Transcript Conflict of Interest Reporting for Personnel

Conflict of Interest for
Research Administrators
August 2007
Susan MacNally
Compliance Coordinator, Research Integrity
Research and Graduate Studies
“Please create a conflict of interest…
Yes, I really mean this. Please conduct research, write
papers, give talks, consult, publish books, serve on
boards and panels, invent, start companies, testify,
collect honoraria... do the things that create a
healthy, vibrant campus where research and
scholarship thrive. As a result, you will often create
conflicts of interest. Good for you.”
James A. Roberts,
Vice Provost for Research and Graduate Studies
Research@KU, May, 2006
A Conflict of Interest is…
…the possibility, from the perspective of an
independent observer, that an individual’s private
financial interests or his or her families’ interests,
may influence their professional actions, decisions
or judgments.
Conflict of Interest in the Headlines
New York Times, August 1, 2006
Tough-Talking Journal Editor Faces Accusations of Leniency
By DONALD G. McNEIL Jr.
“…In one case, the authors of a study on the use of antidepressants during
pregnancy, published in JAMA in February, neglected to disclose fees and
research money from drug makers. The study found that pregnant women
who stopped taking antidepressants risked renewed depression.
In another case at JAMA, the authors of a study saying that women with
migraines were more likely to get heart disease did not mention they had
received money from companies that make painkillers. The authors of a
study linking some arthritis drugs to cancer omitted mention of speaking
fees. …”
Appearance, Reality and COI
The existence of a COI does not mean that
unethical behavior has occurred
The existence of a COI can
cast doubt on integrity
An undisclosed COI has
great potential for damage
What is at Stake?
Individual
and
Institutional
Integrity
Perceptions that
Public funds have been used for private gain
An investigator’s research may be biased
An investigator has behaved unethically
KU is a poor steward of public funds
KU research may not be credible
KU is not fulfilling its mission
The University recognizes that
Conflicts may be inherent in trying to balance
various roles
Failure to disclose is a breach of policy
Employees may be able to act in dual roles if
an approved management plan is in place
Conflicts may be so profound that they
require severance of relationship
In other words,
the University recognizes that
Conflicts happen
Some conflicts can be managed
Some conflicts must be eliminated
Disclosure is an individual responsibility
How does COI affect research
administrators?
Policies – who, what, how often
Processes – reporting and COIC
Compliance – reviews, consequences
Policies – Federal
PHS, NSF
•1995-federal standards
•Institutions
•Investigators
Policies – Kansas Board of Regents
KBOR
• 1995-Compatible
with federal
• Broader than
federal
• Sets reporting
requirements
PHS, NSF
Policies –
All
•F/US Handbook
•Supplemental
policies
KU
KBOR
PHS, NSF
WHO has to file?
Faculty and Unclassified Staff (KBOR)
ALL Full-time
Some Part-time – researchers, those with conflict
Investigators (PHS/NSF)
Anyone responsible for the design,
conduct or reporting of research
Can include Adjuncts, USS, Students
HOW Often are COI reports required?
Upon employment
Annually, on
academic year cycle
Ad hoc, whenever
one’s circumstances change
All of the above
KBOR COI Forms
Declaration Form A
CONFIDENTIAL
FORM A
DECLARATION FOR CONFLICT OF INTEREST
AND CONFLICT OF TIME COMMITMENT
Form A has 6 yes/no questions.
Only one has a correct answer.
EMPLOYEE IDENTIFICATION
Name:
Last Name
 First Name
 Middle Initial
Department/Division
Position Title
Phone/e-mail



Full Time Employee
Part Time Employee
Adjunct Appointment



First Time Filing This Form
Annual Update
Ad Hoc Report
SECTION A - CONFLICT OF INTEREST
1.
Ownership: Ownership interest in any corporation, partnership, trust, joint venture, and every
other business interest, including land used for income which you or other members of your
household own or have owned within the preceding 12 months, which represents a legal or equitable
interest exceeding $10,000 or five percent whichever is less. Ownership of intellectual property,
e.g., patents, royalties, and copyrights is also included. Ownership of funds and holdings acquired
through the Regents retirement programs are not included.
