The
Belmont
Report

Ethical Principles
and Guidelines for
the Protection of
Human Subjects

of Research

US. The National Commission

for the Protection of Human Subjects
of Biomedical and Behavioral
Research.

DHEW Publication No. (OS) 78-0012

For sale by the Superintendent of Documents, U.S. Government Printing Office, Washington, D.C. 20402

EJ AU. XF

National Commission for the Protection of Human Subjects

of Biomedical and Behavioral Research

Westwood Building, Room 125 5333 Westbard Avenue Bethesda, Maryland 20016

September 30, 1978

Honorable Joseph A. Califano, Jr.

Secretary of Health, Education, and Welfare

Washington, D. C. 20201

Dear Mr. Secretary:

On behalf of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, I am pleased to transmit our "Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research." The identification of basic ethical principles that should underlie the conduct of research involving human subjects, and the development of guidelines to assure that such principles are followed, were topics of studies set forth in the Commission's mandate under Public Law 93-348. This mandate also directs the Commission to submit its report to the President, the Congress, and the Secretary of Health, Education, and Welfare.

Unlike most of the previous reports of the Commission, the Belmont Report does not make specific recommendations for administrative actions by the Secretary of Health, Education, and Welfare. Instead, it is our recommendation that the Belmont Report be adopted in its entirety as a statement of departmental policy on the conduct of research involving human subjects. Publication and dissemination of this policy will provide federal employees, members of Institutional Review Boards and scientific investigators with common points of reference for the analysis of ethical issues in human experimentation. While the principles cannot always be applied so as to resolve beyond dispute particular ethical problems, they provide an analytical framework that will guide the resolution of ethical problems arising from research involving human subjects.

The Belmont Report is the outgrowth of an intensive four-day period of discussions that were held in February 1976 at the Smithsonian Institution's Belmont Conference Center and the monthly Commission's deliberations that have been conducted over the nearly four years of our existence.

We appreciate the opportunity to have worked on this fundamental task in the protection of human research subjects.

Respectfully,

Kenneth J. Ryan, M. D.
Chairman