Which federal regulations govern research involving human subjects?

The Common Rule (45 CFR 46) is a set of federal regulations that govern research involving human subjects in the United States. This regulation establishes the fundamental ethical principles and guidelines that researchers must follow to ensure the protection of human participants. The key components of the Common Rule include informed consent, institutional review board (IRB) oversight, and ensuring that risks to participants are minimized and justified by anticipated benefits.

While the other options may address various aspects of research or provide guidelines, they do not specifically encompass the comprehensive regulatory framework that the Common Rule provides for human subjects research. For instance, the Federal Drug Administration (FDA) guidelines focus primarily on the regulation of clinical trials related to drugs and medical devices, whereas the National Institutes of Health (NIH) policies may provide ethical guidance and funding requirements but do not serve as overarching federal regulations like the Common Rule does. Similarly, the Ethical Standards for Research Regulations is a more generalized term that does not refer to a specific regulatory framework governing human subjects research. Thus, the Common Rule is recognized as the primary federal regulation specifically addressing research involving human subjects.