Ethical Guidance Documents

Here are some of the important guidelines and laws that have emerged over time, with a brief summary of the document and what important new idea it brought to the field of biomedical research. Some are historical documents, and others are periodically updated. The year reported in this list represents the first year the document was published.

Nuremberg Code - 1949
This code of research ethics came out of the ruling of the International Military Tribunal at the end of World War II, which prosecuted Nazi war criminals.

Declaration of Helsinki - 1964
This declaration of the World Medical Association is often considered to be the first document to set world standards for research on human participants.

The Belmont Report - 1978
This report was written by the US National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, which was established after the US public learned about the Tuskegee Syphilis Study.

US Code of Federal Regulations, Tile 45, Public Welfare, Part 46, Protection of Human Subjects (45 CFR 46) - 1991
These are United States federal laws that regulate how research involving human participants must be conducted when funded by the US government.

International Ethical Guidelines for Biomedical Research Involving Human Subjects, CIOMS
These guidelines were published by the Council for International Organizations of Medical Science (CIOMS) and added guidance around conduct research in developing countries to the body of ethical guidelines.

Guidelines for Good Clinical Practice (GCP) - 1996
These guidelines were issued by the International Conference on Harmonization and outline "an international ethical and scientific quality standard for designing, conducting, recording and reporting trials that involve human subjects."

Ethical Considerations in Biomedical HIV Prevention Trials - 2007
This is an ethical guidance document, issued by UNAIDS and WHO, for biomedical HIV prevention research .

Good Participatory Practice (GPP) in Biomedical HIV Prevention Trials - 2011
These guidelines, published by UNAIDS and AVAC, provide systematic guidance for how research entities should conduct biomedical HIV prevention with respect to facilitating community engagement.

For more information on GPP, visit here.

Ethically Impossible: STD Research in Guatemala from 1946 to 1948
Following the revelation that the U.S. Public Health Service supported research on sexually transmitted diseases in Guatemala from 1946 to 1948, President Obama asked his Bioethics Commission to oversee a thorough fact-finding investigation into the studies.

AVAC Executive Director, Mitchell Warren, spoke before the panel on the urgent need for community engagement.

Ethical Resources
Research use of human biological specimens and other private information - Office for Human Research Protections (OHRP)

Discusses reviewing and reporting unanticipated problems and adverse events - Office for Human Research Protections (OHRP)

OHRP anticipates the release of additional educational videos in the future on a variety of topics including IRB membership, general informed consent requirements, IRB records, and complex issues with research involving vulnerable populations. Additional information on OHRP's educational videos can be found at: www.hhs.gov/ohrp/education/#materials