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WebAssisting members in their efforts to promote effective fire prevention and suppression, emergency medical services, and other emergency services through educational, … The IRB Written Procedures Checklist included below identifies the HHS and FDA regulatory requirements and recommendations for IRB written procedures. The regulatory requirements are denoted in the Checklist as headers to sections I, II, III and IV. The Checklist also includes recommendations on topics to … See more This draft guidance has been prepared jointly by the Department of Health and Human Services (HHS’s) Office for Human Research Protections (OHRP) and … See more OHRP and FDA frequently receive requests for clarification regarding the scope and content of IRB written procedures. We recognize that procedures may vary … See more IRBs that are subject to both the HHS and FDA regulations in Titles 45 (45 CFR Part 46), and 21 (21 CFR Parts 50 and 56), respectively, must comply with the … See more drasko
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