What is the correct procedure for reporting potential unanticipated problems to the IRB?

The correct procedure for reporting potential unanticipated problems to the Institutional Review Board (IRB) is determined by the institution in its written policies and procedures. Each institution has specific guidelines that align with federal regulations but may also reflect the unique context of the institution's research and oversight. These guidelines provide a framework for researchers on how to identify and report unanticipated problems, ensuring consistent and compliant communication with the IRB.

Having these procedures documented formally ensures that all researchers within the institution are aware of their responsibilities and the steps they need to take when an unanticipated problem arises. This process is essential for protecting human subjects, as it helps the IRB assess risks and implement necessary changes or actions to safeguard participants.

The other options do not adequately establish a procedure that is universally applicable. While the consent process may inform participants of risks, it does not serve as a formal reporting mechanism. Mentioning human subjects protection regulation without specifying the institution's policies does not provide a clear directive. Finally, leaving the determination of the reporting procedure to research staff can lead to inconsistency and lack of compliance, as individual interpretations can vary without a standardized policy.