Which document approves research involving human subjects?

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

Answer: (D)

Approval for research involving human subjects comes from the institutional review board, a committee whose job is to protect participants. The IRB carefully reviews the study plan to weigh risks against potential benefits, ensures that informed consent will be properly obtained and documented, and checks that privacy and confidentiality of participants are protected. Only after the IRB approves the protocol and consent materials can the study begin at a site. Other bodies exist in various contexts—an office that provides regulatory oversight, a general term like an ethics committee, or a data safety monitoring board that watches safety during the trial—but they do not issue the initial approval document for the study.