Which group evaluates all clinical trials in relation to human subject protections?

• A. Office of Human Research Protections
• B. Institutional Review Board
• C. Data Safety Monitoring Board
• D. Ethics Committee

Answer: (B)

Protecting people in research hinges on review by the Institutional Review Board, which evaluates every clinical trial to ensure human subject protections are in place. The IRB looks at the study design to ensure the risks are minimized and reasonable in relation to the anticipated benefits, that informed consent is appropriate, voluntary, and understandable, and that participant selection and privacy protections are fair and adequate. It conducts continuing oversight, reviewing amendments and monitoring adverse events, with the authority to suspend or modify the study if protections lapse. While the Office of Human Research Protections sets overarching policies and the Data Safety Monitoring Board monitors safety data during a trial, they do not perform the comprehensive, trial-by-trial protection review the IRB conducts. An Ethics Committee serves a similar protective function in some regions, but the standard term and role used in many contexts is the Institutional Review Board.