
for their academic, research and service
obligations
“Employee Participation in Authorized Private
Companies Commercializing Ohio University
Research”
Applies to “employees, faculty, staff and students,
who create intellectual property owned by the Ohio
University and who desire to hold an equity interest
in a firm, corporation, or other association to which
Ohio University has assigned, licensed or
transferred Ohio University’s interests…”
Consulting
Licensing University Technology
Clinical Studies
Procurement
Mentoring
Institutional
A disclosure is filed specific to the funding
application.
If you have a potential conflict for one
proposal, it does not automatically apply to
all of your proposals.
Research conflicts of interest are usually
disclosed using LEO as you apply for funding
by completing the conflict of interest section
of the electronic transmittal
If you are not using LEO, you can download
the appropriate disclosure form from
www.ohio.edu/research/compliance
“A” is selected if you have no conflicts to
disclose
“B” is selected if you have a potential conflict
to disclose relative to the submission.
(Requires a subsequent paper process)
“C” is selected if you have a current disclosure
on file, but it is not relevant to the proposal
you are submitting
Still uses option A, B or C
Requires that you gather signatures on paper
for all options, however
Generally used for personnel not listed on the
grant proposal or “key personnel”
We have revised the COI forms to word forms
This should be easier to complete than the
previous form
PDF versions are also available
Should be on the compliance web site soon,
but we can e-mail them to you until then
Use this form only if you are unable to use
the LEO transmittal form to assure that no
conflict of interest exists. A form must be
completed for each proposal.
I assure that I have read Ohio University
Policy 19.058, “Conflict of Interest in
Research, Educational, and Public Service
Activities” and declare that I have nothing
that is, or could be perceived to be a conflict
of interest with this proposal.
Use this form to disclose a potential conflict
of interest situation.
A separate disclosure form must be used for
each entity with which you conduct business
Conflict includes any member of your
immediate family (spouse, domestic partner
or children)
Require that you complete an option “B”
disclosure statement in addition to
completing the LEO transmittal form.
Require you to obtain signatures from Center
or Institute (if applicable), Chair and Dean on
the additional disclosure statement!!
The B disclosure form is available at
www.ohio.edu/research/compliance
Use this form only if you are unable to use
the LEO transmittal form. Complete this form
if you have a current conflict of interest
disclosure on file with the Office of Research
Compliance, but that disclosure is not
applicable to this proposal.
*New Option for 2008*
A management plan is developed for some
disclosures to mitigate the potential conflict
Management plans are specific to each
disclosure
May require submission of additional pieces,
such as a student employment plan
Reduce or remove the financial interest creating the
conflict
Place safeguards that mitigate the conflict potential,
such having some decisions made by an independent
entity
Limit participation in portions of the proposed
research likely to create a conflict
Require that the researcher disclose his or her
conflicting financial interests to all collaborators and
any proposed trainees;
Disclose the conflict in publications
Work to remove students from being directly advised
or taught by faculty where a conflict exists
Assure publication rights for student participants
Student Use
Nepotism and Cronyism
Intellectual Property
Use of University Resources
Publication provisions
Use of Human Subjects
Oversight Requirements
Reporting and Annual Reviews
You must submit an annual renewal for your
disclosure
◦ If the potential conflict no longer exists you must
notify us
If significant changes occur during the year
you should submit an update to your
disclosure as they occur
Yes. We encourage employees to disclose
potential conflicts that do not meet the
financial threshold, but may still be
problematic, such as student employment.
This allows you to be transparent with
respect to outside interests.
Allowable situations
Situations that require disclosure but may not
need an extensive management plan
Situations that require disclosure and have
problematic elements that will require
mitigation and/or a management plan
Situations that are not permitted
Receipt of royalties or honoraria for
published scholarly works, seminars,
teaching, etc.
Honoraria for serving as a special reviewer
or work on review panels
Royalties under our intellectual property
policies if no other relationship with entity
Clinical income at OUCOM
You participate in research developed in
whole or part by you, and you or your
family receive royalties from an existing
agreement with the business, but have
no other significant financial interest
You assign students, etc. to research
projects where you are entitled to
receive royalties, but have no other
significant financial interest
You assign students, etc. to projects supported
by the business through an SRA, and have a
significant financial interest other than royalty
income
You receive research support from a business in
which you serve on the board of directors, or
other advisory board, even if you are not
compensated.
You hold an executive position in a business
engaged in commercial or research activities
directly related to your Ohio University
responsibilities.
Any situation in which an actual conflict
exists is not permitted.
The only “exceptions” are those handled
under Ohio University Policy and Procedure
19.059 where faculty entrepreneurship is
addressed.
Participation in clinical trials or evaluation
of other research in which you have a
significant financial interest other than
royalty income.
In the context of your position at Ohio
University, you make professional referrals
to a business in which you have a
significant financial interest.
Letter of admonition
Ineligibility to submit grant applications
Withholding of IRB or IACUC approvals
Suspension
Non-Renewal
Loss of Tenure
Consulting
Procurement
Mentoring
Clinical Studies
Avoid consulting relationships that have
the potential to divert time and effort from
your responsibilities to Ohio University.
Do not use students.
Be wary of situations that limit publication.
Do not use university stationary, etc. that
could create an impression the university
is involved with the activities.
Make sure you are devoting sufficient time
to your university obligations.
Be cautious that the potential financial gain
cannot be perceived to influence your
university mentoring relationships.
Disclose any personal or familial financial
interest or equity in a company that is
doing business with Ohio University.
If you make purchases using public funds,
you should not use companies which will
benefit you or your family. If there is no
alternative you must seek and receive
permission prior to purchasing.
Any relationship in which there is a real or
perceived power or influence imbalance has
the potential for conflict. (Faculty:Student)
Isolating these relationships with respect to
areas of personal financial gain is best.
If they cannot be isolated, then safeguards
must be created.
If you have a financial interest, it is best to
isolate yourself from the study.
At a minimum, expect a more intense review
and a robust management plan if you have a
financial interest.
If both the institution and you have financial
interests the clinical study should be
conducted elsewhere.
You have administrative responsibilities on
behalf of Ohio University that is beneficial to
the business in which you have a significant
financial interest
You have administrative responsibilities on
behalf of Ohio University with respect to an
SRA where you have a significant financial
interest
Slide 8
Jo Ellen Sherow
Ohio University
Office of Research Compliance
Researchers’ Financial Disclosures in the
Spotlight
Conflicts of interest, always an emotional topic,
returned to the headlines this week as Sen.
Charles Grassley, a longtime critic of the drug
industry’s potential influence on research,
released new evidence that prominent Harvard
University scientists had failed to disclose much
of their outside income from pharmaceutical
companies over the past eight years.
http://www.insidehighered.com/news/2008/06/12/conflict January 15, 2008
WEDNESDAY, JANUARY 21, 2009
In a review of the literature regarding the relationship between
smokeless tobacco use and cancer, a conflict of interest of one of the
article's authors was initially not disclosed (see: Boffetta P, Hecht S, Gray
N, Gupta P, Straif K. Smokeless tobacco and cancer. Lancet Oncology
2008; 9:667-675). The original article was published in July, 2008. That
article stated: "The authors declare no conflicts of interest." After the
editor of the journal was notified by a researcher with knowledge of a
potential conflict of interest of Dr. Stephen Hecht (one of the study
authors), an erratum was published in September 2008, which noted:
"During the immediate months preceding submission of the review SH
was acting in the capacity of an expert witness for the plaintiff in a
future court case against a smokeless tobacco company. SH declares his
participation in this case in no way influenced his writing or involvement
in the review."
http://tobaccoanalysis.blogspot.com/2009/01/conflict-of-interestnot.html
January 16, 2009 — More than one third of new
drug marketing applications approved by the US
Food and Drug Administration (FDA) were
missing information about potential conflicts of
interest for clinical trial investigators, which
could allow bias to creep into the approvals
process, a government report released this week
has found. The FDA has said that it agrees with
most of the report's findings.
http://www.medscape.com/viewarticle/586980
Do collaborations between biotech companies
and academic centers constitute a conflict of
interest?
Biotechnology industry partnerships with
universities and academic centers have been
fruitful for both. So why is there so much
concern about conflict of interest and is that
concern appropriate?
http://www.redorbit.com/news/health/750100/genetic_engineering_news_p
osts_podcast_on_industrialacademic_collaborations_are_these/index.html
Universities are responsible for use of public
funds and therefore must maintain the public
trust.
Identifying and mitigating situations that may
have the potential for conflict maintains the
integrity of the university.
Maintaining integrity allows the university to
do credible academic research.
To provide information on the purpose of the
conflict of interest requirements.
To provide a basic overview of conflicts of
interest
To introduce the disclosure process and the use
of management plans
To provide information on the need for updates
and annual renewals.
Situations where financial considerations
compromise your professional judgment.
“Actual Conflict of Interest”
◦ Not permitted
Situations where an independent observer
might reasonably question whether your
professional actions or decisions are
determined by considerations of personal
gain. “Perceived Conflict of Interest”
◦ Managed
Potential conflicts may be financial or may be
a conflict of time, effort and/or commitment.
Potential conflicts can occur as a result of
administrative, scientific, academic, fiduciary
or familial situations.
They are situations that can be PERCEIVED to
be conflicting, whether a “real” conflict exists
or not.
Ohio University Policy has a mandatory
disclosure policy if you:
Earn over $10,000 in a twelve month period
from your outside activity OR
Have over 5% equity in the entity
Applies to members of your immediate family
(spouse, domestic partner, dependent
children) as well as yourself.
Anything of monetary value, including but not
limited to:
◦
◦
◦
◦
Salary
Payments for services
Equity interests over 5%
Intellectual property rights
Excludes mutual, pension and other
investments over which you have no control
Outside work during regular academic year
should not exceed equivalent of 1 day per
week.
Consulting work must avoid activities that
involve a conflict of interest with assigned
Ohio University activities and programs
Faculty Handbook, section IV-D
Outside interests cannot interfere with
primary loyalty to Ohio University and your
academic role
Use of university resources must have prior
approval of Chair, Dean and VPR.
Your outside interests should not be in
direct competition with university interests
Full time administrative employees are
expected to devote their full-time
professional loyalty, time and energy to their
position.
You must use non-work hours and no
university resources
Federal Agencies
State Law
University Policies
Many Academic Publications
45 CFR Part 50, Subpart F
“Responsibility of Applicants for Promoting
Objectivity in Research for Which PHS Funding
is Sought”
Authority: 42 U.S.C. 216, 289b-1, 299c-3.
Intent is to assure objectivity by establishing
standards that preclude bias in design, conduct, or
reporting of research
Focuses on financial conflicts of interest
(FCOI)
Regulations apply to investigators, including
sub grantees, contractors, and collaborating
investigators.
Does not apply to applications for support
under Phase I of SBIR and STTR programs
An institutional conflict of interest policy should
require that each investigator disclose to a
responsible representative of the institution all
significant financial interests of the investigator
(including those of the investigator’s spouse and
dependent children) (i) that would reasonably
appear to be affected by the research or
educational activities funded or proposed for
funding by NSF; or (ii) in entities whose financial
interests would reasonably appear to be affected
by such activities.
Chapter 1 (Subchapter A) (Part 54)
Financial Disclosure by Clinical Investigators
The Food and Drug Administration (FDA)
regulations state that investigators that
receive compensation in excess of $25,000
from a corporate sponsor of a trial in which
the investigator is engaged must disclose to
the FDA at the time of filing for a new drug
application.
19.058, Conflict of Interest in Research,
Educational, and Public Service Activities
19.059, Employee Participation in Authorized
Private Companies Commercializing Ohio
University Research
“Conflict of Interest in Research, Educational,
and Public Service Activities”
Most conflict disclosures fall within the
parameters of this policy
States that faculty are primarily responsible
for their academic, research and service
obligations
“Employee Participation in Authorized Private
Companies Commercializing Ohio University
Research”
Applies to “employees, faculty, staff and students,
who create intellectual property owned by the Ohio
University and who desire to hold an equity interest
in a firm, corporation, or other association to which
Ohio University has assigned, licensed or
transferred Ohio University’s interests…”
Consulting
Licensing University Technology
Clinical Studies
Procurement
Mentoring
Institutional
A disclosure is filed specific to the funding
application.
If you have a potential conflict for one
proposal, it does not automatically apply to
all of your proposals.
Research conflicts of interest are usually
disclosed using LEO as you apply for funding
by completing the conflict of interest section
of the electronic transmittal
If you are not using LEO, you can download
the appropriate disclosure form from
www.ohio.edu/research/compliance
“A” is selected if you have no conflicts to
disclose
“B” is selected if you have a potential conflict
to disclose relative to the submission.
(Requires a subsequent paper process)
“C” is selected if you have a current disclosure
on file, but it is not relevant to the proposal
you are submitting
Still uses option A, B or C
Requires that you gather signatures on paper
for all options, however
Generally used for personnel not listed on the
grant proposal or “key personnel”
We have revised the COI forms to word forms
This should be easier to complete than the
previous form
PDF versions are also available
Should be on the compliance web site soon,
but we can e-mail them to you until then
Use this form only if you are unable to use
the LEO transmittal form to assure that no
conflict of interest exists. A form must be
completed for each proposal.
I assure that I have read Ohio University
Policy 19.058, “Conflict of Interest in
Research, Educational, and Public Service
Activities” and declare that I have nothing
that is, or could be perceived to be a conflict
of interest with this proposal.
Use this form to disclose a potential conflict
of interest situation.
A separate disclosure form must be used for
each entity with which you conduct business
Conflict includes any member of your
immediate family (spouse, domestic partner
or children)
Require that you complete an option “B”
disclosure statement in addition to
completing the LEO transmittal form.
Require you to obtain signatures from Center
or Institute (if applicable), Chair and Dean on
the additional disclosure statement!!
The B disclosure form is available at
www.ohio.edu/research/compliance
Use this form only if you are unable to use
the LEO transmittal form. Complete this form
if you have a current conflict of interest
disclosure on file with the Office of Research
Compliance, but that disclosure is not
applicable to this proposal.
*New Option for 2008*
A management plan is developed for some
disclosures to mitigate the potential conflict
Management plans are specific to each
disclosure
May require submission of additional pieces,
such as a student employment plan
Reduce or remove the financial interest creating the
conflict
Place safeguards that mitigate the conflict potential,
such having some decisions made by an independent
entity
Limit participation in portions of the proposed
research likely to create a conflict
Require that the researcher disclose his or her
conflicting financial interests to all collaborators and
any proposed trainees;
Disclose the conflict in publications
Work to remove students from being directly advised
or taught by faculty where a conflict exists
Assure publication rights for student participants
Student Use
Nepotism and Cronyism
Intellectual Property
Use of University Resources
Publication provisions
Use of Human Subjects
Oversight Requirements
Reporting and Annual Reviews
You must submit an annual renewal for your
disclosure
◦ If the potential conflict no longer exists you must
notify us
If significant changes occur during the year
you should submit an update to your
disclosure as they occur
Yes. We encourage employees to disclose
potential conflicts that do not meet the
financial threshold, but may still be
problematic, such as student employment.
This allows you to be transparent with
respect to outside interests.
Allowable situations
Situations that require disclosure but may not
need an extensive management plan
Situations that require disclosure and have
problematic elements that will require
mitigation and/or a management plan
Situations that are not permitted
Receipt of royalties or honoraria for
published scholarly works, seminars,
teaching, etc.
Honoraria for serving as a special reviewer
or work on review panels
Royalties under our intellectual property
policies if no other relationship with entity
Clinical income at OUCOM
You participate in research developed in
whole or part by you, and you or your
family receive royalties from an existing
agreement with the business, but have
no other significant financial interest
You assign students, etc. to research
projects where you are entitled to
receive royalties, but have no other
significant financial interest
You assign students, etc. to projects supported
by the business through an SRA, and have a
significant financial interest other than royalty
income
You receive research support from a business in
which you serve on the board of directors, or
other advisory board, even if you are not
compensated.
You hold an executive position in a business
engaged in commercial or research activities
directly related to your Ohio University
responsibilities.
Any situation in which an actual conflict
exists is not permitted.
The only “exceptions” are those handled
under Ohio University Policy and Procedure
19.059 where faculty entrepreneurship is
addressed.
Participation in clinical trials or evaluation
of other research in which you have a
significant financial interest other than
royalty income.
In the context of your position at Ohio
University, you make professional referrals
to a business in which you have a
significant financial interest.
Letter of admonition
Ineligibility to submit grant applications
Withholding of IRB or IACUC approvals
Suspension
Non-Renewal
Loss of Tenure
Consulting
Procurement
Mentoring
Clinical Studies
Avoid consulting relationships that have
the potential to divert time and effort from
your responsibilities to Ohio University.
Do not use students.
Be wary of situations that limit publication.
Do not use university stationary, etc. that
could create an impression the university
is involved with the activities.
Make sure you are devoting sufficient time
to your university obligations.
Be cautious that the potential financial gain
cannot be perceived to influence your
university mentoring relationships.
Disclose any personal or familial financial
interest or equity in a company that is
doing business with Ohio University.
If you make purchases using public funds,
you should not use companies which will
benefit you or your family. If there is no
alternative you must seek and receive
permission prior to purchasing.
Any relationship in which there is a real or
perceived power or influence imbalance has
the potential for conflict. (Faculty:Student)
Isolating these relationships with respect to
areas of personal financial gain is best.
If they cannot be isolated, then safeguards
must be created.
If you have a financial interest, it is best to
isolate yourself from the study.
At a minimum, expect a more intense review
and a robust management plan if you have a
financial interest.
If both the institution and you have financial
interests the clinical study should be
conducted elsewhere.
You have administrative responsibilities on
behalf of Ohio University that is beneficial to
the business in which you have a significant
financial interest
You have administrative responsibilities on
behalf of Ohio University with respect to an
SRA where you have a significant financial
interest
Slide 9
Jo Ellen Sherow
Ohio University
Office of Research Compliance
Researchers’ Financial Disclosures in the
Spotlight
Conflicts of interest, always an emotional topic,
returned to the headlines this week as Sen.
Charles Grassley, a longtime critic of the drug
industry’s potential influence on research,
released new evidence that prominent Harvard
University scientists had failed to disclose much
of their outside income from pharmaceutical
companies over the past eight years.
http://www.insidehighered.com/news/2008/06/12/conflict January 15, 2008
WEDNESDAY, JANUARY 21, 2009
In a review of the literature regarding the relationship between
smokeless tobacco use and cancer, a conflict of interest of one of the
article's authors was initially not disclosed (see: Boffetta P, Hecht S, Gray
N, Gupta P, Straif K. Smokeless tobacco and cancer. Lancet Oncology
2008; 9:667-675). The original article was published in July, 2008. That
article stated: "The authors declare no conflicts of interest." After the
editor of the journal was notified by a researcher with knowledge of a
potential conflict of interest of Dr. Stephen Hecht (one of the study
authors), an erratum was published in September 2008, which noted:
"During the immediate months preceding submission of the review SH
was acting in the capacity of an expert witness for the plaintiff in a
future court case against a smokeless tobacco company. SH declares his
participation in this case in no way influenced his writing or involvement
in the review."
http://tobaccoanalysis.blogspot.com/2009/01/conflict-of-interestnot.html
January 16, 2009 — More than one third of new
drug marketing applications approved by the US
Food and Drug Administration (FDA) were
missing information about potential conflicts of
interest for clinical trial investigators, which
could allow bias to creep into the approvals
process, a government report released this week
has found. The FDA has said that it agrees with
most of the report's findings.
http://www.medscape.com/viewarticle/586980
Do collaborations between biotech companies
and academic centers constitute a conflict of
interest?
Biotechnology industry partnerships with
universities and academic centers have been
fruitful for both. So why is there so much
concern about conflict of interest and is that
concern appropriate?
http://www.redorbit.com/news/health/750100/genetic_engineering_news_p
osts_podcast_on_industrialacademic_collaborations_are_these/index.html
Universities are responsible for use of public
funds and therefore must maintain the public
trust.
Identifying and mitigating situations that may
have the potential for conflict maintains the
integrity of the university.
Maintaining integrity allows the university to
do credible academic research.
To provide information on the purpose of the
conflict of interest requirements.
To provide a basic overview of conflicts of
interest
To introduce the disclosure process and the use
of management plans
To provide information on the need for updates
and annual renewals.
Situations where financial considerations
compromise your professional judgment.
“Actual Conflict of Interest”
◦ Not permitted
Situations where an independent observer
might reasonably question whether your
professional actions or decisions are
determined by considerations of personal
gain. “Perceived Conflict of Interest”
◦ Managed
Potential conflicts may be financial or may be
a conflict of time, effort and/or commitment.
Potential conflicts can occur as a result of
administrative, scientific, academic, fiduciary
or familial situations.
They are situations that can be PERCEIVED to
be conflicting, whether a “real” conflict exists
or not.
Ohio University Policy has a mandatory
disclosure policy if you:
Earn over $10,000 in a twelve month period
from your outside activity OR
Have over 5% equity in the entity
Applies to members of your immediate family
(spouse, domestic partner, dependent
children) as well as yourself.
Anything of monetary value, including but not
limited to:
◦
◦
◦
◦
Salary
Payments for services
Equity interests over 5%
Intellectual property rights
Excludes mutual, pension and other
investments over which you have no control
Outside work during regular academic year
should not exceed equivalent of 1 day per
week.
Consulting work must avoid activities that
involve a conflict of interest with assigned
Ohio University activities and programs
Faculty Handbook, section IV-D
Outside interests cannot interfere with
primary loyalty to Ohio University and your
academic role
Use of university resources must have prior
approval of Chair, Dean and VPR.
Your outside interests should not be in
direct competition with university interests
Full time administrative employees are
expected to devote their full-time
professional loyalty, time and energy to their
position.
You must use non-work hours and no
university resources
Federal Agencies
State Law
University Policies
Many Academic Publications
45 CFR Part 50, Subpart F
“Responsibility of Applicants for Promoting
Objectivity in Research for Which PHS Funding
is Sought”
Authority: 42 U.S.C. 216, 289b-1, 299c-3.
Intent is to assure objectivity by establishing
standards that preclude bias in design, conduct, or
reporting of research
Focuses on financial conflicts of interest
(FCOI)
Regulations apply to investigators, including
sub grantees, contractors, and collaborating
investigators.
Does not apply to applications for support
under Phase I of SBIR and STTR programs
An institutional conflict of interest policy should
require that each investigator disclose to a
responsible representative of the institution all
significant financial interests of the investigator
(including those of the investigator’s spouse and
dependent children) (i) that would reasonably
appear to be affected by the research or
educational activities funded or proposed for
funding by NSF; or (ii) in entities whose financial
interests would reasonably appear to be affected
by such activities.
Chapter 1 (Subchapter A) (Part 54)
Financial Disclosure by Clinical Investigators
The Food and Drug Administration (FDA)
regulations state that investigators that
receive compensation in excess of $25,000
from a corporate sponsor of a trial in which
the investigator is engaged must disclose to
the FDA at the time of filing for a new drug
application.
19.058, Conflict of Interest in Research,
Educational, and Public Service Activities
19.059, Employee Participation in Authorized
Private Companies Commercializing Ohio
University Research
“Conflict of Interest in Research, Educational,
and Public Service Activities”
Most conflict disclosures fall within the
parameters of this policy
States that faculty are primarily responsible
for their academic, research and service
obligations
“Employee Participation in Authorized Private
Companies Commercializing Ohio University
Research”
Applies to “employees, faculty, staff and students,
who create intellectual property owned by the Ohio
University and who desire to hold an equity interest
in a firm, corporation, or other association to which
Ohio University has assigned, licensed or
transferred Ohio University’s interests…”
Consulting
Licensing University Technology
Clinical Studies
Procurement
Mentoring
Institutional
A disclosure is filed specific to the funding
application.
If you have a potential conflict for one
proposal, it does not automatically apply to
all of your proposals.
Research conflicts of interest are usually
disclosed using LEO as you apply for funding
by completing the conflict of interest section
of the electronic transmittal
If you are not using LEO, you can download
the appropriate disclosure form from
www.ohio.edu/research/compliance
“A” is selected if you have no conflicts to
disclose
“B” is selected if you have a potential conflict
to disclose relative to the submission.
(Requires a subsequent paper process)
“C” is selected if you have a current disclosure
on file, but it is not relevant to the proposal
you are submitting
Still uses option A, B or C
Requires that you gather signatures on paper
for all options, however
Generally used for personnel not listed on the
grant proposal or “key personnel”
We have revised the COI forms to word forms
This should be easier to complete than the
previous form
PDF versions are also available
Should be on the compliance web site soon,
but we can e-mail them to you until then
Use this form only if you are unable to use
the LEO transmittal form to assure that no
conflict of interest exists. A form must be
completed for each proposal.
I assure that I have read Ohio University
Policy 19.058, “Conflict of Interest in
Research, Educational, and Public Service
Activities” and declare that I have nothing
that is, or could be perceived to be a conflict
of interest with this proposal.
Use this form to disclose a potential conflict
of interest situation.
A separate disclosure form must be used for
each entity with which you conduct business
Conflict includes any member of your
immediate family (spouse, domestic partner
or children)
Require that you complete an option “B”
disclosure statement in addition to
completing the LEO transmittal form.
Require you to obtain signatures from Center
or Institute (if applicable), Chair and Dean on
the additional disclosure statement!!
The B disclosure form is available at
www.ohio.edu/research/compliance
Use this form only if you are unable to use
the LEO transmittal form. Complete this form
if you have a current conflict of interest
disclosure on file with the Office of Research
Compliance, but that disclosure is not
applicable to this proposal.
*New Option for 2008*
A management plan is developed for some
disclosures to mitigate the potential conflict
Management plans are specific to each
disclosure
May require submission of additional pieces,
such as a student employment plan
Reduce or remove the financial interest creating the
conflict
Place safeguards that mitigate the conflict potential,
such having some decisions made by an independent
entity
Limit participation in portions of the proposed
research likely to create a conflict
Require that the researcher disclose his or her
conflicting financial interests to all collaborators and
any proposed trainees;
Disclose the conflict in publications
Work to remove students from being directly advised
or taught by faculty where a conflict exists
Assure publication rights for student participants
Student Use
Nepotism and Cronyism
Intellectual Property
Use of University Resources
Publication provisions
Use of Human Subjects
Oversight Requirements
Reporting and Annual Reviews
You must submit an annual renewal for your
disclosure
◦ If the potential conflict no longer exists you must
notify us
If significant changes occur during the year
you should submit an update to your
disclosure as they occur
Yes. We encourage employees to disclose
potential conflicts that do not meet the
financial threshold, but may still be
problematic, such as student employment.
This allows you to be transparent with
respect to outside interests.
Allowable situations
Situations that require disclosure but may not
need an extensive management plan
Situations that require disclosure and have
problematic elements that will require
mitigation and/or a management plan
Situations that are not permitted
Receipt of royalties or honoraria for
published scholarly works, seminars,
teaching, etc.
Honoraria for serving as a special reviewer
or work on review panels
Royalties under our intellectual property
policies if no other relationship with entity
Clinical income at OUCOM
You participate in research developed in
whole or part by you, and you or your
family receive royalties from an existing
agreement with the business, but have
no other significant financial interest
You assign students, etc. to research
projects where you are entitled to
receive royalties, but have no other
significant financial interest
You assign students, etc. to projects supported
by the business through an SRA, and have a
significant financial interest other than royalty
income
You receive research support from a business in
which you serve on the board of directors, or
other advisory board, even if you are not
compensated.
You hold an executive position in a business
engaged in commercial or research activities
directly related to your Ohio University
responsibilities.
Any situation in which an actual conflict
exists is not permitted.
The only “exceptions” are those handled
under Ohio University Policy and Procedure
19.059 where faculty entrepreneurship is
addressed.
Participation in clinical trials or evaluation
of other research in which you have a
significant financial interest other than
royalty income.
In the context of your position at Ohio
University, you make professional referrals
to a business in which you have a
significant financial interest.
Letter of admonition
Ineligibility to submit grant applications
Withholding of IRB or IACUC approvals
Suspension
Non-Renewal
Loss of Tenure
Consulting
Procurement
Mentoring
Clinical Studies
Avoid consulting relationships that have
the potential to divert time and effort from
your responsibilities to Ohio University.
Do not use students.
Be wary of situations that limit publication.
Do not use university stationary, etc. that
could create an impression the university
is involved with the activities.
Make sure you are devoting sufficient time
to your university obligations.
Be cautious that the potential financial gain
cannot be perceived to influence your
university mentoring relationships.
Disclose any personal or familial financial
interest or equity in a company that is
doing business with Ohio University.
If you make purchases using public funds,
you should not use companies which will
benefit you or your family. If there is no
alternative you must seek and receive
permission prior to purchasing.
Any relationship in which there is a real or
perceived power or influence imbalance has
the potential for conflict. (Faculty:Student)
Isolating these relationships with respect to
areas of personal financial gain is best.
If they cannot be isolated, then safeguards
must be created.
If you have a financial interest, it is best to
isolate yourself from the study.
At a minimum, expect a more intense review
and a robust management plan if you have a
financial interest.
If both the institution and you have financial
interests the clinical study should be
conducted elsewhere.
You have administrative responsibilities on
behalf of Ohio University that is beneficial to
the business in which you have a significant
financial interest
You have administrative responsibilities on
behalf of Ohio University with respect to an
SRA where you have a significant financial
interest
Slide 10
Jo Ellen Sherow
Ohio University
Office of Research Compliance
Researchers’ Financial Disclosures in the
Spotlight
Conflicts of interest, always an emotional topic,
returned to the headlines this week as Sen.
Charles Grassley, a longtime critic of the drug
industry’s potential influence on research,
released new evidence that prominent Harvard
University scientists had failed to disclose much
of their outside income from pharmaceutical
companies over the past eight years.
http://www.insidehighered.com/news/2008/06/12/conflict January 15, 2008
WEDNESDAY, JANUARY 21, 2009
In a review of the literature regarding the relationship between
smokeless tobacco use and cancer, a conflict of interest of one of the
article's authors was initially not disclosed (see: Boffetta P, Hecht S, Gray
N, Gupta P, Straif K. Smokeless tobacco and cancer. Lancet Oncology
2008; 9:667-675). The original article was published in July, 2008. That
article stated: "The authors declare no conflicts of interest." After the
editor of the journal was notified by a researcher with knowledge of a
potential conflict of interest of Dr. Stephen Hecht (one of the study
authors), an erratum was published in September 2008, which noted:
"During the immediate months preceding submission of the review SH
was acting in the capacity of an expert witness for the plaintiff in a
future court case against a smokeless tobacco company. SH declares his
participation in this case in no way influenced his writing or involvement
in the review."
http://tobaccoanalysis.blogspot.com/2009/01/conflict-of-interestnot.html
January 16, 2009 — More than one third of new
drug marketing applications approved by the US
Food and Drug Administration (FDA) were
missing information about potential conflicts of
interest for clinical trial investigators, which
could allow bias to creep into the approvals
process, a government report released this week
has found. The FDA has said that it agrees with
most of the report's findings.
http://www.medscape.com/viewarticle/586980
Do collaborations between biotech companies
and academic centers constitute a conflict of
interest?
Biotechnology industry partnerships with
universities and academic centers have been
fruitful for both. So why is there so much
concern about conflict of interest and is that
concern appropriate?
http://www.redorbit.com/news/health/750100/genetic_engineering_news_p
osts_podcast_on_industrialacademic_collaborations_are_these/index.html
Universities are responsible for use of public
funds and therefore must maintain the public
trust.
Identifying and mitigating situations that may
have the potential for conflict maintains the
integrity of the university.
Maintaining integrity allows the university to
do credible academic research.
To provide information on the purpose of the
conflict of interest requirements.
To provide a basic overview of conflicts of
interest
To introduce the disclosure process and the use
of management plans
To provide information on the need for updates
and annual renewals.
Situations where financial considerations
compromise your professional judgment.
“Actual Conflict of Interest”
◦ Not permitted
Situations where an independent observer
might reasonably question whether your
professional actions or decisions are
determined by considerations of personal
gain. “Perceived Conflict of Interest”
◦ Managed
Potential conflicts may be financial or may be
a conflict of time, effort and/or commitment.
Potential conflicts can occur as a result of
administrative, scientific, academic, fiduciary
or familial situations.
They are situations that can be PERCEIVED to
be conflicting, whether a “real” conflict exists
or not.
Ohio University Policy has a mandatory
disclosure policy if you:
Earn over $10,000 in a twelve month period
from your outside activity OR
Have over 5% equity in the entity
Applies to members of your immediate family
(spouse, domestic partner, dependent
children) as well as yourself.
Anything of monetary value, including but not
limited to:
◦
◦
◦
◦
Salary
Payments for services
Equity interests over 5%
Intellectual property rights
Excludes mutual, pension and other
investments over which you have no control
Outside work during regular academic year
should not exceed equivalent of 1 day per
week.
Consulting work must avoid activities that
involve a conflict of interest with assigned
Ohio University activities and programs
Faculty Handbook, section IV-D
Outside interests cannot interfere with
primary loyalty to Ohio University and your
academic role
Use of university resources must have prior
approval of Chair, Dean and VPR.
Your outside interests should not be in
direct competition with university interests
Full time administrative employees are
expected to devote their full-time
professional loyalty, time and energy to their
position.
You must use non-work hours and no
university resources
Federal Agencies
State Law
University Policies
Many Academic Publications
45 CFR Part 50, Subpart F
“Responsibility of Applicants for Promoting
Objectivity in Research for Which PHS Funding
is Sought”
Authority: 42 U.S.C. 216, 289b-1, 299c-3.
Intent is to assure objectivity by establishing
standards that preclude bias in design, conduct, or
reporting of research
Focuses on financial conflicts of interest
(FCOI)
Regulations apply to investigators, including
sub grantees, contractors, and collaborating
investigators.
Does not apply to applications for support
under Phase I of SBIR and STTR programs
An institutional conflict of interest policy should
require that each investigator disclose to a
responsible representative of the institution all
significant financial interests of the investigator
(including those of the investigator’s spouse and
dependent children) (i) that would reasonably
appear to be affected by the research or
educational activities funded or proposed for
funding by NSF; or (ii) in entities whose financial
interests would reasonably appear to be affected
by such activities.
Chapter 1 (Subchapter A) (Part 54)
Financial Disclosure by Clinical Investigators
The Food and Drug Administration (FDA)
regulations state that investigators that
receive compensation in excess of $25,000
from a corporate sponsor of a trial in which
the investigator is engaged must disclose to
the FDA at the time of filing for a new drug
application.
19.058, Conflict of Interest in Research,
Educational, and Public Service Activities
19.059, Employee Participation in Authorized
Private Companies Commercializing Ohio
University Research
“Conflict of Interest in Research, Educational,
and Public Service Activities”
Most conflict disclosures fall within the
parameters of this policy
States that faculty are primarily responsible
for their academic, research and service
obligations
“Employee Participation in Authorized Private
Companies Commercializing Ohio University
Research”
Applies to “employees, faculty, staff and students,
who create intellectual property owned by the Ohio
University and who desire to hold an equity interest
in a firm, corporation, or other association to which
Ohio University has assigned, licensed or
transferred Ohio University’s interests…”
Consulting
Licensing University Technology
Clinical Studies
Procurement
Mentoring
Institutional
A disclosure is filed specific to the funding
application.
If you have a potential conflict for one
proposal, it does not automatically apply to
all of your proposals.
Research conflicts of interest are usually
disclosed using LEO as you apply for funding
by completing the conflict of interest section
of the electronic transmittal
If you are not using LEO, you can download
the appropriate disclosure form from
www.ohio.edu/research/compliance
“A” is selected if you have no conflicts to
disclose
“B” is selected if you have a potential conflict
to disclose relative to the submission.
(Requires a subsequent paper process)
“C” is selected if you have a current disclosure
on file, but it is not relevant to the proposal
you are submitting
Still uses option A, B or C
Requires that you gather signatures on paper
for all options, however
Generally used for personnel not listed on the
grant proposal or “key personnel”
We have revised the COI forms to word forms
This should be easier to complete than the
previous form
PDF versions are also available
Should be on the compliance web site soon,
but we can e-mail them to you until then
Use this form only if you are unable to use
the LEO transmittal form to assure that no
conflict of interest exists. A form must be
completed for each proposal.
I assure that I have read Ohio University
Policy 19.058, “Conflict of Interest in
Research, Educational, and Public Service
Activities” and declare that I have nothing
that is, or could be perceived to be a conflict
of interest with this proposal.
Use this form to disclose a potential conflict
of interest situation.
A separate disclosure form must be used for
each entity with which you conduct business
Conflict includes any member of your
immediate family (spouse, domestic partner
or children)
Require that you complete an option “B”
disclosure statement in addition to
completing the LEO transmittal form.
Require you to obtain signatures from Center
or Institute (if applicable), Chair and Dean on
the additional disclosure statement!!
The B disclosure form is available at
www.ohio.edu/research/compliance
Use this form only if you are unable to use
the LEO transmittal form. Complete this form
if you have a current conflict of interest
disclosure on file with the Office of Research
Compliance, but that disclosure is not
applicable to this proposal.
*New Option for 2008*
A management plan is developed for some
disclosures to mitigate the potential conflict
Management plans are specific to each
disclosure
May require submission of additional pieces,
such as a student employment plan
Reduce or remove the financial interest creating the
conflict
Place safeguards that mitigate the conflict potential,
such having some decisions made by an independent
entity
Limit participation in portions of the proposed
research likely to create a conflict
Require that the researcher disclose his or her
conflicting financial interests to all collaborators and
any proposed trainees;
Disclose the conflict in publications
Work to remove students from being directly advised
or taught by faculty where a conflict exists
Assure publication rights for student participants
Student Use
Nepotism and Cronyism
Intellectual Property
Use of University Resources
Publication provisions
Use of Human Subjects
Oversight Requirements
Reporting and Annual Reviews
You must submit an annual renewal for your
disclosure
◦ If the potential conflict no longer exists you must
notify us
If significant changes occur during the year
you should submit an update to your
disclosure as they occur
Yes. We encourage employees to disclose
potential conflicts that do not meet the
financial threshold, but may still be
problematic, such as student employment.
This allows you to be transparent with
respect to outside interests.
Allowable situations
Situations that require disclosure but may not
need an extensive management plan
Situations that require disclosure and have
problematic elements that will require
mitigation and/or a management plan
Situations that are not permitted
Receipt of royalties or honoraria for
published scholarly works, seminars,
teaching, etc.
Honoraria for serving as a special reviewer
or work on review panels
Royalties under our intellectual property
policies if no other relationship with entity
Clinical income at OUCOM
You participate in research developed in
whole or part by you, and you or your
family receive royalties from an existing
agreement with the business, but have
no other significant financial interest
You assign students, etc. to research
projects where you are entitled to
receive royalties, but have no other
significant financial interest
You assign students, etc. to projects supported
by the business through an SRA, and have a
significant financial interest other than royalty
income
You receive research support from a business in
which you serve on the board of directors, or
other advisory board, even if you are not
compensated.
You hold an executive position in a business
engaged in commercial or research activities
directly related to your Ohio University
responsibilities.
Any situation in which an actual conflict
exists is not permitted.
The only “exceptions” are those handled
under Ohio University Policy and Procedure
19.059 where faculty entrepreneurship is
addressed.
Participation in clinical trials or evaluation
of other research in which you have a
significant financial interest other than
royalty income.
In the context of your position at Ohio
University, you make professional referrals
to a business in which you have a
significant financial interest.
Letter of admonition
Ineligibility to submit grant applications
Withholding of IRB or IACUC approvals
Suspension
Non-Renewal
Loss of Tenure
Consulting
Procurement
Mentoring
Clinical Studies
Avoid consulting relationships that have
the potential to divert time and effort from
your responsibilities to Ohio University.
Do not use students.
Be wary of situations that limit publication.
Do not use university stationary, etc. that
could create an impression the university
is involved with the activities.
Make sure you are devoting sufficient time
to your university obligations.
Be cautious that the potential financial gain
cannot be perceived to influence your
university mentoring relationships.
Disclose any personal or familial financial
interest or equity in a company that is
doing business with Ohio University.
If you make purchases using public funds,
you should not use companies which will
benefit you or your family. If there is no
alternative you must seek and receive
permission prior to purchasing.
Any relationship in which there is a real or
perceived power or influence imbalance has
the potential for conflict. (Faculty:Student)
Isolating these relationships with respect to
areas of personal financial gain is best.
If they cannot be isolated, then safeguards
must be created.
If you have a financial interest, it is best to
isolate yourself from the study.
At a minimum, expect a more intense review
and a robust management plan if you have a
financial interest.
If both the institution and you have financial
interests the clinical study should be
conducted elsewhere.
You have administrative responsibilities on
behalf of Ohio University that is beneficial to
the business in which you have a significant
financial interest
You have administrative responsibilities on
behalf of Ohio University with respect to an
SRA where you have a significant financial
interest
Slide 11
Jo Ellen Sherow
Ohio University
Office of Research Compliance
Researchers’ Financial Disclosures in the
Spotlight
Conflicts of interest, always an emotional topic,
returned to the headlines this week as Sen.
Charles Grassley, a longtime critic of the drug
industry’s potential influence on research,
released new evidence that prominent Harvard
University scientists had failed to disclose much
of their outside income from pharmaceutical
companies over the past eight years.
http://www.insidehighered.com/news/2008/06/12/conflict January 15, 2008
WEDNESDAY, JANUARY 21, 2009
In a review of the literature regarding the relationship between
smokeless tobacco use and cancer, a conflict of interest of one of the
article's authors was initially not disclosed (see: Boffetta P, Hecht S, Gray
N, Gupta P, Straif K. Smokeless tobacco and cancer. Lancet Oncology
2008; 9:667-675). The original article was published in July, 2008. That
article stated: "The authors declare no conflicts of interest." After the
editor of the journal was notified by a researcher with knowledge of a
potential conflict of interest of Dr. Stephen Hecht (one of the study
authors), an erratum was published in September 2008, which noted:
"During the immediate months preceding submission of the review SH
was acting in the capacity of an expert witness for the plaintiff in a
future court case against a smokeless tobacco company. SH declares his
participation in this case in no way influenced his writing or involvement
in the review."
http://tobaccoanalysis.blogspot.com/2009/01/conflict-of-interestnot.html
January 16, 2009 — More than one third of new
drug marketing applications approved by the US
Food and Drug Administration (FDA) were
missing information about potential conflicts of
interest for clinical trial investigators, which
could allow bias to creep into the approvals
process, a government report released this week
has found. The FDA has said that it agrees with
most of the report's findings.
http://www.medscape.com/viewarticle/586980
Do collaborations between biotech companies
and academic centers constitute a conflict of
interest?
Biotechnology industry partnerships with
universities and academic centers have been
fruitful for both. So why is there so much
concern about conflict of interest and is that
concern appropriate?
http://www.redorbit.com/news/health/750100/genetic_engineering_news_p
osts_podcast_on_industrialacademic_collaborations_are_these/index.html
Universities are responsible for use of public
funds and therefore must maintain the public
trust.
Identifying and mitigating situations that may
have the potential for conflict maintains the
integrity of the university.
Maintaining integrity allows the university to
do credible academic research.
To provide information on the purpose of the
conflict of interest requirements.
To provide a basic overview of conflicts of
interest
To introduce the disclosure process and the use
of management plans
To provide information on the need for updates
and annual renewals.
Situations where financial considerations
compromise your professional judgment.
“Actual Conflict of Interest”
◦ Not permitted
Situations where an independent observer
might reasonably question whether your
professional actions or decisions are
determined by considerations of personal
gain. “Perceived Conflict of Interest”
◦ Managed
Potential conflicts may be financial or may be
a conflict of time, effort and/or commitment.
Potential conflicts can occur as a result of
administrative, scientific, academic, fiduciary
or familial situations.
They are situations that can be PERCEIVED to
be conflicting, whether a “real” conflict exists
or not.
Ohio University Policy has a mandatory
disclosure policy if you:
Earn over $10,000 in a twelve month period
from your outside activity OR
Have over 5% equity in the entity
Applies to members of your immediate family
(spouse, domestic partner, dependent
children) as well as yourself.
Anything of monetary value, including but not
limited to:
◦
◦
◦
◦
Salary
Payments for services
Equity interests over 5%
Intellectual property rights
Excludes mutual, pension and other
investments over which you have no control
Outside work during regular academic year
should not exceed equivalent of 1 day per
week.
Consulting work must avoid activities that
involve a conflict of interest with assigned
Ohio University activities and programs
Faculty Handbook, section IV-D
Outside interests cannot interfere with
primary loyalty to Ohio University and your
academic role
Use of university resources must have prior
approval of Chair, Dean and VPR.
Your outside interests should not be in
direct competition with university interests
Full time administrative employees are
expected to devote their full-time
professional loyalty, time and energy to their
position.
You must use non-work hours and no
university resources
Federal Agencies
State Law
University Policies
Many Academic Publications
45 CFR Part 50, Subpart F
“Responsibility of Applicants for Promoting
Objectivity in Research for Which PHS Funding
is Sought”
Authority: 42 U.S.C. 216, 289b-1, 299c-3.
Intent is to assure objectivity by establishing
standards that preclude bias in design, conduct, or
reporting of research
Focuses on financial conflicts of interest
(FCOI)
Regulations apply to investigators, including
sub grantees, contractors, and collaborating
investigators.
Does not apply to applications for support
under Phase I of SBIR and STTR programs
An institutional conflict of interest policy should
require that each investigator disclose to a
responsible representative of the institution all
significant financial interests of the investigator
(including those of the investigator’s spouse and
dependent children) (i) that would reasonably
appear to be affected by the research or
educational activities funded or proposed for
funding by NSF; or (ii) in entities whose financial
interests would reasonably appear to be affected
by such activities.
Chapter 1 (Subchapter A) (Part 54)
Financial Disclosure by Clinical Investigators
The Food and Drug Administration (FDA)
regulations state that investigators that
receive compensation in excess of $25,000
from a corporate sponsor of a trial in which
the investigator is engaged must disclose to
the FDA at the time of filing for a new drug
application.
19.058, Conflict of Interest in Research,
Educational, and Public Service Activities
19.059, Employee Participation in Authorized
Private Companies Commercializing Ohio
University Research
“Conflict of Interest in Research, Educational,
and Public Service Activities”
Most conflict disclosures fall within the
parameters of this policy
States that faculty are primarily responsible
for their academic, research and service
obligations
“Employee Participation in Authorized Private
Companies Commercializing Ohio University
Research”
Applies to “employees, faculty, staff and students,
who create intellectual property owned by the Ohio
University and who desire to hold an equity interest
in a firm, corporation, or other association to which
Ohio University has assigned, licensed or
transferred Ohio University’s interests…”
Consulting
Licensing University Technology
Clinical Studies
Procurement
Mentoring
Institutional
A disclosure is filed specific to the funding
application.
If you have a potential conflict for one
proposal, it does not automatically apply to
all of your proposals.
Research conflicts of interest are usually
disclosed using LEO as you apply for funding
by completing the conflict of interest section
of the electronic transmittal
If you are not using LEO, you can download
the appropriate disclosure form from
www.ohio.edu/research/compliance
“A” is selected if you have no conflicts to
disclose
“B” is selected if you have a potential conflict
to disclose relative to the submission.
(Requires a subsequent paper process)
“C” is selected if you have a current disclosure
on file, but it is not relevant to the proposal
you are submitting
Still uses option A, B or C
Requires that you gather signatures on paper
for all options, however
Generally used for personnel not listed on the
grant proposal or “key personnel”
We have revised the COI forms to word forms
This should be easier to complete than the
previous form
PDF versions are also available
Should be on the compliance web site soon,
but we can e-mail them to you until then
Use this form only if you are unable to use
the LEO transmittal form to assure that no
conflict of interest exists. A form must be
completed for each proposal.
I assure that I have read Ohio University
Policy 19.058, “Conflict of Interest in
Research, Educational, and Public Service
Activities” and declare that I have nothing
that is, or could be perceived to be a conflict
of interest with this proposal.
Use this form to disclose a potential conflict
of interest situation.
A separate disclosure form must be used for
each entity with which you conduct business
Conflict includes any member of your
immediate family (spouse, domestic partner
or children)
Require that you complete an option “B”
disclosure statement in addition to
completing the LEO transmittal form.
Require you to obtain signatures from Center
or Institute (if applicable), Chair and Dean on
the additional disclosure statement!!
The B disclosure form is available at
www.ohio.edu/research/compliance
Use this form only if you are unable to use
the LEO transmittal form. Complete this form
if you have a current conflict of interest
disclosure on file with the Office of Research
Compliance, but that disclosure is not
applicable to this proposal.
*New Option for 2008*
A management plan is developed for some
disclosures to mitigate the potential conflict
Management plans are specific to each
disclosure
May require submission of additional pieces,
such as a student employment plan
Reduce or remove the financial interest creating the
conflict
Place safeguards that mitigate the conflict potential,
such having some decisions made by an independent
entity
Limit participation in portions of the proposed
research likely to create a conflict
Require that the researcher disclose his or her
conflicting financial interests to all collaborators and
any proposed trainees;
Disclose the conflict in publications
Work to remove students from being directly advised
or taught by faculty where a conflict exists
Assure publication rights for student participants
Student Use
Nepotism and Cronyism
Intellectual Property
Use of University Resources
Publication provisions
Use of Human Subjects
Oversight Requirements
Reporting and Annual Reviews
You must submit an annual renewal for your
disclosure
◦ If the potential conflict no longer exists you must
notify us
If significant changes occur during the year
you should submit an update to your
disclosure as they occur
Yes. We encourage employees to disclose
potential conflicts that do not meet the
financial threshold, but may still be
problematic, such as student employment.
This allows you to be transparent with
respect to outside interests.
Allowable situations
Situations that require disclosure but may not
need an extensive management plan
Situations that require disclosure and have
problematic elements that will require
mitigation and/or a management plan
Situations that are not permitted
Receipt of royalties or honoraria for
published scholarly works, seminars,
teaching, etc.
Honoraria for serving as a special reviewer
or work on review panels
Royalties under our intellectual property
policies if no other relationship with entity
Clinical income at OUCOM
You participate in research developed in
whole or part by you, and you or your
family receive royalties from an existing
agreement with the business, but have
no other significant financial interest
You assign students, etc. to research
projects where you are entitled to
receive royalties, but have no other
significant financial interest
You assign students, etc. to projects supported
by the business through an SRA, and have a
significant financial interest other than royalty
income
You receive research support from a business in
which you serve on the board of directors, or
other advisory board, even if you are not
compensated.
You hold an executive position in a business
engaged in commercial or research activities
directly related to your Ohio University
responsibilities.
Any situation in which an actual conflict
exists is not permitted.
The only “exceptions” are those handled
under Ohio University Policy and Procedure
19.059 where faculty entrepreneurship is
addressed.
Participation in clinical trials or evaluation
of other research in which you have a
significant financial interest other than
royalty income.
In the context of your position at Ohio
University, you make professional referrals
to a business in which you have a
significant financial interest.
Letter of admonition
Ineligibility to submit grant applications
Withholding of IRB or IACUC approvals
Suspension
Non-Renewal
Loss of Tenure
Consulting
Procurement
Mentoring
Clinical Studies
Avoid consulting relationships that have
the potential to divert time and effort from
your responsibilities to Ohio University.
Do not use students.
Be wary of situations that limit publication.
Do not use university stationary, etc. that
could create an impression the university
is involved with the activities.
Make sure you are devoting sufficient time
to your university obligations.
Be cautious that the potential financial gain
cannot be perceived to influence your
university mentoring relationships.
Disclose any personal or familial financial
interest or equity in a company that is
doing business with Ohio University.
If you make purchases using public funds,
you should not use companies which will
benefit you or your family. If there is no
alternative you must seek and receive
permission prior to purchasing.
Any relationship in which there is a real or
perceived power or influence imbalance has
the potential for conflict. (Faculty:Student)
Isolating these relationships with respect to
areas of personal financial gain is best.
If they cannot be isolated, then safeguards
must be created.
If you have a financial interest, it is best to
isolate yourself from the study.
At a minimum, expect a more intense review
and a robust management plan if you have a
financial interest.
If both the institution and you have financial
interests the clinical study should be
conducted elsewhere.
You have administrative responsibilities on
behalf of Ohio University that is beneficial to
the business in which you have a significant
financial interest
You have administrative responsibilities on
behalf of Ohio University with respect to an
SRA where you have a significant financial
interest
Slide 12
Jo Ellen Sherow
Ohio University
Office of Research Compliance
Researchers’ Financial Disclosures in the
Spotlight
Conflicts of interest, always an emotional topic,
returned to the headlines this week as Sen.
Charles Grassley, a longtime critic of the drug
industry’s potential influence on research,
released new evidence that prominent Harvard
University scientists had failed to disclose much
of their outside income from pharmaceutical
companies over the past eight years.
http://www.insidehighered.com/news/2008/06/12/conflict January 15, 2008
WEDNESDAY, JANUARY 21, 2009
In a review of the literature regarding the relationship between
smokeless tobacco use and cancer, a conflict of interest of one of the
article's authors was initially not disclosed (see: Boffetta P, Hecht S, Gray
N, Gupta P, Straif K. Smokeless tobacco and cancer. Lancet Oncology
2008; 9:667-675). The original article was published in July, 2008. That
article stated: "The authors declare no conflicts of interest." After the
editor of the journal was notified by a researcher with knowledge of a
potential conflict of interest of Dr. Stephen Hecht (one of the study
authors), an erratum was published in September 2008, which noted:
"During the immediate months preceding submission of the review SH
was acting in the capacity of an expert witness for the plaintiff in a
future court case against a smokeless tobacco company. SH declares his
participation in this case in no way influenced his writing or involvement
in the review."
http://tobaccoanalysis.blogspot.com/2009/01/conflict-of-interestnot.html
January 16, 2009 — More than one third of new
drug marketing applications approved by the US
Food and Drug Administration (FDA) were
missing information about potential conflicts of
interest for clinical trial investigators, which
could allow bias to creep into the approvals
process, a government report released this week
has found. The FDA has said that it agrees with
most of the report's findings.
http://www.medscape.com/viewarticle/586980
Do collaborations between biotech companies
and academic centers constitute a conflict of
interest?
Biotechnology industry partnerships with
universities and academic centers have been
fruitful for both. So why is there so much
concern about conflict of interest and is that
concern appropriate?
http://www.redorbit.com/news/health/750100/genetic_engineering_news_p
osts_podcast_on_industrialacademic_collaborations_are_these/index.html
Universities are responsible for use of public
funds and therefore must maintain the public
trust.
Identifying and mitigating situations that may
have the potential for conflict maintains the
integrity of the university.
Maintaining integrity allows the university to
do credible academic research.
To provide information on the purpose of the
conflict of interest requirements.
To provide a basic overview of conflicts of
interest
To introduce the disclosure process and the use
of management plans
To provide information on the need for updates
and annual renewals.
Situations where financial considerations
compromise your professional judgment.
“Actual Conflict of Interest”
◦ Not permitted
Situations where an independent observer
might reasonably question whether your
professional actions or decisions are
determined by considerations of personal
gain. “Perceived Conflict of Interest”
◦ Managed
Potential conflicts may be financial or may be
a conflict of time, effort and/or commitment.
Potential conflicts can occur as a result of
administrative, scientific, academic, fiduciary
or familial situations.
They are situations that can be PERCEIVED to
be conflicting, whether a “real” conflict exists
or not.
Ohio University Policy has a mandatory
disclosure policy if you:
Earn over $10,000 in a twelve month period
from your outside activity OR
Have over 5% equity in the entity
Applies to members of your immediate family
(spouse, domestic partner, dependent
children) as well as yourself.
Anything of monetary value, including but not
limited to:
◦
◦
◦
◦
Salary
Payments for services
Equity interests over 5%
Intellectual property rights
Excludes mutual, pension and other
investments over which you have no control
Outside work during regular academic year
should not exceed equivalent of 1 day per
week.
Consulting work must avoid activities that
involve a conflict of interest with assigned
Ohio University activities and programs
Faculty Handbook, section IV-D
Outside interests cannot interfere with
primary loyalty to Ohio University and your
academic role
Use of university resources must have prior
approval of Chair, Dean and VPR.
Your outside interests should not be in
direct competition with university interests
Full time administrative employees are
expected to devote their full-time
professional loyalty, time and energy to their
position.
You must use non-work hours and no
university resources
Federal Agencies
State Law
University Policies
Many Academic Publications
45 CFR Part 50, Subpart F
“Responsibility of Applicants for Promoting
Objectivity in Research for Which PHS Funding
is Sought”
Authority: 42 U.S.C. 216, 289b-1, 299c-3.
Intent is to assure objectivity by establishing
standards that preclude bias in design, conduct, or
reporting of research
Focuses on financial conflicts of interest
(FCOI)
Regulations apply to investigators, including
sub grantees, contractors, and collaborating
investigators.
Does not apply to applications for support
under Phase I of SBIR and STTR programs
An institutional conflict of interest policy should
require that each investigator disclose to a
responsible representative of the institution all
significant financial interests of the investigator
(including those of the investigator’s spouse and
dependent children) (i) that would reasonably
appear to be affected by the research or
educational activities funded or proposed for
funding by NSF; or (ii) in entities whose financial
interests would reasonably appear to be affected
by such activities.
Chapter 1 (Subchapter A) (Part 54)
Financial Disclosure by Clinical Investigators
The Food and Drug Administration (FDA)
regulations state that investigators that
receive compensation in excess of $25,000
from a corporate sponsor of a trial in which
the investigator is engaged must disclose to
the FDA at the time of filing for a new drug
application.
19.058, Conflict of Interest in Research,
Educational, and Public Service Activities
19.059, Employee Participation in Authorized
Private Companies Commercializing Ohio
University Research
“Conflict of Interest in Research, Educational,
and Public Service Activities”
Most conflict disclosures fall within the
parameters of this policy
States that faculty are primarily responsible
for their academic, research and service
obligations
“Employee Participation in Authorized Private
Companies Commercializing Ohio University
Research”
Applies to “employees, faculty, staff and students,
who create intellectual property owned by the Ohio
University and who desire to hold an equity interest
in a firm, corporation, or other association to which
Ohio University has assigned, licensed or
transferred Ohio University’s interests…”
Consulting
Licensing University Technology
Clinical Studies
Procurement
Mentoring
Institutional
A disclosure is filed specific to the funding
application.
If you have a potential conflict for one
proposal, it does not automatically apply to
all of your proposals.
Research conflicts of interest are usually
disclosed using LEO as you apply for funding
by completing the conflict of interest section
of the electronic transmittal
If you are not using LEO, you can download
the appropriate disclosure form from
www.ohio.edu/research/compliance
“A” is selected if you have no conflicts to
disclose
“B” is selected if you have a potential conflict
to disclose relative to the submission.
(Requires a subsequent paper process)
“C” is selected if you have a current disclosure
on file, but it is not relevant to the proposal
you are submitting
Still uses option A, B or C
Requires that you gather signatures on paper
for all options, however
Generally used for personnel not listed on the
grant proposal or “key personnel”
We have revised the COI forms to word forms
This should be easier to complete than the
previous form
PDF versions are also available
Should be on the compliance web site soon,
but we can e-mail them to you until then
Use this form only if you are unable to use
the LEO transmittal form to assure that no
conflict of interest exists. A form must be
completed for each proposal.
I assure that I have read Ohio University
Policy 19.058, “Conflict of Interest in
Research, Educational, and Public Service
Activities” and declare that I have nothing
that is, or could be perceived to be a conflict
of interest with this proposal.
Use this form to disclose a potential conflict
of interest situation.
A separate disclosure form must be used for
each entity with which you conduct business
Conflict includes any member of your
immediate family (spouse, domestic partner
or children)
Require that you complete an option “B”
disclosure statement in addition to
completing the LEO transmittal form.
Require you to obtain signatures from Center
or Institute (if applicable), Chair and Dean on
the additional disclosure statement!!
The B disclosure form is available at
www.ohio.edu/research/compliance
Use this form only if you are unable to use
the LEO transmittal form. Complete this form
if you have a current conflict of interest
disclosure on file with the Office of Research
Compliance, but that disclosure is not
applicable to this proposal.
*New Option for 2008*
A management plan is developed for some
disclosures to mitigate the potential conflict
Management plans are specific to each
disclosure
May require submission of additional pieces,
such as a student employment plan
Reduce or remove the financial interest creating the
conflict
Place safeguards that mitigate the conflict potential,
such having some decisions made by an independent
entity
Limit participation in portions of the proposed
research likely to create a conflict
Require that the researcher disclose his or her
conflicting financial interests to all collaborators and
any proposed trainees;
Disclose the conflict in publications
Work to remove students from being directly advised
or taught by faculty where a conflict exists
Assure publication rights for student participants
Student Use
Nepotism and Cronyism
Intellectual Property
Use of University Resources
Publication provisions
Use of Human Subjects
Oversight Requirements
Reporting and Annual Reviews
You must submit an annual renewal for your
disclosure
◦ If the potential conflict no longer exists you must
notify us
If significant changes occur during the year
you should submit an update to your
disclosure as they occur
Yes. We encourage employees to disclose
potential conflicts that do not meet the
financial threshold, but may still be
problematic, such as student employment.
This allows you to be transparent with
respect to outside interests.
Allowable situations
Situations that require disclosure but may not
need an extensive management plan
Situations that require disclosure and have
problematic elements that will require
mitigation and/or a management plan
Situations that are not permitted
Receipt of royalties or honoraria for
published scholarly works, seminars,
teaching, etc.
Honoraria for serving as a special reviewer
or work on review panels
Royalties under our intellectual property
policies if no other relationship with entity
Clinical income at OUCOM
You participate in research developed in
whole or part by you, and you or your
family receive royalties from an existing
agreement with the business, but have
no other significant financial interest
You assign students, etc. to research
projects where you are entitled to
receive royalties, but have no other
significant financial interest
You assign students, etc. to projects supported
by the business through an SRA, and have a
significant financial interest other than royalty
income
You receive research support from a business in
which you serve on the board of directors, or
other advisory board, even if you are not
compensated.
You hold an executive position in a business
engaged in commercial or research activities
directly related to your Ohio University
responsibilities.
Any situation in which an actual conflict
exists is not permitted.
The only “exceptions” are those handled
under Ohio University Policy and Procedure
19.059 where faculty entrepreneurship is
addressed.
Participation in clinical trials or evaluation
of other research in which you have a
significant financial interest other than
royalty income.
In the context of your position at Ohio
University, you make professional referrals
to a business in which you have a
significant financial interest.
Letter of admonition
Ineligibility to submit grant applications
Withholding of IRB or IACUC approvals
Suspension
Non-Renewal
Loss of Tenure
Consulting
Procurement
Mentoring
Clinical Studies
Avoid consulting relationships that have
the potential to divert time and effort from
your responsibilities to Ohio University.
Do not use students.
Be wary of situations that limit publication.
Do not use university stationary, etc. that
could create an impression the university
is involved with the activities.
Make sure you are devoting sufficient time
to your university obligations.
Be cautious that the potential financial gain
cannot be perceived to influence your
university mentoring relationships.
Disclose any personal or familial financial
interest or equity in a company that is
doing business with Ohio University.
If you make purchases using public funds,
you should not use companies which will
benefit you or your family. If there is no
alternative you must seek and receive
permission prior to purchasing.
Any relationship in which there is a real or
perceived power or influence imbalance has
the potential for conflict. (Faculty:Student)
Isolating these relationships with respect to
areas of personal financial gain is best.
If they cannot be isolated, then safeguards
must be created.
If you have a financial interest, it is best to
isolate yourself from the study.
At a minimum, expect a more intense review
and a robust management plan if you have a
financial interest.
If both the institution and you have financial
interests the clinical study should be
conducted elsewhere.
You have administrative responsibilities on
behalf of Ohio University that is beneficial to
the business in which you have a significant
financial interest
You have administrative responsibilities on
behalf of Ohio University with respect to an
SRA where you have a significant financial
interest
Slide 13
Jo Ellen Sherow
Ohio University
Office of Research Compliance
Researchers’ Financial Disclosures in the
Spotlight
Conflicts of interest, always an emotional topic,
returned to the headlines this week as Sen.
