specific attention to quality improvement, provide flexibility in achieving performance goals (e.g., increased protection of research participants), and are explicit in their grounding in current regulations.

The committee recommends that pilot accreditation programs should start from the accreditation standards and processes proposed by NCQA for VA facilities and be adapted for use in other organizational contexts by NCQA or other accreditation bodies. In expanding the draft NCQA accreditation standards for use beyond VA facilities, the committee recommends that the standards be strengthened in several specific ways. These include how investigators will be reviewed, beyond the review of protocols by institutional review boards; how sponsors will be assessed; how participants will be involved in setting performance standards; and how oversight mechanisms can ensure participants ' safety.

The committee further recommends that (1) the organizations formulating accreditation standards and carrying out the accreditation process be independent, nongovernmental organizations; (2) the formulation of accreditation standards, the accreditation process, and human research participant protection program operations directly involve research participants; and (3) the accreditation process accommodate organizations involved in research beyond the traditional models of academic health centers and VA facilities and be appropriate for research methods other than clinical research.

Only by experience gained through pilot testing can the value that accreditation adds to the current regulatory system, in terms of enhanced protection of human research participants, be adequately assessed.

Beginning in the 1960s, a formal system for ensuring the ethical conduct of research with humans developed in the United States. This system traditionally centered on the institutional review board (IRB). However, the Committee on Assessing the System for Protecting Human Research Subjects and others now envision a broader system with multiple functional elements that will be referred to in this report as human research participant protection programs (HRPPPs) (Figure 1). That system is the central element for protecting the interests of those who participate in research, and it has four principal functions: (1) to ensure that research design is sound and that a study's promise for augmenting knowledge justifies the involvement of human participants, 1 (2) to assess the risks and benefits independently of the investigators who carry out the research; (3) to ensure that participation is voluntary and informed; and (4) to ensure that participants are recruited equitably and that risks and benefits are fairly distributed.


See Chapter 1 for discussion regarding the committee's use of the term “participant” versus “subject.”

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