The first phase of work by the Committee on Assessing the System for Protecting Human Research Participants (“the committee”) focused almost exclusively on accreditation. While examining the issues relevant to this subject, the committee introduced the concept of the Human Research Participant Protection Program (HRPPP) as the appropriate functional unit to implement and oversee protection functions. The committee’s first report, Preserving Public Trust: Accreditation and Human Research Participant Protection Programs, provided a foundation for establishing an HRPPP, but was unable to provide much more than a sketch of the intended program (IOM, 2001a). The current report represents the culmination of the committee’s deliberations and provides substantive descriptions of the functions and responsibilities intrinsic to a robust participant protection program.

In phase two, the committee was charged with the following tasks:

  1. Review the ethical foundations for protecting human participants in research.

  2. Assess and describe the current system for protecting human participants and make recommendations for potential enhancements and improvements to

    1. ensure informed consent,

    2. monitor ongoing research,

    3. accommodate private IRBs, multicenter research, and non-medical research,

    4. ensure continuous improvement in the system, and

    5. educate researchers, participants, and others involved in research with human participants.

  1. Assess the potential impact of recommended changes on resource needs and how to address them.

  2. Consider the effects of accreditation on improving human participant protection activities.

  3. Determine the need and develop potential mechanisms for on-going independent review of the national system.

Many of the issues and policies pertinent to the committee’s task have been in flux, with a number of commissions and organizations, including research institutions, professional associations, and the federal government, all working to find solutions to previously identified problems. In addition to countless news stories highlighting and influencing public discussion,2


Blumenstyk, 2002; DeYoung and Nelson, 2000a,b; Flaherty et al., 2000; Flaherty and Struck, 2000; LaFraniere et al., 2000; Lemonick and Goldstein, 2002; Nelson, 2000; Shaywitz and Ausiello, 2001; Stephens, 2000; Stolberg, 2001; Wilson and Heath, 2001a,b,c,d,e,f,g.

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