Reporting of Unanticipated Problems and Adverse Events

Researchers encountering a problem or adverse event that is both unanticipated and indicates that the research places subjects or others at a greater risk of harm (including physical, psychological, economic, or social harm) than was previously known or recognized, must promptly report such problems or events to the IRB. The document below provides Office for Human Protections in Research (OHRP) definitions of unanticipated problems and adverse events as well as provides guidance to KSU researchers on how and when to report such problems and events.

 

Reporting of Unanticipated Problems and Adverse Events (PDF)