ment of Health and Human Services (DHHS) began looking at how the system for the protection of participants in human research could be brought into line with the new challenges that it faced without unduly limiting opportunities for advancing knowledge through innovative research. In spring 2000, congressional hearings, legislation, and new initiatives announced by the Secretary of Health and Human Services and the VA sought to assure the public that policy makers were aware of the fundamental need to ensure access to the great potential offered by research without sacrificing participant safety or well-being. Likewise, organizations within the research community responded to public concern by reaffirming their commitment to the safe and ethical pursuit of research and by establishing focused task forces to examine identified areas of concern (AAMC et al., 2000; AAU Task Force on Research Accountability, 2000; AAUP, forthcoming) Accreditation of HRPPPs was one of the ideas that emerged from these discussions.
One component of the DHHS effort to examine the system for the protection of human research participants was to ask the Institute of Medicine (IOM) to initiate an in-depth study of how to improve the structure and function of activities related to the protection of participants in human research, with an emphasis on the responsibilities and elements of HRPPPs. In this framework, HRPPPs include, but are not limited to, programs that use the traditional IRB model. The complexity of significant and delicate issues that are encompassed in such a task merits an in-depth examination by IOM, and thus, the task is to be conducted in two phases.
This report represents the results of phase 1 of the IOM study. It examines the potential benefits and strengths that an accreditation strategy, such as those under development within the research community and at the direction of the VA (see Appendix B and Appendix C), could bring to ongoing efforts to enhance HRPPPs. More specifically, the report addresses the following three tasks:
review and consider proposed human research review program3 performance standards;
recommend standards for accreditation of HRPPPs, considering measures of structure, process, and performance, as well as resource sufficiency; and
In the course of committee deliberations, the term “human research participant protection program” was substituted for “human research review program,” as the former term better reflected the system of oversight that the committee hopes will result from its recommendations.