What defines an unanticipated problem that must be reported to the IRB?

An unanticipated problem that must be reported to the IRB is defined as unexpected events related to the research that increase risk to subjects. This is crucial because such incidents can significantly impact the safety and well-being of the participants involved in the study. When researchers encounter unforeseen events that elevate risks, it is imperative to communicate these to the IRB to ensure proper oversight and intervention if necessary.

In contrast, events documented before the study begins would not classify as unanticipated problems, as they have already been identified and accounted for in the study design. Incidents that are expected by the researchers do not fall into this category either, as they do not represent an increase in risk but rather events that have been anticipated and planned for. Similarly, negative feedback received during the study, while potentially concerning, does not necessarily reflect an unexpected risk to subjects, and thus is not defined as an unanticipated problem that must be reported to the IRB.