A researcher collecting identifiable sensitive information about illicit drug use; one subject has an auto accident two weeks after participation. Is this an unanticipated problem that must be reported to the IRB?

A researcher collecting identifiable sensitive information about illicit drug use; one subject has an auto accident two weeks after participation. Is this an unanticipated problem that must be reported to the IRB?

• A. Yes, this must be reported to the IRB
• B. No, not report because it is unrelated to the research
• C. Yes, but only if the accident occurred during participation
• D. Only if the researcher judges it was related to the study

Answer: (B)

Unanticipated problems involve events that are both unexpected and related to the research or participation in the study, and they create or reveal increased risk to participants or others. For an event to need IRB reporting as an unanticipated problem, there has to be a plausible connection to the study procedures, involvement, or the consented risks. In this scenario, the auto accident occurred two weeks after participation and there’s no stated link to the study procedures or to risks described in the protocol. If there’s no evidence that participation or the research activities contributed to the accident, it isn’t considered related to the study. Therefore, it isn’t an unanticipated problem that must be reported to the IRB. If, however, there were a plausible connection—such as the study involving a driving task that caused fatigue or impairment, or the data collected during participation being tied to driving risk—the event would need to be reconsidered for reporting. The key point is the relation to the research, not just the occurrence of an unfortunate event.

Unanticipated problems involve events that are both unexpected and related to the research or participation in the study, and they create or reveal increased risk to participants or others. For an event to need IRB reporting as an unanticipated problem, there has to be a plausible connection to the study procedures, involvement, or the consented risks.

In this scenario, the auto accident occurred two weeks after participation and there’s no stated link to the study procedures or to risks described in the protocol. If there’s no evidence that participation or the research activities contributed to the accident, it isn’t considered related to the study. Therefore, it isn’t an unanticipated problem that must be reported to the IRB.

If, however, there were a plausible connection—such as the study involving a driving task that caused fatigue or impairment, or the data collected during participation being tied to driving risk—the event would need to be reconsidered for reporting. The key point is the relation to the research, not just the occurrence of an unfortunate event.