Which body is primarily responsible for ethical review and participant protection in clinical trials?

• A. IRB/IEC
• B. Sponsor
• C. Regulatory authority
• D. Data Safety Monitoring Board

Answer: (A)

The main function here is ethical review and participant protection. An Institutional Review Board (IRB) or Ethics Committee (EC/IEC) is tasked with evaluating and approving the study protocol, ensuring informed consent is clear and voluntary, and that risks to participants are minimized and reasonable in relation to potential benefits. They also review recruitment materials, safeguard privacy and confidentiality, and conduct ongoing oversight through continuing reviews and monitoring of adverse events. While sponsors must conduct the study properly and regulatory authorities enforce rules, they are not the bodies that perform the day-to-day ethical review of the protocol and participant protections. A Data Safety Monitoring Board focuses on safety data during the trial but does not oversee the overall ethics review and consent protections. Therefore, the IRB/IEC is the body primarily responsible for ethical review and participant protection.