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Preserving Public Trust: Accreditation and Human Research Participant Protection Programs
subsequently, the National Committee for Quality Assurance (NCQA), were provided to the committee. To assess those materials, the committee found it useful to use the following general criteria: (1) their scope and focus; (2) their relationship to the existing regulatory standards; and (3) the extent to which the standards can be consistently implemented, measured, and enforced, as well as their inclusion of various key elements. For more discussion on the review and elements considered, please see Chapter 3.
Finding 1: The standards proposed by NCQA for VA facilities appear promising for use in the accreditation of VA facilities. Those same standards are the strongest basis for use in the accreditation of other research institutions (see Table 1). The committee regards the standards prepared by NCQA to be more suitable than those prepared by PRIM&R for not only pilot testing in VA facilities but also, with modification, for the accreditation of other research institutions.
Finding 2: Neither set of proposed standards applies readily to the full range of research involving human participants or to the diversity of research institutions that conduct it. Both sets of standards understandably and reasonably start from the kinds of research and the types of research organizations where recent problems have been best documented. It is not clear, however, how standards should be applied to nonbiomedical research settings, contract management organizations, clinical trials cooperative groups, independent IRBs, central IRBs, site management organizations, or units of research sponsors that conduct human research (e.g., research units within federal agencies and private pharmaceutical, biotechnology, and device companies).
How the proposed standards can be adapted to the large and growing fraction of research not conducted in the framework of biomedical research institutions will be an important question to be addressed in pilot tests. This is problematic in two respects. First, many institutions performing research with humans are not primarily focused on clinical research, yet the standards have clearly been formulated with medical research in mind. Second, the accreditation system must cover all types of research organizations. A very large fraction, probably a majority, of clinical research is privately sponsored and conducted outside traditional medical research institutions for which both sets of standards were developed. Failure to include privately sponsored research reviewed by independent IRBs would not only exclude a significant fraction of research with humans but would also call into question whether the accreditation process was skewed in favor of academic health centers. It is premature to judge how accreditation can work for these organizations, but it is critical to include them in any credible accreditation system.