Charles Grassley, a longtime critic of the drug
industry’s potential influence on research,
released new evidence that prominent Harvard
University scientists had failed to disclose much
of their outside income from pharmaceutical
companies over the past eight years.
http://www.insidehighered.com/news/2008/06/12/conflict January 15, 2008
WEDNESDAY, JANUARY 21, 2009
In a review of the literature regarding the relationship between
smokeless tobacco use and cancer, a conflict of interest of one of the
article's authors was initially not disclosed (see: Boffetta P, Hecht S, Gray
N, Gupta P, Straif K. Smokeless tobacco and cancer. Lancet Oncology
2008; 9:667-675). The original article was published in July, 2008. That
article stated: "The authors declare no conflicts of interest." After the
editor of the journal was notified by a researcher with knowledge of a
potential conflict of interest of Dr. Stephen Hecht (one of the study
authors), an erratum was published in September 2008, which noted:
"During the immediate months preceding submission of the review SH
was acting in the capacity of an expert witness for the plaintiff in a
future court case against a smokeless tobacco company. SH declares his
participation in this case in no way influenced his writing or involvement
in the review."
http://tobaccoanalysis.blogspot.com/2009/01/conflict-of-interestnot.html
January 16, 2009 — More than one third of new
drug marketing applications approved by the US
Food and Drug Administration (FDA) were
missing information about potential conflicts of
interest for clinical trial investigators, which
could allow bias to creep into the approvals
process, a government report released this week
has found. The FDA has said that it agrees with
most of the report's findings.
http://www.medscape.com/viewarticle/586980
Do collaborations between biotech companies
and academic centers constitute a conflict of
interest?
Biotechnology industry partnerships with
universities and academic centers have been
fruitful for both. So why is there so much
concern about conflict of interest and is that
concern appropriate?
http://www.redorbit.com/news/health/750100/genetic_engineering_news_p
osts_podcast_on_industrialacademic_collaborations_are_these/index.html
Universities are responsible for use of public
funds and therefore must maintain the public
trust.
Identifying and mitigating situations that may
have the potential for conflict maintains the
integrity of the university.
Maintaining integrity allows the university to
do credible academic research.
To provide information on the purpose of the
conflict of interest requirements.
To provide a basic overview of conflicts of
interest
To introduce the disclosure process and the use
of management plans
To provide information on the need for updates
and annual renewals.
Situations where financial considerations
compromise your professional judgment.
“Actual Conflict of Interest”
◦ Not permitted
Situations where an independent observer
might reasonably question whether your
professional actions or decisions are
determined by considerations of personal
gain. “Perceived Conflict of Interest”
◦ Managed
Potential conflicts may be financial or may be
a conflict of time, effort and/or commitment.
Potential conflicts can occur as a result of
administrative, scientific, academic, fiduciary
or familial situations.
They are situations that can be PERCEIVED to
be conflicting, whether a “real” conflict exists
or not.
Ohio University Policy has a mandatory
disclosure policy if you:
Earn over $10,000 in a twelve month period
from your outside activity OR
Have over 5% equity in the entity
Applies to members of your immediate family
(spouse, domestic partner, dependent
children) as well as yourself.
Anything of monetary value, including but not
limited to:
◦
◦
◦
◦
Salary
Payments for services
Equity interests over 5%
Intellectual property rights
Excludes mutual, pension and other
investments over which you have no control
Outside work during regular academic year
should not exceed equivalent of 1 day per
week.
Consulting work must avoid activities that
involve a conflict of interest with assigned
Ohio University activities and programs
Faculty Handbook, section IV-D
Outside interests cannot interfere with
primary loyalty to Ohio University and your
academic role
Use of university resources must have prior
approval of Chair, Dean and VPR.
Your outside interests should not be in
direct competition with university interests
Full time administrative employees are
expected to devote their full-time
professional loyalty, time and energy to their
position.
You must use non-work hours and no
university resources
Federal Agencies
State Law
University Policies
Many Academic Publications
45 CFR Part 50, Subpart F
“Responsibility of Applicants for Promoting
Objectivity in Research for Which PHS Funding
is Sought”
Authority: 42 U.S.C. 216, 289b-1, 299c-3.
Intent is to assure objectivity by establishing
standards that preclude bias in design, conduct, or
reporting of research
Focuses on financial conflicts of interest
(FCOI)
Regulations apply to investigators, including
sub grantees, contractors, and collaborating
investigators.
Does not apply to applications for support
under Phase I of SBIR and STTR programs
An institutional conflict of interest policy should
require that each investigator disclose to a
responsible representative of the institution all
significant financial interests of the investigator
(including those of the investigator’s spouse and
dependent children) (i) that would reasonably
appear to be affected by the research or
educational activities funded or proposed for
funding by NSF; or (ii) in entities whose financial
interests would reasonably appear to be affected
by such activities.
Chapter 1 (Subchapter A) (Part 54)
Financial Disclosure by Clinical Investigators
The Food and Drug Administration (FDA)
regulations state that investigators that
receive compensation in excess of $25,000
from a corporate sponsor of a trial in which
the investigator is engaged must disclose to
the FDA at the time of filing for a new drug
application.
19.058, Conflict of Interest in Research,
Educational, and Public Service Activities
19.059, Employee Participation in Authorized
Private Companies Commercializing Ohio
University Research
“Conflict of Interest in Research, Educational,
and Public Service Activities”
Most conflict disclosures fall within the
parameters of this policy
States that faculty are primarily responsible
for their academic, research and service
obligations
“Employee Participation in Authorized Private
Companies Commercializing Ohio University
Research”
Applies to “employees, faculty, staff and students,
who create intellectual property owned by the Ohio
University and who desire to hold an equity interest
in a firm, corporation, or other association to which
Ohio University has assigned, licensed or
transferred Ohio University’s interests…”
Consulting
Licensing University Technology
Clinical Studies
Procurement
Mentoring
Institutional
A disclosure is filed specific to the funding
application.
If you have a potential conflict for one
proposal, it does not automatically apply to
all of your proposals.
Research conflicts of interest are usually
disclosed using LEO as you apply for funding
by completing the conflict of interest section
of the electronic transmittal
If you are not using LEO, you can download
the appropriate disclosure form from
www.ohio.edu/research/compliance
“A” is selected if you have no conflicts to
disclose
“B” is selected if you have a potential conflict
to disclose relative to the submission.
(Requires a subsequent paper process)
“C” is selected if you have a current disclosure
on file, but it is not relevant to the proposal
you are submitting
Still uses option A, B or C
Requires that you gather signatures on paper
for all options, however
Generally used for personnel not listed on the
grant proposal or “key personnel”
We have revised the COI forms to word forms
This should be easier to complete than the
previous form
PDF versions are also available
Should be on the compliance web site soon,
but we can e-mail them to you until then
Use this form only if you are unable to use
the LEO transmittal form to assure that no
conflict of interest exists. A form must be
completed for each proposal.
I assure that I have read Ohio University
Policy 19.058, “Conflict of Interest in
Research, Educational, and Public Service
Activities” and declare that I have nothing
that is, or could be perceived to be a conflict
of interest with this proposal.
Use this form to disclose a potential conflict
of interest situation.
A separate disclosure form must be used for
each entity with which you conduct business
Conflict includes any member of your
immediate family (spouse, domestic partner
or children)
Require that you complete an option “B”
disclosure statement in addition to
completing the LEO transmittal form.
Require you to obtain signatures from Center
or Institute (if applicable), Chair and Dean on
the additional disclosure statement!!
The B disclosure form is available at
www.ohio.edu/research/compliance
Use this form only if you are unable to use
the LEO transmittal form. Complete this form
if you have a current conflict of interest
disclosure on file with the Office of Research
Compliance, but that disclosure is not
applicable to this proposal.
*New Option for 2008*
A management plan is developed for some
disclosures to mitigate the potential conflict
Management plans are specific to each
disclosure
May require submission of additional pieces,
such as a student employment plan
Reduce or remove the financial interest creating the
conflict
Place safeguards that mitigate the conflict potential,
such having some decisions made by an independent
entity
Limit participation in portions of the proposed
research likely to create a conflict
Require that the researcher disclose his or her
conflicting financial interests to all collaborators and
any proposed trainees;
Disclose the conflict in publications
Work to remove students from being directly advised
or taught by faculty where a conflict exists
Assure publication rights for student participants
Student Use
Nepotism and Cronyism
Intellectual Property
Use of University Resources
Publication provisions
Use of Human Subjects
Oversight Requirements
Reporting and Annual Reviews
You must submit an annual renewal for your
disclosure
◦ If the potential conflict no longer exists you must
notify us
If significant changes occur during the year
you should submit an update to your
disclosure as they occur
Yes. We encourage employees to disclose
potential conflicts that do not meet the
financial threshold, but may still be
problematic, such as student employment.
This allows you to be transparent with
respect to outside interests.
Allowable situations
Situations that require disclosure but may not
need an extensive management plan
Situations that require disclosure and have
problematic elements that will require
mitigation and/or a management plan
Situations that are not permitted
Receipt of royalties or honoraria for
published scholarly works, seminars,
teaching, etc.
Honoraria for serving as a special reviewer
or work on review panels
Royalties under our intellectual property
policies if no other relationship with entity
Clinical income at OUCOM
You participate in research developed in
whole or part by you, and you or your
family receive royalties from an existing
agreement with the business, but have
no other significant financial interest
You assign students, etc. to research
projects where you are entitled to
receive royalties, but have no other
significant financial interest
You assign students, etc. to projects supported
by the business through an SRA, and have a
significant financial interest other than royalty
income
You receive research support from a business in
which you serve on the board of directors, or
other advisory board, even if you are not
compensated.
You hold an executive position in a business
engaged in commercial or research activities
directly related to your Ohio University
responsibilities.
Any situation in which an actual conflict
exists is not permitted.
The only “exceptions” are those handled
under Ohio University Policy and Procedure
19.059 where faculty entrepreneurship is
addressed.
Participation in clinical trials or evaluation
of other research in which you have a
significant financial interest other than
royalty income.
In the context of your position at Ohio
University, you make professional referrals
to a business in which you have a
significant financial interest.
Letter of admonition
Ineligibility to submit grant applications
Withholding of IRB or IACUC approvals
Suspension
Non-Renewal
Loss of Tenure
Consulting
Procurement
Mentoring
Clinical Studies
Avoid consulting relationships that have
the potential to divert time and effort from
your responsibilities to Ohio University.
Do not use students.
Be wary of situations that limit publication.
Do not use university stationary, etc. that
could create an impression the university
is involved with the activities.
Make sure you are devoting sufficient time
to your university obligations.
Be cautious that the potential financial gain
cannot be perceived to influence your
university mentoring relationships.
Disclose any personal or familial financial
interest or equity in a company that is
doing business with Ohio University.
If you make purchases using public funds,
you should not use companies which will
benefit you or your family. If there is no
alternative you must seek and receive
permission prior to purchasing.
Any relationship in which there is a real or
perceived power or influence imbalance has
the potential for conflict. (Faculty:Student)
Isolating these relationships with respect to
areas of personal financial gain is best.
If they cannot be isolated, then safeguards
must be created.
If you have a financial interest, it is best to
isolate yourself from the study.
At a minimum, expect a more intense review
and a robust management plan if you have a
financial interest.
If both the institution and you have financial
interests the clinical study should be
conducted elsewhere.
You have administrative responsibilities on
behalf of Ohio University that is beneficial to
the business in which you have a significant
financial interest
You have administrative responsibilities on
behalf of Ohio University with respect to an
SRA where you have a significant financial
interest
Slide 14
Jo Ellen Sherow
Ohio University
Office of Research Compliance
Researchers’ Financial Disclosures in the
Spotlight
Conflicts of interest, always an emotional topic,
returned to the headlines this week as Sen.
Charles Grassley, a longtime critic of the drug
industry’s potential influence on research,
released new evidence that prominent Harvard
University scientists had failed to disclose much
of their outside income from pharmaceutical
companies over the past eight years.
http://www.insidehighered.com/news/2008/06/12/conflict January 15, 2008
WEDNESDAY, JANUARY 21, 2009
In a review of the literature regarding the relationship between
smokeless tobacco use and cancer, a conflict of interest of one of the
article's authors was initially not disclosed (see: Boffetta P, Hecht S, Gray
N, Gupta P, Straif K. Smokeless tobacco and cancer. Lancet Oncology
2008; 9:667-675). The original article was published in July, 2008. That
article stated: "The authors declare no conflicts of interest." After the
editor of the journal was notified by a researcher with knowledge of a
potential conflict of interest of Dr. Stephen Hecht (one of the study
authors), an erratum was published in September 2008, which noted:
"During the immediate months preceding submission of the review SH
was acting in the capacity of an expert witness for the plaintiff in a
future court case against a smokeless tobacco company. SH declares his
participation in this case in no way influenced his writing or involvement
in the review."
http://tobaccoanalysis.blogspot.com/2009/01/conflict-of-interestnot.html
January 16, 2009 — More than one third of new
drug marketing applications approved by the US
Food and Drug Administration (FDA) were
missing information about potential conflicts of
interest for clinical trial investigators, which
could allow bias to creep into the approvals
process, a government report released this week
has found. The FDA has said that it agrees with
most of the report's findings.
http://www.medscape.com/viewarticle/586980
Do collaborations between biotech companies
and academic centers constitute a conflict of
interest?
Biotechnology industry partnerships with
universities and academic centers have been
fruitful for both. So why is there so much
concern about conflict of interest and is that
concern appropriate?
http://www.redorbit.com/news/health/750100/genetic_engineering_news_p
osts_podcast_on_industrialacademic_collaborations_are_these/index.html
Universities are responsible for use of public
funds and therefore must maintain the public
trust.
Identifying and mitigating situations that may
have the potential for conflict maintains the
integrity of the university.
Maintaining integrity allows the university to
do credible academic research.
To provide information on the purpose of the
conflict of interest requirements.
To provide a basic overview of conflicts of
interest
To introduce the disclosure process and the use
of management plans
To provide information on the need for updates
and annual renewals.
Situations where financial considerations
compromise your professional judgment.
“Actual Conflict of Interest”
◦ Not permitted
Situations where an independent observer
might reasonably question whether your
professional actions or decisions are
determined by considerations of personal
gain. “Perceived Conflict of Interest”
◦ Managed
Potential conflicts may be financial or may be
a conflict of time, effort and/or commitment.
Potential conflicts can occur as a result of
administrative, scientific, academic, fiduciary
or familial situations.
They are situations that can be PERCEIVED to
be conflicting, whether a “real” conflict exists
or not.
Ohio University Policy has a mandatory
disclosure policy if you:
Earn over $10,000 in a twelve month period
from your outside activity OR
Have over 5% equity in the entity
Applies to members of your immediate family
(spouse, domestic partner, dependent
children) as well as yourself.
Anything of monetary value, including but not
limited to:
◦
◦
◦
◦
Salary
Payments for services
Equity interests over 5%
Intellectual property rights
Excludes mutual, pension and other
investments over which you have no control
Outside work during regular academic year
should not exceed equivalent of 1 day per
week.
Consulting work must avoid activities that
involve a conflict of interest with assigned
Ohio University activities and programs
Faculty Handbook, section IV-D
Outside interests cannot interfere with
primary loyalty to Ohio University and your
academic role
Use of university resources must have prior
approval of Chair, Dean and VPR.
Your outside interests should not be in
direct competition with university interests
Full time administrative employees are
expected to devote their full-time
professional loyalty, time and energy to their
position.
You must use non-work hours and no
university resources
Federal Agencies
State Law
University Policies
Many Academic Publications
45 CFR Part 50, Subpart F
“Responsibility of Applicants for Promoting
Objectivity in Research for Which PHS Funding
is Sought”
Authority: 42 U.S.C. 216, 289b-1, 299c-3.
Intent is to assure objectivity by establishing
standards that preclude bias in design, conduct, or
reporting of research
Focuses on financial conflicts of interest
(FCOI)
Regulations apply to investigators, including
sub grantees, contractors, and collaborating
investigators.
Does not apply to applications for support
under Phase I of SBIR and STTR programs
An institutional conflict of interest policy should
require that each investigator disclose to a
responsible representative of the institution all
significant financial interests of the investigator
(including those of the investigator’s spouse and
dependent children) (i) that would reasonably
appear to be affected by the research or
educational activities funded or proposed for
funding by NSF; or (ii) in entities whose financial
interests would reasonably appear to be affected
by such activities.
Chapter 1 (Subchapter A) (Part 54)
Financial Disclosure by Clinical Investigators
The Food and Drug Administration (FDA)
regulations state that investigators that
receive compensation in excess of $25,000
from a corporate sponsor of a trial in which
the investigator is engaged must disclose to
the FDA at the time of filing for a new drug
application.
19.058, Conflict of Interest in Research,
Educational, and Public Service Activities
19.059, Employee Participation in Authorized
Private Companies Commercializing Ohio
University Research
“Conflict of Interest in Research, Educational,
and Public Service Activities”
Most conflict disclosures fall within the
parameters of this policy
States that faculty are primarily responsible
for their academic, research and service
obligations
“Employee Participation in Authorized Private
Companies Commercializing Ohio University
Research”
Applies to “employees, faculty, staff and students,
who create intellectual property owned by the Ohio
University and who desire to hold an equity interest
in a firm, corporation, or other association to which
Ohio University has assigned, licensed or
transferred Ohio University’s interests…”
Consulting
Licensing University Technology
Clinical Studies
Procurement
Mentoring
Institutional
A disclosure is filed specific to the funding
application.
If you have a potential conflict for one
proposal, it does not automatically apply to
all of your proposals.
Research conflicts of interest are usually
disclosed using LEO as you apply for funding
by completing the conflict of interest section
of the electronic transmittal
If you are not using LEO, you can download
the appropriate disclosure form from
www.ohio.edu/research/compliance
“A” is selected if you have no conflicts to
disclose
“B” is selected if you have a potential conflict
to disclose relative to the submission.
(Requires a subsequent paper process)
“C” is selected if you have a current disclosure
on file, but it is not relevant to the proposal
you are submitting
Still uses option A, B or C
Requires that you gather signatures on paper
for all options, however
Generally used for personnel not listed on the
grant proposal or “key personnel”
We have revised the COI forms to word forms
This should be easier to complete than the
previous form
PDF versions are also available
Should be on the compliance web site soon,
but we can e-mail them to you until then
Use this form only if you are unable to use
the LEO transmittal form to assure that no
conflict of interest exists. A form must be
completed for each proposal.
I assure that I have read Ohio University
Policy 19.058, “Conflict of Interest in
Research, Educational, and Public Service
Activities” and declare that I have nothing
that is, or could be perceived to be a conflict
of interest with this proposal.
Use this form to disclose a potential conflict
of interest situation.
A separate disclosure form must be used for
each entity with which you conduct business
Conflict includes any member of your
immediate family (spouse, domestic partner
or children)
Require that you complete an option “B”
disclosure statement in addition to
completing the LEO transmittal form.
Require you to obtain signatures from Center
or Institute (if applicable), Chair and Dean on
the additional disclosure statement!!
The B disclosure form is available at
www.ohio.edu/research/compliance
Use this form only if you are unable to use
the LEO transmittal form. Complete this form
if you have a current conflict of interest
disclosure on file with the Office of Research
Compliance, but that disclosure is not
applicable to this proposal.
*New Option for 2008*
A management plan is developed for some
disclosures to mitigate the potential conflict
Management plans are specific to each
disclosure
May require submission of additional pieces,
such as a student employment plan
Reduce or remove the financial interest creating the
conflict
Place safeguards that mitigate the conflict potential,
such having some decisions made by an independent
entity
Limit participation in portions of the proposed
research likely to create a conflict
Require that the researcher disclose his or her
conflicting financial interests to all collaborators and
any proposed trainees;
Disclose the conflict in publications
Work to remove students from being directly advised
or taught by faculty where a conflict exists
Assure publication rights for student participants
Student Use
Nepotism and Cronyism
Intellectual Property
Use of University Resources
Publication provisions
Use of Human Subjects
Oversight Requirements
Reporting and Annual Reviews
You must submit an annual renewal for your
disclosure
◦ If the potential conflict no longer exists you must
notify us
If significant changes occur during the year
you should submit an update to your
disclosure as they occur
Yes. We encourage employees to disclose
potential conflicts that do not meet the
financial threshold, but may still be
problematic, such as student employment.
This allows you to be transparent with
respect to outside interests.
Allowable situations
Situations that require disclosure but may not
need an extensive management plan
Situations that require disclosure and have
problematic elements that will require
mitigation and/or a management plan
Situations that are not permitted
Receipt of royalties or honoraria for
published scholarly works, seminars,
teaching, etc.
Honoraria for serving as a special reviewer
or work on review panels
Royalties under our intellectual property
policies if no other relationship with entity
Clinical income at OUCOM
You participate in research developed in
whole or part by you, and you or your
family receive royalties from an existing
agreement with the business, but have
no other significant financial interest
You assign students, etc. to research
projects where you are entitled to
receive royalties, but have no other
significant financial interest
You assign students, etc. to projects supported
by the business through an SRA, and have a
significant financial interest other than royalty
income
You receive research support from a business in
which you serve on the board of directors, or
other advisory board, even if you are not
compensated.
You hold an executive position in a business
engaged in commercial or research activities
directly related to your Ohio University
responsibilities.
Any situation in which an actual conflict
exists is not permitted.
The only “exceptions” are those handled
under Ohio University Policy and Procedure
19.059 where faculty entrepreneurship is
addressed.
Participation in clinical trials or evaluation
of other research in which you have a
significant financial interest other than
royalty income.
In the context of your position at Ohio
University, you make professional referrals
to a business in which you have a
significant financial interest.
Letter of admonition
Ineligibility to submit grant applications
Withholding of IRB or IACUC approvals
Suspension
Non-Renewal
Loss of Tenure
Consulting
Procurement
Mentoring
Clinical Studies
Avoid consulting relationships that have
the potential to divert time and effort from
your responsibilities to Ohio University.
Do not use students.
Be wary of situations that limit publication.
Do not use university stationary, etc. that
could create an impression the university
is involved with the activities.
Make sure you are devoting sufficient time
to your university obligations.
Be cautious that the potential financial gain
cannot be perceived to influence your
university mentoring relationships.
Disclose any personal or familial financial
interest or equity in a company that is
doing business with Ohio University.
If you make purchases using public funds,
you should not use companies which will
benefit you or your family. If there is no
alternative you must seek and receive
permission prior to purchasing.
Any relationship in which there is a real or
perceived power or influence imbalance has
the potential for conflict. (Faculty:Student)
Isolating these relationships with respect to
areas of personal financial gain is best.
If they cannot be isolated, then safeguards
must be created.
If you have a financial interest, it is best to
isolate yourself from the study.
At a minimum, expect a more intense review
and a robust management plan if you have a
financial interest.
If both the institution and you have financial
interests the clinical study should be
conducted elsewhere.
You have administrative responsibilities on
behalf of Ohio University that is beneficial to
the business in which you have a significant
financial interest
You have administrative responsibilities on
behalf of Ohio University with respect to an
SRA where you have a significant financial
interest
Slide 15
Jo Ellen Sherow
Ohio University
Office of Research Compliance
Researchers’ Financial Disclosures in the
Spotlight
Conflicts of interest, always an emotional topic,
returned to the headlines this week as Sen.
Charles Grassley, a longtime critic of the drug
industry’s potential influence on research,
released new evidence that prominent Harvard
University scientists had failed to disclose much
of their outside income from pharmaceutical
companies over the past eight years.
http://www.insidehighered.com/news/2008/06/12/conflict January 15, 2008
WEDNESDAY, JANUARY 21, 2009
In a review of the literature regarding the relationship between
smokeless tobacco use and cancer, a conflict of interest of one of the
article's authors was initially not disclosed (see: Boffetta P, Hecht S, Gray
N, Gupta P, Straif K. Smokeless tobacco and cancer. Lancet Oncology
2008; 9:667-675). The original article was published in July, 2008. That
article stated: "The authors declare no conflicts of interest." After the
editor of the journal was notified by a researcher with knowledge of a
potential conflict of interest of Dr. Stephen Hecht (one of the study
authors), an erratum was published in September 2008, which noted:
"During the immediate months preceding submission of the review SH
was acting in the capacity of an expert witness for the plaintiff in a
future court case against a smokeless tobacco company. SH declares his
participation in this case in no way influenced his writing or involvement
in the review."
http://tobaccoanalysis.blogspot.com/2009/01/conflict-of-interestnot.html
January 16, 2009 — More than one third of new
drug marketing applications approved by the US
Food and Drug Administration (FDA) were
missing information about potential conflicts of
interest for clinical trial investigators, which
could allow bias to creep into the approvals
process, a government report released this week
has found. The FDA has said that it agrees with
most of the report's findings.
http://www.medscape.com/viewarticle/586980
Do collaborations between biotech companies
and academic centers constitute a conflict of
interest?
Biotechnology industry partnerships with
universities and academic centers have been
fruitful for both. So why is there so much
concern about conflict of interest and is that
concern appropriate?
http://www.redorbit.com/news/health/750100/genetic_engineering_news_p
osts_podcast_on_industrialacademic_collaborations_are_these/index.html
Universities are responsible for use of public
funds and therefore must maintain the public
trust.
Identifying and mitigating situations that may
have the potential for conflict maintains the
integrity of the university.
Maintaining integrity allows the university to
do credible academic research.
To provide information on the purpose of the
conflict of interest requirements.
To provide a basic overview of conflicts of
interest
To introduce the disclosure process and the use
of management plans
To provide information on the need for updates
and annual renewals.
Situations where financial considerations
compromise your professional judgment.
“Actual Conflict of Interest”
◦ Not permitted
Situations where an independent observer
might reasonably question whether your
professional actions or decisions are
determined by considerations of personal
gain. “Perceived Conflict of Interest”
◦ Managed
Potential conflicts may be financial or may be
a conflict of time, effort and/or commitment.
Potential conflicts can occur as a result of
administrative, scientific, academic, fiduciary
or familial situations.
They are situations that can be PERCEIVED to
be conflicting, whether a “real” conflict exists
or not.
Ohio University Policy has a mandatory
disclosure policy if you:
Earn over $10,000 in a twelve month period
from your outside activity OR
Have over 5% equity in the entity
Applies to members of your immediate family
(spouse, domestic partner, dependent
children) as well as yourself.
Anything of monetary value, including but not
limited to:
◦
◦
◦
◦
Salary
Payments for services
Equity interests over 5%
Intellectual property rights
Excludes mutual, pension and other
investments over which you have no control
Outside work during regular academic year
should not exceed equivalent of 1 day per
week.
Consulting work must avoid activities that
involve a conflict of interest with assigned
Ohio University activities and programs
Faculty Handbook, section IV-D
Outside interests cannot interfere with
primary loyalty to Ohio University and your
academic role
Use of university resources must have prior
approval of Chair, Dean and VPR.
Your outside interests should not be in
direct competition with university interests
Full time administrative employees are
expected to devote their full-time
professional loyalty, time and energy to their
position.
You must use non-work hours and no
university resources
Federal Agencies
State Law
University Policies
Many Academic Publications
45 CFR Part 50, Subpart F
“Responsibility of Applicants for Promoting
Objectivity in Research for Which PHS Funding
is Sought”
Authority: 42 U.S.C. 216, 289b-1, 299c-3.
Intent is to assure objectivity by establishing
standards that preclude bias in design, conduct, or
reporting of research
Focuses on financial conflicts of interest
(FCOI)
Regulations apply to investigators, including
sub grantees, contractors, and collaborating
investigators.
Does not apply to applications for support
under Phase I of SBIR and STTR programs
An institutional conflict of interest policy should
require that each investigator disclose to a
responsible representative of the institution all
significant financial interests of the investigator
(including those of the investigator’s spouse and
dependent children) (i) that would reasonably
appear to be affected by the research or
educational activities funded or proposed for
funding by NSF; or (ii) in entities whose financial
interests would reasonably appear to be affected
by such activities.
Chapter 1 (Subchapter A) (Part 54)
Financial Disclosure by Clinical Investigators
The Food and Drug Administration (FDA)
regulations state that investigators that
receive compensation in excess of $25,000
from a corporate sponsor of a trial in which
the investigator is engaged must disclose to
the FDA at the time of filing for a new drug
application.
19.058, Conflict of Interest in Research,
Educational, and Public Service Activities
19.059, Employee Participation in Authorized
Private Companies Commercializing Ohio
University Research
“Conflict of Interest in Research, Educational,
and Public Service Activities”
Most conflict disclosures fall within the
parameters of this policy
States that faculty are primarily responsible
for their academic, research and service
obligations
“Employee Participation in Authorized Private
Companies Commercializing Ohio University
Research”
Applies to “employees, faculty, staff and students,
who create intellectual property owned by the Ohio
University and who desire to hold an equity interest
in a firm, corporation, or other association to which
Ohio University has assigned, licensed or
transferred Ohio University’s interests…”
Consulting
Licensing University Technology
Clinical Studies
Procurement
Mentoring
Institutional
A disclosure is filed specific to the funding
application.
If you have a potential conflict for one
proposal, it does not automatically apply to
all of your proposals.
Research conflicts of interest are usually
disclosed using LEO as you apply for funding
by completing the conflict of interest section
of the electronic transmittal
If you are not using LEO, you can download
the appropriate disclosure form from
www.ohio.edu/research/compliance
“A” is selected if you have no conflicts to
disclose
“B” is selected if you have a potential conflict
to disclose relative to the submission.
(Requires a subsequent paper process)
“C” is selected if you have a current disclosure
on file, but it is not relevant to the proposal
you are submitting
Still uses option A, B or C
Requires that you gather signatures on paper
for all options, however
Generally used for personnel not listed on the
grant proposal or “key personnel”
We have revised the COI forms to word forms
This should be easier to complete than the
previous form
PDF versions are also available
Should be on the compliance web site soon,
but we can e-mail them to you until then
Use this form only if you are unable to use
the LEO transmittal form to assure that no
conflict of interest exists. A form must be
completed for each proposal.
I assure that I have read Ohio University
Policy 19.058, “Conflict of Interest in
Research, Educational, and Public Service
Activities” and declare that I have nothing
that is, or could be perceived to be a conflict
of interest with this proposal.
Use this form to disclose a potential conflict
of interest situation.
A separate disclosure form must be used for
each entity with which you conduct business
Conflict includes any member of your
immediate family (spouse, domestic partner
or children)
Require that you complete an option “B”
disclosure statement in addition to
completing the LEO transmittal form.
Require you to obtain signatures from Center
or Institute (if applicable), Chair and Dean on
the additional disclosure statement!!
The B disclosure form is available at
www.ohio.edu/research/compliance
Use this form only if you are unable to use
the LEO transmittal form. Complete this form
if you have a current conflict of interest
disclosure on file with the Office of Research
Compliance, but that disclosure is not
applicable to this proposal.
*New Option for 2008*
A management plan is developed for some
disclosures to mitigate the potential conflict
Management plans are specific to each
disclosure
May require submission of additional pieces,
such as a student employment plan
Reduce or remove the financial interest creating the
conflict
Place safeguards that mitigate the conflict potential,
such having some decisions made by an independent
entity
Limit participation in portions of the proposed
research likely to create a conflict
Require that the researcher disclose his or her
conflicting financial interests to all collaborators and
any proposed trainees;
Disclose the conflict in publications
Work to remove students from being directly advised
or taught by faculty where a conflict exists
Assure publication rights for student participants
Student Use
Nepotism and Cronyism
Intellectual Property
Use of University Resources
Publication provisions
Use of Human Subjects
Oversight Requirements
Reporting and Annual Reviews
You must submit an annual renewal for your
disclosure
◦ If the potential conflict no longer exists you must
notify us
If significant changes occur during the year
you should submit an update to your
disclosure as they occur
Yes. We encourage employees to disclose
potential conflicts that do not meet the
financial threshold, but may still be
problematic, such as student employment.
This allows you to be transparent with
respect to outside interests.
Allowable situations
Situations that require disclosure but may not
need an extensive management plan
Situations that require disclosure and have
problematic elements that will require
mitigation and/or a management plan
Situations that are not permitted
Receipt of royalties or honoraria for
published scholarly works, seminars,
teaching, etc.
Honoraria for serving as a special reviewer
or work on review panels
Royalties under our intellectual property
policies if no other relationship with entity
Clinical income at OUCOM
You participate in research developed in
whole or part by you, and you or your
family receive royalties from an existing
agreement with the business, but have
no other significant financial interest
You assign students, etc. to research
projects where you are entitled to
receive royalties, but have no other
significant financial interest
You assign students, etc. to projects supported
by the business through an SRA, and have a
significant financial interest other than royalty
income
You receive research support from a business in
which you serve on the board of directors, or
other advisory board, even if you are not
compensated.
You hold an executive position in a business
engaged in commercial or research activities
directly related to your Ohio University
responsibilities.
Any situation in which an actual conflict
exists is not permitted.
The only “exceptions” are those handled
under Ohio University Policy and Procedure
19.059 where faculty entrepreneurship is
addressed.
Participation in clinical trials or evaluation
of other research in which you have a
significant financial interest other than
royalty income.
In the context of your position at Ohio
University, you make professional referrals
to a business in which you have a
significant financial interest.
Letter of admonition
Ineligibility to submit grant applications
Withholding of IRB or IACUC approvals
Suspension
Non-Renewal
Loss of Tenure
Consulting
Procurement
Mentoring
Clinical Studies
Avoid consulting relationships that have
the potential to divert time and effort from
your responsibilities to Ohio University.
Do not use students.
Be wary of situations that limit publication.
Do not use university stationary, etc. that
could create an impression the university
is involved with the activities.
Make sure you are devoting sufficient time
to your university obligations.
Be cautious that the potential financial gain
cannot be perceived to influence your
university mentoring relationships.
Disclose any personal or familial financial
interest or equity in a company that is
doing business with Ohio University.
If you make purchases using public funds,
you should not use companies which will
benefit you or your family. If there is no
alternative you must seek and receive
permission prior to purchasing.
Any relationship in which there is a real or
perceived power or influence imbalance has
the potential for conflict. (Faculty:Student)
Isolating these relationships with respect to
areas of personal financial gain is best.
If they cannot be isolated, then safeguards
must be created.
If you have a financial interest, it is best to
isolate yourself from the study.
At a minimum, expect a more intense review
and a robust management plan if you have a
financial interest.
If both the institution and you have financial
interests the clinical study should be
conducted elsewhere.
You have administrative responsibilities on
behalf of Ohio University that is beneficial to
the business in which you have a significant
financial interest
You have administrative responsibilities on
behalf of Ohio University with respect to an
SRA where you have a significant financial
interest
Slide 16
Jo Ellen Sherow
Ohio University
Office of Research Compliance
Researchers’ Financial Disclosures in the
Spotlight
Conflicts of interest, always an emotional topic,
returned to the headlines this week as Sen.
Charles Grassley, a longtime critic of the drug
industry’s potential influence on research,
released new evidence that prominent Harvard
University scientists had failed to disclose much
of their outside income from pharmaceutical
companies over the past eight years.
http://www.insidehighered.com/news/2008/06/12/conflict January 15, 2008
WEDNESDAY, JANUARY 21, 2009
In a review of the literature regarding the relationship between
smokeless tobacco use and cancer, a conflict of interest of one of the
article's authors was initially not disclosed (see: Boffetta P, Hecht S, Gray
N, Gupta P, Straif K. Smokeless tobacco and cancer. Lancet Oncology
2008; 9:667-675). The original article was published in July, 2008. That
article stated: "The authors declare no conflicts of interest." After the
editor of the journal was notified by a researcher with knowledge of a
potential conflict of interest of Dr. Stephen Hecht (one of the study
authors), an erratum was published in September 2008, which noted:
"During the immediate months preceding submission of the review SH
was acting in the capacity of an expert witness for the plaintiff in a
future court case against a smokeless tobacco company. SH declares his
participation in this case in no way influenced his writing or involvement
in the review."
http://tobaccoanalysis.blogspot.com/2009/01/conflict-of-interestnot.html
January 16, 2009 — More than one third of new
drug marketing applications approved by the US
Food and Drug Administration (FDA) were
missing information about potential conflicts of
interest for clinical trial investigators, which
could allow bias to creep into the approvals
process, a government report released this week
has found. The FDA has said that it agrees with
most of the report's findings.
http://www.medscape.com/viewarticle/586980
Do collaborations between biotech companies
and academic centers constitute a conflict of
interest?
Biotechnology industry partnerships with
universities and academic centers have been
fruitful for both. So why is there so much
concern about conflict of interest and is that
concern appropriate?
http://www.redorbit.com/news/health/750100/genetic_engineering_news_p
osts_podcast_on_industrialacademic_collaborations_are_these/index.html
Universities are responsible for use of public
funds and therefore must maintain the public
trust.
Identifying and mitigating situations that may
have the potential for conflict maintains the
integrity of the university.
Maintaining integrity allows the university to
do credible academic research.
To provide information on the purpose of the
conflict of interest requirements.
To provide a basic overview of conflicts of
interest
To introduce the disclosure process and the use
of management plans
To provide information on the need for updates
and annual renewals.
Situations where financial considerations
compromise your professional judgment.
“Actual Conflict of Interest”
◦ Not permitted
Situations where an independent observer
might reasonably question whether your
professional actions or decisions are
determined by considerations of personal
gain. “Perceived Conflict of Interest”
◦ Managed
Potential conflicts may be financial or may be
a conflict of time, effort and/or commitment.
Potential conflicts can occur as a result of
administrative, scientific, academic, fiduciary
or familial situations.
They are situations that can be PERCEIVED to
be conflicting, whether a “real” conflict exists
or not.
Ohio University Policy has a mandatory
disclosure policy if you:
Earn over $10,000 in a twelve month period
from your outside activity OR
Have over 5% equity in the entity
Applies to members of your immediate family
(spouse, domestic partner, dependent
children) as well as yourself.
Anything of monetary value, including but not
limited to:
◦
◦
◦
◦
Salary
Payments for services
Equity interests over 5%
Intellectual property rights
Excludes mutual, pension and other
investments over which you have no control
Outside work during regular academic year
should not exceed equivalent of 1 day per
week.
Consulting work must avoid activities that
involve a conflict of interest with assigned
Ohio University activities and programs
Faculty Handbook, section IV-D
Outside interests cannot interfere with
primary loyalty to Ohio University and your
academic role
Use of university resources must have prior
approval of Chair, Dean and VPR.
Your outside interests should not be in
direct competition with university interests
Full time administrative employees are
expected to devote their full-time
professional loyalty, time and energy to their
position.
You must use non-work hours and no
university resources
Federal Agencies
State Law
University Policies
Many Academic Publications
45 CFR Part 50, Subpart F
“Responsibility of Applicants for Promoting
Objectivity in Research for Which PHS Funding
is Sought”
Authority: 42 U.S.C. 216, 289b-1, 299c-3.
Intent is to assure objectivity by establishing
standards that preclude bias in design, conduct, or
reporting of research
Focuses on financial conflicts of interest
(FCOI)
Regulations apply to investigators, including
sub grantees, contractors, and collaborating
investigators.
Does not apply to applications for support
under Phase I of SBIR and STTR programs
An institutional conflict of interest policy should
require that each investigator disclose to a
responsible representative of the institution all
significant financial interests of the investigator
(including those of the investigator’s spouse and
dependent children) (i) that would reasonably
appear to be affected by the research or
educational activities funded or proposed for
funding by NSF; or (ii) in entities whose financial
interests would reasonably appear to be affected
by such activities.
Chapter 1 (Subchapter A) (Part 54)
Financial Disclosure by Clinical Investigators
The Food and Drug Administration (FDA)
regulations state that investigators that
receive compensation in excess of $25,000
from a corporate sponsor of a trial in which
the investigator is engaged must disclose to
the FDA at the time of filing for a new drug
application.
19.058, Conflict of Interest in Research,
Educational, and Public Service Activities
19.059, Employee Participation in Authorized
Private Companies Commercializing Ohio
University Research
“Conflict of Interest in Research, Educational,
and Public Service Activities”
Most conflict disclosures fall within the
parameters of this policy
States that faculty are primarily responsible
for their academic, research and service
obligations
“Employee Participation in Authorized Private
Companies Commercializing Ohio University
Research”
Applies to “employees, faculty, staff and students,
who create intellectual property owned by the Ohio
University and who desire to hold an equity interest
in a firm, corporation, or other association to which
Ohio University has assigned, licensed or
transferred Ohio University’s interests…”
Consulting
Licensing University Technology
Clinical Studies
Procurement
Mentoring
Institutional
A disclosure is filed specific to the funding
application.
If you have a potential conflict for one
proposal, it does not automatically apply to
all of your proposals.
Research conflicts of interest are usually
disclosed using LEO as you apply for funding
by completing the conflict of interest section
of the electronic transmittal
If you are not using LEO, you can download
the appropriate disclosure form from
www.ohio.edu/research/compliance
“A” is selected if you have no conflicts to
disclose
“B” is selected if you have a potential conflict
to disclose relative to the submission.
(Requires a subsequent paper process)
“C” is selected if you have a current disclosure
on file, but it is not relevant to the proposal
you are submitting
Still uses option A, B or C
Requires that you gather signatures on paper
for all options, however
Generally used for personnel not listed on the
grant proposal or “key personnel”
We have revised the COI forms to word forms
This should be easier to complete than the
previous form
PDF versions are also available
Should be on the compliance web site soon,
but we can e-mail them to you until then
Use this form only if you are unable to use
the LEO transmittal form to assure that no
conflict of interest exists. A form must be
completed for each proposal.
I assure that I have read Ohio University
Policy 19.058, “Conflict of Interest in
Research, Educational, and Public Service
Activities” and declare that I have nothing
that is, or could be perceived to be a conflict
of interest with this proposal.
Use this form to disclose a potential conflict
of interest situation.
A separate disclosure form must be used for
each entity with which you conduct business
Conflict includes any member of your
immediate family (spouse, domestic partner
or children)
Require that you complete an option “B”
disclosure statement in addition to
completing the LEO transmittal form.
Require you to obtain signatures from Center
or Institute (if applicable), Chair and Dean on
the additional disclosure statement!!
The B disclosure form is available at
www.ohio.edu/research/compliance
Use this form only if you are unable to use
the LEO transmittal form. Complete this form
if you have a current conflict of interest
disclosure on file with the Office of Research
Compliance, but that disclosure is not
applicable to this proposal.
*New Option for 2008*
A management plan is developed for some
disclosures to mitigate the potential conflict
Management plans are specific to each
disclosure
May require submission of additional pieces,
such as a student employment plan
Reduce or remove the financial interest creating the
conflict
Place safeguards that mitigate the conflict potential,
such having some decisions made by an independent
entity
Limit participation in portions of the proposed
research likely to create a conflict
Require that the researcher disclose his or her
conflicting financial interests to all collaborators and
any proposed trainees;
Disclose the conflict in publications
Work to remove students from being directly advised
or taught by faculty where a conflict exists
Assure publication rights for student participants
Student Use
Nepotism and Cronyism
Intellectual Property
Use of University Resources
Publication provisions
Use of Human Subjects
Oversight Requirements
Reporting and Annual Reviews
You must submit an annual renewal for your
disclosure
◦ If the potential conflict no longer exists you must
notify us
If significant changes occur during the year
you should submit an update to your
disclosure as they occur
Yes. We encourage employees to disclose
potential conflicts that do not meet the
financial threshold, but may still be
problematic, such as student employment.
This allows you to be transparent with
respect to outside interests.
Allowable situations
Situations that require disclosure but may not
need an extensive management plan
Situations that require disclosure and have
problematic elements that will require
mitigation and/or a management plan
Situations that are not permitted
Receipt of royalties or honoraria for
published scholarly works, seminars,
teaching, etc.
Honoraria for serving as a special reviewer
or work on review panels
Royalties under our intellectual property
policies if no other relationship with entity
Clinical income at OUCOM
You participate in research developed in
whole or part by you, and you or your
family receive royalties from an existing
agreement with the business, but have
no other significant financial interest
You assign students, etc. to research
projects where you are entitled to
receive royalties, but have no other
significant financial interest
You assign students, etc. to projects supported
by the business through an SRA, and have a
significant financial interest other than royalty
income
You receive research support from a business in
which you serve on the board of directors, or
other advisory board, even if you are not
compensated.
You hold an executive position in a business
engaged in commercial or research activities
directly related to your Ohio University
responsibilities.
Any situation in which an actual conflict
exists is not permitted.
The only “exceptions” are those handled
under Ohio University Policy and Procedure
19.059 where faculty entrepreneurship is
addressed.
Participation in clinical trials or evaluation
of other research in which you have a
significant financial interest other than
royalty income.
In the context of your position at Ohio
University, you make professional referrals
to a business in which you have a
significant financial interest.
Letter of admonition
Ineligibility to submit grant applications
Withholding of IRB or IACUC approvals
Suspension
Non-Renewal
Loss of Tenure
Consulting
Procurement
Mentoring
Clinical Studies
Avoid consulting relationships that have
the potential to divert time and effort from
your responsibilities to Ohio University.
Do not use students.
Be wary of situations that limit publication.
Do not use university stationary, etc. that
could create an impression the university
is involved with the activities.
Make sure you are devoting sufficient time
to your university obligations.
Be cautious that the potential financial gain
cannot be perceived to influence your
university mentoring relationships.
Disclose any personal or familial financial
interest or equity in a company that is
doing business with Ohio University.
If you make purchases using public funds,
you should not use companies which will
benefit you or your family. If there is no
alternative you must seek and receive
permission prior to purchasing.
Any relationship in which there is a real or
perceived power or influence imbalance has
the potential for conflict. (Faculty:Student)
Isolating these relationships with respect to
areas of personal financial gain is best.
If they cannot be isolated, then safeguards
must be created.
If you have a financial interest, it is best to
isolate yourself from the study.
At a minimum, expect a more intense review
and a robust management plan if you have a
financial interest.
If both the institution and you have financial
interests the clinical study should be
conducted elsewhere.
You have administrative responsibilities on
behalf of Ohio University that is beneficial to
the business in which you have a significant
financial interest
You have administrative responsibilities on
behalf of Ohio University with respect to an
SRA where you have a significant financial
interest
Slide 17
Jo Ellen Sherow
Ohio University
Office of Research Compliance
Researchers’ Financial Disclosures in the
Spotlight
Conflicts of interest, always an emotional topic,
returned to the headlines this week as Sen.
Charles Grassley, a longtime critic of the drug
industry’s potential influence on research,
released new evidence that prominent Harvard
University scientists had failed to disclose much
of their outside income from pharmaceutical
companies over the past eight years.
http://www.insidehighered.com/news/2008/06/12/conflict January 15, 2008
WEDNESDAY, JANUARY 21, 2009
In a review of the literature regarding the relationship between
smokeless tobacco use and cancer, a conflict of interest of one of the
article's authors was initially not disclosed (see: Boffetta P, Hecht S, Gray
N, Gupta P, Straif K. Smokeless tobacco and cancer. Lancet Oncology
2008; 9:667-675). The original article was published in July, 2008. That
article stated: "The authors declare no conflicts of interest." After the
editor of the journal was notified by a researcher with knowledge of a
potential conflict of interest of Dr. Stephen Hecht (one of the study
authors), an erratum was published in September 2008, which noted:
"During the immediate months preceding submission of the review SH
was acting in the capacity of an expert witness for the plaintiff in a
future court case against a smokeless tobacco company. SH declares his
participation in this case in no way influenced his writing or involvement
in the review."
http://tobaccoanalysis.blogspot.com/2009/01/conflict-of-interestnot.html
January 16, 2009 — More than one third of new
drug marketing applications approved by the US
Food and Drug Administration (FDA) were
missing information about potential conflicts of
interest for clinical trial investigators, which
could allow bias to creep into the approvals
process, a government report released this week
has found. The FDA has said that it agrees with
most of the report's findings.
http://www.medscape.com/viewarticle/586980
Do collaborations between biotech companies
and academic centers constitute a conflict of
interest?
Biotechnology industry partnerships with
universities and academic centers have been
fruitful for both. So why is there so much
concern about conflict of interest and is that
concern appropriate?
http://www.redorbit.com/news/health/750100/genetic_engineering_news_p
osts_podcast_on_industrialacademic_collaborations_are_these/index.html
Universities are responsible for use of public
funds and therefore must maintain the public
trust.
Identifying and mitigating situations that may
have the potential for conflict maintains the
integrity of the university.
Maintaining integrity allows the university to
do credible academic research.
To provide information on the purpose of the
conflict of interest requirements.
To provide a basic overview of conflicts of
interest
To introduce the disclosure process and the use
of management plans
To provide information on the need for updates
and annual renewals.
Situations where financial considerations
compromise your professional judgment.
“Actual Conflict of Interest”
◦ Not permitted
Situations where an independent observer
might reasonably question whether your
professional actions or decisions are
determined by considerations of personal
gain. “Perceived Conflict of Interest”
◦ Managed
Potential conflicts may be financial or may be
a conflict of time, effort and/or commitment.
Potential conflicts can occur as a result of
administrative, scientific, academic, fiduciary
or familial situations.
They are situations that can be PERCEIVED to
be conflicting, whether a “real” conflict exists
or not.
Ohio University Policy has a mandatory
disclosure policy if you:
Earn over $10,000 in a twelve month period
from your outside activity OR
Have over 5% equity in the entity
Applies to members of your immediate family
(spouse, domestic partner, dependent
children) as well as yourself.
Anything of monetary value, including but not
limited to:
◦
◦
◦
◦
Salary
Payments for services
Equity interests over 5%
Intellectual property rights
Excludes mutual, pension and other
investments over which you have no control
Outside work during regular academic year
should not exceed equivalent of 1 day per
week.
Consulting work must avoid activities that
involve a conflict of interest with assigned
Ohio University activities and programs
Faculty Handbook, section IV-D
Outside interests cannot interfere with
primary loyalty to Ohio University and your
academic role
Use of university resources must have prior
approval of Chair, Dean and VPR.
Your outside interests should not be in
direct competition with university interests
Full time administrative employees are
expected to devote their full-time
professional loyalty, time and energy to their
position.
You must use non-work hours and no
university resources
Federal Agencies
State Law
University Policies
Many Academic Publications
45 CFR Part 50, Subpart F
“Responsibility of Applicants for Promoting
Objectivity in Research for Which PHS Funding
is Sought”
Authority: 42 U.S.C. 216, 289b-1, 299c-3.
Intent is to assure objectivity by establishing
standards that preclude bias in design, conduct, or
reporting of research
Focuses on financial conflicts of interest
(FCOI)
Regulations apply to investigators, including
sub grantees, contractors, and collaborating
investigators.
Does not apply to applications for support
under Phase I of SBIR and STTR programs
An institutional conflict of interest policy should
require that each investigator disclose to a
responsible representative of the institution all
significant financial interests of the investigator
(including those of the investigator’s spouse and
dependent children) (i) that would reasonably
appear to be affected by the research or
educational activities funded or proposed for
funding by NSF; or (ii) in entities whose financial
interests would reasonably appear to be affected
by such activities.
Chapter 1 (Subchapter A) (Part 54)
Financial Disclosure by Clinical Investigators
The Food and Drug Administration (FDA)
regulations state that investigators that
receive compensation in excess of $25,000
from a corporate sponsor of a trial in which
the investigator is engaged must disclose to
the FDA at the time of filing for a new drug
application.
19.058, Conflict of Interest in Research,
Educational, and Public Service Activities
19.059, Employee Participation in Authorized
Private Companies Commercializing Ohio
University Research
“Conflict of Interest in Research, Educational,
and Public Service Activities”
Most conflict disclosures fall within the
parameters of this policy
States that faculty are primarily responsible
for their academic, research and service
obligations
“Employee Participation in Authorized Private
Companies Commercializing Ohio University
Research”
Applies to “employees, faculty, staff and students,
who create intellectual property owned by the Ohio
University and who desire to hold an equity interest
in a firm, corporation, or other association to which
Ohio University has assigned, licensed or
transferred Ohio University’s interests…”
Consulting
Licensing University Technology
Clinical Studies
Procurement
Mentoring
Institutional
A disclosure is filed specific to the funding
application.
If you have a potential conflict for one
proposal, it does not automatically apply to
all of your proposals.
Research conflicts of interest are usually
disclosed using LEO as you apply for funding
by completing the conflict of interest section
of the electronic transmittal
If you are not using LEO, you can download
the appropriate disclosure form from
www.ohio.edu/research/compliance
“A” is selected if you have no conflicts to
disclose
“B” is selected if you have a potential conflict
to disclose relative to the submission.
(Requires a subsequent paper process)
“C” is selected if you have a current disclosure
on file, but it is not relevant to the proposal
you are submitting
Still uses option A, B or C
Requires that you gather signatures on paper
for all options, however
Generally used for personnel not listed on the
grant proposal or “key personnel”
We have revised the COI forms to word forms
This should be easier to complete than the
previous form
PDF versions are also available
Should be on the compliance web site soon,
but we can e-mail them to you until then
Use this form only if you are unable to use
the LEO transmittal form to assure that no
conflict of interest exists. A form must be
completed for each proposal.
I assure that I have read Ohio University
Policy 19.058, “Conflict of Interest in
Research, Educational, and Public Service
Activities” and declare that I have nothing
that is, or could be perceived to be a conflict
of interest with this proposal.
Use this form to disclose a potential conflict
of interest situation.
A separate disclosure form must be used for
each entity with which you conduct business
Conflict includes any member of your
immediate family (spouse, domestic partner
or children)
Require that you complete an option “B”
disclosure statement in addition to
completing the LEO transmittal form.
Require you to obtain signatures from Center
or Institute (if applicable), Chair and Dean on
the additional disclosure statement!!
The B disclosure form is available at
www.ohio.edu/research/compliance
Use this form only if you are unable to use
the LEO transmittal form. Complete this form
if you have a current conflict of interest
disclosure on file with the Office of Research
Compliance, but that disclosure is not
applicable to this proposal.
*New Option for 2008*
A management plan is developed for some
disclosures to mitigate the potential conflict
Management plans are specific to each
disclosure
May require submission of additional pieces,
such as a student employment plan
Reduce or remove the financial interest creating the
conflict
Place safeguards that mitigate the conflict potential,
such having some decisions made by an independent
entity
Limit participation in portions of the proposed
research likely to create a conflict
Require that the researcher disclose his or her
conflicting financial interests to all collaborators and
any proposed trainees;
Disclose the conflict in publications
Work to remove students from being directly advised
or taught by faculty where a conflict exists
Assure publication rights for student participants
Student Use
Nepotism and Cronyism
Intellectual Property
Use of University Resources
Publication provisions
Use of Human Subjects
Oversight Requirements
Reporting and Annual Reviews
You must submit an annual renewal for your
disclosure
◦ If the potential conflict no longer exists you must
notify us
If significant changes occur during the year
you should submit an update to your
disclosure as they occur
Yes. We encourage employees to disclose
potential conflicts that do not meet the
financial threshold, but may still be
problematic, such as student employment.
This allows you to be transparent with
respect to outside interests.
Allowable situations
Situations that require disclosure but may not
need an extensive management plan
Situations that require disclosure and have
problematic elements that will require
mitigation and/or a management plan
Situations that are not permitted
Receipt of royalties or honoraria for
published scholarly works, seminars,
teaching, etc.
Honoraria for serving as a special reviewer
or work on review panels
Royalties under our intellectual property
policies if no other relationship with entity
Clinical income at OUCOM
You participate in research developed in
whole or part by you, and you or your
family receive royalties from an existing
agreement with the business, but have
no other significant financial interest
You assign students, etc. to research
projects where you are entitled to
receive royalties, but have no other
significant financial interest
You assign students, etc. to projects supported
by the business through an SRA, and have a
significant financial interest other than royalty
income
You receive research support from a business in
which you serve on the board of directors, or
other advisory board, even if you are not
compensated.
You hold an executive position in a business
engaged in commercial or research activities
directly related to your Ohio University
responsibilities.
Any situation in which an actual conflict
exists is not permitted.
The only “exceptions” are those handled
under Ohio University Policy and Procedure
19.059 where faculty entrepreneurship is
addressed.
Participation in clinical trials or evaluation
of other research in which you have a
significant financial interest other than
royalty income.
In the context of your position at Ohio
University, you make professional referrals
to a business in which you have a
significant financial interest.
Letter of admonition
Ineligibility to submit grant applications
Withholding of IRB or IACUC approvals
Suspension
Non-Renewal
Loss of Tenure
Consulting
Procurement
Mentoring
Clinical Studies
Avoid consulting relationships that have
the potential to divert time and effort from
your responsibilities to Ohio University.
Do not use students.
Be wary of situations that limit publication.
Do not use university stationary, etc. that
could create an impression the university
is involved with the activities.
Make sure you are devoting sufficient time
to your university obligations.
Be cautious that the potential financial gain
cannot be perceived to influence your
university mentoring relationships.
Disclose any personal or familial financial
interest or equity in a company that is
doing business with Ohio University.
If you make purchases using public funds,
you should not use companies which will
benefit you or your family. If there is no
alternative you must seek and receive
permission prior to purchasing.
Any relationship in which there is a real or
perceived power or influence imbalance has
the potential for conflict. (Faculty:Student)
Isolating these relationships with respect to
areas of personal financial gain is best.
If they cannot be isolated, then safeguards
must be created.
If you have a financial interest, it is best to
isolate yourself from the study.
At a minimum, expect a more intense review
and a robust management plan if you have a
financial interest.
If both the institution and you have financial
interests the clinical study should be
conducted elsewhere.
You have administrative responsibilities on
behalf of Ohio University that is beneficial to
the business in which you have a significant
financial interest
You have administrative responsibilities on
behalf of Ohio University with respect to an
SRA where you have a significant financial
interest
Slide 18
Jo Ellen Sherow
Ohio University
Office of Research Compliance
Researchers’ Financial Disclosures in the
Spotlight
Conflicts of interest, always an emotional topic,
returned to the headlines this week as Sen.
Charles Grassley, a longtime critic of the drug
industry’s potential influence on research,
released new evidence that prominent Harvard
University scientists had failed to disclose much
of their outside income from pharmaceutical
companies over the past eight years.
http://www.insidehighered.com/news/2008/06/12/conflict January 15, 2008
WEDNESDAY, JANUARY 21, 2009
In a review of the literature regarding the relationship between
smokeless tobacco use and cancer, a conflict of interest of one of the
article's authors was initially not disclosed (see: Boffetta P, Hecht S, Gray
N, Gupta P, Straif K. Smokeless tobacco and cancer. Lancet Oncology
2008; 9:667-675). The original article was published in July, 2008. That
article stated: "The authors declare no conflicts of interest." After the
editor of the journal was notified by a researcher with knowledge of a
potential conflict of interest of Dr. Stephen Hecht (one of the study
authors), an erratum was published in September 2008, which noted:
"During the immediate months preceding submission of the review SH
was acting in the capacity of an expert witness for the plaintiff in a
future court case against a smokeless tobacco company. SH declares his
participation in this case in no way influenced his writing or involvement
in the review."
http://tobaccoanalysis.blogspot.com/2009/01/conflict-of-interestnot.html
January 16, 2009 — More than one third of new
drug marketing applications approved by the US
Food and Drug Administration (FDA) were
missing information about potential conflicts of
interest for clinical trial investigators, which
could allow bias to creep into the approvals
process, a government report released this week
has found. The FDA has said that it agrees with
most of the report's findings.
http://www.medscape.com/viewarticle/586980
Do collaborations between biotech companies
and academic centers constitute a conflict of
interest?
Biotechnology industry partnerships with
universities and academic centers have been
fruitful for both. So why is there so much
concern about conflict of interest and is that
concern appropriate?
http://www.redorbit.com/news/health/750100/genetic_engineering_news_p
osts_podcast_on_industrialacademic_collaborations_are_these/index.html
Universities are responsible for use of public
funds and therefore must maintain the public
trust.
Identifying and mitigating situations that may
have the potential for conflict maintains the
integrity of the university.
Maintaining integrity allows the university to
do credible academic research.
To provide information on the purpose of the
conflict of interest requirements.
To provide a basic overview of conflicts of
interest
To introduce the disclosure process and the use
of management plans
To provide information on the need for updates
and annual renewals.
Situations where financial considerations
compromise your professional judgment.
“Actual Conflict of Interest”
◦ Not permitted
Situations where an independent observer
might reasonably question whether your
professional actions or decisions are
determined by considerations of personal
gain. “Perceived Conflict of Interest”
◦ Managed
Potential conflicts may be financial or may be
a conflict of time, effort and/or commitment.
Potential conflicts can occur as a result of
administrative, scientific, academic, fiduciary
or familial situations.
They are situations that can be PERCEIVED to
be conflicting, whether a “real” conflict exists
or not.
Ohio University Policy has a mandatory
disclosure policy if you:
Earn over $10,000 in a twelve month period
from your outside activity OR
Have over 5% equity in the entity
Applies to members of your immediate family
(spouse, domestic partner, dependent
children) as well as yourself.
Anything of monetary value, including but not
limited to:
◦
◦
◦
◦
Salary
Payments for services
Equity interests over 5%
Intellectual property rights
Excludes mutual, pension and other
investments over which you have no control
Outside work during regular academic year
should not exceed equivalent of 1 day per
week.
Consulting work must avoid activities that
involve a conflict of interest with assigned
Ohio University activities and programs
Faculty Handbook, section IV-D
Outside interests cannot interfere with
primary loyalty to Ohio University and your
academic role
Use of university resources must have prior
approval of Chair, Dean and VPR.
Your outside interests should not be in
direct competition with university interests
Full time administrative employees are
expected to devote their full-time
professional loyalty, time and energy to their
position.
You must use non-work hours and no
university resources
Federal Agencies
State Law
University Policies
Many Academic Publications
45 CFR Part 50, Subpart F
“Responsibility of Applicants for Promoting
Objectivity in Research for Which PHS Funding
is Sought”
Authority: 42 U.S.C. 216, 289b-1, 299c-3.
Intent is to assure objectivity by establishing
standards that preclude bias in design, conduct, or
reporting of research
Focuses on financial conflicts of interest
(FCOI)
Regulations apply to investigators, including
sub grantees, contractors, and collaborating
investigators.
Does not apply to applications for support
under Phase I of SBIR and STTR programs
An institutional conflict of interest policy should
require that each investigator disclose to a
responsible representative of the institution all
significant financial interests of the investigator
(including those of the investigator’s spouse and
dependent children) (i) that would reasonably
appear to be affected by the research or
educational activities funded or proposed for
funding by NSF; or (ii) in entities whose financial
interests would reasonably appear to be affected
by such activities.
Chapter 1 (Subchapter A) (Part 54)
Financial Disclosure by Clinical Investigators
The Food and Drug Administration (FDA)
regulations state that investigators that
receive compensation in excess of $25,000
from a corporate sponsor of a trial in which
the investigator is engaged must disclose to
the FDA at the time of filing for a new drug
application.
19.058, Conflict of Interest in Research,
Educational, and Public Service Activities
19.059, Employee Participation in Authorized
Private Companies Commercializing Ohio
University Research
“Conflict of Interest in Research, Educational,
and Public Service Activities”
Most conflict disclosures fall within the
parameters of this policy
States that faculty are primarily responsible
for their academic, research and service
obligations
“Employee Participation in Authorized Private
Companies Commercializing Ohio University
Research”
Applies to “employees, faculty, staff and students,
who create intellectual property owned by the Ohio
University and who desire to hold an equity interest
in a firm, corporation, or other association to which
Ohio University has assigned, licensed or
transferred Ohio University’s interests…”
Consulting
Licensing University Technology
Clinical Studies
Procurement
Mentoring
Institutional
A disclosure is filed specific to the funding
application.
If you have a potential conflict for one
proposal, it does not automatically apply to
all of your proposals.
Research conflicts of interest are usually
disclosed using LEO as you apply for funding
by completing the conflict of interest section
of the electronic transmittal
If you are not using LEO, you can download
the appropriate disclosure form from
www.ohio.edu/research/compliance
“A” is selected if you have no conflicts to
disclose
“B” is selected if you have a potential conflict
to disclose relative to the submission.
(Requires a subsequent paper process)
“C” is selected if you have a current disclosure
on file, but it is not relevant to the proposal
you are submitting
Still uses option A, B or C
Requires that you gather signatures on paper
for all options, however
Generally used for personnel not listed on the
grant proposal or “key personnel”
We have revised the COI forms to word forms
This should be easier to complete than the
previous form
PDF versions are also available
Should be on the compliance web site soon,
but we can e-mail them to you until then
Use this form only if you are unable to use
the LEO transmittal form to assure that no
conflict of interest exists. A form must be
completed for each proposal.
