IRB Member Fact Sheet--Version Date: Unknown
UW-Madison has submitted its application for accreditation of the University’s Human Research Protection Program (HRPP), including the campus’ four Institutional Review Boards (IRBs). The accrediting agency is the Association for the Accreditation of Human Research Protection Programs, Inc. (AAHRPP), a nonprofit organization founded in 2001 by several educational organizations.
The Human Research Protection Program (HRPP)
The HRPP exists to ensure the protection of the rights and welfare of individuals recruited to participate in research conducted under the auspices of UW-Madison. UW-Madison strives to adhere to the highest ethical standards in its protection of human research participants in addition to ensuring compliance with all relevant federal regulations.
The major components of the HRPP, which is coordinated by the UW-Madison’s Research Policy Office, are the campus’ four Institutional Review Boards (IRBs) and IRB staff, the HRPP Advisory Committee and all UW-Madison investigators and staff involved in human subjects research.
The Accreditation Process
The accreditation process includes two major phases: preparation of a written application addressing each of the AAHRPP accreditation standards and a site visit by a team of professionals assembled by AAHRPP to inspect program operations.
While preparing the written accreditation application, the UW-Madison HRPP conducted a lengthy self-assessment of its operations, including the operations of the four UW-Madison IRBs, to assure that they comply with federal regulations and federal guidance applicable to human research protections. You may have noticed some changes in IRB practices that were made as a result of this review to bring some IRB practices into alignment with federal guidelines and AAHRPP expectations. The written application to AAHRPP was submitted in December 2006.
The second phase of AAHRPP accreditation, the site visit, is scheduled for September 24-27, 2007, and will require additional education of IRB staff, IRB members, and researchers. Within 30 days of the site visit, AAHRPP will provide UW-Madison with a written evaluation of its findings. UW-Madison then has 30 days to respond to these written comments. The written application, site visit findings, and response to the AAHRPP report are then reviewed by AAHRPP’s Council on Accreditation. The Council then determines whether the institution is granted one of the following statuses: full accreditation, qualified accreditation, accreditation withheld, or accreditation-pending. Full or qualified accreditation is granted for 3 years.
Policies and Guidance
As a result of the self-assessment, the HRPP and IRBs wrote and revised policies and procedures, investigator guidance and forms applicable to the conduct of human subjects research by UW-Madison investigators and the review of that research by the IRBs. Those policies, guidance and forms, which reflect any changes required to comply with State law and federal regulations governing human subjects research, are now available on the HRPP website.
Information about AAHRPP
The AAHRPP web site contains a number of useful documents such as information on AAHRPP's history and formation in 2001, its approach to evaluation, and standards for accrediting human research protection programs. More information may be found at http://www.aahrpp.org