Regulatory and Ethical Codes

Within the Department of Health and Human Services (HHS)

HHS Regulation 45 CFR part 46 at the Office for Human Research Protections

HHS Guidance at the Office for Human Research Protections

Regulation and guidance at the Food and Drug Administration’s Good Clinical Practice portal

The Belmont Report Written in 1979 by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research.

Outside HHS

Association for the Accreditation of Human Research Protection Programs

Council for International Organizations of Medical Sciences (CIOMS), including International Ethical Guidelines for Biomedical Research Involving Human Subjects [PDF – 1.6 mb]

Declaration of Helsinki – International doctrine, written in 1964 by the World Medical Organization and revised several times since then. The Declaration defines basic tenets of human rights in biomedical research involving human subjects.

Nuremberg Code – The ethical guideline written as a result of World War II Nazi war crimes against humanity.