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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 âretreatsâ 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