Which body must approve clinical trials in hospital settings under federal rules?

• A. An ethics committee
• B. A data safety monitoring board
• C. A hospital research committee
• D. An institutional review board

Answer: (D)

The main idea is safeguarding people who participate in research through independent ethical review. Under federal rules, any hospital-based clinical trial involving human subjects must receive approval from an Institutional Review Board before it starts. The IRB reviews the study protocol to ensure risks are minimized and reasonable in relation to anticipated benefits, that subject selection is fair, and that informed consent will be obtained and documented properly. It also protects privacy and data security and monitors compliance with the approved plan.

A data safety monitoring board focuses on safety data during the trial and can recommend changes or termination if risks become unacceptable, but it does not grant initial trial approval.

An ethics committee may perform similar oversight in some settings, but federally required review for initiating the trial is conducted by the Institutional Review Board. A hospital research committee may oversee research governance at the institution but is not the mandated approval body under federal rules.