Which regulation governs the management of research with human subjects?

The management of research involving human subjects is primarily governed by The Common Rule, which is articulated in 45 CFR 46. This regulation provides a set of federal guidelines designed to protect the rights and welfare of human subjects participating in research. It establishes the requirements for Institutional Review Boards (IRBs), informed consent processes, and the ethical treatment of participants in research studies.

The Common Rule applies to research funded by federal agencies, including the Department of Health and Human Services (HHS), and outlines the obligations of institutions and researchers to ensure that the rights of participants are safeguarded. This includes ensuring that potential risks are minimized, that informed consent is adequately obtained and documented, and that privacy and confidentiality are protected.

In contrast, the other options address different areas of governance. The Privacy Act of 1974 primarily focuses on protecting the privacy of individuals' personal information held by federal agencies, but it does not specifically target the management of research involving human subjects. The Federal Acquisition Regulation (FAR) is concerned with the procurement process for federal government contracts, while the Freedom of Information Act (FOIA) ensures public access to government records but does not regulate research practices. These distinctions clarify why The Common Rule is the relevant regulation for managing research with human subjects.