Which federal entity is responsible for overseeing regulations for human research protections in the U.S.?

The Office for Human Research Protections (OHRP) is the federal entity specifically tasked with overseeing regulations related to the protection of human subjects in research within the United States. This includes ensuring that research is conducted ethically and that the rights and welfare of participants are safeguarded. OHRP implements and enforces federal regulations that govern research conducted or supported by the Department of Health and Human Services (HHS), and it provides guidance and oversight to institutional review boards (IRBs) responsible for reviewing research protocols.

While other entities, such as the National Institutes of Health (NIH), Food and Drug Administration (FDA), and the Centers for Disease Control and Prevention (CDC), play important roles in health research and the regulation of various aspects of public health, they are not primarily focused on the overarching framework for human research protections. The NIH primarily funds and conducts medical research, the FDA regulates drugs and medical devices, and the CDC addresses public health issues, but the OHRP is fundamentally dedicated to ensuring that ethical standards are upheld in research involving human subjects.