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STANDARDS FOR ACCREDITATION 69 NEED FOR STANDARDS TO ENCOMPASS MULTIPLE RESEARCH SETTINGS AND METHODS Recommendation 5: Accommodate Distinct Research Methods and Models Within Accreditation Programs The accreditation process should accommodate other research organizations in addition to the tradtional models provided by academic health centers and VA facilities. The accreditation process should also cover research other than clinical research. Standards must accommodate the distinct natures of several types of organizations, including research institutions, educational institutions, independent IRBs, academic medical centers, nongovernmental organizations, and private interests. A set of standards can make clear the scope of institutions to which they apply in several ways: (1) state explicitly in the preamble the intended focus of the standards; (2) include flexible language, such as âwhere applicableâ or âas appropriateâ to certain standards so that institutions not engaged in particular activities (e.g., nonmedical, low-risk research) could be exempt from certain standards (e.g., reporting of adverse events); or (3) organize the standards so that institutions and accreditation bodies can quickly ascertain which sections apply to them and which ones do not. If standards were structured in a manner that requires the existence of a single entity with exclusive authority over all parties involved in the research process, then the three requirements listed above would not apply. It must be recognized, however, that certain organizations, such as independent IRBs and some private sponsors of research, would then not be eligible for accreditation. This would be an unfortunate consequence, as it would exclude organizations that play an increasing role in the research enterprise. Accreditation of an independent IRB, for example, might use only the subset of standards pertinent to IRBs, but doing so would also require formal assurance regarding the functions covered by proposed standards that pertain to investigators, research institutions, and research participants, as well as standards that pertain to sponsors but that are not yet incorporated into NCQA or PRIM&R standards (but covered by ICH-GCP guidelines) (see discussion below). Another approach would be to accredit the organization that directly controls 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). 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. It is not yet clear, however, how the current proposed standards or accreditation processes would do so.
STANDARDS FOR ACCREDITATION 70 Although there is a natural tendency to develop standards and review procedures around a specific model, accommodation of innovative or unique organizations is central, and although âbasing development on a commonly accepted template may benefit the accrediting organization, there is a danger that innovative structures or processes undergoing accreditation will encounter additional challenges or problems in the review processâ (Hamm, 1997, p. 31). In addition to accommodating distinct types of research infrastructures, the language of standards should acknowledge that even though the principles that underlie them apply to all human research, the criteria and mechanisms for review must be adaptable and must be based on the nature of the research being conducted and the context within which the research is to be performed. The committee heard strong, consistent comments that the proposed standards (in this case, those of PRIM&R) do not fully recognize either the diversity of institutions or the full range of research (AAU, COGR, NASULGC, 2001; Kulakowski, 2001; Ryan, 2001). The standards proposed by NCQA under contract with the VA, however, are necessarily limited in scope to VA facilities. Although the committee believes that the same principles for protection of the rights and interests of research participants apply to all researchâfor example, biomedical, behavioral and social, public health, and outcomes researchâit is likely that the processes needed to comply with the standards will differ depending on the nature of the research. Thus, it is an open question whether the best accreditation strategy would be to use one set of operational standards for all research. That might well prove viable, but it also might prove better to encourage the evolution of different specific standards for different kinds of research institutions. Those in the best position to make this determination will be organizations devising the nongovernmental accreditation processes, not this committee or the federal government. Whether to develop one set of standards or a few sets of standards specific to a few different classes of research organizations should not be decided by fiat but should be decided in light of experience gained through pilot accreditation programs that include medical and nonmedical sites. Accreditation pilot programs can begin by focusing on the research institutions for which they were designed, but they might evolve in many different ways. In the future, there could be one or a few accreditation bodies and one or a few sets of accreditation standards, and many different kinds of organizations will certainly be involved in research with human participants.
