Regarding incidents involving research subjects, what is expected if an unanticipated problem occurs?

When an unanticipated problem involving research subjects occurs, it is essential to report the issue to the Institutional Review Board (IRB) based on institutional guidelines. This requirement is in place to ensure participant safety and to maintain ethical standards within research activities. The IRB is responsible for overseeing the conduct of research involving human subjects and must be informed of any issues that could potentially affect participants' rights and welfare. Reporting such incidents allows the IRB to review the situation, assess risks, and implement necessary changes to protocols or procedures to protect current and future participants. The emphasis on reporting aligns with ethical principles of transparency and accountability in research.

While conducting an internal investigation or having a follow-up meeting may be part of the response to an incident, the primary obligation is to communicate with the IRB. Additionally, not reporting an incident unless multiple occurrences happen undermines the proactive approach necessary for participant safety. Adhering to institutional guidelines regarding reporting ensures that all parties are well-informed and that appropriate actions can be taken swiftly.