An independent committee that reviews research involving human subjects to protect their rights, safety, and welfare is called what?

• A. institutional review board (IRB)
• B. ethics committee
• C. data safety monitoring board
• D. research governance council

Answer: (A)

Independent review to protect people who participate in research is carried out by an institutional review board, which serves as the gatekeeper for ethical and safety standards in human-subject studies. The IRB carefully examines the research plan before it begins to ensure risks are minimized and reasonable in relation to potential benefits, and that the rights and welfare of participants are protected throughout the study. It scrutinizes how informed consent will be obtained and documented, ensures participation is voluntary and based on a clear understanding of what’s involved, and checks that recruitment and inclusion criteria don’t unfairly target or exclude groups. The board also looks at privacy and confidentiality protections for data, and it reviews procedures for ongoing monitoring of the study, including how adverse events will be reported and addressed. Based on this review, the IRB can approve the protocol, require modifications, or disapprove it, and it retains authority to suspend or terminate approval if new information raises concerns.

Ethics committee is a broader term used in some contexts to describe similar bodies, but the formal, federally regulated body responsible for this review in many institutions is the IRB. A data safety monitoring board focuses specifically on interim safety data during a trial and is not the entity that reviews the entire study protocol for ethical and regulatory compliance. A governance council is not the standard term for this function.