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RED 502

Advanced Consideration of Reportable Events in Human Subject Research

Scheduled Sessions


Melinda Boulter
Institutional Review Board Administrator
Institutional Review Board (IRB) 

Lacy Clegg
Institutional Review Board Administrator
Institutional Review Board (IRB)




About 1.5 hours





This is a REd Synchronous (live) class.

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.

REd Synchronous classes are taught by subject matter experts and provide both fundamental and advanced skills training in flipped classroom format. To register for upcoming trainings, click here to view our calendar.

Last Updated: 5/20/24