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.
Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author.While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server.
Reporting Adverse Events to the IRB
OHRP Guidance Topic III
38 CFR 16.103(b)(5)(i)
VHA Handbook 1200.5, p. 13-14