Should a researcher report a participant's unrelated medical event to the IRB?

In the context of research ethics and institutional review board (IRB) requirements, it is important to distinguish between events that are related to study participation and those that are not. A participant's unrelated medical event typically does not require reporting to the IRB, as it does not pertain to the research study or the risks associated with being a participant in that study. The purpose of the IRB is to oversee the protection of participants involved in research, primarily focusing on issues directly related to the study, including informed consent, risk assessment, and participant welfare.

If an incident is unrelated to the study, it does not fall under the research's ethical framework or oversight. Thus, unless the unrelated medical event poses specific ethical concerns that could impact the study or its findings indirectly, the researcher is not obligated to report it. This understanding helps ensure that the IRB's resources are concentrated on relevant matters pertaining to participant safety and research integrity.