Are there any ownership interests you have or a member of your family has which meet this criteria
and could an independent observer conclude that they appear to influence or potentially conflict
with any of your research/educational activities?
 No
2.
 Yes
(If Yes, disclose on Form B, section C)
Compensation: Receipt of salary, anything of value, or economic benefit in return for services
rendered conferred within the past 12 months or to be conferred in excess of $10,000, including
consulting fees in excess of $10,000 from any one entity.
Have you or your family received or do you expect to receive compensation as defined above and
could an independent observer conclude that said compensation influences or potentially conflicts
with any of your research/educational activities?
 No
 Yes
Question B.1.
(If Yes, disclose on Form B, section D)
Have you read the
Regents COI Policy?
Yes
KBOR COI Forms
Disclosure Form B
Each section in Form B
CONFIDENTIAL
corresponds to a
question on Form A
Form B
DISCLOSURE OF CONFLICT OF INTEREST
AND/OR TIME COMMITMENT INTERESTS
(ONLY TO BE COMPLETED IF REQUIRED BY ANSWERS TO FORM A DISCLOSURE)
SECTION I - CONFLICT OF INTEREST
In compliance with federal, Regents, and University of Kansas policies, disclosure of relevant significant
financial interest is required of all full time faculty and unclassified staff and all other members of the
University community who are responsible for the design, conduct, or reporting of research or educational
activities. The disclosure of interests includes those of the University employee, his or her spouse,
dependent children, and other members of the personal household.
If you declare that you
Significant Financial Interest means anything of monetary value including, but not limited to, salary or other
payments for services (e.g., consulting fees or honoraria), equity interests (e.g., stocks, stock options, or
other ownership interests), and intellectual property rights (e.g., patents, copyrights, and royalties from
such rights). The term does not include any of the following:
i.
have a significant interest
Salary, royalties, or other remuneration from the University including funds and holdings
acquired through the Regents retirement programs;
ii. Income (e.g., salary, fees, or other continuing payments) in an amount of $10,000 or less per
annum from any one business enterprise or entity when aggregated for the employee and
members of his/her family.
iii. Financial interest in any one business enterprise or entity if the value of those interests does not
exceed a five percent ownership interest when aggregated for the employee and members of
his/her family and the value of that five percent ownership interest does not exceed $10,000.
on form A, then you must
A. EMPLOYEE IDENTIFICATION
disclose details on Form B
Name:
Last Name
 First Name
 Middle Initial
Department/Division
Position Title
Phone/e-mail
KBOR COI Forms
Declaration Form A
+
Disclosure Form B
CONFIDENTIAL
CONFIDENTIAL
FORM A
Form B
DECLARATION FOR CONFLICT OF INTEREST
AND CONFLICT OF TIME COMMITMENT
DISCLOSURE OF CONFLICT OF INTEREST
AND/OR TIME COMMITMENT INTERESTS
EMPLOYEE IDENTIFICATION
(ONLY TO BE COMPLETED IF REQUIRED BY ANSWERS TO FORM A DISCLOSURE)
Name:
Last Name
 First Name
 Middle Initial
Department/Division
Position Title
Phone/e-mail



Full Time Employee
Part Time Employee
Adjunct Appointment



First Time Filing This Form
Annual Update
Ad Hoc Report
SECTION A - CONFLICT OF INTEREST
1.
In compliance with federal, Regents, and University of Kansas policies, disclosure of relevant significant
financial interest is required of all full time faculty and unclassified staff and all other members of the
University community who are responsible for the design, conduct, or reporting of research or educational
activities. The disclosure of interests includes those of the University employee, his or her spouse,
dependent children, and other members of the personal household.
Significant Financial Interest means anything of monetary value including, but not limited to, salary or other
payments for services (e.g., consulting fees or honoraria), equity interests (e.g., stocks, stock options, or
other ownership interests), and intellectual property rights (e.g., patents, copyrights, and royalties from
such rights). The term does not include any of the following:
Ownership: Ownership interest in any corporation, partnership, trust, joint venture, and every
other business interest, including land used for income which you or other members of your
household own or have owned within the preceding 12 months, which represents a legal or equitable
interest exceeding $10,000 or five percent whichever is less. Ownership of intellectual property,
e.g., patents, royalties, and copyrights is also included. Ownership of funds and holdings acquired
through the Regents retirement programs are not included.
i.
