Which elements should be included in the IRB/IEC's documented procedures?

• A. Protocol amendments only.
• B. The composition of the IRB/IEC, meeting schedules, review processes, and record retention policies.
• C. Site locations.
• D. Budget, recruitment targets, sponsor contacts.

Answer: (B)

The element should be the framework that governs how the IRB/IEC operates to protect participants and ensure regulatory compliance. Documented procedures must spell out who serves on the IRB/IEC, how often it meets and in what format, how reviews are conducted (including initial, continuing, and expedited reviews), and how records are created, stored, and retained. These specifics ensure consistent decisions, clear accountability, and traceable documentation across all reviews and over time.

Other elements like site locations, or budget, recruitment targets, and sponsor contacts, don’t belong to the IRB/IEC’s operating procedures because they pertain to study logistics and sponsor relationships rather than the governance and functioning of the IRB/IEC itself. Similarly, focusing only on protocol amendments misses the broader governance framework that guides every review and decision.