What should the IRB/IEC establish and document regarding its procedures?

• A. The IRB/IEC should adopt standard operating procedures only for meetings.
• B. The IRB/IEC should establish and document its procedures, including composition, scheduling of meetings, conducting reviews, and ensuring compliance with regulatory requirements.
• C. The IRB/IEC should not document procedures to maintain flexibility.
• D. The IRB/IEC should only document minutes of reviews.

Answer: (B)

The essential idea is that the IRB/IEC must have and formally document its operating procedures. This means creating written standards that guide how the board operates, keeps things consistent, and shows it follows the rules.

These procedures should cover who makes up the board and the qualifications needed, how meetings are scheduled and convened, and how reviews are conducted—both initial protocol reviews and ongoing/continuing reviews. They should also specify how the IRB/IEC ensures adherence to regulatory requirements, applicable laws, and guidance. Having these documented procedures provides a clear, auditable framework for decisions, improves accountability, and helps ensure decisions are made in a fair, consistent, and compliant manner.

Minutes are important records of what happened at meetings, but they are not a substitute for the formal written procedures that govern how the IRB/IEC operates on a day-to-day basis.