Is an automobile accident involving a subject in a research study an unanticipated problem requiring reporting to the IRB?

The situation of an automobile accident involving a subject in a research study is nuanced. It is essential to determine whether the incident is related to the research activities or the procedures involved. When a researcher assesses an incident as unrelated to the study, it implies that the accident did not stem from the research design, data collection, or any activities directly related to the study's execution.

In this context, if there is evidence or clear reasoning showing that the automobile accident occurred independently of the research activities—such as being off-site from the study procedures and involving factors that are not connected to the research—then it would be appropriate not to report the incident to the Institutional Review Board (IRB). Reporting requirements are typically in place for incidents that have a direct link to the research and its impact on the subjects' well-being or safety.

Understanding the reasoning behind this choice can help clarify the responsibilities of researchers regarding incident reporting in human subjects research. It emphasizes the importance of evaluating the relationship between the incident and the study parameters before making reporting decisions.