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Suggested Citation:"MODELS OF ACCREDITATION." Institute of Medicine. 2001. Preserving Public Trust: Accreditation and Human Research Participant Protection Programs. Washington, DC: The National Academies Press. doi: 10.17226/10085.
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Page 45
Suggested Citation:"MODELS OF ACCREDITATION." Institute of Medicine. 2001. Preserving Public Trust: Accreditation and Human Research Participant Protection Programs. Washington, DC: The National Academies Press. doi: 10.17226/10085.
×
Page 46
Suggested Citation:"MODELS OF ACCREDITATION." Institute of Medicine. 2001. Preserving Public Trust: Accreditation and Human Research Participant Protection Programs. Washington, DC: The National Academies Press. doi: 10.17226/10085.
×
Page 47

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MODELS OF ACCREDITATION 45 2 Models of Accreditation The committee was presented with the task of making recommendations about accreditation standards and does so in more detail in the next chapter. With the basic terminology for the committee's view of a human research participant protection program (HRPPP) defined in Chapter 1, this chapter lays the groundwork for the elements of an accreditation process. It starts by considering the various models available for accreditation systems and asks, “What is the role of accreditation in a human research protection system?” The present committee will spend another year thinking about the design and implementation of an improved system of human research protection, so it has not had the opportunity to consider the value of accreditation compared with other strategies to ensure the ethical conduct of research. However, even if one begins with the current system rather than a reconstructed one, accreditation should not be evaluated in a vacuum—it is still necessary to have a theory of accreditation and a process for carrying it out. Specifically, the value that accreditation adds to the system that already exists must be considered. MODELS OF ACCREDITATION Accreditation efforts in the United States have historically followed one of two models, although a third model can also be observed. The first of these is accreditation as a supplement to government regulation. Under this model, entities that are otherwise already regulated by the government seek accreditation as a mark of excellence, as it is above and beyond government regulation. Ac

MODELS OF ACCREDITATION 46 creditation, however, has become a mark of excellence achieved by only a fraction of regulated entities. The National Committee for Quality Assurance (NCQA) program for the accreditation of managed care organizations illustrates this model (NCQA, 2001a). Managed care organizations are regulated by state insurance departments, state health departments, or the U.S. Department of Health and Human Services (DHHS) (if they are Medicare or Medicaid managed care organizations). They also seek accreditation, however, to demonstrate their commitment to excellence, as many employers and other purchasers of managed care organization services look to accreditation as an indicator of performance above the required minimum. In a second model, accreditation substitutes private regulation for public regulation. One version of this is seen in accreditation of institutions of higher education, for which formal government regulation is (for various reasons not explored here) largely absent. Accreditation serves effectively as the only oversight system. Another variant of nongovernmental voluntary accreditation is seen under Medicare's “deemed-status” program, in which the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) hospital accreditation program serves as an alternative to state certification, which uses Medicare's own federal regulatory standards as a basis for hospital participation in Medicare (Jost, 1994). JCAHO's accreditation standards are quite different from Medicare's own standards, but JCAHO accreditation is accepted in the place of Medicare certification. That is, a hospital or health care facility is deemed to meet federal standards by dint of being accredited by JCAHO and is thereby authorized to participate in (and be paid through) Medicare. There are significant benefits to the use of accreditation as an alternative to regulation and to the deemed-status model in particular. Accreditation reduces the cost of oversight to government, as it is effectively paid for by user fees rather than taxes. Accreditation programs, especially nongovernmental programs, tend to be much more flexible and responsive to change than regulatory programs because they are not bound by the rigidities of administrative rulemaking procedures and are more responsive to regulated constituencies. Accreditation, however, also has its costs. It is not directly accountable to the public, and there is a constant concern that the “fox is guarding the henhouse” (DHHS OIG, 1999a,b). Even JCAHO is not given unfettered authority to regulate hospitals for Medicare. The Health Care Financing Administration (HCFA), which administers Medicare, retains authority to directly assess (or “look behind”) the accreditation of hospitals. HCFA conducts its own surveys for cause, surveying a small fraction of validation surveys each year, and reviews JCAHO's “deeming” authority at least once every 6 years (Lewin Group, 1998). Furthermore, if accreditation is to be more than a pro forma exercise, it can be resource-intensive. This can be corroborated by any health care facility or educational administrator who has recently undergone accreditation.

MODELS OF ACCREDITATION 47 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). 1 For more information, see http://www.aaalac.org/.

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Amid increasing concern for patient safety and the shutdown of prominent research operations, the need to improve protections for individuals who volunteer to participate in research has become critical. Preserving Public Trust: Accreditation and Human Research Participant Protection Programs considers the possible impact of creating an accreditation system to raise the performance of local protection mechanisms. In the United States, the system for human research participant protections has centered on the Institutional Review Board (IRB); however, this report envisions a broader system with multiple functional elements.

In this context, two draft sets of accreditation standards are reviewed (authored by Public Responsibility in Medicine & Research and the National Committee for Quality Assurance) for their specific content in core areas, as well as their objectivity and validity as measurement tools. The recommendations in the report support the concept of accreditation as a quality improvement strategy, suggesting that the model should be initially pursued through pilot testing of the proposed accreditation programs.

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