RED 502 | Advanced Consideration of Reportable Events in Human Subject Research
Unanticipated problems in research involving risk to human subjects or others must be reported to the Institutional Review Board (IRB). An "Unanticipated Problem" includes some types of adverse events, protocol deviations, non-compliance, and other incidents that place individuals at risk of harm. This presentation will include advanced case studies involving IRB reporting policies for unanticipated problems. The criteria for reporting an unanticipated problem, including various definitions and guidance contributing to the interpretation of the criteria, will be discussed. Participants will learn how to apply the criteria for an unanticipated problem in different scenarios and will better understand how to provide complete and accurate information in the IRB Report Form for complex unanticipated problems.
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IRB Manager, Operation