According to the Common Rule, institutions' IRBs must do what?

Institutions' Institutional Review Boards (IRBs) must adhere to specific written procedures established by the Common Rule, which governs the ethical standards and protocols for human subjects research. This requirement ensures consistency, transparency, and accountability in the review and approval process of research studies involving human participants. By having clear procedures, IRBs can effectively evaluate protocols to ensure that they comply with ethical guidelines, prioritize participant protection, and assess the potential risks and benefits of research. This written framework also aids in maintaining compliance with regulatory requirements and helps to standardize the oversight process across various research projects, contributing to the integrity of human research protection efforts.

While ensuring ethical conduct and the qualifications of IRB members are important aspects of an IRB's function, the foundational requirement laid out in the Common Rule focuses primarily on the necessity for established written procedures to guide the IRB's operations. The option regarding funding substantiation does not directly relate to the responsibilities outlined in the Common Rule concerning IRB operations.