Reporting Adverse Events to the IRB. IRB Responsibilities. Ensure that local management of unanticipated problems in research Assure maximal protection for research participants Comply fully with all laws, regulations, and standards. Purpose of IRB Review of AEs.
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OHRP Guidance Topic III
38 CFR 16.103(b)(5)(i)
VHA Handbook 1200.5, p. 13-14