USF Health Conflict of Interest Committee. New Member Orientation. Who’s on the USF Health COI Committee?. VOTING MEMBERS At least: 1 faculty member representing each of the USF Health Core facilities. COM: Anthony Morrison, Robert Hauser, Bill Marshall, Richard Heller, Barry Bercu
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New Member Orientation
VOTING MEMBERS (con’t)
VOTING MEMBERS (con’t)
EX OFFICIO MEMBERS (NON-VOTING)
EX OFFICIO (NON-VOTING)
EX OFFICIO (NON-VOTING)
There are two COI committees (and two COI policies) at USF:
To review disclosures/management plans of USF Health employee investigators and those conducting human subjects research; and
To ensure (by imposing appropriate management controls) that the disclosing investigator’s financial interests will not bias the design, conduct or reporting of the research project.
Conflict of Interest - A conflict of interest exists when professional or ethical obligations may be compromised by self-interest. Self-interest could manifest in the form of
Example: where an investigator has a financial or business interest related to the research that would be affected by the outcome of the research.
Investigator - Any person responsible for the design, conduct or reporting of research (includes extended family).
Interested Investigator - An Investigator who has a financial or other business interest that could reasonably be affected by a research study in which the Investigator is participating.
USF Health Policy (and most other university COI policies) focus on potential financial benefits and the professional relationships (but not other personal considerations, like reputation) of investigators that create a conflict of interest in research.
USF Health Conflict of Interest and Commitment Policy has a “zero threshold” requirement for the disclosure of financial interests in a research study.
(This means that investigators must disclose their financial interests even if they do not rise to the level of a Significant Financial Interest.)
USF Health Conflict of Interest and Commitment Policy states as a rebuttable presumption that interested investigators may not conduct human subjects research.
The presumption must be overcome by “compelling circumstances”.
Compelling Circumstances (paraphrased):
Any circumstances that convince the COI Committee that the interested investigator should be able to conduct the research.
(More on that later….)
What is an individual conflict of interest?
A conflict that may influence the individual’s ability to act impartially, such as having a financial interest in an entity related to the research.
What is an institutional conflict of interest?
A conflict that may influence the institution’s ability to act impartially. These types of conflicts occur when an institution’s financial or other interests may affect how it reviews or conducts research. Must also consider the financial interests of institutional officials as an institutional conflict.
Federal government owns and licenses technology coming out of federal support. (But studies showed that only 2% of federally sponsored technology made it to the market!)
Bayh-Dole represented a fundamental change in federal government outlook on IP. It gave universities and inventors incentive to transfer the benefits of scientific research to commercial applications for public benefit.
Funding agencies can assign IP rights resulting from agency sponsored research to the academic institution.
Academic institutions are encouraged to license IP to for-profit entities for development and commercialization.
Federal government retains the non-exclusive, royalty free right to use the results for government purposes.
Bayh-Dole has complicated relationships between researchers, research institutions and commercial businesses.
“Anyone who submits a marketing application of any drug, biological product or device must submit certain information concerning compensation to, and financial interests of, any clinical investigator conducting studies covered by this rule.”
21 CFR Part 54
Applicant must EITHER certify that:
Disclose the specified financial arrangement and any steps taken to minimize the potential for bias.
Then, FDA will determine whether conflicting interest could jeopardize the integrity of the study. Such a determination can result in severe delays and significant financial losses. So….institutions are doing it for themselves.
If the FDA is concerned about the conflict, the FDA can:
Must disclose any
Significant Financial Interestmeans anything of monetary value, including salary, consulting fees or honoraria, equity interests (stock, ownership interests) and intellectual property rights.
The PHS/NSF regulations are broader:
Written enforced policies on COI
Designated institutional official to review COI
Require that each investigator submits a disclosure form for PHS and NSF research annually
Provide guidelines to review and manage COI
Maintain records for 3 years
Establish enforcement mechanisms and sanctions
Report failures to comply to awarding agency
COI can be subtle and complex, often involving ethical issues beyond the scope of regulation. Also, the regulations that do exist are purposefully flexible in order to allow the institutions to apply them in the way that best suits the institution. So the regulations can often seem vague and open to interpretation.
This presentation (and omitted slides that summarize the industry recommendations for COI review) will be accessible on the USF COI Committee Website.
MOTIVATION (Amount & Nature of Interest)
How much incentive does the INV have to bias the design, conduct or reporting of the research?
OPPORTUNITY (Contacts with Research)
Is the INV in a position to bias the design, conduct or reporting of the research?
Outcome of research will be directly relevant to the development, manufacturing or improvement of products or services of the business entity (secondary interest).
Value of business entity, earnings or sales revenue will be materially affected by the outcome of the research.Useful Concepts in Committee Review
If so, the Committee should not allow an interested investigator to participate unless the “compelling circumstances” threshold is met. In other words, there is a rebuttable presumption that the investigator may not conduct the research.
Compelling Circumstances are
circumstances that convince the COI Committee that the interested investigator should be able to conduct the research.
1. No significant connection between the research study and the investigator’s financial interest,
THEREFORE, the investigator's financial involvement with the business entity will not in any way affect or impair the conduct of the research.
2. There is a significant connection between the research study and the investigator’s financial interest,
BUT, the interested investigator is uniquely qualified by virtue of expertise and experience and the research could not otherwise be conducted as safely or effectively without that individual…
Is it sufficient to eliminate or reduce the investigator’s influence in the design and/or conduct of the research study and/or the reporting of the research results? Take into account the closeness of the connection between the financial interests and the outcome of the research.
Elimination of the conflicting interest
Substitution of personnel on the project
Public disclosure of significant financial interests
Monitoring of research by independent reviewers