Transcript Conflict of Interest - Office for the Responsible Conduct

Conflict of Interest
Victoria Tugade, COI Officer
Today we will cover…
What's new?
Why is this important?
Important Definitions
What do Investigators need to do?
How is funding affected?
What are the Institutions responsibilities?
Where can we go for help?
What is new?
Changes in federal regulations.
2011– DHHS announced new rules (effective August 24,
2012) relating to conflict of interest. New rules require
organizations to have an enforced conflict of interest
policy for individuals participating in research
(Investigators) and require Investigators to complete
training and disclosure prior to expenditure of any
DHHS funds.
November 2013 – NSF announced new rules (effective
February 24, 2014) relating to conflict of interest. New
rules require institutions to have an enforced conflict of
interest policy for Investigators, requiring Investigators
to be in compliance with the policy at the time of
proposal submission.
Code of Federal Regulations (cfr) 200.112 requires all
federal agencies to have an enforced COI policy and to
require all funding recipients to comply with said policy.
Why is this so important?
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The conflict of interest requirements
protect you, your research and the
University from concerns relating to the
intersection of research and personal
financial interests.
This is not a question of right or wrong,
and having a financial interest is not
inherently a bad thing.
Issues arise when a financial conflict of
interest is undisclosed and unmanaged.
Why is this so Important?
Very real consequences exist when conflicts of
interest are not properly disclosed and managed.
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See Jesse Gelsinger case from 1999. Patient died
while enrolled in a clinical trial where the Principal
Investigator and the Institution had a financial
interest.
See Yudong Zhu FBI case from 2013. Principal
Investigator and several Investigators on project
failed to disclose financial interest and were found
to be sending proprietary information from the
project to their financial interest in China.
Important Definitions
Investigator:
Any person who is responsible for the design, conduct or
reporting of Research under the auspices of the University.
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This includes, but is not limited to, the Principal Investigator
(PI), Co-Investigator, Project Director (PD), Co- PD,
Senior/Key Personnel and any other persons involved in the
Conduct of Research, regardless of title or position.
An individual’s position, title on the project, employment
status (full or part-time), or percent of effort devoted to the
project , pay, etc., do not factor into the definition of
Investigator.
The term “Investigator” is based upon the individuals
independence in the design, conduct or reporting of the
Research and students, trainees, collaborators, volunteers,
and consultants may be considered an Investigator.
The term, “Investigator,” does not include individuals whose
performance within the Research is purely ancillary or
occurs solely under immediate supervision.
Important Definitions
Institutional Responsibilities:
An Investigator’s Institutional Responsibilities may include, but are
not limited to, the following activities, regardless of when and where
the activities occur:
•Research
•Scholarship
•Teaching and instruction
•Development and commercialization of research results
•Administrative service to the University
•Membership on institutional committees
•All other work and activities that the University considers in its
review of an individual’s performance in the course
and
scope of his/her University employment or other obligations
Important Definitions
Financial Interest:
Exists when the Investigator, the Investigator’s spouse or domestic
partner, and/or dependent children, are financially invested in,
and/or receive compensation from any of the following:
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Publicly traded entities
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Non-publicly traded entities
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Positions outside of University employment
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Intellectual Property rights or interest
Important Definitions
Significant Financial Interest (SFI):
Compensation and/or equity that is considered a financial interest and meets
one of following three criteria:
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Remuneration from any publicly traded entity in the twelve months
prior to disclosure; and/or (ii) ANY Equity Interest in the publicly traded
entity as of the date of disclosure and the combined total of all such
Remuneration and Equity Interests exceeds $5,000 in value.
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Remuneration from a non-publicly traded entity in the twelve months
prior to a disclosure, and the value of all such Remuneration exceeds
$5,000 when aggregated; or (ii) ANY Equity Interest in a non-publicly
traded entity, regardless of the percentage of equity or value.
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Income related to intellectual property rights or interests (e.g., as
owner of a patent or copyright or as a licensee of such rights) except for
those interests determined to be Investigator’s Excluded Interests.
Important Definitions
Excluded Interests:
Under UA’s Conflict of Interest Policy, the following interests do
not need to be disclosed:
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Salary, royalties or other Remuneration paid by the University to a
current University employee or appointee; and
Payments made by the University in exchange for the transfer of
intellectual property rights assigned to the University and from
agreements by the University to share any royalties related to such
rights; and
Important Definitions
Excluded Interests (continued):
•Income
from investment vehicles such as mutual funds and
retirement accounts, as long as the Investigator does not directly
control the investment decisions made by the investment managers
within these funds or accounts; and
•Income
from seminars, lectures, teaching engagements or service on
advisory committees or review panels sponsored by: (i) a government
agency (federal, state or local), or (ii) an institution of higher
education as defined at 20 USC § 1001(a); or (iii) an academic
teaching hospital, medical center, or research institute that is affiliated
with an institution of higher education.
Important Definitions
Financial Conflict of Interest:
•Any
Significant Financial Interest that is deemed to have potential to
directly and significantly affect the design, conduct or reporting of
research.
•Such
determinations are made by the University’s Institutional Review
Committee (IRC) for individual Investigator’s financial interests, and by
the Executive Review Committee (ERC) for financial interests held by
the University.
What do Investigators need to do?
Training
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For University personnel, online training is
available through D2L
For Non-University personnel, online training
is available through CITI
Training must be completed once every 4
years (or more often if requirements change
or the COI office determines that additional
training is necessary)
Disclosure
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On an annual basis between June 1 and
June 30 of every year
Within 30 days of a change to the existing
disclosure (ex. acquiring a new SFI)
With each new proposal and/or award for
Investigators with one or more SFIs
disclosed.
How is funding affected?
Proposal stage:
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Proposal might not be submitted if everyone who is considered an
Investigator is not up-to-date on training and disclosure
requirements.
Proposal might be delayed, or get stuck, in the routing process while
those considered Investigators are completing training and disclosure
requirements.
Award Stage:
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New awards will be held until everyone who meets the definition of
Investigator is up to date with their training and disclosure
requirements. Note: If an Investigator discloses an entity and it is
determined the project needs to be reviewed by the IRC, the funds will
not be released until the IRC approves the project, or if necessary, the
management plan.
What are the Institutions responsibilities?
The Conflict of Interest Office:
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Provides oversight, management and training for COI policies and
procedures related to research at the UA.
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Manages the committees that review disclosures.
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Manages and tracks training and disclosures relating to COI
requirements.
Committees:
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The Institutional Review Committee (IRC), comprised of faculty voting
members and advisory non-voting members, reviews individual
Investigator disclosures of Significant Financial Interests to determine
if a financial conflict of interest exists.
The Executive Review Committee (ERC), comprised of senior University
Administrator voting members and advisory non-voting members,
reviews financial interests of the Institution for potential conflicts
Where can we go for help?
The Conflict of Interest Program Office is here to help. Please feel free to
contact us at any time with questions or concerns:
[email protected]
Victoria Tugade
Conflict of Interest Officer
520-626-8266, [email protected]
Bethany Peters
Program Coordinator Senior
520-626-7879, [email protected]
To report suspected illegal or unethical conduct confidentially:
866-364-1908
Where can we go for help?
COI Office Hours
Every Tuesday and Thursday from 11 am – 1 pm
Call: 626-7879
Stop by: 1618 E. Helen Street (SE corner of Cherry and Helen)
E-mail: [email protected]
IM via Lync: blpeters
Conflict of Interest Program Office