Which body is primarily responsible for approving clinical trial protocols to protect human subjects?

• A. The FDA
• B. The Institutional Review Board
• C. The DSMB
• D. The WHO

Answer: (B)

The main idea is that protecting people in research happens through independent ethical review of the study plan and consent materials. An Institutional Review Board reviews and approves the protocol before a study starts, ensuring that risks are minimized, potential benefits are reasonable, subjects are selected fairly, informed consent is obtained properly, and privacy and welfare protections are in place. This ongoing review continues as the study progresses or as the protocol is amended.

The FDA does regulate and oversee safety and regulatory compliance for drugs and medical devices, and it can require changes or approve certain aspects, but it is not the body that primarily approves the protocol to protect human subjects. The data and safety monitoring board focuses on monitoring safety data during the trial and may recommend changes or stopping a study, not the initial protocol approval. The WHO sets international guidelines but does not approve individual trial protocols.