The Department of Health and Human Services (HHS), also called DHHS, is the U.S. federal agency overseeing public health, medical research, and healthcare programs.
HHS includes key agencies that affect clinical research governance, including FDA, NIH, and the Office for Human Research Protections. HHS regulations establish core requirements for human subject protections, including the Common Rule (45 CFR 46). These standards shape IRB review, consent requirements, and ongoing study oversight. Alignment with HHS policy is foundational for compliant conduct of federally regulated research.