What is the primary role of the Institutional Review Board (IRB) in human subjects research?

• A. Determine funding
• B. Protect human subjects and assess protocols
• C. Conduct patient care
• D. Write clinical trial protocols

Answer: (B)

The main function of the IRB is to protect people who participate in research by reviewing proposed studies to ensure that their rights and welfare are safeguarded. It focuses on whether the risks to participants are minimized and reasonable in relation to potential benefits, whether subject selection is fair, whether the informed consent process is adequate and voluntary, and whether privacy and confidentiality protections are in place. The IRB also oversees ongoing studies, requiring modifications if new risks emerge and sometimes halting a study to protect participants. This protective role draws on ethical principles like respect for persons, beneficence, and justice, and is codified in regulations such as the Common Rule (45 CFR 46).

It does not determine funding, provide patient care, or write clinical trial protocols; those tasks belong to funders, clinicians, and investigators, respectively, with the IRB serving as an independent oversight body to ensure ethical and regulatory compliance.