Are there any ownership interests you have or a member of your family has which meet this criteria
and could an independent observer conclude that they appear to influence or potentially conflict
with any of your research/educational activities?
iii. Financial interest in any one business enterprise or entity if the value of those interests does not
exceed a five percent ownership interest when aggregated for the employee and members of
his/her family and the value of that five percent ownership interest does not exceed $10,000.
 No
2.
~8% ~92%
SECTION I - CONFLICT OF INTEREST
 Yes
Have you or your family received or do you expect to receive compensation as defined above and
could an independent observer conclude that said compensation influences or potentially conflicts
with any of your research/educational activities?
 Yes
ii. Income (e.g., salary, fees, or other continuing payments) in an amount of $10,000 or less per
annum from any one business enterprise or entity when aggregated for the employee and
members of his/her family.
(If Yes, disclose on Form B, section C)
Compensation: Receipt of salary, anything of value, or economic benefit in return for services
rendered conferred within the past 12 months or to be conferred in excess of $10,000, including
consulting fees in excess of $10,000 from any one entity.
 No
Salary, royalties, or other remuneration from the University including funds and holdings
acquired through the Regents retirement programs;
(If Yes, disclose on Form B, section D)
A. EMPLOYEE IDENTIFICATION
Name:
Last Name
 First Name
 Middle Initial
Department/Division
Position Title
Phone/e-mail
WHAT information is disclosed?
Significant financial interests
of employee or other household member
which exceed defined thresholds AND
which an independent observer could conclude
influences or potentially conflicts with
employee’s research or educational activities.
Ownership  Compensation  Fees/Commissions  Office
KU/KBOR COI Reporting Process
Declare Form A
If Yes
If No
RI
In compliance for
proposal submission
Disclose Form B
COI Committee
Review/Response
Management Plan
Must be resolved before
award expenditures
Checking COI compliance for proposal
submission
COI Forms
All F/US
Check COI in
CTS/COI Lite
Yes
Others
PI
Decides
No
Note PI decision in
file
Review WHO has to file
PI makes the call as to who is an Investigator
Check compliance in CTS system
Checking COI compliance for
proposal submission
Good to go!
Up to date, no disclosures
Not up to date
Not in database
Stop! Message
No fully-signed
report on file
Must verify
they have begun
to file by proposal
submission date
Contact RI
immediately
RI will follow up
Checking proposal for COI disclosures
If disclosed interest is involved as a sponsor,
subcontractor, provider of services, contact RI
RI will check to see whether a management
plan is in place and, if not, will work with PI
and COIC to create one
The funding agency may have to be notified.
KU COI information on the web
Web-facilitated
reporting
Download
forms
Policies
FAQs
www.rgs.ku.edu/rcr
Web-facilitated COI Reporting
New employees fill out paper forms
All others via website
View prior reports
Confirm no changes
Fill out new reports
Print reports
https://webapp.research.ku.edu/COI/home.html
Web-facilitated COI Reporting
https://webapp.research.ku.edu/COI/home.html
Web-facilitated COI Reporting –
secure KU login
https://webapp.research.ku.edu/COI/home.html
Web-facilitated COI Reporting
User’s reports
Prior reports
Scroll down to
begin new report
or confirm most
recent report
Web-facilitated COI ReportingReporting
User’s reports
Confirm
no changes
Fill out
new reports
https://webapp.research.ku.edu/COI/home.html
Confirm or Begin New Report?
Confirm most recent report
Done completely online –
no printouts, no signatures required.
Fully-executed hard copy of prior
report must be on file at RI.
Confirm or Begin New Report???
Begin new report online
If you have a new significant interest to disclose.
Print both Form A and Form B.
All signatures required.
