facilities, academic health centers, and some other research organizations. Many organizations that might reasonably apply for HRPPP accreditation, however, do not conform to the traditional research organization model. Independent IRBs do not directly conduct research, for example, and so entire sections of the proposed standards are inapplicable to them.

To be credible, the accreditation process should expand to include independent IRBs; cooperative groups; contract research organizations; site management organizations; units within federal research agencies that conduct their own research; and units of pharmaceutical, medical device, and biotechnology firms that carry out research with human participants. The accreditation process must be sufficiently elastic to accommodate all major organizational structures involved in research with humans. Failure to cover the full range of research organizations under an accreditation program would undermine the credibility of the accreditation process so essential to the program's success in two ways. First, it would eliminate a large and growing fraction of research with humans, and second, it could be perceived as a subterfuge to protect the competitive advantage of academic health centers to the detriment of private independent IRBs on the basis of categorical exclusion rather than quality. Yet, neither NCQA nor PRIM&R draft standards can be directly applied to many organizations conducting research with humans. Discovering how to do this with one or several sets of standards, whether under one accreditation body or a few, will be an important question to address in pilot tests.

Accreditation of an independent IRB, for example, might use only the subset of standards pertinent to IRBs, but doing so would also require assurance regarding the functions covered by proposed standards that pertain to investigators, research institutions, and research participants, as well as standards not yet incorporated into NCQA or PRIM&R standards (but covered by the guidelines of the International Conference on Harmonisation; see Chapter 3) pertaining to sponsors. Independent IRBs could be accredited with such assurances, perhaps on the basis of binding written agreements between the independent IRB and the research sponsors contracting for its services.

Another approach would be to accredit the organization that does directly control all the relevant elements of an HRPPP (e.g., a contract research organization that has a formal agreement with an independent IRB to review all its protocols, the research unit of a private firm, the unit of a federal agency that performs research, or a clinical trials cooperative group). These approaches are not mutually exclusive, but neither approach is reflected in the NCQA and PRIM&R draft standards. One of the virtues of a nongovernmental voluntary accreditation process is its flexibility, and nongovernmental accreditation bodies should not find it difficult to accommodate disparate organizational structures, but it is not yet clear how the current proposed standards or accreditation processes would do so.



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