The Health Sciences (HS) Institutional Review Board (IRB) and the Minimal Risk Research (MRR) IRB do not provide their roster to study sponsors and instead have issued this document to describe membership and expertise as well as how the committees comply with IRB and human subjects regulations.
The HS IRB and MRR IRB serve as the two institutional review boards for human subjects research conducted at the University of Wisconsin – Madison. The University of Wisconsin – Madison received accreditation of its Human Research Protection Program, which includes the IRBs, from the Association of Accreditation of Human Research Protection Programs in 2009 and was re-accredited in 2012 and 2016.
The HS IRB and the MRR IRB review and approve research in accordance with the laws of the United States of America and the State of Wisconsin. The IRBs comply with the applicable requirements of the Department of Health and Human Services (DHHS) regulations, 45 CFR Part 46; the Food and Drug Administration (FDA) regulations, 21 CFR Parts 50, 56, 312, and 812; Veteran’s Administration (VA) Regulations pertaining to the protection of human subjects, 38 CFR Part 16; and the privacy requirements of the Health Insurance Portability and Accountability Act of 1996 implemented by 45 CFR Parts 160 and 164 (Privacy Rule).
The University of Wisconsin – Madison holds a current Federalwide Assurance (FWA) from the Office of Human Research Protection (OHRP) at the United States Department of Health and Human Services, #FWA00005399, which is periodically updated as required by OHRP.
The HS IRB and the MRR IRB both consist of more than 5 members and membership includes scientists and non-scientists, as well as non-affiliated members. IRB members do not participate in the discussion (except to answer questions) or vote on research protocols in which they may have a conflict of interest. The IRBs are composed of individuals, both female and male, with varying expertise and perspectives.
The IRBs consider the scientific and medical review of other University of Wisconsin – Madison committees, such as the Carbone Comprehensive Cancer Center Protocol Review & Monitoring Committee and Institute for Clinical & Translational Research Scientific Review Committees and involves consultants with particular expertise as needed.