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Suggested Citation:"MAJOR FINDINGS." 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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Suggested Citation:"MAJOR FINDINGS." 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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Suggested Citation:"MAJOR FINDINGS." 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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Suggested Citation:"MAJOR FINDINGS." 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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EXECUTIVE SUMMARY 6 3. recommend steps that the organizations and institutions that conduct research and that the federal government should take to collect and analyze data to monitor and evaluate how well the system for protecting human research participants is operating. This report therefore provides recommendations for core standards with which to initiate pilot accreditation programs for HRPPPs, specific comments on standards under development, and suggested interim actions that can be used to initiate and monitor the impact of accreditation on the system and its ability to achieve the intended goals. The recommendations, listed below, appear in Box 1, at the conclusion of the Executive Summary, according to how they relate to the three broad categories; that is, whether they respond to the goal of developing an accreditation program, standards, or a system of evaluation. However, all comments are made in the context of the current policy and existing regulatory structures and without the benefit of a full examination of the underlying issues and possible solutions. The structures and processes constituting an accreditation system are only coming into being and still need to be tested. Therefore, the committee's recommendations are aimed at a moving target. Its recommendations about accreditation standards in particular presume that those standards will evolve substantially, especially with the benefit of feedback from initial pilot tests. The committee recommends standards for pilot testing of accreditation programs, but the committee did not itself formulate those standards. It neither could nor should have done so, for several reasons. First, the accreditation standards should be formulated in a “bootstrap” process, with strong feedback between the formulation of standards and direct experience with the implementation of HRPPP standards. Second, accreditation bodies should be accountable for their standards as well as their accreditation processes. Reliance on “IOM standards” would thus undermine this alignment between authority and responsibility for standard setting at a critical point in the development of (an) accreditation program(s). Finally, the standards will evolve over time and will do so rapidly during initial pilot testing. This iterative process would not be possible with a set of IOM standards produced at this time. As the committee formulated its recommendations, no pilot testing had taken place, and reliance on standards in advance of and independent of such testing runs contrary to early experience with the development of new oversight mechanisms in general and past models of accreditation in particular. MAJOR FINDINGS In accordance with its task, the committee reviewed available draft accreditation standards at the time of its deliberations. For this purpose, materials developed by Public Responsibility in Medicine and Research (PRIM&R) and,

EXECUTIVE SUMMARY 7 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.

EXECUTIVE SUMMARY 8 TABLE 1 Comparison of Draft NCQA and PRIM&R Accreditation Standards Organization preparing Strengths Weaknesses standards NCQA • Direct linkage to quality • Because of an exclusive improvement programs focus on VA facilities, will • Grounded in baseline need to be modified for use regulatory requirements for organizations for which • Measurement criteria and standards were not data sources specified originally designeda • Interpretive guidance • Insufficient standards provided relating to participant • Accreditation process involvement beyond specified informed consent • IRB decision appeals • Insufficient attention to role process specified of HRPPP accreditation vis- • Thresholds for compliance à-vis external research specified sponsors • Formulation of standards • Insufficient standards for and accreditation of VA research monitoring facilities by the same • Uncertain application to organization nonmedical research • Lack of specificity in PRIM&R standards for investigator • Grounded in ethical and institutional obligations principles of The Belmont • Documentation standards Report b for IRB recordkeeping • Reflect strong expertise inapplicable to many IRBs about IRB operations in • Uncertain application to academic health centers nonmedical research, • Differentiate substandards independent IRBs, contract for IRBs, institutions, and research organizations, investigators clinical trials cooperative groups, central IRBs, and other research organizations • Lack of cross-tabulation of standards to regulations

EXECUTIVE SUMMARY 9 • Inadequate specification of data sources, except documentation standards • Insufficient attention to role of HRPPP accreditation vis-à-vis external research sponsors • Insufficient standards relating to participant involvement beyond informed consent • Insufficient standards for research monitoring • Lack of specificity regarding measures and thresholds for compliance • Lack of interpretive guidance • Lack of specificity regarding accreditation judgments • Formulated with an inadequate link between responsibility for developing standards (an ongoing process) and responsibility for implementing accreditation process a Although it is identified as a weakness in this table, the NCQA standards were designed only for VA facilities, so a lack of more general applicability is not a criticism of the NCQA formulation but is an observation about their use of the NCQA standards for purposes that the committee recommends, that is, for non- VA organizations. b National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (1979).

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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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