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Suggested Citation:"3 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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Page 63

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STANDARDS FOR ACCREDITATION 63 3 Standards for Accreditation Any set of standards used by accreditation organizations responsible for the protection of research participants must be flexible enough to be applicable to a variety of institutions yet rigorous enough to ensure that their enactment enhances protection of human research participants. In addition, they must be clearly written, relatively straightforward to execute, consistently applicable, and measurable. These are not easy goals. In response to a request from the U.S. Department of Health and Human Services (DHHS), the Institute of Medicine was asked to address accreditation standards for human research participant protection programs (HRPPPs). To accomplish this task, the committee reviewed draft versions of proposed standards developed by Public Responsibility in Medicine and Research (PRIM&R) and the National Committee for Quality Assurance (NCQA), as well as the International Conference on Harmonisation Guidelines for Good Clinical Practice (ICH-GCP). The PRIM&R standards were drafted to be used as measurement criteria for a new voluntary program for research protection. The standards are intended to guide organizations seeking private voluntary accreditation in the assessment of their human research protection programs (HRPPs) and to be used by independent site visitors during the accreditation process. NCQA is an independent, nonprofit organization under contract with the U.S. Department of Veterans Affairs (VA) to operate an accreditation program to ensure that VA medical centers are complying with VA and other relevant federal regulations designed to protect human participants in research.

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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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