In 2006, National Institutes of Health (NIH) adopted new standards established by the Association for the Accreditation of Human Subjects Protection Programs to maintain its compliance with policies, laws, and regulations related to human subjects' research. This study assessed the extent to which the NIH-wide Human Research Protection Program (HRPP) was meeting these standards. Evaluators surveyed NIH Institutes and Centers to determine if their Institutional Review Boards were performing at the standards set by the Association. They collected and analyzed data from document reviews of policies and procedures of the HRPP, individual institute review boards, the NIH Office of Human Subjects Research, clinical programs, the Medical Administrative Service, and the Medical Executive Committee. Some document reviews were supplemented by interviews, focus groups, expert panels, structured observations, and/or questionnaires depending on the data needed.
The Human Research Protection Program was found deficient in various respects and NIH is following up accordingly.
Report Title: Evaluation of the NIH Human Subjects Protection Program to Acquire Accreditation from the Association of Human Research Protection Program, Inc.
Agency Sponsor: NIH, National Institutes of Health
Federal Contact: Rosanna Ng, 301-496-5367
Performer: HRP Associates, Inc.
Record ID: 9380 (Report issued March 15, 2010)