Which CFR Part is titled 'human subjects protection'?

Which CFR Part is titled 'human subjects protection'?

• A. 21 CFR Part 50
• B. 21 CFR Part 56
• C. 21 CFR Part 58
• D. 21 CFR Part 210

Answer: (A)

The key idea is identifying which regulation explicitly governs how people participating in FDA-regulated research are protected. The regulation that carries the title Protection of Human Subjects sets the requirements for informed consent and general safeguards for participants in such research, including how subjects are recruited, how risks are minimized, and what protections are in place for vulnerable individuals. The other options correspond to areas like the ethical review process handled by approving bodies, nonclinical laboratory study standards, and manufacturing quality controls—topics that do not directly address safeguarding human subjects. So, the regulation with the title Protection of Human Subjects is the one that directly covers human subject protections.

The key idea is identifying which regulation explicitly governs how people participating in FDA-regulated research are protected. The regulation that carries the title Protection of Human Subjects sets the requirements for informed consent and general safeguards for participants in such research, including how subjects are recruited, how risks are minimized, and what protections are in place for vulnerable individuals. The other options correspond to areas like the ethical review process handled by approving bodies, nonclinical laboratory study standards, and manufacturing quality controls—topics that do not directly address safeguarding human subjects. So, the regulation with the title Protection of Human Subjects is the one that directly covers human subject protections.