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IRB Member Conflicts of Interest

Summary

The University has policy in place to identify, evaluate and manage conflicts of interest (COI) of Institutional Review Board (IRB) members and IRB consultants that may affect decision-making by the IRB member or consultant in the review of research protocols. This policy places restrictions on participation in the review process by IRB members and consultants who have a conflict of interest, as defined in this policy.

Policy Overview

An IRB member may not participate in the initial or continuing review of any research protocol in which the member has a conflict of interest, except to provide information at the IRB's request. The IRB also cannot use the services of a consultant in the review of a research protocol in which the consultant has a conflict of interest.

IRB Member COI Process

Before the IRB office assigns protocols for review, it makes an initial assessment whether there is a conflict of interest on the part of an IRB member. When IRB members receive materials before a meeting, they have a responsibility to review the list of protocols for initial or continuing review with the issue of conflicts of interest mind and disclose any potential issue to the IRB office or IRB chair in advance of the meeting when possible. Early disclosure permits the IRB office to assure a quorum for review and the IRB chair to excuse the member from any final discussion of, and voting on, the protocol.

IRB Consultant COI Process

Before the IRB office assigns protocols to an IRB consultant for review, it makes an initial assessment whether there is a conflict of interest on the part of an IRB consultant. When requesting a consultant to review a protocol, the IRB office will provide each IRB consultant with guidance on the conflicts of interest policy applicable to IRB consultants. Upon receipt of a request to provide consultation to the IRB, IRB consultants have the responsibility to determine whether they have a conflict of interest with a protocol they are asked to review and should notify the IRB office immediately if there is a potential conflict of interest with respect to the protocol. When appropriate, the IRB office asks the investigator's permission to share the protocol with the consultant to ensure there is no perception of conflict of interest. The IRB office will reassign any protocol with which a consultant has a conflict of interest.