What is a potential “unanticipated problem involving risk to participants or others”?

Federal regulations require IRBs to collect reports of potential “unanticipated problems involving risk to participants or others” (“Unanticipated Problems”). Unanticipated Problems are events that occur during the course of a research trial that potentially increase the risk to participants or others; adversely affect the rights, safety, or welfare of participants; or affect the integrity of the study. An “unanticipated” event is one that is not identified in nature, severity, or frequency in the relevant safety documents(s) for the study product or is not identified as a possible risk in the study protocol or the informed consent form for the study. A reportable Unanticipated Problem can occur in either a clinical or a non-clinical setting and is reportable if it poses risk to research participants, research staff, or others. Quorum expects investigators to report potential Unanticipated Problems to Quorum Review IRB within ten (10) business days of becoming aware of the event’s occurrence.