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Suggested Citation:"DRAFT STANDARDS FOR 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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APPENDIX A 114 history of human subjects protections; the laws, processes, and groups that regulate human research; critiques of the current system for protecting human research subjects; sample accreditation programs; and ethical issues surrounding human research. DRAFT STANDARDS FOR ACCREDITATION Due to the fast-track nature of this study, the Institute of Medicine sought to assist the committee in completing its task in a timely manner. For this reason, the IOM funded the completion of a two-year effort by PRIM&R to establish accreditation standards. The resulting standards were intended to assist the committee in its deliberations about accreditation strategies and their strengths and weaknesses. In addition, in the course of the committee's analysis, the draft standards developed by NCQA under contract with the Department of Veterans Affairs were provided to the committee for inclusion in their assessment of accreditation standards.

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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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