In Compliance = Fully Executed
3 Required Signatures*
•Individual
•Chair, Director or Unit Head
•Dean or Vice Provost
*some administrators require only one signature
Frequently Confused with COI
Consulting Policy
Overseen by Office of the Provost
Forms on Provost’s website
Send forms to Office of the Provost
Frequently Confused with COI
State of Kansas
Statement of Substantial Interests
Very similar to COI questions
Required of certain State employees
Notification from Provost every April
Sent directly to Topeka
Why Comply with COI?
Preserve credibility, reputation
Sanctions for non-compliance
Individual can be barred from submitting
proposals
May be noted on employee record
“…This follows them for the rest of their life.”
Dr. Catherine D. DeAngelis, Editor in Chief, JAMA
“Disclose and Manage – it works
… So, go out there and create productive and ethical
conflicts of interest. Just make sure you fully disclose
and have a management plan that will protect
KU's integrity and yours.”
James A. Roberts
Vice Provost for Research
and Graduate Studies
Questions about COI
Susan MacNally
Compliance Coordinator
Research Integrity, RGS
864-4148
[email protected]
William Sharp
Director
Research Integrity, RGS
864-7430
Conflicts of Financial Interest
can arise with significant levels of
Ownership
Compensation
Office or Directorship
Fees and Commissions
Examples of disclosures
You have 10% ownership in a company.
The company is worth less than $10K.
The company business is not related to your research.
You have equity in excess of $10,000 in a company.
Your hold only 1% ownership in the company.
The company is related to your area of research.
Your spouse is employed by a company that does R&D in your
field of research.
S/he receives over $100K in salary.
S/he does not have an officer position with the company.
What is disclosable?
Your live-in lover is an officer or director of a company.
S/he is paid $2K per year.
The company’s work is relevant to your area of research.
Your spouse is an independent consultant in your area of
research.
S/he receives $20K per annum for consulting.
You have many speaking engagements due to your exciting
discovery.
Over the course of the year, your speaking fees add up to
$15K.
Conflicts of interest can pose risks to:
Direction and Control of Research
Publication and Dissemination of Research
Education and Direction of Student’ Research and
Career Development
Appointments and Promotions
University Commitment
Use of University Facilities and Resources
Service on University Committees
University values that guide
management of conflicts
Ensuring unbiased research
Maintaining a free marketplace of ideas
Directing education of students
Ensuring best use of public funds
Preserving our identity as a university
Some Management Plan Strategies
Public disclosure of relevant financial interests
In publications and oral presentations, to laboratory students and
staff, to collaborating colleagues
Disqualification from participation in some portion of
research / development program
PI status on University research funded by company
Monitoring of research by independent reviewers
Modification of research plan
Divestiture of significant financial interest
Severance of relationships that create conflicts
Allowable? Manageable?
PI Walter Wiggle invents a widget.
KU patents widget and licenses it to WidgetWorks.
Dr. Wiggle has no ownership in WidgetWorks.
Dr. Wiggle receives royalties through KU.
Dr. Wiggle participates on Scientific Advisory Board.
Dr. Wiggle’s wife Wanda is the CFO of WidgetWorks.
Dr. Wiggle is offered a BoD position.
WidgetWorks wants to employ Dr. W’s GRAs.
Allowable? Manageable?
PI Samuel Script creates artificial intelligence software.
KU copyrights software. Dr. Script creates start-up, Scriptel, to
develop and market the software.
KU licenses software to Scriptel.Dr. Script and KU are owners
of Scriptel. Dr. Script and KU receive royalties from Scriptel.
Dr. Script pursues further research on the software.
What roles can Dr. Script assume at Scriptel? Scientific
Advisor? Board of Directors? COO?
Scriptel funds research project to develop software. Can
Dr. Script act as PI?
WidgetWorks wants to employ Dr. W’s GRAs.
Management Plan Elements
Background
Details of outside interest and relation/involvement with employee’s
work at KU
Management strategies to implement (as appropriate)
Separation of time
Use of University facilities and resources
Public disclosure
Recusal / disqualification from participation
Employment of students in outside interest
Monitoring of research, transactions with outside interest
Oversight person or committee
Timetable (if appropriate)
Dated signatures of employee, unit head, dean / vice provost