The Office for Human Research Protections defines Adverse Events as: any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the subject’s participation in the research, whether or not considered related to the subject’s participation in the research.

IUP requires submission of Adverse Events that qualify as: any unexpected, physical, psychological, or social research-related event which is definitely, probably, or possibly related to the study; where the risk is not included, or exceeds the nature, severity, or frequency described in the protocol, study consent form, or other study information previously reviewed and approved by the Institutional Review Board.

Principal Investigators and, if applicable, their faculty advisors are required to email the IUP IRB at immediately upon discovery of an Adverse Event. The email should include a completed IRB Adverse Event form.