In the case of a potential unanticipated problem involving risks to participants or others, when is the principal investigator expected to report this occurrence to the IRB?
Serious adverse events must be reported to the IRB immediately, with a written report by the PI following within 24 hours of the PIs becoming aware of the event. Serious adverse events are (1) death of a research participant; or (2) serious injury to a research participant. All other non-serious unanticipated problems should be reported to the IRB within 2 weeks of the first awareness of the problem by the Protocol PI or another researcher, ORIA, or a member of the IRB. Prompt reporting is important, as unanticipated problems often require some modification of study procedures, protocols, and/or informed consent processes. Such modifications require the review and approval of the IRB. The Unexpected Event Report form is available on the IRB website.
