IRB Composition and Quality Performance

This document describes the composition of UW-Madison IRBs, recording of membership, and how UW-Madison assures that IRB personnel have the knowledge, skills, and abilities necessary to carry out the function of the IRB.

  1. UW-Madison complies with the DHHS, FDA, and VA regulations governing the composition of IRBs and the content of IRB rosters when applicable.

  2. The following composition criteria apply to UW-Madison IRBs.

    1. The IRB is composed of at least five members with varying backgrounds and professions.

    2. The IRB includes both male and female members, with representation of minority populations.

    3. The IRB includes at least one unaffiliated member (also known as the “community representative”).

      1. To be eligible for participation on the IRB as an unaffiliated member, neither the member nor any member of his/her immediate family may otherwise have a direct and current affiliation with the University or institutions with which the University has standing agreements to serve as their primary IRB of record (e.g., Madison VA Hospital, University of Wisconsin Hospital and Clinics, or University of Medical Foundation). Direct affiliation includes employees, contractors, student in a degree program, or active emeritus faculty members, but does not include individuals who are patients or have an immediate family member who is a patient at institutions with which the University has a standing agreement to serve as their primary IRB of record.

      2. Unaffiliated members are individuals who represent the general perspective of participants; provide balance to race, gender, and cultural issues in research review; are sensitive to community attitudes; provide the perspective of the community beyond the University and its affiliates; or provide their perspective on safeguarding the rights and welfare of human participants.

      3. Unaffiliated members may be scientists or non-scientists.

    4. The IRB includes at least one member who has professional expertise in a scientific field relevant to the type of research reviewed by that committee.

    5. The IRB includes at least one member who has primary expertise in a nonscientific field.

    6. Alternate members, if appointed, are designated for a specific member or class of members.

    7. By agreement with the University of Wisconsin Hospital and Clinics Authority (UWHCA), two members of both the HS IRB and MR IRB must be representatives of the UWHCA.

      1. Also, a UWHCA representative must review all studies submitted to the Education Research and Social/Behavioral Science IRB that involve UWHCA employees, patients, medical records or facilities.

  3. IRB Member Selection and Appointment

    1. Each IRB Office identifies needed areas of expertise within the committee based upon the above requirements and type of studies reviewed by the committee and shares this information with the relevant Deputy Institutional Official (DIOs).

    2. The DIOs solicit schools and colleges for individuals that fulfill these needs.

    3. The DIOs appoint committee members for a period of three years with the option to extend the appointment at the DIO’s discretion.

    4. The DIOs retain the option to rescind these appointments at any time.

  4. The UW-Madison will maintain rosters of each IRB’s membership and member resumes.

    1. Rosters will include the following information on every IRB member.

      1. name

      2. earned degrees

      3. representative capacity

      4. indications of experience (such as subject area expertise, title and/or department)

      5. affiliated or non-affiliated status of each member, including employment relationship with UW-Madison and the entities for which UW-Madison serves as a standing IRB

      6. whether the member is a primary member or alternate member

      7. if an alternate member, the primary member or members for whom the alternate may serve as substitute

      8. whether the member is a scientific or nonscientific member

    2. Changes in IRB composition will be reported to the federal Office of Human Research Protections (OHRP) and Madison VA, as appropriate.

  5. Each IRB Office periodically surveys IRB members to assess the performance of their office, chairs, members, staff, committees, and review processes through formal and informal means.

  6. IRB Members and Chairs are evaluated and results are provided to DIOs for further action as needed.

Adopted By: Cross Campus Human Research Protection Program Advisory (HRPP) Advisory Committee
Adoption Date: August 28, 2015
Revision Date: November 11, 2015

Copyright © 2015 University of Wisconsin System Board of Regents



Keywords:IRB composition VA representation UWHC representation quorum prisoner representative report changes OHRP   Doc ID:29464
Owner:Ryan M.Group:VCRGE and Graduate School
Created:2013-04-15 09:29 CDTUpdated:2015-12-10 15:48 CDT
Sites:VCRGE and Graduate School
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