What is the purpose of the Common Rule?

• A. It establishes uniform human subjects research practices across US federal agencies.
• B. It regulates research on animals.
• C. It governs international clinical trials.
• D. It defines ethical norms for physicians conducting research.

Answer: (A)

The main concept is protecting people who participate in research by providing a single, uniform set of federal rules across the United States. The Common Rule lays out core protections for human subjects, including informed consent that adequately explains risks and benefits, oversight by an institutional review board, and extra safeguards for vulnerable groups. It applies to research funded or conducted by federal agencies and, through those agencies’ adoption, creates consistent standards across many institutions and studies.

This isn’t about animal research, which is governed by separate rules and the Animal Welfare Act with its own oversight. It isn’t primarily about international trials either; its authority is domestic and tied to federal involvement in the research. And it isn’t simply about broad ethical norms for physicians in general; it provides concrete, enforceable protections for human subjects in federally regulated research.