Transcript Conflict of Interest - USF Research & Innovation

Conflicts of Interests
in Research
UNIVERSITY OF SOUTH FLORIDA
Vinita Witanachchi, J.D.
Division of Research Integrity & Compliance
Assistant Director, HIPAA & COI
Learning Objectives
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Generally:
 Define a conflict of interest (COI)
 Define a COI in research
 Understand when a COI is a “COI in research”
 Understand the process involved:
Disclosure
Review
Management
Plan
What is a conflict of interest?
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 A conflict between a person’s private interests, and
public obligations
 A “COI” is a situation in which someone in a position of
trust has competing interests which makes it difficult to
fulfill his/her duties impartially. Even if no unethical or
improper act results from it, a conflict could still exist.
Importantly, a COI can create an appearance of
wrongness which can undermine confidence in the
person or the institution at large. A conflict can be
mitigated by third party evaluation
 Multiple interests, one of which could possible corrupt
the motivation for an act in the other
Types of Conflicts
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1.
Conflicts of Interest and commitment with
university employment
 Time spent on external endeavors
2.
General conflict of interest
 Nepotism, doing business with USF in private
capacity, Board memberships and purchasing
decisions
3.
Conflict of interest in research
 Personal Financial interest that may bias the designconduct or reporting of USF research
What is Conflict of Interest in Research?
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●Competition between ‘Primary Interest’ vs.
‘Secondary financial interest’
●It is a situation in which professional judgment
concerning the primary interest in research is
unduly influenced, compromised (or appear to
influence) as a result of a competing secondary
financial interests held by the investigator
“Working” Definitions
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Conflict of Interest in Research
 A conflict of interest in research exists when an
investigator’s self interests may compromise, or have the
appearance of compromising, an investigator’s
professional judgment in the design, conduct or reporting
of research
Investigator
 Any person responsible for the design, conduct or
reporting of research
Working Definitions (con’t)
COI=
Individual +
Self-Interest +
An Ethical or
Professional Duty
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COI in Research=
Investigator +
Self-Interest +
Objectivity in the
Design/Conduct/
Reporting of research
HINT: The management goal is to
protect the integrity of the research
Federal Regulations
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The federal regulations only address one
type of “self-interests:”
FINANCIAL INTERESTS
Other Types:
•Enhanced reputation
•Personal relationships
•Professional relationships
•Political, religious…….
General Principles in Dealing with COI in Research
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 COI is virtually unavoidable
 COI does not preclude participation of an
investigator in a project
 Must have a culture of honest and full disclosure so
that steps can be taken to manage conflicts
effectively
 Not all COI can be managed
What are ‘secondary financial interests?’
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Some examples:
 Receiving payment for speaking engagements
from the sponsor of the study
 Holding an ownership interest in the company
that manufactures the drug/devise being tested
 Having intellectual property rights to the
drug/device being tested, just to name a few
Conflicts of Interests in Research
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 It is illegal or unethical to have a secondary financial
interest? NO!
 Bayh-Dole Act of 1980 encourages
entrepreneurships among private industry,
institution and the researcher
 Benefits to the institution? YES!
 Any unintended by-product of Bayh-Dole Act? Yes,
possibly conflicting interests!
What types of research-related conflicts exist?
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It is anything that could be quantified, but not limited
to the following:
 Payment for services, consulting fees, honoraria,
reimbursements of expenses, dividends, any other
payments or consideration
 Equity interests (such as stocks, stock options)
 Intellectual property rights (patents, copyrights,
royalties)
How do you know you have a reportable interest?
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Do you own stocks, stock options, real estate or have other
ownership interests in an ‘entity related to the research?’
Do you or your domestic partner or dependant children own stock,
stock options, or other ownership interest in an entity related to
the research?
Did you or will you (including family members) receive salary,
consulting fees, royalties, honoraria, dividends or other payments
from an entity related to research?
Do you or your family members hold a management position such
as director, officer, partner or trustee in an entity related to the
research?
Important: If the answer to any of the questions above is YES, you may
have a conflict of interest in research that you must disclose
to the institution for management
What is an ‘entity that is related to research?’
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To name some:
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Sponsor or the funding source of the research
Supplier of equipment, materials, products, or services related
to research
Holder of any ownership interest in a product/device being
investigated
Business enterprise which is commercializing a product that
the research is intended to evaluate of further develop
Anyone whose financial interests would seem to be directly
and significantly affected by the proposed research
Exceptions to reportable interest
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The following financial interests and commitments are
generally recognized as NOT relating to or not being
impacted by the outcome of the research and therefore do
NOT need to be disclosed:
 Salary, royalties or other remuneration received from USF or the
USFPG
 Receipt of royalties for any published scholarly works and other
writings
 Income from seminars, lectures, or teaching engagements sponsored
by public or nonprofit entities. NOTE: All honoraria received from
commercial entities must be disclosed.
Exceptions to reportable interest (con’t)
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 Income from service on advisory committees or review
panels for public or nonprofit entities.
 Interests in commercial enterprises on the part of an
investigator which commercial enterprises are in no way
related to the investigator’s professional role and/or
obligations
 Any “arms length” financial interest (i.e., those that occur
through participation in a mutual fund or employer
retirement plans), where the participant has no control
over the investment decision
 Income from speaking engagements sponsored by
government or non-profit
Why does the university want to avoid/manage COI?
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● Public Trust: To gain public trust in the research
conducted at public universities
● Integrity: To maintain integrity of research
process and research results
How might conflicts in research be avoided or mitigated?
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● Disclosure! Disclosure! And Disclosure! Always
remember – “Disclosure is the Golden Rule to gaining
public trust!”
● What is the institutional process? Disclosure to the
institution who then will conduct a thorough review of
the financial relationships involved, and place
management controls to thwart bias being introduced to
each of the phases (design-conduct-reporting) of
research.
Examples of some management controls
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• Provide notice of the conflicting interest to study
participants, research personnel, collaborators, editors
of journals funding agencies
• Engage independent reviewers to monitor certain
aspects of the study
• Specific data management strategies
• Additional independent studies to confirm the results
• Blinding the interested investigator
• Multiple non-interested investigators
• Objective end-points
• Divestiture of the related interest
When should financial interests be reported ?
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• Upon initial submission of research proposal
• To DSR (for sponsored research)
• To the investigator’s Department Chair or Committee (for
non-sponsored research)
• To review committees (IRB, IACUC) for approval
• Within 30 days from when the previously disclosed interest
has changed
• Upon Joining a research project
• Must submit a disclosure within 30 days of beginning work
on the research
COI Committee Review
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● Motivation
How much incentive does the INV have to bias the
design, conduct or reporting of the research?
● Opportunity
Is the INV in a position to bias the design, conduct
or reporting of the research?
Review Process for Financial Interests in
Research at USF (Cont’d)
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 COI Administrator develops management plan in
consultation with interested investigator
 COI Administrator may approve without committee
review if certain conditions are met (BUT not for
human subjects research)
 COI Committee Reviews FRDF and Management
plan
 Notification to
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Interested Person
DSR
IRB (if USF IRB is IRB of record)
New Online COI Process
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 How to access the online site?
Applications for Research Compliance (ARC) site
https://arc.research.usf.edu/prod
 Help Desk at 813-974-2880 or email at
[email protected]
To learn more about the institutional COI
process, please visit the following:
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Conflict of Interests Administrators
Contact Person: Camille McWhirter, J.D.
813-974-6676
http://www.health.usf.edu/research/compliance/
coiusfpolicy.htm
Contact person: Vinita Witanachchi, J.D.
813-974-5478
http://www.research.usf.edu/cs/coi.htm