I assure that I have read Ohio University
Policy 19.058, “Conflict of Interest in
Research, Educational, and Public Service
Activities” and declare that I have nothing
that is, or could be perceived to be a conflict
of interest with this proposal.
Use this form to disclose a potential conflict
of interest situation.
A separate disclosure form must be used for
each entity with which you conduct business
Conflict includes any member of your
immediate family (spouse, domestic partner
or children)
Require that you complete an option “B”
disclosure statement in addition to
completing the LEO transmittal form.
Require you to obtain signatures from Center
or Institute (if applicable), Chair and Dean on
the additional disclosure statement!!
The B disclosure form is available at
www.ohio.edu/research/compliance
Use this form only if you are unable to use
the LEO transmittal form. Complete this form
if you have a current conflict of interest
disclosure on file with the Office of Research
Compliance, but that disclosure is not
applicable to this proposal.
*New Option for 2008*
A management plan is developed for some
disclosures to mitigate the potential conflict
Management plans are specific to each
disclosure
May require submission of additional pieces,
such as a student employment plan
Reduce or remove the financial interest creating the
conflict
Place safeguards that mitigate the conflict potential,
such having some decisions made by an independent
entity
Limit participation in portions of the proposed
research likely to create a conflict
Require that the researcher disclose his or her
conflicting financial interests to all collaborators and
any proposed trainees;
Disclose the conflict in publications
Work to remove students from being directly advised
or taught by faculty where a conflict exists
Assure publication rights for student participants
Student Use
Nepotism and Cronyism
Intellectual Property
Use of University Resources
Publication provisions
Use of Human Subjects
Oversight Requirements
Reporting and Annual Reviews
You must submit an annual renewal for your
disclosure
◦ If the potential conflict no longer exists you must
notify us
If significant changes occur during the year
you should submit an update to your
disclosure as they occur
Yes. We encourage employees to disclose
potential conflicts that do not meet the
financial threshold, but may still be
problematic, such as student employment.
This allows you to be transparent with
respect to outside interests.
Allowable situations
Situations that require disclosure but may not
need an extensive management plan
Situations that require disclosure and have
problematic elements that will require
mitigation and/or a management plan
Situations that are not permitted
Receipt of royalties or honoraria for
published scholarly works, seminars,
teaching, etc.
Honoraria for serving as a special reviewer
or work on review panels
Royalties under our intellectual property
policies if no other relationship with entity
Clinical income at OUCOM
You participate in research developed in
whole or part by you, and you or your
family receive royalties from an existing
agreement with the business, but have
no other significant financial interest
You assign students, etc. to research
projects where you are entitled to
receive royalties, but have no other
significant financial interest
You assign students, etc. to projects supported
by the business through an SRA, and have a
significant financial interest other than royalty
income
You receive research support from a business in
which you serve on the board of directors, or
other advisory board, even if you are not
compensated.
You hold an executive position in a business
engaged in commercial or research activities
directly related to your Ohio University
responsibilities.
Any situation in which an actual conflict
exists is not permitted.
The only “exceptions” are those handled
under Ohio University Policy and Procedure
19.059 where faculty entrepreneurship is
addressed.
Participation in clinical trials or evaluation
of other research in which you have a
significant financial interest other than
royalty income.
In the context of your position at Ohio
University, you make professional referrals
to a business in which you have a
significant financial interest.
Letter of admonition
Ineligibility to submit grant applications
Withholding of IRB or IACUC approvals
Suspension
Non-Renewal
Loss of Tenure
Consulting
Procurement
Mentoring
Clinical Studies
Avoid consulting relationships that have
the potential to divert time and effort from
your responsibilities to Ohio University.
Do not use students.
Be wary of situations that limit publication.
Do not use university stationary, etc. that
could create an impression the university
is involved with the activities.
Make sure you are devoting sufficient time
to your university obligations.
Be cautious that the potential financial gain
cannot be perceived to influence your
university mentoring relationships.
Disclose any personal or familial financial
interest or equity in a company that is
doing business with Ohio University.
If you make purchases using public funds,
you should not use companies which will
benefit you or your family. If there is no
alternative you must seek and receive
permission prior to purchasing.
Any relationship in which there is a real or
perceived power or influence imbalance has
the potential for conflict. (Faculty:Student)
Isolating these relationships with respect to
areas of personal financial gain is best.
If they cannot be isolated, then safeguards
must be created.
If you have a financial interest, it is best to
isolate yourself from the study.
At a minimum, expect a more intense review
and a robust management plan if you have a
financial interest.
If both the institution and you have financial
interests the clinical study should be
conducted elsewhere.
You have administrative responsibilities on
behalf of Ohio University that is beneficial to
the business in which you have a significant
financial interest
You have administrative responsibilities on
behalf of Ohio University with respect to an
SRA where you have a significant financial
interest
Slide 19
Jo Ellen Sherow
Ohio University
Office of Research Compliance
Researchers’ Financial Disclosures in the
Spotlight
Conflicts of interest, always an emotional topic,
returned to the headlines this week as Sen.
Charles Grassley, a longtime critic of the drug
industry’s potential influence on research,
released new evidence that prominent Harvard
University scientists had failed to disclose much
of their outside income from pharmaceutical
companies over the past eight years.
http://www.insidehighered.com/news/2008/06/12/conflict January 15, 2008
WEDNESDAY, JANUARY 21, 2009
In a review of the literature regarding the relationship between
smokeless tobacco use and cancer, a conflict of interest of one of the
article's authors was initially not disclosed (see: Boffetta P, Hecht S, Gray
N, Gupta P, Straif K. Smokeless tobacco and cancer. Lancet Oncology
2008; 9:667-675). The original article was published in July, 2008. That
article stated: "The authors declare no conflicts of interest." After the
editor of the journal was notified by a researcher with knowledge of a
potential conflict of interest of Dr. Stephen Hecht (one of the study
authors), an erratum was published in September 2008, which noted:
"During the immediate months preceding submission of the review SH
was acting in the capacity of an expert witness for the plaintiff in a
future court case against a smokeless tobacco company. SH declares his
participation in this case in no way influenced his writing or involvement
in the review."
http://tobaccoanalysis.blogspot.com/2009/01/conflict-of-interestnot.html
January 16, 2009 — More than one third of new
drug marketing applications approved by the US
Food and Drug Administration (FDA) were
missing information about potential conflicts of
interest for clinical trial investigators, which
could allow bias to creep into the approvals
process, a government report released this week
has found. The FDA has said that it agrees with
most of the report's findings.
http://www.medscape.com/viewarticle/586980
Do collaborations between biotech companies
and academic centers constitute a conflict of
interest?
Biotechnology industry partnerships with
universities and academic centers have been
fruitful for both. So why is there so much
concern about conflict of interest and is that
concern appropriate?
http://www.redorbit.com/news/health/750100/genetic_engineering_news_p
osts_podcast_on_industrialacademic_collaborations_are_these/index.html
Universities are responsible for use of public
funds and therefore must maintain the public
trust.
Identifying and mitigating situations that may
have the potential for conflict maintains the
integrity of the university.
Maintaining integrity allows the university to
do credible academic research.
To provide information on the purpose of the
conflict of interest requirements.
To provide a basic overview of conflicts of
interest
To introduce the disclosure process and the use
of management plans
To provide information on the need for updates
and annual renewals.
Situations where financial considerations
compromise your professional judgment.
“Actual Conflict of Interest”
◦ Not permitted
Situations where an independent observer
might reasonably question whether your
professional actions or decisions are
determined by considerations of personal
gain. “Perceived Conflict of Interest”
◦ Managed
Potential conflicts may be financial or may be
a conflict of time, effort and/or commitment.
Potential conflicts can occur as a result of
administrative, scientific, academic, fiduciary
or familial situations.
They are situations that can be PERCEIVED to
be conflicting, whether a “real” conflict exists
or not.
Ohio University Policy has a mandatory
disclosure policy if you:
Earn over $10,000 in a twelve month period
from your outside activity OR
Have over 5% equity in the entity
Applies to members of your immediate family
(spouse, domestic partner, dependent
children) as well as yourself.
Anything of monetary value, including but not
limited to:
◦
◦
◦
◦
Salary
Payments for services
Equity interests over 5%
Intellectual property rights
Excludes mutual, pension and other
investments over which you have no control
Outside work during regular academic year
should not exceed equivalent of 1 day per
week.
Consulting work must avoid activities that
involve a conflict of interest with assigned
Ohio University activities and programs
Faculty Handbook, section IV-D
Outside interests cannot interfere with
primary loyalty to Ohio University and your
academic role
Use of university resources must have prior
approval of Chair, Dean and VPR.
Your outside interests should not be in
direct competition with university interests
Full time administrative employees are
expected to devote their full-time
professional loyalty, time and energy to their
position.
You must use non-work hours and no
university resources
Federal Agencies
State Law
University Policies
Many Academic Publications
45 CFR Part 50, Subpart F
“Responsibility of Applicants for Promoting
Objectivity in Research for Which PHS Funding
is Sought”
Authority: 42 U.S.C. 216, 289b-1, 299c-3.
Intent is to assure objectivity by establishing
standards that preclude bias in design, conduct, or
reporting of research
Focuses on financial conflicts of interest
(FCOI)
Regulations apply to investigators, including
sub grantees, contractors, and collaborating
investigators.
Does not apply to applications for support
under Phase I of SBIR and STTR programs
An institutional conflict of interest policy should
require that each investigator disclose to a
responsible representative of the institution all
significant financial interests of the investigator
(including those of the investigator’s spouse and
dependent children) (i) that would reasonably
appear to be affected by the research or
educational activities funded or proposed for
funding by NSF; or (ii) in entities whose financial
interests would reasonably appear to be affected
by such activities.
Chapter 1 (Subchapter A) (Part 54)
Financial Disclosure by Clinical Investigators
The Food and Drug Administration (FDA)
regulations state that investigators that
receive compensation in excess of $25,000
from a corporate sponsor of a trial in which
the investigator is engaged must disclose to
the FDA at the time of filing for a new drug
application.
19.058, Conflict of Interest in Research,
Educational, and Public Service Activities
19.059, Employee Participation in Authorized
Private Companies Commercializing Ohio
University Research
“Conflict of Interest in Research, Educational,
and Public Service Activities”
Most conflict disclosures fall within the
parameters of this policy
States that faculty are primarily responsible
for their academic, research and service
obligations
“Employee Participation in Authorized Private
Companies Commercializing Ohio University
Research”
Applies to “employees, faculty, staff and students,
who create intellectual property owned by the Ohio
University and who desire to hold an equity interest
in a firm, corporation, or other association to which
Ohio University has assigned, licensed or
transferred Ohio University’s interests…”
Consulting
Licensing University Technology
Clinical Studies
Procurement
Mentoring
Institutional
A disclosure is filed specific to the funding
application.
If you have a potential conflict for one
proposal, it does not automatically apply to
all of your proposals.
Research conflicts of interest are usually
disclosed using LEO as you apply for funding
by completing the conflict of interest section
of the electronic transmittal
If you are not using LEO, you can download
the appropriate disclosure form from
www.ohio.edu/research/compliance
“A” is selected if you have no conflicts to
disclose
“B” is selected if you have a potential conflict
to disclose relative to the submission.
(Requires a subsequent paper process)
“C” is selected if you have a current disclosure
on file, but it is not relevant to the proposal
you are submitting
Still uses option A, B or C
Requires that you gather signatures on paper
for all options, however
Generally used for personnel not listed on the
grant proposal or “key personnel”
We have revised the COI forms to word forms
This should be easier to complete than the
previous form
PDF versions are also available
Should be on the compliance web site soon,
but we can e-mail them to you until then
Use this form only if you are unable to use
the LEO transmittal form to assure that no
conflict of interest exists. A form must be
completed for each proposal.
I assure that I have read Ohio University
Policy 19.058, “Conflict of Interest in
Research, Educational, and Public Service
Activities” and declare that I have nothing
that is, or could be perceived to be a conflict
of interest with this proposal.
Use this form to disclose a potential conflict
of interest situation.
A separate disclosure form must be used for
each entity with which you conduct business
Conflict includes any member of your
immediate family (spouse, domestic partner
or children)
Require that you complete an option “B”
disclosure statement in addition to
completing the LEO transmittal form.
Require you to obtain signatures from Center
or Institute (if applicable), Chair and Dean on
the additional disclosure statement!!
The B disclosure form is available at
www.ohio.edu/research/compliance
Use this form only if you are unable to use
the LEO transmittal form. Complete this form
if you have a current conflict of interest
disclosure on file with the Office of Research
Compliance, but that disclosure is not
applicable to this proposal.
*New Option for 2008*
A management plan is developed for some
disclosures to mitigate the potential conflict
Management plans are specific to each
disclosure
May require submission of additional pieces,
such as a student employment plan
Reduce or remove the financial interest creating the
conflict
Place safeguards that mitigate the conflict potential,
such having some decisions made by an independent
entity
Limit participation in portions of the proposed
research likely to create a conflict
Require that the researcher disclose his or her
conflicting financial interests to all collaborators and
any proposed trainees;
Disclose the conflict in publications
Work to remove students from being directly advised
or taught by faculty where a conflict exists
Assure publication rights for student participants
Student Use
Nepotism and Cronyism
Intellectual Property
Use of University Resources
Publication provisions
Use of Human Subjects
Oversight Requirements
Reporting and Annual Reviews
You must submit an annual renewal for your
disclosure
◦ If the potential conflict no longer exists you must
notify us
If significant changes occur during the year
you should submit an update to your
disclosure as they occur
Yes. We encourage employees to disclose
potential conflicts that do not meet the
financial threshold, but may still be
problematic, such as student employment.
This allows you to be transparent with
respect to outside interests.
Allowable situations
Situations that require disclosure but may not
need an extensive management plan
Situations that require disclosure and have
problematic elements that will require
mitigation and/or a management plan
Situations that are not permitted
Receipt of royalties or honoraria for
published scholarly works, seminars,
teaching, etc.
Honoraria for serving as a special reviewer
or work on review panels
Royalties under our intellectual property
policies if no other relationship with entity
Clinical income at OUCOM
You participate in research developed in
whole or part by you, and you or your
family receive royalties from an existing
agreement with the business, but have
no other significant financial interest
You assign students, etc. to research
projects where you are entitled to
receive royalties, but have no other
significant financial interest
You assign students, etc. to projects supported
by the business through an SRA, and have a
significant financial interest other than royalty
income
You receive research support from a business in
which you serve on the board of directors, or
other advisory board, even if you are not
compensated.
You hold an executive position in a business
engaged in commercial or research activities
directly related to your Ohio University
responsibilities.
Any situation in which an actual conflict
exists is not permitted.
The only “exceptions” are those handled
under Ohio University Policy and Procedure
19.059 where faculty entrepreneurship is
addressed.
Participation in clinical trials or evaluation
of other research in which you have a
significant financial interest other than
royalty income.
In the context of your position at Ohio
University, you make professional referrals
to a business in which you have a
significant financial interest.
Letter of admonition
Ineligibility to submit grant applications
Withholding of IRB or IACUC approvals
Suspension
Non-Renewal
Loss of Tenure
Consulting
Procurement
Mentoring
Clinical Studies
Avoid consulting relationships that have
the potential to divert time and effort from
your responsibilities to Ohio University.
Do not use students.
Be wary of situations that limit publication.
Do not use university stationary, etc. that
could create an impression the university
is involved with the activities.
Make sure you are devoting sufficient time
to your university obligations.
Be cautious that the potential financial gain
cannot be perceived to influence your
university mentoring relationships.
Disclose any personal or familial financial
interest or equity in a company that is
doing business with Ohio University.
If you make purchases using public funds,
you should not use companies which will
benefit you or your family. If there is no
alternative you must seek and receive
permission prior to purchasing.
Any relationship in which there is a real or
perceived power or influence imbalance has
the potential for conflict. (Faculty:Student)
Isolating these relationships with respect to
areas of personal financial gain is best.
If they cannot be isolated, then safeguards
must be created.
If you have a financial interest, it is best to
isolate yourself from the study.
At a minimum, expect a more intense review
and a robust management plan if you have a
financial interest.
If both the institution and you have financial
interests the clinical study should be
conducted elsewhere.
You have administrative responsibilities on
behalf of Ohio University that is beneficial to
the business in which you have a significant
financial interest
You have administrative responsibilities on
behalf of Ohio University with respect to an
SRA where you have a significant financial
interest
Slide 20
Jo Ellen Sherow
Ohio University
Office of Research Compliance
Researchers’ Financial Disclosures in the
Spotlight
Conflicts of interest, always an emotional topic,
returned to the headlines this week as Sen.
Charles Grassley, a longtime critic of the drug
industry’s potential influence on research,
released new evidence that prominent Harvard
University scientists had failed to disclose much
of their outside income from pharmaceutical
companies over the past eight years.
http://www.insidehighered.com/news/2008/06/12/conflict January 15, 2008
WEDNESDAY, JANUARY 21, 2009
In a review of the literature regarding the relationship between
smokeless tobacco use and cancer, a conflict of interest of one of the
article's authors was initially not disclosed (see: Boffetta P, Hecht S, Gray
N, Gupta P, Straif K. Smokeless tobacco and cancer. Lancet Oncology
2008; 9:667-675). The original article was published in July, 2008. That
article stated: "The authors declare no conflicts of interest." After the
editor of the journal was notified by a researcher with knowledge of a
potential conflict of interest of Dr. Stephen Hecht (one of the study
authors), an erratum was published in September 2008, which noted:
"During the immediate months preceding submission of the review SH
was acting in the capacity of an expert witness for the plaintiff in a
future court case against a smokeless tobacco company. SH declares his
participation in this case in no way influenced his writing or involvement
in the review."
http://tobaccoanalysis.blogspot.com/2009/01/conflict-of-interestnot.html
January 16, 2009 — More than one third of new
drug marketing applications approved by the US
Food and Drug Administration (FDA) were
missing information about potential conflicts of
interest for clinical trial investigators, which
could allow bias to creep into the approvals
process, a government report released this week
has found. The FDA has said that it agrees with
most of the report's findings.
http://www.medscape.com/viewarticle/586980
Do collaborations between biotech companies
and academic centers constitute a conflict of
interest?
Biotechnology industry partnerships with
universities and academic centers have been
fruitful for both. So why is there so much
concern about conflict of interest and is that
concern appropriate?
http://www.redorbit.com/news/health/750100/genetic_engineering_news_p
osts_podcast_on_industrialacademic_collaborations_are_these/index.html
Universities are responsible for use of public
funds and therefore must maintain the public
trust.
Identifying and mitigating situations that may
have the potential for conflict maintains the
integrity of the university.
Maintaining integrity allows the university to
do credible academic research.
To provide information on the purpose of the
conflict of interest requirements.
To provide a basic overview of conflicts of
interest
To introduce the disclosure process and the use
of management plans
To provide information on the need for updates
and annual renewals.
Situations where financial considerations
compromise your professional judgment.
“Actual Conflict of Interest”
◦ Not permitted
Situations where an independent observer
might reasonably question whether your
professional actions or decisions are
determined by considerations of personal
gain. “Perceived Conflict of Interest”
◦ Managed
Potential conflicts may be financial or may be
a conflict of time, effort and/or commitment.
Potential conflicts can occur as a result of
administrative, scientific, academic, fiduciary
or familial situations.
They are situations that can be PERCEIVED to
be conflicting, whether a “real” conflict exists
or not.
Ohio University Policy has a mandatory
disclosure policy if you:
Earn over $10,000 in a twelve month period
from your outside activity OR
Have over 5% equity in the entity
Applies to members of your immediate family
(spouse, domestic partner, dependent
children) as well as yourself.
Anything of monetary value, including but not
limited to:
◦
◦
◦
◦
Salary
Payments for services
Equity interests over 5%
Intellectual property rights
Excludes mutual, pension and other
investments over which you have no control
Outside work during regular academic year
should not exceed equivalent of 1 day per
week.
Consulting work must avoid activities that
involve a conflict of interest with assigned
Ohio University activities and programs
Faculty Handbook, section IV-D
Outside interests cannot interfere with
primary loyalty to Ohio University and your
academic role
Use of university resources must have prior
approval of Chair, Dean and VPR.
Your outside interests should not be in
direct competition with university interests
Full time administrative employees are
expected to devote their full-time
professional loyalty, time and energy to their
position.
You must use non-work hours and no
university resources
Federal Agencies
State Law
University Policies
Many Academic Publications
45 CFR Part 50, Subpart F
“Responsibility of Applicants for Promoting
Objectivity in Research for Which PHS Funding
is Sought”
Authority: 42 U.S.C. 216, 289b-1, 299c-3.
Intent is to assure objectivity by establishing
standards that preclude bias in design, conduct, or
reporting of research
Focuses on financial conflicts of interest
(FCOI)
Regulations apply to investigators, including
sub grantees, contractors, and collaborating
investigators.
Does not apply to applications for support
under Phase I of SBIR and STTR programs
An institutional conflict of interest policy should
require that each investigator disclose to a
responsible representative of the institution all
significant financial interests of the investigator
(including those of the investigator’s spouse and
dependent children) (i) that would reasonably
appear to be affected by the research or
educational activities funded or proposed for
funding by NSF; or (ii) in entities whose financial
interests would reasonably appear to be affected
by such activities.
Chapter 1 (Subchapter A) (Part 54)
Financial Disclosure by Clinical Investigators
The Food and Drug Administration (FDA)
regulations state that investigators that
receive compensation in excess of $25,000
from a corporate sponsor of a trial in which
the investigator is engaged must disclose to
the FDA at the time of filing for a new drug
application.
19.058, Conflict of Interest in Research,
Educational, and Public Service Activities
19.059, Employee Participation in Authorized
Private Companies Commercializing Ohio
University Research
“Conflict of Interest in Research, Educational,
and Public Service Activities”
Most conflict disclosures fall within the
parameters of this policy
States that faculty are primarily responsible
for their academic, research and service
obligations
“Employee Participation in Authorized Private
Companies Commercializing Ohio University
Research”
Applies to “employees, faculty, staff and students,
who create intellectual property owned by the Ohio
University and who desire to hold an equity interest
in a firm, corporation, or other association to which
Ohio University has assigned, licensed or
transferred Ohio University’s interests…”
Consulting
Licensing University Technology
Clinical Studies
Procurement
Mentoring
Institutional
A disclosure is filed specific to the funding
application.
If you have a potential conflict for one
proposal, it does not automatically apply to
all of your proposals.
Research conflicts of interest are usually
disclosed using LEO as you apply for funding
by completing the conflict of interest section
of the electronic transmittal
If you are not using LEO, you can download
the appropriate disclosure form from
www.ohio.edu/research/compliance
“A” is selected if you have no conflicts to
disclose
“B” is selected if you have a potential conflict
to disclose relative to the submission.
(Requires a subsequent paper process)
“C” is selected if you have a current disclosure
on file, but it is not relevant to the proposal
you are submitting
Still uses option A, B or C
Requires that you gather signatures on paper
for all options, however
Generally used for personnel not listed on the
grant proposal or “key personnel”
We have revised the COI forms to word forms
This should be easier to complete than the
previous form
PDF versions are also available
Should be on the compliance web site soon,
but we can e-mail them to you until then
Use this form only if you are unable to use
the LEO transmittal form to assure that no
conflict of interest exists. A form must be
completed for each proposal.
I assure that I have read Ohio University
Policy 19.058, “Conflict of Interest in
Research, Educational, and Public Service
Activities” and declare that I have nothing
that is, or could be perceived to be a conflict
of interest with this proposal.
Use this form to disclose a potential conflict
of interest situation.
A separate disclosure form must be used for
each entity with which you conduct business
Conflict includes any member of your
immediate family (spouse, domestic partner
or children)
Require that you complete an option “B”
disclosure statement in addition to
completing the LEO transmittal form.
Require you to obtain signatures from Center
or Institute (if applicable), Chair and Dean on
the additional disclosure statement!!
The B disclosure form is available at
www.ohio.edu/research/compliance
Use this form only if you are unable to use
the LEO transmittal form. Complete this form
if you have a current conflict of interest
disclosure on file with the Office of Research
Compliance, but that disclosure is not
applicable to this proposal.
*New Option for 2008*
A management plan is developed for some
disclosures to mitigate the potential conflict
Management plans are specific to each
disclosure
May require submission of additional pieces,
such as a student employment plan
Reduce or remove the financial interest creating the
conflict
Place safeguards that mitigate the conflict potential,
such having some decisions made by an independent
entity
Limit participation in portions of the proposed
research likely to create a conflict
Require that the researcher disclose his or her
conflicting financial interests to all collaborators and
any proposed trainees;
Disclose the conflict in publications
Work to remove students from being directly advised
or taught by faculty where a conflict exists
Assure publication rights for student participants
Student Use
Nepotism and Cronyism
Intellectual Property
Use of University Resources
Publication provisions
Use of Human Subjects
Oversight Requirements
Reporting and Annual Reviews
You must submit an annual renewal for your
disclosure
◦ If the potential conflict no longer exists you must
notify us
If significant changes occur during the year
you should submit an update to your
disclosure as they occur
Yes. We encourage employees to disclose
potential conflicts that do not meet the
financial threshold, but may still be
problematic, such as student employment.
This allows you to be transparent with
respect to outside interests.
Allowable situations
Situations that require disclosure but may not
need an extensive management plan
Situations that require disclosure and have
problematic elements that will require
mitigation and/or a management plan
Situations that are not permitted
Receipt of royalties or honoraria for
published scholarly works, seminars,
teaching, etc.
Honoraria for serving as a special reviewer
or work on review panels
Royalties under our intellectual property
policies if no other relationship with entity
Clinical income at OUCOM
You participate in research developed in
whole or part by you, and you or your
family receive royalties from an existing
agreement with the business, but have
no other significant financial interest
You assign students, etc. to research
projects where you are entitled to
receive royalties, but have no other
significant financial interest
You assign students, etc. to projects supported
by the business through an SRA, and have a
significant financial interest other than royalty
income
You receive research support from a business in
which you serve on the board of directors, or
other advisory board, even if you are not
compensated.
You hold an executive position in a business
engaged in commercial or research activities
directly related to your Ohio University
responsibilities.
Any situation in which an actual conflict
exists is not permitted.
The only “exceptions” are those handled
under Ohio University Policy and Procedure
19.059 where faculty entrepreneurship is
addressed.
Participation in clinical trials or evaluation
of other research in which you have a
significant financial interest other than
royalty income.
In the context of your position at Ohio
University, you make professional referrals
to a business in which you have a
significant financial interest.
Letter of admonition
Ineligibility to submit grant applications
Withholding of IRB or IACUC approvals
Suspension
Non-Renewal
Loss of Tenure
Consulting
Procurement
Mentoring
Clinical Studies
Avoid consulting relationships that have
the potential to divert time and effort from
your responsibilities to Ohio University.
Do not use students.
Be wary of situations that limit publication.
Do not use university stationary, etc. that
could create an impression the university
is involved with the activities.
Make sure you are devoting sufficient time
to your university obligations.
Be cautious that the potential financial gain
cannot be perceived to influence your
university mentoring relationships.
Disclose any personal or familial financial
interest or equity in a company that is
doing business with Ohio University.
If you make purchases using public funds,
you should not use companies which will
benefit you or your family. If there is no
alternative you must seek and receive
permission prior to purchasing.
Any relationship in which there is a real or
perceived power or influence imbalance has
the potential for conflict. (Faculty:Student)
Isolating these relationships with respect to
areas of personal financial gain is best.
If they cannot be isolated, then safeguards
must be created.
If you have a financial interest, it is best to
isolate yourself from the study.
At a minimum, expect a more intense review
and a robust management plan if you have a
financial interest.
If both the institution and you have financial
interests the clinical study should be
conducted elsewhere.
You have administrative responsibilities on
behalf of Ohio University that is beneficial to
the business in which you have a significant
financial interest
You have administrative responsibilities on
behalf of Ohio University with respect to an
SRA where you have a significant financial
interest
Slide 21
Jo Ellen Sherow
Ohio University
Office of Research Compliance
Researchers’ Financial Disclosures in the
Spotlight
Conflicts of interest, always an emotional topic,
returned to the headlines this week as Sen.
Charles Grassley, a longtime critic of the drug
industry’s potential influence on research,
released new evidence that prominent Harvard
University scientists had failed to disclose much
of their outside income from pharmaceutical
companies over the past eight years.
http://www.insidehighered.com/news/2008/06/12/conflict January 15, 2008
WEDNESDAY, JANUARY 21, 2009
In a review of the literature regarding the relationship between
smokeless tobacco use and cancer, a conflict of interest of one of the
article's authors was initially not disclosed (see: Boffetta P, Hecht S, Gray
N, Gupta P, Straif K. Smokeless tobacco and cancer. Lancet Oncology
2008; 9:667-675). The original article was published in July, 2008. That
article stated: "The authors declare no conflicts of interest." After the
editor of the journal was notified by a researcher with knowledge of a
potential conflict of interest of Dr. Stephen Hecht (one of the study
authors), an erratum was published in September 2008, which noted:
"During the immediate months preceding submission of the review SH
was acting in the capacity of an expert witness for the plaintiff in a
future court case against a smokeless tobacco company. SH declares his
participation in this case in no way influenced his writing or involvement
in the review."
http://tobaccoanalysis.blogspot.com/2009/01/conflict-of-interestnot.html
January 16, 2009 — More than one third of new
drug marketing applications approved by the US
Food and Drug Administration (FDA) were
missing information about potential conflicts of
interest for clinical trial investigators, which
could allow bias to creep into the approvals
process, a government report released this week
has found. The FDA has said that it agrees with
most of the report's findings.
http://www.medscape.com/viewarticle/586980
Do collaborations between biotech companies
and academic centers constitute a conflict of
interest?
Biotechnology industry partnerships with
universities and academic centers have been
fruitful for both. So why is there so much
concern about conflict of interest and is that
concern appropriate?
http://www.redorbit.com/news/health/750100/genetic_engineering_news_p
osts_podcast_on_industrialacademic_collaborations_are_these/index.html
Universities are responsible for use of public
funds and therefore must maintain the public
trust.
Identifying and mitigating situations that may
have the potential for conflict maintains the
integrity of the university.
Maintaining integrity allows the university to
do credible academic research.
To provide information on the purpose of the
conflict of interest requirements.
To provide a basic overview of conflicts of
interest
To introduce the disclosure process and the use
of management plans
To provide information on the need for updates
and annual renewals.
Situations where financial considerations
compromise your professional judgment.
“Actual Conflict of Interest”
◦ Not permitted
Situations where an independent observer
might reasonably question whether your
professional actions or decisions are
determined by considerations of personal
gain. “Perceived Conflict of Interest”
◦ Managed
Potential conflicts may be financial or may be
a conflict of time, effort and/or commitment.
Potential conflicts can occur as a result of
administrative, scientific, academic, fiduciary
or familial situations.
They are situations that can be PERCEIVED to
be conflicting, whether a “real” conflict exists
or not.
Ohio University Policy has a mandatory
disclosure policy if you:
Earn over $10,000 in a twelve month period
from your outside activity OR
Have over 5% equity in the entity
Applies to members of your immediate family
(spouse, domestic partner, dependent
children) as well as yourself.
Anything of monetary value, including but not
limited to:
◦
◦
◦
◦
Salary
Payments for services
Equity interests over 5%
Intellectual property rights
Excludes mutual, pension and other
investments over which you have no control
Outside work during regular academic year
should not exceed equivalent of 1 day per
week.
Consulting work must avoid activities that
involve a conflict of interest with assigned
Ohio University activities and programs
Faculty Handbook, section IV-D
Outside interests cannot interfere with
primary loyalty to Ohio University and your
academic role
Use of university resources must have prior
approval of Chair, Dean and VPR.
Your outside interests should not be in
direct competition with university interests
Full time administrative employees are
expected to devote their full-time
professional loyalty, time and energy to their
position.
You must use non-work hours and no
university resources
Federal Agencies
State Law
University Policies
Many Academic Publications
45 CFR Part 50, Subpart F
“Responsibility of Applicants for Promoting
Objectivity in Research for Which PHS Funding
is Sought”
Authority: 42 U.S.C. 216, 289b-1, 299c-3.
Intent is to assure objectivity by establishing
standards that preclude bias in design, conduct, or
reporting of research
Focuses on financial conflicts of interest
(FCOI)
Regulations apply to investigators, including
sub grantees, contractors, and collaborating
investigators.
Does not apply to applications for support
under Phase I of SBIR and STTR programs
An institutional conflict of interest policy should
require that each investigator disclose to a
responsible representative of the institution all
significant financial interests of the investigator
(including those of the investigator’s spouse and
dependent children) (i) that would reasonably
appear to be affected by the research or
educational activities funded or proposed for
funding by NSF; or (ii) in entities whose financial
interests would reasonably appear to be affected
by such activities.
Chapter 1 (Subchapter A) (Part 54)
Financial Disclosure by Clinical Investigators
The Food and Drug Administration (FDA)
regulations state that investigators that
receive compensation in excess of $25,000
from a corporate sponsor of a trial in which
the investigator is engaged must disclose to
the FDA at the time of filing for a new drug
application.
19.058, Conflict of Interest in Research,
Educational, and Public Service Activities
19.059, Employee Participation in Authorized
Private Companies Commercializing Ohio
University Research
“Conflict of Interest in Research, Educational,
and Public Service Activities”
Most conflict disclosures fall within the
parameters of this policy
States that faculty are primarily responsible
for their academic, research and service
obligations
“Employee Participation in Authorized Private
Companies Commercializing Ohio University
Research”
Applies to “employees, faculty, staff and students,
who create intellectual property owned by the Ohio
University and who desire to hold an equity interest
in a firm, corporation, or other association to which
Ohio University has assigned, licensed or
transferred Ohio University’s interests…”
Consulting
Licensing University Technology
Clinical Studies
Procurement
Mentoring
Institutional
A disclosure is filed specific to the funding
application.
If you have a potential conflict for one
proposal, it does not automatically apply to
all of your proposals.
Research conflicts of interest are usually
disclosed using LEO as you apply for funding
by completing the conflict of interest section
of the electronic transmittal
If you are not using LEO, you can download
the appropriate disclosure form from
www.ohio.edu/research/compliance
“A” is selected if you have no conflicts to
disclose
“B” is selected if you have a potential conflict
to disclose relative to the submission.
(Requires a subsequent paper process)
“C” is selected if you have a current disclosure
on file, but it is not relevant to the proposal
you are submitting
Still uses option A, B or C
Requires that you gather signatures on paper
for all options, however
Generally used for personnel not listed on the
grant proposal or “key personnel”
We have revised the COI forms to word forms
This should be easier to complete than the
previous form
PDF versions are also available
Should be on the compliance web site soon,
but we can e-mail them to you until then
Use this form only if you are unable to use
the LEO transmittal form to assure that no
conflict of interest exists. A form must be
completed for each proposal.
I assure that I have read Ohio University
Policy 19.058, “Conflict of Interest in
Research, Educational, and Public Service
Activities” and declare that I have nothing
that is, or could be perceived to be a conflict
of interest with this proposal.
Use this form to disclose a potential conflict
of interest situation.
A separate disclosure form must be used for
each entity with which you conduct business
Conflict includes any member of your
immediate family (spouse, domestic partner
or children)
Require that you complete an option “B”
disclosure statement in addition to
completing the LEO transmittal form.
Require you to obtain signatures from Center
or Institute (if applicable), Chair and Dean on
the additional disclosure statement!!
The B disclosure form is available at
www.ohio.edu/research/compliance
Use this form only if you are unable to use
the LEO transmittal form. Complete this form
if you have a current conflict of interest
disclosure on file with the Office of Research
Compliance, but that disclosure is not
applicable to this proposal.
*New Option for 2008*
A management plan is developed for some
disclosures to mitigate the potential conflict
Management plans are specific to each
disclosure
May require submission of additional pieces,
such as a student employment plan
Reduce or remove the financial interest creating the
conflict
Place safeguards that mitigate the conflict potential,
such having some decisions made by an independent
entity
Limit participation in portions of the proposed
research likely to create a conflict
Require that the researcher disclose his or her
conflicting financial interests to all collaborators and
any proposed trainees;
Disclose the conflict in publications
Work to remove students from being directly advised
or taught by faculty where a conflict exists
Assure publication rights for student participants
Student Use
Nepotism and Cronyism
Intellectual Property
Use of University Resources
Publication provisions
Use of Human Subjects
Oversight Requirements
Reporting and Annual Reviews
You must submit an annual renewal for your
disclosure
◦ If the potential conflict no longer exists you must
notify us
If significant changes occur during the year
you should submit an update to your
disclosure as they occur
Yes. We encourage employees to disclose
potential conflicts that do not meet the
financial threshold, but may still be
problematic, such as student employment.
This allows you to be transparent with
respect to outside interests.
Allowable situations
Situations that require disclosure but may not
need an extensive management plan
Situations that require disclosure and have
problematic elements that will require
mitigation and/or a management plan
Situations that are not permitted
Receipt of royalties or honoraria for
published scholarly works, seminars,
teaching, etc.
Honoraria for serving as a special reviewer
or work on review panels
Royalties under our intellectual property
policies if no other relationship with entity
Clinical income at OUCOM
You participate in research developed in
whole or part by you, and you or your
family receive royalties from an existing
agreement with the business, but have
no other significant financial interest
You assign students, etc. to research
projects where you are entitled to
receive royalties, but have no other
significant financial interest
You assign students, etc. to projects supported
by the business through an SRA, and have a
significant financial interest other than royalty
income
You receive research support from a business in
which you serve on the board of directors, or
other advisory board, even if you are not
compensated.
You hold an executive position in a business
engaged in commercial or research activities
directly related to your Ohio University
responsibilities.
Any situation in which an actual conflict
exists is not permitted.
The only “exceptions” are those handled
under Ohio University Policy and Procedure
19.059 where faculty entrepreneurship is
addressed.
Participation in clinical trials or evaluation
of other research in which you have a
significant financial interest other than
royalty income.
In the context of your position at Ohio
University, you make professional referrals
to a business in which you have a
significant financial interest.
Letter of admonition
Ineligibility to submit grant applications
Withholding of IRB or IACUC approvals
Suspension
Non-Renewal
Loss of Tenure
Consulting
Procurement
Mentoring
Clinical Studies
Avoid consulting relationships that have
the potential to divert time and effort from
your responsibilities to Ohio University.
Do not use students.
Be wary of situations that limit publication.
Do not use university stationary, etc. that
could create an impression the university
is involved with the activities.
Make sure you are devoting sufficient time
to your university obligations.
Be cautious that the potential financial gain
cannot be perceived to influence your
university mentoring relationships.
Disclose any personal or familial financial
interest or equity in a company that is
doing business with Ohio University.
If you make purchases using public funds,
you should not use companies which will
benefit you or your family. If there is no
alternative you must seek and receive
permission prior to purchasing.
Any relationship in which there is a real or
perceived power or influence imbalance has
the potential for conflict. (Faculty:Student)
Isolating these relationships with respect to
areas of personal financial gain is best.
If they cannot be isolated, then safeguards
must be created.
If you have a financial interest, it is best to
isolate yourself from the study.
At a minimum, expect a more intense review
and a robust management plan if you have a
financial interest.
If both the institution and you have financial
interests the clinical study should be
conducted elsewhere.
You have administrative responsibilities on
behalf of Ohio University that is beneficial to
the business in which you have a significant
financial interest
You have administrative responsibilities on
behalf of Ohio University with respect to an
SRA where you have a significant financial
interest
Slide 22
Jo Ellen Sherow
Ohio University
Office of Research Compliance
Researchers’ Financial Disclosures in the
Spotlight
Conflicts of interest, always an emotional topic,
returned to the headlines this week as Sen.
Charles Grassley, a longtime critic of the drug
industry’s potential influence on research,
released new evidence that prominent Harvard
University scientists had failed to disclose much
of their outside income from pharmaceutical
companies over the past eight years.
http://www.insidehighered.com/news/2008/06/12/conflict January 15, 2008
WEDNESDAY, JANUARY 21, 2009
In a review of the literature regarding the relationship between
smokeless tobacco use and cancer, a conflict of interest of one of the
article's authors was initially not disclosed (see: Boffetta P, Hecht S, Gray
N, Gupta P, Straif K. Smokeless tobacco and cancer. Lancet Oncology
2008; 9:667-675). The original article was published in July, 2008. That
article stated: "The authors declare no conflicts of interest." After the
editor of the journal was notified by a researcher with knowledge of a
potential conflict of interest of Dr. Stephen Hecht (one of the study
authors), an erratum was published in September 2008, which noted:
"During the immediate months preceding submission of the review SH
was acting in the capacity of an expert witness for the plaintiff in a
future court case against a smokeless tobacco company. SH declares his
participation in this case in no way influenced his writing or involvement
in the review."
http://tobaccoanalysis.blogspot.com/2009/01/conflict-of-interestnot.html
January 16, 2009 — More than one third of new
drug marketing applications approved by the US
Food and Drug Administration (FDA) were
missing information about potential conflicts of
interest for clinical trial investigators, which
could allow bias to creep into the approvals
process, a government report released this week
has found. The FDA has said that it agrees with
most of the report's findings.
http://www.medscape.com/viewarticle/586980
Do collaborations between biotech companies
and academic centers constitute a conflict of
interest?
Biotechnology industry partnerships with
universities and academic centers have been
fruitful for both. So why is there so much
concern about conflict of interest and is that
concern appropriate?
http://www.redorbit.com/news/health/750100/genetic_engineering_news_p
osts_podcast_on_industrialacademic_collaborations_are_these/index.html
Universities are responsible for use of public
funds and therefore must maintain the public
trust.
Identifying and mitigating situations that may
have the potential for conflict maintains the
integrity of the university.
Maintaining integrity allows the university to
do credible academic research.
To provide information on the purpose of the
conflict of interest requirements.
To provide a basic overview of conflicts of
interest
To introduce the disclosure process and the use
of management plans
To provide information on the need for updates
and annual renewals.
Situations where financial considerations
compromise your professional judgment.
“Actual Conflict of Interest”
◦ Not permitted
Situations where an independent observer
might reasonably question whether your
professional actions or decisions are
determined by considerations of personal
gain. “Perceived Conflict of Interest”
◦ Managed
Potential conflicts may be financial or may be
a conflict of time, effort and/or commitment.
Potential conflicts can occur as a result of
administrative, scientific, academic, fiduciary
or familial situations.
They are situations that can be PERCEIVED to
be conflicting, whether a “real” conflict exists
or not.
Ohio University Policy has a mandatory
disclosure policy if you:
Earn over $10,000 in a twelve month period
from your outside activity OR
Have over 5% equity in the entity
Applies to members of your immediate family
(spouse, domestic partner, dependent
children) as well as yourself.
Anything of monetary value, including but not
limited to:
◦
◦
◦
◦
Salary
Payments for services
Equity interests over 5%
Intellectual property rights
Excludes mutual, pension and other
investments over which you have no control
Outside work during regular academic year
should not exceed equivalent of 1 day per
week.
Consulting work must avoid activities that
involve a conflict of interest with assigned
Ohio University activities and programs
Faculty Handbook, section IV-D
Outside interests cannot interfere with
primary loyalty to Ohio University and your
academic role
Use of university resources must have prior
approval of Chair, Dean and VPR.
Your outside interests should not be in
direct competition with university interests
Full time administrative employees are
expected to devote their full-time
professional loyalty, time and energy to their
position.
You must use non-work hours and no
university resources
Federal Agencies
State Law
University Policies
Many Academic Publications
45 CFR Part 50, Subpart F
“Responsibility of Applicants for Promoting
Objectivity in Research for Which PHS Funding
is Sought”
Authority: 42 U.S.C. 216, 289b-1, 299c-3.
Intent is to assure objectivity by establishing
standards that preclude bias in design, conduct, or
reporting of research
Focuses on financial conflicts of interest
(FCOI)
Regulations apply to investigators, including
sub grantees, contractors, and collaborating
investigators.
Does not apply to applications for support
under Phase I of SBIR and STTR programs
An institutional conflict of interest policy should
require that each investigator disclose to a
responsible representative of the institution all
significant financial interests of the investigator
(including those of the investigator’s spouse and
dependent children) (i) that would reasonably
appear to be affected by the research or
educational activities funded or proposed for
funding by NSF; or (ii) in entities whose financial
interests would reasonably appear to be affected
by such activities.
Chapter 1 (Subchapter A) (Part 54)
Financial Disclosure by Clinical Investigators
The Food and Drug Administration (FDA)
regulations state that investigators that
receive compensation in excess of $25,000
from a corporate sponsor of a trial in which
the investigator is engaged must disclose to
the FDA at the time of filing for a new drug
application.
19.058, Conflict of Interest in Research,
Educational, and Public Service Activities
19.059, Employee Participation in Authorized
Private Companies Commercializing Ohio
University Research
“Conflict of Interest in Research, Educational,
and Public Service Activities”
Most conflict disclosures fall within the
parameters of this policy
States that faculty are primarily responsible
for their academic, research and service
obligations
“Employee Participation in Authorized Private
Companies Commercializing Ohio University
Research”
Applies to “employees, faculty, staff and students,
who create intellectual property owned by the Ohio
University and who desire to hold an equity interest
in a firm, corporation, or other association to which
Ohio University has assigned, licensed or
transferred Ohio University’s interests…”
Consulting
Licensing University Technology
Clinical Studies
Procurement
Mentoring
Institutional
A disclosure is filed specific to the funding
application.
If you have a potential conflict for one
proposal, it does not automatically apply to
all of your proposals.
Research conflicts of interest are usually
disclosed using LEO as you apply for funding
by completing the conflict of interest section
of the electronic transmittal
If you are not using LEO, you can download
the appropriate disclosure form from
www.ohio.edu/research/compliance
“A” is selected if you have no conflicts to
disclose
“B” is selected if you have a potential conflict
to disclose relative to the submission.
(Requires a subsequent paper process)
“C” is selected if you have a current disclosure
on file, but it is not relevant to the proposal
you are submitting
Still uses option A, B or C
Requires that you gather signatures on paper
for all options, however
Generally used for personnel not listed on the
grant proposal or “key personnel”
We have revised the COI forms to word forms
This should be easier to complete than the
previous form
PDF versions are also available
Should be on the compliance web site soon,
but we can e-mail them to you until then
Use this form only if you are unable to use
the LEO transmittal form to assure that no
conflict of interest exists. A form must be
completed for each proposal.
I assure that I have read Ohio University
Policy 19.058, “Conflict of Interest in
Research, Educational, and Public Service
Activities” and declare that I have nothing
that is, or could be perceived to be a conflict
of interest with this proposal.
Use this form to disclose a potential conflict
of interest situation.
A separate disclosure form must be used for
each entity with which you conduct business
Conflict includes any member of your
immediate family (spouse, domestic partner
or children)
Require that you complete an option “B”
disclosure statement in addition to
completing the LEO transmittal form.
Require you to obtain signatures from Center
or Institute (if applicable), Chair and Dean on
the additional disclosure statement!!
The B disclosure form is available at
www.ohio.edu/research/compliance
Use this form only if you are unable to use
the LEO transmittal form. Complete this form
if you have a current conflict of interest
disclosure on file with the Office of Research
Compliance, but that disclosure is not
applicable to this proposal.
*New Option for 2008*
A management plan is developed for some
disclosures to mitigate the potential conflict
Management plans are specific to each
disclosure
May require submission of additional pieces,
such as a student employment plan
Reduce or remove the financial interest creating the
conflict
Place safeguards that mitigate the conflict potential,
such having some decisions made by an independent
entity
Limit participation in portions of the proposed
research likely to create a conflict
Require that the researcher disclose his or her
conflicting financial interests to all collaborators and
any proposed trainees;
Disclose the conflict in publications
Work to remove students from being directly advised
or taught by faculty where a conflict exists
Assure publication rights for student participants
Student Use
Nepotism and Cronyism
Intellectual Property
Use of University Resources
Publication provisions
Use of Human Subjects
Oversight Requirements
Reporting and Annual Reviews
You must submit an annual renewal for your
disclosure
◦ If the potential conflict no longer exists you must
notify us
If significant changes occur during the year
you should submit an update to your
disclosure as they occur
Yes. We encourage employees to disclose
potential conflicts that do not meet the
financial threshold, but may still be
problematic, such as student employment.
This allows you to be transparent with
respect to outside interests.
Allowable situations
Situations that require disclosure but may not
need an extensive management plan
Situations that require disclosure and have
problematic elements that will require
mitigation and/or a management plan
Situations that are not permitted
Receipt of royalties or honoraria for
published scholarly works, seminars,
teaching, etc.
Honoraria for serving as a special reviewer
or work on review panels
Royalties under our intellectual property
policies if no other relationship with entity
Clinical income at OUCOM
You participate in research developed in
whole or part by you, and you or your
family receive royalties from an existing
agreement with the business, but have
no other significant financial interest
You assign students, etc. to research
projects where you are entitled to
receive royalties, but have no other
significant financial interest
You assign students, etc. to projects supported
by the business through an SRA, and have a
significant financial interest other than royalty
income
You receive research support from a business in
which you serve on the board of directors, or
other advisory board, even if you are not
compensated.
You hold an executive position in a business
engaged in commercial or research activities
directly related to your Ohio University
responsibilities.
Any situation in which an actual conflict
exists is not permitted.
The only “exceptions” are those handled
under Ohio University Policy and Procedure
19.059 where faculty entrepreneurship is
addressed.
Participation in clinical trials or evaluation
of other research in which you have a
significant financial interest other than
royalty income.
In the context of your position at Ohio
University, you make professional referrals
to a business in which you have a
significant financial interest.
Letter of admonition
Ineligibility to submit grant applications
Withholding of IRB or IACUC approvals
Suspension
Non-Renewal
Loss of Tenure
Consulting
Procurement
Mentoring
Clinical Studies
Avoid consulting relationships that have
the potential to divert time and effort from
your responsibilities to Ohio University.
Do not use students.
Be wary of situations that limit publication.
Do not use university stationary, etc. that
could create an impression the university
is involved with the activities.
Make sure you are devoting sufficient time
to your university obligations.
Be cautious that the potential financial gain
cannot be perceived to influence your
university mentoring relationships.
Disclose any personal or familial financial
interest or equity in a company that is
doing business with Ohio University.
If you make purchases using public funds,
you should not use companies which will
benefit you or your family. If there is no
alternative you must seek and receive
permission prior to purchasing.
Any relationship in which there is a real or
perceived power or influence imbalance has
the potential for conflict. (Faculty:Student)
Isolating these relationships with respect to
areas of personal financial gain is best.
If they cannot be isolated, then safeguards
must be created.
If you have a financial interest, it is best to
isolate yourself from the study.
At a minimum, expect a more intense review
and a robust management plan if you have a
financial interest.
If both the institution and you have financial
interests the clinical study should be
conducted elsewhere.
You have administrative responsibilities on
behalf of Ohio University that is beneficial to
the business in which you have a significant
financial interest
You have administrative responsibilities on
behalf of Ohio University with respect to an
SRA where you have a significant financial
interest
Slide 23
Jo Ellen Sherow
Ohio University
Office of Research Compliance
Researchers’ Financial Disclosures in the
Spotlight
Conflicts of interest, always an emotional topic,
returned to the headlines this week as Sen.
Charles Grassley, a longtime critic of the drug
industry’s potential influence on research,
released new evidence that prominent Harvard
University scientists had failed to disclose much
of their outside income from pharmaceutical
companies over the past eight years.
http://www.insidehighered.com/news/2008/06/12/conflict January 15, 2008
WEDNESDAY, JANUARY 21, 2009
In a review of the literature regarding the relationship between
smokeless tobacco use and cancer, a conflict of interest of one of the
article's authors was initially not disclosed (see: Boffetta P, Hecht S, Gray
N, Gupta P, Straif K. Smokeless tobacco and cancer. Lancet Oncology
2008; 9:667-675). The original article was published in July, 2008. That
article stated: "The authors declare no conflicts of interest." After the
editor of the journal was notified by a researcher with knowledge of a
potential conflict of interest of Dr. Stephen Hecht (one of the study
authors), an erratum was published in September 2008, which noted:
"During the immediate months preceding submission of the review SH
was acting in the capacity of an expert witness for the plaintiff in a
future court case against a smokeless tobacco company. SH declares his
participation in this case in no way influenced his writing or involvement
in the review."
http://tobaccoanalysis.blogspot.com/2009/01/conflict-of-interestnot.html
January 16, 2009 — More than one third of new
drug marketing applications approved by the US
Food and Drug Administration (FDA) were
missing information about potential conflicts of
interest for clinical trial investigators, which
could allow bias to creep into the approvals
process, a government report released this week
has found. The FDA has said that it agrees with
most of the report's findings.
http://www.medscape.com/viewarticle/586980
Do collaborations between biotech companies
and academic centers constitute a conflict of
interest?
Biotechnology industry partnerships with
universities and academic centers have been
fruitful for both. So why is there so much
concern about conflict of interest and is that
concern appropriate?
http://www.redorbit.com/news/health/750100/genetic_engineering_news_p
osts_podcast_on_industrialacademic_collaborations_are_these/index.html
Universities are responsible for use of public
funds and therefore must maintain the public
trust.
Identifying and mitigating situations that may
have the potential for conflict maintains the
integrity of the university.
Maintaining integrity allows the university to
do credible academic research.
To provide information on the purpose of the
conflict of interest requirements.
To provide a basic overview of conflicts of
interest
To introduce the disclosure process and the use
of management plans
To provide information on the need for updates
and annual renewals.
Situations where financial considerations
compromise your professional judgment.
“Actual Conflict of Interest”
◦ Not permitted
Situations where an independent observer
might reasonably question whether your
professional actions or decisions are
determined by considerations of personal
gain. “Perceived Conflict of Interest”
◦ Managed
Potential conflicts may be financial or may be
a conflict of time, effort and/or commitment.
Potential conflicts can occur as a result of
administrative, scientific, academic, fiduciary
or familial situations.
They are situations that can be PERCEIVED to
be conflicting, whether a “real” conflict exists
or not.
Ohio University Policy has a mandatory
disclosure policy if you:
Earn over $10,000 in a twelve month period
from your outside activity OR
Have over 5% equity in the entity
Applies to members of your immediate family
(spouse, domestic partner, dependent
children) as well as yourself.
Anything of monetary value, including but not
limited to:
◦
◦
◦
◦
Salary
Payments for services
Equity interests over 5%
Intellectual property rights
Excludes mutual, pension and other
investments over which you have no control
Outside work during regular academic year
should not exceed equivalent of 1 day per
week.
Consulting work must avoid activities that
involve a conflict of interest with assigned
Ohio University activities and programs
Faculty Handbook, section IV-D
Outside interests cannot interfere with
primary loyalty to Ohio University and your
academic role
Use of university resources must have prior
approval of Chair, Dean and VPR.
Your outside interests should not be in
direct competition with university interests
Full time administrative employees are
expected to devote their full-time
professional loyalty, time and energy to their
position.
You must use non-work hours and no
university resources
Federal Agencies
State Law
University Policies
Many Academic Publications
45 CFR Part 50, Subpart F
“Responsibility of Applicants for Promoting
Objectivity in Research for Which PHS Funding
is Sought”
Authority: 42 U.S.C. 216, 289b-1, 299c-3.
Intent is to assure objectivity by establishing
standards that preclude bias in design, conduct, or
reporting of research
Focuses on financial conflicts of interest
(FCOI)
Regulations apply to investigators, including
sub grantees, contractors, and collaborating
investigators.
Does not apply to applications for support
under Phase I of SBIR and STTR programs
An institutional conflict of interest policy should
require that each investigator disclose to a
responsible representative of the institution all
significant financial interests of the investigator
(including those of the investigator’s spouse and
dependent children) (i) that would reasonably
appear to be affected by the research or
educational activities funded or proposed for
funding by NSF; or (ii) in entities whose financial
interests would reasonably appear to be affected
by such activities.
Chapter 1 (Subchapter A) (Part 54)
Financial Disclosure by Clinical Investigators
The Food and Drug Administration (FDA)
regulations state that investigators that
receive compensation in excess of $25,000
from a corporate sponsor of a trial in which
the investigator is engaged must disclose to
the FDA at the time of filing for a new drug
application.
19.058, Conflict of Interest in Research,
Educational, and Public Service Activities
19.059, Employee Participation in Authorized
Private Companies Commercializing Ohio
University Research
“Conflict of Interest in Research, Educational,
and Public Service Activities”
Most conflict disclosures fall within the
parameters of this policy
States that faculty are primarily responsible
for their academic, research and service
obligations
“Employee Participation in Authorized Private
Companies Commercializing Ohio University
Research”
Applies to “employees, faculty, staff and students,
who create intellectual property owned by the Ohio
University and who desire to hold an equity interest
in a firm, corporation, or other association to which
Ohio University has assigned, licensed or
transferred Ohio University’s interests…”
Consulting
Licensing University Technology
Clinical Studies
Procurement
Mentoring
Institutional
A disclosure is filed specific to the funding
application.
If you have a potential conflict for one
proposal, it does not automatically apply to
all of your proposals.
Research conflicts of interest are usually
disclosed using LEO as you apply for funding
by completing the conflict of interest section
of the electronic transmittal
If you are not using LEO, you can download
the appropriate disclosure form from
www.ohio.edu/research/compliance
“A” is selected if you have no conflicts to
disclose
“B” is selected if you have a potential conflict
to disclose relative to the submission.
(Requires a subsequent paper process)
“C” is selected if you have a current disclosure
on file, but it is not relevant to the proposal
you are submitting
Still uses option A, B or C
Requires that you gather signatures on paper
for all options, however
Generally used for personnel not listed on the
grant proposal or “key personnel”
We have revised the COI forms to word forms
This should be easier to complete than the
previous form
PDF versions are also available
Should be on the compliance web site soon,
but we can e-mail them to you until then
Use this form only if you are unable to use
the LEO transmittal form to assure that no
conflict of interest exists. A form must be
completed for each proposal.
I assure that I have read Ohio University
Policy 19.058, “Conflict of Interest in
Research, Educational, and Public Service
Activities” and declare that I have nothing
that is, or could be perceived to be a conflict
of interest with this proposal.
Use this form to disclose a potential conflict
of interest situation.
A separate disclosure form must be used for
each entity with which you conduct business
Conflict includes any member of your
immediate family (spouse, domestic partner
or children)
Require that you complete an option “B”
disclosure statement in addition to
completing the LEO transmittal form.
Require you to obtain signatures from Center
or Institute (if applicable), Chair and Dean on
the additional disclosure statement!!
The B disclosure form is available at
www.ohio.edu/research/compliance
Use this form only if you are unable to use
the LEO transmittal form. Complete this form
if you have a current conflict of interest
disclosure on file with the Office of Research
Compliance, but that disclosure is not
applicable to this proposal.
*New Option for 2008*
A management plan is developed for some
disclosures to mitigate the potential conflict
Management plans are specific to each
disclosure
May require submission of additional pieces,
such as a student employment plan
Reduce or remove the financial interest creating the
conflict
Place safeguards that mitigate the conflict potential,
such having some decisions made by an independent
entity
Limit participation in portions of the proposed
research likely to create a conflict
Require that the researcher disclose his or her
conflicting financial interests to all collaborators and
any proposed trainees;
Disclose the conflict in publications
Work to remove students from being directly advised
or taught by faculty where a conflict exists
Assure publication rights for student participants
Student Use
Nepotism and Cronyism
Intellectual Property
Use of University Resources
Publication provisions
Use of Human Subjects
Oversight Requirements
Reporting and Annual Reviews
You must submit an annual renewal for your
disclosure
◦ If the potential conflict no longer exists you must
notify us
If significant changes occur during the year
you should submit an update to your
disclosure as they occur
Yes. We encourage employees to disclose
potential conflicts that do not meet the
financial threshold, but may still be
problematic, such as student employment.
This allows you to be transparent with
respect to outside interests.
Allowable situations
Situations that require disclosure but may not
need an extensive management plan
Situations that require disclosure and have
problematic elements that will require
mitigation and/or a management plan
Situations that are not permitted
Receipt of royalties or honoraria for
published scholarly works, seminars,
teaching, etc.
Honoraria for serving as a special reviewer
or work on review panels
Royalties under our intellectual property
policies if no other relationship with entity
Clinical income at OUCOM
You participate in research developed in
whole or part by you, and you or your
family receive royalties from an existing
agreement with the business, but have
no other significant financial interest
You assign students, etc. to research
projects where you are entitled to
receive royalties, but have no other
significant financial interest
You assign students, etc. to projects supported
by the business through an SRA, and have a
significant financial interest other than royalty
income
You receive research support from a business in
which you serve on the board of directors, or
other advisory board, even if you are not
compensated.
You hold an executive position in a business
engaged in commercial or research activities
directly related to your Ohio University
responsibilities.
Any situation in which an actual conflict
exists is not permitted.
The only “exceptions” are those handled
under Ohio University Policy and Procedure
19.059 where faculty entrepreneurship is
addressed.
Participation in clinical trials or evaluation
of other research in which you have a
significant financial interest other than
royalty income.
In the context of your position at Ohio
University, you make professional referrals
to a business in which you have a
significant financial interest.
Letter of admonition
Ineligibility to submit grant applications
Withholding of IRB or IACUC approvals
Suspension
Non-Renewal
Loss of Tenure
Consulting
Procurement
Mentoring
Clinical Studies
Avoid consulting relationships that have
the potential to divert time and effort from
your responsibilities to Ohio University.
Do not use students.
Be wary of situations that limit publication.
Do not use university stationary, etc. that
could create an impression the university
is involved with the activities.
Make sure you are devoting sufficient time
to your university obligations.
Be cautious that the potential financial gain
cannot be perceived to influence your
university mentoring relationships.
Disclose any personal or familial financial
interest or equity in a company that is
doing business with Ohio University.
If you make purchases using public funds,
you should not use companies which will
benefit you or your family. If there is no
alternative you must seek and receive
permission prior to purchasing.
Any relationship in which there is a real or
perceived power or influence imbalance has
the potential for conflict. (Faculty:Student)
Isolating these relationships with respect to
areas of personal financial gain is best.
If they cannot be isolated, then safeguards
must be created.
If you have a financial interest, it is best to
isolate yourself from the study.
At a minimum, expect a more intense review
and a robust management plan if you have a
financial interest.
If both the institution and you have financial
interests the clinical study should be
conducted elsewhere.
You have administrative responsibilities on
behalf of Ohio University that is beneficial to
the business in which you have a significant
financial interest
You have administrative responsibilities on
behalf of Ohio University with respect to an
SRA where you have a significant financial
interest
Slide 24
Jo Ellen Sherow
Ohio University
Office of Research Compliance
Researchers’ Financial Disclosures in the
Spotlight
Conflicts of interest, always an emotional topic,
returned to the headlines this week as Sen.
Charles Grassley, a longtime critic of the drug
industry’s potential influence on research,
released new evidence that prominent Harvard
University scientists had failed to disclose much
of their outside income from pharmaceutical
companies over the past eight years.
http://www.insidehighered.com/news/2008/06/12/conflict January 15, 2008
WEDNESDAY, JANUARY 21, 2009
In a review of the literature regarding the relationship between
smokeless tobacco use and cancer, a conflict of interest of one of the
article's authors was initially not disclosed (see: Boffetta P, Hecht S, Gray
N, Gupta P, Straif K. Smokeless tobacco and cancer. Lancet Oncology
2008; 9:667-675). The original article was published in July, 2008. That
article stated: "The authors declare no conflicts of interest." After the
editor of the journal was notified by a researcher with knowledge of a
potential conflict of interest of Dr. Stephen Hecht (one of the study
authors), an erratum was published in September 2008, which noted:
"During the immediate months preceding submission of the review SH
was acting in the capacity of an expert witness for the plaintiff in a
future court case against a smokeless tobacco company. SH declares his
participation in this case in no way influenced his writing or involvement
in the review."
http://tobaccoanalysis.blogspot.com/2009/01/conflict-of-interestnot.html
January 16, 2009 — More than one third of new
drug marketing applications approved by the US
Food and Drug Administration (FDA) were
missing information about potential conflicts of
interest for clinical trial investigators, which
could allow bias to creep into the approvals
process, a government report released this week
has found. The FDA has said that it agrees with
most of the report's findings.
http://www.medscape.com/viewarticle/586980
Do collaborations between biotech companies
and academic centers constitute a conflict of
interest?
Biotechnology industry partnerships with
universities and academic centers have been
fruitful for both. So why is there so much
concern about conflict of interest and is that
concern appropriate?
http://www.redorbit.com/news/health/750100/genetic_engineering_news_p
osts_podcast_on_industrialacademic_collaborations_are_these/index.html
Universities are responsible for use of public
funds and therefore must maintain the public
trust.
