Which federal regulations govern the protection of human subjects in research?

The correct response emphasizes the significance of The Common Rule, officially set forth in 45 CFR 46, as the primary federal regulation that protects human subjects involved in research. The Common Rule establishes ethical principles and guidelines that ensure the safety, rights, and welfare of participants in research studies. This regulation mandates that research involving human subjects receive appropriate Institutional Review Board (IRB) review to assess risks, informed consent procedures to ensure that participants are fully aware of their involvement, and ongoing monitoring to protect participants throughout the study.

The other options listed do not specifically focus on the protection of human subjects in research. For instance, the Food Drug and Cosmetic Act regulates the safety of food, drugs, and cosmetic products, rather than addressing research ethics directly. The Family Educational Rights and Privacy Act primarily protects the privacy of student education records, which is unrelated to the ethical considerations for research involving human participants. The Health Insurance Portability and Accountability Act focuses on the privacy and security of individual health information, mainly in the context of health care providers and insurers, rather than on research ethics.

Thus, the recognition of The Common Rule as the governing regulation ensures that research involving human subjects is conducted with ethical integrity and respect for participants.