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The Belmont Report
Office of the Secretary
Ethical Principles and Guidelines for the Protection of Human
Subjects of Research
The National Commission for the Protection of Human Subjects
of Biomedical and Behavioral Research
April 18, 1979
Department of Health, Education, and Welfare.
Notice of Report for Public Comment.
On July 12, 1974, the National Research Act (Pub. L. 93-348) was signed into law, there-by creating the National
Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. One of the charges to the
Commission was to identify the basic ethical principles that should underlie the conduct of biomedical and
behavioral research involving human subjects and to develop guidelines which should be followed to assure that
such research is conducted in accordance with those principles. In carrying out the above, the Commission was
directed to consider:
the boundaries between biomedical and behavioral research and the accepted and routine practice of medicine,
the role of assessment of risk-benefit criteria in the determination of the appropriateness of research involving human
appropriate guidelines for the selection of human subjects for participation in such research and
nature and definition of informed consent in various research settings.
The Belmont Report attempts to summarize the basic ethical principles identified by the Commission in the course of
its deliberations. It 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 supplemented by the monthly deliberations of the
Commission that were held over a period of nearly four years. It is a statement of basic ethical principles and
guidelines that should assist in resolving the ethical problems that surround the conduct of research with human
subjects. By publishing the Report in the Federal Register, and providing reprints upon request, the Secretary intends
that it may be made readily available to scientists, members of Institutional Review Boards, and Federal employees.
The two-volume Appendix, containing the lengthy reports of experts and specialists who assisted the Commission in
fulfilling this part of its charge, is available as DHEW Publication No. (OS) 78-0013 and No. (OS) 78-0014, for sale
by the Superintendent of Documents, U.S. Government Printing Office, Washington, D.C. 20402.
Unlike most other reports of the Commission, the Belmont Report does not make specific recommendations for
administrative action by the Secretary of Health, Education, and Welfare. Rather, the Commission recommended that
the Belmont Report be adopted in its entirety, as a statement of the Department's policy. The Department requests
public comment on this recommendation.
National Commission for the Protection of Human Subjects