Which federal policy addresses the protection of human subjects in research?

Which federal policy addresses the protection of human subjects in research?

• A. The Health Insurance Portability and Accountability Act (HIPAA)
• B. The Common Rule (45 CFR 46)
• C. The Patient Protection and Affordable Care Act (PPACA)
• D. The Federal Food, Drug, and Cosmetic Act

Answer: (B)

The Common Rule (45 CFR 46) is the federal policy specifically designed to protect human subjects in research. This set of regulations establishes the basic ethical principles and practices for the conduct of research involving human participants. It requires institutions to obtain informed consent from participants, ensure that risks are minimized and justified, and provide adequate protections for vulnerable populations. The significance of the Common Rule lies in its comprehensive framework, which governs a wide range of research activities, thereby promoting ethical practices in research and safeguarding participants' rights and welfare. Through these regulations, it also aims to enhance the integrity of research involving human subjects. The other options, while important in their respective domains, do not specifically deal with the governance of human subject protection in research. For instance, HIPAA is more focused on the privacy and security of health information, while the Patient Protection and Affordable Care Act primarily addresses health insurance coverage and access to care. The Federal Food, Drug, and Cosmetic Act regulates the safety and efficacy of drugs and medical devices, but it does not directly address the protections for human subjects involved in research.

The Common Rule (45 CFR 46) is the federal policy specifically designed to protect human subjects in research. This set of regulations establishes the basic ethical principles and practices for the conduct of research involving human participants. It requires institutions to obtain informed consent from participants, ensure that risks are minimized and justified, and provide adequate protections for vulnerable populations.

The significance of the Common Rule lies in its comprehensive framework, which governs a wide range of research activities, thereby promoting ethical practices in research and safeguarding participants' rights and welfare. Through these regulations, it also aims to enhance the integrity of research involving human subjects.

The other options, while important in their respective domains, do not specifically deal with the governance of human subject protection in research. For instance, HIPAA is more focused on the privacy and security of health information, while the Patient Protection and Affordable Care Act primarily addresses health insurance coverage and access to care. The Federal Food, Drug, and Cosmetic Act regulates the safety and efficacy of drugs and medical devices, but it does not directly address the protections for human subjects involved in research.