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APPENDIX C 135 APPENDIX C VA Human Research Protection Accreditation Program Draft Accreditation Standards BACKGROUND The Department of Veterans Affairs has contracted with NCQA to develop and implement an accreditation program for Veterans Affairs Medical Center (VAMC) Human Research Protection Programs (HRPPs). The purpose of the program is to strengthen the protections afforded human subjects of research at VAMCs through an ongoing program of independent, external review. The public must be assured that research is performed ethically and in the best interests of study volunteers to ensure its continued support for, and participation in, research studies. The VA has long held a set of policies governing the conduct of research, and in particular, the protection of human study participants. This program is the first to provide a routine, independent evaluation of VAMCs' compliance with these policies. These draft standards for the accreditation of Veterans Affairs Medical Center (VAMC) Human Research Protection Programs (HRPPs) are being published for public comment. In June 2001, program standards will be finalized after analysis of public comments and results of pilot tests to be conducted in April and May, 2001. The resultant standards will be revised annually to reflect changes in VA policy and other applicable federal regulation. These standards apply to VAMCs that operate their own IRBs, those that operate an IRB jointly with an affiliated university, and those that delegate IRB functions to the affiliated university's IRB. Standards include requirements for the oversight of affiliated IRBs. The VAMC retains responsibility for protecting human subjects of research even when it delegates the performance of some functions (e.g., IRB) to the affiliated university. All the standards for the performance