Identifying and mitigating situations that may
have the potential for conflict maintains the
integrity of the university.
Maintaining integrity allows the university to
do credible academic research.
To provide information on the purpose of the
conflict of interest requirements.
To provide a basic overview of conflicts of
interest
To introduce the disclosure process and the use
of management plans
To provide information on the need for updates
and annual renewals.
Situations where financial considerations
compromise your professional judgment.
“Actual Conflict of Interest”
◦ Not permitted
Situations where an independent observer
might reasonably question whether your
professional actions or decisions are
determined by considerations of personal
gain. “Perceived Conflict of Interest”
◦ Managed
Potential conflicts may be financial or may be
a conflict of time, effort and/or commitment.
Potential conflicts can occur as a result of
administrative, scientific, academic, fiduciary
or familial situations.
They are situations that can be PERCEIVED to
be conflicting, whether a “real” conflict exists
or not.
Ohio University Policy has a mandatory
disclosure policy if you:
Earn over $10,000 in a twelve month period
from your outside activity OR
Have over 5% equity in the entity
Applies to members of your immediate family
(spouse, domestic partner, dependent
children) as well as yourself.
Anything of monetary value, including but not
limited to:
◦
◦
◦
◦
Salary
Payments for services
Equity interests over 5%
Intellectual property rights
Excludes mutual, pension and other
investments over which you have no control
Outside work during regular academic year
should not exceed equivalent of 1 day per
week.
Consulting work must avoid activities that
involve a conflict of interest with assigned
Ohio University activities and programs
Faculty Handbook, section IV-D
Outside interests cannot interfere with
primary loyalty to Ohio University and your
academic role
Use of university resources must have prior
approval of Chair, Dean and VPR.
Your outside interests should not be in
direct competition with university interests
Full time administrative employees are
expected to devote their full-time
professional loyalty, time and energy to their
position.
You must use non-work hours and no
university resources
Federal Agencies
State Law
University Policies
Many Academic Publications
45 CFR Part 50, Subpart F
“Responsibility of Applicants for Promoting
Objectivity in Research for Which PHS Funding
is Sought”
Authority: 42 U.S.C. 216, 289b-1, 299c-3.
Intent is to assure objectivity by establishing
standards that preclude bias in design, conduct, or
reporting of research
Focuses on financial conflicts of interest
(FCOI)
Regulations apply to investigators, including
sub grantees, contractors, and collaborating
investigators.
Does not apply to applications for support
under Phase I of SBIR and STTR programs
An institutional conflict of interest policy should
require that each investigator disclose to a
responsible representative of the institution all
significant financial interests of the investigator
(including those of the investigator’s spouse and
dependent children) (i) that would reasonably
appear to be affected by the research or
educational activities funded or proposed for
funding by NSF; or (ii) in entities whose financial
interests would reasonably appear to be affected
by such activities.
Chapter 1 (Subchapter A) (Part 54)
Financial Disclosure by Clinical Investigators
The Food and Drug Administration (FDA)
regulations state that investigators that
receive compensation in excess of $25,000
from a corporate sponsor of a trial in which
the investigator is engaged must disclose to
the FDA at the time of filing for a new drug
application.
19.058, Conflict of Interest in Research,
Educational, and Public Service Activities
19.059, Employee Participation in Authorized
Private Companies Commercializing Ohio
University Research
“Conflict of Interest in Research, Educational,
and Public Service Activities”
Most conflict disclosures fall within the
parameters of this policy
States that faculty are primarily responsible
for their academic, research and service
obligations
“Employee Participation in Authorized Private
Companies Commercializing Ohio University
Research”
Applies to “employees, faculty, staff and students,
who create intellectual property owned by the Ohio
University and who desire to hold an equity interest
in a firm, corporation, or other association to which
Ohio University has assigned, licensed or
transferred Ohio University’s interests…”
Consulting
Licensing University Technology
Clinical Studies
Procurement
Mentoring
Institutional
A disclosure is filed specific to the funding
application.
If you have a potential conflict for one
proposal, it does not automatically apply to
all of your proposals.
Research conflicts of interest are usually
disclosed using LEO as you apply for funding
by completing the conflict of interest section
of the electronic transmittal
If you are not using LEO, you can download
the appropriate disclosure form from
www.ohio.edu/research/compliance
“A” is selected if you have no conflicts to
disclose
“B” is selected if you have a potential conflict
to disclose relative to the submission.
(Requires a subsequent paper process)
“C” is selected if you have a current disclosure
on file, but it is not relevant to the proposal
you are submitting
Still uses option A, B or C
Requires that you gather signatures on paper
for all options, however
Generally used for personnel not listed on the
grant proposal or “key personnel”
We have revised the COI forms to word forms
This should be easier to complete than the
previous form
PDF versions are also available
Should be on the compliance web site soon,
but we can e-mail them to you until then
Use this form only if you are unable to use
the LEO transmittal form to assure that no
conflict of interest exists. A form must be
completed for each proposal.
I assure that I have read Ohio University
Policy 19.058, “Conflict of Interest in
Research, Educational, and Public Service
Activities” and declare that I have nothing
that is, or could be perceived to be a conflict
of interest with this proposal.
Use this form to disclose a potential conflict
of interest situation.
A separate disclosure form must be used for
each entity with which you conduct business
Conflict includes any member of your
immediate family (spouse, domestic partner
or children)
Require that you complete an option “B”
disclosure statement in addition to
completing the LEO transmittal form.
Require you to obtain signatures from Center
or Institute (if applicable), Chair and Dean on
the additional disclosure statement!!
The B disclosure form is available at
www.ohio.edu/research/compliance
Use this form only if you are unable to use
the LEO transmittal form. Complete this form
if you have a current conflict of interest
disclosure on file with the Office of Research
Compliance, but that disclosure is not
applicable to this proposal.
*New Option for 2008*
A management plan is developed for some
disclosures to mitigate the potential conflict
Management plans are specific to each
disclosure
May require submission of additional pieces,
such as a student employment plan
Reduce or remove the financial interest creating the
conflict
Place safeguards that mitigate the conflict potential,
such having some decisions made by an independent
entity
Limit participation in portions of the proposed
research likely to create a conflict
Require that the researcher disclose his or her
conflicting financial interests to all collaborators and
any proposed trainees;
Disclose the conflict in publications
Work to remove students from being directly advised
or taught by faculty where a conflict exists
Assure publication rights for student participants
Student Use
Nepotism and Cronyism
Intellectual Property
Use of University Resources
Publication provisions
Use of Human Subjects
Oversight Requirements
Reporting and Annual Reviews
You must submit an annual renewal for your
disclosure
◦ If the potential conflict no longer exists you must
notify us
If significant changes occur during the year
you should submit an update to your
disclosure as they occur
Yes. We encourage employees to disclose
potential conflicts that do not meet the
financial threshold, but may still be
problematic, such as student employment.
This allows you to be transparent with
respect to outside interests.
Allowable situations
Situations that require disclosure but may not
need an extensive management plan
Situations that require disclosure and have
problematic elements that will require
mitigation and/or a management plan
Situations that are not permitted
Receipt of royalties or honoraria for
published scholarly works, seminars,
teaching, etc.
Honoraria for serving as a special reviewer
or work on review panels
Royalties under our intellectual property
policies if no other relationship with entity
Clinical income at OUCOM
You participate in research developed in
whole or part by you, and you or your
family receive royalties from an existing
agreement with the business, but have
no other significant financial interest
You assign students, etc. to research
projects where you are entitled to
receive royalties, but have no other
significant financial interest
You assign students, etc. to projects supported
by the business through an SRA, and have a
significant financial interest other than royalty
income
You receive research support from a business in
which you serve on the board of directors, or
other advisory board, even if you are not
compensated.
You hold an executive position in a business
engaged in commercial or research activities
directly related to your Ohio University
responsibilities.
Any situation in which an actual conflict
exists is not permitted.
The only “exceptions” are those handled
under Ohio University Policy and Procedure
19.059 where faculty entrepreneurship is
addressed.
Participation in clinical trials or evaluation
of other research in which you have a
significant financial interest other than
royalty income.
In the context of your position at Ohio
University, you make professional referrals
to a business in which you have a
significant financial interest.
Letter of admonition
Ineligibility to submit grant applications
Withholding of IRB or IACUC approvals
Suspension
Non-Renewal
Loss of Tenure
Consulting
Procurement
Mentoring
Clinical Studies
Avoid consulting relationships that have
the potential to divert time and effort from
your responsibilities to Ohio University.
Do not use students.
Be wary of situations that limit publication.
Do not use university stationary, etc. that
could create an impression the university
is involved with the activities.
Make sure you are devoting sufficient time
to your university obligations.
Be cautious that the potential financial gain
cannot be perceived to influence your
university mentoring relationships.
Disclose any personal or familial financial
interest or equity in a company that is
doing business with Ohio University.
If you make purchases using public funds,
you should not use companies which will
benefit you or your family. If there is no
alternative you must seek and receive
permission prior to purchasing.
Any relationship in which there is a real or
perceived power or influence imbalance has
the potential for conflict. (Faculty:Student)
Isolating these relationships with respect to
areas of personal financial gain is best.
If they cannot be isolated, then safeguards
must be created.
If you have a financial interest, it is best to
isolate yourself from the study.
At a minimum, expect a more intense review
and a robust management plan if you have a
financial interest.
If both the institution and you have financial
interests the clinical study should be
conducted elsewhere.
You have administrative responsibilities on
behalf of Ohio University that is beneficial to
the business in which you have a significant
financial interest
You have administrative responsibilities on
behalf of Ohio University with respect to an
SRA where you have a significant financial
interest
Slide 25
Jo Ellen Sherow
Ohio University
Office of Research Compliance
Researchers’ Financial Disclosures in the
Spotlight
Conflicts of interest, always an emotional topic,
returned to the headlines this week as Sen.
Charles Grassley, a longtime critic of the drug
industry’s potential influence on research,
released new evidence that prominent Harvard
University scientists had failed to disclose much
of their outside income from pharmaceutical
companies over the past eight years.
http://www.insidehighered.com/news/2008/06/12/conflict January 15, 2008
WEDNESDAY, JANUARY 21, 2009
In a review of the literature regarding the relationship between
smokeless tobacco use and cancer, a conflict of interest of one of the
article's authors was initially not disclosed (see: Boffetta P, Hecht S, Gray
N, Gupta P, Straif K. Smokeless tobacco and cancer. Lancet Oncology
2008; 9:667-675). The original article was published in July, 2008. That
article stated: "The authors declare no conflicts of interest." After the
editor of the journal was notified by a researcher with knowledge of a
potential conflict of interest of Dr. Stephen Hecht (one of the study
authors), an erratum was published in September 2008, which noted:
"During the immediate months preceding submission of the review SH
was acting in the capacity of an expert witness for the plaintiff in a
future court case against a smokeless tobacco company. SH declares his
participation in this case in no way influenced his writing or involvement
in the review."
http://tobaccoanalysis.blogspot.com/2009/01/conflict-of-interestnot.html
January 16, 2009 — More than one third of new
drug marketing applications approved by the US
Food and Drug Administration (FDA) were
missing information about potential conflicts of
interest for clinical trial investigators, which
could allow bias to creep into the approvals
process, a government report released this week
has found. The FDA has said that it agrees with
most of the report's findings.
http://www.medscape.com/viewarticle/586980
Do collaborations between biotech companies
and academic centers constitute a conflict of
interest?
Biotechnology industry partnerships with
universities and academic centers have been
fruitful for both. So why is there so much
concern about conflict of interest and is that
concern appropriate?
http://www.redorbit.com/news/health/750100/genetic_engineering_news_p
osts_podcast_on_industrialacademic_collaborations_are_these/index.html
Universities are responsible for use of public
funds and therefore must maintain the public
trust.
Identifying and mitigating situations that may
have the potential for conflict maintains the
integrity of the university.
Maintaining integrity allows the university to
do credible academic research.
To provide information on the purpose of the
conflict of interest requirements.
To provide a basic overview of conflicts of
interest
To introduce the disclosure process and the use
of management plans
To provide information on the need for updates
and annual renewals.
Situations where financial considerations
compromise your professional judgment.
“Actual Conflict of Interest”
◦ Not permitted
Situations where an independent observer
might reasonably question whether your
professional actions or decisions are
determined by considerations of personal
gain. “Perceived Conflict of Interest”
◦ Managed
Potential conflicts may be financial or may be
a conflict of time, effort and/or commitment.
Potential conflicts can occur as a result of
administrative, scientific, academic, fiduciary
or familial situations.
They are situations that can be PERCEIVED to
be conflicting, whether a “real” conflict exists
or not.
Ohio University Policy has a mandatory
disclosure policy if you:
Earn over $10,000 in a twelve month period
from your outside activity OR
Have over 5% equity in the entity
Applies to members of your immediate family
(spouse, domestic partner, dependent
children) as well as yourself.
Anything of monetary value, including but not
limited to:
◦
◦
◦
◦
Salary
Payments for services
Equity interests over 5%
Intellectual property rights
Excludes mutual, pension and other
investments over which you have no control
Outside work during regular academic year
should not exceed equivalent of 1 day per
week.
Consulting work must avoid activities that
involve a conflict of interest with assigned
Ohio University activities and programs
Faculty Handbook, section IV-D
Outside interests cannot interfere with
primary loyalty to Ohio University and your
academic role
Use of university resources must have prior
approval of Chair, Dean and VPR.
Your outside interests should not be in
direct competition with university interests
Full time administrative employees are
expected to devote their full-time
professional loyalty, time and energy to their
position.
You must use non-work hours and no
university resources
Federal Agencies
State Law
University Policies
Many Academic Publications
45 CFR Part 50, Subpart F
“Responsibility of Applicants for Promoting
Objectivity in Research for Which PHS Funding
is Sought”
Authority: 42 U.S.C. 216, 289b-1, 299c-3.
Intent is to assure objectivity by establishing
standards that preclude bias in design, conduct, or
reporting of research
Focuses on financial conflicts of interest
(FCOI)
Regulations apply to investigators, including
sub grantees, contractors, and collaborating
investigators.
Does not apply to applications for support
under Phase I of SBIR and STTR programs
An institutional conflict of interest policy should
require that each investigator disclose to a
responsible representative of the institution all
significant financial interests of the investigator
(including those of the investigator’s spouse and
dependent children) (i) that would reasonably
appear to be affected by the research or
educational activities funded or proposed for
funding by NSF; or (ii) in entities whose financial
interests would reasonably appear to be affected
by such activities.
Chapter 1 (Subchapter A) (Part 54)
Financial Disclosure by Clinical Investigators
The Food and Drug Administration (FDA)
regulations state that investigators that
receive compensation in excess of $25,000
from a corporate sponsor of a trial in which
the investigator is engaged must disclose to
the FDA at the time of filing for a new drug
application.
19.058, Conflict of Interest in Research,
Educational, and Public Service Activities
19.059, Employee Participation in Authorized
Private Companies Commercializing Ohio
University Research
“Conflict of Interest in Research, Educational,
and Public Service Activities”
Most conflict disclosures fall within the
parameters of this policy
States that faculty are primarily responsible
for their academic, research and service
obligations
“Employee Participation in Authorized Private
Companies Commercializing Ohio University
Research”
Applies to “employees, faculty, staff and students,
who create intellectual property owned by the Ohio
University and who desire to hold an equity interest
in a firm, corporation, or other association to which
Ohio University has assigned, licensed or
transferred Ohio University’s interests…”
Consulting
Licensing University Technology
Clinical Studies
Procurement
Mentoring
Institutional
A disclosure is filed specific to the funding
application.
If you have a potential conflict for one
proposal, it does not automatically apply to
all of your proposals.
Research conflicts of interest are usually
disclosed using LEO as you apply for funding
by completing the conflict of interest section
of the electronic transmittal
If you are not using LEO, you can download
the appropriate disclosure form from
www.ohio.edu/research/compliance
“A” is selected if you have no conflicts to
disclose
“B” is selected if you have a potential conflict
to disclose relative to the submission.
(Requires a subsequent paper process)
“C” is selected if you have a current disclosure
on file, but it is not relevant to the proposal
you are submitting
Still uses option A, B or C
Requires that you gather signatures on paper
for all options, however
Generally used for personnel not listed on the
grant proposal or “key personnel”
We have revised the COI forms to word forms
This should be easier to complete than the
previous form
PDF versions are also available
Should be on the compliance web site soon,
but we can e-mail them to you until then
Use this form only if you are unable to use
the LEO transmittal form to assure that no
conflict of interest exists. A form must be
completed for each proposal.
I assure that I have read Ohio University
Policy 19.058, “Conflict of Interest in
Research, Educational, and Public Service
Activities” and declare that I have nothing
that is, or could be perceived to be a conflict
of interest with this proposal.
Use this form to disclose a potential conflict
of interest situation.
A separate disclosure form must be used for
each entity with which you conduct business
Conflict includes any member of your
immediate family (spouse, domestic partner
or children)
Require that you complete an option “B”
disclosure statement in addition to
completing the LEO transmittal form.
Require you to obtain signatures from Center
or Institute (if applicable), Chair and Dean on
the additional disclosure statement!!
The B disclosure form is available at
www.ohio.edu/research/compliance
Use this form only if you are unable to use
the LEO transmittal form. Complete this form
if you have a current conflict of interest
disclosure on file with the Office of Research
Compliance, but that disclosure is not
applicable to this proposal.
*New Option for 2008*
A management plan is developed for some
disclosures to mitigate the potential conflict
Management plans are specific to each
disclosure
May require submission of additional pieces,
such as a student employment plan
Reduce or remove the financial interest creating the
conflict
Place safeguards that mitigate the conflict potential,
such having some decisions made by an independent
entity
Limit participation in portions of the proposed
research likely to create a conflict
Require that the researcher disclose his or her
conflicting financial interests to all collaborators and
any proposed trainees;
Disclose the conflict in publications
Work to remove students from being directly advised
or taught by faculty where a conflict exists
Assure publication rights for student participants
Student Use
Nepotism and Cronyism
Intellectual Property
Use of University Resources
Publication provisions
Use of Human Subjects
Oversight Requirements
Reporting and Annual Reviews
You must submit an annual renewal for your
disclosure
◦ If the potential conflict no longer exists you must
notify us
If significant changes occur during the year
you should submit an update to your
disclosure as they occur
Yes. We encourage employees to disclose
potential conflicts that do not meet the
financial threshold, but may still be
problematic, such as student employment.
This allows you to be transparent with
respect to outside interests.
Allowable situations
Situations that require disclosure but may not
need an extensive management plan
Situations that require disclosure and have
problematic elements that will require
mitigation and/or a management plan
Situations that are not permitted
Receipt of royalties or honoraria for
published scholarly works, seminars,
teaching, etc.
Honoraria for serving as a special reviewer
or work on review panels
Royalties under our intellectual property
policies if no other relationship with entity
Clinical income at OUCOM
You participate in research developed in
whole or part by you, and you or your
family receive royalties from an existing
agreement with the business, but have
no other significant financial interest
You assign students, etc. to research
projects where you are entitled to
receive royalties, but have no other
significant financial interest
You assign students, etc. to projects supported
by the business through an SRA, and have a
significant financial interest other than royalty
income
You receive research support from a business in
which you serve on the board of directors, or
other advisory board, even if you are not
compensated.
You hold an executive position in a business
engaged in commercial or research activities
directly related to your Ohio University
responsibilities.
Any situation in which an actual conflict
exists is not permitted.
The only “exceptions” are those handled
under Ohio University Policy and Procedure
19.059 where faculty entrepreneurship is
addressed.
Participation in clinical trials or evaluation
of other research in which you have a
significant financial interest other than
royalty income.
In the context of your position at Ohio
University, you make professional referrals
to a business in which you have a
significant financial interest.
Letter of admonition
Ineligibility to submit grant applications
Withholding of IRB or IACUC approvals
Suspension
Non-Renewal
Loss of Tenure
Consulting
Procurement
Mentoring
Clinical Studies
Avoid consulting relationships that have
the potential to divert time and effort from
your responsibilities to Ohio University.
Do not use students.
Be wary of situations that limit publication.
Do not use university stationary, etc. that
could create an impression the university
is involved with the activities.
Make sure you are devoting sufficient time
to your university obligations.
Be cautious that the potential financial gain
cannot be perceived to influence your
university mentoring relationships.
Disclose any personal or familial financial
interest or equity in a company that is
doing business with Ohio University.
If you make purchases using public funds,
you should not use companies which will
benefit you or your family. If there is no
alternative you must seek and receive
permission prior to purchasing.
Any relationship in which there is a real or
perceived power or influence imbalance has
the potential for conflict. (Faculty:Student)
Isolating these relationships with respect to
areas of personal financial gain is best.
If they cannot be isolated, then safeguards
must be created.
If you have a financial interest, it is best to
isolate yourself from the study.
At a minimum, expect a more intense review
and a robust management plan if you have a
financial interest.
If both the institution and you have financial
interests the clinical study should be
conducted elsewhere.
You have administrative responsibilities on
behalf of Ohio University that is beneficial to
the business in which you have a significant
financial interest
You have administrative responsibilities on
behalf of Ohio University with respect to an
SRA where you have a significant financial
interest
Slide 26
Jo Ellen Sherow
Ohio University
Office of Research Compliance
Researchers’ Financial Disclosures in the
Spotlight
Conflicts of interest, always an emotional topic,
returned to the headlines this week as Sen.
Charles Grassley, a longtime critic of the drug
industry’s potential influence on research,
released new evidence that prominent Harvard
University scientists had failed to disclose much
of their outside income from pharmaceutical
companies over the past eight years.
http://www.insidehighered.com/news/2008/06/12/conflict January 15, 2008
WEDNESDAY, JANUARY 21, 2009
In a review of the literature regarding the relationship between
smokeless tobacco use and cancer, a conflict of interest of one of the
article's authors was initially not disclosed (see: Boffetta P, Hecht S, Gray
N, Gupta P, Straif K. Smokeless tobacco and cancer. Lancet Oncology
2008; 9:667-675). The original article was published in July, 2008. That
article stated: "The authors declare no conflicts of interest." After the
editor of the journal was notified by a researcher with knowledge of a
potential conflict of interest of Dr. Stephen Hecht (one of the study
authors), an erratum was published in September 2008, which noted:
"During the immediate months preceding submission of the review SH
was acting in the capacity of an expert witness for the plaintiff in a
future court case against a smokeless tobacco company. SH declares his
participation in this case in no way influenced his writing or involvement
in the review."
http://tobaccoanalysis.blogspot.com/2009/01/conflict-of-interestnot.html
January 16, 2009 — More than one third of new
drug marketing applications approved by the US
Food and Drug Administration (FDA) were
missing information about potential conflicts of
interest for clinical trial investigators, which
could allow bias to creep into the approvals
process, a government report released this week
has found. The FDA has said that it agrees with
most of the report's findings.
http://www.medscape.com/viewarticle/586980
Do collaborations between biotech companies
and academic centers constitute a conflict of
interest?
Biotechnology industry partnerships with
universities and academic centers have been
fruitful for both. So why is there so much
concern about conflict of interest and is that
concern appropriate?
http://www.redorbit.com/news/health/750100/genetic_engineering_news_p
osts_podcast_on_industrialacademic_collaborations_are_these/index.html
Universities are responsible for use of public
funds and therefore must maintain the public
trust.
Identifying and mitigating situations that may
have the potential for conflict maintains the
integrity of the university.
Maintaining integrity allows the university to
do credible academic research.
To provide information on the purpose of the
conflict of interest requirements.
To provide a basic overview of conflicts of
interest
To introduce the disclosure process and the use
of management plans
To provide information on the need for updates
and annual renewals.
Situations where financial considerations
compromise your professional judgment.
“Actual Conflict of Interest”
◦ Not permitted
Situations where an independent observer
might reasonably question whether your
professional actions or decisions are
determined by considerations of personal
gain. “Perceived Conflict of Interest”
◦ Managed
Potential conflicts may be financial or may be
a conflict of time, effort and/or commitment.
Potential conflicts can occur as a result of
administrative, scientific, academic, fiduciary
or familial situations.
They are situations that can be PERCEIVED to
be conflicting, whether a “real” conflict exists
or not.
Ohio University Policy has a mandatory
disclosure policy if you:
Earn over $10,000 in a twelve month period
from your outside activity OR
Have over 5% equity in the entity
Applies to members of your immediate family
(spouse, domestic partner, dependent
children) as well as yourself.
Anything of monetary value, including but not
limited to:
◦
◦
◦
◦
Salary
Payments for services
Equity interests over 5%
Intellectual property rights
Excludes mutual, pension and other
investments over which you have no control
Outside work during regular academic year
should not exceed equivalent of 1 day per
week.
Consulting work must avoid activities that
involve a conflict of interest with assigned
Ohio University activities and programs
Faculty Handbook, section IV-D
Outside interests cannot interfere with
primary loyalty to Ohio University and your
academic role
Use of university resources must have prior
approval of Chair, Dean and VPR.
Your outside interests should not be in
direct competition with university interests
Full time administrative employees are
expected to devote their full-time
professional loyalty, time and energy to their
position.
You must use non-work hours and no
university resources
Federal Agencies
State Law
University Policies
Many Academic Publications
45 CFR Part 50, Subpart F
“Responsibility of Applicants for Promoting
Objectivity in Research for Which PHS Funding
is Sought”
Authority: 42 U.S.C. 216, 289b-1, 299c-3.
Intent is to assure objectivity by establishing
standards that preclude bias in design, conduct, or
reporting of research
Focuses on financial conflicts of interest
(FCOI)
Regulations apply to investigators, including
sub grantees, contractors, and collaborating
investigators.
Does not apply to applications for support
under Phase I of SBIR and STTR programs
An institutional conflict of interest policy should
require that each investigator disclose to a
responsible representative of the institution all
significant financial interests of the investigator
(including those of the investigator’s spouse and
dependent children) (i) that would reasonably
appear to be affected by the research or
educational activities funded or proposed for
funding by NSF; or (ii) in entities whose financial
interests would reasonably appear to be affected
by such activities.
Chapter 1 (Subchapter A) (Part 54)
Financial Disclosure by Clinical Investigators
The Food and Drug Administration (FDA)
regulations state that investigators that
receive compensation in excess of $25,000
from a corporate sponsor of a trial in which
the investigator is engaged must disclose to
the FDA at the time of filing for a new drug
application.
19.058, Conflict of Interest in Research,
Educational, and Public Service Activities
19.059, Employee Participation in Authorized
Private Companies Commercializing Ohio
University Research
“Conflict of Interest in Research, Educational,
and Public Service Activities”
Most conflict disclosures fall within the
parameters of this policy
States that faculty are primarily responsible
for their academic, research and service
obligations
“Employee Participation in Authorized Private
Companies Commercializing Ohio University
Research”
Applies to “employees, faculty, staff and students,
who create intellectual property owned by the Ohio
University and who desire to hold an equity interest
in a firm, corporation, or other association to which
Ohio University has assigned, licensed or
transferred Ohio University’s interests…”
Consulting
Licensing University Technology
Clinical Studies
Procurement
Mentoring
Institutional
A disclosure is filed specific to the funding
application.
If you have a potential conflict for one
proposal, it does not automatically apply to
all of your proposals.
Research conflicts of interest are usually
disclosed using LEO as you apply for funding
by completing the conflict of interest section
of the electronic transmittal
If you are not using LEO, you can download
the appropriate disclosure form from
www.ohio.edu/research/compliance
“A” is selected if you have no conflicts to
disclose
“B” is selected if you have a potential conflict
to disclose relative to the submission.
(Requires a subsequent paper process)
“C” is selected if you have a current disclosure
on file, but it is not relevant to the proposal
you are submitting
Still uses option A, B or C
Requires that you gather signatures on paper
for all options, however
Generally used for personnel not listed on the
grant proposal or “key personnel”
We have revised the COI forms to word forms
This should be easier to complete than the
previous form
PDF versions are also available
Should be on the compliance web site soon,
but we can e-mail them to you until then
Use this form only if you are unable to use
the LEO transmittal form to assure that no
conflict of interest exists. A form must be
completed for each proposal.
I assure that I have read Ohio University
Policy 19.058, “Conflict of Interest in
Research, Educational, and Public Service
Activities” and declare that I have nothing
that is, or could be perceived to be a conflict
of interest with this proposal.
Use this form to disclose a potential conflict
of interest situation.
A separate disclosure form must be used for
each entity with which you conduct business
Conflict includes any member of your
immediate family (spouse, domestic partner
or children)
Require that you complete an option “B”
disclosure statement in addition to
completing the LEO transmittal form.
Require you to obtain signatures from Center
or Institute (if applicable), Chair and Dean on
the additional disclosure statement!!
The B disclosure form is available at
www.ohio.edu/research/compliance
Use this form only if you are unable to use
the LEO transmittal form. Complete this form
if you have a current conflict of interest
disclosure on file with the Office of Research
Compliance, but that disclosure is not
applicable to this proposal.
*New Option for 2008*
A management plan is developed for some
disclosures to mitigate the potential conflict
Management plans are specific to each
disclosure
May require submission of additional pieces,
such as a student employment plan
Reduce or remove the financial interest creating the
conflict
Place safeguards that mitigate the conflict potential,
such having some decisions made by an independent
entity
Limit participation in portions of the proposed
research likely to create a conflict
Require that the researcher disclose his or her
conflicting financial interests to all collaborators and
any proposed trainees;
Disclose the conflict in publications
Work to remove students from being directly advised
or taught by faculty where a conflict exists
Assure publication rights for student participants
Student Use
Nepotism and Cronyism
Intellectual Property
Use of University Resources
Publication provisions
Use of Human Subjects
Oversight Requirements
Reporting and Annual Reviews
You must submit an annual renewal for your
disclosure
◦ If the potential conflict no longer exists you must
notify us
If significant changes occur during the year
you should submit an update to your
disclosure as they occur
Yes. We encourage employees to disclose
potential conflicts that do not meet the
financial threshold, but may still be
problematic, such as student employment.
This allows you to be transparent with
respect to outside interests.
Allowable situations
Situations that require disclosure but may not
need an extensive management plan
Situations that require disclosure and have
problematic elements that will require
mitigation and/or a management plan
Situations that are not permitted
Receipt of royalties or honoraria for
published scholarly works, seminars,
teaching, etc.
Honoraria for serving as a special reviewer
or work on review panels
Royalties under our intellectual property
policies if no other relationship with entity
Clinical income at OUCOM
You participate in research developed in
whole or part by you, and you or your
family receive royalties from an existing
agreement with the business, but have
no other significant financial interest
You assign students, etc. to research
projects where you are entitled to
receive royalties, but have no other
significant financial interest
You assign students, etc. to projects supported
by the business through an SRA, and have a
significant financial interest other than royalty
income
You receive research support from a business in
which you serve on the board of directors, or
other advisory board, even if you are not
compensated.
You hold an executive position in a business
engaged in commercial or research activities
directly related to your Ohio University
responsibilities.
Any situation in which an actual conflict
exists is not permitted.
The only “exceptions” are those handled
under Ohio University Policy and Procedure
19.059 where faculty entrepreneurship is
addressed.
Participation in clinical trials or evaluation
of other research in which you have a
significant financial interest other than
royalty income.
In the context of your position at Ohio
University, you make professional referrals
to a business in which you have a
significant financial interest.
Letter of admonition
Ineligibility to submit grant applications
Withholding of IRB or IACUC approvals
Suspension
Non-Renewal
Loss of Tenure
Consulting
Procurement
Mentoring
Clinical Studies
Avoid consulting relationships that have
the potential to divert time and effort from
your responsibilities to Ohio University.
Do not use students.
Be wary of situations that limit publication.
Do not use university stationary, etc. that
could create an impression the university
is involved with the activities.
Make sure you are devoting sufficient time
to your university obligations.
Be cautious that the potential financial gain
cannot be perceived to influence your
university mentoring relationships.
Disclose any personal or familial financial
interest or equity in a company that is
doing business with Ohio University.
If you make purchases using public funds,
you should not use companies which will
benefit you or your family. If there is no
alternative you must seek and receive
permission prior to purchasing.
Any relationship in which there is a real or
perceived power or influence imbalance has
the potential for conflict. (Faculty:Student)
Isolating these relationships with respect to
areas of personal financial gain is best.
If they cannot be isolated, then safeguards
must be created.
If you have a financial interest, it is best to
isolate yourself from the study.
At a minimum, expect a more intense review
and a robust management plan if you have a
financial interest.
If both the institution and you have financial
interests the clinical study should be
conducted elsewhere.
You have administrative responsibilities on
behalf of Ohio University that is beneficial to
the business in which you have a significant
financial interest
You have administrative responsibilities on
behalf of Ohio University with respect to an
SRA where you have a significant financial
interest
Slide 27
Jo Ellen Sherow
Ohio University
Office of Research Compliance
Researchers’ Financial Disclosures in the
Spotlight
Conflicts of interest, always an emotional topic,
returned to the headlines this week as Sen.
Charles Grassley, a longtime critic of the drug
industry’s potential influence on research,
released new evidence that prominent Harvard
University scientists had failed to disclose much
of their outside income from pharmaceutical
companies over the past eight years.
http://www.insidehighered.com/news/2008/06/12/conflict January 15, 2008
WEDNESDAY, JANUARY 21, 2009
In a review of the literature regarding the relationship between
smokeless tobacco use and cancer, a conflict of interest of one of the
article's authors was initially not disclosed (see: Boffetta P, Hecht S, Gray
N, Gupta P, Straif K. Smokeless tobacco and cancer. Lancet Oncology
2008; 9:667-675). The original article was published in July, 2008. That
article stated: "The authors declare no conflicts of interest." After the
editor of the journal was notified by a researcher with knowledge of a
potential conflict of interest of Dr. Stephen Hecht (one of the study
authors), an erratum was published in September 2008, which noted:
"During the immediate months preceding submission of the review SH
was acting in the capacity of an expert witness for the plaintiff in a
future court case against a smokeless tobacco company. SH declares his
participation in this case in no way influenced his writing or involvement
in the review."
http://tobaccoanalysis.blogspot.com/2009/01/conflict-of-interestnot.html
January 16, 2009 — More than one third of new
drug marketing applications approved by the US
Food and Drug Administration (FDA) were
missing information about potential conflicts of
interest for clinical trial investigators, which
could allow bias to creep into the approvals
process, a government report released this week
has found. The FDA has said that it agrees with
most of the report's findings.
http://www.medscape.com/viewarticle/586980
Do collaborations between biotech companies
and academic centers constitute a conflict of
interest?
Biotechnology industry partnerships with
universities and academic centers have been
fruitful for both. So why is there so much
concern about conflict of interest and is that
concern appropriate?
http://www.redorbit.com/news/health/750100/genetic_engineering_news_p
osts_podcast_on_industrialacademic_collaborations_are_these/index.html
Universities are responsible for use of public
funds and therefore must maintain the public
trust.
Identifying and mitigating situations that may
have the potential for conflict maintains the
integrity of the university.
Maintaining integrity allows the university to
do credible academic research.
To provide information on the purpose of the
conflict of interest requirements.
To provide a basic overview of conflicts of
interest
To introduce the disclosure process and the use
of management plans
To provide information on the need for updates
and annual renewals.
Situations where financial considerations
compromise your professional judgment.
“Actual Conflict of Interest”
◦ Not permitted
Situations where an independent observer
might reasonably question whether your
professional actions or decisions are
determined by considerations of personal
gain. “Perceived Conflict of Interest”
◦ Managed
Potential conflicts may be financial or may be
a conflict of time, effort and/or commitment.
Potential conflicts can occur as a result of
administrative, scientific, academic, fiduciary
or familial situations.
They are situations that can be PERCEIVED to
be conflicting, whether a “real” conflict exists
or not.
Ohio University Policy has a mandatory
disclosure policy if you:
Earn over $10,000 in a twelve month period
from your outside activity OR
Have over 5% equity in the entity
Applies to members of your immediate family
(spouse, domestic partner, dependent
children) as well as yourself.
Anything of monetary value, including but not
limited to:
◦
◦
◦
◦
Salary
Payments for services
Equity interests over 5%
Intellectual property rights
Excludes mutual, pension and other
investments over which you have no control
Outside work during regular academic year
should not exceed equivalent of 1 day per
week.
Consulting work must avoid activities that
involve a conflict of interest with assigned
Ohio University activities and programs
Faculty Handbook, section IV-D
Outside interests cannot interfere with
primary loyalty to Ohio University and your
academic role
Use of university resources must have prior
approval of Chair, Dean and VPR.
Your outside interests should not be in
direct competition with university interests
Full time administrative employees are
expected to devote their full-time
professional loyalty, time and energy to their
position.
You must use non-work hours and no
university resources
Federal Agencies
State Law
University Policies
Many Academic Publications
45 CFR Part 50, Subpart F
“Responsibility of Applicants for Promoting
Objectivity in Research for Which PHS Funding
is Sought”
Authority: 42 U.S.C. 216, 289b-1, 299c-3.
Intent is to assure objectivity by establishing
standards that preclude bias in design, conduct, or
reporting of research
Focuses on financial conflicts of interest
(FCOI)
Regulations apply to investigators, including
sub grantees, contractors, and collaborating
investigators.
Does not apply to applications for support
under Phase I of SBIR and STTR programs
An institutional conflict of interest policy should
require that each investigator disclose to a
responsible representative of the institution all
significant financial interests of the investigator
(including those of the investigator’s spouse and
dependent children) (i) that would reasonably
appear to be affected by the research or
educational activities funded or proposed for
funding by NSF; or (ii) in entities whose financial
interests would reasonably appear to be affected
by such activities.
Chapter 1 (Subchapter A) (Part 54)
Financial Disclosure by Clinical Investigators
The Food and Drug Administration (FDA)
regulations state that investigators that
receive compensation in excess of $25,000
from a corporate sponsor of a trial in which
the investigator is engaged must disclose to
the FDA at the time of filing for a new drug
application.
19.058, Conflict of Interest in Research,
Educational, and Public Service Activities
19.059, Employee Participation in Authorized
Private Companies Commercializing Ohio
University Research
“Conflict of Interest in Research, Educational,
and Public Service Activities”
Most conflict disclosures fall within the
parameters of this policy
States that faculty are primarily responsible
for their academic, research and service
obligations
“Employee Participation in Authorized Private
Companies Commercializing Ohio University
Research”
Applies to “employees, faculty, staff and students,
who create intellectual property owned by the Ohio
University and who desire to hold an equity interest
in a firm, corporation, or other association to which
Ohio University has assigned, licensed or
transferred Ohio University’s interests…”
Consulting
Licensing University Technology
Clinical Studies
Procurement
Mentoring
Institutional
A disclosure is filed specific to the funding
application.
If you have a potential conflict for one
proposal, it does not automatically apply to
all of your proposals.
Research conflicts of interest are usually
disclosed using LEO as you apply for funding
by completing the conflict of interest section
of the electronic transmittal
If you are not using LEO, you can download
the appropriate disclosure form from
www.ohio.edu/research/compliance
“A” is selected if you have no conflicts to
disclose
“B” is selected if you have a potential conflict
to disclose relative to the submission.
(Requires a subsequent paper process)
“C” is selected if you have a current disclosure
on file, but it is not relevant to the proposal
you are submitting
Still uses option A, B or C
Requires that you gather signatures on paper
for all options, however
Generally used for personnel not listed on the
grant proposal or “key personnel”
We have revised the COI forms to word forms
This should be easier to complete than the
previous form
PDF versions are also available
Should be on the compliance web site soon,
but we can e-mail them to you until then
Use this form only if you are unable to use
the LEO transmittal form to assure that no
conflict of interest exists. A form must be
completed for each proposal.
I assure that I have read Ohio University
Policy 19.058, “Conflict of Interest in
Research, Educational, and Public Service
Activities” and declare that I have nothing
that is, or could be perceived to be a conflict
of interest with this proposal.
Use this form to disclose a potential conflict
of interest situation.
A separate disclosure form must be used for
each entity with which you conduct business
Conflict includes any member of your
immediate family (spouse, domestic partner
or children)
Require that you complete an option “B”
disclosure statement in addition to
completing the LEO transmittal form.
Require you to obtain signatures from Center
or Institute (if applicable), Chair and Dean on
the additional disclosure statement!!
The B disclosure form is available at
www.ohio.edu/research/compliance
Use this form only if you are unable to use
the LEO transmittal form. Complete this form
if you have a current conflict of interest
disclosure on file with the Office of Research
Compliance, but that disclosure is not
applicable to this proposal.
*New Option for 2008*
A management plan is developed for some
disclosures to mitigate the potential conflict
Management plans are specific to each
disclosure
May require submission of additional pieces,
such as a student employment plan
Reduce or remove the financial interest creating the
conflict
Place safeguards that mitigate the conflict potential,
such having some decisions made by an independent
entity
Limit participation in portions of the proposed
research likely to create a conflict
Require that the researcher disclose his or her
conflicting financial interests to all collaborators and
any proposed trainees;
Disclose the conflict in publications
Work to remove students from being directly advised
or taught by faculty where a conflict exists
Assure publication rights for student participants
Student Use
Nepotism and Cronyism
Intellectual Property
Use of University Resources
Publication provisions
Use of Human Subjects
Oversight Requirements
Reporting and Annual Reviews
You must submit an annual renewal for your
disclosure
◦ If the potential conflict no longer exists you must
notify us
If significant changes occur during the year
you should submit an update to your
disclosure as they occur
Yes. We encourage employees to disclose
potential conflicts that do not meet the
financial threshold, but may still be
problematic, such as student employment.
This allows you to be transparent with
respect to outside interests.
Allowable situations
Situations that require disclosure but may not
need an extensive management plan
Situations that require disclosure and have
problematic elements that will require
mitigation and/or a management plan
Situations that are not permitted
Receipt of royalties or honoraria for
published scholarly works, seminars,
teaching, etc.
Honoraria for serving as a special reviewer
or work on review panels
Royalties under our intellectual property
policies if no other relationship with entity
Clinical income at OUCOM
You participate in research developed in
whole or part by you, and you or your
family receive royalties from an existing
agreement with the business, but have
no other significant financial interest
You assign students, etc. to research
projects where you are entitled to
receive royalties, but have no other
significant financial interest
You assign students, etc. to projects supported
by the business through an SRA, and have a
significant financial interest other than royalty
income
You receive research support from a business in
which you serve on the board of directors, or
other advisory board, even if you are not
compensated.
You hold an executive position in a business
engaged in commercial or research activities
directly related to your Ohio University
responsibilities.
Any situation in which an actual conflict
exists is not permitted.
The only “exceptions” are those handled
under Ohio University Policy and Procedure
19.059 where faculty entrepreneurship is
addressed.
Participation in clinical trials or evaluation
of other research in which you have a
significant financial interest other than
royalty income.
In the context of your position at Ohio
University, you make professional referrals
to a business in which you have a
significant financial interest.
Letter of admonition
Ineligibility to submit grant applications
Withholding of IRB or IACUC approvals
Suspension
Non-Renewal
Loss of Tenure
Consulting
Procurement
Mentoring
Clinical Studies
Avoid consulting relationships that have
the potential to divert time and effort from
your responsibilities to Ohio University.
Do not use students.
Be wary of situations that limit publication.
Do not use university stationary, etc. that
could create an impression the university
is involved with the activities.
Make sure you are devoting sufficient time
to your university obligations.
Be cautious that the potential financial gain
cannot be perceived to influence your
university mentoring relationships.
Disclose any personal or familial financial
interest or equity in a company that is
doing business with Ohio University.
If you make purchases using public funds,
you should not use companies which will
benefit you or your family. If there is no
alternative you must seek and receive
permission prior to purchasing.
Any relationship in which there is a real or
perceived power or influence imbalance has
the potential for conflict. (Faculty:Student)
Isolating these relationships with respect to
areas of personal financial gain is best.
If they cannot be isolated, then safeguards
must be created.
If you have a financial interest, it is best to
isolate yourself from the study.
At a minimum, expect a more intense review
and a robust management plan if you have a
financial interest.
If both the institution and you have financial
interests the clinical study should be
conducted elsewhere.
You have administrative responsibilities on
behalf of Ohio University that is beneficial to
the business in which you have a significant
financial interest
You have administrative responsibilities on
behalf of Ohio University with respect to an
SRA where you have a significant financial
interest
Slide 28
Jo Ellen Sherow
Ohio University
Office of Research Compliance
Researchers’ Financial Disclosures in the
Spotlight
Conflicts of interest, always an emotional topic,
returned to the headlines this week as Sen.
Charles Grassley, a longtime critic of the drug
industry’s potential influence on research,
released new evidence that prominent Harvard
University scientists had failed to disclose much
of their outside income from pharmaceutical
companies over the past eight years.
http://www.insidehighered.com/news/2008/06/12/conflict January 15, 2008
WEDNESDAY, JANUARY 21, 2009
In a review of the literature regarding the relationship between
smokeless tobacco use and cancer, a conflict of interest of one of the
article's authors was initially not disclosed (see: Boffetta P, Hecht S, Gray
N, Gupta P, Straif K. Smokeless tobacco and cancer. Lancet Oncology
2008; 9:667-675). The original article was published in July, 2008. That
article stated: "The authors declare no conflicts of interest." After the
editor of the journal was notified by a researcher with knowledge of a
potential conflict of interest of Dr. Stephen Hecht (one of the study
authors), an erratum was published in September 2008, which noted:
"During the immediate months preceding submission of the review SH
was acting in the capacity of an expert witness for the plaintiff in a
future court case against a smokeless tobacco company. SH declares his
participation in this case in no way influenced his writing or involvement
in the review."
http://tobaccoanalysis.blogspot.com/2009/01/conflict-of-interestnot.html
January 16, 2009 — More than one third of new
drug marketing applications approved by the US
Food and Drug Administration (FDA) were
missing information about potential conflicts of
interest for clinical trial investigators, which
could allow bias to creep into the approvals
process, a government report released this week
has found. The FDA has said that it agrees with
most of the report's findings.
http://www.medscape.com/viewarticle/586980
Do collaborations between biotech companies
and academic centers constitute a conflict of
interest?
Biotechnology industry partnerships with
universities and academic centers have been
fruitful for both. So why is there so much
concern about conflict of interest and is that
concern appropriate?
http://www.redorbit.com/news/health/750100/genetic_engineering_news_p
osts_podcast_on_industrialacademic_collaborations_are_these/index.html
Universities are responsible for use of public
funds and therefore must maintain the public
trust.
Identifying and mitigating situations that may
have the potential for conflict maintains the
integrity of the university.
Maintaining integrity allows the university to
do credible academic research.
To provide information on the purpose of the
conflict of interest requirements.
To provide a basic overview of conflicts of
interest
To introduce the disclosure process and the use
of management plans
To provide information on the need for updates
and annual renewals.
Situations where financial considerations
compromise your professional judgment.
“Actual Conflict of Interest”
◦ Not permitted
Situations where an independent observer
might reasonably question whether your
professional actions or decisions are
determined by considerations of personal
gain. “Perceived Conflict of Interest”
◦ Managed
Potential conflicts may be financial or may be
a conflict of time, effort and/or commitment.
Potential conflicts can occur as a result of
administrative, scientific, academic, fiduciary
or familial situations.
They are situations that can be PERCEIVED to
be conflicting, whether a “real” conflict exists
or not.
Ohio University Policy has a mandatory
disclosure policy if you:
Earn over $10,000 in a twelve month period
from your outside activity OR
Have over 5% equity in the entity
Applies to members of your immediate family
(spouse, domestic partner, dependent
children) as well as yourself.
Anything of monetary value, including but not
limited to:
◦
◦
◦
◦
Salary
Payments for services
Equity interests over 5%
Intellectual property rights
Excludes mutual, pension and other
investments over which you have no control
Outside work during regular academic year
should not exceed equivalent of 1 day per
week.
Consulting work must avoid activities that
involve a conflict of interest with assigned
Ohio University activities and programs
Faculty Handbook, section IV-D
Outside interests cannot interfere with
primary loyalty to Ohio University and your
academic role
Use of university resources must have prior
approval of Chair, Dean and VPR.
Your outside interests should not be in
direct competition with university interests
Full time administrative employees are
expected to devote their full-time
professional loyalty, time and energy to their
position.
You must use non-work hours and no
university resources
Federal Agencies
State Law
University Policies
Many Academic Publications
45 CFR Part 50, Subpart F
“Responsibility of Applicants for Promoting
Objectivity in Research for Which PHS Funding
is Sought”
Authority: 42 U.S.C. 216, 289b-1, 299c-3.
Intent is to assure objectivity by establishing
standards that preclude bias in design, conduct, or
reporting of research
Focuses on financial conflicts of interest
(FCOI)
Regulations apply to investigators, including
sub grantees, contractors, and collaborating
investigators.
Does not apply to applications for support
under Phase I of SBIR and STTR programs
An institutional conflict of interest policy should
require that each investigator disclose to a
responsible representative of the institution all
significant financial interests of the investigator
(including those of the investigator’s spouse and
dependent children) (i) that would reasonably
appear to be affected by the research or
educational activities funded or proposed for
funding by NSF; or (ii) in entities whose financial
interests would reasonably appear to be affected
by such activities.
Chapter 1 (Subchapter A) (Part 54)
Financial Disclosure by Clinical Investigators
The Food and Drug Administration (FDA)
regulations state that investigators that
receive compensation in excess of $25,000
from a corporate sponsor of a trial in which
the investigator is engaged must disclose to
the FDA at the time of filing for a new drug
application.
19.058, Conflict of Interest in Research,
Educational, and Public Service Activities
19.059, Employee Participation in Authorized
Private Companies Commercializing Ohio
University Research
“Conflict of Interest in Research, Educational,
and Public Service Activities”
Most conflict disclosures fall within the
parameters of this policy
States that faculty are primarily responsible
for their academic, research and service
obligations
“Employee Participation in Authorized Private
Companies Commercializing Ohio University
Research”
Applies to “employees, faculty, staff and students,
who create intellectual property owned by the Ohio
University and who desire to hold an equity interest
in a firm, corporation, or other association to which
Ohio University has assigned, licensed or
transferred Ohio University’s interests…”
Consulting
Licensing University Technology
Clinical Studies
Procurement
Mentoring
Institutional
A disclosure is filed specific to the funding
application.
If you have a potential conflict for one
proposal, it does not automatically apply to
all of your proposals.
Research conflicts of interest are usually
disclosed using LEO as you apply for funding
by completing the conflict of interest section
of the electronic transmittal
If you are not using LEO, you can download
the appropriate disclosure form from
www.ohio.edu/research/compliance
“A” is selected if you have no conflicts to
disclose
“B” is selected if you have a potential conflict
to disclose relative to the submission.
(Requires a subsequent paper process)
“C” is selected if you have a current disclosure
on file, but it is not relevant to the proposal
you are submitting
Still uses option A, B or C
Requires that you gather signatures on paper
for all options, however
Generally used for personnel not listed on the
grant proposal or “key personnel”
We have revised the COI forms to word forms
This should be easier to complete than the
previous form
PDF versions are also available
Should be on the compliance web site soon,
but we can e-mail them to you until then
Use this form only if you are unable to use
the LEO transmittal form to assure that no
conflict of interest exists. A form must be
completed for each proposal.
I assure that I have read Ohio University
Policy 19.058, “Conflict of Interest in
Research, Educational, and Public Service
Activities” and declare that I have nothing
that is, or could be perceived to be a conflict
of interest with this proposal.
Use this form to disclose a potential conflict
of interest situation.
A separate disclosure form must be used for
each entity with which you conduct business
Conflict includes any member of your
immediate family (spouse, domestic partner
or children)
Require that you complete an option “B”
disclosure statement in addition to
completing the LEO transmittal form.
Require you to obtain signatures from Center
or Institute (if applicable), Chair and Dean on
the additional disclosure statement!!
The B disclosure form is available at
www.ohio.edu/research/compliance
Use this form only if you are unable to use
the LEO transmittal form. Complete this form
if you have a current conflict of interest
disclosure on file with the Office of Research
Compliance, but that disclosure is not
applicable to this proposal.
*New Option for 2008*
A management plan is developed for some
disclosures to mitigate the potential conflict
Management plans are specific to each
disclosure
May require submission of additional pieces,
such as a student employment plan
Reduce or remove the financial interest creating the
conflict
Place safeguards that mitigate the conflict potential,
such having some decisions made by an independent
entity
Limit participation in portions of the proposed
research likely to create a conflict
Require that the researcher disclose his or her
conflicting financial interests to all collaborators and
any proposed trainees;
Disclose the conflict in publications
Work to remove students from being directly advised
or taught by faculty where a conflict exists
Assure publication rights for student participants
Student Use
Nepotism and Cronyism
Intellectual Property
Use of University Resources
Publication provisions
Use of Human Subjects
Oversight Requirements
Reporting and Annual Reviews
You must submit an annual renewal for your
disclosure
◦ If the potential conflict no longer exists you must
notify us
If significant changes occur during the year
you should submit an update to your
disclosure as they occur
Yes. We encourage employees to disclose
potential conflicts that do not meet the
financial threshold, but may still be
problematic, such as student employment.
This allows you to be transparent with
respect to outside interests.
Allowable situations
Situations that require disclosure but may not
need an extensive management plan
Situations that require disclosure and have
problematic elements that will require
mitigation and/or a management plan
Situations that are not permitted
Receipt of royalties or honoraria for
published scholarly works, seminars,
teaching, etc.
Honoraria for serving as a special reviewer
or work on review panels
Royalties under our intellectual property
policies if no other relationship with entity
Clinical income at OUCOM
You participate in research developed in
whole or part by you, and you or your
family receive royalties from an existing
agreement with the business, but have
no other significant financial interest
You assign students, etc. to research
projects where you are entitled to
receive royalties, but have no other
significant financial interest
You assign students, etc. to projects supported
by the business through an SRA, and have a
significant financial interest other than royalty
income
You receive research support from a business in
which you serve on the board of directors, or
other advisory board, even if you are not
compensated.
You hold an executive position in a business
engaged in commercial or research activities
directly related to your Ohio University
responsibilities.
Any situation in which an actual conflict
exists is not permitted.
The only “exceptions” are those handled
under Ohio University Policy and Procedure
19.059 where faculty entrepreneurship is
addressed.
Participation in clinical trials or evaluation
of other research in which you have a
significant financial interest other than
royalty income.
In the context of your position at Ohio
University, you make professional referrals
to a business in which you have a
significant financial interest.
Letter of admonition
Ineligibility to submit grant applications
Withholding of IRB or IACUC approvals
Suspension
Non-Renewal
Loss of Tenure
Consulting
Procurement
Mentoring
Clinical Studies
Avoid consulting relationships that have
the potential to divert time and effort from
your responsibilities to Ohio University.
Do not use students.
Be wary of situations that limit publication.
Do not use university stationary, etc. that
could create an impression the university
is involved with the activities.
Make sure you are devoting sufficient time
to your university obligations.
Be cautious that the potential financial gain
cannot be perceived to influence your
university mentoring relationships.
Disclose any personal or familial financial
interest or equity in a company that is
doing business with Ohio University.
If you make purchases using public funds,
you should not use companies which will
benefit you or your family. If there is no
alternative you must seek and receive
permission prior to purchasing.
Any relationship in which there is a real or
perceived power or influence imbalance has
the potential for conflict. (Faculty:Student)
Isolating these relationships with respect to
areas of personal financial gain is best.
If they cannot be isolated, then safeguards
must be created.
If you have a financial interest, it is best to
isolate yourself from the study.
At a minimum, expect a more intense review
and a robust management plan if you have a
financial interest.
If both the institution and you have financial
interests the clinical study should be
conducted elsewhere.
You have administrative responsibilities on
behalf of Ohio University that is beneficial to
the business in which you have a significant
financial interest
You have administrative responsibilities on
behalf of Ohio University with respect to an
SRA where you have a significant financial
interest
Slide 29
Jo Ellen Sherow
Ohio University
Office of Research Compliance
Researchers’ Financial Disclosures in the
Spotlight
Conflicts of interest, always an emotional topic,
returned to the headlines this week as Sen.
Charles Grassley, a longtime critic of the drug
industry’s potential influence on research,
released new evidence that prominent Harvard
University scientists had failed to disclose much
of their outside income from pharmaceutical
companies over the past eight years.
http://www.insidehighered.com/news/2008/06/12/conflict January 15, 2008
WEDNESDAY, JANUARY 21, 2009
In a review of the literature regarding the relationship between
smokeless tobacco use and cancer, a conflict of interest of one of the
article's authors was initially not disclosed (see: Boffetta P, Hecht S, Gray
N, Gupta P, Straif K. Smokeless tobacco and cancer. Lancet Oncology
2008; 9:667-675). The original article was published in July, 2008. That
article stated: "The authors declare no conflicts of interest." After the
editor of the journal was notified by a researcher with knowledge of a
potential conflict of interest of Dr. Stephen Hecht (one of the study
authors), an erratum was published in September 2008, which noted:
"During the immediate months preceding submission of the review SH
was acting in the capacity of an expert witness for the plaintiff in a
future court case against a smokeless tobacco company. SH declares his
participation in this case in no way influenced his writing or involvement
in the review."
http://tobaccoanalysis.blogspot.com/2009/01/conflict-of-interestnot.html
January 16, 2009 — More than one third of new
drug marketing applications approved by the US
Food and Drug Administration (FDA) were
missing information about potential conflicts of
interest for clinical trial investigators, which
could allow bias to creep into the approvals
process, a government report released this week
has found. The FDA has said that it agrees with
most of the report's findings.
http://www.medscape.com/viewarticle/586980
Do collaborations between biotech companies
and academic centers constitute a conflict of
interest?
Biotechnology industry partnerships with
universities and academic centers have been
fruitful for both. So why is there so much
concern about conflict of interest and is that
concern appropriate?
http://www.redorbit.com/news/health/750100/genetic_engineering_news_p
osts_podcast_on_industrialacademic_collaborations_are_these/index.html
Universities are responsible for use of public
funds and therefore must maintain the public
trust.
Identifying and mitigating situations that may
have the potential for conflict maintains the
integrity of the university.
Maintaining integrity allows the university to
do credible academic research.
To provide information on the purpose of the
conflict of interest requirements.
To provide a basic overview of conflicts of
interest
To introduce the disclosure process and the use
of management plans
To provide information on the need for updates
and annual renewals.
Situations where financial considerations
compromise your professional judgment.
“Actual Conflict of Interest”
◦ Not permitted
Situations where an independent observer
might reasonably question whether your
professional actions or decisions are
determined by considerations of personal
gain. “Perceived Conflict of Interest”
◦ Managed
Potential conflicts may be financial or may be
a conflict of time, effort and/or commitment.
Potential conflicts can occur as a result of
administrative, scientific, academic, fiduciary
or familial situations.
They are situations that can be PERCEIVED to
be conflicting, whether a “real” conflict exists
or not.
Ohio University Policy has a mandatory
disclosure policy if you:
Earn over $10,000 in a twelve month period
from your outside activity OR
Have over 5% equity in the entity
Applies to members of your immediate family
(spouse, domestic partner, dependent
children) as well as yourself.
Anything of monetary value, including but not
limited to:
◦
◦
◦
◦
Salary
Payments for services
Equity interests over 5%
Intellectual property rights
Excludes mutual, pension and other
investments over which you have no control
Outside work during regular academic year
should not exceed equivalent of 1 day per
week.
Consulting work must avoid activities that
involve a conflict of interest with assigned
Ohio University activities and programs
Faculty Handbook, section IV-D
Outside interests cannot interfere with
primary loyalty to Ohio University and your
academic role
Use of university resources must have prior
approval of Chair, Dean and VPR.
Your outside interests should not be in
direct competition with university interests
Full time administrative employees are
expected to devote their full-time
professional loyalty, time and energy to their
position.
You must use non-work hours and no
university resources
Federal Agencies
State Law
University Policies
Many Academic Publications
45 CFR Part 50, Subpart F
“Responsibility of Applicants for Promoting
Objectivity in Research for Which PHS Funding
is Sought”
Authority: 42 U.S.C. 216, 289b-1, 299c-3.
Intent is to assure objectivity by establishing
standards that preclude bias in design, conduct, or
reporting of research
Focuses on financial conflicts of interest
(FCOI)
Regulations apply to investigators, including
sub grantees, contractors, and collaborating
investigators.
Does not apply to applications for support
under Phase I of SBIR and STTR programs
An institutional conflict of interest policy should
require that each investigator disclose to a
responsible representative of the institution all
significant financial interests of the investigator
(including those of the investigator’s spouse and
dependent children) (i) that would reasonably
appear to be affected by the research or
educational activities funded or proposed for
funding by NSF; or (ii) in entities whose financial
interests would reasonably appear to be affected
by such activities.
Chapter 1 (Subchapter A) (Part 54)
Financial Disclosure by Clinical Investigators
The Food and Drug Administration (FDA)
regulations state that investigators that
receive compensation in excess of $25,000
from a corporate sponsor of a trial in which
the investigator is engaged must disclose to
the FDA at the time of filing for a new drug
application.
19.058, Conflict of Interest in Research,
Educational, and Public Service Activities
19.059, Employee Participation in Authorized
Private Companies Commercializing Ohio
University Research
“Conflict of Interest in Research, Educational,
and Public Service Activities”
Most conflict disclosures fall within the
parameters of this policy
States that faculty are primarily responsible
for their academic, research and service
obligations
“Employee Participation in Authorized Private
Companies Commercializing Ohio University
Research”
Applies to “employees, faculty, staff and students,
who create intellectual property owned by the Ohio
University and who desire to hold an equity interest
in a firm, corporation, or other association to which
Ohio University has assigned, licensed or
transferred Ohio University’s interests…”
Consulting
Licensing University Technology
Clinical Studies
Procurement
Mentoring
Institutional
A disclosure is filed specific to the funding
application.
If you have a potential conflict for one
proposal, it does not automatically apply to
all of your proposals.
Research conflicts of interest are usually
disclosed using LEO as you apply for funding
by completing the conflict of interest section
of the electronic transmittal
If you are not using LEO, you can download
the appropriate disclosure form from
www.ohio.edu/research/compliance
“A” is selected if you have no conflicts to
disclose
“B” is selected if you have a potential conflict
to disclose relative to the submission.
(Requires a subsequent paper process)
“C” is selected if you have a current disclosure
on file, but it is not relevant to the proposal
you are submitting
Still uses option A, B or C
Requires that you gather signatures on paper
for all options, however
Generally used for personnel not listed on the
grant proposal or “key personnel”
We have revised the COI forms to word forms
This should be easier to complete than the
previous form
PDF versions are also available
Should be on the compliance web site soon,
but we can e-mail them to you until then
Use this form only if you are unable to use
the LEO transmittal form to assure that no
conflict of interest exists. A form must be
completed for each proposal.
I assure that I have read Ohio University
Policy 19.058, “Conflict of Interest in
Research, Educational, and Public Service
Activities” and declare that I have nothing
that is, or could be perceived to be a conflict
of interest with this proposal.
Use this form to disclose a potential conflict
of interest situation.
A separate disclosure form must be used for
each entity with which you conduct business
Conflict includes any member of your
immediate family (spouse, domestic partner
or children)
Require that you complete an option “B”
disclosure statement in addition to
completing the LEO transmittal form.
Require you to obtain signatures from Center
or Institute (if applicable), Chair and Dean on
the additional disclosure statement!!
The B disclosure form is available at
www.ohio.edu/research/compliance
Use this form only if you are unable to use
the LEO transmittal form. Complete this form
if you have a current conflict of interest
disclosure on file with the Office of Research
Compliance, but that disclosure is not
applicable to this proposal.
*New Option for 2008*
A management plan is developed for some
disclosures to mitigate the potential conflict
Management plans are specific to each
disclosure
May require submission of additional pieces,
such as a student employment plan
Reduce or remove the financial interest creating the
conflict
Place safeguards that mitigate the conflict potential,
such having some decisions made by an independent
entity
Limit participation in portions of the proposed
research likely to create a conflict
Require that the researcher disclose his or her
conflicting financial interests to all collaborators and
any proposed trainees;
Disclose the conflict in publications
Work to remove students from being directly advised
or taught by faculty where a conflict exists
Assure publication rights for student participants
Student Use
Nepotism and Cronyism
Intellectual Property
Use of University Resources
Publication provisions
Use of Human Subjects
Oversight Requirements
Reporting and Annual Reviews
You must submit an annual renewal for your
disclosure
◦ If the potential conflict no longer exists you must
notify us
If significant changes occur during the year
you should submit an update to your
disclosure as they occur
Yes. We encourage employees to disclose
potential conflicts that do not meet the
financial threshold, but may still be
problematic, such as student employment.
