What should be included in the documentation for IRB/IEC review?

• A. All relevant documents that the IRB/IEC may need to fulfill its responsibilities.
• B. Only the consent form.
• C. Only the protocol.
• D. Only the safety reports.

Answer: (A)

IRB/IEC review relies on a complete set of materials so members can properly assess risks, protections, and rights of participants. All relevant documents that the IRB/IEC may need to fulfill its responsibilities should be included. This means more than just one piece of information—the protocol outlines study design and procedures, the informed consent forms and participant information, recruitment materials, any amendments, investigator brochures where applicable, and safety data such as adverse event reports. Including everything the board might need allows a thorough, informed review and supports ongoing oversight. Providing only a single type of document would prevent the IRB/IEC from evaluating the full study and could delay or undermine protection of participants.