IRB Member Conflicts of Interest

IRB Member Fact Sheet--Version Date: Unknown

Summary
The University of Wisconsin Madison (UW-Madison) 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.

An IRB member or IRB consultant has a conflict of interest with respect to a protocol when:
  • An IRB member or IRB consultant, or an immediate family member of the IRB member or IRB consultant, has a professional interest as a principal investigator or co-investigator in the protocol, or
  • An IRB member or IRB consultant, or an immediate family member of an IRB member or IRB consultant, has a financial interest in a business entity that (a) sponsors the study or (b) owns or licenses a technology tested in the study, and the IRB member’s or IRB consultant’s financial interest meets or exceeds one of the following thresholds:
    • Compensation of $20,000 or more in a calendar year from a business entity.
    • An ownership interest in a publicly traded business entity valued at $20,000 or more or a 5% or greater equity interest.
    • An ownership interest in a privately held business entity.
    • A leadership position in a business entity (e.g. service as an officer, member of the board of directors, or in any other position of trust, confidence, and responsibility for a business entity, whether or not the investigator receives compensation for such service).
  • An IRB member or IRB consultant, or an immediate family member of an IRB member or IRB consultant, has a personal relationship that may cause bias or create the appearance of bias by the member or consultant in the review of the protocol.
Any IRB member with a conflict of interest in a research protocol under review by the IRB must disclose the conflict of interest to the IRB Chair and leave the room during the discussion of the protocol and the related vote, except if the member is providing information at the IRB’s request. The meeting minutes will document the recusal (i.e., the temporary absence of the IRB member during the deliberation and vote on the protocol with respect to which the member 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.

Further Information
For further information about IRB member conflicts of interest, please contact the Health Sciences IRBs Office at (608) 263-2362 or consult our website at http://www.medicine.wisc.edu/irb



Keywords:IRBM, COI   Doc ID:19233
Owner:Monica E.Group:Health Sciences IRBs
Created:2011-07-21 18:00 CSTUpdated:2016-12-22 12:46 CST
Sites:Health Sciences IRBs
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