This allows you to be transparent with
respect to outside interests.
Allowable situations
Situations that require disclosure but may not
need an extensive management plan
Situations that require disclosure and have
problematic elements that will require
mitigation and/or a management plan
Situations that are not permitted
Receipt of royalties or honoraria for
published scholarly works, seminars,
teaching, etc.
Honoraria for serving as a special reviewer
or work on review panels
Royalties under our intellectual property
policies if no other relationship with entity
Clinical income at OUCOM
You participate in research developed in
whole or part by you, and you or your
family receive royalties from an existing
agreement with the business, but have
no other significant financial interest
You assign students, etc. to research
projects where you are entitled to
receive royalties, but have no other
significant financial interest
You assign students, etc. to projects supported
by the business through an SRA, and have a
significant financial interest other than royalty
income
You receive research support from a business in
which you serve on the board of directors, or
other advisory board, even if you are not
compensated.
You hold an executive position in a business
engaged in commercial or research activities
directly related to your Ohio University
responsibilities.
Any situation in which an actual conflict
exists is not permitted.
The only “exceptions” are those handled
under Ohio University Policy and Procedure
19.059 where faculty entrepreneurship is
addressed.
Participation in clinical trials or evaluation
of other research in which you have a
significant financial interest other than
royalty income.
In the context of your position at Ohio
University, you make professional referrals
to a business in which you have a
significant financial interest.
Letter of admonition
Ineligibility to submit grant applications
Withholding of IRB or IACUC approvals
Suspension
Non-Renewal
Loss of Tenure
Consulting
Procurement
Mentoring
Clinical Studies
Avoid consulting relationships that have
the potential to divert time and effort from
your responsibilities to Ohio University.
Do not use students.
Be wary of situations that limit publication.
Do not use university stationary, etc. that
could create an impression the university
is involved with the activities.
Make sure you are devoting sufficient time
to your university obligations.
Be cautious that the potential financial gain
cannot be perceived to influence your
university mentoring relationships.
Disclose any personal or familial financial
interest or equity in a company that is
doing business with Ohio University.
If you make purchases using public funds,
you should not use companies which will
benefit you or your family. If there is no
alternative you must seek and receive
permission prior to purchasing.
Any relationship in which there is a real or
perceived power or influence imbalance has
the potential for conflict. (Faculty:Student)
Isolating these relationships with respect to
areas of personal financial gain is best.
If they cannot be isolated, then safeguards
must be created.
If you have a financial interest, it is best to
isolate yourself from the study.
At a minimum, expect a more intense review
and a robust management plan if you have a
financial interest.
If both the institution and you have financial
interests the clinical study should be
conducted elsewhere.
You have administrative responsibilities on
behalf of Ohio University that is beneficial to
the business in which you have a significant
financial interest
You have administrative responsibilities on
behalf of Ohio University with respect to an
SRA where you have a significant financial
interest
Slide 30
Jo Ellen Sherow
Ohio University
Office of Research Compliance
Researchers’ Financial Disclosures in the
Spotlight
Conflicts of interest, always an emotional topic,
returned to the headlines this week as Sen.
Charles Grassley, a longtime critic of the drug
industry’s potential influence on research,
released new evidence that prominent Harvard
University scientists had failed to disclose much
of their outside income from pharmaceutical
companies over the past eight years.
http://www.insidehighered.com/news/2008/06/12/conflict January 15, 2008
WEDNESDAY, JANUARY 21, 2009
In a review of the literature regarding the relationship between
smokeless tobacco use and cancer, a conflict of interest of one of the
article's authors was initially not disclosed (see: Boffetta P, Hecht S, Gray
N, Gupta P, Straif K. Smokeless tobacco and cancer. Lancet Oncology
2008; 9:667-675). The original article was published in July, 2008. That
article stated: "The authors declare no conflicts of interest." After the
editor of the journal was notified by a researcher with knowledge of a
potential conflict of interest of Dr. Stephen Hecht (one of the study
authors), an erratum was published in September 2008, which noted:
"During the immediate months preceding submission of the review SH
was acting in the capacity of an expert witness for the plaintiff in a
future court case against a smokeless tobacco company. SH declares his
participation in this case in no way influenced his writing or involvement
in the review."
http://tobaccoanalysis.blogspot.com/2009/01/conflict-of-interestnot.html
January 16, 2009 — More than one third of new
drug marketing applications approved by the US
Food and Drug Administration (FDA) were
missing information about potential conflicts of
interest for clinical trial investigators, which
could allow bias to creep into the approvals
process, a government report released this week
has found. The FDA has said that it agrees with
most of the report's findings.
http://www.medscape.com/viewarticle/586980
Do collaborations between biotech companies
and academic centers constitute a conflict of
interest?
Biotechnology industry partnerships with
universities and academic centers have been
fruitful for both. So why is there so much
concern about conflict of interest and is that
concern appropriate?
http://www.redorbit.com/news/health/750100/genetic_engineering_news_p
osts_podcast_on_industrialacademic_collaborations_are_these/index.html
Universities are responsible for use of public
funds and therefore must maintain the public
trust.
Identifying and mitigating situations that may
have the potential for conflict maintains the
integrity of the university.
Maintaining integrity allows the university to
do credible academic research.
To provide information on the purpose of the
conflict of interest requirements.
To provide a basic overview of conflicts of
interest
To introduce the disclosure process and the use
of management plans
To provide information on the need for updates
and annual renewals.
Situations where financial considerations
compromise your professional judgment.
“Actual Conflict of Interest”
◦ Not permitted
Situations where an independent observer
might reasonably question whether your
professional actions or decisions are
determined by considerations of personal
gain. “Perceived Conflict of Interest”
◦ Managed
Potential conflicts may be financial or may be
a conflict of time, effort and/or commitment.
Potential conflicts can occur as a result of
administrative, scientific, academic, fiduciary
or familial situations.
They are situations that can be PERCEIVED to
be conflicting, whether a “real” conflict exists
or not.
Ohio University Policy has a mandatory
disclosure policy if you:
Earn over $10,000 in a twelve month period
from your outside activity OR
Have over 5% equity in the entity
Applies to members of your immediate family
(spouse, domestic partner, dependent
children) as well as yourself.
Anything of monetary value, including but not
limited to:
◦
◦
◦
◦
Salary
Payments for services
Equity interests over 5%
Intellectual property rights
Excludes mutual, pension and other
investments over which you have no control
Outside work during regular academic year
should not exceed equivalent of 1 day per
week.
Consulting work must avoid activities that
involve a conflict of interest with assigned
Ohio University activities and programs
Faculty Handbook, section IV-D
Outside interests cannot interfere with
primary loyalty to Ohio University and your
academic role
Use of university resources must have prior
approval of Chair, Dean and VPR.
Your outside interests should not be in
direct competition with university interests
Full time administrative employees are
expected to devote their full-time
professional loyalty, time and energy to their
position.
You must use non-work hours and no
university resources
Federal Agencies
State Law
University Policies
Many Academic Publications
45 CFR Part 50, Subpart F
“Responsibility of Applicants for Promoting
Objectivity in Research for Which PHS Funding
is Sought”
Authority: 42 U.S.C. 216, 289b-1, 299c-3.
Intent is to assure objectivity by establishing
standards that preclude bias in design, conduct, or
reporting of research
Focuses on financial conflicts of interest
(FCOI)
Regulations apply to investigators, including
sub grantees, contractors, and collaborating
investigators.
Does not apply to applications for support
under Phase I of SBIR and STTR programs
An institutional conflict of interest policy should
require that each investigator disclose to a
responsible representative of the institution all
significant financial interests of the investigator
(including those of the investigator’s spouse and
dependent children) (i) that would reasonably
appear to be affected by the research or
educational activities funded or proposed for
funding by NSF; or (ii) in entities whose financial
interests would reasonably appear to be affected
by such activities.
Chapter 1 (Subchapter A) (Part 54)
Financial Disclosure by Clinical Investigators
The Food and Drug Administration (FDA)
regulations state that investigators that
receive compensation in excess of $25,000
from a corporate sponsor of a trial in which
the investigator is engaged must disclose to
the FDA at the time of filing for a new drug
application.
19.058, Conflict of Interest in Research,
Educational, and Public Service Activities
19.059, Employee Participation in Authorized
Private Companies Commercializing Ohio
University Research
“Conflict of Interest in Research, Educational,
and Public Service Activities”
Most conflict disclosures fall within the
parameters of this policy
States that faculty are primarily responsible
for their academic, research and service
obligations
“Employee Participation in Authorized Private
Companies Commercializing Ohio University
Research”
Applies to “employees, faculty, staff and students,
who create intellectual property owned by the Ohio
University and who desire to hold an equity interest
in a firm, corporation, or other association to which
Ohio University has assigned, licensed or
transferred Ohio University’s interests…”
Consulting
Licensing University Technology
Clinical Studies
Procurement
Mentoring
Institutional
A disclosure is filed specific to the funding
application.
If you have a potential conflict for one
proposal, it does not automatically apply to
all of your proposals.
Research conflicts of interest are usually
disclosed using LEO as you apply for funding
by completing the conflict of interest section
of the electronic transmittal
If you are not using LEO, you can download
the appropriate disclosure form from
www.ohio.edu/research/compliance
“A” is selected if you have no conflicts to
disclose
“B” is selected if you have a potential conflict
to disclose relative to the submission.
(Requires a subsequent paper process)
“C” is selected if you have a current disclosure
on file, but it is not relevant to the proposal
you are submitting
Still uses option A, B or C
Requires that you gather signatures on paper
for all options, however
Generally used for personnel not listed on the
grant proposal or “key personnel”
We have revised the COI forms to word forms
This should be easier to complete than the
previous form
PDF versions are also available
Should be on the compliance web site soon,
but we can e-mail them to you until then
Use this form only if you are unable to use
the LEO transmittal form to assure that no
conflict of interest exists. A form must be
completed for each proposal.
I assure that I have read Ohio University
Policy 19.058, “Conflict of Interest in
Research, Educational, and Public Service
Activities” and declare that I have nothing
that is, or could be perceived to be a conflict
of interest with this proposal.
Use this form to disclose a potential conflict
of interest situation.
A separate disclosure form must be used for
each entity with which you conduct business
Conflict includes any member of your
immediate family (spouse, domestic partner
or children)
Require that you complete an option “B”
disclosure statement in addition to
completing the LEO transmittal form.
Require you to obtain signatures from Center
or Institute (if applicable), Chair and Dean on
the additional disclosure statement!!
The B disclosure form is available at
www.ohio.edu/research/compliance
Use this form only if you are unable to use
the LEO transmittal form. Complete this form
if you have a current conflict of interest
disclosure on file with the Office of Research
Compliance, but that disclosure is not
applicable to this proposal.
*New Option for 2008*
A management plan is developed for some
disclosures to mitigate the potential conflict
Management plans are specific to each
disclosure
May require submission of additional pieces,
such as a student employment plan
Reduce or remove the financial interest creating the
conflict
Place safeguards that mitigate the conflict potential,
such having some decisions made by an independent
entity
Limit participation in portions of the proposed
research likely to create a conflict
Require that the researcher disclose his or her
conflicting financial interests to all collaborators and
any proposed trainees;
Disclose the conflict in publications
Work to remove students from being directly advised
or taught by faculty where a conflict exists
Assure publication rights for student participants
Student Use
Nepotism and Cronyism
Intellectual Property
Use of University Resources
Publication provisions
Use of Human Subjects
Oversight Requirements
Reporting and Annual Reviews
You must submit an annual renewal for your
disclosure
◦ If the potential conflict no longer exists you must
notify us
If significant changes occur during the year
you should submit an update to your
disclosure as they occur
Yes. We encourage employees to disclose
potential conflicts that do not meet the
financial threshold, but may still be
problematic, such as student employment.
This allows you to be transparent with
respect to outside interests.
Allowable situations
Situations that require disclosure but may not
need an extensive management plan
Situations that require disclosure and have
problematic elements that will require
mitigation and/or a management plan
Situations that are not permitted
Receipt of royalties or honoraria for
published scholarly works, seminars,
teaching, etc.
Honoraria for serving as a special reviewer
or work on review panels
Royalties under our intellectual property
policies if no other relationship with entity
Clinical income at OUCOM
You participate in research developed in
whole or part by you, and you or your
family receive royalties from an existing
agreement with the business, but have
no other significant financial interest
You assign students, etc. to research
projects where you are entitled to
receive royalties, but have no other
significant financial interest
You assign students, etc. to projects supported
by the business through an SRA, and have a
significant financial interest other than royalty
income
You receive research support from a business in
which you serve on the board of directors, or
other advisory board, even if you are not
compensated.
You hold an executive position in a business
engaged in commercial or research activities
directly related to your Ohio University
responsibilities.
Any situation in which an actual conflict
exists is not permitted.
The only “exceptions” are those handled
under Ohio University Policy and Procedure
19.059 where faculty entrepreneurship is
addressed.
Participation in clinical trials or evaluation
of other research in which you have a
significant financial interest other than
royalty income.
In the context of your position at Ohio
University, you make professional referrals
to a business in which you have a
significant financial interest.
Letter of admonition
Ineligibility to submit grant applications
Withholding of IRB or IACUC approvals
Suspension
Non-Renewal
Loss of Tenure
Consulting
Procurement
Mentoring
Clinical Studies
Avoid consulting relationships that have
the potential to divert time and effort from
your responsibilities to Ohio University.
Do not use students.
Be wary of situations that limit publication.
Do not use university stationary, etc. that
could create an impression the university
is involved with the activities.
Make sure you are devoting sufficient time
to your university obligations.
Be cautious that the potential financial gain
cannot be perceived to influence your
university mentoring relationships.
Disclose any personal or familial financial
interest or equity in a company that is
doing business with Ohio University.
If you make purchases using public funds,
you should not use companies which will
benefit you or your family. If there is no
alternative you must seek and receive
permission prior to purchasing.
Any relationship in which there is a real or
perceived power or influence imbalance has
the potential for conflict. (Faculty:Student)
Isolating these relationships with respect to
areas of personal financial gain is best.
If they cannot be isolated, then safeguards
must be created.
If you have a financial interest, it is best to
isolate yourself from the study.
At a minimum, expect a more intense review
and a robust management plan if you have a
financial interest.
If both the institution and you have financial
interests the clinical study should be
conducted elsewhere.
You have administrative responsibilities on
behalf of Ohio University that is beneficial to
the business in which you have a significant
financial interest
You have administrative responsibilities on
behalf of Ohio University with respect to an
SRA where you have a significant financial
interest
Slide 31
Jo Ellen Sherow
Ohio University
Office of Research Compliance
Researchers’ Financial Disclosures in the
Spotlight
Conflicts of interest, always an emotional topic,
returned to the headlines this week as Sen.
Charles Grassley, a longtime critic of the drug
industry’s potential influence on research,
released new evidence that prominent Harvard
University scientists had failed to disclose much
of their outside income from pharmaceutical
companies over the past eight years.
http://www.insidehighered.com/news/2008/06/12/conflict January 15, 2008
WEDNESDAY, JANUARY 21, 2009
In a review of the literature regarding the relationship between
smokeless tobacco use and cancer, a conflict of interest of one of the
article's authors was initially not disclosed (see: Boffetta P, Hecht S, Gray
N, Gupta P, Straif K. Smokeless tobacco and cancer. Lancet Oncology
2008; 9:667-675). The original article was published in July, 2008. That
article stated: "The authors declare no conflicts of interest." After the
editor of the journal was notified by a researcher with knowledge of a
potential conflict of interest of Dr. Stephen Hecht (one of the study
authors), an erratum was published in September 2008, which noted:
"During the immediate months preceding submission of the review SH
was acting in the capacity of an expert witness for the plaintiff in a
future court case against a smokeless tobacco company. SH declares his
participation in this case in no way influenced his writing or involvement
in the review."
http://tobaccoanalysis.blogspot.com/2009/01/conflict-of-interestnot.html
January 16, 2009 — More than one third of new
drug marketing applications approved by the US
Food and Drug Administration (FDA) were
missing information about potential conflicts of
interest for clinical trial investigators, which
could allow bias to creep into the approvals
process, a government report released this week
has found. The FDA has said that it agrees with
most of the report's findings.
http://www.medscape.com/viewarticle/586980
Do collaborations between biotech companies
and academic centers constitute a conflict of
interest?
Biotechnology industry partnerships with
universities and academic centers have been
fruitful for both. So why is there so much
concern about conflict of interest and is that
concern appropriate?
http://www.redorbit.com/news/health/750100/genetic_engineering_news_p
osts_podcast_on_industrialacademic_collaborations_are_these/index.html
Universities are responsible for use of public
funds and therefore must maintain the public
trust.
Identifying and mitigating situations that may
have the potential for conflict maintains the
integrity of the university.
Maintaining integrity allows the university to
do credible academic research.
To provide information on the purpose of the
conflict of interest requirements.
To provide a basic overview of conflicts of
interest
To introduce the disclosure process and the use
of management plans
To provide information on the need for updates
and annual renewals.
Situations where financial considerations
compromise your professional judgment.
“Actual Conflict of Interest”
◦ Not permitted
Situations where an independent observer
might reasonably question whether your
professional actions or decisions are
determined by considerations of personal
gain. “Perceived Conflict of Interest”
◦ Managed
Potential conflicts may be financial or may be
a conflict of time, effort and/or commitment.
Potential conflicts can occur as a result of
administrative, scientific, academic, fiduciary
or familial situations.
They are situations that can be PERCEIVED to
be conflicting, whether a “real” conflict exists
or not.
Ohio University Policy has a mandatory
disclosure policy if you:
Earn over $10,000 in a twelve month period
from your outside activity OR
Have over 5% equity in the entity
Applies to members of your immediate family
(spouse, domestic partner, dependent
children) as well as yourself.
Anything of monetary value, including but not
limited to:
◦
◦
◦
◦
Salary
Payments for services
Equity interests over 5%
Intellectual property rights
Excludes mutual, pension and other
investments over which you have no control
Outside work during regular academic year
should not exceed equivalent of 1 day per
week.
Consulting work must avoid activities that
involve a conflict of interest with assigned
Ohio University activities and programs
Faculty Handbook, section IV-D
Outside interests cannot interfere with
primary loyalty to Ohio University and your
academic role
Use of university resources must have prior
approval of Chair, Dean and VPR.
Your outside interests should not be in
direct competition with university interests
Full time administrative employees are
expected to devote their full-time
professional loyalty, time and energy to their
position.
You must use non-work hours and no
university resources
Federal Agencies
State Law
University Policies
Many Academic Publications
45 CFR Part 50, Subpart F
“Responsibility of Applicants for Promoting
Objectivity in Research for Which PHS Funding
is Sought”
Authority: 42 U.S.C. 216, 289b-1, 299c-3.
Intent is to assure objectivity by establishing
standards that preclude bias in design, conduct, or
reporting of research
Focuses on financial conflicts of interest
(FCOI)
Regulations apply to investigators, including
sub grantees, contractors, and collaborating
investigators.
Does not apply to applications for support
under Phase I of SBIR and STTR programs
An institutional conflict of interest policy should
require that each investigator disclose to a
responsible representative of the institution all
significant financial interests of the investigator
(including those of the investigator’s spouse and
dependent children) (i) that would reasonably
appear to be affected by the research or
educational activities funded or proposed for
funding by NSF; or (ii) in entities whose financial
interests would reasonably appear to be affected
by such activities.
Chapter 1 (Subchapter A) (Part 54)
Financial Disclosure by Clinical Investigators
The Food and Drug Administration (FDA)
regulations state that investigators that
receive compensation in excess of $25,000
from a corporate sponsor of a trial in which
the investigator is engaged must disclose to
the FDA at the time of filing for a new drug
application.
19.058, Conflict of Interest in Research,
Educational, and Public Service Activities
19.059, Employee Participation in Authorized
Private Companies Commercializing Ohio
University Research
“Conflict of Interest in Research, Educational,
and Public Service Activities”
Most conflict disclosures fall within the
parameters of this policy
States that faculty are primarily responsible
for their academic, research and service
obligations
“Employee Participation in Authorized Private
Companies Commercializing Ohio University
Research”
Applies to “employees, faculty, staff and students,
who create intellectual property owned by the Ohio
University and who desire to hold an equity interest
in a firm, corporation, or other association to which
Ohio University has assigned, licensed or
transferred Ohio University’s interests…”
Consulting
Licensing University Technology
Clinical Studies
Procurement
Mentoring
Institutional
A disclosure is filed specific to the funding
application.
If you have a potential conflict for one
proposal, it does not automatically apply to
all of your proposals.
Research conflicts of interest are usually
disclosed using LEO as you apply for funding
by completing the conflict of interest section
of the electronic transmittal
If you are not using LEO, you can download
the appropriate disclosure form from
www.ohio.edu/research/compliance
“A” is selected if you have no conflicts to
disclose
“B” is selected if you have a potential conflict
to disclose relative to the submission.
(Requires a subsequent paper process)
“C” is selected if you have a current disclosure
on file, but it is not relevant to the proposal
you are submitting
Still uses option A, B or C
Requires that you gather signatures on paper
for all options, however
Generally used for personnel not listed on the
grant proposal or “key personnel”
We have revised the COI forms to word forms
This should be easier to complete than the
previous form
PDF versions are also available
Should be on the compliance web site soon,
but we can e-mail them to you until then
Use this form only if you are unable to use
the LEO transmittal form to assure that no
conflict of interest exists. A form must be
completed for each proposal.
I assure that I have read Ohio University
Policy 19.058, “Conflict of Interest in
Research, Educational, and Public Service
Activities” and declare that I have nothing
that is, or could be perceived to be a conflict
of interest with this proposal.
Use this form to disclose a potential conflict
of interest situation.
A separate disclosure form must be used for
each entity with which you conduct business
Conflict includes any member of your
immediate family (spouse, domestic partner
or children)
Require that you complete an option “B”
disclosure statement in addition to
completing the LEO transmittal form.
Require you to obtain signatures from Center
or Institute (if applicable), Chair and Dean on
the additional disclosure statement!!
The B disclosure form is available at
www.ohio.edu/research/compliance
Use this form only if you are unable to use
the LEO transmittal form. Complete this form
if you have a current conflict of interest
disclosure on file with the Office of Research
Compliance, but that disclosure is not
applicable to this proposal.
*New Option for 2008*
A management plan is developed for some
disclosures to mitigate the potential conflict
Management plans are specific to each
disclosure
May require submission of additional pieces,
such as a student employment plan
Reduce or remove the financial interest creating the
conflict
Place safeguards that mitigate the conflict potential,
such having some decisions made by an independent
entity
Limit participation in portions of the proposed
research likely to create a conflict
Require that the researcher disclose his or her
conflicting financial interests to all collaborators and
any proposed trainees;
Disclose the conflict in publications
Work to remove students from being directly advised
or taught by faculty where a conflict exists
Assure publication rights for student participants
Student Use
Nepotism and Cronyism
Intellectual Property
Use of University Resources
Publication provisions
Use of Human Subjects
Oversight Requirements
Reporting and Annual Reviews
You must submit an annual renewal for your
disclosure
◦ If the potential conflict no longer exists you must
notify us
If significant changes occur during the year
you should submit an update to your
disclosure as they occur
Yes. We encourage employees to disclose
potential conflicts that do not meet the
financial threshold, but may still be
problematic, such as student employment.
This allows you to be transparent with
respect to outside interests.
Allowable situations
Situations that require disclosure but may not
need an extensive management plan
Situations that require disclosure and have
problematic elements that will require
mitigation and/or a management plan
Situations that are not permitted
Receipt of royalties or honoraria for
published scholarly works, seminars,
teaching, etc.
Honoraria for serving as a special reviewer
or work on review panels
Royalties under our intellectual property
policies if no other relationship with entity
Clinical income at OUCOM
You participate in research developed in
whole or part by you, and you or your
family receive royalties from an existing
agreement with the business, but have
no other significant financial interest
You assign students, etc. to research
projects where you are entitled to
receive royalties, but have no other
significant financial interest
You assign students, etc. to projects supported
by the business through an SRA, and have a
significant financial interest other than royalty
income
You receive research support from a business in
which you serve on the board of directors, or
other advisory board, even if you are not
compensated.
You hold an executive position in a business
engaged in commercial or research activities
directly related to your Ohio University
responsibilities.
Any situation in which an actual conflict
exists is not permitted.
The only “exceptions” are those handled
under Ohio University Policy and Procedure
19.059 where faculty entrepreneurship is
addressed.
Participation in clinical trials or evaluation
of other research in which you have a
significant financial interest other than
royalty income.
In the context of your position at Ohio
University, you make professional referrals
to a business in which you have a
significant financial interest.
Letter of admonition
Ineligibility to submit grant applications
Withholding of IRB or IACUC approvals
Suspension
Non-Renewal
Loss of Tenure
Consulting
Procurement
Mentoring
Clinical Studies
Avoid consulting relationships that have
the potential to divert time and effort from
your responsibilities to Ohio University.
Do not use students.
Be wary of situations that limit publication.
Do not use university stationary, etc. that
could create an impression the university
is involved with the activities.
Make sure you are devoting sufficient time
to your university obligations.
Be cautious that the potential financial gain
cannot be perceived to influence your
university mentoring relationships.
Disclose any personal or familial financial
interest or equity in a company that is
doing business with Ohio University.
If you make purchases using public funds,
you should not use companies which will
benefit you or your family. If there is no
alternative you must seek and receive
permission prior to purchasing.
Any relationship in which there is a real or
perceived power or influence imbalance has
the potential for conflict. (Faculty:Student)
Isolating these relationships with respect to
areas of personal financial gain is best.
If they cannot be isolated, then safeguards
must be created.
If you have a financial interest, it is best to
isolate yourself from the study.
At a minimum, expect a more intense review
and a robust management plan if you have a
financial interest.
If both the institution and you have financial
interests the clinical study should be
conducted elsewhere.
You have administrative responsibilities on
behalf of Ohio University that is beneficial to
the business in which you have a significant
financial interest
You have administrative responsibilities on
behalf of Ohio University with respect to an
SRA where you have a significant financial
interest
Slide 32
Jo Ellen Sherow
Ohio University
Office of Research Compliance
Researchers’ Financial Disclosures in the
Spotlight
Conflicts of interest, always an emotional topic,
returned to the headlines this week as Sen.
Charles Grassley, a longtime critic of the drug
industry’s potential influence on research,
released new evidence that prominent Harvard
University scientists had failed to disclose much
of their outside income from pharmaceutical
companies over the past eight years.
http://www.insidehighered.com/news/2008/06/12/conflict January 15, 2008
WEDNESDAY, JANUARY 21, 2009
In a review of the literature regarding the relationship between
smokeless tobacco use and cancer, a conflict of interest of one of the
article's authors was initially not disclosed (see: Boffetta P, Hecht S, Gray
N, Gupta P, Straif K. Smokeless tobacco and cancer. Lancet Oncology
2008; 9:667-675). The original article was published in July, 2008. That
article stated: "The authors declare no conflicts of interest." After the
editor of the journal was notified by a researcher with knowledge of a
potential conflict of interest of Dr. Stephen Hecht (one of the study
authors), an erratum was published in September 2008, which noted:
"During the immediate months preceding submission of the review SH
was acting in the capacity of an expert witness for the plaintiff in a
future court case against a smokeless tobacco company. SH declares his
participation in this case in no way influenced his writing or involvement
in the review."
http://tobaccoanalysis.blogspot.com/2009/01/conflict-of-interestnot.html
January 16, 2009 — More than one third of new
drug marketing applications approved by the US
Food and Drug Administration (FDA) were
missing information about potential conflicts of
interest for clinical trial investigators, which
could allow bias to creep into the approvals
process, a government report released this week
has found. The FDA has said that it agrees with
most of the report's findings.
http://www.medscape.com/viewarticle/586980
Do collaborations between biotech companies
and academic centers constitute a conflict of
interest?
Biotechnology industry partnerships with
universities and academic centers have been
fruitful for both. So why is there so much
concern about conflict of interest and is that
concern appropriate?
http://www.redorbit.com/news/health/750100/genetic_engineering_news_p
osts_podcast_on_industrialacademic_collaborations_are_these/index.html
Universities are responsible for use of public
funds and therefore must maintain the public
trust.
Identifying and mitigating situations that may
have the potential for conflict maintains the
integrity of the university.
Maintaining integrity allows the university to
do credible academic research.
To provide information on the purpose of the
conflict of interest requirements.
To provide a basic overview of conflicts of
interest
To introduce the disclosure process and the use
of management plans
To provide information on the need for updates
and annual renewals.
Situations where financial considerations
compromise your professional judgment.
“Actual Conflict of Interest”
◦ Not permitted
Situations where an independent observer
might reasonably question whether your
professional actions or decisions are
determined by considerations of personal
gain. “Perceived Conflict of Interest”
◦ Managed
Potential conflicts may be financial or may be
a conflict of time, effort and/or commitment.
Potential conflicts can occur as a result of
administrative, scientific, academic, fiduciary
or familial situations.
They are situations that can be PERCEIVED to
be conflicting, whether a “real” conflict exists
or not.
Ohio University Policy has a mandatory
disclosure policy if you:
Earn over $10,000 in a twelve month period
from your outside activity OR
Have over 5% equity in the entity
Applies to members of your immediate family
(spouse, domestic partner, dependent
children) as well as yourself.
Anything of monetary value, including but not
limited to:
◦
◦
◦
◦
Salary
Payments for services
Equity interests over 5%
Intellectual property rights
Excludes mutual, pension and other
investments over which you have no control
Outside work during regular academic year
should not exceed equivalent of 1 day per
week.
Consulting work must avoid activities that
involve a conflict of interest with assigned
Ohio University activities and programs
Faculty Handbook, section IV-D
Outside interests cannot interfere with
primary loyalty to Ohio University and your
academic role
Use of university resources must have prior
approval of Chair, Dean and VPR.
Your outside interests should not be in
direct competition with university interests
Full time administrative employees are
expected to devote their full-time
professional loyalty, time and energy to their
position.
You must use non-work hours and no
university resources
Federal Agencies
State Law
University Policies
Many Academic Publications
45 CFR Part 50, Subpart F
“Responsibility of Applicants for Promoting
Objectivity in Research for Which PHS Funding
is Sought”
Authority: 42 U.S.C. 216, 289b-1, 299c-3.
Intent is to assure objectivity by establishing
standards that preclude bias in design, conduct, or
reporting of research
Focuses on financial conflicts of interest
(FCOI)
Regulations apply to investigators, including
sub grantees, contractors, and collaborating
investigators.
Does not apply to applications for support
under Phase I of SBIR and STTR programs
An institutional conflict of interest policy should
require that each investigator disclose to a
responsible representative of the institution all
significant financial interests of the investigator
(including those of the investigator’s spouse and
dependent children) (i) that would reasonably
appear to be affected by the research or
educational activities funded or proposed for
funding by NSF; or (ii) in entities whose financial
interests would reasonably appear to be affected
by such activities.
Chapter 1 (Subchapter A) (Part 54)
Financial Disclosure by Clinical Investigators
The Food and Drug Administration (FDA)
regulations state that investigators that
receive compensation in excess of $25,000
from a corporate sponsor of a trial in which
the investigator is engaged must disclose to
the FDA at the time of filing for a new drug
application.
19.058, Conflict of Interest in Research,
Educational, and Public Service Activities
19.059, Employee Participation in Authorized
Private Companies Commercializing Ohio
University Research
“Conflict of Interest in Research, Educational,
and Public Service Activities”
Most conflict disclosures fall within the
parameters of this policy
States that faculty are primarily responsible
for their academic, research and service
obligations
“Employee Participation in Authorized Private
Companies Commercializing Ohio University
Research”
Applies to “employees, faculty, staff and students,
who create intellectual property owned by the Ohio
University and who desire to hold an equity interest
in a firm, corporation, or other association to which
Ohio University has assigned, licensed or
transferred Ohio University’s interests…”
Consulting
Licensing University Technology
Clinical Studies
Procurement
Mentoring
Institutional
A disclosure is filed specific to the funding
application.
If you have a potential conflict for one
proposal, it does not automatically apply to
all of your proposals.
Research conflicts of interest are usually
disclosed using LEO as you apply for funding
by completing the conflict of interest section
of the electronic transmittal
If you are not using LEO, you can download
the appropriate disclosure form from
www.ohio.edu/research/compliance
“A” is selected if you have no conflicts to
disclose
“B” is selected if you have a potential conflict
to disclose relative to the submission.
(Requires a subsequent paper process)
“C” is selected if you have a current disclosure
on file, but it is not relevant to the proposal
you are submitting
Still uses option A, B or C
Requires that you gather signatures on paper
for all options, however
Generally used for personnel not listed on the
grant proposal or “key personnel”
We have revised the COI forms to word forms
This should be easier to complete than the
previous form
PDF versions are also available
Should be on the compliance web site soon,
but we can e-mail them to you until then
Use this form only if you are unable to use
the LEO transmittal form to assure that no
conflict of interest exists. A form must be
completed for each proposal.
I assure that I have read Ohio University
Policy 19.058, “Conflict of Interest in
Research, Educational, and Public Service
Activities” and declare that I have nothing
that is, or could be perceived to be a conflict
of interest with this proposal.
Use this form to disclose a potential conflict
of interest situation.
A separate disclosure form must be used for
each entity with which you conduct business
Conflict includes any member of your
immediate family (spouse, domestic partner
or children)
Require that you complete an option “B”
disclosure statement in addition to
completing the LEO transmittal form.
Require you to obtain signatures from Center
or Institute (if applicable), Chair and Dean on
the additional disclosure statement!!
The B disclosure form is available at
www.ohio.edu/research/compliance
Use this form only if you are unable to use
the LEO transmittal form. Complete this form
if you have a current conflict of interest
disclosure on file with the Office of Research
Compliance, but that disclosure is not
applicable to this proposal.
*New Option for 2008*
A management plan is developed for some
disclosures to mitigate the potential conflict
Management plans are specific to each
disclosure
May require submission of additional pieces,
such as a student employment plan
Reduce or remove the financial interest creating the
conflict
Place safeguards that mitigate the conflict potential,
such having some decisions made by an independent
entity
Limit participation in portions of the proposed
research likely to create a conflict
Require that the researcher disclose his or her
conflicting financial interests to all collaborators and
any proposed trainees;
Disclose the conflict in publications
Work to remove students from being directly advised
or taught by faculty where a conflict exists
Assure publication rights for student participants
Student Use
Nepotism and Cronyism
Intellectual Property
Use of University Resources
Publication provisions
Use of Human Subjects
Oversight Requirements
Reporting and Annual Reviews
You must submit an annual renewal for your
disclosure
◦ If the potential conflict no longer exists you must
notify us
If significant changes occur during the year
you should submit an update to your
disclosure as they occur
Yes. We encourage employees to disclose
potential conflicts that do not meet the
financial threshold, but may still be
problematic, such as student employment.
This allows you to be transparent with
respect to outside interests.
Allowable situations
Situations that require disclosure but may not
need an extensive management plan
Situations that require disclosure and have
problematic elements that will require
mitigation and/or a management plan
Situations that are not permitted
Receipt of royalties or honoraria for
published scholarly works, seminars,
teaching, etc.
Honoraria for serving as a special reviewer
or work on review panels
Royalties under our intellectual property
policies if no other relationship with entity
Clinical income at OUCOM
You participate in research developed in
whole or part by you, and you or your
family receive royalties from an existing
agreement with the business, but have
no other significant financial interest
You assign students, etc. to research
projects where you are entitled to
receive royalties, but have no other
significant financial interest
You assign students, etc. to projects supported
by the business through an SRA, and have a
significant financial interest other than royalty
income
You receive research support from a business in
which you serve on the board of directors, or
other advisory board, even if you are not
compensated.
You hold an executive position in a business
engaged in commercial or research activities
directly related to your Ohio University
responsibilities.
Any situation in which an actual conflict
exists is not permitted.
The only “exceptions” are those handled
under Ohio University Policy and Procedure
19.059 where faculty entrepreneurship is
addressed.
Participation in clinical trials or evaluation
of other research in which you have a
significant financial interest other than
royalty income.
In the context of your position at Ohio
University, you make professional referrals
to a business in which you have a
significant financial interest.
Letter of admonition
Ineligibility to submit grant applications
Withholding of IRB or IACUC approvals
Suspension
Non-Renewal
Loss of Tenure
Consulting
Procurement
Mentoring
Clinical Studies
Avoid consulting relationships that have
the potential to divert time and effort from
your responsibilities to Ohio University.
Do not use students.
Be wary of situations that limit publication.
Do not use university stationary, etc. that
could create an impression the university
is involved with the activities.
Make sure you are devoting sufficient time
to your university obligations.
Be cautious that the potential financial gain
cannot be perceived to influence your
university mentoring relationships.
Disclose any personal or familial financial
interest or equity in a company that is
doing business with Ohio University.
If you make purchases using public funds,
you should not use companies which will
benefit you or your family. If there is no
alternative you must seek and receive
permission prior to purchasing.
Any relationship in which there is a real or
perceived power or influence imbalance has
the potential for conflict. (Faculty:Student)
Isolating these relationships with respect to
areas of personal financial gain is best.
If they cannot be isolated, then safeguards
must be created.
If you have a financial interest, it is best to
isolate yourself from the study.
At a minimum, expect a more intense review
and a robust management plan if you have a
financial interest.
If both the institution and you have financial
interests the clinical study should be
conducted elsewhere.
You have administrative responsibilities on
behalf of Ohio University that is beneficial to
the business in which you have a significant
financial interest
You have administrative responsibilities on
behalf of Ohio University with respect to an
SRA where you have a significant financial
interest
Slide 33
Jo Ellen Sherow
Ohio University
Office of Research Compliance
Researchers’ Financial Disclosures in the
Spotlight
Conflicts of interest, always an emotional topic,
returned to the headlines this week as Sen.
Charles Grassley, a longtime critic of the drug
industry’s potential influence on research,
released new evidence that prominent Harvard
University scientists had failed to disclose much
of their outside income from pharmaceutical
companies over the past eight years.
http://www.insidehighered.com/news/2008/06/12/conflict January 15, 2008
WEDNESDAY, JANUARY 21, 2009
In a review of the literature regarding the relationship between
smokeless tobacco use and cancer, a conflict of interest of one of the
article's authors was initially not disclosed (see: Boffetta P, Hecht S, Gray
N, Gupta P, Straif K. Smokeless tobacco and cancer. Lancet Oncology
2008; 9:667-675). The original article was published in July, 2008. That
article stated: "The authors declare no conflicts of interest." After the
editor of the journal was notified by a researcher with knowledge of a
potential conflict of interest of Dr. Stephen Hecht (one of the study
authors), an erratum was published in September 2008, which noted:
"During the immediate months preceding submission of the review SH
was acting in the capacity of an expert witness for the plaintiff in a
future court case against a smokeless tobacco company. SH declares his
participation in this case in no way influenced his writing or involvement
in the review."
http://tobaccoanalysis.blogspot.com/2009/01/conflict-of-interestnot.html
January 16, 2009 — More than one third of new
drug marketing applications approved by the US
Food and Drug Administration (FDA) were
missing information about potential conflicts of
interest for clinical trial investigators, which
could allow bias to creep into the approvals
process, a government report released this week
has found. The FDA has said that it agrees with
most of the report's findings.
http://www.medscape.com/viewarticle/586980
Do collaborations between biotech companies
and academic centers constitute a conflict of
interest?
Biotechnology industry partnerships with
universities and academic centers have been
fruitful for both. So why is there so much
concern about conflict of interest and is that
concern appropriate?
http://www.redorbit.com/news/health/750100/genetic_engineering_news_p
osts_podcast_on_industrialacademic_collaborations_are_these/index.html
Universities are responsible for use of public
funds and therefore must maintain the public
trust.
Identifying and mitigating situations that may
have the potential for conflict maintains the
integrity of the university.
Maintaining integrity allows the university to
do credible academic research.
To provide information on the purpose of the
conflict of interest requirements.
To provide a basic overview of conflicts of
interest
To introduce the disclosure process and the use
of management plans
To provide information on the need for updates
and annual renewals.
Situations where financial considerations
compromise your professional judgment.
“Actual Conflict of Interest”
◦ Not permitted
Situations where an independent observer
might reasonably question whether your
professional actions or decisions are
determined by considerations of personal
gain. “Perceived Conflict of Interest”
◦ Managed
Potential conflicts may be financial or may be
a conflict of time, effort and/or commitment.
Potential conflicts can occur as a result of
administrative, scientific, academic, fiduciary
or familial situations.
They are situations that can be PERCEIVED to
be conflicting, whether a “real” conflict exists
or not.
Ohio University Policy has a mandatory
disclosure policy if you:
Earn over $10,000 in a twelve month period
from your outside activity OR
Have over 5% equity in the entity
Applies to members of your immediate family
(spouse, domestic partner, dependent
children) as well as yourself.
Anything of monetary value, including but not
limited to:
◦
◦
◦
◦
Salary
Payments for services
Equity interests over 5%
Intellectual property rights
Excludes mutual, pension and other
investments over which you have no control
Outside work during regular academic year
should not exceed equivalent of 1 day per
week.
Consulting work must avoid activities that
involve a conflict of interest with assigned
Ohio University activities and programs
Faculty Handbook, section IV-D
Outside interests cannot interfere with
primary loyalty to Ohio University and your
academic role
Use of university resources must have prior
approval of Chair, Dean and VPR.
Your outside interests should not be in
direct competition with university interests
Full time administrative employees are
expected to devote their full-time
professional loyalty, time and energy to their
position.
You must use non-work hours and no
university resources
Federal Agencies
State Law
University Policies
Many Academic Publications
45 CFR Part 50, Subpart F
“Responsibility of Applicants for Promoting
Objectivity in Research for Which PHS Funding
is Sought”
Authority: 42 U.S.C. 216, 289b-1, 299c-3.
Intent is to assure objectivity by establishing
standards that preclude bias in design, conduct, or
reporting of research
Focuses on financial conflicts of interest
(FCOI)
Regulations apply to investigators, including
sub grantees, contractors, and collaborating
investigators.
Does not apply to applications for support
under Phase I of SBIR and STTR programs
An institutional conflict of interest policy should
require that each investigator disclose to a
responsible representative of the institution all
significant financial interests of the investigator
(including those of the investigator’s spouse and
dependent children) (i) that would reasonably
appear to be affected by the research or
educational activities funded or proposed for
funding by NSF; or (ii) in entities whose financial
interests would reasonably appear to be affected
by such activities.
Chapter 1 (Subchapter A) (Part 54)
Financial Disclosure by Clinical Investigators
The Food and Drug Administration (FDA)
regulations state that investigators that
receive compensation in excess of $25,000
from a corporate sponsor of a trial in which
the investigator is engaged must disclose to
the FDA at the time of filing for a new drug
application.
19.058, Conflict of Interest in Research,
Educational, and Public Service Activities
19.059, Employee Participation in Authorized
Private Companies Commercializing Ohio
University Research
“Conflict of Interest in Research, Educational,
and Public Service Activities”
Most conflict disclosures fall within the
parameters of this policy
States that faculty are primarily responsible
for their academic, research and service
obligations
“Employee Participation in Authorized Private
Companies Commercializing Ohio University
Research”
Applies to “employees, faculty, staff and students,
who create intellectual property owned by the Ohio
University and who desire to hold an equity interest
in a firm, corporation, or other association to which
Ohio University has assigned, licensed or
transferred Ohio University’s interests…”
Consulting
Licensing University Technology
Clinical Studies
Procurement
Mentoring
Institutional
A disclosure is filed specific to the funding
application.
If you have a potential conflict for one
proposal, it does not automatically apply to
all of your proposals.
Research conflicts of interest are usually
disclosed using LEO as you apply for funding
by completing the conflict of interest section
of the electronic transmittal
If you are not using LEO, you can download
the appropriate disclosure form from
www.ohio.edu/research/compliance
“A” is selected if you have no conflicts to
disclose
“B” is selected if you have a potential conflict
to disclose relative to the submission.
(Requires a subsequent paper process)
“C” is selected if you have a current disclosure
on file, but it is not relevant to the proposal
you are submitting
Still uses option A, B or C
Requires that you gather signatures on paper
for all options, however
Generally used for personnel not listed on the
grant proposal or “key personnel”
We have revised the COI forms to word forms
This should be easier to complete than the
previous form
PDF versions are also available
Should be on the compliance web site soon,
but we can e-mail them to you until then
Use this form only if you are unable to use
the LEO transmittal form to assure that no
conflict of interest exists. A form must be
completed for each proposal.
I assure that I have read Ohio University
Policy 19.058, “Conflict of Interest in
Research, Educational, and Public Service
Activities” and declare that I have nothing
that is, or could be perceived to be a conflict
of interest with this proposal.
Use this form to disclose a potential conflict
of interest situation.
A separate disclosure form must be used for
each entity with which you conduct business
Conflict includes any member of your
immediate family (spouse, domestic partner
or children)
Require that you complete an option “B”
disclosure statement in addition to
completing the LEO transmittal form.
Require you to obtain signatures from Center
or Institute (if applicable), Chair and Dean on
the additional disclosure statement!!
The B disclosure form is available at
www.ohio.edu/research/compliance
Use this form only if you are unable to use
the LEO transmittal form. Complete this form
if you have a current conflict of interest
disclosure on file with the Office of Research
Compliance, but that disclosure is not
applicable to this proposal.
*New Option for 2008*
A management plan is developed for some
disclosures to mitigate the potential conflict
Management plans are specific to each
disclosure
May require submission of additional pieces,
such as a student employment plan
Reduce or remove the financial interest creating the
conflict
Place safeguards that mitigate the conflict potential,
such having some decisions made by an independent
entity
Limit participation in portions of the proposed
research likely to create a conflict
Require that the researcher disclose his or her
conflicting financial interests to all collaborators and
any proposed trainees;
Disclose the conflict in publications
Work to remove students from being directly advised
or taught by faculty where a conflict exists
Assure publication rights for student participants
Student Use
Nepotism and Cronyism
Intellectual Property
Use of University Resources
Publication provisions
Use of Human Subjects
Oversight Requirements
Reporting and Annual Reviews
You must submit an annual renewal for your
disclosure
◦ If the potential conflict no longer exists you must
notify us
If significant changes occur during the year
you should submit an update to your
disclosure as they occur
Yes. We encourage employees to disclose
potential conflicts that do not meet the
financial threshold, but may still be
problematic, such as student employment.
This allows you to be transparent with
respect to outside interests.
Allowable situations
Situations that require disclosure but may not
need an extensive management plan
Situations that require disclosure and have
problematic elements that will require
mitigation and/or a management plan
Situations that are not permitted
Receipt of royalties or honoraria for
published scholarly works, seminars,
teaching, etc.
Honoraria for serving as a special reviewer
or work on review panels
Royalties under our intellectual property
policies if no other relationship with entity
Clinical income at OUCOM
You participate in research developed in
whole or part by you, and you or your
family receive royalties from an existing
agreement with the business, but have
no other significant financial interest
You assign students, etc. to research
projects where you are entitled to
receive royalties, but have no other
significant financial interest
You assign students, etc. to projects supported
by the business through an SRA, and have a
significant financial interest other than royalty
income
You receive research support from a business in
which you serve on the board of directors, or
other advisory board, even if you are not
compensated.
You hold an executive position in a business
engaged in commercial or research activities
directly related to your Ohio University
responsibilities.
Any situation in which an actual conflict
exists is not permitted.
The only “exceptions” are those handled
under Ohio University Policy and Procedure
19.059 where faculty entrepreneurship is
addressed.
Participation in clinical trials or evaluation
of other research in which you have a
significant financial interest other than
royalty income.
In the context of your position at Ohio
University, you make professional referrals
to a business in which you have a
significant financial interest.
Letter of admonition
Ineligibility to submit grant applications
Withholding of IRB or IACUC approvals
Suspension
Non-Renewal
Loss of Tenure
Consulting
Procurement
Mentoring
Clinical Studies
Avoid consulting relationships that have
the potential to divert time and effort from
your responsibilities to Ohio University.
Do not use students.
Be wary of situations that limit publication.
Do not use university stationary, etc. that
could create an impression the university
is involved with the activities.
Make sure you are devoting sufficient time
to your university obligations.
Be cautious that the potential financial gain
cannot be perceived to influence your
university mentoring relationships.
Disclose any personal or familial financial
interest or equity in a company that is
doing business with Ohio University.
If you make purchases using public funds,
you should not use companies which will
benefit you or your family. If there is no
alternative you must seek and receive
permission prior to purchasing.
Any relationship in which there is a real or
perceived power or influence imbalance has
the potential for conflict. (Faculty:Student)
Isolating these relationships with respect to
areas of personal financial gain is best.
If they cannot be isolated, then safeguards
must be created.
If you have a financial interest, it is best to
isolate yourself from the study.
At a minimum, expect a more intense review
and a robust management plan if you have a
financial interest.
If both the institution and you have financial
interests the clinical study should be
conducted elsewhere.
You have administrative responsibilities on
behalf of Ohio University that is beneficial to
the business in which you have a significant
financial interest
You have administrative responsibilities on
behalf of Ohio University with respect to an
SRA where you have a significant financial
interest
Slide 34
Jo Ellen Sherow
Ohio University
Office of Research Compliance
Researchers’ Financial Disclosures in the
Spotlight
Conflicts of interest, always an emotional topic,
returned to the headlines this week as Sen.
Charles Grassley, a longtime critic of the drug
industry’s potential influence on research,
released new evidence that prominent Harvard
University scientists had failed to disclose much
of their outside income from pharmaceutical
companies over the past eight years.
http://www.insidehighered.com/news/2008/06/12/conflict January 15, 2008
WEDNESDAY, JANUARY 21, 2009
In a review of the literature regarding the relationship between
smokeless tobacco use and cancer, a conflict of interest of one of the
article's authors was initially not disclosed (see: Boffetta P, Hecht S, Gray
N, Gupta P, Straif K. Smokeless tobacco and cancer. Lancet Oncology
2008; 9:667-675). The original article was published in July, 2008. That
article stated: "The authors declare no conflicts of interest." After the
editor of the journal was notified by a researcher with knowledge of a
potential conflict of interest of Dr. Stephen Hecht (one of the study
authors), an erratum was published in September 2008, which noted:
"During the immediate months preceding submission of the review SH
was acting in the capacity of an expert witness for the plaintiff in a
future court case against a smokeless tobacco company. SH declares his
participation in this case in no way influenced his writing or involvement
in the review."
http://tobaccoanalysis.blogspot.com/2009/01/conflict-of-interestnot.html
January 16, 2009 — More than one third of new
drug marketing applications approved by the US
Food and Drug Administration (FDA) were
missing information about potential conflicts of
interest for clinical trial investigators, which
could allow bias to creep into the approvals
process, a government report released this week
has found. The FDA has said that it agrees with
most of the report's findings.
http://www.medscape.com/viewarticle/586980
Do collaborations between biotech companies
and academic centers constitute a conflict of
interest?
Biotechnology industry partnerships with
universities and academic centers have been
fruitful for both. So why is there so much
concern about conflict of interest and is that
concern appropriate?
http://www.redorbit.com/news/health/750100/genetic_engineering_news_p
osts_podcast_on_industrialacademic_collaborations_are_these/index.html
Universities are responsible for use of public
funds and therefore must maintain the public
trust.
Identifying and mitigating situations that may
have the potential for conflict maintains the
integrity of the university.
Maintaining integrity allows the university to
do credible academic research.
To provide information on the purpose of the
conflict of interest requirements.
To provide a basic overview of conflicts of
interest
To introduce the disclosure process and the use
of management plans
To provide information on the need for updates
and annual renewals.
Situations where financial considerations
compromise your professional judgment.
“Actual Conflict of Interest”
◦ Not permitted
Situations where an independent observer
might reasonably question whether your
professional actions or decisions are
determined by considerations of personal
gain. “Perceived Conflict of Interest”
◦ Managed
Potential conflicts may be financial or may be
a conflict of time, effort and/or commitment.
Potential conflicts can occur as a result of
administrative, scientific, academic, fiduciary
or familial situations.
They are situations that can be PERCEIVED to
be conflicting, whether a “real” conflict exists
or not.
Ohio University Policy has a mandatory
disclosure policy if you:
Earn over $10,000 in a twelve month period
from your outside activity OR
Have over 5% equity in the entity
Applies to members of your immediate family
(spouse, domestic partner, dependent
children) as well as yourself.
Anything of monetary value, including but not
limited to:
◦
◦
◦
◦
Salary
Payments for services
Equity interests over 5%
Intellectual property rights
Excludes mutual, pension and other
investments over which you have no control
Outside work during regular academic year
should not exceed equivalent of 1 day per
week.
Consulting work must avoid activities that
involve a conflict of interest with assigned
Ohio University activities and programs
Faculty Handbook, section IV-D
Outside interests cannot interfere with
primary loyalty to Ohio University and your
academic role
Use of university resources must have prior
approval of Chair, Dean and VPR.
Your outside interests should not be in
direct competition with university interests
Full time administrative employees are
expected to devote their full-time
professional loyalty, time and energy to their
position.
You must use non-work hours and no
university resources
Federal Agencies
State Law
University Policies
Many Academic Publications
45 CFR Part 50, Subpart F
“Responsibility of Applicants for Promoting
Objectivity in Research for Which PHS Funding
is Sought”
Authority: 42 U.S.C. 216, 289b-1, 299c-3.
Intent is to assure objectivity by establishing
standards that preclude bias in design, conduct, or
reporting of research
Focuses on financial conflicts of interest
(FCOI)
Regulations apply to investigators, including
sub grantees, contractors, and collaborating
investigators.
Does not apply to applications for support
under Phase I of SBIR and STTR programs
An institutional conflict of interest policy should
require that each investigator disclose to a
responsible representative of the institution all
significant financial interests of the investigator
(including those of the investigator’s spouse and
dependent children) (i) that would reasonably
appear to be affected by the research or
educational activities funded or proposed for
funding by NSF; or (ii) in entities whose financial
interests would reasonably appear to be affected
by such activities.
Chapter 1 (Subchapter A) (Part 54)
Financial Disclosure by Clinical Investigators
The Food and Drug Administration (FDA)
regulations state that investigators that
receive compensation in excess of $25,000
from a corporate sponsor of a trial in which
the investigator is engaged must disclose to
the FDA at the time of filing for a new drug
application.
19.058, Conflict of Interest in Research,
Educational, and Public Service Activities
19.059, Employee Participation in Authorized
Private Companies Commercializing Ohio
University Research
“Conflict of Interest in Research, Educational,
and Public Service Activities”
Most conflict disclosures fall within the
parameters of this policy
States that faculty are primarily responsible
for their academic, research and service
obligations
“Employee Participation in Authorized Private
Companies Commercializing Ohio University
Research”
Applies to “employees, faculty, staff and students,
who create intellectual property owned by the Ohio
University and who desire to hold an equity interest
in a firm, corporation, or other association to which
Ohio University has assigned, licensed or
transferred Ohio University’s interests…”
Consulting
Licensing University Technology
Clinical Studies
Procurement
Mentoring
Institutional
A disclosure is filed specific to the funding
application.
If you have a potential conflict for one
proposal, it does not automatically apply to
all of your proposals.
Research conflicts of interest are usually
disclosed using LEO as you apply for funding
by completing the conflict of interest section
of the electronic transmittal
If you are not using LEO, you can download
the appropriate disclosure form from
www.ohio.edu/research/compliance
“A” is selected if you have no conflicts to
disclose
“B” is selected if you have a potential conflict
to disclose relative to the submission.
(Requires a subsequent paper process)
“C” is selected if you have a current disclosure
on file, but it is not relevant to the proposal
you are submitting
Still uses option A, B or C
Requires that you gather signatures on paper
for all options, however
Generally used for personnel not listed on the
grant proposal or “key personnel”
We have revised the COI forms to word forms
This should be easier to complete than the
previous form
PDF versions are also available
Should be on the compliance web site soon,
but we can e-mail them to you until then
Use this form only if you are unable to use
the LEO transmittal form to assure that no
conflict of interest exists. A form must be
completed for each proposal.
I assure that I have read Ohio University
Policy 19.058, “Conflict of Interest in
Research, Educational, and Public Service
Activities” and declare that I have nothing
that is, or could be perceived to be a conflict
of interest with this proposal.
Use this form to disclose a potential conflict
of interest situation.
A separate disclosure form must be used for
each entity with which you conduct business
Conflict includes any member of your
immediate family (spouse, domestic partner
or children)
Require that you complete an option “B”
disclosure statement in addition to
completing the LEO transmittal form.
Require you to obtain signatures from Center
or Institute (if applicable), Chair and Dean on
the additional disclosure statement!!
The B disclosure form is available at
www.ohio.edu/research/compliance
Use this form only if you are unable to use
the LEO transmittal form. Complete this form
if you have a current conflict of interest
disclosure on file with the Office of Research
Compliance, but that disclosure is not
applicable to this proposal.
*New Option for 2008*
A management plan is developed for some
disclosures to mitigate the potential conflict
Management plans are specific to each
disclosure
May require submission of additional pieces,
such as a student employment plan
Reduce or remove the financial interest creating the
conflict
Place safeguards that mitigate the conflict potential,
such having some decisions made by an independent
entity
Limit participation in portions of the proposed
research likely to create a conflict
Require that the researcher disclose his or her
conflicting financial interests to all collaborators and
any proposed trainees;
Disclose the conflict in publications
Work to remove students from being directly advised
or taught by faculty where a conflict exists
Assure publication rights for student participants
Student Use
Nepotism and Cronyism
Intellectual Property
Use of University Resources
Publication provisions
Use of Human Subjects
Oversight Requirements
Reporting and Annual Reviews
You must submit an annual renewal for your
disclosure
◦ If the potential conflict no longer exists you must
notify us
If significant changes occur during the year
you should submit an update to your
disclosure as they occur
Yes. We encourage employees to disclose
potential conflicts that do not meet the
financial threshold, but may still be
problematic, such as student employment.
This allows you to be transparent with
respect to outside interests.
Allowable situations
Situations that require disclosure but may not
need an extensive management plan
Situations that require disclosure and have
problematic elements that will require
mitigation and/or a management plan
Situations that are not permitted
Receipt of royalties or honoraria for
published scholarly works, seminars,
teaching, etc.
Honoraria for serving as a special reviewer
or work on review panels
Royalties under our intellectual property
policies if no other relationship with entity
Clinical income at OUCOM
You participate in research developed in
whole or part by you, and you or your
family receive royalties from an existing
agreement with the business, but have
no other significant financial interest
You assign students, etc. to research
projects where you are entitled to
receive royalties, but have no other
significant financial interest
You assign students, etc. to projects supported
by the business through an SRA, and have a
significant financial interest other than royalty
income
You receive research support from a business in
which you serve on the board of directors, or
other advisory board, even if you are not
compensated.
You hold an executive position in a business
engaged in commercial or research activities
directly related to your Ohio University
responsibilities.
Any situation in which an actual conflict
exists is not permitted.
The only “exceptions” are those handled
under Ohio University Policy and Procedure
19.059 where faculty entrepreneurship is
addressed.
Participation in clinical trials or evaluation
of other research in which you have a
significant financial interest other than
royalty income.
In the context of your position at Ohio
University, you make professional referrals
to a business in which you have a
significant financial interest.
Letter of admonition
Ineligibility to submit grant applications
Withholding of IRB or IACUC approvals
Suspension
Non-Renewal
Loss of Tenure
Consulting
Procurement
Mentoring
Clinical Studies
Avoid consulting relationships that have
the potential to divert time and effort from
your responsibilities to Ohio University.
Do not use students.
Be wary of situations that limit publication.
Do not use university stationary, etc. that
could create an impression the university
is involved with the activities.
Make sure you are devoting sufficient time
to your university obligations.
Be cautious that the potential financial gain
cannot be perceived to influence your
university mentoring relationships.
Disclose any personal or familial financial
interest or equity in a company that is
doing business with Ohio University.
If you make purchases using public funds,
you should not use companies which will
benefit you or your family. If there is no
alternative you must seek and receive
permission prior to purchasing.
Any relationship in which there is a real or
perceived power or influence imbalance has
the potential for conflict. (Faculty:Student)
Isolating these relationships with respect to
areas of personal financial gain is best.
If they cannot be isolated, then safeguards
must be created.
If you have a financial interest, it is best to
isolate yourself from the study.
At a minimum, expect a more intense review
and a robust management plan if you have a
financial interest.
If both the institution and you have financial
interests the clinical study should be
conducted elsewhere.
You have administrative responsibilities on
behalf of Ohio University that is beneficial to
the business in which you have a significant
financial interest
You have administrative responsibilities on
behalf of Ohio University with respect to an
SRA where you have a significant financial
interest
Slide 35
Jo Ellen Sherow
Ohio University
Office of Research Compliance
Researchers’ Financial Disclosures in the
Spotlight
Conflicts of interest, always an emotional topic,
returned to the headlines this week as Sen.
Charles Grassley, a longtime critic of the drug
industry’s potential influence on research,
released new evidence that prominent Harvard
University scientists had failed to disclose much
of their outside income from pharmaceutical
companies over the past eight years.
http://www.insidehighered.com/news/2008/06/12/conflict January 15, 2008
WEDNESDAY, JANUARY 21, 2009
In a review of the literature regarding the relationship between
smokeless tobacco use and cancer, a conflict of interest of one of the
article's authors was initially not disclosed (see: Boffetta P, Hecht S, Gray
N, Gupta P, Straif K. Smokeless tobacco and cancer. Lancet Oncology
2008; 9:667-675). The original article was published in July, 2008. That
article stated: "The authors declare no conflicts of interest." After the
editor of the journal was notified by a researcher with knowledge of a
potential conflict of interest of Dr. Stephen Hecht (one of the study
authors), an erratum was published in September 2008, which noted:
"During the immediate months preceding submission of the review SH
was acting in the capacity of an expert witness for the plaintiff in a
future court case against a smokeless tobacco company. SH declares his
participation in this case in no way influenced his writing or involvement
in the review."
http://tobaccoanalysis.blogspot.com/2009/01/conflict-of-interestnot.html
January 16, 2009 — More than one third of new
drug marketing applications approved by the US
Food and Drug Administration (FDA) were
missing information about potential conflicts of
interest for clinical trial investigators, which
could allow bias to creep into the approvals
process, a government report released this week
has found. The FDA has said that it agrees with
most of the report's findings.
http://www.medscape.com/viewarticle/586980
Do collaborations between biotech companies
and academic centers constitute a conflict of
interest?
Biotechnology industry partnerships with
universities and academic centers have been
fruitful for both. So why is there so much
concern about conflict of interest and is that
concern appropriate?
http://www.redorbit.com/news/health/750100/genetic_engineering_news_p
osts_podcast_on_industrialacademic_collaborations_are_these/index.html
Universities are responsible for use of public
funds and therefore must maintain the public
trust.
Identifying and mitigating situations that may
have the potential for conflict maintains the
integrity of the university.
Maintaining integrity allows the university to
do credible academic research.
To provide information on the purpose of the
conflict of interest requirements.
To provide a basic overview of conflicts of
interest
To introduce the disclosure process and the use
of management plans
To provide information on the need for updates
and annual renewals.
Situations where financial considerations
compromise your professional judgment.
“Actual Conflict of Interest”
◦ Not permitted
Situations where an independent observer
might reasonably question whether your
professional actions or decisions are
determined by considerations of personal
gain. “Perceived Conflict of Interest”
◦ Managed
Potential conflicts may be financial or may be
a conflict of time, effort and/or commitment.
Potential conflicts can occur as a result of
administrative, scientific, academic, fiduciary
or familial situations.
They are situations that can be PERCEIVED to
be conflicting, whether a “real” conflict exists
or not.
Ohio University Policy has a mandatory
disclosure policy if you:
Earn over $10,000 in a twelve month period
from your outside activity OR
Have over 5% equity in the entity
Applies to members of your immediate family
(spouse, domestic partner, dependent
children) as well as yourself.
Anything of monetary value, including but not
limited to:
◦
◦
◦
◦
Salary
Payments for services
Equity interests over 5%
Intellectual property rights
Excludes mutual, pension and other
investments over which you have no control
Outside work during regular academic year
should not exceed equivalent of 1 day per
week.
