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Suggested Citation:"NCQA Standards." 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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STANDARDS FOR ACCREDITATION 80 roles and responsibilities of investigators and the “organization” (e.g., institutional officials, administrative offices, personnel, existing compliance programs, or oversight mechanisms), there is far less attention to these parties than to IRBs, and little to no mention is made of the roles and responsibilities of research sponsors, despite the central role that sponsors play in much of the privately funded research. NCQA Standards The standards developed for the VA by NCQA (Appendix C) are distinct in that they are applicable to a defined system. The VA conducts biomedical, health services, and rehabilitation research to improve the health care delivered to the nation's veterans. The VA has developed policies, consistent with the Common Rule and FDA regulations, to safeguard human participants in research and has established the Office of Research Compliance and Assurance (ORCA) to support the field operations in protecting human participants and to assess their compliance with regulations that protect human research participants. The standards will be applied to VA hospitals and VA employees. In that sense, the standards do not face the same level of complexity in the field as the proposed PRIM&R standards do. Nonetheless, they appear to be potentially applicable, with some additions and modifications, to research conducted in other, non-VA, nonmedical settings (see Table 3-1). The draft NCQA standards are notable in several respects. First, they are not overly prescriptive, although they do begin (as do the PRIM&R standards) from the base of federal regulations (see below). Second, the NCQA standards specifically rely on institutional policies and procedures as the methods by which standards are met. The explicit “data source” for several of the standards is the policies and procedures documentation on file at the institution or the quality improvement document maintained by the institution (see Recommendation 7). This is noteworthy because although the standards will apply to a system that is far more homogeneous than the general research environment, they allow variations in procedures, perhaps recognizing that even within the VA health care system there will be institutional variations. Third, the standards provide thresholds for compliance in each core area: the IRB, informed consent, institutional accountability, privacy and confidentiality, recruitment and subject selection, and risks and benefits. Thus, to receive full compliance with a requirement, a site must achieve compliance with specified “critical elements.” The site may still receive partial compliance with the requirement if those elements are not met6 (see previous discussion in the section Developing Measures to Accompany Standards). 6For more information on this process, see http://www.ncqa.org/Pages/ Programs/QSG/vastandards.htm.

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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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