If a subject in a behavioral research study is in an automobile accident unrelated to the study, does it require reporting to the IRB?

In behavioral research, reporting to the Institutional Review Board (IRB) is typically required for events that are directly related to the research study or that could potentially affect the rights, welfare, or safety of the participants. An automobile accident that occurs independently of the research study does not meet these criteria. Since the accident is unrelated to the study's procedures or some aspect of the research, it does not require reporting to the IRB.

The primary purpose of the IRB's oversight is to ensure that any adverse events related to the study are monitored and addressed to protect participants. Events occurring outside the scope of the research, such as a personal automobile accident, do not fall within this purview, as they do not pertain to the integrity of the research or the treatment of the participants within the study.

This understanding is crucial for both researchers and participants, as it clarifies the obligations associated with reporting and helps distinguish between unrelated incidents and those that could impact the study or its subjects.