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Suggested Citation:"INTRODUCTION." 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 B 115 APPENDIX B PRIM&R Accreditation Standards © Copyright 2001 by Public Responsibility in Medicine and Research (PRIM&R). All rights reserved. These standards or parts thereof, cannot be used or reproduced in any manner without the written permission of PRIM&R. Contact PRIM&R, 132 Boylston, St., 4th Floor, Boston, MA 02116, 617-423-4112 or email rachlinj@aol.com. INTRODUCTION The research community, Congress, and the public have all voiced concerns regarding the adequacy of the system for the protection of human research participants. In response to these concerns, and to suspensions of research at a few institutions around the country, in May 1999 Public Responsibility in Medicine and Research (PRIM&R) began the development of a proposed accreditation program. The accreditation program would be voluntary and educationally driven, directed toward improving human subject protection programs and thereby promoting the strongest possible system of protections for individuals studied in research. The planned accreditation program has two phases: The first phase has been the development and planned promulgation of objective, outcome-oriented performance standards, which can then serve as the measurement criteria for the new private, voluntary accreditation program described above. Beginning in the fall of 1999, PRIM&R convened a multi-disciplinary group of individuals, all of whom have been leaders in their respective fields, to write these draft Standards. Four writing group “retreats” were held, and the balance of the work was conducted via telephone and e- mail. Once these standards have been reviewed and accepted, they will be suitable for both self-assessment and formal peer review during the accreditation process. With respect to their self-assessment function, it is expected that the

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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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