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Preserving Public Trust: Accreditation and Human Research Participant Protection Programs
In a third, less common, model, the accreditation program does not create its own standards but, rather, ensures compliance with standards on the basis of interpretation of regulatory standards determined by the government or another entity. The program might also offer guidance about regulatory compliance. This is the accreditation model used by the Association for Assessment and Accreditation of Laboratory Animal Care (AAALAC),1 which does not create its own standards but which is a private voluntary accreditation system that operates in compliance with regulations from the U.S. Department of Agriculture, funding agencies, and the Animal Welfare Act, a federal statute. AAALAC standards are supplemented by the Guide for the Care and Use of Laboratory Animals, produced by the National Research Council (NRC, 1996). This volume lays out best practices and benchmarks based on science and knowledge developed from past accreditation efforts.
AAALAC dates back to 1965. Until recently, the National Institutes of Health (NIH) office that had oversight over protection of humans involved in research also had responsibility for compliance with animal care regulations, so this model is familiar to both the federal officials and research centers. This is the model explicitly cited by the Association for the Accreditation of Human Research Protection Programs (AAHRPP) (see below). The analogy is not direct in one area, however, in that in research involving humans, participants can have a direct voice and those with direct experience as participants or those familiar with the concerns of human participants in research can be directly engaged in oversight of the research. The draft standards that the committee has seen to date do not fully take advantage of this possibility (see discussions in Chapter 1 and Chapter 3).
On the basis of the standards shared with the committee, it appears that the framework proposed by NCQA under its contract with the U.S. Department of Veterans Affairs (VA), at least initially, is to use accreditation as a tool to implement existing regulations better, adopting this aspect of the AAALAC model (in effect, using current regulations as standards and using accreditation to bring VA facilities into compliance with them). The committee believes that this is a good way in which to get an accreditation program under way. It might also serve to supplement a regulatory program that is overburdened. Its main value is to move those being accredited into compliance with existing regulations. This strategy will improve research oversight only if noncompliance is one of the system's major problems. The same model could, however, also be used to augment regulatory standards if some accreditation standards exceed the regulatory minimum. The NCQA linkage to quality improvement programs is a step along this path (see Chapter 3).