Unanticipated Problems that arise during human subjects research must be reported to the IRB as soon as possible - at the most within five business days of their being detected. See the “Submitting an Incident” guide on the Protocol Submission (eIRB) page for instructions.
An Unanticipated Problem is defined as any incident, experience or outcome involving risk to subjects or others in any human subjects research that meets all of the following criteria:
- unexpected (in terms of nature, severity or frequency) given the research procedures that are described in the IRB-approval protocol and other study documents, and the characteristics of the subject population being studied;
- related or possibly related to or caused by participation in such research (i.e., there is a reasonable possibility that the incident, experience or outcome may have been caused by the procedures involved in such research); and
- suggests 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.
Researchers should also note the occurrence of any Adverse Events, i.e. any untoward or unfavorable medical occurrence in a human subject; including any abnormal sign, symptoms 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. Studies that were approved by Full Board Review will have to summarize these events every year in their Renewal submission.