Health Sciences Minimal Risk Institutional Review Board Compliance Statement
The Health Sciences Institutional Review Board (IRB) does not provide its roster to study sponsors and instead has issued this document to describe membership and expertise as well as how the committee complies with IRB and human subjects regulations.
The Health Sciences Minimal Risk Institutional Review Board (MR-IRB) serves as one of the institutional review boards (IRB) 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 MR-IRB, from the Association of Accreditation of Human Research Protection Programs in 2009, and was re-accredited in 2012.
The MR-IRB reviews and approved research accordance with the laws of the United States of America and the State of Wisconsin. The MR-IRB complies 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 MR-IRB consists of more than 5 members and membership includes scientists and non-scientists, as well as non-affiliated members. Two members serve as representatives for the Madison VA Hospital and at least two members represent the University of Wisconsin Hospital and Clinics. MR-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 MR-IRB is composed of individuals, both female and male, with the following expertise and perspectives:
||Population Health Sciences
|Law and Human Subjects Regulations
The MR-IRB considers 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.