Consulting work must avoid activities that
involve a conflict of interest with assigned
Ohio University activities and programs
Faculty Handbook, section IV-D
Outside interests cannot interfere with
primary loyalty to Ohio University and your
academic role
Use of university resources must have prior
approval of Chair, Dean and VPR.
Your outside interests should not be in
direct competition with university interests
Full time administrative employees are
expected to devote their full-time
professional loyalty, time and energy to their
position.
You must use non-work hours and no
university resources
Federal Agencies
State Law
University Policies
Many Academic Publications
45 CFR Part 50, Subpart F
“Responsibility of Applicants for Promoting
Objectivity in Research for Which PHS Funding
is Sought”
Authority: 42 U.S.C. 216, 289b-1, 299c-3.
Intent is to assure objectivity by establishing
standards that preclude bias in design, conduct, or
reporting of research
Focuses on financial conflicts of interest
(FCOI)
Regulations apply to investigators, including
sub grantees, contractors, and collaborating
investigators.
Does not apply to applications for support
under Phase I of SBIR and STTR programs
An institutional conflict of interest policy should
require that each investigator disclose to a
responsible representative of the institution all
significant financial interests of the investigator
(including those of the investigator’s spouse and
dependent children) (i) that would reasonably
appear to be affected by the research or
educational activities funded or proposed for
funding by NSF; or (ii) in entities whose financial
interests would reasonably appear to be affected
by such activities.
Chapter 1 (Subchapter A) (Part 54)
Financial Disclosure by Clinical Investigators
The Food and Drug Administration (FDA)
regulations state that investigators that
receive compensation in excess of $25,000
from a corporate sponsor of a trial in which
the investigator is engaged must disclose to
the FDA at the time of filing for a new drug
application.
19.058, Conflict of Interest in Research,
Educational, and Public Service Activities
19.059, Employee Participation in Authorized
Private Companies Commercializing Ohio
University Research
“Conflict of Interest in Research, Educational,
and Public Service Activities”
Most conflict disclosures fall within the
parameters of this policy
States that faculty are primarily responsible
for their academic, research and service
obligations
“Employee Participation in Authorized Private
Companies Commercializing Ohio University
Research”
Applies to “employees, faculty, staff and students,
who create intellectual property owned by the Ohio
University and who desire to hold an equity interest
in a firm, corporation, or other association to which
Ohio University has assigned, licensed or
transferred Ohio University’s interests…”
Consulting
Licensing University Technology
Clinical Studies
Procurement
Mentoring
Institutional
A disclosure is filed specific to the funding
application.
If you have a potential conflict for one
proposal, it does not automatically apply to
all of your proposals.
Research conflicts of interest are usually
disclosed using LEO as you apply for funding
by completing the conflict of interest section
of the electronic transmittal
If you are not using LEO, you can download
the appropriate disclosure form from
www.ohio.edu/research/compliance
“A” is selected if you have no conflicts to
disclose
“B” is selected if you have a potential conflict
to disclose relative to the submission.
(Requires a subsequent paper process)
“C” is selected if you have a current disclosure
on file, but it is not relevant to the proposal
you are submitting
Still uses option A, B or C
Requires that you gather signatures on paper
for all options, however
Generally used for personnel not listed on the
grant proposal or “key personnel”
We have revised the COI forms to word forms
This should be easier to complete than the
previous form
PDF versions are also available
Should be on the compliance web site soon,
but we can e-mail them to you until then
Use this form only if you are unable to use
the LEO transmittal form to assure that no
conflict of interest exists. A form must be
completed for each proposal.
I assure that I have read Ohio University
Policy 19.058, “Conflict of Interest in
Research, Educational, and Public Service
Activities” and declare that I have nothing
that is, or could be perceived to be a conflict
of interest with this proposal.
Use this form to disclose a potential conflict
of interest situation.
A separate disclosure form must be used for
each entity with which you conduct business
Conflict includes any member of your
immediate family (spouse, domestic partner
or children)
Require that you complete an option “B”
disclosure statement in addition to
completing the LEO transmittal form.
Require you to obtain signatures from Center
or Institute (if applicable), Chair and Dean on
the additional disclosure statement!!
The B disclosure form is available at
www.ohio.edu/research/compliance
Use this form only if you are unable to use
the LEO transmittal form. Complete this form
if you have a current conflict of interest
disclosure on file with the Office of Research
Compliance, but that disclosure is not
applicable to this proposal.
*New Option for 2008*
A management plan is developed for some
disclosures to mitigate the potential conflict
Management plans are specific to each
disclosure
May require submission of additional pieces,
such as a student employment plan
Reduce or remove the financial interest creating the
conflict
Place safeguards that mitigate the conflict potential,
such having some decisions made by an independent
entity
Limit participation in portions of the proposed
research likely to create a conflict
Require that the researcher disclose his or her
conflicting financial interests to all collaborators and
any proposed trainees;
Disclose the conflict in publications
Work to remove students from being directly advised
or taught by faculty where a conflict exists
Assure publication rights for student participants
Student Use
Nepotism and Cronyism
Intellectual Property
Use of University Resources
Publication provisions
Use of Human Subjects
Oversight Requirements
Reporting and Annual Reviews
You must submit an annual renewal for your
disclosure
◦ If the potential conflict no longer exists you must
notify us
If significant changes occur during the year
you should submit an update to your
disclosure as they occur
Yes. We encourage employees to disclose
potential conflicts that do not meet the
financial threshold, but may still be
problematic, such as student employment.
This allows you to be transparent with
respect to outside interests.
Allowable situations
Situations that require disclosure but may not
need an extensive management plan
Situations that require disclosure and have
problematic elements that will require
mitigation and/or a management plan
Situations that are not permitted
Receipt of royalties or honoraria for
published scholarly works, seminars,
teaching, etc.
Honoraria for serving as a special reviewer
or work on review panels
Royalties under our intellectual property
policies if no other relationship with entity
Clinical income at OUCOM
You participate in research developed in
whole or part by you, and you or your
family receive royalties from an existing
agreement with the business, but have
no other significant financial interest
You assign students, etc. to research
projects where you are entitled to
receive royalties, but have no other
significant financial interest
You assign students, etc. to projects supported
by the business through an SRA, and have a
significant financial interest other than royalty
income
You receive research support from a business in
which you serve on the board of directors, or
other advisory board, even if you are not
compensated.
You hold an executive position in a business
engaged in commercial or research activities
directly related to your Ohio University
responsibilities.
Any situation in which an actual conflict
exists is not permitted.
The only “exceptions” are those handled
under Ohio University Policy and Procedure
19.059 where faculty entrepreneurship is
addressed.
Participation in clinical trials or evaluation
of other research in which you have a
significant financial interest other than
royalty income.
In the context of your position at Ohio
University, you make professional referrals
to a business in which you have a
significant financial interest.
Letter of admonition
Ineligibility to submit grant applications
Withholding of IRB or IACUC approvals
Suspension
Non-Renewal
Loss of Tenure
Consulting
Procurement
Mentoring
Clinical Studies
Avoid consulting relationships that have
the potential to divert time and effort from
your responsibilities to Ohio University.
Do not use students.
Be wary of situations that limit publication.
Do not use university stationary, etc. that
could create an impression the university
is involved with the activities.
Make sure you are devoting sufficient time
to your university obligations.
Be cautious that the potential financial gain
cannot be perceived to influence your
university mentoring relationships.
Disclose any personal or familial financial
interest or equity in a company that is
doing business with Ohio University.
If you make purchases using public funds,
you should not use companies which will
benefit you or your family. If there is no
alternative you must seek and receive
permission prior to purchasing.
Any relationship in which there is a real or
perceived power or influence imbalance has
the potential for conflict. (Faculty:Student)
Isolating these relationships with respect to
areas of personal financial gain is best.
If they cannot be isolated, then safeguards
must be created.
If you have a financial interest, it is best to
isolate yourself from the study.
At a minimum, expect a more intense review
and a robust management plan if you have a
financial interest.
If both the institution and you have financial
interests the clinical study should be
conducted elsewhere.
You have administrative responsibilities on
behalf of Ohio University that is beneficial to
the business in which you have a significant
financial interest
You have administrative responsibilities on
behalf of Ohio University with respect to an
SRA where you have a significant financial
interest
Slide 36
Jo Ellen Sherow
Ohio University
Office of Research Compliance
Researchers’ Financial Disclosures in the
Spotlight
Conflicts of interest, always an emotional topic,
returned to the headlines this week as Sen.
Charles Grassley, a longtime critic of the drug
industry’s potential influence on research,
released new evidence that prominent Harvard
University scientists had failed to disclose much
of their outside income from pharmaceutical
companies over the past eight years.
http://www.insidehighered.com/news/2008/06/12/conflict January 15, 2008
WEDNESDAY, JANUARY 21, 2009
In a review of the literature regarding the relationship between
smokeless tobacco use and cancer, a conflict of interest of one of the
article's authors was initially not disclosed (see: Boffetta P, Hecht S, Gray
N, Gupta P, Straif K. Smokeless tobacco and cancer. Lancet Oncology
2008; 9:667-675). The original article was published in July, 2008. That
article stated: "The authors declare no conflicts of interest." After the
editor of the journal was notified by a researcher with knowledge of a
potential conflict of interest of Dr. Stephen Hecht (one of the study
authors), an erratum was published in September 2008, which noted:
"During the immediate months preceding submission of the review SH
was acting in the capacity of an expert witness for the plaintiff in a
future court case against a smokeless tobacco company. SH declares his
participation in this case in no way influenced his writing or involvement
in the review."
http://tobaccoanalysis.blogspot.com/2009/01/conflict-of-interestnot.html
January 16, 2009 — More than one third of new
drug marketing applications approved by the US
Food and Drug Administration (FDA) were
missing information about potential conflicts of
interest for clinical trial investigators, which
could allow bias to creep into the approvals
process, a government report released this week
has found. The FDA has said that it agrees with
most of the report's findings.
http://www.medscape.com/viewarticle/586980
Do collaborations between biotech companies
and academic centers constitute a conflict of
interest?
Biotechnology industry partnerships with
universities and academic centers have been
fruitful for both. So why is there so much
concern about conflict of interest and is that
concern appropriate?
http://www.redorbit.com/news/health/750100/genetic_engineering_news_p
osts_podcast_on_industrialacademic_collaborations_are_these/index.html
Universities are responsible for use of public
funds and therefore must maintain the public
trust.
Identifying and mitigating situations that may
have the potential for conflict maintains the
integrity of the university.
Maintaining integrity allows the university to
do credible academic research.
To provide information on the purpose of the
conflict of interest requirements.
To provide a basic overview of conflicts of
interest
To introduce the disclosure process and the use
of management plans
To provide information on the need for updates
and annual renewals.
Situations where financial considerations
compromise your professional judgment.
“Actual Conflict of Interest”
◦ Not permitted
Situations where an independent observer
might reasonably question whether your
professional actions or decisions are
determined by considerations of personal
gain. “Perceived Conflict of Interest”
◦ Managed
Potential conflicts may be financial or may be
a conflict of time, effort and/or commitment.
Potential conflicts can occur as a result of
administrative, scientific, academic, fiduciary
or familial situations.
They are situations that can be PERCEIVED to
be conflicting, whether a “real” conflict exists
or not.
Ohio University Policy has a mandatory
disclosure policy if you:
Earn over $10,000 in a twelve month period
from your outside activity OR
Have over 5% equity in the entity
Applies to members of your immediate family
(spouse, domestic partner, dependent
children) as well as yourself.
Anything of monetary value, including but not
limited to:
◦
◦
◦
◦
Salary
Payments for services
Equity interests over 5%
Intellectual property rights
Excludes mutual, pension and other
investments over which you have no control
Outside work during regular academic year
should not exceed equivalent of 1 day per
week.
Consulting work must avoid activities that
involve a conflict of interest with assigned
Ohio University activities and programs
Faculty Handbook, section IV-D
Outside interests cannot interfere with
primary loyalty to Ohio University and your
academic role
Use of university resources must have prior
approval of Chair, Dean and VPR.
Your outside interests should not be in
direct competition with university interests
Full time administrative employees are
expected to devote their full-time
professional loyalty, time and energy to their
position.
You must use non-work hours and no
university resources
Federal Agencies
State Law
University Policies
Many Academic Publications
45 CFR Part 50, Subpart F
“Responsibility of Applicants for Promoting
Objectivity in Research for Which PHS Funding
is Sought”
Authority: 42 U.S.C. 216, 289b-1, 299c-3.
Intent is to assure objectivity by establishing
standards that preclude bias in design, conduct, or
reporting of research
Focuses on financial conflicts of interest
(FCOI)
Regulations apply to investigators, including
sub grantees, contractors, and collaborating
investigators.
Does not apply to applications for support
under Phase I of SBIR and STTR programs
An institutional conflict of interest policy should
require that each investigator disclose to a
responsible representative of the institution all
significant financial interests of the investigator
(including those of the investigator’s spouse and
dependent children) (i) that would reasonably
appear to be affected by the research or
educational activities funded or proposed for
funding by NSF; or (ii) in entities whose financial
interests would reasonably appear to be affected
by such activities.
Chapter 1 (Subchapter A) (Part 54)
Financial Disclosure by Clinical Investigators
The Food and Drug Administration (FDA)
regulations state that investigators that
receive compensation in excess of $25,000
from a corporate sponsor of a trial in which
the investigator is engaged must disclose to
the FDA at the time of filing for a new drug
application.
19.058, Conflict of Interest in Research,
Educational, and Public Service Activities
19.059, Employee Participation in Authorized
Private Companies Commercializing Ohio
University Research
“Conflict of Interest in Research, Educational,
and Public Service Activities”
Most conflict disclosures fall within the
parameters of this policy
States that faculty are primarily responsible
for their academic, research and service
obligations
“Employee Participation in Authorized Private
Companies Commercializing Ohio University
Research”
Applies to “employees, faculty, staff and students,
who create intellectual property owned by the Ohio
University and who desire to hold an equity interest
in a firm, corporation, or other association to which
Ohio University has assigned, licensed or
transferred Ohio University’s interests…”
Consulting
Licensing University Technology
Clinical Studies
Procurement
Mentoring
Institutional
A disclosure is filed specific to the funding
application.
If you have a potential conflict for one
proposal, it does not automatically apply to
all of your proposals.
Research conflicts of interest are usually
disclosed using LEO as you apply for funding
by completing the conflict of interest section
of the electronic transmittal
If you are not using LEO, you can download
the appropriate disclosure form from
www.ohio.edu/research/compliance
“A” is selected if you have no conflicts to
disclose
“B” is selected if you have a potential conflict
to disclose relative to the submission.
(Requires a subsequent paper process)
“C” is selected if you have a current disclosure
on file, but it is not relevant to the proposal
you are submitting
Still uses option A, B or C
Requires that you gather signatures on paper
for all options, however
Generally used for personnel not listed on the
grant proposal or “key personnel”
We have revised the COI forms to word forms
This should be easier to complete than the
previous form
PDF versions are also available
Should be on the compliance web site soon,
but we can e-mail them to you until then
Use this form only if you are unable to use
the LEO transmittal form to assure that no
conflict of interest exists. A form must be
completed for each proposal.
I assure that I have read Ohio University
Policy 19.058, “Conflict of Interest in
Research, Educational, and Public Service
Activities” and declare that I have nothing
that is, or could be perceived to be a conflict
of interest with this proposal.
Use this form to disclose a potential conflict
of interest situation.
A separate disclosure form must be used for
each entity with which you conduct business
Conflict includes any member of your
immediate family (spouse, domestic partner
or children)
Require that you complete an option “B”
disclosure statement in addition to
completing the LEO transmittal form.
Require you to obtain signatures from Center
or Institute (if applicable), Chair and Dean on
the additional disclosure statement!!
The B disclosure form is available at
www.ohio.edu/research/compliance
Use this form only if you are unable to use
the LEO transmittal form. Complete this form
if you have a current conflict of interest
disclosure on file with the Office of Research
Compliance, but that disclosure is not
applicable to this proposal.
*New Option for 2008*
A management plan is developed for some
disclosures to mitigate the potential conflict
Management plans are specific to each
disclosure
May require submission of additional pieces,
such as a student employment plan
Reduce or remove the financial interest creating the
conflict
Place safeguards that mitigate the conflict potential,
such having some decisions made by an independent
entity
Limit participation in portions of the proposed
research likely to create a conflict
Require that the researcher disclose his or her
conflicting financial interests to all collaborators and
any proposed trainees;
Disclose the conflict in publications
Work to remove students from being directly advised
or taught by faculty where a conflict exists
Assure publication rights for student participants
Student Use
Nepotism and Cronyism
Intellectual Property
Use of University Resources
Publication provisions
Use of Human Subjects
Oversight Requirements
Reporting and Annual Reviews
You must submit an annual renewal for your
disclosure
◦ If the potential conflict no longer exists you must
notify us
If significant changes occur during the year
you should submit an update to your
disclosure as they occur
Yes. We encourage employees to disclose
potential conflicts that do not meet the
financial threshold, but may still be
problematic, such as student employment.
This allows you to be transparent with
respect to outside interests.
Allowable situations
Situations that require disclosure but may not
need an extensive management plan
Situations that require disclosure and have
problematic elements that will require
mitigation and/or a management plan
Situations that are not permitted
Receipt of royalties or honoraria for
published scholarly works, seminars,
teaching, etc.
Honoraria for serving as a special reviewer
or work on review panels
Royalties under our intellectual property
policies if no other relationship with entity
Clinical income at OUCOM
You participate in research developed in
whole or part by you, and you or your
family receive royalties from an existing
agreement with the business, but have
no other significant financial interest
You assign students, etc. to research
projects where you are entitled to
receive royalties, but have no other
significant financial interest
You assign students, etc. to projects supported
by the business through an SRA, and have a
significant financial interest other than royalty
income
You receive research support from a business in
which you serve on the board of directors, or
other advisory board, even if you are not
compensated.
You hold an executive position in a business
engaged in commercial or research activities
directly related to your Ohio University
responsibilities.
Any situation in which an actual conflict
exists is not permitted.
The only “exceptions” are those handled
under Ohio University Policy and Procedure
19.059 where faculty entrepreneurship is
addressed.
Participation in clinical trials or evaluation
of other research in which you have a
significant financial interest other than
royalty income.
In the context of your position at Ohio
University, you make professional referrals
to a business in which you have a
significant financial interest.
Letter of admonition
Ineligibility to submit grant applications
Withholding of IRB or IACUC approvals
Suspension
Non-Renewal
Loss of Tenure
Consulting
Procurement
Mentoring
Clinical Studies
Avoid consulting relationships that have
the potential to divert time and effort from
your responsibilities to Ohio University.
Do not use students.
Be wary of situations that limit publication.
Do not use university stationary, etc. that
could create an impression the university
is involved with the activities.
Make sure you are devoting sufficient time
to your university obligations.
Be cautious that the potential financial gain
cannot be perceived to influence your
university mentoring relationships.
Disclose any personal or familial financial
interest or equity in a company that is
doing business with Ohio University.
If you make purchases using public funds,
you should not use companies which will
benefit you or your family. If there is no
alternative you must seek and receive
permission prior to purchasing.
Any relationship in which there is a real or
perceived power or influence imbalance has
the potential for conflict. (Faculty:Student)
Isolating these relationships with respect to
areas of personal financial gain is best.
If they cannot be isolated, then safeguards
must be created.
If you have a financial interest, it is best to
isolate yourself from the study.
At a minimum, expect a more intense review
and a robust management plan if you have a
financial interest.
If both the institution and you have financial
interests the clinical study should be
conducted elsewhere.
You have administrative responsibilities on
behalf of Ohio University that is beneficial to
the business in which you have a significant
financial interest
You have administrative responsibilities on
behalf of Ohio University with respect to an
SRA where you have a significant financial
interest
Slide 37
Jo Ellen Sherow
Ohio University
Office of Research Compliance
Researchers’ Financial Disclosures in the
Spotlight
Conflicts of interest, always an emotional topic,
returned to the headlines this week as Sen.
Charles Grassley, a longtime critic of the drug
industry’s potential influence on research,
released new evidence that prominent Harvard
University scientists had failed to disclose much
of their outside income from pharmaceutical
companies over the past eight years.
http://www.insidehighered.com/news/2008/06/12/conflict January 15, 2008
WEDNESDAY, JANUARY 21, 2009
In a review of the literature regarding the relationship between
smokeless tobacco use and cancer, a conflict of interest of one of the
article's authors was initially not disclosed (see: Boffetta P, Hecht S, Gray
N, Gupta P, Straif K. Smokeless tobacco and cancer. Lancet Oncology
2008; 9:667-675). The original article was published in July, 2008. That
article stated: "The authors declare no conflicts of interest." After the
editor of the journal was notified by a researcher with knowledge of a
potential conflict of interest of Dr. Stephen Hecht (one of the study
authors), an erratum was published in September 2008, which noted:
"During the immediate months preceding submission of the review SH
was acting in the capacity of an expert witness for the plaintiff in a
future court case against a smokeless tobacco company. SH declares his
participation in this case in no way influenced his writing or involvement
in the review."
http://tobaccoanalysis.blogspot.com/2009/01/conflict-of-interestnot.html
January 16, 2009 — More than one third of new
drug marketing applications approved by the US
Food and Drug Administration (FDA) were
missing information about potential conflicts of
interest for clinical trial investigators, which
could allow bias to creep into the approvals
process, a government report released this week
has found. The FDA has said that it agrees with
most of the report's findings.
http://www.medscape.com/viewarticle/586980
Do collaborations between biotech companies
and academic centers constitute a conflict of
interest?
Biotechnology industry partnerships with
universities and academic centers have been
fruitful for both. So why is there so much
concern about conflict of interest and is that
concern appropriate?
http://www.redorbit.com/news/health/750100/genetic_engineering_news_p
osts_podcast_on_industrialacademic_collaborations_are_these/index.html
Universities are responsible for use of public
funds and therefore must maintain the public
trust.
Identifying and mitigating situations that may
have the potential for conflict maintains the
integrity of the university.
Maintaining integrity allows the university to
do credible academic research.
To provide information on the purpose of the
conflict of interest requirements.
To provide a basic overview of conflicts of
interest
To introduce the disclosure process and the use
of management plans
To provide information on the need for updates
and annual renewals.
Situations where financial considerations
compromise your professional judgment.
“Actual Conflict of Interest”
◦ Not permitted
Situations where an independent observer
might reasonably question whether your
professional actions or decisions are
determined by considerations of personal
gain. “Perceived Conflict of Interest”
◦ Managed
Potential conflicts may be financial or may be
a conflict of time, effort and/or commitment.
Potential conflicts can occur as a result of
administrative, scientific, academic, fiduciary
or familial situations.
They are situations that can be PERCEIVED to
be conflicting, whether a “real” conflict exists
or not.
Ohio University Policy has a mandatory
disclosure policy if you:
Earn over $10,000 in a twelve month period
from your outside activity OR
Have over 5% equity in the entity
Applies to members of your immediate family
(spouse, domestic partner, dependent
children) as well as yourself.
Anything of monetary value, including but not
limited to:
◦
◦
◦
◦
Salary
Payments for services
Equity interests over 5%
Intellectual property rights
Excludes mutual, pension and other
investments over which you have no control
Outside work during regular academic year
should not exceed equivalent of 1 day per
week.
Consulting work must avoid activities that
involve a conflict of interest with assigned
Ohio University activities and programs
Faculty Handbook, section IV-D
Outside interests cannot interfere with
primary loyalty to Ohio University and your
academic role
Use of university resources must have prior
approval of Chair, Dean and VPR.
Your outside interests should not be in
direct competition with university interests
Full time administrative employees are
expected to devote their full-time
professional loyalty, time and energy to their
position.
You must use non-work hours and no
university resources
Federal Agencies
State Law
University Policies
Many Academic Publications
45 CFR Part 50, Subpart F
“Responsibility of Applicants for Promoting
Objectivity in Research for Which PHS Funding
is Sought”
Authority: 42 U.S.C. 216, 289b-1, 299c-3.
Intent is to assure objectivity by establishing
standards that preclude bias in design, conduct, or
reporting of research
Focuses on financial conflicts of interest
(FCOI)
Regulations apply to investigators, including
sub grantees, contractors, and collaborating
investigators.
Does not apply to applications for support
under Phase I of SBIR and STTR programs
An institutional conflict of interest policy should
require that each investigator disclose to a
responsible representative of the institution all
significant financial interests of the investigator
(including those of the investigator’s spouse and
dependent children) (i) that would reasonably
appear to be affected by the research or
educational activities funded or proposed for
funding by NSF; or (ii) in entities whose financial
interests would reasonably appear to be affected
by such activities.
Chapter 1 (Subchapter A) (Part 54)
Financial Disclosure by Clinical Investigators
The Food and Drug Administration (FDA)
regulations state that investigators that
receive compensation in excess of $25,000
from a corporate sponsor of a trial in which
the investigator is engaged must disclose to
the FDA at the time of filing for a new drug
application.
19.058, Conflict of Interest in Research,
Educational, and Public Service Activities
19.059, Employee Participation in Authorized
Private Companies Commercializing Ohio
University Research
“Conflict of Interest in Research, Educational,
and Public Service Activities”
Most conflict disclosures fall within the
parameters of this policy
States that faculty are primarily responsible
for their academic, research and service
obligations
“Employee Participation in Authorized Private
Companies Commercializing Ohio University
Research”
Applies to “employees, faculty, staff and students,
who create intellectual property owned by the Ohio
University and who desire to hold an equity interest
in a firm, corporation, or other association to which
Ohio University has assigned, licensed or
transferred Ohio University’s interests…”
Consulting
Licensing University Technology
Clinical Studies
Procurement
Mentoring
Institutional
A disclosure is filed specific to the funding
application.
If you have a potential conflict for one
proposal, it does not automatically apply to
all of your proposals.
Research conflicts of interest are usually
disclosed using LEO as you apply for funding
by completing the conflict of interest section
of the electronic transmittal
If you are not using LEO, you can download
the appropriate disclosure form from
www.ohio.edu/research/compliance
“A” is selected if you have no conflicts to
disclose
“B” is selected if you have a potential conflict
to disclose relative to the submission.
(Requires a subsequent paper process)
“C” is selected if you have a current disclosure
on file, but it is not relevant to the proposal
you are submitting
Still uses option A, B or C
Requires that you gather signatures on paper
for all options, however
Generally used for personnel not listed on the
grant proposal or “key personnel”
We have revised the COI forms to word forms
This should be easier to complete than the
previous form
PDF versions are also available
Should be on the compliance web site soon,
but we can e-mail them to you until then
Use this form only if you are unable to use
the LEO transmittal form to assure that no
conflict of interest exists. A form must be
completed for each proposal.
I assure that I have read Ohio University
Policy 19.058, “Conflict of Interest in
Research, Educational, and Public Service
Activities” and declare that I have nothing
that is, or could be perceived to be a conflict
of interest with this proposal.
Use this form to disclose a potential conflict
of interest situation.
A separate disclosure form must be used for
each entity with which you conduct business
Conflict includes any member of your
immediate family (spouse, domestic partner
or children)
Require that you complete an option “B”
disclosure statement in addition to
completing the LEO transmittal form.
Require you to obtain signatures from Center
or Institute (if applicable), Chair and Dean on
the additional disclosure statement!!
The B disclosure form is available at
www.ohio.edu/research/compliance
Use this form only if you are unable to use
the LEO transmittal form. Complete this form
if you have a current conflict of interest
disclosure on file with the Office of Research
Compliance, but that disclosure is not
applicable to this proposal.
*New Option for 2008*
A management plan is developed for some
disclosures to mitigate the potential conflict
Management plans are specific to each
disclosure
May require submission of additional pieces,
such as a student employment plan
Reduce or remove the financial interest creating the
conflict
Place safeguards that mitigate the conflict potential,
such having some decisions made by an independent
entity
Limit participation in portions of the proposed
research likely to create a conflict
Require that the researcher disclose his or her
conflicting financial interests to all collaborators and
any proposed trainees;
Disclose the conflict in publications
Work to remove students from being directly advised
or taught by faculty where a conflict exists
Assure publication rights for student participants
Student Use
Nepotism and Cronyism
Intellectual Property
Use of University Resources
Publication provisions
Use of Human Subjects
Oversight Requirements
Reporting and Annual Reviews
You must submit an annual renewal for your
disclosure
◦ If the potential conflict no longer exists you must
notify us
If significant changes occur during the year
you should submit an update to your
disclosure as they occur
Yes. We encourage employees to disclose
potential conflicts that do not meet the
financial threshold, but may still be
problematic, such as student employment.
This allows you to be transparent with
respect to outside interests.
Allowable situations
Situations that require disclosure but may not
need an extensive management plan
Situations that require disclosure and have
problematic elements that will require
mitigation and/or a management plan
Situations that are not permitted
Receipt of royalties or honoraria for
published scholarly works, seminars,
teaching, etc.
Honoraria for serving as a special reviewer
or work on review panels
Royalties under our intellectual property
policies if no other relationship with entity
Clinical income at OUCOM
You participate in research developed in
whole or part by you, and you or your
family receive royalties from an existing
agreement with the business, but have
no other significant financial interest
You assign students, etc. to research
projects where you are entitled to
receive royalties, but have no other
significant financial interest
You assign students, etc. to projects supported
by the business through an SRA, and have a
significant financial interest other than royalty
income
You receive research support from a business in
which you serve on the board of directors, or
other advisory board, even if you are not
compensated.
You hold an executive position in a business
engaged in commercial or research activities
directly related to your Ohio University
responsibilities.
Any situation in which an actual conflict
exists is not permitted.
The only “exceptions” are those handled
under Ohio University Policy and Procedure
19.059 where faculty entrepreneurship is
addressed.
Participation in clinical trials or evaluation
of other research in which you have a
significant financial interest other than
royalty income.
In the context of your position at Ohio
University, you make professional referrals
to a business in which you have a
significant financial interest.
Letter of admonition
Ineligibility to submit grant applications
Withholding of IRB or IACUC approvals
Suspension
Non-Renewal
Loss of Tenure
Consulting
Procurement
Mentoring
Clinical Studies
Avoid consulting relationships that have
the potential to divert time and effort from
your responsibilities to Ohio University.
Do not use students.
Be wary of situations that limit publication.
Do not use university stationary, etc. that
could create an impression the university
is involved with the activities.
Make sure you are devoting sufficient time
to your university obligations.
Be cautious that the potential financial gain
cannot be perceived to influence your
university mentoring relationships.
Disclose any personal or familial financial
interest or equity in a company that is
doing business with Ohio University.
If you make purchases using public funds,
you should not use companies which will
benefit you or your family. If there is no
alternative you must seek and receive
permission prior to purchasing.
Any relationship in which there is a real or
perceived power or influence imbalance has
the potential for conflict. (Faculty:Student)
Isolating these relationships with respect to
areas of personal financial gain is best.
If they cannot be isolated, then safeguards
must be created.
If you have a financial interest, it is best to
isolate yourself from the study.
At a minimum, expect a more intense review
and a robust management plan if you have a
financial interest.
If both the institution and you have financial
interests the clinical study should be
conducted elsewhere.
You have administrative responsibilities on
behalf of Ohio University that is beneficial to
the business in which you have a significant
financial interest
You have administrative responsibilities on
behalf of Ohio University with respect to an
SRA where you have a significant financial
interest
Slide 38
Jo Ellen Sherow
Ohio University
Office of Research Compliance
Researchers’ Financial Disclosures in the
Spotlight
Conflicts of interest, always an emotional topic,
returned to the headlines this week as Sen.
Charles Grassley, a longtime critic of the drug
industry’s potential influence on research,
released new evidence that prominent Harvard
University scientists had failed to disclose much
of their outside income from pharmaceutical
companies over the past eight years.
http://www.insidehighered.com/news/2008/06/12/conflict January 15, 2008
WEDNESDAY, JANUARY 21, 2009
In a review of the literature regarding the relationship between
smokeless tobacco use and cancer, a conflict of interest of one of the
article's authors was initially not disclosed (see: Boffetta P, Hecht S, Gray
N, Gupta P, Straif K. Smokeless tobacco and cancer. Lancet Oncology
2008; 9:667-675). The original article was published in July, 2008. That
article stated: "The authors declare no conflicts of interest." After the
editor of the journal was notified by a researcher with knowledge of a
potential conflict of interest of Dr. Stephen Hecht (one of the study
authors), an erratum was published in September 2008, which noted:
"During the immediate months preceding submission of the review SH
was acting in the capacity of an expert witness for the plaintiff in a
future court case against a smokeless tobacco company. SH declares his
participation in this case in no way influenced his writing or involvement
in the review."
http://tobaccoanalysis.blogspot.com/2009/01/conflict-of-interestnot.html
January 16, 2009 — More than one third of new
drug marketing applications approved by the US
Food and Drug Administration (FDA) were
missing information about potential conflicts of
interest for clinical trial investigators, which
could allow bias to creep into the approvals
process, a government report released this week
has found. The FDA has said that it agrees with
most of the report's findings.
http://www.medscape.com/viewarticle/586980
Do collaborations between biotech companies
and academic centers constitute a conflict of
interest?
Biotechnology industry partnerships with
universities and academic centers have been
fruitful for both. So why is there so much
concern about conflict of interest and is that
concern appropriate?
http://www.redorbit.com/news/health/750100/genetic_engineering_news_p
osts_podcast_on_industrialacademic_collaborations_are_these/index.html
Universities are responsible for use of public
funds and therefore must maintain the public
trust.
Identifying and mitigating situations that may
have the potential for conflict maintains the
integrity of the university.
Maintaining integrity allows the university to
do credible academic research.
To provide information on the purpose of the
conflict of interest requirements.
To provide a basic overview of conflicts of
interest
To introduce the disclosure process and the use
of management plans
To provide information on the need for updates
and annual renewals.
Situations where financial considerations
compromise your professional judgment.
“Actual Conflict of Interest”
◦ Not permitted
Situations where an independent observer
might reasonably question whether your
professional actions or decisions are
determined by considerations of personal
gain. “Perceived Conflict of Interest”
◦ Managed
Potential conflicts may be financial or may be
a conflict of time, effort and/or commitment.
Potential conflicts can occur as a result of
administrative, scientific, academic, fiduciary
or familial situations.
They are situations that can be PERCEIVED to
be conflicting, whether a “real” conflict exists
or not.
Ohio University Policy has a mandatory
disclosure policy if you:
Earn over $10,000 in a twelve month period
from your outside activity OR
Have over 5% equity in the entity
Applies to members of your immediate family
(spouse, domestic partner, dependent
children) as well as yourself.
Anything of monetary value, including but not
limited to:
◦
◦
◦
◦
Salary
Payments for services
Equity interests over 5%
Intellectual property rights
Excludes mutual, pension and other
investments over which you have no control
Outside work during regular academic year
should not exceed equivalent of 1 day per
week.
Consulting work must avoid activities that
involve a conflict of interest with assigned
Ohio University activities and programs
Faculty Handbook, section IV-D
Outside interests cannot interfere with
primary loyalty to Ohio University and your
academic role
Use of university resources must have prior
approval of Chair, Dean and VPR.
Your outside interests should not be in
direct competition with university interests
Full time administrative employees are
expected to devote their full-time
professional loyalty, time and energy to their
position.
You must use non-work hours and no
university resources
Federal Agencies
State Law
University Policies
Many Academic Publications
45 CFR Part 50, Subpart F
“Responsibility of Applicants for Promoting
Objectivity in Research for Which PHS Funding
is Sought”
Authority: 42 U.S.C. 216, 289b-1, 299c-3.
Intent is to assure objectivity by establishing
standards that preclude bias in design, conduct, or
reporting of research
Focuses on financial conflicts of interest
(FCOI)
Regulations apply to investigators, including
sub grantees, contractors, and collaborating
investigators.
Does not apply to applications for support
under Phase I of SBIR and STTR programs
An institutional conflict of interest policy should
require that each investigator disclose to a
responsible representative of the institution all
significant financial interests of the investigator
(including those of the investigator’s spouse and
dependent children) (i) that would reasonably
appear to be affected by the research or
educational activities funded or proposed for
funding by NSF; or (ii) in entities whose financial
interests would reasonably appear to be affected
by such activities.
Chapter 1 (Subchapter A) (Part 54)
Financial Disclosure by Clinical Investigators
The Food and Drug Administration (FDA)
regulations state that investigators that
receive compensation in excess of $25,000
from a corporate sponsor of a trial in which
the investigator is engaged must disclose to
the FDA at the time of filing for a new drug
application.
19.058, Conflict of Interest in Research,
Educational, and Public Service Activities
19.059, Employee Participation in Authorized
Private Companies Commercializing Ohio
University Research
“Conflict of Interest in Research, Educational,
and Public Service Activities”
Most conflict disclosures fall within the
parameters of this policy
States that faculty are primarily responsible
for their academic, research and service
obligations
“Employee Participation in Authorized Private
Companies Commercializing Ohio University
Research”
Applies to “employees, faculty, staff and students,
who create intellectual property owned by the Ohio
University and who desire to hold an equity interest
in a firm, corporation, or other association to which
Ohio University has assigned, licensed or
transferred Ohio University’s interests…”
Consulting
Licensing University Technology
Clinical Studies
Procurement
Mentoring
Institutional
A disclosure is filed specific to the funding
application.
If you have a potential conflict for one
proposal, it does not automatically apply to
all of your proposals.
Research conflicts of interest are usually
disclosed using LEO as you apply for funding
by completing the conflict of interest section
of the electronic transmittal
If you are not using LEO, you can download
the appropriate disclosure form from
www.ohio.edu/research/compliance
“A” is selected if you have no conflicts to
disclose
“B” is selected if you have a potential conflict
to disclose relative to the submission.
(Requires a subsequent paper process)
“C” is selected if you have a current disclosure
on file, but it is not relevant to the proposal
you are submitting
Still uses option A, B or C
Requires that you gather signatures on paper
for all options, however
Generally used for personnel not listed on the
grant proposal or “key personnel”
We have revised the COI forms to word forms
This should be easier to complete than the
previous form
PDF versions are also available
Should be on the compliance web site soon,
but we can e-mail them to you until then
Use this form only if you are unable to use
the LEO transmittal form to assure that no
conflict of interest exists. A form must be
completed for each proposal.
I assure that I have read Ohio University
Policy 19.058, “Conflict of Interest in
Research, Educational, and Public Service
Activities” and declare that I have nothing
that is, or could be perceived to be a conflict
of interest with this proposal.
Use this form to disclose a potential conflict
of interest situation.
A separate disclosure form must be used for
each entity with which you conduct business
Conflict includes any member of your
immediate family (spouse, domestic partner
or children)
Require that you complete an option “B”
disclosure statement in addition to
completing the LEO transmittal form.
Require you to obtain signatures from Center
or Institute (if applicable), Chair and Dean on
the additional disclosure statement!!
The B disclosure form is available at
www.ohio.edu/research/compliance
Use this form only if you are unable to use
the LEO transmittal form. Complete this form
if you have a current conflict of interest
disclosure on file with the Office of Research
Compliance, but that disclosure is not
applicable to this proposal.
*New Option for 2008*
A management plan is developed for some
disclosures to mitigate the potential conflict
Management plans are specific to each
disclosure
May require submission of additional pieces,
such as a student employment plan
Reduce or remove the financial interest creating the
conflict
Place safeguards that mitigate the conflict potential,
such having some decisions made by an independent
entity
Limit participation in portions of the proposed
research likely to create a conflict
Require that the researcher disclose his or her
conflicting financial interests to all collaborators and
any proposed trainees;
Disclose the conflict in publications
Work to remove students from being directly advised
or taught by faculty where a conflict exists
Assure publication rights for student participants
Student Use
Nepotism and Cronyism
Intellectual Property
Use of University Resources
Publication provisions
Use of Human Subjects
Oversight Requirements
Reporting and Annual Reviews
You must submit an annual renewal for your
disclosure
◦ If the potential conflict no longer exists you must
notify us
If significant changes occur during the year
you should submit an update to your
disclosure as they occur
Yes. We encourage employees to disclose
potential conflicts that do not meet the
financial threshold, but may still be
problematic, such as student employment.
This allows you to be transparent with
respect to outside interests.
Allowable situations
Situations that require disclosure but may not
need an extensive management plan
Situations that require disclosure and have
problematic elements that will require
mitigation and/or a management plan
Situations that are not permitted
Receipt of royalties or honoraria for
published scholarly works, seminars,
teaching, etc.
Honoraria for serving as a special reviewer
or work on review panels
Royalties under our intellectual property
policies if no other relationship with entity
Clinical income at OUCOM
You participate in research developed in
whole or part by you, and you or your
family receive royalties from an existing
agreement with the business, but have
no other significant financial interest
You assign students, etc. to research
projects where you are entitled to
receive royalties, but have no other
significant financial interest
You assign students, etc. to projects supported
by the business through an SRA, and have a
significant financial interest other than royalty
income
You receive research support from a business in
which you serve on the board of directors, or
other advisory board, even if you are not
compensated.
You hold an executive position in a business
engaged in commercial or research activities
directly related to your Ohio University
responsibilities.
Any situation in which an actual conflict
exists is not permitted.
The only “exceptions” are those handled
under Ohio University Policy and Procedure
19.059 where faculty entrepreneurship is
addressed.
Participation in clinical trials or evaluation
of other research in which you have a
significant financial interest other than
royalty income.
In the context of your position at Ohio
University, you make professional referrals
to a business in which you have a
significant financial interest.
Letter of admonition
Ineligibility to submit grant applications
Withholding of IRB or IACUC approvals
Suspension
Non-Renewal
Loss of Tenure
Consulting
Procurement
Mentoring
Clinical Studies
Avoid consulting relationships that have
the potential to divert time and effort from
your responsibilities to Ohio University.
Do not use students.
Be wary of situations that limit publication.
Do not use university stationary, etc. that
could create an impression the university
is involved with the activities.
Make sure you are devoting sufficient time
to your university obligations.
Be cautious that the potential financial gain
cannot be perceived to influence your
university mentoring relationships.
Disclose any personal or familial financial
interest or equity in a company that is
doing business with Ohio University.
If you make purchases using public funds,
you should not use companies which will
benefit you or your family. If there is no
alternative you must seek and receive
permission prior to purchasing.
Any relationship in which there is a real or
perceived power or influence imbalance has
the potential for conflict. (Faculty:Student)
Isolating these relationships with respect to
areas of personal financial gain is best.
If they cannot be isolated, then safeguards
must be created.
If you have a financial interest, it is best to
isolate yourself from the study.
At a minimum, expect a more intense review
and a robust management plan if you have a
financial interest.
If both the institution and you have financial
interests the clinical study should be
conducted elsewhere.
You have administrative responsibilities on
behalf of Ohio University that is beneficial to
the business in which you have a significant
financial interest
You have administrative responsibilities on
behalf of Ohio University with respect to an
SRA where you have a significant financial
interest
Slide 39
Jo Ellen Sherow
Ohio University
Office of Research Compliance
Researchers’ Financial Disclosures in the
Spotlight
Conflicts of interest, always an emotional topic,
returned to the headlines this week as Sen.
Charles Grassley, a longtime critic of the drug
industry’s potential influence on research,
released new evidence that prominent Harvard
University scientists had failed to disclose much
of their outside income from pharmaceutical
companies over the past eight years.
http://www.insidehighered.com/news/2008/06/12/conflict January 15, 2008
WEDNESDAY, JANUARY 21, 2009
In a review of the literature regarding the relationship between
smokeless tobacco use and cancer, a conflict of interest of one of the
article's authors was initially not disclosed (see: Boffetta P, Hecht S, Gray
N, Gupta P, Straif K. Smokeless tobacco and cancer. Lancet Oncology
2008; 9:667-675). The original article was published in July, 2008. That
article stated: "The authors declare no conflicts of interest." After the
editor of the journal was notified by a researcher with knowledge of a
potential conflict of interest of Dr. Stephen Hecht (one of the study
authors), an erratum was published in September 2008, which noted:
"During the immediate months preceding submission of the review SH
was acting in the capacity of an expert witness for the plaintiff in a
future court case against a smokeless tobacco company. SH declares his
participation in this case in no way influenced his writing or involvement
in the review."
http://tobaccoanalysis.blogspot.com/2009/01/conflict-of-interestnot.html
January 16, 2009 — More than one third of new
drug marketing applications approved by the US
Food and Drug Administration (FDA) were
missing information about potential conflicts of
interest for clinical trial investigators, which
could allow bias to creep into the approvals
process, a government report released this week
has found. The FDA has said that it agrees with
most of the report's findings.
http://www.medscape.com/viewarticle/586980
Do collaborations between biotech companies
and academic centers constitute a conflict of
interest?
Biotechnology industry partnerships with
universities and academic centers have been
fruitful for both. So why is there so much
concern about conflict of interest and is that
concern appropriate?
http://www.redorbit.com/news/health/750100/genetic_engineering_news_p
osts_podcast_on_industrialacademic_collaborations_are_these/index.html
Universities are responsible for use of public
funds and therefore must maintain the public
trust.
Identifying and mitigating situations that may
have the potential for conflict maintains the
integrity of the university.
Maintaining integrity allows the university to
do credible academic research.
To provide information on the purpose of the
conflict of interest requirements.
To provide a basic overview of conflicts of
interest
To introduce the disclosure process and the use
of management plans
To provide information on the need for updates
and annual renewals.
Situations where financial considerations
compromise your professional judgment.
“Actual Conflict of Interest”
◦ Not permitted
Situations where an independent observer
might reasonably question whether your
professional actions or decisions are
determined by considerations of personal
gain. “Perceived Conflict of Interest”
◦ Managed
Potential conflicts may be financial or may be
a conflict of time, effort and/or commitment.
Potential conflicts can occur as a result of
administrative, scientific, academic, fiduciary
or familial situations.
They are situations that can be PERCEIVED to
be conflicting, whether a “real” conflict exists
or not.
Ohio University Policy has a mandatory
disclosure policy if you:
Earn over $10,000 in a twelve month period
from your outside activity OR
Have over 5% equity in the entity
Applies to members of your immediate family
(spouse, domestic partner, dependent
children) as well as yourself.
Anything of monetary value, including but not
limited to:
◦
◦
◦
◦
Salary
Payments for services
Equity interests over 5%
Intellectual property rights
Excludes mutual, pension and other
investments over which you have no control
Outside work during regular academic year
should not exceed equivalent of 1 day per
week.
Consulting work must avoid activities that
involve a conflict of interest with assigned
Ohio University activities and programs
Faculty Handbook, section IV-D
Outside interests cannot interfere with
primary loyalty to Ohio University and your
academic role
Use of university resources must have prior
approval of Chair, Dean and VPR.
Your outside interests should not be in
direct competition with university interests
Full time administrative employees are
expected to devote their full-time
professional loyalty, time and energy to their
position.
You must use non-work hours and no
university resources
Federal Agencies
State Law
University Policies
Many Academic Publications
45 CFR Part 50, Subpart F
“Responsibility of Applicants for Promoting
Objectivity in Research for Which PHS Funding
is Sought”
Authority: 42 U.S.C. 216, 289b-1, 299c-3.
Intent is to assure objectivity by establishing
standards that preclude bias in design, conduct, or
reporting of research
Focuses on financial conflicts of interest
(FCOI)
Regulations apply to investigators, including
sub grantees, contractors, and collaborating
investigators.
Does not apply to applications for support
under Phase I of SBIR and STTR programs
An institutional conflict of interest policy should
require that each investigator disclose to a
responsible representative of the institution all
significant financial interests of the investigator
(including those of the investigator’s spouse and
dependent children) (i) that would reasonably
appear to be affected by the research or
educational activities funded or proposed for
funding by NSF; or (ii) in entities whose financial
interests would reasonably appear to be affected
by such activities.
Chapter 1 (Subchapter A) (Part 54)
Financial Disclosure by Clinical Investigators
The Food and Drug Administration (FDA)
regulations state that investigators that
receive compensation in excess of $25,000
from a corporate sponsor of a trial in which
the investigator is engaged must disclose to
the FDA at the time of filing for a new drug
application.
19.058, Conflict of Interest in Research,
Educational, and Public Service Activities
19.059, Employee Participation in Authorized
Private Companies Commercializing Ohio
University Research
“Conflict of Interest in Research, Educational,
and Public Service Activities”
Most conflict disclosures fall within the
parameters of this policy
States that faculty are primarily responsible
for their academic, research and service
obligations
“Employee Participation in Authorized Private
Companies Commercializing Ohio University
Research”
Applies to “employees, faculty, staff and students,
who create intellectual property owned by the Ohio
University and who desire to hold an equity interest
in a firm, corporation, or other association to which
Ohio University has assigned, licensed or
transferred Ohio University’s interests…”
Consulting
Licensing University Technology
Clinical Studies
Procurement
Mentoring
Institutional
A disclosure is filed specific to the funding
application.
If you have a potential conflict for one
proposal, it does not automatically apply to
all of your proposals.
Research conflicts of interest are usually
disclosed using LEO as you apply for funding
by completing the conflict of interest section
of the electronic transmittal
If you are not using LEO, you can download
the appropriate disclosure form from
www.ohio.edu/research/compliance
“A” is selected if you have no conflicts to
disclose
“B” is selected if you have a potential conflict
to disclose relative to the submission.
(Requires a subsequent paper process)
“C” is selected if you have a current disclosure
on file, but it is not relevant to the proposal
you are submitting
Still uses option A, B or C
Requires that you gather signatures on paper
for all options, however
Generally used for personnel not listed on the
grant proposal or “key personnel”
We have revised the COI forms to word forms
This should be easier to complete than the
previous form
PDF versions are also available
Should be on the compliance web site soon,
but we can e-mail them to you until then
Use this form only if you are unable to use
the LEO transmittal form to assure that no
conflict of interest exists. A form must be
completed for each proposal.
I assure that I have read Ohio University
Policy 19.058, “Conflict of Interest in
Research, Educational, and Public Service
Activities” and declare that I have nothing
that is, or could be perceived to be a conflict
of interest with this proposal.
Use this form to disclose a potential conflict
of interest situation.
A separate disclosure form must be used for
each entity with which you conduct business
Conflict includes any member of your
immediate family (spouse, domestic partner
or children)
Require that you complete an option “B”
disclosure statement in addition to
completing the LEO transmittal form.
Require you to obtain signatures from Center
or Institute (if applicable), Chair and Dean on
the additional disclosure statement!!
The B disclosure form is available at
www.ohio.edu/research/compliance
Use this form only if you are unable to use
the LEO transmittal form. Complete this form
if you have a current conflict of interest
disclosure on file with the Office of Research
Compliance, but that disclosure is not
applicable to this proposal.
*New Option for 2008*
A management plan is developed for some
disclosures to mitigate the potential conflict
Management plans are specific to each
disclosure
May require submission of additional pieces,
such as a student employment plan
Reduce or remove the financial interest creating the
conflict
Place safeguards that mitigate the conflict potential,
such having some decisions made by an independent
entity
Limit participation in portions of the proposed
research likely to create a conflict
Require that the researcher disclose his or her
conflicting financial interests to all collaborators and
any proposed trainees;
Disclose the conflict in publications
Work to remove students from being directly advised
or taught by faculty where a conflict exists
Assure publication rights for student participants
Student Use
Nepotism and Cronyism
Intellectual Property
Use of University Resources
Publication provisions
Use of Human Subjects
Oversight Requirements
Reporting and Annual Reviews
You must submit an annual renewal for your
disclosure
◦ If the potential conflict no longer exists you must
notify us
If significant changes occur during the year
you should submit an update to your
disclosure as they occur
Yes. We encourage employees to disclose
potential conflicts that do not meet the
financial threshold, but may still be
problematic, such as student employment.
This allows you to be transparent with
respect to outside interests.
Allowable situations
Situations that require disclosure but may not
need an extensive management plan
Situations that require disclosure and have
problematic elements that will require
mitigation and/or a management plan
Situations that are not permitted
Receipt of royalties or honoraria for
published scholarly works, seminars,
teaching, etc.
Honoraria for serving as a special reviewer
or work on review panels
Royalties under our intellectual property
policies if no other relationship with entity
Clinical income at OUCOM
You participate in research developed in
whole or part by you, and you or your
family receive royalties from an existing
agreement with the business, but have
no other significant financial interest
You assign students, etc. to research
projects where you are entitled to
receive royalties, but have no other
significant financial interest
You assign students, etc. to projects supported
by the business through an SRA, and have a
significant financial interest other than royalty
income
You receive research support from a business in
which you serve on the board of directors, or
other advisory board, even if you are not
compensated.
You hold an executive position in a business
engaged in commercial or research activities
directly related to your Ohio University
responsibilities.
Any situation in which an actual conflict
exists is not permitted.
The only “exceptions” are those handled
under Ohio University Policy and Procedure
19.059 where faculty entrepreneurship is
addressed.
Participation in clinical trials or evaluation
of other research in which you have a
significant financial interest other than
royalty income.
In the context of your position at Ohio
University, you make professional referrals
to a business in which you have a
significant financial interest.
Letter of admonition
Ineligibility to submit grant applications
Withholding of IRB or IACUC approvals
Suspension
Non-Renewal
Loss of Tenure
Consulting
Procurement
Mentoring
Clinical Studies
Avoid consulting relationships that have
the potential to divert time and effort from
your responsibilities to Ohio University.
Do not use students.
Be wary of situations that limit publication.
Do not use university stationary, etc. that
could create an impression the university
is involved with the activities.
Make sure you are devoting sufficient time
to your university obligations.
Be cautious that the potential financial gain
cannot be perceived to influence your
university mentoring relationships.
Disclose any personal or familial financial
interest or equity in a company that is
doing business with Ohio University.
If you make purchases using public funds,
you should not use companies which will
benefit you or your family. If there is no
alternative you must seek and receive
permission prior to purchasing.
Any relationship in which there is a real or
perceived power or influence imbalance has
the potential for conflict. (Faculty:Student)
Isolating these relationships with respect to
areas of personal financial gain is best.
If they cannot be isolated, then safeguards
must be created.
If you have a financial interest, it is best to
isolate yourself from the study.
At a minimum, expect a more intense review
and a robust management plan if you have a
financial interest.
If both the institution and you have financial
interests the clinical study should be
conducted elsewhere.
You have administrative responsibilities on
behalf of Ohio University that is beneficial to
the business in which you have a significant
financial interest
You have administrative responsibilities on
behalf of Ohio University with respect to an
SRA where you have a significant financial
interest
Slide 40
Jo Ellen Sherow
Ohio University
Office of Research Compliance
Researchers’ Financial Disclosures in the
Spotlight
Conflicts of interest, always an emotional topic,
returned to the headlines this week as Sen.
Charles Grassley, a longtime critic of the drug
industry’s potential influence on research,
released new evidence that prominent Harvard
University scientists had failed to disclose much
of their outside income from pharmaceutical
companies over the past eight years.
http://www.insidehighered.com/news/2008/06/12/conflict January 15, 2008
WEDNESDAY, JANUARY 21, 2009
In a review of the literature regarding the relationship between
smokeless tobacco use and cancer, a conflict of interest of one of the
article's authors was initially not disclosed (see: Boffetta P, Hecht S, Gray
N, Gupta P, Straif K. Smokeless tobacco and cancer. Lancet Oncology
2008; 9:667-675). The original article was published in July, 2008. That
article stated: "The authors declare no conflicts of interest." After the
editor of the journal was notified by a researcher with knowledge of a
potential conflict of interest of Dr. Stephen Hecht (one of the study
authors), an erratum was published in September 2008, which noted:
"During the immediate months preceding submission of the review SH
was acting in the capacity of an expert witness for the plaintiff in a
future court case against a smokeless tobacco company. SH declares his
participation in this case in no way influenced his writing or involvement
in the review."
http://tobaccoanalysis.blogspot.com/2009/01/conflict-of-interestnot.html
January 16, 2009 — More than one third of new
drug marketing applications approved by the US
Food and Drug Administration (FDA) were
missing information about potential conflicts of
interest for clinical trial investigators, which
could allow bias to creep into the approvals
process, a government report released this week
has found. The FDA has said that it agrees with
most of the report's findings.
http://www.medscape.com/viewarticle/586980
Do collaborations between biotech companies
and academic centers constitute a conflict of
interest?
Biotechnology industry partnerships with
universities and academic centers have been
fruitful for both. So why is there so much
concern about conflict of interest and is that
concern appropriate?
http://www.redorbit.com/news/health/750100/genetic_engineering_news_p
osts_podcast_on_industrialacademic_collaborations_are_these/index.html
Universities are responsible for use of public
funds and therefore must maintain the public
trust.
Identifying and mitigating situations that may
have the potential for conflict maintains the
integrity of the university.
Maintaining integrity allows the university to
do credible academic research.
To provide information on the purpose of the
conflict of interest requirements.
To provide a basic overview of conflicts of
interest
To introduce the disclosure process and the use
of management plans
To provide information on the need for updates
and annual renewals.
Situations where financial considerations
compromise your professional judgment.
“Actual Conflict of Interest”
◦ Not permitted
Situations where an independent observer
might reasonably question whether your
professional actions or decisions are
determined by considerations of personal
gain. “Perceived Conflict of Interest”
◦ Managed
Potential conflicts may be financial or may be
a conflict of time, effort and/or commitment.
Potential conflicts can occur as a result of
administrative, scientific, academic, fiduciary
or familial situations.
They are situations that can be PERCEIVED to
be conflicting, whether a “real” conflict exists
or not.
Ohio University Policy has a mandatory
disclosure policy if you:
Earn over $10,000 in a twelve month period
from your outside activity OR
Have over 5% equity in the entity
Applies to members of your immediate family
(spouse, domestic partner, dependent
children) as well as yourself.
Anything of monetary value, including but not
limited to:
◦
◦
◦
◦
Salary
Payments for services
Equity interests over 5%
Intellectual property rights
Excludes mutual, pension and other
investments over which you have no control
Outside work during regular academic year
should not exceed equivalent of 1 day per
week.
Consulting work must avoid activities that
involve a conflict of interest with assigned
Ohio University activities and programs
Faculty Handbook, section IV-D
Outside interests cannot interfere with
primary loyalty to Ohio University and your
academic role
Use of university resources must have prior
approval of Chair, Dean and VPR.
Your outside interests should not be in
direct competition with university interests
Full time administrative employees are
expected to devote their full-time
professional loyalty, time and energy to their
position.
You must use non-work hours and no
university resources
Federal Agencies
State Law
University Policies
Many Academic Publications
45 CFR Part 50, Subpart F
“Responsibility of Applicants for Promoting
Objectivity in Research for Which PHS Funding
is Sought”
Authority: 42 U.S.C. 216, 289b-1, 299c-3.
Intent is to assure objectivity by establishing
standards that preclude bias in design, conduct, or
reporting of research
Focuses on financial conflicts of interest
(FCOI)
Regulations apply to investigators, including
sub grantees, contractors, and collaborating
investigators.
Does not apply to applications for support
under Phase I of SBIR and STTR programs
An institutional conflict of interest policy should
require that each investigator disclose to a
responsible representative of the institution all
significant financial interests of the investigator
(including those of the investigator’s spouse and
dependent children) (i) that would reasonably
appear to be affected by the research or
educational activities funded or proposed for
funding by NSF; or (ii) in entities whose financial
interests would reasonably appear to be affected
by such activities.
Chapter 1 (Subchapter A) (Part 54)
Financial Disclosure by Clinical Investigators
The Food and Drug Administration (FDA)
regulations state that investigators that
receive compensation in excess of $25,000
from a corporate sponsor of a trial in which
the investigator is engaged must disclose to
the FDA at the time of filing for a new drug
application.
19.058, Conflict of Interest in Research,
Educational, and Public Service Activities
19.059, Employee Participation in Authorized
Private Companies Commercializing Ohio
University Research
“Conflict of Interest in Research, Educational,
and Public Service Activities”
Most conflict disclosures fall within the
parameters of this policy
States that faculty are primarily responsible
for their academic, research and service
obligations
“Employee Participation in Authorized Private
Companies Commercializing Ohio University
Research”
Applies to “employees, faculty, staff and students,
who create intellectual property owned by the Ohio
University and who desire to hold an equity interest
in a firm, corporation, or other association to which
Ohio University has assigned, licensed or
transferred Ohio University’s interests…”
Consulting
Licensing University Technology
Clinical Studies
Procurement
Mentoring
Institutional
A disclosure is filed specific to the funding
application.
If you have a potential conflict for one
proposal, it does not automatically apply to
all of your proposals.
Research conflicts of interest are usually
disclosed using LEO as you apply for funding
by completing the conflict of interest section
of the electronic transmittal
If you are not using LEO, you can download
the appropriate disclosure form from
www.ohio.edu/research/compliance
“A” is selected if you have no conflicts to
disclose
“B” is selected if you have a potential conflict
to disclose relative to the submission.
(Requires a subsequent paper process)
“C” is selected if you have a current disclosure
on file, but it is not relevant to the proposal
you are submitting
Still uses option A, B or C
Requires that you gather signatures on paper
for all options, however
Generally used for personnel not listed on the
grant proposal or “key personnel”
We have revised the COI forms to word forms
This should be easier to complete than the
previous form
PDF versions are also available
Should be on the compliance web site soon,
but we can e-mail them to you until then
Use this form only if you are unable to use
the LEO transmittal form to assure that no
conflict of interest exists. A form must be
completed for each proposal.
I assure that I have read Ohio University
Policy 19.058, “Conflict of Interest in
Research, Educational, and Public Service
Activities” and declare that I have nothing
that is, or could be perceived to be a conflict
of interest with this proposal.
Use this form to disclose a potential conflict
of interest situation.
A separate disclosure form must be used for
each entity with which you conduct business
Conflict includes any member of your
immediate family (spouse, domestic partner
or children)
Require that you complete an option “B”
disclosure statement in addition to
completing the LEO transmittal form.
Require you to obtain signatures from Center
or Institute (if applicable), Chair and Dean on
the additional disclosure statement!!
The B disclosure form is available at
www.ohio.edu/research/compliance
Use this form only if you are unable to use
the LEO transmittal form. Complete this form
if you have a current conflict of interest
disclosure on file with the Office of Research
Compliance, but that disclosure is not
applicable to this proposal.
*New Option for 2008*
A management plan is developed for some
disclosures to mitigate the potential conflict
Management plans are specific to each
disclosure
May require submission of additional pieces,
such as a student employment plan
Reduce or remove the financial interest creating the
conflict
Place safeguards that mitigate the conflict potential,
such having some decisions made by an independent
entity
Limit participation in portions of the proposed
research likely to create a conflict
Require that the researcher disclose his or her
conflicting financial interests to all collaborators and
any proposed trainees;
Disclose the conflict in publications
Work to remove students from being directly advised
or taught by faculty where a conflict exists
Assure publication rights for student participants
Student Use
Nepotism and Cronyism
Intellectual Property
Use of University Resources
Publication provisions
Use of Human Subjects
Oversight Requirements
Reporting and Annual Reviews
You must submit an annual renewal for your
disclosure
◦ If the potential conflict no longer exists you must
notify us
If significant changes occur during the year
you should submit an update to your
disclosure as they occur
Yes. We encourage employees to disclose
potential conflicts that do not meet the
financial threshold, but may still be
problematic, such as student employment.
This allows you to be transparent with
respect to outside interests.
Allowable situations
Situations that require disclosure but may not
need an extensive management plan
Situations that require disclosure and have
problematic elements that will require
mitigation and/or a management plan
Situations that are not permitted
Receipt of royalties or honoraria for
published scholarly works, seminars,
teaching, etc.
Honoraria for serving as a special reviewer
or work on review panels
Royalties under our intellectual property
policies if no other relationship with entity
Clinical income at OUCOM
You participate in research developed in
whole or part by you, and you or your
family receive royalties from an existing
agreement with the business, but have
no other significant financial interest
You assign students, etc. to research
projects where you are entitled to
receive royalties, but have no other
significant financial interest
You assign students, etc. to projects supported
by the business through an SRA, and have a
significant financial interest other than royalty
income
You receive research support from a business in
which you serve on the board of directors, or
other advisory board, even if you are not
compensated.
You hold an executive position in a business
engaged in commercial or research activities
directly related to your Ohio University
responsibilities.
Any situation in which an actual conflict
exists is not permitted.
The only “exceptions” are those handled
under Ohio University Policy and Procedure
19.059 where faculty entrepreneurship is
addressed.
Participation in clinical trials or evaluation
of other research in which you have a
significant financial interest other than
royalty income.
