Policies & Procedures - Emory IRB - Emory University

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Emory University IRB P&Ps Revised 1/18/2013 Local Research Context, July 21, 2000 FDA Information Sheet: Non-Local IRB Review See also specific regulatory references set forth in specific provisions above. DOD Directive 3216.2, Para. 4.9; SECNAVINST 3900.39D, Para. 6i. Page 50 of 370
Emory University IRB P&Ps Revised 1/18/2013 POLICY: 17 HUMAN SUBJECTS RESEARCH AT THE ATLANTA VETERANS AFFAIRS MEDICAL CENTER (AVAMC)/ATLANTA RESEARCH AND EDUCATION FOUNDATION (AREF) The provision of services by the Emory IRB to the Atlanta Veterans Affairs Medical Center (AVAMC) and to the Atlanta Research and Education Foundation (AREF) is established through the AVAMC Memorandum of Understanding that outlines the responsibilities of the AVAMC/AREF and Emory University through its Emory IRB. The Emory IRB is designated as the IRB of record for the AVAMC/AREF pursuant to these entities’ respective FWAs. Protocols reviewed by the Emory IRB on behalf of the AVAMC/AREF receive the same IRB review, both initial and continuing, as those conducted at Emory University; provided, however, that Emory shall assure that AVAMC Research or other VA-supported Research shall not be assigned to a commercial IRB for review. The Emory IRB does and shall continue to meet all Department of Veterans Affairs requirements for an affiliate human studies subcommittee of the AVAMC Research & Development Committee (hereafter referred to as “RDC”). PROCEDURES: Relationship between Emory IRB and RDC: The AVAMC has a Research and Development Committee that reviews AVAMC Research protocols. Review of an AVAMC Research protocol by the RDC is in addition to, and not in lieu of, Emory IRB review and approval. AVAMC Responsibilities: The AVAMC remains responsible for ensuring compliance with the Emory IRB’s determinations and with the terms of its own FWA. Specifically, the RDC shall be responsible for reviewing and approving all Emory IRB determinations for AVAMC Research. However, the RDC may not overrule negative decisions made by the Emory IRB. The AVAMC shall initiate a quality assurance program for Human Subject Research protection in conjunction with the Emory IRB to evaluate programs on an on-going basis. Findings and follow-up from any review will be shared with the Emory IRB. Documentation of Relationship: The AVAMC and Emory University have entered into the following agreements regarding IRB arrangements: Federalwide Assurance (FWA): Emory University, Atlanta Veterans Affairs Medical Center (AVAMC), and Atlanta Research and Education Foundation (AREF) have entered into Federalwide Assurances (FWAs) with OHRP. Under these FWAs, Emory University operates the Emory IRB, which is the designated IRB for VAMC and the AREF. Current information regarding the Emory FWA (FWA 00005792), the VAMC, Decatur FWA (FWA 00002551), and AREF (FWA 00003511) can be found at the following OHRP website: http://ohrp.cit.nih.qov/search/asearch.asp Memorandum of Understanding: Emory University, AVAMC, and the AREF have documented their relationship through the AVAMC Memorandum of Understanding. The Emory IRB is subject to and agrees to abide by the terms of its FWA: Number Page 51 of 370
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Policies & Procedures - Emory IRB - Emory University

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