Who determines the procedures for reporting potential unanticipated problems to the IRB?

The procedures for reporting potential unanticipated problems to the Institutional Review Board (IRB) are determined by the institution's written policies and procedures. These policies provide a structured framework that aligns with regulatory requirements while catering to the specific operational needs of the institution. This ensures consistency, transparency, and compliance with ethical standards across all research conducted within the institution.

Institutional policies are designed to reflect both federal regulations and best practices in research ethics, allowing institutions to tailor their reporting procedures based on their unique research environment and risk profiles. This formal establishment of procedures is essential for maintaining participant safety and ensuring that any unanticipated problems are effectively communicated and addressed.

When each institution develops its specific guidelines, they can include various components such as timelines for reporting, mechanisms for assessment, and protocols for handling the reports once received. This systematic approach helps foster a culture of safety and ethical accountability in research.