In what scenario must a heart attack post-focus group be reported to the IRB?

In the context of research studies, reporting to the Institutional Review Board (IRB) is typically required when an incident is related to the study and poses a risk to participant safety or the integrity of the research. If a heart attack occurs post-focus group but is determined to be unrelated to participation in the study, it does not meet the criteria for mandatory reporting.

The IRB's primary focus is to ensure the protection of human subjects involved in research. If the incident is not connected to the study activities, it would not fall under the purview of the IRB's oversight responsibilities, which are specifically designed to address issues arising from study participation. Thus, when the heart attack is deemed unrelated to the study, it can be concluded that there is no obligation to report it to the IRB.