Regulatory and Ethical Codes

Within the Department of Health and Human Services (HHS)

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

HHS Guidanceexternal icon at the Office for Human Research Protections

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

The Belmont Reportexternal icon 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 Programsexternal icon

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

Declaration of Helsinkiexternal icon – 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 Codepdf iconexternal icon – The ethical guideline written as a result of World War II Nazi war crimes against humanity.

President’s Council on Bioethicsexternal icon


Page last reviewed: October 11, 2017
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