To perform clinical trials, researchers must be compliant with federal guidelines established by the FDA. The guidelines require that all research be approved by:

• A. An Ethics Committee
• B. An Institutional Review Board
• C. A Departmental Research Committee
• D. Hospital Administration

Answer: (B)

The essential idea is protecting people who participate in research through independent oversight. In the United States, the FDA and federal regulations require that any study involving human subjects receive approval from an Institutional Review Board before enrolling participants, with ongoing oversight during the trial. The IRB reviews the protocol to ensure risks are minimized and reasonable in relation to potential benefits, that informed consent is clear and properly obtained, and that participant selection is fair, privacy is protected, and safeguards exist for vulnerable populations. It also ensures proper safety monitoring and the possibility of stopping the study if new risks emerge. The board’s diverse membership— including scientists, non-scientists, and community representatives—provides independent judgment aimed at protecting participants’ rights and welfare.

An Ethics Committee is a term used in various contexts outside the U.S.; hospital administration focuses on logistics and operations rather than ethical/regulatory protection of participants; a departmental research committee might assess scientific merit within a department but does not fulfill the mandatory oversight role of the IRB.