Is an automobile accident involving a subject who participated in a research study an unanticipated problem that requires reporting to the IRB?

An automobile accident involving a subject who participated in a research study is typically considered unrelated to the research study unless there is a clear connection between the accident and the research activities. For reporting purposes to the Institutional Review Board (IRB), an unanticipated problem generally refers to incidents that directly affect the safety or welfare of research subjects in the context of the study.

If the accident does not involve study-related activities, such as a procedure, intervention, or any part of the research protocol, then it does not qualify as an unanticipated problem that requires reporting. Therefore, if the accident was entirely personal and unrelated to any potential risks or activities within the study, it would not necessitate reporting to the IRB. This delineation helps to focus on issues that directly impact the research and subjects involved, aligned with ethical and regulatory standards governing human subject research.