Which item belongs in the IRB/IEC review submission to fulfill its responsibilities?

• A. Consent forms.
• B. All safety reports.
• C. The protocol.
• D. All relevant documents.

Answer: (D)

Having oversight of human subject research requires the IRB/IEC to review every document that could affect participant rights, safety, or welfare. If you submit only a single element, important context is missing: the protocol shows the study design and risk justification; the consent forms reveal what participants are told and what they consent to; safety reports illustrate actual or potential harms. Together these pieces let the IRB evaluate risks, benefits, and whether consent is truly informed. Therefore, the submission should include all relevant documents—protocol and amendments, informed consent documents and the consent process description, recruitment materials, investigator brochure or equivalent, data collection tools, monitoring plans, and safety reports—so the IRB can perform a complete and responsible review in line with GCP E6(R3).