Who is primarily responsible for protecting participants through ethical review in research?

• A. The sponsor
• B. Institutional Review Board or Ethics Committee
• C. Government regulators
• D. The general public

Answer: (B)

The main responsibility for protecting participants through ethical review rests with the Institutional Review Board or Ethics Committee. This body systematically evaluates research proposals to ensure respect for persons, beneficence, and justice, making sure the risks are minimized and reasonable compared with potential benefits. It also checks that informed consent will be obtained in a clear, voluntary way and that participants’ privacy and data confidentiality are safeguarded. By reviewing study procedures, recruitment materials, consent forms, and plans for monitoring ongoing risk, the board provides formal approval before any research begins and continues oversight throughout the study. While sponsors fund and conduct research and government regulators enforce rules and monitor compliance, they rely on IRBs/ethics committees to carry out the ethical review that directly protects participants. The general public does not play a formal role in the day-to-day ethical review process.