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

The determination of procedures for reporting potential unanticipated problems to the Institutional Review Board (IRB) falls under the purview of the institution and is outlined in its written policies and procedures. This is because each institution is tasked with developing and managing its own guidelines which conform to federal regulations and ethical standards while addressing specific institutional needs and contexts.

Written policies and procedures offer a structured approach that ensures consistency in how unanticipated problems are identified, reported, and addressed. They help maintain accountability and facilitate effective communication between researchers and the IRB. Different institutions may have unique processes depending on their size, type, and specific research focus, which necessitates this institutional control.

The other options do not effectively encapsulate how the procedures are determined. While the federal government sets overarching regulations regarding IRB practices, it does not dictate specific reporting procedures for individual institutions. Research ethics committees, which may offer guidance, do not have the authority to set mandatory procedures without the institution's backing. Similarly, while individual researchers play a crucial role in reporting issues, they rely on the established institutional policies to guide their actions, and do not independently determine the procedures.