What is a potential “unanticipated problem involving risk to participants or others” (“Unanticipated Problem”)?

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 event can occur in either a clinical setting (such as a serious and unanticipated reaction to the study drug) or a non-clinical setting (such as the loss of a laptop with study data). The event is reportable if it poses risk to research participants, research staff, or others and is possibly related to the study.

It is ultimately the decision of the Board whether a reportable event constitutes an Unanticipated Problem. In the U.S., Quorum is required to report a Board determination of an Unanticipated Problem to the FDA, OHRP or other appropriate oversight agency.