Which of the following best describes what the IRB/IEC review should encompass?

• A. Review of trial protocols/amendments, consent forms, recruitment procedures, information provided to subjects, Investigator's Brochure, safety information, payments and compensation, investigator's qualifications, and other documents.
• B. Review only the trial budget.
• C. Review only the sponsor's safety reports.
• D. Review only the consent forms.

Answer: (A)

IRB/IEC review is aimed at protecting participants by evaluating every document and item that shapes their participation and the study’s ethics. The review should cover the trial protocol and any amendments, the informed consent forms, recruitment procedures, all information provided to subjects, the Investigator’s Brochure, safety information, payments and compensation, the investigator’s qualifications, and other trial-related documents. This broad scope ensures that risks are adequately disclosed, consent is truly informed, subject safety is monitored, and the study complies with regulatory and ethical standards.

Focusing only on the budget, or only on sponsor safety reports, or only on consent forms would leave important aspects unchecked. The budget doesn’t address how participants are informed or how risks are communicated; sponsor safety reports don’t ensure that the consent process or investigator qualifications meet ethical requirements; and reviewing only consent forms ignores protocol design, safety data, and study materials that influence participant welfare.