Accreditation of Human Research Protection Program

HRPP Accreditation Update
The UW-Madison held its site visit by the Association for the Accreditation of Human Research Protection Programs, Inc. (AAHRPP) the week of September 24 - 27, 2007. The site visit went smoothly, and the site visitors were very impressed with UW-Madison's researchers and research staff as well as with the Madison area food.

The site visitors spent four days on campus reviewing UW-Madison's program operations and records and interviewing IRB members and staff, investigators, research staff and students as well as University administrators and personnel from the Office of Research Policy.

The next step in the accreditation process is responding to the formal site visit report, which was received on October 26, 2007. UW-Madison's written response is due on November 26, 2007.

Accreditation Site Visit Agenda Released
The UW-Madison has finalized its agenda for its upcoming site visit by the Association for the Accreditation of Human Research Protection Programs, Inc. (AAHRPP), scheduled for the week of September 24 - 27, 2007.

Site visitors coming to UW-Madison are:

David Segal, Ph.D.
Professor of Sociology and Director of the Center for Research on Military Organization
University of Maryland

Jennifer Ruocco, Ph.D.
Director, Office of Research Compliance and Regulatory Affairs
Cincinnati Children's Hospital Medical Center

John A. Bertolatus, MD
Associate Professor
Internal Medicine
The University of Iowa College of Medicine

Susan Z. Kornetsky, M.P.H., C.I.P.
Director, Clinical Research Compliance
Department of Clinical Investigation
Boston Children's Hospital

The team will be led by Michael Pagliaro, Accreditation Director, AAHRPP, Inc.

The following group presentations are open to all. They will all be held in Room 260 Bascom Hall.

• Monday, 9/24, from 8:00 to 8:30 AM - AAHRPP Inc. will explain the site visit process.
• Monday, 9/24, from 8:30 to 9:30 AM, - one hour overview of our Human Research Protection Program, including a brief presentation by Bill Mellon.
• Thursday, 9/27, from 9:50 to 11:50 - Detailed presentation by AAHRPP Inc. of their site visit findings and recommendations covering each of AAHRPP's accreditation standards. A written report of these findings and recommendations will be sent to us on October 26.
• Thursday, 9/27, from 12:00 to 12:30 PM - Executive summary of the detailed presentation given by AAHRPP in 9:50 AM session.

Powerpoints are now available: AAHRPP Site Visit Information and Interview Tips.

The site visit is the UW-Madison's next step in seeking accreditation of its Human Research Protection Program (HRPP). The site visitors will spend four days on campus reviewing UW-Madison's program operations and records and interviewing IRB members and staff, investigators, research staff and students as well as University administrators and personnel from the Office of Research Policy.

Accreditation Site Visit Scheduled
UW-Madison has scheduled a site visit by the Association for the Accreditation of Human Research Protection Programs, Inc. (AAHRPP) for the week of September 24, 2007. A team of AAHRP professionals will spend four days on campus reviewing UW-Madison's Human Research Protection Program (HRPP) and Institutional Review Boards (IRBs) operations. The site visit will include interviews by the site visitors of IRB members, investigators, research coordinators, and administrators and staff of the IRBs and the Office of Research Policy and other indivuduals involved with the HRPP and IRBs.

UW-Madison Applies for Accreditation of HRPP
UW-Madison submitted its application for accreditation of the University's Human Research Protection Program (HRPP), including the campus' four Institutional Review Boards (IRBs) in December 2006. The accrediting agency is the Association for the Accreditation of Human Research Protection Programs, Inc. (AAHRPP), a non-profit 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 the 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 and state law.

The major components of the HRPP, which is coordinated by the Office of Research Policy, are the campus' four IRBs and the IRB staff, the HRPP Advisory Committee, and all UW-Madison investigators and research staff involved in human subjects research.

The Accreditation Process
The accreditation process includes two major phases: preparation of a written application addressing each of AAHRPP's accreditation standards and a site visit by a team of professionals assembled by AAHRPP to inspect program operations.

While preparing its written 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 complied with AAHRPP's accreditation standards.

Although, in most instances, the operations of the UW-Madison HRPP and IRBs were in line with the accreditation standards, in some instances, IRB practices with respect to protocol submission and IRB review were modified to meet those standards.

Policies and Guidance Posted on HRPP Website
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.

Those policies and procedures, investigator guidance and forms, which reflect any changes required to comply with accreditation standards, are now available on the HRPP website. Please take a look at the website at your convenience and email any questions or comments to HRPP@bascom.wisc.edu.

Information about AAHRPP
AAHRPP was founded in 2001 by the Association of American Medical Colleges, Association of American Universities, Consortium of Social Science Associations, Federation of American Societies for Experimental Biology, National Association of State Universities and Land-Grant Colleges, National Health Council, and Public Responsibility in Medicine and Research.

The AAHRPP website contains a number of useful documents such as information on AAHRPP's history and formation, its approach to evaluation, and standards for accrediting human research protection programs.

UW-Madison Resources
Investigator's Guidance - Guidance for investigators and other research personnel involved in human subjects research. A downloadable PDF version of this guidance is also available on the HRPP website.

HRPP and IRB Policies and Procedures - A link to the policies and procedures for the operation of the HRPP and the IRBs. UW-Madison policies establish the authority of the IRBs, define human subjects research, outline investigators responsibilities, and address issues relating to the review of research by the IRBs and the protection of human subjects, including minimization of risk, informed consent and vulnerable participants.

UW-Madison Human Subjects Tutorial - Certification of completion of the UW-Madison Human Subjects Tutorial is required for all personnel engaged in human subjects research at UW-Madison.

Helpful Links
Education Research IRB
Health Sciences IRBs (both Health Sciences IRB and Minimal Risk IRB)
Social and Behavioral Science IRB
UW-Madison HRPP Website
UW-Madison Office of Research and Sponsored Programs
UW-Madison Research Policy and Compliance Programs - information about other research integrity, safety and compliance programs at the UW-Madison.

News Releases

Accreditation Site Visit Agenda Released (September 19, 2007)
Accreditation Site Visit Scheduled (April 17, 2007)
Updated Human Subjects Polices, Guidanc../newsrelease/1.newsrelease2.htmle and Forms Available (March 9, 2007)

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