While the ethical principles for the protection of human research subjects were outlined in the Nuremberg Code, the Declaration of Helsinki, the Belmont Report, and the U.S. Federal Common Rule, the continuing adequacy of the current system of protections for human subjects involved in biomedical and behavioral research is the focus of much concern.

In response to growing concerns about the safety of participating in research and about access to clinical trials, the Department of Health and Human Services and several components therein asked the IOM to conduct a two-year study, with a six-month fast track component, to address:

• accreditation standards for Human Research Participant Protection Programs (HRPPPs);
• the overall structure and functioning of human subject protection activities, including but not restricted to IRBs; and
• criteria for evaluating the performance of HRPPPs

The fast-track study focused on the accreditation standards for HRPPPs (topic 1), while the second two phases extended the inquiry to topics 2 and 3.