Membership of the IRB Committees

Criteria for Diversity

Diversity enables the IRB to effectively evaluate a wide range of research. The professional preparation of IRB members includes expertise in a wide range of medical and social research areas, familiarity with applicable regulations and laws and with relevant standards of professional conduct and practice, and knowledge of vulnerable or special populations such as children, prisoners, pregnant women, and disabled persons.

The committee strives for a balance of men and women, with representation from minority populations.

The following criteria apply to each of the review panels:

1. Each IRB panel is composed of at least five members with varying backgrounds. Every nondiscriminatory effort is made to assure that no panel is composed entirely of either men or women.
2. At least one member (the Community Representative) has no affiliation, other than IRB membership, with the University and is not an immediate family member of anyone affiliated with the University. Whenever the primary Community Representative is unable to attend an IRB meeting, every attempt is made to appoint an alternate Community Representative to serve.
3. Typically, at least one IRB panel member has primary professional expertise in a scientific field relevant to the type of research reviewed by that panel, and at least one member has primary concerns in a nonscientific field. To ensure that there is always a non-scientific member present, senior IRB staff serve as voting members for each panel. No IRB panel consists entirely of members of the same profession.

How Members are Appointed

In selecting new members, the Director of the HRPP works with department heads and other University officials to seek candidates for nomination with consideration for maintaining the diversity and specialty requirements of the individual panels.

When an appropriate candidate is found, an invitation letter is sent requesting confirmation of intention to serve. The formal appointment of new members is made by the designated Institutional Official for Human Subject Protection.

Length of Terms of Service

Each member is appointed to a three-year renewable term.

Liability Coverage

With regard to potential legal action, IRB members are covered under the University Legal Defense and Indemnification of Employees policy which provides coverage for those University of Minnesota faculty and staff serving the University and also covers any non-affiliated member acting on behalf of the University.

List of University of Minnesota's IRB Members

This IRB does not provide rosters of individual committees, but provides a list of active members and provides a narrative description of our compliance with federal rules and regulations. See the list of members on the right of this page.

Mitigating Conflict of Interest

No IRB member participates (other than to provide requested information) in the initial or continuing review of any protocol in which they have a conflicting interest. This includes review of any material submitted over the course of the study or the duration of the member’s term.

Every effort is made to prevent new applications in which a member has an interest from being reviewed by that member’s panel. If time constraints or study content require that such a study be considered by the member’s panel, those members must recuse themselves from the deliberation, discussion, and vote on that study. Unless requested to remain in order to provide additional information, it is expected that the member leave the room until after the vote is taken.

Abstention from the vote is noted both in the minutes and in regular post-meeting correspondence to the investigator.

Conflicting interest includes, but is not limited to, the following:

The IRB member…

• is or will be an investigator in the research;
• has a financial or managerial interest in a sponsoring entity or product being evaluated in the research;
• has a close family relationship with an individual who is one of the investigators or who has a significant financial or managerial interest in a sponsoring entity or product being evaluated in the research; and/or
• voluntarily recuses him/herself for personal reasons.

Membership Expectations

Members on the IRB act as surrogates and advocates for potential subjects in research at the University of Minnesota, Fairview Health Services and Gillette Children’s Specialty Healthcare. Members attend meetings to discuss regulatory and ethical considerations surrounding proposed research. The homework preparation for the meetings can be significant, but results in substantive discussion at the meeting. Members forge a connection with the other members and are soon acting as a unit to understand, clarify, and improve the research enterprise. Members participate in analysis of the risk/benefit relationship before the meeting and during the discussion sessions.

Members are expected to prepare for and attend meetings. Each IRB meeting must have a quorum of members present in order for official meeting business to take place. Committee members should anticipate spending approximately six hours to review meeting materials. HRPP is currently using a modified electronic review process and is developing a new system. In addition, lunch is provided at committee meetings and parking is paid.

New committee members will be introduced to the principles of the Belmont Report, along with federal regulations pertaining to human subject protections. They will then learn to apply those principles and regulations within the review process. Members are also expected to participate actively in continuing education to assure continued excellence in the research review process. Despite the work burden, the overwhelming majority of presons serving on the IRB opt to extend their three-year terms. The work is rewarding. Come join this impressive group.

For more information contact:

 

 

Patrice Webster, Assistant Director
Human Research Protection Program

612-626-5941 | webst019@umn.edu

Cynthia McGill, Assistant Director
Human Research Protection Program

612-626-5827 | mcgil018@umn.edu