In the context of your position at Ohio
University, you make professional referrals
to a business in which you have a
significant financial interest.
Letter of admonition
Ineligibility to submit grant applications
Withholding of IRB or IACUC approvals
Suspension
Non-Renewal
Loss of Tenure
Consulting
Procurement
Mentoring
Clinical Studies
Avoid consulting relationships that have
the potential to divert time and effort from
your responsibilities to Ohio University.
Do not use students.
Be wary of situations that limit publication.
Do not use university stationary, etc. that
could create an impression the university
is involved with the activities.
Make sure you are devoting sufficient time
to your university obligations.
Be cautious that the potential financial gain
cannot be perceived to influence your
university mentoring relationships.
Disclose any personal or familial financial
interest or equity in a company that is
doing business with Ohio University.
If you make purchases using public funds,
you should not use companies which will
benefit you or your family. If there is no
alternative you must seek and receive
permission prior to purchasing.
Any relationship in which there is a real or
perceived power or influence imbalance has
the potential for conflict. (Faculty:Student)
Isolating these relationships with respect to
areas of personal financial gain is best.
If they cannot be isolated, then safeguards
must be created.
If you have a financial interest, it is best to
isolate yourself from the study.
At a minimum, expect a more intense review
and a robust management plan if you have a
financial interest.
If both the institution and you have financial
interests the clinical study should be
conducted elsewhere.
You have administrative responsibilities on
behalf of Ohio University that is beneficial to
the business in which you have a significant
financial interest
You have administrative responsibilities on
behalf of Ohio University with respect to an
SRA where you have a significant financial
interest
Slide 41
Jo Ellen Sherow
Ohio University
Office of Research Compliance
Researchers’ Financial Disclosures in the
Spotlight
Conflicts of interest, always an emotional topic,
returned to the headlines this week as Sen.
Charles Grassley, a longtime critic of the drug
industry’s potential influence on research,
released new evidence that prominent Harvard
University scientists had failed to disclose much
of their outside income from pharmaceutical
companies over the past eight years.
http://www.insidehighered.com/news/2008/06/12/conflict January 15, 2008
WEDNESDAY, JANUARY 21, 2009
In a review of the literature regarding the relationship between
smokeless tobacco use and cancer, a conflict of interest of one of the
article's authors was initially not disclosed (see: Boffetta P, Hecht S, Gray
N, Gupta P, Straif K. Smokeless tobacco and cancer. Lancet Oncology
2008; 9:667-675). The original article was published in July, 2008. That
article stated: "The authors declare no conflicts of interest." After the
editor of the journal was notified by a researcher with knowledge of a
potential conflict of interest of Dr. Stephen Hecht (one of the study
authors), an erratum was published in September 2008, which noted:
"During the immediate months preceding submission of the review SH
was acting in the capacity of an expert witness for the plaintiff in a
future court case against a smokeless tobacco company. SH declares his
participation in this case in no way influenced his writing or involvement
in the review."
http://tobaccoanalysis.blogspot.com/2009/01/conflict-of-interestnot.html
January 16, 2009 — More than one third of new
drug marketing applications approved by the US
Food and Drug Administration (FDA) were
missing information about potential conflicts of
interest for clinical trial investigators, which
could allow bias to creep into the approvals
process, a government report released this week
has found. The FDA has said that it agrees with
most of the report's findings.
http://www.medscape.com/viewarticle/586980
Do collaborations between biotech companies
and academic centers constitute a conflict of
interest?
Biotechnology industry partnerships with
universities and academic centers have been
fruitful for both. So why is there so much
concern about conflict of interest and is that
concern appropriate?
http://www.redorbit.com/news/health/750100/genetic_engineering_news_p
osts_podcast_on_industrialacademic_collaborations_are_these/index.html
Universities are responsible for use of public
funds and therefore must maintain the public
trust.
Identifying and mitigating situations that may
have the potential for conflict maintains the
integrity of the university.
Maintaining integrity allows the university to
do credible academic research.
To provide information on the purpose of the
conflict of interest requirements.
To provide a basic overview of conflicts of
interest
To introduce the disclosure process and the use
of management plans
To provide information on the need for updates
and annual renewals.
Situations where financial considerations
compromise your professional judgment.
“Actual Conflict of Interest”
◦ Not permitted
Situations where an independent observer
might reasonably question whether your
professional actions or decisions are
determined by considerations of personal
gain. “Perceived Conflict of Interest”
◦ Managed
Potential conflicts may be financial or may be
a conflict of time, effort and/or commitment.
Potential conflicts can occur as a result of
administrative, scientific, academic, fiduciary
or familial situations.
They are situations that can be PERCEIVED to
be conflicting, whether a “real” conflict exists
or not.
Ohio University Policy has a mandatory
disclosure policy if you:
Earn over $10,000 in a twelve month period
from your outside activity OR
Have over 5% equity in the entity
Applies to members of your immediate family
(spouse, domestic partner, dependent
children) as well as yourself.
Anything of monetary value, including but not
limited to:
◦
◦
◦
◦
Salary
Payments for services
Equity interests over 5%
Intellectual property rights
Excludes mutual, pension and other
investments over which you have no control
Outside work during regular academic year
should not exceed equivalent of 1 day per
week.
Consulting work must avoid activities that
involve a conflict of interest with assigned
Ohio University activities and programs
Faculty Handbook, section IV-D
Outside interests cannot interfere with
primary loyalty to Ohio University and your
academic role
Use of university resources must have prior
approval of Chair, Dean and VPR.
Your outside interests should not be in
direct competition with university interests
Full time administrative employees are
expected to devote their full-time
professional loyalty, time and energy to their
position.
You must use non-work hours and no
university resources
Federal Agencies
State Law
University Policies
Many Academic Publications
45 CFR Part 50, Subpart F
“Responsibility of Applicants for Promoting
Objectivity in Research for Which PHS Funding
is Sought”
Authority: 42 U.S.C. 216, 289b-1, 299c-3.
Intent is to assure objectivity by establishing
standards that preclude bias in design, conduct, or
reporting of research
Focuses on financial conflicts of interest
(FCOI)
Regulations apply to investigators, including
sub grantees, contractors, and collaborating
investigators.
Does not apply to applications for support
under Phase I of SBIR and STTR programs
An institutional conflict of interest policy should
require that each investigator disclose to a
responsible representative of the institution all
significant financial interests of the investigator
(including those of the investigator’s spouse and
dependent children) (i) that would reasonably
appear to be affected by the research or
educational activities funded or proposed for
funding by NSF; or (ii) in entities whose financial
interests would reasonably appear to be affected
by such activities.
Chapter 1 (Subchapter A) (Part 54)
Financial Disclosure by Clinical Investigators
The Food and Drug Administration (FDA)
regulations state that investigators that
receive compensation in excess of $25,000
from a corporate sponsor of a trial in which
the investigator is engaged must disclose to
the FDA at the time of filing for a new drug
application.
19.058, Conflict of Interest in Research,
Educational, and Public Service Activities
19.059, Employee Participation in Authorized
Private Companies Commercializing Ohio
University Research
“Conflict of Interest in Research, Educational,
and Public Service Activities”
Most conflict disclosures fall within the
parameters of this policy
States that faculty are primarily responsible
for their academic, research and service
obligations
“Employee Participation in Authorized Private
Companies Commercializing Ohio University
Research”
Applies to “employees, faculty, staff and students,
who create intellectual property owned by the Ohio
University and who desire to hold an equity interest
in a firm, corporation, or other association to which
Ohio University has assigned, licensed or
transferred Ohio University’s interests…”
Consulting
Licensing University Technology
Clinical Studies
Procurement
Mentoring
Institutional
A disclosure is filed specific to the funding
application.
If you have a potential conflict for one
proposal, it does not automatically apply to
all of your proposals.
Research conflicts of interest are usually
disclosed using LEO as you apply for funding
by completing the conflict of interest section
of the electronic transmittal
If you are not using LEO, you can download
the appropriate disclosure form from
www.ohio.edu/research/compliance
“A” is selected if you have no conflicts to
disclose
“B” is selected if you have a potential conflict
to disclose relative to the submission.
(Requires a subsequent paper process)
“C” is selected if you have a current disclosure
on file, but it is not relevant to the proposal
you are submitting
Still uses option A, B or C
Requires that you gather signatures on paper
for all options, however
Generally used for personnel not listed on the
grant proposal or “key personnel”
We have revised the COI forms to word forms
This should be easier to complete than the
previous form
PDF versions are also available
Should be on the compliance web site soon,
but we can e-mail them to you until then
Use this form only if you are unable to use
the LEO transmittal form to assure that no
conflict of interest exists. A form must be
completed for each proposal.
I assure that I have read Ohio University
Policy 19.058, “Conflict of Interest in
Research, Educational, and Public Service
Activities” and declare that I have nothing
that is, or could be perceived to be a conflict
of interest with this proposal.
Use this form to disclose a potential conflict
of interest situation.
A separate disclosure form must be used for
each entity with which you conduct business
Conflict includes any member of your
immediate family (spouse, domestic partner
or children)
Require that you complete an option “B”
disclosure statement in addition to
completing the LEO transmittal form.
Require you to obtain signatures from Center
or Institute (if applicable), Chair and Dean on
the additional disclosure statement!!
The B disclosure form is available at
www.ohio.edu/research/compliance
Use this form only if you are unable to use
the LEO transmittal form. Complete this form
if you have a current conflict of interest
disclosure on file with the Office of Research
Compliance, but that disclosure is not
applicable to this proposal.
*New Option for 2008*
A management plan is developed for some
disclosures to mitigate the potential conflict
Management plans are specific to each
disclosure
May require submission of additional pieces,
such as a student employment plan
Reduce or remove the financial interest creating the
conflict
Place safeguards that mitigate the conflict potential,
such having some decisions made by an independent
entity
Limit participation in portions of the proposed
research likely to create a conflict
Require that the researcher disclose his or her
conflicting financial interests to all collaborators and
any proposed trainees;
Disclose the conflict in publications
Work to remove students from being directly advised
or taught by faculty where a conflict exists
Assure publication rights for student participants
Student Use
Nepotism and Cronyism
Intellectual Property
Use of University Resources
Publication provisions
Use of Human Subjects
Oversight Requirements
Reporting and Annual Reviews
You must submit an annual renewal for your
disclosure
◦ If the potential conflict no longer exists you must
notify us
If significant changes occur during the year
you should submit an update to your
disclosure as they occur
Yes. We encourage employees to disclose
potential conflicts that do not meet the
financial threshold, but may still be
problematic, such as student employment.
This allows you to be transparent with
respect to outside interests.
Allowable situations
Situations that require disclosure but may not
need an extensive management plan
Situations that require disclosure and have
problematic elements that will require
mitigation and/or a management plan
Situations that are not permitted
Receipt of royalties or honoraria for
published scholarly works, seminars,
teaching, etc.
Honoraria for serving as a special reviewer
or work on review panels
Royalties under our intellectual property
policies if no other relationship with entity
Clinical income at OUCOM
You participate in research developed in
whole or part by you, and you or your
family receive royalties from an existing
agreement with the business, but have
no other significant financial interest
You assign students, etc. to research
projects where you are entitled to
receive royalties, but have no other
significant financial interest
You assign students, etc. to projects supported
by the business through an SRA, and have a
significant financial interest other than royalty
income
You receive research support from a business in
which you serve on the board of directors, or
other advisory board, even if you are not
compensated.
You hold an executive position in a business
engaged in commercial or research activities
directly related to your Ohio University
responsibilities.
Any situation in which an actual conflict
exists is not permitted.
The only “exceptions” are those handled
under Ohio University Policy and Procedure
19.059 where faculty entrepreneurship is
addressed.
Participation in clinical trials or evaluation
of other research in which you have a
significant financial interest other than
royalty income.
In the context of your position at Ohio
University, you make professional referrals
to a business in which you have a
significant financial interest.
Letter of admonition
Ineligibility to submit grant applications
Withholding of IRB or IACUC approvals
Suspension
Non-Renewal
Loss of Tenure
Consulting
Procurement
Mentoring
Clinical Studies
Avoid consulting relationships that have
the potential to divert time and effort from
your responsibilities to Ohio University.
Do not use students.
Be wary of situations that limit publication.
Do not use university stationary, etc. that
could create an impression the university
is involved with the activities.
Make sure you are devoting sufficient time
to your university obligations.
Be cautious that the potential financial gain
cannot be perceived to influence your
university mentoring relationships.
Disclose any personal or familial financial
interest or equity in a company that is
doing business with Ohio University.
If you make purchases using public funds,
you should not use companies which will
benefit you or your family. If there is no
alternative you must seek and receive
permission prior to purchasing.
Any relationship in which there is a real or
perceived power or influence imbalance has
the potential for conflict. (Faculty:Student)
Isolating these relationships with respect to
areas of personal financial gain is best.
If they cannot be isolated, then safeguards
must be created.
If you have a financial interest, it is best to
isolate yourself from the study.
At a minimum, expect a more intense review
and a robust management plan if you have a
financial interest.
If both the institution and you have financial
interests the clinical study should be
conducted elsewhere.
You have administrative responsibilities on
behalf of Ohio University that is beneficial to
the business in which you have a significant
financial interest
You have administrative responsibilities on
behalf of Ohio University with respect to an
SRA where you have a significant financial
interest
Slide 42
Jo Ellen Sherow
Ohio University
Office of Research Compliance
Researchers’ Financial Disclosures in the
Spotlight
Conflicts of interest, always an emotional topic,
returned to the headlines this week as Sen.
Charles Grassley, a longtime critic of the drug
industry’s potential influence on research,
released new evidence that prominent Harvard
University scientists had failed to disclose much
of their outside income from pharmaceutical
companies over the past eight years.
http://www.insidehighered.com/news/2008/06/12/conflict January 15, 2008
WEDNESDAY, JANUARY 21, 2009
In a review of the literature regarding the relationship between
smokeless tobacco use and cancer, a conflict of interest of one of the
article's authors was initially not disclosed (see: Boffetta P, Hecht S, Gray
N, Gupta P, Straif K. Smokeless tobacco and cancer. Lancet Oncology
2008; 9:667-675). The original article was published in July, 2008. That
article stated: "The authors declare no conflicts of interest." After the
editor of the journal was notified by a researcher with knowledge of a
potential conflict of interest of Dr. Stephen Hecht (one of the study
authors), an erratum was published in September 2008, which noted:
"During the immediate months preceding submission of the review SH
was acting in the capacity of an expert witness for the plaintiff in a
future court case against a smokeless tobacco company. SH declares his
participation in this case in no way influenced his writing or involvement
in the review."
http://tobaccoanalysis.blogspot.com/2009/01/conflict-of-interestnot.html
January 16, 2009 — More than one third of new
drug marketing applications approved by the US
Food and Drug Administration (FDA) were
missing information about potential conflicts of
interest for clinical trial investigators, which
could allow bias to creep into the approvals
process, a government report released this week
has found. The FDA has said that it agrees with
most of the report's findings.
http://www.medscape.com/viewarticle/586980
Do collaborations between biotech companies
and academic centers constitute a conflict of
interest?
Biotechnology industry partnerships with
universities and academic centers have been
fruitful for both. So why is there so much
concern about conflict of interest and is that
concern appropriate?
http://www.redorbit.com/news/health/750100/genetic_engineering_news_p
osts_podcast_on_industrialacademic_collaborations_are_these/index.html
Universities are responsible for use of public
funds and therefore must maintain the public
trust.
Identifying and mitigating situations that may
have the potential for conflict maintains the
integrity of the university.
Maintaining integrity allows the university to
do credible academic research.
To provide information on the purpose of the
conflict of interest requirements.
To provide a basic overview of conflicts of
interest
To introduce the disclosure process and the use
of management plans
To provide information on the need for updates
and annual renewals.
Situations where financial considerations
compromise your professional judgment.
“Actual Conflict of Interest”
◦ Not permitted
Situations where an independent observer
might reasonably question whether your
professional actions or decisions are
determined by considerations of personal
gain. “Perceived Conflict of Interest”
◦ Managed
Potential conflicts may be financial or may be
a conflict of time, effort and/or commitment.
Potential conflicts can occur as a result of
administrative, scientific, academic, fiduciary
or familial situations.
They are situations that can be PERCEIVED to
be conflicting, whether a “real” conflict exists
or not.
Ohio University Policy has a mandatory
disclosure policy if you:
Earn over $10,000 in a twelve month period
from your outside activity OR
Have over 5% equity in the entity
Applies to members of your immediate family
(spouse, domestic partner, dependent
children) as well as yourself.
Anything of monetary value, including but not
limited to:
◦
◦
◦
◦
Salary
Payments for services
Equity interests over 5%
Intellectual property rights
Excludes mutual, pension and other
investments over which you have no control
Outside work during regular academic year
should not exceed equivalent of 1 day per
week.
Consulting work must avoid activities that
involve a conflict of interest with assigned
Ohio University activities and programs
Faculty Handbook, section IV-D
Outside interests cannot interfere with
primary loyalty to Ohio University and your
academic role
Use of university resources must have prior
approval of Chair, Dean and VPR.
Your outside interests should not be in
direct competition with university interests
Full time administrative employees are
expected to devote their full-time
professional loyalty, time and energy to their
position.
You must use non-work hours and no
university resources
Federal Agencies
State Law
University Policies
Many Academic Publications
45 CFR Part 50, Subpart F
“Responsibility of Applicants for Promoting
Objectivity in Research for Which PHS Funding
is Sought”
Authority: 42 U.S.C. 216, 289b-1, 299c-3.
Intent is to assure objectivity by establishing
standards that preclude bias in design, conduct, or
reporting of research
Focuses on financial conflicts of interest
(FCOI)
Regulations apply to investigators, including
sub grantees, contractors, and collaborating
investigators.
Does not apply to applications for support
under Phase I of SBIR and STTR programs
An institutional conflict of interest policy should
require that each investigator disclose to a
responsible representative of the institution all
significant financial interests of the investigator
(including those of the investigator’s spouse and
dependent children) (i) that would reasonably
appear to be affected by the research or
educational activities funded or proposed for
funding by NSF; or (ii) in entities whose financial
interests would reasonably appear to be affected
by such activities.
Chapter 1 (Subchapter A) (Part 54)
Financial Disclosure by Clinical Investigators
The Food and Drug Administration (FDA)
regulations state that investigators that
receive compensation in excess of $25,000
from a corporate sponsor of a trial in which
the investigator is engaged must disclose to
the FDA at the time of filing for a new drug
application.
19.058, Conflict of Interest in Research,
Educational, and Public Service Activities
19.059, Employee Participation in Authorized
Private Companies Commercializing Ohio
University Research
“Conflict of Interest in Research, Educational,
and Public Service Activities”
Most conflict disclosures fall within the
parameters of this policy
States that faculty are primarily responsible
for their academic, research and service
obligations
“Employee Participation in Authorized Private
Companies Commercializing Ohio University
Research”
Applies to “employees, faculty, staff and students,
who create intellectual property owned by the Ohio
University and who desire to hold an equity interest
in a firm, corporation, or other association to which
Ohio University has assigned, licensed or
transferred Ohio University’s interests…”
Consulting
Licensing University Technology
Clinical Studies
Procurement
Mentoring
Institutional
A disclosure is filed specific to the funding
application.
If you have a potential conflict for one
proposal, it does not automatically apply to
all of your proposals.
Research conflicts of interest are usually
disclosed using LEO as you apply for funding
by completing the conflict of interest section
of the electronic transmittal
If you are not using LEO, you can download
the appropriate disclosure form from
www.ohio.edu/research/compliance
“A” is selected if you have no conflicts to
disclose
“B” is selected if you have a potential conflict
to disclose relative to the submission.
(Requires a subsequent paper process)
“C” is selected if you have a current disclosure
on file, but it is not relevant to the proposal
you are submitting
Still uses option A, B or C
Requires that you gather signatures on paper
for all options, however
Generally used for personnel not listed on the
grant proposal or “key personnel”
We have revised the COI forms to word forms
This should be easier to complete than the
previous form
PDF versions are also available
Should be on the compliance web site soon,
but we can e-mail them to you until then
Use this form only if you are unable to use
the LEO transmittal form to assure that no
conflict of interest exists. A form must be
completed for each proposal.
I assure that I have read Ohio University
Policy 19.058, “Conflict of Interest in
Research, Educational, and Public Service
Activities” and declare that I have nothing
that is, or could be perceived to be a conflict
of interest with this proposal.
Use this form to disclose a potential conflict
of interest situation.
A separate disclosure form must be used for
each entity with which you conduct business
Conflict includes any member of your
immediate family (spouse, domestic partner
or children)
Require that you complete an option “B”
disclosure statement in addition to
completing the LEO transmittal form.
Require you to obtain signatures from Center
or Institute (if applicable), Chair and Dean on
the additional disclosure statement!!
The B disclosure form is available at
www.ohio.edu/research/compliance
Use this form only if you are unable to use
the LEO transmittal form. Complete this form
if you have a current conflict of interest
disclosure on file with the Office of Research
Compliance, but that disclosure is not
applicable to this proposal.
*New Option for 2008*
A management plan is developed for some
disclosures to mitigate the potential conflict
Management plans are specific to each
disclosure
May require submission of additional pieces,
such as a student employment plan
Reduce or remove the financial interest creating the
conflict
Place safeguards that mitigate the conflict potential,
such having some decisions made by an independent
entity
Limit participation in portions of the proposed
research likely to create a conflict
Require that the researcher disclose his or her
conflicting financial interests to all collaborators and
any proposed trainees;
Disclose the conflict in publications
Work to remove students from being directly advised
or taught by faculty where a conflict exists
Assure publication rights for student participants
Student Use
Nepotism and Cronyism
Intellectual Property
Use of University Resources
Publication provisions
Use of Human Subjects
Oversight Requirements
Reporting and Annual Reviews
You must submit an annual renewal for your
disclosure
◦ If the potential conflict no longer exists you must
notify us
If significant changes occur during the year
you should submit an update to your
disclosure as they occur
Yes. We encourage employees to disclose
potential conflicts that do not meet the
financial threshold, but may still be
problematic, such as student employment.
This allows you to be transparent with
respect to outside interests.
Allowable situations
Situations that require disclosure but may not
need an extensive management plan
Situations that require disclosure and have
problematic elements that will require
mitigation and/or a management plan
Situations that are not permitted
Receipt of royalties or honoraria for
published scholarly works, seminars,
teaching, etc.
Honoraria for serving as a special reviewer
or work on review panels
Royalties under our intellectual property
policies if no other relationship with entity
Clinical income at OUCOM
You participate in research developed in
whole or part by you, and you or your
family receive royalties from an existing
agreement with the business, but have
no other significant financial interest
You assign students, etc. to research
projects where you are entitled to
receive royalties, but have no other
significant financial interest
You assign students, etc. to projects supported
by the business through an SRA, and have a
significant financial interest other than royalty
income
You receive research support from a business in
which you serve on the board of directors, or
other advisory board, even if you are not
compensated.
You hold an executive position in a business
engaged in commercial or research activities
directly related to your Ohio University
responsibilities.
Any situation in which an actual conflict
exists is not permitted.
The only “exceptions” are those handled
under Ohio University Policy and Procedure
19.059 where faculty entrepreneurship is
addressed.
Participation in clinical trials or evaluation
of other research in which you have a
significant financial interest other than
royalty income.
In the context of your position at Ohio
University, you make professional referrals
to a business in which you have a
significant financial interest.
Letter of admonition
Ineligibility to submit grant applications
Withholding of IRB or IACUC approvals
Suspension
Non-Renewal
Loss of Tenure
Consulting
Procurement
Mentoring
Clinical Studies
Avoid consulting relationships that have
the potential to divert time and effort from
your responsibilities to Ohio University.
Do not use students.
Be wary of situations that limit publication.
Do not use university stationary, etc. that
could create an impression the university
is involved with the activities.
Make sure you are devoting sufficient time
to your university obligations.
Be cautious that the potential financial gain
cannot be perceived to influence your
university mentoring relationships.
Disclose any personal or familial financial
interest or equity in a company that is
doing business with Ohio University.
If you make purchases using public funds,
you should not use companies which will
benefit you or your family. If there is no
alternative you must seek and receive
permission prior to purchasing.
Any relationship in which there is a real or
perceived power or influence imbalance has
the potential for conflict. (Faculty:Student)
Isolating these relationships with respect to
areas of personal financial gain is best.
If they cannot be isolated, then safeguards
must be created.
If you have a financial interest, it is best to
isolate yourself from the study.
At a minimum, expect a more intense review
and a robust management plan if you have a
financial interest.
If both the institution and you have financial
interests the clinical study should be
conducted elsewhere.
You have administrative responsibilities on
behalf of Ohio University that is beneficial to
the business in which you have a significant
financial interest
You have administrative responsibilities on
behalf of Ohio University with respect to an
SRA where you have a significant financial
interest
Slide 43
Jo Ellen Sherow
Ohio University
Office of Research Compliance
Researchers’ Financial Disclosures in the
Spotlight
Conflicts of interest, always an emotional topic,
returned to the headlines this week as Sen.
Charles Grassley, a longtime critic of the drug
industry’s potential influence on research,
released new evidence that prominent Harvard
University scientists had failed to disclose much
of their outside income from pharmaceutical
companies over the past eight years.
http://www.insidehighered.com/news/2008/06/12/conflict January 15, 2008
WEDNESDAY, JANUARY 21, 2009
In a review of the literature regarding the relationship between
smokeless tobacco use and cancer, a conflict of interest of one of the
article's authors was initially not disclosed (see: Boffetta P, Hecht S, Gray
N, Gupta P, Straif K. Smokeless tobacco and cancer. Lancet Oncology
2008; 9:667-675). The original article was published in July, 2008. That
article stated: "The authors declare no conflicts of interest." After the
editor of the journal was notified by a researcher with knowledge of a
potential conflict of interest of Dr. Stephen Hecht (one of the study
authors), an erratum was published in September 2008, which noted:
"During the immediate months preceding submission of the review SH
was acting in the capacity of an expert witness for the plaintiff in a
future court case against a smokeless tobacco company. SH declares his
participation in this case in no way influenced his writing or involvement
in the review."
http://tobaccoanalysis.blogspot.com/2009/01/conflict-of-interestnot.html
January 16, 2009 — More than one third of new
drug marketing applications approved by the US
Food and Drug Administration (FDA) were
missing information about potential conflicts of
interest for clinical trial investigators, which
could allow bias to creep into the approvals
process, a government report released this week
has found. The FDA has said that it agrees with
most of the report's findings.
http://www.medscape.com/viewarticle/586980
Do collaborations between biotech companies
and academic centers constitute a conflict of
interest?
Biotechnology industry partnerships with
universities and academic centers have been
fruitful for both. So why is there so much
concern about conflict of interest and is that
concern appropriate?
http://www.redorbit.com/news/health/750100/genetic_engineering_news_p
osts_podcast_on_industrialacademic_collaborations_are_these/index.html
Universities are responsible for use of public
funds and therefore must maintain the public
trust.
Identifying and mitigating situations that may
have the potential for conflict maintains the
integrity of the university.
Maintaining integrity allows the university to
do credible academic research.
To provide information on the purpose of the
conflict of interest requirements.
To provide a basic overview of conflicts of
interest
To introduce the disclosure process and the use
of management plans
To provide information on the need for updates
and annual renewals.
Situations where financial considerations
compromise your professional judgment.
“Actual Conflict of Interest”
◦ Not permitted
Situations where an independent observer
might reasonably question whether your
professional actions or decisions are
determined by considerations of personal
gain. “Perceived Conflict of Interest”
◦ Managed
Potential conflicts may be financial or may be
a conflict of time, effort and/or commitment.
Potential conflicts can occur as a result of
administrative, scientific, academic, fiduciary
or familial situations.
They are situations that can be PERCEIVED to
be conflicting, whether a “real” conflict exists
or not.
Ohio University Policy has a mandatory
disclosure policy if you:
Earn over $10,000 in a twelve month period
from your outside activity OR
Have over 5% equity in the entity
Applies to members of your immediate family
(spouse, domestic partner, dependent
children) as well as yourself.
Anything of monetary value, including but not
limited to:
◦
◦
◦
◦
Salary
Payments for services
Equity interests over 5%
Intellectual property rights
Excludes mutual, pension and other
investments over which you have no control
Outside work during regular academic year
should not exceed equivalent of 1 day per
week.
Consulting work must avoid activities that
involve a conflict of interest with assigned
Ohio University activities and programs
Faculty Handbook, section IV-D
Outside interests cannot interfere with
primary loyalty to Ohio University and your
academic role
Use of university resources must have prior
approval of Chair, Dean and VPR.
Your outside interests should not be in
direct competition with university interests
Full time administrative employees are
expected to devote their full-time
professional loyalty, time and energy to their
position.
You must use non-work hours and no
university resources
Federal Agencies
State Law
University Policies
Many Academic Publications
45 CFR Part 50, Subpart F
“Responsibility of Applicants for Promoting
Objectivity in Research for Which PHS Funding
is Sought”
Authority: 42 U.S.C. 216, 289b-1, 299c-3.
Intent is to assure objectivity by establishing
standards that preclude bias in design, conduct, or
reporting of research
Focuses on financial conflicts of interest
(FCOI)
Regulations apply to investigators, including
sub grantees, contractors, and collaborating
investigators.
Does not apply to applications for support
under Phase I of SBIR and STTR programs
An institutional conflict of interest policy should
require that each investigator disclose to a
responsible representative of the institution all
significant financial interests of the investigator
(including those of the investigator’s spouse and
dependent children) (i) that would reasonably
appear to be affected by the research or
educational activities funded or proposed for
funding by NSF; or (ii) in entities whose financial
interests would reasonably appear to be affected
by such activities.
Chapter 1 (Subchapter A) (Part 54)
Financial Disclosure by Clinical Investigators
The Food and Drug Administration (FDA)
regulations state that investigators that
receive compensation in excess of $25,000
from a corporate sponsor of a trial in which
the investigator is engaged must disclose to
the FDA at the time of filing for a new drug
application.
19.058, Conflict of Interest in Research,
Educational, and Public Service Activities
19.059, Employee Participation in Authorized
Private Companies Commercializing Ohio
University Research
“Conflict of Interest in Research, Educational,
and Public Service Activities”
Most conflict disclosures fall within the
parameters of this policy
States that faculty are primarily responsible
for their academic, research and service
obligations
“Employee Participation in Authorized Private
Companies Commercializing Ohio University
Research”
Applies to “employees, faculty, staff and students,
who create intellectual property owned by the Ohio
University and who desire to hold an equity interest
in a firm, corporation, or other association to which
Ohio University has assigned, licensed or
transferred Ohio University’s interests…”
Consulting
Licensing University Technology
Clinical Studies
Procurement
Mentoring
Institutional
A disclosure is filed specific to the funding
application.
If you have a potential conflict for one
proposal, it does not automatically apply to
all of your proposals.
Research conflicts of interest are usually
disclosed using LEO as you apply for funding
by completing the conflict of interest section
of the electronic transmittal
If you are not using LEO, you can download
the appropriate disclosure form from
www.ohio.edu/research/compliance
“A” is selected if you have no conflicts to
disclose
“B” is selected if you have a potential conflict
to disclose relative to the submission.
(Requires a subsequent paper process)
“C” is selected if you have a current disclosure
on file, but it is not relevant to the proposal
you are submitting
Still uses option A, B or C
Requires that you gather signatures on paper
for all options, however
Generally used for personnel not listed on the
grant proposal or “key personnel”
We have revised the COI forms to word forms
This should be easier to complete than the
previous form
PDF versions are also available
Should be on the compliance web site soon,
but we can e-mail them to you until then
Use this form only if you are unable to use
the LEO transmittal form to assure that no
conflict of interest exists. A form must be
completed for each proposal.
I assure that I have read Ohio University
Policy 19.058, “Conflict of Interest in
Research, Educational, and Public Service
Activities” and declare that I have nothing
that is, or could be perceived to be a conflict
of interest with this proposal.
Use this form to disclose a potential conflict
of interest situation.
A separate disclosure form must be used for
each entity with which you conduct business
Conflict includes any member of your
immediate family (spouse, domestic partner
or children)
Require that you complete an option “B”
disclosure statement in addition to
completing the LEO transmittal form.
Require you to obtain signatures from Center
or Institute (if applicable), Chair and Dean on
the additional disclosure statement!!
The B disclosure form is available at
www.ohio.edu/research/compliance
Use this form only if you are unable to use
the LEO transmittal form. Complete this form
if you have a current conflict of interest
disclosure on file with the Office of Research
Compliance, but that disclosure is not
applicable to this proposal.
*New Option for 2008*
A management plan is developed for some
disclosures to mitigate the potential conflict
Management plans are specific to each
disclosure
May require submission of additional pieces,
such as a student employment plan
Reduce or remove the financial interest creating the
conflict
Place safeguards that mitigate the conflict potential,
such having some decisions made by an independent
entity
Limit participation in portions of the proposed
research likely to create a conflict
Require that the researcher disclose his or her
conflicting financial interests to all collaborators and
any proposed trainees;
Disclose the conflict in publications
Work to remove students from being directly advised
or taught by faculty where a conflict exists
Assure publication rights for student participants
Student Use
Nepotism and Cronyism
Intellectual Property
Use of University Resources
Publication provisions
Use of Human Subjects
Oversight Requirements
Reporting and Annual Reviews
You must submit an annual renewal for your
disclosure
◦ If the potential conflict no longer exists you must
notify us
If significant changes occur during the year
you should submit an update to your
disclosure as they occur
Yes. We encourage employees to disclose
potential conflicts that do not meet the
financial threshold, but may still be
problematic, such as student employment.
This allows you to be transparent with
respect to outside interests.
Allowable situations
Situations that require disclosure but may not
need an extensive management plan
Situations that require disclosure and have
problematic elements that will require
mitigation and/or a management plan
Situations that are not permitted
Receipt of royalties or honoraria for
published scholarly works, seminars,
teaching, etc.
Honoraria for serving as a special reviewer
or work on review panels
Royalties under our intellectual property
policies if no other relationship with entity
Clinical income at OUCOM
You participate in research developed in
whole or part by you, and you or your
family receive royalties from an existing
agreement with the business, but have
no other significant financial interest
You assign students, etc. to research
projects where you are entitled to
receive royalties, but have no other
significant financial interest
You assign students, etc. to projects supported
by the business through an SRA, and have a
significant financial interest other than royalty
income
You receive research support from a business in
which you serve on the board of directors, or
other advisory board, even if you are not
compensated.
You hold an executive position in a business
engaged in commercial or research activities
directly related to your Ohio University
responsibilities.
Any situation in which an actual conflict
exists is not permitted.
The only “exceptions” are those handled
under Ohio University Policy and Procedure
19.059 where faculty entrepreneurship is
addressed.
Participation in clinical trials or evaluation
of other research in which you have a
significant financial interest other than
royalty income.
In the context of your position at Ohio
University, you make professional referrals
to a business in which you have a
significant financial interest.
Letter of admonition
Ineligibility to submit grant applications
Withholding of IRB or IACUC approvals
Suspension
Non-Renewal
Loss of Tenure
Consulting
Procurement
Mentoring
Clinical Studies
Avoid consulting relationships that have
the potential to divert time and effort from
your responsibilities to Ohio University.
Do not use students.
Be wary of situations that limit publication.
Do not use university stationary, etc. that
could create an impression the university
is involved with the activities.
Make sure you are devoting sufficient time
to your university obligations.
Be cautious that the potential financial gain
cannot be perceived to influence your
university mentoring relationships.
Disclose any personal or familial financial
interest or equity in a company that is
doing business with Ohio University.
If you make purchases using public funds,
you should not use companies which will
benefit you or your family. If there is no
alternative you must seek and receive
permission prior to purchasing.
Any relationship in which there is a real or
perceived power or influence imbalance has
the potential for conflict. (Faculty:Student)
Isolating these relationships with respect to
areas of personal financial gain is best.
If they cannot be isolated, then safeguards
must be created.
If you have a financial interest, it is best to
isolate yourself from the study.
At a minimum, expect a more intense review
and a robust management plan if you have a
financial interest.
If both the institution and you have financial
interests the clinical study should be
conducted elsewhere.
You have administrative responsibilities on
behalf of Ohio University that is beneficial to
the business in which you have a significant
financial interest
You have administrative responsibilities on
behalf of Ohio University with respect to an
SRA where you have a significant financial
interest
Slide 44
Jo Ellen Sherow
Ohio University
Office of Research Compliance
Researchers’ Financial Disclosures in the
Spotlight
Conflicts of interest, always an emotional topic,
returned to the headlines this week as Sen.
Charles Grassley, a longtime critic of the drug
industry’s potential influence on research,
released new evidence that prominent Harvard
University scientists had failed to disclose much
of their outside income from pharmaceutical
companies over the past eight years.
http://www.insidehighered.com/news/2008/06/12/conflict January 15, 2008
WEDNESDAY, JANUARY 21, 2009
In a review of the literature regarding the relationship between
smokeless tobacco use and cancer, a conflict of interest of one of the
article's authors was initially not disclosed (see: Boffetta P, Hecht S, Gray
N, Gupta P, Straif K. Smokeless tobacco and cancer. Lancet Oncology
2008; 9:667-675). The original article was published in July, 2008. That
article stated: "The authors declare no conflicts of interest." After the
editor of the journal was notified by a researcher with knowledge of a
potential conflict of interest of Dr. Stephen Hecht (one of the study
authors), an erratum was published in September 2008, which noted:
"During the immediate months preceding submission of the review SH
was acting in the capacity of an expert witness for the plaintiff in a
future court case against a smokeless tobacco company. SH declares his
participation in this case in no way influenced his writing or involvement
in the review."
http://tobaccoanalysis.blogspot.com/2009/01/conflict-of-interestnot.html
January 16, 2009 — More than one third of new
drug marketing applications approved by the US
Food and Drug Administration (FDA) were
missing information about potential conflicts of
interest for clinical trial investigators, which
could allow bias to creep into the approvals
process, a government report released this week
has found. The FDA has said that it agrees with
most of the report's findings.
http://www.medscape.com/viewarticle/586980
Do collaborations between biotech companies
and academic centers constitute a conflict of
interest?
Biotechnology industry partnerships with
universities and academic centers have been
fruitful for both. So why is there so much
concern about conflict of interest and is that
concern appropriate?
http://www.redorbit.com/news/health/750100/genetic_engineering_news_p
osts_podcast_on_industrialacademic_collaborations_are_these/index.html
Universities are responsible for use of public
funds and therefore must maintain the public
trust.
Identifying and mitigating situations that may
have the potential for conflict maintains the
integrity of the university.
Maintaining integrity allows the university to
do credible academic research.
To provide information on the purpose of the
conflict of interest requirements.
To provide a basic overview of conflicts of
interest
To introduce the disclosure process and the use
of management plans
To provide information on the need for updates
and annual renewals.
Situations where financial considerations
compromise your professional judgment.
“Actual Conflict of Interest”
◦ Not permitted
Situations where an independent observer
might reasonably question whether your
professional actions or decisions are
determined by considerations of personal
gain. “Perceived Conflict of Interest”
◦ Managed
Potential conflicts may be financial or may be
a conflict of time, effort and/or commitment.
Potential conflicts can occur as a result of
administrative, scientific, academic, fiduciary
or familial situations.
They are situations that can be PERCEIVED to
be conflicting, whether a “real” conflict exists
or not.
Ohio University Policy has a mandatory
disclosure policy if you:
Earn over $10,000 in a twelve month period
from your outside activity OR
Have over 5% equity in the entity
Applies to members of your immediate family
(spouse, domestic partner, dependent
children) as well as yourself.
Anything of monetary value, including but not
limited to:
◦
◦
◦
◦
Salary
Payments for services
Equity interests over 5%
Intellectual property rights
Excludes mutual, pension and other
investments over which you have no control
Outside work during regular academic year
should not exceed equivalent of 1 day per
week.
Consulting work must avoid activities that
involve a conflict of interest with assigned
Ohio University activities and programs
Faculty Handbook, section IV-D
Outside interests cannot interfere with
primary loyalty to Ohio University and your
academic role
Use of university resources must have prior
approval of Chair, Dean and VPR.
Your outside interests should not be in
direct competition with university interests
Full time administrative employees are
expected to devote their full-time
professional loyalty, time and energy to their
position.
You must use non-work hours and no
university resources
Federal Agencies
State Law
University Policies
Many Academic Publications
45 CFR Part 50, Subpart F
“Responsibility of Applicants for Promoting
Objectivity in Research for Which PHS Funding
is Sought”
Authority: 42 U.S.C. 216, 289b-1, 299c-3.
Intent is to assure objectivity by establishing
standards that preclude bias in design, conduct, or
reporting of research
Focuses on financial conflicts of interest
(FCOI)
Regulations apply to investigators, including
sub grantees, contractors, and collaborating
investigators.
Does not apply to applications for support
under Phase I of SBIR and STTR programs
An institutional conflict of interest policy should
require that each investigator disclose to a
responsible representative of the institution all
significant financial interests of the investigator
(including those of the investigator’s spouse and
dependent children) (i) that would reasonably
appear to be affected by the research or
educational activities funded or proposed for
funding by NSF; or (ii) in entities whose financial
interests would reasonably appear to be affected
by such activities.
Chapter 1 (Subchapter A) (Part 54)
Financial Disclosure by Clinical Investigators
The Food and Drug Administration (FDA)
regulations state that investigators that
receive compensation in excess of $25,000
from a corporate sponsor of a trial in which
the investigator is engaged must disclose to
the FDA at the time of filing for a new drug
application.
19.058, Conflict of Interest in Research,
Educational, and Public Service Activities
19.059, Employee Participation in Authorized
Private Companies Commercializing Ohio
University Research
“Conflict of Interest in Research, Educational,
and Public Service Activities”
Most conflict disclosures fall within the
parameters of this policy
States that faculty are primarily responsible
for their academic, research and service
obligations
“Employee Participation in Authorized Private
Companies Commercializing Ohio University
Research”
Applies to “employees, faculty, staff and students,
who create intellectual property owned by the Ohio
University and who desire to hold an equity interest
in a firm, corporation, or other association to which
Ohio University has assigned, licensed or
transferred Ohio University’s interests…”
Consulting
Licensing University Technology
Clinical Studies
Procurement
Mentoring
Institutional
A disclosure is filed specific to the funding
application.
If you have a potential conflict for one
proposal, it does not automatically apply to
all of your proposals.
Research conflicts of interest are usually
disclosed using LEO as you apply for funding
by completing the conflict of interest section
of the electronic transmittal
If you are not using LEO, you can download
the appropriate disclosure form from
www.ohio.edu/research/compliance
“A” is selected if you have no conflicts to
disclose
“B” is selected if you have a potential conflict
to disclose relative to the submission.
(Requires a subsequent paper process)
“C” is selected if you have a current disclosure
on file, but it is not relevant to the proposal
you are submitting
Still uses option A, B or C
Requires that you gather signatures on paper
for all options, however
Generally used for personnel not listed on the
grant proposal or “key personnel”
We have revised the COI forms to word forms
This should be easier to complete than the
previous form
PDF versions are also available
Should be on the compliance web site soon,
but we can e-mail them to you until then
Use this form only if you are unable to use
the LEO transmittal form to assure that no
conflict of interest exists. A form must be
completed for each proposal.
I assure that I have read Ohio University
Policy 19.058, “Conflict of Interest in
Research, Educational, and Public Service
Activities” and declare that I have nothing
that is, or could be perceived to be a conflict
of interest with this proposal.
Use this form to disclose a potential conflict
of interest situation.
A separate disclosure form must be used for
each entity with which you conduct business
Conflict includes any member of your
immediate family (spouse, domestic partner
or children)
Require that you complete an option “B”
disclosure statement in addition to
completing the LEO transmittal form.
Require you to obtain signatures from Center
or Institute (if applicable), Chair and Dean on
the additional disclosure statement!!
The B disclosure form is available at
www.ohio.edu/research/compliance
Use this form only if you are unable to use
the LEO transmittal form. Complete this form
if you have a current conflict of interest
disclosure on file with the Office of Research
Compliance, but that disclosure is not
applicable to this proposal.
*New Option for 2008*
A management plan is developed for some
disclosures to mitigate the potential conflict
Management plans are specific to each
disclosure
May require submission of additional pieces,
such as a student employment plan
Reduce or remove the financial interest creating the
conflict
Place safeguards that mitigate the conflict potential,
such having some decisions made by an independent
entity
Limit participation in portions of the proposed
research likely to create a conflict
Require that the researcher disclose his or her
conflicting financial interests to all collaborators and
any proposed trainees;
Disclose the conflict in publications
Work to remove students from being directly advised
or taught by faculty where a conflict exists
Assure publication rights for student participants
Student Use
Nepotism and Cronyism
Intellectual Property
Use of University Resources
Publication provisions
Use of Human Subjects
Oversight Requirements
Reporting and Annual Reviews
You must submit an annual renewal for your
disclosure
◦ If the potential conflict no longer exists you must
notify us
If significant changes occur during the year
you should submit an update to your
disclosure as they occur
Yes. We encourage employees to disclose
potential conflicts that do not meet the
financial threshold, but may still be
problematic, such as student employment.
This allows you to be transparent with
respect to outside interests.
Allowable situations
Situations that require disclosure but may not
need an extensive management plan
Situations that require disclosure and have
problematic elements that will require
mitigation and/or a management plan
Situations that are not permitted
Receipt of royalties or honoraria for
published scholarly works, seminars,
teaching, etc.
Honoraria for serving as a special reviewer
or work on review panels
Royalties under our intellectual property
policies if no other relationship with entity
Clinical income at OUCOM
You participate in research developed in
whole or part by you, and you or your
family receive royalties from an existing
agreement with the business, but have
no other significant financial interest
You assign students, etc. to research
projects where you are entitled to
receive royalties, but have no other
significant financial interest
You assign students, etc. to projects supported
by the business through an SRA, and have a
significant financial interest other than royalty
income
You receive research support from a business in
which you serve on the board of directors, or
other advisory board, even if you are not
compensated.
You hold an executive position in a business
engaged in commercial or research activities
directly related to your Ohio University
responsibilities.
Any situation in which an actual conflict
exists is not permitted.
The only “exceptions” are those handled
under Ohio University Policy and Procedure
19.059 where faculty entrepreneurship is
addressed.
Participation in clinical trials or evaluation
of other research in which you have a
significant financial interest other than
royalty income.
In the context of your position at Ohio
University, you make professional referrals
to a business in which you have a
significant financial interest.
Letter of admonition
Ineligibility to submit grant applications
Withholding of IRB or IACUC approvals
Suspension
Non-Renewal
Loss of Tenure
Consulting
Procurement
Mentoring
Clinical Studies
Avoid consulting relationships that have
the potential to divert time and effort from
your responsibilities to Ohio University.
Do not use students.
Be wary of situations that limit publication.
Do not use university stationary, etc. that
could create an impression the university
is involved with the activities.
Make sure you are devoting sufficient time
to your university obligations.
Be cautious that the potential financial gain
cannot be perceived to influence your
university mentoring relationships.
Disclose any personal or familial financial
interest or equity in a company that is
doing business with Ohio University.
If you make purchases using public funds,
you should not use companies which will
benefit you or your family. If there is no
alternative you must seek and receive
permission prior to purchasing.
Any relationship in which there is a real or
perceived power or influence imbalance has
the potential for conflict. (Faculty:Student)
Isolating these relationships with respect to
areas of personal financial gain is best.
If they cannot be isolated, then safeguards
must be created.
If you have a financial interest, it is best to
isolate yourself from the study.
At a minimum, expect a more intense review
and a robust management plan if you have a
financial interest.
If both the institution and you have financial
interests the clinical study should be
conducted elsewhere.
You have administrative responsibilities on
behalf of Ohio University that is beneficial to
the business in which you have a significant
financial interest
You have administrative responsibilities on
behalf of Ohio University with respect to an
SRA where you have a significant financial
interest
Slide 45
Jo Ellen Sherow
Ohio University
Office of Research Compliance
Researchers’ Financial Disclosures in the
Spotlight
Conflicts of interest, always an emotional topic,
returned to the headlines this week as Sen.
Charles Grassley, a longtime critic of the drug
industry’s potential influence on research,
released new evidence that prominent Harvard
University scientists had failed to disclose much
of their outside income from pharmaceutical
companies over the past eight years.
http://www.insidehighered.com/news/2008/06/12/conflict January 15, 2008
WEDNESDAY, JANUARY 21, 2009
In a review of the literature regarding the relationship between
smokeless tobacco use and cancer, a conflict of interest of one of the
article's authors was initially not disclosed (see: Boffetta P, Hecht S, Gray
N, Gupta P, Straif K. Smokeless tobacco and cancer. Lancet Oncology
2008; 9:667-675). The original article was published in July, 2008. That
article stated: "The authors declare no conflicts of interest." After the
editor of the journal was notified by a researcher with knowledge of a
potential conflict of interest of Dr. Stephen Hecht (one of the study
authors), an erratum was published in September 2008, which noted:
"During the immediate months preceding submission of the review SH
was acting in the capacity of an expert witness for the plaintiff in a
future court case against a smokeless tobacco company. SH declares his
participation in this case in no way influenced his writing or involvement
in the review."
http://tobaccoanalysis.blogspot.com/2009/01/conflict-of-interestnot.html
January 16, 2009 — More than one third of new
drug marketing applications approved by the US
Food and Drug Administration (FDA) were
missing information about potential conflicts of
interest for clinical trial investigators, which
could allow bias to creep into the approvals
process, a government report released this week
has found. The FDA has said that it agrees with
most of the report's findings.
http://www.medscape.com/viewarticle/586980
Do collaborations between biotech companies
and academic centers constitute a conflict of
interest?
Biotechnology industry partnerships with
universities and academic centers have been
fruitful for both. So why is there so much
concern about conflict of interest and is that
concern appropriate?
http://www.redorbit.com/news/health/750100/genetic_engineering_news_p
osts_podcast_on_industrialacademic_collaborations_are_these/index.html
Universities are responsible for use of public
funds and therefore must maintain the public
trust.
Identifying and mitigating situations that may
have the potential for conflict maintains the
integrity of the university.
Maintaining integrity allows the university to
do credible academic research.
To provide information on the purpose of the
conflict of interest requirements.
To provide a basic overview of conflicts of
interest
To introduce the disclosure process and the use
of management plans
To provide information on the need for updates
and annual renewals.
Situations where financial considerations
compromise your professional judgment.
“Actual Conflict of Interest”
◦ Not permitted
Situations where an independent observer
might reasonably question whether your
professional actions or decisions are
determined by considerations of personal
gain. “Perceived Conflict of Interest”
◦ Managed
Potential conflicts may be financial or may be
a conflict of time, effort and/or commitment.
Potential conflicts can occur as a result of
administrative, scientific, academic, fiduciary
or familial situations.
They are situations that can be PERCEIVED to
be conflicting, whether a “real” conflict exists
or not.
Ohio University Policy has a mandatory
disclosure policy if you:
Earn over $10,000 in a twelve month period
from your outside activity OR
Have over 5% equity in the entity
Applies to members of your immediate family
(spouse, domestic partner, dependent
children) as well as yourself.
Anything of monetary value, including but not
limited to:
◦
◦
◦
◦
Salary
Payments for services
Equity interests over 5%
Intellectual property rights
Excludes mutual, pension and other
investments over which you have no control
Outside work during regular academic year
should not exceed equivalent of 1 day per
week.
Consulting work must avoid activities that
involve a conflict of interest with assigned
Ohio University activities and programs
Faculty Handbook, section IV-D
Outside interests cannot interfere with
primary loyalty to Ohio University and your
academic role
Use of university resources must have prior
approval of Chair, Dean and VPR.
Your outside interests should not be in
direct competition with university interests
Full time administrative employees are
expected to devote their full-time
professional loyalty, time and energy to their
position.
You must use non-work hours and no
university resources
Federal Agencies
State Law
University Policies
Many Academic Publications
45 CFR Part 50, Subpart F
“Responsibility of Applicants for Promoting
Objectivity in Research for Which PHS Funding
is Sought”
Authority: 42 U.S.C. 216, 289b-1, 299c-3.
Intent is to assure objectivity by establishing
standards that preclude bias in design, conduct, or
reporting of research
Focuses on financial conflicts of interest
(FCOI)
Regulations apply to investigators, including
sub grantees, contractors, and collaborating
investigators.
Does not apply to applications for support
under Phase I of SBIR and STTR programs
An institutional conflict of interest policy should
require that each investigator disclose to a
responsible representative of the institution all
significant financial interests of the investigator
(including those of the investigator’s spouse and
dependent children) (i) that would reasonably
appear to be affected by the research or
educational activities funded or proposed for
funding by NSF; or (ii) in entities whose financial
interests would reasonably appear to be affected
by such activities.
Chapter 1 (Subchapter A) (Part 54)
Financial Disclosure by Clinical Investigators
The Food and Drug Administration (FDA)
regulations state that investigators that
receive compensation in excess of $25,000
from a corporate sponsor of a trial in which
the investigator is engaged must disclose to
the FDA at the time of filing for a new drug
application.
19.058, Conflict of Interest in Research,
Educational, and Public Service Activities
19.059, Employee Participation in Authorized
Private Companies Commercializing Ohio
University Research
“Conflict of Interest in Research, Educational,
and Public Service Activities”
Most conflict disclosures fall within the
parameters of this policy
States that faculty are primarily responsible
for their academic, research and service
obligations
“Employee Participation in Authorized Private
Companies Commercializing Ohio University
Research”
Applies to “employees, faculty, staff and students,
who create intellectual property owned by the Ohio
University and who desire to hold an equity interest
in a firm, corporation, or other association to which
Ohio University has assigned, licensed or
transferred Ohio University’s interests…”
Consulting
Licensing University Technology
Clinical Studies
Procurement
Mentoring
Institutional
A disclosure is filed specific to the funding
application.
If you have a potential conflict for one
proposal, it does not automatically apply to
all of your proposals.
Research conflicts of interest are usually
disclosed using LEO as you apply for funding
by completing the conflict of interest section
of the electronic transmittal
If you are not using LEO, you can download
the appropriate disclosure form from
www.ohio.edu/research/compliance
“A” is selected if you have no conflicts to
disclose
“B” is selected if you have a potential conflict
to disclose relative to the submission.
(Requires a subsequent paper process)
“C” is selected if you have a current disclosure
on file, but it is not relevant to the proposal
you are submitting
Still uses option A, B or C
Requires that you gather signatures on paper
for all options, however
Generally used for personnel not listed on the
grant proposal or “key personnel”
We have revised the COI forms to word forms
This should be easier to complete than the
previous form
PDF versions are also available
Should be on the compliance web site soon,
but we can e-mail them to you until then
Use this form only if you are unable to use
the LEO transmittal form to assure that no
conflict of interest exists. A form must be
completed for each proposal.
I assure that I have read Ohio University
Policy 19.058, “Conflict of Interest in
Research, Educational, and Public Service
Activities” and declare that I have nothing
that is, or could be perceived to be a conflict
of interest with this proposal.
Use this form to disclose a potential conflict
of interest situation.
A separate disclosure form must be used for
each entity with which you conduct business
Conflict includes any member of your
immediate family (spouse, domestic partner
or children)
Require that you complete an option “B”
disclosure statement in addition to
completing the LEO transmittal form.
Require you to obtain signatures from Center
or Institute (if applicable), Chair and Dean on
the additional disclosure statement!!
The B disclosure form is available at
www.ohio.edu/research/compliance
Use this form only if you are unable to use
the LEO transmittal form. Complete this form
if you have a current conflict of interest
disclosure on file with the Office of Research
Compliance, but that disclosure is not
applicable to this proposal.
*New Option for 2008*
A management plan is developed for some
disclosures to mitigate the potential conflict
Management plans are specific to each
disclosure
May require submission of additional pieces,
such as a student employment plan
Reduce or remove the financial interest creating the
conflict
Place safeguards that mitigate the conflict potential,
such having some decisions made by an independent
entity
Limit participation in portions of the proposed
research likely to create a conflict
Require that the researcher disclose his or her
conflicting financial interests to all collaborators and
any proposed trainees;
Disclose the conflict in publications
Work to remove students from being directly advised
or taught by faculty where a conflict exists
Assure publication rights for student participants
Student Use
Nepotism and Cronyism
Intellectual Property
Use of University Resources
Publication provisions
Use of Human Subjects
Oversight Requirements
Reporting and Annual Reviews
You must submit an annual renewal for your
disclosure
◦ If the potential conflict no longer exists you must
notify us
If significant changes occur during the year
you should submit an update to your
disclosure as they occur
Yes. We encourage employees to disclose
potential conflicts that do not meet the
financial threshold, but may still be
problematic, such as student employment.
This allows you to be transparent with
respect to outside interests.
Allowable situations
Situations that require disclosure but may not
need an extensive management plan
Situations that require disclosure and have
problematic elements that will require
mitigation and/or a management plan
Situations that are not permitted
Receipt of royalties or honoraria for
published scholarly works, seminars,
teaching, etc.
Honoraria for serving as a special reviewer
or work on review panels
Royalties under our intellectual property
policies if no other relationship with entity
Clinical income at OUCOM
You participate in research developed in
whole or part by you, and you or your
family receive royalties from an existing
agreement with the business, but have
no other significant financial interest
You assign students, etc. to research
projects where you are entitled to
receive royalties, but have no other
significant financial interest
You assign students, etc. to projects supported
by the business through an SRA, and have a
significant financial interest other than royalty
income
You receive research support from a business in
which you serve on the board of directors, or
other advisory board, even if you are not
compensated.
You hold an executive position in a business
engaged in commercial or research activities
directly related to your Ohio University
responsibilities.
Any situation in which an actual conflict
exists is not permitted.
The only “exceptions” are those handled
under Ohio University Policy and Procedure
19.059 where faculty entrepreneurship is
addressed.
Participation in clinical trials or evaluation
of other research in which you have a
significant financial interest other than
royalty income.
In the context of your position at Ohio
University, you make professional referrals
to a business in which you have a
significant financial interest.
Letter of admonition
Ineligibility to submit grant applications
Withholding of IRB or IACUC approvals
Suspension
Non-Renewal
Loss of Tenure
Consulting
Procurement
Mentoring
Clinical Studies
Avoid consulting relationships that have
the potential to divert time and effort from
your responsibilities to Ohio University.
Do not use students.
Be wary of situations that limit publication.
Do not use university stationary, etc. that
could create an impression the university
is involved with the activities.
Make sure you are devoting sufficient time
to your university obligations.
Be cautious that the potential financial gain
cannot be perceived to influence your
university mentoring relationships.
Disclose any personal or familial financial
interest or equity in a company that is
doing business with Ohio University.
If you make purchases using public funds,
you should not use companies which will
benefit you or your family. If there is no
alternative you must seek and receive
permission prior to purchasing.
Any relationship in which there is a real or
perceived power or influence imbalance has
the potential for conflict. (Faculty:Student)
Isolating these relationships with respect to
areas of personal financial gain is best.
If they cannot be isolated, then safeguards
must be created.
If you have a financial interest, it is best to
isolate yourself from the study.
At a minimum, expect a more intense review
and a robust management plan if you have a
financial interest.
If both the institution and you have financial
interests the clinical study should be
conducted elsewhere.
You have administrative responsibilities on
behalf of Ohio University that is beneficial to
the business in which you have a significant
financial interest
You have administrative responsibilities on
behalf of Ohio University with respect to an
SRA where you have a significant financial
interest
Slide 46
Jo Ellen Sherow
Ohio University
Office of Research Compliance
Researchers’ Financial Disclosures in the
Spotlight
Conflicts of interest, always an emotional topic,
returned to the headlines this week as Sen.
Charles Grassley, a longtime critic of the drug
industry’s potential influence on research,
released new evidence that prominent Harvard
University scientists had failed to disclose much
of their outside income from pharmaceutical
companies over the past eight years.
http://www.insidehighered.com/news/2008/06/12/conflict January 15, 2008
WEDNESDAY, JANUARY 21, 2009
In a review of the literature regarding the relationship between
smokeless tobacco use and cancer, a conflict of interest of one of the
article's authors was initially not disclosed (see: Boffetta P, Hecht S, Gray
N, Gupta P, Straif K. Smokeless tobacco and cancer. Lancet Oncology
2008; 9:667-675). The original article was published in July, 2008. That
article stated: "The authors declare no conflicts of interest." After the
editor of the journal was notified by a researcher with knowledge of a
potential conflict of interest of Dr. Stephen Hecht (one of the study
authors), an erratum was published in September 2008, which noted:
"During the immediate months preceding submission of the review SH
was acting in the capacity of an expert witness for the plaintiff in a
future court case against a smokeless tobacco company. SH declares his
participation in this case in no way influenced his writing or involvement
in the review."
http://tobaccoanalysis.blogspot.com/2009/01/conflict-of-interestnot.html
January 16, 2009 — More than one third of new
drug marketing applications approved by the US
Food and Drug Administration (FDA) were
missing information about potential conflicts of
interest for clinical trial investigators, which
could allow bias to creep into the approvals
process, a government report released this week
has found. The FDA has said that it agrees with
most of the report's findings.
http://www.medscape.com/viewarticle/586980
Do collaborations between biotech companies
and academic centers constitute a conflict of
interest?
Biotechnology industry partnerships with
universities and academic centers have been
fruitful for both. So why is there so much
concern about conflict of interest and is that
concern appropriate?
http://www.redorbit.com/news/health/750100/genetic_engineering_news_p
osts_podcast_on_industrialacademic_collaborations_are_these/index.html
Universities are responsible for use of public
funds and therefore must maintain the public
trust.
Identifying and mitigating situations that may
have the potential for conflict maintains the
integrity of the university.
Maintaining integrity allows the university to
do credible academic research.
To provide information on the purpose of the
conflict of interest requirements.
To provide a basic overview of conflicts of
interest
To introduce the disclosure process and the use
of management plans
To provide information on the need for updates
and annual renewals.
Situations where financial considerations
compromise your professional judgment.
“Actual Conflict of Interest”
◦ Not permitted
Situations where an independent observer
might reasonably question whether your
professional actions or decisions are
determined by considerations of personal
gain. “Perceived Conflict of Interest”
◦ Managed
Potential conflicts may be financial or may be
a conflict of time, effort and/or commitment.
Potential conflicts can occur as a result of
administrative, scientific, academic, fiduciary
or familial situations.
They are situations that can be PERCEIVED to
be conflicting, whether a “real” conflict exists
or not.
Ohio University Policy has a mandatory
disclosure policy if you:
Earn over $10,000 in a twelve month period
from your outside activity OR
Have over 5% equity in the entity
Applies to members of your immediate family
(spouse, domestic partner, dependent
children) as well as yourself.
Anything of monetary value, including but not
limited to:
◦
◦
◦
◦
Salary
Payments for services
Equity interests over 5%
Intellectual property rights
Excludes mutual, pension and other
investments over which you have no control
Outside work during regular academic year
should not exceed equivalent of 1 day per
week.
Consulting work must avoid activities that
involve a conflict of interest with assigned
Ohio University activities and programs
Faculty Handbook, section IV-D
Outside interests cannot interfere with
primary loyalty to Ohio University and your
academic role
Use of university resources must have prior
approval of Chair, Dean and VPR.
Your outside interests should not be in
direct competition with university interests
Full time administrative employees are
expected to devote their full-time
professional loyalty, time and energy to their
position.
You must use non-work hours and no
university resources
Federal Agencies
State Law
University Policies
Many Academic Publications
45 CFR Part 50, Subpart F
“Responsibility of Applicants for Promoting
Objectivity in Research for Which PHS Funding
is Sought”
Authority: 42 U.S.C. 216, 289b-1, 299c-3.
Intent is to assure objectivity by establishing
standards that preclude bias in design, conduct, or
reporting of research
Focuses on financial conflicts of interest
(FCOI)
Regulations apply to investigators, including
sub grantees, contractors, and collaborating
investigators.
Does not apply to applications for support
under Phase I of SBIR and STTR programs
An institutional conflict of interest policy should
require that each investigator disclose to a
responsible representative of the institution all
significant financial interests of the investigator
(including those of the investigator’s spouse and
dependent children) (i) that would reasonably
appear to be affected by the research or
educational activities funded or proposed for
funding by NSF; or (ii) in entities whose financial
interests would reasonably appear to be affected
by such activities.
