To whom must researchers report potential unanticipated problems involving risks to others?

Researchers are required to report potential unanticipated problems involving risks to others to the Institutional Review Board (IRB). The IRB plays a crucial role in overseeing the ethical conduct of research involving human subjects. They are responsible for protecting the rights and welfare of those subjects, and they need to be informed of any issues that could pose new risks or unexpected challenges.

When unanticipated problems arise, it is essential for researchers to immediately report these incidents to the IRB so that timely evaluations can be made. This allows the IRB to take appropriate actions, which might include altering approval conditions, revising consent processes, or enhancing participant protections. The oversight that the IRB provides is fundamental to maintaining ethical research standards and ensuring participant safety, which is why reporting such problems to them is imperative.

Other entities, such as funding agencies or ethics committees, may have roles in the research environment, but the immediate responsibility for reviewing unanticipated problems rests with the IRB. The principal investigator is accountable for managing the research project and ensuring compliance with ethical standards, but they must report these issues to the IRB for further oversight.