UNMC Management of Conflict of Interest (COI) of IRB Members

1	SACHRP Ernest D. Prentice, Ph.D. University of Nebraska Medical Center
2	Outline of Presentation Genesis of concern about COI 45 CFR 46 and HHS Guidance on IRB Member COI Definition of UNMC IRB Member COI Types of COIs Management of UNMC IRB Member COI
3	Genesis of Concern About COI
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8	Our Charge “We must manage research scrupulously so that neither individual nor institutional financial interests result in danger to participants”
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10	Question
11	Question
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13	COI Clarification “Conflict of interest represents the potential for biased judgment, but is not an indicator of the likelihood or certainty that such judgment or compromises will occur.”
14	Determination of UNMC IRB Member COI
15	Covered Person IRB Member IRB Consultant IRB Staff Immediate family member of above Spouse Dependent Child Sibling Parent
16	COIs The Covered Person Serves as an investigator or serves as a scientific/medical adviser to the PI. Serves as an adviser, or a direct supervisor, of a trainee’s research. Receives financial compensation to which the research under review is directly connected including salary, consulting fees, royalty, or licensing payments from intellectual property, honoraria, and/or gifts from the sponsor of the research, or their representative (s) over the past 12 months or during the course of the research.
17	COIs (cont’d) The Covered Person Owns any equity interest in the company sponsoring the research excluding mutual funds. Holds a position as director, officer, partner, trustee, or any other influential position in the company sponsoring the research or has held such a position in the past 12 months. Is appointed to the sponsor’s scientific advisory board which is directly related to the research under review. Holds patent rights or royalties from such rights whose value may be affected by the outcome of the research, including royalties under any royalty-sharing agreements involving the institution.
18	COIs (cont’d) The Covered Person Has a financial interest in a company that has a marketed product, or is in the process of developing a new product that is, or will be, in direct market competition with the product in the protocol under IRB review. Is involved in research with a drug, biologic, or device which is or will be in direct market competition with the sponsor of the research under review. Has a personal relationship, or a conflict, with any investigator(s) listed on the protocol that potentially would cause the IRB member to be perceived as less than objective in his/her review. Does not have a COI providing his/her only involvement in the protocol is in the context of providing clinical care to subjects. Does not have a COI if he/she is serving on an NIH study review section or is a consultant to FDA.
19	Management of UNMC IRB Member COI IRB Members Receive an electronic copy of the COI policy prior to each convened meeting Must notify the IRB office if they have a COI. Are not required to describe the nature of the COI to the Board.
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21	Management of COI (cont’d) IRB Members Must reaffirm that there are no undeclared COIs at the start of each meeting. Who have a COI are recused. They do not deliberate or vote. Who have a financial COI and are also investigators must disclose the financial interest in the ICP and CF
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23	Fulfillment of The Charge The integrity, validity and objectivity of IRB review must be beyond reproach. This is not a question of minimizing COI but rather it’s elimination
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