FAQ - Can I get a list of committee members' names?

Information about IRB Composition at the University of Minnesota

From Moira Keane, Director, Research Subjects' Protection Program

Committee Member List

This IRB holds a Federal Wide Assurance, number FWA00000312 from the Office For Human Research Protection (OHRP) in the Department of Health and Human Services (DHHS). This FWA is a binding agreement between DHHS and the University of Minnesota and is updated and renegotiated at regular intervals. This Assurance remains in effect until November 16, 2010 unless the University of Minnesota is otherwise notified.

In this document, the University assures the federal government that it will meet all requirements of Title 45, Part 46 of the Code of Federal Regulations (45 CFR 46) for all human subject research regardless of sponsorship. Section 45 CFR 46.107 is identical to Section 21 CFR 56.107 in its discussion of the IRB membership requirements; therefore, The University of Minnesota’s IRB also meets FDA requirements for IRB membership.

As an additional point of information, Paragraph (e) of both these sections of the regulations states that “No IRB may have a member participate in the IRB’s initial or continuing review of any project in which the member has a conflicting interest, except to provide information requested by the IRB.” The IRB is in compliance with this regulation. Nor, by extension, will any investigator participate in convened discussion or voting of the IRB except, in very rare occasions, by invited attendance to provide information to the IRB upon request.

The IRB at the University of Minnesota is in compliance with the guidelines promulgated by the International Conference of Harmonization (ICH) Good Clinical Practice (GCP) guidelines for IRBs.

This IRB is regularly audited by the Food and Drug Administration. At its most recent audit, completed in July 2002, no deficiencies were noted in the membership composition of the Institutional Review Board: Human Subjects Committee (IRB). If you have any other questions about the IRB membership, please call (612) 626-5654.

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