The Association for the Accreditation of Human Research Protection Programs was incorporated as a nonprofit in 2001 to serve as a voluntary accreditation and standards setting body for human research protection programs. The AAHRPP’s press release explains that it "offers accreditation to institutions engaged in research involving human participants using a voluntary, peer-driven, educational model."

The AAHRPP was founded by the following nonprofit member organizations:

• 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
• Public Responsibility in Medicine and Research

The AAHRPP will charge institutions an application fee for AAHRPP accreditation.

The AAHRPP’s first goal is to develop a set of performance standards for human subjects research. It plans on pilot-testing these standards by the end of summer. Institutions performing human subjects research would perform two assessments of their compliance with these performance standards: a first "self assessment"; and a second on-site assessment by the AAHRPP. At the end of this process, assuming the institution passed, it would be accredited by the AAHRPP.

The AAHRPP will be headquartered in Rockville, Maryland. Its 21-person Board is now conducting an intensive search for an Executive Director.

The AAHRPP’s potential is very interesting. The Federal Government is reviewing its regulation of human subjects research. The National Bioethics Advisory Commission has now issued its reports on international and domestic human subject research issues. The NBAC reports contain sweeping recommendations for reform, focusing on more stringent and pervasive federal regulation. Institutional accreditation and performance standards are primary issues in what may be dramatic regulatory change.

A new office within HHS, the Office of Human Research Protections, has been created to oversea this regulatory review and change. The OHRP favors the type of voluntary accreditation program exemplified by the AAHRPP.

Performance and accreditation standards developed by the AAHRPP could be voluntary consensus standards under the federal Technology Transfer Act, 15 U.S.C. § 272 note, and OMB Circular A-119. If so, then any federal agency revising its human research regulations or policies may be statutorily required to adopt the AAHRPP standards unless they were for some reason impracticable or inconsistent with applicable law. In addition, under the Tech Transfer Act and the OMB Circular the Government could be obliged to participate in development of the AAHRPP standards.

Given this potential, and given CRE’s long-standing interest in both human testing and voluntary standards setting bodies, we intend to follow the AAHRPP’s progress and report further on it in the CRE website.