Chapter 1 (Subchapter A) (Part 54)
Financial Disclosure by Clinical Investigators
The Food and Drug Administration (FDA)
regulations state that investigators that
receive compensation in excess of $25,000
from a corporate sponsor of a trial in which
the investigator is engaged must disclose to
the FDA at the time of filing for a new drug
application.
19.058, Conflict of Interest in Research,
Educational, and Public Service Activities
19.059, Employee Participation in Authorized
Private Companies Commercializing Ohio
University Research
“Conflict of Interest in Research, Educational,
and Public Service Activities”
Most conflict disclosures fall within the
parameters of this policy
States that faculty are primarily responsible
for their academic, research and service
obligations
“Employee Participation in Authorized Private
Companies Commercializing Ohio University
Research”
Applies to “employees, faculty, staff and students,
who create intellectual property owned by the Ohio
University and who desire to hold an equity interest
in a firm, corporation, or other association to which
Ohio University has assigned, licensed or
transferred Ohio University’s interests…”
Consulting
Licensing University Technology
Clinical Studies
Procurement
Mentoring
Institutional
A disclosure is filed specific to the funding
application.
If you have a potential conflict for one
proposal, it does not automatically apply to
all of your proposals.
Research conflicts of interest are usually
disclosed using LEO as you apply for funding
by completing the conflict of interest section
of the electronic transmittal
If you are not using LEO, you can download
the appropriate disclosure form from
www.ohio.edu/research/compliance
“A” is selected if you have no conflicts to
disclose
“B” is selected if you have a potential conflict
to disclose relative to the submission.
(Requires a subsequent paper process)
“C” is selected if you have a current disclosure
on file, but it is not relevant to the proposal
you are submitting
Still uses option A, B or C
Requires that you gather signatures on paper
for all options, however
Generally used for personnel not listed on the
grant proposal or “key personnel”
We have revised the COI forms to word forms
This should be easier to complete than the
previous form
PDF versions are also available
Should be on the compliance web site soon,
but we can e-mail them to you until then
Use this form only if you are unable to use
the LEO transmittal form to assure that no
conflict of interest exists. A form must be
completed for each proposal.
I assure that I have read Ohio University
Policy 19.058, “Conflict of Interest in
Research, Educational, and Public Service
Activities” and declare that I have nothing
that is, or could be perceived to be a conflict
of interest with this proposal.
Use this form to disclose a potential conflict
of interest situation.
A separate disclosure form must be used for
each entity with which you conduct business
Conflict includes any member of your
immediate family (spouse, domestic partner
or children)
Require that you complete an option “B”
disclosure statement in addition to
completing the LEO transmittal form.
Require you to obtain signatures from Center
or Institute (if applicable), Chair and Dean on
the additional disclosure statement!!
The B disclosure form is available at
www.ohio.edu/research/compliance
Use this form only if you are unable to use
the LEO transmittal form. Complete this form
if you have a current conflict of interest
disclosure on file with the Office of Research
Compliance, but that disclosure is not
applicable to this proposal.
*New Option for 2008*
A management plan is developed for some
disclosures to mitigate the potential conflict
Management plans are specific to each
disclosure
May require submission of additional pieces,
such as a student employment plan
Reduce or remove the financial interest creating the
conflict
Place safeguards that mitigate the conflict potential,
such having some decisions made by an independent
entity
Limit participation in portions of the proposed
research likely to create a conflict
Require that the researcher disclose his or her
conflicting financial interests to all collaborators and
any proposed trainees;
Disclose the conflict in publications
Work to remove students from being directly advised
or taught by faculty where a conflict exists
Assure publication rights for student participants
Student Use
Nepotism and Cronyism
Intellectual Property
Use of University Resources
Publication provisions
Use of Human Subjects
Oversight Requirements
Reporting and Annual Reviews
You must submit an annual renewal for your
disclosure
◦ If the potential conflict no longer exists you must
notify us
If significant changes occur during the year
you should submit an update to your
disclosure as they occur
Yes. We encourage employees to disclose
potential conflicts that do not meet the
financial threshold, but may still be
problematic, such as student employment.
This allows you to be transparent with
respect to outside interests.
Allowable situations
Situations that require disclosure but may not
need an extensive management plan
Situations that require disclosure and have
problematic elements that will require
mitigation and/or a management plan
Situations that are not permitted
Receipt of royalties or honoraria for
published scholarly works, seminars,
teaching, etc.
Honoraria for serving as a special reviewer
or work on review panels
Royalties under our intellectual property
policies if no other relationship with entity
Clinical income at OUCOM
You participate in research developed in
whole or part by you, and you or your
family receive royalties from an existing
agreement with the business, but have
no other significant financial interest
You assign students, etc. to research
projects where you are entitled to
receive royalties, but have no other
significant financial interest
You assign students, etc. to projects supported
by the business through an SRA, and have a
significant financial interest other than royalty
income
You receive research support from a business in
which you serve on the board of directors, or
other advisory board, even if you are not
compensated.
You hold an executive position in a business
engaged in commercial or research activities
directly related to your Ohio University
responsibilities.
Any situation in which an actual conflict
exists is not permitted.
The only “exceptions” are those handled
under Ohio University Policy and Procedure
19.059 where faculty entrepreneurship is
addressed.
Participation in clinical trials or evaluation
of other research in which you have a
significant financial interest other than
royalty income.
In the context of your position at Ohio
University, you make professional referrals
to a business in which you have a
significant financial interest.
Letter of admonition
Ineligibility to submit grant applications
Withholding of IRB or IACUC approvals
Suspension
Non-Renewal
Loss of Tenure
Consulting
Procurement
Mentoring
Clinical Studies
Avoid consulting relationships that have
the potential to divert time and effort from
your responsibilities to Ohio University.
Do not use students.
Be wary of situations that limit publication.
Do not use university stationary, etc. that
could create an impression the university
is involved with the activities.
Make sure you are devoting sufficient time
to your university obligations.
Be cautious that the potential financial gain
cannot be perceived to influence your
university mentoring relationships.
Disclose any personal or familial financial
interest or equity in a company that is
doing business with Ohio University.
If you make purchases using public funds,
you should not use companies which will
benefit you or your family. If there is no
alternative you must seek and receive
permission prior to purchasing.
Any relationship in which there is a real or
perceived power or influence imbalance has
the potential for conflict. (Faculty:Student)
Isolating these relationships with respect to
areas of personal financial gain is best.
If they cannot be isolated, then safeguards
must be created.
If you have a financial interest, it is best to
isolate yourself from the study.
At a minimum, expect a more intense review
and a robust management plan if you have a
financial interest.
If both the institution and you have financial
interests the clinical study should be
conducted elsewhere.
You have administrative responsibilities on
behalf of Ohio University that is beneficial to
the business in which you have a significant
financial interest
You have administrative responsibilities on
behalf of Ohio University with respect to an
SRA where you have a significant financial
interest
Slide 47
Jo Ellen Sherow
Ohio University
Office of Research Compliance
Researchers’ Financial Disclosures in the
Spotlight
Conflicts of interest, always an emotional topic,
returned to the headlines this week as Sen.
Charles Grassley, a longtime critic of the drug
industry’s potential influence on research,
released new evidence that prominent Harvard
University scientists had failed to disclose much
of their outside income from pharmaceutical
companies over the past eight years.
http://www.insidehighered.com/news/2008/06/12/conflict January 15, 2008
WEDNESDAY, JANUARY 21, 2009
In a review of the literature regarding the relationship between
smokeless tobacco use and cancer, a conflict of interest of one of the
article's authors was initially not disclosed (see: Boffetta P, Hecht S, Gray
N, Gupta P, Straif K. Smokeless tobacco and cancer. Lancet Oncology
2008; 9:667-675). The original article was published in July, 2008. That
article stated: "The authors declare no conflicts of interest." After the
editor of the journal was notified by a researcher with knowledge of a
potential conflict of interest of Dr. Stephen Hecht (one of the study
authors), an erratum was published in September 2008, which noted:
"During the immediate months preceding submission of the review SH
was acting in the capacity of an expert witness for the plaintiff in a
future court case against a smokeless tobacco company. SH declares his
participation in this case in no way influenced his writing or involvement
in the review."
http://tobaccoanalysis.blogspot.com/2009/01/conflict-of-interestnot.html
January 16, 2009 — More than one third of new
drug marketing applications approved by the US
Food and Drug Administration (FDA) were
missing information about potential conflicts of
interest for clinical trial investigators, which
could allow bias to creep into the approvals
process, a government report released this week
has found. The FDA has said that it agrees with
most of the report's findings.
http://www.medscape.com/viewarticle/586980
Do collaborations between biotech companies
and academic centers constitute a conflict of
interest?
Biotechnology industry partnerships with
universities and academic centers have been
fruitful for both. So why is there so much
concern about conflict of interest and is that
concern appropriate?
http://www.redorbit.com/news/health/750100/genetic_engineering_news_p
osts_podcast_on_industrialacademic_collaborations_are_these/index.html
Universities are responsible for use of public
funds and therefore must maintain the public
trust.
Identifying and mitigating situations that may
have the potential for conflict maintains the
integrity of the university.
Maintaining integrity allows the university to
do credible academic research.
To provide information on the purpose of the
conflict of interest requirements.
To provide a basic overview of conflicts of
interest
To introduce the disclosure process and the use
of management plans
To provide information on the need for updates
and annual renewals.
Situations where financial considerations
compromise your professional judgment.
“Actual Conflict of Interest”
◦ Not permitted
Situations where an independent observer
might reasonably question whether your
professional actions or decisions are
determined by considerations of personal
gain. “Perceived Conflict of Interest”
◦ Managed
Potential conflicts may be financial or may be
a conflict of time, effort and/or commitment.
Potential conflicts can occur as a result of
administrative, scientific, academic, fiduciary
or familial situations.
They are situations that can be PERCEIVED to
be conflicting, whether a “real” conflict exists
or not.
Ohio University Policy has a mandatory
disclosure policy if you:
Earn over $10,000 in a twelve month period
from your outside activity OR
Have over 5% equity in the entity
Applies to members of your immediate family
(spouse, domestic partner, dependent
children) as well as yourself.
Anything of monetary value, including but not
limited to:
◦
◦
◦
◦
Salary
Payments for services
Equity interests over 5%
Intellectual property rights
Excludes mutual, pension and other
investments over which you have no control
Outside work during regular academic year
should not exceed equivalent of 1 day per
week.
Consulting work must avoid activities that
involve a conflict of interest with assigned
Ohio University activities and programs
Faculty Handbook, section IV-D
Outside interests cannot interfere with
primary loyalty to Ohio University and your
academic role
Use of university resources must have prior
approval of Chair, Dean and VPR.
Your outside interests should not be in
direct competition with university interests
Full time administrative employees are
expected to devote their full-time
professional loyalty, time and energy to their
position.
You must use non-work hours and no
university resources
Federal Agencies
State Law
University Policies
Many Academic Publications
45 CFR Part 50, Subpart F
“Responsibility of Applicants for Promoting
Objectivity in Research for Which PHS Funding
is Sought”
Authority: 42 U.S.C. 216, 289b-1, 299c-3.
Intent is to assure objectivity by establishing
standards that preclude bias in design, conduct, or
reporting of research
Focuses on financial conflicts of interest
(FCOI)
Regulations apply to investigators, including
sub grantees, contractors, and collaborating
investigators.
Does not apply to applications for support
under Phase I of SBIR and STTR programs
An institutional conflict of interest policy should
require that each investigator disclose to a
responsible representative of the institution all
significant financial interests of the investigator
(including those of the investigator’s spouse and
dependent children) (i) that would reasonably
appear to be affected by the research or
educational activities funded or proposed for
funding by NSF; or (ii) in entities whose financial
interests would reasonably appear to be affected
by such activities.
Chapter 1 (Subchapter A) (Part 54)
Financial Disclosure by Clinical Investigators
The Food and Drug Administration (FDA)
regulations state that investigators that
receive compensation in excess of $25,000
from a corporate sponsor of a trial in which
the investigator is engaged must disclose to
the FDA at the time of filing for a new drug
application.
19.058, Conflict of Interest in Research,
Educational, and Public Service Activities
19.059, Employee Participation in Authorized
Private Companies Commercializing Ohio
University Research
“Conflict of Interest in Research, Educational,
and Public Service Activities”
Most conflict disclosures fall within the
parameters of this policy
States that faculty are primarily responsible
for their academic, research and service
obligations
“Employee Participation in Authorized Private
Companies Commercializing Ohio University
Research”
Applies to “employees, faculty, staff and students,
who create intellectual property owned by the Ohio
University and who desire to hold an equity interest
in a firm, corporation, or other association to which
Ohio University has assigned, licensed or
transferred Ohio University’s interests…”
Consulting
Licensing University Technology
Clinical Studies
Procurement
Mentoring
Institutional
A disclosure is filed specific to the funding
application.
If you have a potential conflict for one
proposal, it does not automatically apply to
all of your proposals.
Research conflicts of interest are usually
disclosed using LEO as you apply for funding
by completing the conflict of interest section
of the electronic transmittal
If you are not using LEO, you can download
the appropriate disclosure form from
www.ohio.edu/research/compliance
“A” is selected if you have no conflicts to
disclose
“B” is selected if you have a potential conflict
to disclose relative to the submission.
(Requires a subsequent paper process)
“C” is selected if you have a current disclosure
on file, but it is not relevant to the proposal
you are submitting
Still uses option A, B or C
Requires that you gather signatures on paper
for all options, however
Generally used for personnel not listed on the
grant proposal or “key personnel”
We have revised the COI forms to word forms
This should be easier to complete than the
previous form
PDF versions are also available
Should be on the compliance web site soon,
but we can e-mail them to you until then
Use this form only if you are unable to use
the LEO transmittal form to assure that no
conflict of interest exists. A form must be
completed for each proposal.
I assure that I have read Ohio University
Policy 19.058, “Conflict of Interest in
Research, Educational, and Public Service
Activities” and declare that I have nothing
that is, or could be perceived to be a conflict
of interest with this proposal.
Use this form to disclose a potential conflict
of interest situation.
A separate disclosure form must be used for
each entity with which you conduct business
Conflict includes any member of your
immediate family (spouse, domestic partner
or children)
Require that you complete an option “B”
disclosure statement in addition to
completing the LEO transmittal form.
Require you to obtain signatures from Center
or Institute (if applicable), Chair and Dean on
the additional disclosure statement!!
The B disclosure form is available at
www.ohio.edu/research/compliance
Use this form only if you are unable to use
the LEO transmittal form. Complete this form
if you have a current conflict of interest
disclosure on file with the Office of Research
Compliance, but that disclosure is not
applicable to this proposal.
*New Option for 2008*
A management plan is developed for some
disclosures to mitigate the potential conflict
Management plans are specific to each
disclosure
May require submission of additional pieces,
such as a student employment plan
Reduce or remove the financial interest creating the
conflict
Place safeguards that mitigate the conflict potential,
such having some decisions made by an independent
entity
Limit participation in portions of the proposed
research likely to create a conflict
Require that the researcher disclose his or her
conflicting financial interests to all collaborators and
any proposed trainees;
Disclose the conflict in publications
Work to remove students from being directly advised
or taught by faculty where a conflict exists
Assure publication rights for student participants
Student Use
Nepotism and Cronyism
Intellectual Property
Use of University Resources
Publication provisions
Use of Human Subjects
Oversight Requirements
Reporting and Annual Reviews
You must submit an annual renewal for your
disclosure
◦ If the potential conflict no longer exists you must
notify us
If significant changes occur during the year
you should submit an update to your
disclosure as they occur
Yes. We encourage employees to disclose
potential conflicts that do not meet the
financial threshold, but may still be
problematic, such as student employment.
This allows you to be transparent with
respect to outside interests.
Allowable situations
Situations that require disclosure but may not
need an extensive management plan
Situations that require disclosure and have
problematic elements that will require
mitigation and/or a management plan
Situations that are not permitted
Receipt of royalties or honoraria for
published scholarly works, seminars,
teaching, etc.
Honoraria for serving as a special reviewer
or work on review panels
Royalties under our intellectual property
policies if no other relationship with entity
Clinical income at OUCOM
You participate in research developed in
whole or part by you, and you or your
family receive royalties from an existing
agreement with the business, but have
no other significant financial interest
You assign students, etc. to research
projects where you are entitled to
receive royalties, but have no other
significant financial interest
You assign students, etc. to projects supported
by the business through an SRA, and have a
significant financial interest other than royalty
income
You receive research support from a business in
which you serve on the board of directors, or
other advisory board, even if you are not
compensated.
You hold an executive position in a business
engaged in commercial or research activities
directly related to your Ohio University
responsibilities.
Any situation in which an actual conflict
exists is not permitted.
The only “exceptions” are those handled
under Ohio University Policy and Procedure
19.059 where faculty entrepreneurship is
addressed.
Participation in clinical trials or evaluation
of other research in which you have a
significant financial interest other than
royalty income.
In the context of your position at Ohio
University, you make professional referrals
to a business in which you have a
significant financial interest.
Letter of admonition
Ineligibility to submit grant applications
Withholding of IRB or IACUC approvals
Suspension
Non-Renewal
Loss of Tenure
Consulting
Procurement
Mentoring
Clinical Studies
Avoid consulting relationships that have
the potential to divert time and effort from
your responsibilities to Ohio University.
Do not use students.
Be wary of situations that limit publication.
Do not use university stationary, etc. that
could create an impression the university
is involved with the activities.
Make sure you are devoting sufficient time
to your university obligations.
Be cautious that the potential financial gain
cannot be perceived to influence your
university mentoring relationships.
Disclose any personal or familial financial
interest or equity in a company that is
doing business with Ohio University.
If you make purchases using public funds,
you should not use companies which will
benefit you or your family. If there is no
alternative you must seek and receive
permission prior to purchasing.
Any relationship in which there is a real or
perceived power or influence imbalance has
the potential for conflict. (Faculty:Student)
Isolating these relationships with respect to
areas of personal financial gain is best.
If they cannot be isolated, then safeguards
must be created.
If you have a financial interest, it is best to
isolate yourself from the study.
At a minimum, expect a more intense review
and a robust management plan if you have a
financial interest.
If both the institution and you have financial
interests the clinical study should be
conducted elsewhere.
You have administrative responsibilities on
behalf of Ohio University that is beneficial to
the business in which you have a significant
financial interest
You have administrative responsibilities on
behalf of Ohio University with respect to an
SRA where you have a significant financial
interest
Slide 48
Jo Ellen Sherow
Ohio University
Office of Research Compliance
Researchers’ Financial Disclosures in the
Spotlight
Conflicts of interest, always an emotional topic,
returned to the headlines this week as Sen.
Charles Grassley, a longtime critic of the drug
industry’s potential influence on research,
released new evidence that prominent Harvard
University scientists had failed to disclose much
of their outside income from pharmaceutical
companies over the past eight years.
http://www.insidehighered.com/news/2008/06/12/conflict January 15, 2008
WEDNESDAY, JANUARY 21, 2009
In a review of the literature regarding the relationship between
smokeless tobacco use and cancer, a conflict of interest of one of the
article's authors was initially not disclosed (see: Boffetta P, Hecht S, Gray
N, Gupta P, Straif K. Smokeless tobacco and cancer. Lancet Oncology
2008; 9:667-675). The original article was published in July, 2008. That
article stated: "The authors declare no conflicts of interest." After the
editor of the journal was notified by a researcher with knowledge of a
potential conflict of interest of Dr. Stephen Hecht (one of the study
authors), an erratum was published in September 2008, which noted:
"During the immediate months preceding submission of the review SH
was acting in the capacity of an expert witness for the plaintiff in a
future court case against a smokeless tobacco company. SH declares his
participation in this case in no way influenced his writing or involvement
in the review."
http://tobaccoanalysis.blogspot.com/2009/01/conflict-of-interestnot.html
January 16, 2009 — More than one third of new
drug marketing applications approved by the US
Food and Drug Administration (FDA) were
missing information about potential conflicts of
interest for clinical trial investigators, which
could allow bias to creep into the approvals
process, a government report released this week
has found. The FDA has said that it agrees with
most of the report's findings.
http://www.medscape.com/viewarticle/586980
Do collaborations between biotech companies
and academic centers constitute a conflict of
interest?
Biotechnology industry partnerships with
universities and academic centers have been
fruitful for both. So why is there so much
concern about conflict of interest and is that
concern appropriate?
http://www.redorbit.com/news/health/750100/genetic_engineering_news_p
osts_podcast_on_industrialacademic_collaborations_are_these/index.html
Universities are responsible for use of public
funds and therefore must maintain the public
trust.
Identifying and mitigating situations that may
have the potential for conflict maintains the
integrity of the university.
Maintaining integrity allows the university to
do credible academic research.
To provide information on the purpose of the
conflict of interest requirements.
To provide a basic overview of conflicts of
interest
To introduce the disclosure process and the use
of management plans
To provide information on the need for updates
and annual renewals.
Situations where financial considerations
compromise your professional judgment.
“Actual Conflict of Interest”
◦ Not permitted
Situations where an independent observer
might reasonably question whether your
professional actions or decisions are
determined by considerations of personal
gain. “Perceived Conflict of Interest”
◦ Managed
Potential conflicts may be financial or may be
a conflict of time, effort and/or commitment.
Potential conflicts can occur as a result of
administrative, scientific, academic, fiduciary
or familial situations.
They are situations that can be PERCEIVED to
be conflicting, whether a “real” conflict exists
or not.
Ohio University Policy has a mandatory
disclosure policy if you:
Earn over $10,000 in a twelve month period
from your outside activity OR
Have over 5% equity in the entity
Applies to members of your immediate family
(spouse, domestic partner, dependent
children) as well as yourself.
Anything of monetary value, including but not
limited to:
◦
◦
◦
◦
Salary
Payments for services
Equity interests over 5%
Intellectual property rights
Excludes mutual, pension and other
investments over which you have no control
Outside work during regular academic year
should not exceed equivalent of 1 day per
week.
Consulting work must avoid activities that
involve a conflict of interest with assigned
Ohio University activities and programs
Faculty Handbook, section IV-D
Outside interests cannot interfere with
primary loyalty to Ohio University and your
academic role
Use of university resources must have prior
approval of Chair, Dean and VPR.
Your outside interests should not be in
direct competition with university interests
Full time administrative employees are
expected to devote their full-time
professional loyalty, time and energy to their
position.
You must use non-work hours and no
university resources
Federal Agencies
State Law
University Policies
Many Academic Publications
45 CFR Part 50, Subpart F
“Responsibility of Applicants for Promoting
Objectivity in Research for Which PHS Funding
is Sought”
Authority: 42 U.S.C. 216, 289b-1, 299c-3.
Intent is to assure objectivity by establishing
standards that preclude bias in design, conduct, or
reporting of research
Focuses on financial conflicts of interest
(FCOI)
Regulations apply to investigators, including
sub grantees, contractors, and collaborating
investigators.
Does not apply to applications for support
under Phase I of SBIR and STTR programs
An institutional conflict of interest policy should
require that each investigator disclose to a
responsible representative of the institution all
significant financial interests of the investigator
(including those of the investigator’s spouse and
dependent children) (i) that would reasonably
appear to be affected by the research or
educational activities funded or proposed for
funding by NSF; or (ii) in entities whose financial
interests would reasonably appear to be affected
by such activities.
Chapter 1 (Subchapter A) (Part 54)
Financial Disclosure by Clinical Investigators
The Food and Drug Administration (FDA)
regulations state that investigators that
receive compensation in excess of $25,000
from a corporate sponsor of a trial in which
the investigator is engaged must disclose to
the FDA at the time of filing for a new drug
application.
19.058, Conflict of Interest in Research,
Educational, and Public Service Activities
19.059, Employee Participation in Authorized
Private Companies Commercializing Ohio
University Research
“Conflict of Interest in Research, Educational,
and Public Service Activities”
Most conflict disclosures fall within the
parameters of this policy
States that faculty are primarily responsible
for their academic, research and service
obligations
“Employee Participation in Authorized Private
Companies Commercializing Ohio University
Research”
Applies to “employees, faculty, staff and students,
who create intellectual property owned by the Ohio
University and who desire to hold an equity interest
in a firm, corporation, or other association to which
Ohio University has assigned, licensed or
transferred Ohio University’s interests…”
Consulting
Licensing University Technology
Clinical Studies
Procurement
Mentoring
Institutional
A disclosure is filed specific to the funding
application.
If you have a potential conflict for one
proposal, it does not automatically apply to
all of your proposals.
Research conflicts of interest are usually
disclosed using LEO as you apply for funding
by completing the conflict of interest section
of the electronic transmittal
If you are not using LEO, you can download
the appropriate disclosure form from
www.ohio.edu/research/compliance
“A” is selected if you have no conflicts to
disclose
“B” is selected if you have a potential conflict
to disclose relative to the submission.
(Requires a subsequent paper process)
“C” is selected if you have a current disclosure
on file, but it is not relevant to the proposal
you are submitting
Still uses option A, B or C
Requires that you gather signatures on paper
for all options, however
Generally used for personnel not listed on the
grant proposal or “key personnel”
We have revised the COI forms to word forms
This should be easier to complete than the
previous form
PDF versions are also available
Should be on the compliance web site soon,
but we can e-mail them to you until then
Use this form only if you are unable to use
the LEO transmittal form to assure that no
conflict of interest exists. A form must be
completed for each proposal.
I assure that I have read Ohio University
Policy 19.058, “Conflict of Interest in
Research, Educational, and Public Service
Activities” and declare that I have nothing
that is, or could be perceived to be a conflict
of interest with this proposal.
Use this form to disclose a potential conflict
of interest situation.
A separate disclosure form must be used for
each entity with which you conduct business
Conflict includes any member of your
immediate family (spouse, domestic partner
or children)
Require that you complete an option “B”
disclosure statement in addition to
completing the LEO transmittal form.
Require you to obtain signatures from Center
or Institute (if applicable), Chair and Dean on
the additional disclosure statement!!
The B disclosure form is available at
www.ohio.edu/research/compliance
Use this form only if you are unable to use
the LEO transmittal form. Complete this form
if you have a current conflict of interest
disclosure on file with the Office of Research
Compliance, but that disclosure is not
applicable to this proposal.
*New Option for 2008*
A management plan is developed for some
disclosures to mitigate the potential conflict
Management plans are specific to each
disclosure
May require submission of additional pieces,
such as a student employment plan
Reduce or remove the financial interest creating the
conflict
Place safeguards that mitigate the conflict potential,
such having some decisions made by an independent
entity
Limit participation in portions of the proposed
research likely to create a conflict
Require that the researcher disclose his or her
conflicting financial interests to all collaborators and
any proposed trainees;
Disclose the conflict in publications
Work to remove students from being directly advised
or taught by faculty where a conflict exists
Assure publication rights for student participants
Student Use
Nepotism and Cronyism
Intellectual Property
Use of University Resources
Publication provisions
Use of Human Subjects
Oversight Requirements
Reporting and Annual Reviews
You must submit an annual renewal for your
disclosure
◦ If the potential conflict no longer exists you must
notify us
If significant changes occur during the year
you should submit an update to your
disclosure as they occur
Yes. We encourage employees to disclose
potential conflicts that do not meet the
financial threshold, but may still be
problematic, such as student employment.
This allows you to be transparent with
respect to outside interests.
Allowable situations
Situations that require disclosure but may not
need an extensive management plan
Situations that require disclosure and have
problematic elements that will require
mitigation and/or a management plan
Situations that are not permitted
Receipt of royalties or honoraria for
published scholarly works, seminars,
teaching, etc.
Honoraria for serving as a special reviewer
or work on review panels
Royalties under our intellectual property
policies if no other relationship with entity
Clinical income at OUCOM
You participate in research developed in
whole or part by you, and you or your
family receive royalties from an existing
agreement with the business, but have
no other significant financial interest
You assign students, etc. to research
projects where you are entitled to
receive royalties, but have no other
significant financial interest
You assign students, etc. to projects supported
by the business through an SRA, and have a
significant financial interest other than royalty
income
You receive research support from a business in
which you serve on the board of directors, or
other advisory board, even if you are not
compensated.
You hold an executive position in a business
engaged in commercial or research activities
directly related to your Ohio University
responsibilities.
Any situation in which an actual conflict
exists is not permitted.
The only “exceptions” are those handled
under Ohio University Policy and Procedure
19.059 where faculty entrepreneurship is
addressed.
Participation in clinical trials or evaluation
of other research in which you have a
significant financial interest other than
royalty income.
In the context of your position at Ohio
University, you make professional referrals
to a business in which you have a
significant financial interest.
Letter of admonition
Ineligibility to submit grant applications
Withholding of IRB or IACUC approvals
Suspension
Non-Renewal
Loss of Tenure
Consulting
Procurement
Mentoring
Clinical Studies
Avoid consulting relationships that have
the potential to divert time and effort from
your responsibilities to Ohio University.
Do not use students.
Be wary of situations that limit publication.
Do not use university stationary, etc. that
could create an impression the university
is involved with the activities.
Make sure you are devoting sufficient time
to your university obligations.
Be cautious that the potential financial gain
cannot be perceived to influence your
university mentoring relationships.
Disclose any personal or familial financial
interest or equity in a company that is
doing business with Ohio University.
If you make purchases using public funds,
you should not use companies which will
benefit you or your family. If there is no
alternative you must seek and receive
permission prior to purchasing.
Any relationship in which there is a real or
perceived power or influence imbalance has
the potential for conflict. (Faculty:Student)
Isolating these relationships with respect to
areas of personal financial gain is best.
If they cannot be isolated, then safeguards
must be created.
If you have a financial interest, it is best to
isolate yourself from the study.
At a minimum, expect a more intense review
and a robust management plan if you have a
financial interest.
If both the institution and you have financial
interests the clinical study should be
conducted elsewhere.
You have administrative responsibilities on
behalf of Ohio University that is beneficial to
the business in which you have a significant
financial interest
You have administrative responsibilities on
behalf of Ohio University with respect to an
SRA where you have a significant financial
interest
Slide 49
Jo Ellen Sherow
Ohio University
Office of Research Compliance
Researchers’ Financial Disclosures in the
Spotlight
Conflicts of interest, always an emotional topic,
returned to the headlines this week as Sen.
Charles Grassley, a longtime critic of the drug
industry’s potential influence on research,
released new evidence that prominent Harvard
University scientists had failed to disclose much
of their outside income from pharmaceutical
companies over the past eight years.
http://www.insidehighered.com/news/2008/06/12/conflict January 15, 2008
WEDNESDAY, JANUARY 21, 2009
In a review of the literature regarding the relationship between
smokeless tobacco use and cancer, a conflict of interest of one of the
article's authors was initially not disclosed (see: Boffetta P, Hecht S, Gray
N, Gupta P, Straif K. Smokeless tobacco and cancer. Lancet Oncology
2008; 9:667-675). The original article was published in July, 2008. That
article stated: "The authors declare no conflicts of interest." After the
editor of the journal was notified by a researcher with knowledge of a
potential conflict of interest of Dr. Stephen Hecht (one of the study
authors), an erratum was published in September 2008, which noted:
"During the immediate months preceding submission of the review SH
was acting in the capacity of an expert witness for the plaintiff in a
future court case against a smokeless tobacco company. SH declares his
participation in this case in no way influenced his writing or involvement
in the review."
http://tobaccoanalysis.blogspot.com/2009/01/conflict-of-interestnot.html
January 16, 2009 — More than one third of new
drug marketing applications approved by the US
Food and Drug Administration (FDA) were
missing information about potential conflicts of
interest for clinical trial investigators, which
could allow bias to creep into the approvals
process, a government report released this week
has found. The FDA has said that it agrees with
most of the report's findings.
http://www.medscape.com/viewarticle/586980
Do collaborations between biotech companies
and academic centers constitute a conflict of
interest?
Biotechnology industry partnerships with
universities and academic centers have been
fruitful for both. So why is there so much
concern about conflict of interest and is that
concern appropriate?
http://www.redorbit.com/news/health/750100/genetic_engineering_news_p
osts_podcast_on_industrialacademic_collaborations_are_these/index.html
Universities are responsible for use of public
funds and therefore must maintain the public
trust.
Identifying and mitigating situations that may
have the potential for conflict maintains the
integrity of the university.
Maintaining integrity allows the university to
do credible academic research.
To provide information on the purpose of the
conflict of interest requirements.
To provide a basic overview of conflicts of
interest
To introduce the disclosure process and the use
of management plans
To provide information on the need for updates
and annual renewals.
Situations where financial considerations
compromise your professional judgment.
“Actual Conflict of Interest”
◦ Not permitted
Situations where an independent observer
might reasonably question whether your
professional actions or decisions are
determined by considerations of personal
gain. “Perceived Conflict of Interest”
◦ Managed
Potential conflicts may be financial or may be
a conflict of time, effort and/or commitment.
Potential conflicts can occur as a result of
administrative, scientific, academic, fiduciary
or familial situations.
They are situations that can be PERCEIVED to
be conflicting, whether a “real” conflict exists
or not.
Ohio University Policy has a mandatory
disclosure policy if you:
Earn over $10,000 in a twelve month period
from your outside activity OR
Have over 5% equity in the entity
Applies to members of your immediate family
(spouse, domestic partner, dependent
children) as well as yourself.
Anything of monetary value, including but not
limited to:
◦
◦
◦
◦
Salary
Payments for services
Equity interests over 5%
Intellectual property rights
Excludes mutual, pension and other
investments over which you have no control
Outside work during regular academic year
should not exceed equivalent of 1 day per
week.
Consulting work must avoid activities that
involve a conflict of interest with assigned
Ohio University activities and programs
Faculty Handbook, section IV-D
Outside interests cannot interfere with
primary loyalty to Ohio University and your
academic role
Use of university resources must have prior
approval of Chair, Dean and VPR.
Your outside interests should not be in
direct competition with university interests
Full time administrative employees are
expected to devote their full-time
professional loyalty, time and energy to their
position.
You must use non-work hours and no
university resources
Federal Agencies
State Law
University Policies
Many Academic Publications
45 CFR Part 50, Subpart F
“Responsibility of Applicants for Promoting
Objectivity in Research for Which PHS Funding
is Sought”
Authority: 42 U.S.C. 216, 289b-1, 299c-3.
Intent is to assure objectivity by establishing
standards that preclude bias in design, conduct, or
reporting of research
Focuses on financial conflicts of interest
(FCOI)
Regulations apply to investigators, including
sub grantees, contractors, and collaborating
investigators.
Does not apply to applications for support
under Phase I of SBIR and STTR programs
An institutional conflict of interest policy should
require that each investigator disclose to a
responsible representative of the institution all
significant financial interests of the investigator
(including those of the investigator’s spouse and
dependent children) (i) that would reasonably
appear to be affected by the research or
educational activities funded or proposed for
funding by NSF; or (ii) in entities whose financial
interests would reasonably appear to be affected
by such activities.
Chapter 1 (Subchapter A) (Part 54)
Financial Disclosure by Clinical Investigators
The Food and Drug Administration (FDA)
regulations state that investigators that
receive compensation in excess of $25,000
from a corporate sponsor of a trial in which
the investigator is engaged must disclose to
the FDA at the time of filing for a new drug
application.
19.058, Conflict of Interest in Research,
Educational, and Public Service Activities
19.059, Employee Participation in Authorized
Private Companies Commercializing Ohio
University Research
“Conflict of Interest in Research, Educational,
and Public Service Activities”
Most conflict disclosures fall within the
parameters of this policy
States that faculty are primarily responsible
for their academic, research and service
obligations
“Employee Participation in Authorized Private
Companies Commercializing Ohio University
Research”
Applies to “employees, faculty, staff and students,
who create intellectual property owned by the Ohio
University and who desire to hold an equity interest
in a firm, corporation, or other association to which
Ohio University has assigned, licensed or
transferred Ohio University’s interests…”
Consulting
Licensing University Technology
Clinical Studies
Procurement
Mentoring
Institutional
A disclosure is filed specific to the funding
application.
If you have a potential conflict for one
proposal, it does not automatically apply to
all of your proposals.
Research conflicts of interest are usually
disclosed using LEO as you apply for funding
by completing the conflict of interest section
of the electronic transmittal
If you are not using LEO, you can download
the appropriate disclosure form from
www.ohio.edu/research/compliance
“A” is selected if you have no conflicts to
disclose
“B” is selected if you have a potential conflict
to disclose relative to the submission.
(Requires a subsequent paper process)
“C” is selected if you have a current disclosure
on file, but it is not relevant to the proposal
you are submitting
Still uses option A, B or C
Requires that you gather signatures on paper
for all options, however
Generally used for personnel not listed on the
grant proposal or “key personnel”
We have revised the COI forms to word forms
This should be easier to complete than the
previous form
PDF versions are also available
Should be on the compliance web site soon,
but we can e-mail them to you until then
Use this form only if you are unable to use
the LEO transmittal form to assure that no
conflict of interest exists. A form must be
completed for each proposal.
I assure that I have read Ohio University
Policy 19.058, “Conflict of Interest in
Research, Educational, and Public Service
Activities” and declare that I have nothing
that is, or could be perceived to be a conflict
of interest with this proposal.
Use this form to disclose a potential conflict
of interest situation.
A separate disclosure form must be used for
each entity with which you conduct business
Conflict includes any member of your
immediate family (spouse, domestic partner
or children)
Require that you complete an option “B”
disclosure statement in addition to
completing the LEO transmittal form.
Require you to obtain signatures from Center
or Institute (if applicable), Chair and Dean on
the additional disclosure statement!!
The B disclosure form is available at
www.ohio.edu/research/compliance
Use this form only if you are unable to use
the LEO transmittal form. Complete this form
if you have a current conflict of interest
disclosure on file with the Office of Research
Compliance, but that disclosure is not
applicable to this proposal.
*New Option for 2008*
A management plan is developed for some
disclosures to mitigate the potential conflict
Management plans are specific to each
disclosure
May require submission of additional pieces,
such as a student employment plan
Reduce or remove the financial interest creating the
conflict
Place safeguards that mitigate the conflict potential,
such having some decisions made by an independent
entity
Limit participation in portions of the proposed
research likely to create a conflict
Require that the researcher disclose his or her
conflicting financial interests to all collaborators and
any proposed trainees;
Disclose the conflict in publications
Work to remove students from being directly advised
or taught by faculty where a conflict exists
Assure publication rights for student participants
Student Use
Nepotism and Cronyism
Intellectual Property
Use of University Resources
Publication provisions
Use of Human Subjects
Oversight Requirements
Reporting and Annual Reviews
You must submit an annual renewal for your
disclosure
◦ If the potential conflict no longer exists you must
notify us
If significant changes occur during the year
you should submit an update to your
disclosure as they occur
Yes. We encourage employees to disclose
potential conflicts that do not meet the
financial threshold, but may still be
problematic, such as student employment.
This allows you to be transparent with
respect to outside interests.
Allowable situations
Situations that require disclosure but may not
need an extensive management plan
Situations that require disclosure and have
problematic elements that will require
mitigation and/or a management plan
Situations that are not permitted
Receipt of royalties or honoraria for
published scholarly works, seminars,
teaching, etc.
Honoraria for serving as a special reviewer
or work on review panels
Royalties under our intellectual property
policies if no other relationship with entity
Clinical income at OUCOM
You participate in research developed in
whole or part by you, and you or your
family receive royalties from an existing
agreement with the business, but have
no other significant financial interest
You assign students, etc. to research
projects where you are entitled to
receive royalties, but have no other
significant financial interest
You assign students, etc. to projects supported
by the business through an SRA, and have a
significant financial interest other than royalty
income
You receive research support from a business in
which you serve on the board of directors, or
other advisory board, even if you are not
compensated.
You hold an executive position in a business
engaged in commercial or research activities
directly related to your Ohio University
responsibilities.
Any situation in which an actual conflict
exists is not permitted.
The only “exceptions” are those handled
under Ohio University Policy and Procedure
19.059 where faculty entrepreneurship is
addressed.
Participation in clinical trials or evaluation
of other research in which you have a
significant financial interest other than
royalty income.
In the context of your position at Ohio
University, you make professional referrals
to a business in which you have a
significant financial interest.
Letter of admonition
Ineligibility to submit grant applications
Withholding of IRB or IACUC approvals
Suspension
Non-Renewal
Loss of Tenure
Consulting
Procurement
Mentoring
Clinical Studies
Avoid consulting relationships that have
the potential to divert time and effort from
your responsibilities to Ohio University.
Do not use students.
Be wary of situations that limit publication.
Do not use university stationary, etc. that
could create an impression the university
is involved with the activities.
Make sure you are devoting sufficient time
to your university obligations.
Be cautious that the potential financial gain
cannot be perceived to influence your
university mentoring relationships.
Disclose any personal or familial financial
interest or equity in a company that is
doing business with Ohio University.
If you make purchases using public funds,
you should not use companies which will
benefit you or your family. If there is no
alternative you must seek and receive
permission prior to purchasing.
Any relationship in which there is a real or
perceived power or influence imbalance has
the potential for conflict. (Faculty:Student)
Isolating these relationships with respect to
areas of personal financial gain is best.
If they cannot be isolated, then safeguards
must be created.
If you have a financial interest, it is best to
isolate yourself from the study.
At a minimum, expect a more intense review
and a robust management plan if you have a
financial interest.
If both the institution and you have financial
interests the clinical study should be
conducted elsewhere.
You have administrative responsibilities on
behalf of Ohio University that is beneficial to
the business in which you have a significant
financial interest
You have administrative responsibilities on
behalf of Ohio University with respect to an
SRA where you have a significant financial
interest
Slide 50
Jo Ellen Sherow
Ohio University
Office of Research Compliance
Researchers’ Financial Disclosures in the
Spotlight
Conflicts of interest, always an emotional topic,
returned to the headlines this week as Sen.
Charles Grassley, a longtime critic of the drug
industry’s potential influence on research,
released new evidence that prominent Harvard
University scientists had failed to disclose much
of their outside income from pharmaceutical
companies over the past eight years.
http://www.insidehighered.com/news/2008/06/12/conflict January 15, 2008
WEDNESDAY, JANUARY 21, 2009
In a review of the literature regarding the relationship between
smokeless tobacco use and cancer, a conflict of interest of one of the
article's authors was initially not disclosed (see: Boffetta P, Hecht S, Gray
N, Gupta P, Straif K. Smokeless tobacco and cancer. Lancet Oncology
2008; 9:667-675). The original article was published in July, 2008. That
article stated: "The authors declare no conflicts of interest." After the
editor of the journal was notified by a researcher with knowledge of a
potential conflict of interest of Dr. Stephen Hecht (one of the study
authors), an erratum was published in September 2008, which noted:
"During the immediate months preceding submission of the review SH
was acting in the capacity of an expert witness for the plaintiff in a
future court case against a smokeless tobacco company. SH declares his
participation in this case in no way influenced his writing or involvement
in the review."
http://tobaccoanalysis.blogspot.com/2009/01/conflict-of-interestnot.html
January 16, 2009 — More than one third of new
drug marketing applications approved by the US
Food and Drug Administration (FDA) were
missing information about potential conflicts of
interest for clinical trial investigators, which
could allow bias to creep into the approvals
process, a government report released this week
has found. The FDA has said that it agrees with
most of the report's findings.
http://www.medscape.com/viewarticle/586980
Do collaborations between biotech companies
and academic centers constitute a conflict of
interest?
Biotechnology industry partnerships with
universities and academic centers have been
fruitful for both. So why is there so much
concern about conflict of interest and is that
concern appropriate?
http://www.redorbit.com/news/health/750100/genetic_engineering_news_p
osts_podcast_on_industrialacademic_collaborations_are_these/index.html
Universities are responsible for use of public
funds and therefore must maintain the public
trust.
Identifying and mitigating situations that may
have the potential for conflict maintains the
integrity of the university.
Maintaining integrity allows the university to
do credible academic research.
To provide information on the purpose of the
conflict of interest requirements.
To provide a basic overview of conflicts of
interest
To introduce the disclosure process and the use
of management plans
To provide information on the need for updates
and annual renewals.
Situations where financial considerations
compromise your professional judgment.
“Actual Conflict of Interest”
◦ Not permitted
Situations where an independent observer
might reasonably question whether your
professional actions or decisions are
determined by considerations of personal
gain. “Perceived Conflict of Interest”
◦ Managed
Potential conflicts may be financial or may be
a conflict of time, effort and/or commitment.
Potential conflicts can occur as a result of
administrative, scientific, academic, fiduciary
or familial situations.
They are situations that can be PERCEIVED to
be conflicting, whether a “real” conflict exists
or not.
Ohio University Policy has a mandatory
disclosure policy if you:
Earn over $10,000 in a twelve month period
from your outside activity OR
Have over 5% equity in the entity
Applies to members of your immediate family
(spouse, domestic partner, dependent
children) as well as yourself.
Anything of monetary value, including but not
limited to:
◦
◦
◦
◦
Salary
Payments for services
Equity interests over 5%
Intellectual property rights
Excludes mutual, pension and other
investments over which you have no control
Outside work during regular academic year
should not exceed equivalent of 1 day per
week.
Consulting work must avoid activities that
involve a conflict of interest with assigned
Ohio University activities and programs
Faculty Handbook, section IV-D
Outside interests cannot interfere with
primary loyalty to Ohio University and your
academic role
Use of university resources must have prior
approval of Chair, Dean and VPR.
Your outside interests should not be in
direct competition with university interests
Full time administrative employees are
expected to devote their full-time
professional loyalty, time and energy to their
position.
You must use non-work hours and no
university resources
Federal Agencies
State Law
University Policies
Many Academic Publications
45 CFR Part 50, Subpart F
“Responsibility of Applicants for Promoting
Objectivity in Research for Which PHS Funding
is Sought”
Authority: 42 U.S.C. 216, 289b-1, 299c-3.
Intent is to assure objectivity by establishing
standards that preclude bias in design, conduct, or
reporting of research
Focuses on financial conflicts of interest
(FCOI)
Regulations apply to investigators, including
sub grantees, contractors, and collaborating
investigators.
Does not apply to applications for support
under Phase I of SBIR and STTR programs
An institutional conflict of interest policy should
require that each investigator disclose to a
responsible representative of the institution all
significant financial interests of the investigator
(including those of the investigator’s spouse and
dependent children) (i) that would reasonably
appear to be affected by the research or
educational activities funded or proposed for
funding by NSF; or (ii) in entities whose financial
interests would reasonably appear to be affected
by such activities.
Chapter 1 (Subchapter A) (Part 54)
Financial Disclosure by Clinical Investigators
The Food and Drug Administration (FDA)
regulations state that investigators that
receive compensation in excess of $25,000
from a corporate sponsor of a trial in which
the investigator is engaged must disclose to
the FDA at the time of filing for a new drug
application.
19.058, Conflict of Interest in Research,
Educational, and Public Service Activities
19.059, Employee Participation in Authorized
Private Companies Commercializing Ohio
University Research
“Conflict of Interest in Research, Educational,
and Public Service Activities”
Most conflict disclosures fall within the
parameters of this policy
States that faculty are primarily responsible
for their academic, research and service
obligations
“Employee Participation in Authorized Private
Companies Commercializing Ohio University
Research”
Applies to “employees, faculty, staff and students,
who create intellectual property owned by the Ohio
University and who desire to hold an equity interest
in a firm, corporation, or other association to which
Ohio University has assigned, licensed or
transferred Ohio University’s interests…”
Consulting
Licensing University Technology
Clinical Studies
Procurement
Mentoring
Institutional
A disclosure is filed specific to the funding
application.
If you have a potential conflict for one
proposal, it does not automatically apply to
all of your proposals.
Research conflicts of interest are usually
disclosed using LEO as you apply for funding
by completing the conflict of interest section
of the electronic transmittal
If you are not using LEO, you can download
the appropriate disclosure form from
www.ohio.edu/research/compliance
“A” is selected if you have no conflicts to
disclose
“B” is selected if you have a potential conflict
to disclose relative to the submission.
(Requires a subsequent paper process)
“C” is selected if you have a current disclosure
on file, but it is not relevant to the proposal
you are submitting
Still uses option A, B or C
Requires that you gather signatures on paper
for all options, however
Generally used for personnel not listed on the
grant proposal or “key personnel”
We have revised the COI forms to word forms
This should be easier to complete than the
previous form
PDF versions are also available
Should be on the compliance web site soon,
but we can e-mail them to you until then
Use this form only if you are unable to use
the LEO transmittal form to assure that no
conflict of interest exists. A form must be
completed for each proposal.
I assure that I have read Ohio University
Policy 19.058, “Conflict of Interest in
Research, Educational, and Public Service
Activities” and declare that I have nothing
that is, or could be perceived to be a conflict
of interest with this proposal.
Use this form to disclose a potential conflict
of interest situation.
A separate disclosure form must be used for
each entity with which you conduct business
Conflict includes any member of your
immediate family (spouse, domestic partner
or children)
Require that you complete an option “B”
disclosure statement in addition to
completing the LEO transmittal form.
Require you to obtain signatures from Center
or Institute (if applicable), Chair and Dean on
the additional disclosure statement!!
The B disclosure form is available at
www.ohio.edu/research/compliance
Use this form only if you are unable to use
the LEO transmittal form. Complete this form
if you have a current conflict of interest
disclosure on file with the Office of Research
Compliance, but that disclosure is not
applicable to this proposal.
*New Option for 2008*
A management plan is developed for some
disclosures to mitigate the potential conflict
Management plans are specific to each
disclosure
May require submission of additional pieces,
such as a student employment plan
Reduce or remove the financial interest creating the
conflict
Place safeguards that mitigate the conflict potential,
such having some decisions made by an independent
entity
Limit participation in portions of the proposed
research likely to create a conflict
Require that the researcher disclose his or her
conflicting financial interests to all collaborators and
any proposed trainees;
Disclose the conflict in publications
Work to remove students from being directly advised
or taught by faculty where a conflict exists
Assure publication rights for student participants
Student Use
Nepotism and Cronyism
Intellectual Property
Use of University Resources
Publication provisions
Use of Human Subjects
Oversight Requirements
Reporting and Annual Reviews
You must submit an annual renewal for your
disclosure
◦ If the potential conflict no longer exists you must
notify us
If significant changes occur during the year
you should submit an update to your
disclosure as they occur
Yes. We encourage employees to disclose
potential conflicts that do not meet the
financial threshold, but may still be
problematic, such as student employment.
This allows you to be transparent with
respect to outside interests.
Allowable situations
Situations that require disclosure but may not
need an extensive management plan
Situations that require disclosure and have
problematic elements that will require
mitigation and/or a management plan
Situations that are not permitted
Receipt of royalties or honoraria for
published scholarly works, seminars,
teaching, etc.
Honoraria for serving as a special reviewer
or work on review panels
Royalties under our intellectual property
policies if no other relationship with entity
Clinical income at OUCOM
You participate in research developed in
whole or part by you, and you or your
family receive royalties from an existing
agreement with the business, but have
no other significant financial interest
You assign students, etc. to research
projects where you are entitled to
receive royalties, but have no other
significant financial interest
You assign students, etc. to projects supported
by the business through an SRA, and have a
significant financial interest other than royalty
income
You receive research support from a business in
which you serve on the board of directors, or
other advisory board, even if you are not
compensated.
You hold an executive position in a business
engaged in commercial or research activities
directly related to your Ohio University
responsibilities.
Any situation in which an actual conflict
exists is not permitted.
The only “exceptions” are those handled
under Ohio University Policy and Procedure
19.059 where faculty entrepreneurship is
addressed.
Participation in clinical trials or evaluation
of other research in which you have a
significant financial interest other than
royalty income.
In the context of your position at Ohio
University, you make professional referrals
to a business in which you have a
significant financial interest.
Letter of admonition
Ineligibility to submit grant applications
Withholding of IRB or IACUC approvals
Suspension
Non-Renewal
Loss of Tenure
Consulting
Procurement
Mentoring
Clinical Studies
Avoid consulting relationships that have
the potential to divert time and effort from
your responsibilities to Ohio University.
Do not use students.
Be wary of situations that limit publication.
Do not use university stationary, etc. that
could create an impression the university
is involved with the activities.
Make sure you are devoting sufficient time
to your university obligations.
Be cautious that the potential financial gain
cannot be perceived to influence your
university mentoring relationships.
Disclose any personal or familial financial
interest or equity in a company that is
doing business with Ohio University.
If you make purchases using public funds,
you should not use companies which will
benefit you or your family. If there is no
alternative you must seek and receive
permission prior to purchasing.
Any relationship in which there is a real or
perceived power or influence imbalance has
the potential for conflict. (Faculty:Student)
Isolating these relationships with respect to
areas of personal financial gain is best.
If they cannot be isolated, then safeguards
must be created.
If you have a financial interest, it is best to
isolate yourself from the study.
At a minimum, expect a more intense review
and a robust management plan if you have a
financial interest.
If both the institution and you have financial
interests the clinical study should be
conducted elsewhere.
You have administrative responsibilities on
behalf of Ohio University that is beneficial to
the business in which you have a significant
financial interest
You have administrative responsibilities on
behalf of Ohio University with respect to an
SRA where you have a significant financial
interest
Slide 51
Jo Ellen Sherow
Ohio University
Office of Research Compliance
Researchers’ Financial Disclosures in the
Spotlight
Conflicts of interest, always an emotional topic,
returned to the headlines this week as Sen.
Charles Grassley, a longtime critic of the drug
industry’s potential influence on research,
released new evidence that prominent Harvard
University scientists had failed to disclose much
of their outside income from pharmaceutical
companies over the past eight years.
http://www.insidehighered.com/news/2008/06/12/conflict January 15, 2008
WEDNESDAY, JANUARY 21, 2009
In a review of the literature regarding the relationship between
smokeless tobacco use and cancer, a conflict of interest of one of the
article's authors was initially not disclosed (see: Boffetta P, Hecht S, Gray
N, Gupta P, Straif K. Smokeless tobacco and cancer. Lancet Oncology
2008; 9:667-675). The original article was published in July, 2008. That
article stated: "The authors declare no conflicts of interest." After the
editor of the journal was notified by a researcher with knowledge of a
potential conflict of interest of Dr. Stephen Hecht (one of the study
authors), an erratum was published in September 2008, which noted:
"During the immediate months preceding submission of the review SH
was acting in the capacity of an expert witness for the plaintiff in a
future court case against a smokeless tobacco company. SH declares his
participation in this case in no way influenced his writing or involvement
in the review."
http://tobaccoanalysis.blogspot.com/2009/01/conflict-of-interestnot.html
January 16, 2009 — More than one third of new
drug marketing applications approved by the US
Food and Drug Administration (FDA) were
missing information about potential conflicts of
interest for clinical trial investigators, which
could allow bias to creep into the approvals
process, a government report released this week
has found. The FDA has said that it agrees with
most of the report's findings.
http://www.medscape.com/viewarticle/586980
Do collaborations between biotech companies
and academic centers constitute a conflict of
interest?
Biotechnology industry partnerships with
universities and academic centers have been
fruitful for both. So why is there so much
concern about conflict of interest and is that
concern appropriate?
http://www.redorbit.com/news/health/750100/genetic_engineering_news_p
osts_podcast_on_industrialacademic_collaborations_are_these/index.html
Universities are responsible for use of public
funds and therefore must maintain the public
trust.
Identifying and mitigating situations that may
have the potential for conflict maintains the
integrity of the university.
Maintaining integrity allows the university to
do credible academic research.
To provide information on the purpose of the
conflict of interest requirements.
To provide a basic overview of conflicts of
interest
To introduce the disclosure process and the use
of management plans
To provide information on the need for updates
and annual renewals.
Situations where financial considerations
compromise your professional judgment.
“Actual Conflict of Interest”
◦ Not permitted
Situations where an independent observer
might reasonably question whether your
professional actions or decisions are
determined by considerations of personal
gain. “Perceived Conflict of Interest”
◦ Managed
Potential conflicts may be financial or may be
a conflict of time, effort and/or commitment.
Potential conflicts can occur as a result of
administrative, scientific, academic, fiduciary
or familial situations.
They are situations that can be PERCEIVED to
be conflicting, whether a “real” conflict exists
or not.
Ohio University Policy has a mandatory
disclosure policy if you:
Earn over $10,000 in a twelve month period
from your outside activity OR
Have over 5% equity in the entity
Applies to members of your immediate family
(spouse, domestic partner, dependent
children) as well as yourself.
Anything of monetary value, including but not
limited to:
◦
◦
◦
◦
Salary
Payments for services
Equity interests over 5%
Intellectual property rights
Excludes mutual, pension and other
investments over which you have no control
Outside work during regular academic year
should not exceed equivalent of 1 day per
week.
Consulting work must avoid activities that
involve a conflict of interest with assigned
Ohio University activities and programs
Faculty Handbook, section IV-D
Outside interests cannot interfere with
primary loyalty to Ohio University and your
academic role
Use of university resources must have prior
approval of Chair, Dean and VPR.
Your outside interests should not be in
direct competition with university interests
Full time administrative employees are
expected to devote their full-time
professional loyalty, time and energy to their
position.
You must use non-work hours and no
university resources
Federal Agencies
State Law
University Policies
Many Academic Publications
45 CFR Part 50, Subpart F
“Responsibility of Applicants for Promoting
Objectivity in Research for Which PHS Funding
is Sought”
Authority: 42 U.S.C. 216, 289b-1, 299c-3.
Intent is to assure objectivity by establishing
standards that preclude bias in design, conduct, or
reporting of research
Focuses on financial conflicts of interest
(FCOI)
Regulations apply to investigators, including
sub grantees, contractors, and collaborating
investigators.
Does not apply to applications for support
under Phase I of SBIR and STTR programs
An institutional conflict of interest policy should
require that each investigator disclose to a
responsible representative of the institution all
significant financial interests of the investigator
(including those of the investigator’s spouse and
dependent children) (i) that would reasonably
appear to be affected by the research or
educational activities funded or proposed for
funding by NSF; or (ii) in entities whose financial
interests would reasonably appear to be affected
by such activities.
Chapter 1 (Subchapter A) (Part 54)
Financial Disclosure by Clinical Investigators
The Food and Drug Administration (FDA)
regulations state that investigators that
receive compensation in excess of $25,000
from a corporate sponsor of a trial in which
the investigator is engaged must disclose to
the FDA at the time of filing for a new drug
application.
19.058, Conflict of Interest in Research,
Educational, and Public Service Activities
19.059, Employee Participation in Authorized
Private Companies Commercializing Ohio
University Research
“Conflict of Interest in Research, Educational,
and Public Service Activities”
Most conflict disclosures fall within the
parameters of this policy
States that faculty are primarily responsible
for their academic, research and service
obligations
“Employee Participation in Authorized Private
Companies Commercializing Ohio University
Research”
Applies to “employees, faculty, staff and students,
who create intellectual property owned by the Ohio
University and who desire to hold an equity interest
in a firm, corporation, or other association to which
Ohio University has assigned, licensed or
transferred Ohio University’s interests…”
Consulting
Licensing University Technology
Clinical Studies
Procurement
Mentoring
Institutional
A disclosure is filed specific to the funding
application.
If you have a potential conflict for one
proposal, it does not automatically apply to
all of your proposals.
Research conflicts of interest are usually
disclosed using LEO as you apply for funding
by completing the conflict of interest section
of the electronic transmittal
If you are not using LEO, you can download
the appropriate disclosure form from
www.ohio.edu/research/compliance
“A” is selected if you have no conflicts to
disclose
“B” is selected if you have a potential conflict
to disclose relative to the submission.
(Requires a subsequent paper process)
“C” is selected if you have a current disclosure
on file, but it is not relevant to the proposal
you are submitting
Still uses option A, B or C
Requires that you gather signatures on paper
for all options, however
Generally used for personnel not listed on the
grant proposal or “key personnel”
We have revised the COI forms to word forms
This should be easier to complete than the
previous form
PDF versions are also available
Should be on the compliance web site soon,
but we can e-mail them to you until then
Use this form only if you are unable to use
the LEO transmittal form to assure that no
conflict of interest exists. A form must be
completed for each proposal.
I assure that I have read Ohio University
Policy 19.058, “Conflict of Interest in
Research, Educational, and Public Service
Activities” and declare that I have nothing
that is, or could be perceived to be a conflict
of interest with this proposal.
Use this form to disclose a potential conflict
of interest situation.
A separate disclosure form must be used for
each entity with which you conduct business
Conflict includes any member of your
immediate family (spouse, domestic partner
or children)
Require that you complete an option “B”
disclosure statement in addition to
completing the LEO transmittal form.
Require you to obtain signatures from Center
or Institute (if applicable), Chair and Dean on
the additional disclosure statement!!
The B disclosure form is available at
www.ohio.edu/research/compliance
Use this form only if you are unable to use
the LEO transmittal form. Complete this form
if you have a current conflict of interest
disclosure on file with the Office of Research
Compliance, but that disclosure is not
applicable to this proposal.
*New Option for 2008*
A management plan is developed for some
disclosures to mitigate the potential conflict
Management plans are specific to each
disclosure
May require submission of additional pieces,
such as a student employment plan
Reduce or remove the financial interest creating the
conflict
Place safeguards that mitigate the conflict potential,
such having some decisions made by an independent
entity
Limit participation in portions of the proposed
research likely to create a conflict
Require that the researcher disclose his or her
conflicting financial interests to all collaborators and
any proposed trainees;
Disclose the conflict in publications
Work to remove students from being directly advised
or taught by faculty where a conflict exists
Assure publication rights for student participants
Student Use
Nepotism and Cronyism
Intellectual Property
Use of University Resources
Publication provisions
Use of Human Subjects
Oversight Requirements
Reporting and Annual Reviews
You must submit an annual renewal for your
disclosure
◦ If the potential conflict no longer exists you must
notify us
If significant changes occur during the year
you should submit an update to your
disclosure as they occur
Yes. We encourage employees to disclose
potential conflicts that do not meet the
financial threshold, but may still be
problematic, such as student employment.
This allows you to be transparent with
respect to outside interests.
Allowable situations
Situations that require disclosure but may not
need an extensive management plan
Situations that require disclosure and have
problematic elements that will require
mitigation and/or a management plan
Situations that are not permitted
Receipt of royalties or honoraria for
published scholarly works, seminars,
teaching, etc.
Honoraria for serving as a special reviewer
or work on review panels
Royalties under our intellectual property
policies if no other relationship with entity
Clinical income at OUCOM
You participate in research developed in
whole or part by you, and you or your
family receive royalties from an existing
agreement with the business, but have
no other significant financial interest
You assign students, etc. to research
projects where you are entitled to
receive royalties, but have no other
significant financial interest
You assign students, etc. to projects supported
by the business through an SRA, and have a
significant financial interest other than royalty
income
You receive research support from a business in
which you serve on the board of directors, or
other advisory board, even if you are not
compensated.
You hold an executive position in a business
engaged in commercial or research activities
directly related to your Ohio University
responsibilities.
Any situation in which an actual conflict
exists is not permitted.
The only “exceptions” are those handled
under Ohio University Policy and Procedure
19.059 where faculty entrepreneurship is
addressed.
Participation in clinical trials or evaluation
of other research in which you have a
significant financial interest other than
royalty income.
In the context of your position at Ohio
University, you make professional referrals
to a business in which you have a
significant financial interest.
Letter of admonition
Ineligibility to submit grant applications
Withholding of IRB or IACUC approvals
Suspension
Non-Renewal
Loss of Tenure
Consulting
Procurement
Mentoring
Clinical Studies
Avoid consulting relationships that have
the potential to divert time and effort from
your responsibilities to Ohio University.
Do not use students.
Be wary of situations that limit publication.
Do not use university stationary, etc. that
could create an impression the university
is involved with the activities.
Make sure you are devoting sufficient time
to your university obligations.
Be cautious that the potential financial gain
cannot be perceived to influence your
university mentoring relationships.
Disclose any personal or familial financial
interest or equity in a company that is
doing business with Ohio University.
If you make purchases using public funds,
you should not use companies which will
benefit you or your family. If there is no
alternative you must seek and receive
permission prior to purchasing.
Any relationship in which there is a real or
perceived power or influence imbalance has
the potential for conflict. (Faculty:Student)
Isolating these relationships with respect to
areas of personal financial gain is best.
If they cannot be isolated, then safeguards
must be created.
If you have a financial interest, it is best to
isolate yourself from the study.
At a minimum, expect a more intense review
and a robust management plan if you have a
financial interest.
If both the institution and you have financial
interests the clinical study should be
conducted elsewhere.
You have administrative responsibilities on
behalf of Ohio University that is beneficial to
the business in which you have a significant
financial interest
You have administrative responsibilities on
behalf of Ohio University with respect to an
SRA where you have a significant financial
interest