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IRB Members’ Conflicts of Interest

This purpose of this policy is to describe the process for identifying, evaluating and managing Institutional Review Board (IRB) member conflicts of interest that may affect the review of research.

  1. Individuals who are responsible for business development, such as the Vice Chancellor for Research and Graduate Education and Director of Research and Sponsored Programs, are prohibited from:

    1. Serving as members or ex-officio members on the IRB.

    2. Carrying out day-to-day operations of the review process.

  2. UW-Madison IRB members cannot participate in the review (including initial, continuing or change of protocol, and non-compliance or unanticipated problems) of any research for which they have a conflict of interest, except to provide information at the IRB’s request.

    1. An IRB member has a conflict of interest with respect to research when:

      1. The IRB member or an immediate family member (includes spouse, domestic partner, and dependent children) of the IRB member is part of the study team for the study being reviewed.

      2. UW-Madison IRBs follow the Conflict of Interest Committee’s definition of Significant Financial Interest (SFI) when determining if an IRB member or an immediate family member (includes spouse, domestic partner, and dependent children) has an interest that is related to the research being reviewed.

        1. UW-Madison IRBs consider an IRB member’s institutional responsibilities to encompass their role as an IRB member.

      3. An IRB member or an immediate family member (includes spouse, domestic partner, and dependent children) of an IRB member has a relationship that may cause bias or create the appearance of bias by the member in the review of the research.

    2. IRB Member conflicts of interest are identified, evaluated, and managed using the following actions.

      1. The relevant IRB office will provide each IRB member with this policy and will remind members to disclose conflicts of interest with individual studies.

      2. Before the IRB office assigns studies for review, it will make an initial assessment whether there is a conflict of interest on the part of an IRB member.

      3. Any IRB member with a conflict of interest in a study under review by the convened IRB must disclose the conflict of interest to the IRB Chair (or designee, such as the IRB Director) and leave the room during the discussion of the study and the related vote, except if the member is providing information at the IRB’s request.

        1. An IRB member who has a conflict of interest with respect to a study cannot be counted for quorum when the IRB votes on that study

      4. A designated IRB reviewer performing expedited review of studies has the responsibility to review the list of studies he or she is assigned, disclose any potential conflict of interest (when possible) in advance of the review to the IRB office, and not review any study for which has a potential conflict of interest.

        1. The IRB office will re-assign any study with which an expedited reviewer has a conflict of interest.

Adopted By: All Campus IRB
Adoption Date: November 10, 2005
Revised: January 22, 2009
Revised: March 1, 2012 by HRPP Advisory Committee
Revised: December 5, 2012 by HRPP Advisory Committee
Revised By: Cross Campus Human Research Protection Program Advisory (HRPP) Advisory Committee
Revision Date: July 7, 2015

Copyright © 2015 University of Wisconsin System Board of Regents

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Keywords:conflict of interest IRB members IRB consultants COI compensation ownership leadership proprietary interest   Doc ID:29466
Owner:Ryan M.Group:VCRGE and Graduate School
Created:2013-04-15 11:55 CDTUpdated:2015-07-29 15:42 CDT
Sites:VCRGE and Graduate School
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