IRB Member Conflict of Interest Presentation for IRB Members

Regulations... DHHS and FDA regulations [45CFR (e) & 21CFR (e)] prohibit members from participating in IRB reviews if they have a conflict of interest. No IRB may have a member participate in the IRB's initial or continuing review of any project in which the member has a conflicting interest, except to provide information requested by the IRB.

UCI HRPP Policy for Conflict of Interest Disclosure It is the expectation of the University that IRB members will voluntarily recuse themselves from review and discussion of research protocols if they have a conflict of interest. Members of the IRB must disclose to the IRB Chair or Administrator any conflict of interest that may arise in the review of research or compliance matters for the IRB.

Risk of “Non-Recusal” Compromised Objectivity Biased opinion of the merit of the study Biased opinion of whether IRB criteria for approval have been met Undue influence on other IRB members Appearance of impropriety; loss of public trust

Conflicts of Interest that Require Member Recusal Members who are an investigator or faculty sponsor on the project under review, or whose spouse or child is an investigator or faculty sponsor Members who have any financial interests (i) that would reasonably appear to be affected by the research; or (ii) in entities whose financial interests would reasonably appear to be affected by the research Members who believe existing circumstances may directly affect their objectivity should recuse themselves from the review

Financial Interests that Require Recusal from IRB Review Ownership interest, stock, stock options, or other financial interest related to the research--unless it meets 4 tests* Compensation related to the research, including salary, consultant payments, honoraria, royalty payments, dividends, loans, other payments/considerations of value--unless it meets 2 tests* *see members standards document

Other Circumstances for Recusal from IRB Review A member is involved in a potentially competing research program A member has access to funding or intellectual information that may create an unfair competitive advantage A member’s personal biases may interfere with his or her impartial judgment

What to Do if You Have a Conflict of Interest Inform the IRB Chair or Administrator as soon as possible Details of the conflict of interest should not be divulged IRB staff will capture those protocols in which IRB members are a part of the study team Recusals are recorded in the IRB meeting minutes