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Office for Human Research Protections (OHRP)


Belmont Report



25th Anniversary of the Belmont Report – Program

OHRP commemorated the 25th anniversary of the publication of the Belmont Report a milestone in Federal responsibility, leadership and commitment, with a ceremony held on November 16, 2004.� That event honored the writers of the Belmont Report – the members, consultants and staff of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, 1974-78.� You may view the edited version of that 25th Anniversary Program. (67 minutes) You may download Free RealPlayer.

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Belmont Report Educational Video

OHRP also developed a Belmont Report Educational Video (9 minutes)�that provides the context for the Belmont Report for those who are not familiar with its principles and uses.�You may download Free RealPlayer.

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History of the Belmont Report and the Federal Regulations

Based on the work of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (1974-1978), the Department of Health and Human Services (HHS) revised and expanded its regulations for the protection of human subjects 45 CFR part 46 in the late 1970's and early 1980's.� In 1978, the Commission’s report “Ethical Principles and Guidelines for the Protection of Human Subjects of Research” was published.� It was named the Belmont Report, for the Belmont Conference Center, where the National Commission met when first drafting the report.�

The Belmont Report explains the unifying ethical principles that form the basis for the National Commission’s topic-specific reports and the regulations that incorporate its recommendations.� The Belmont Report identifies three fundamental ethical�principles for all human subject research – respect for persons, beneficence, and justice.� Those principles remain the basis for the HHS human subject protection regulations.�

In 1991, 14 other Federal departments and agencies joined HHS in adopting a uniform set of rules for the protection of human subjects, identical to subpart A of 45 CFR part 46 of the HHS regulations.� This uniform set of regulations is the Federal Policy for the Protection of Human Subjects, informally known as the “Common Rule.”�

Today, the Belmont Report continues as an essential reference for institutional review boards (IRBs) that review HHS-conducted or -supported human subjects research proposals involving human subjects, in order to ensure that the research meets the ethical foundations of the regulations.

Oral History Archive

Interviews with members and staff of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research were carried out in 2004.� Transcripts of these interviews are presented here. Some video versions of the interviews are also currently available; the rest will be posted as they become available. As above, the video versions are available in RealPlayer -- you may download Free RealPlayer.

Duane Alexander, M.D. (Commission Staff)

Tom L. Beauchamp, Ph.D. (Commission Staff)

Robert Cooke, MD, National Commission

F. William Dommel, J.D. (NIH Liaison to Commission)

Norman Fost, MD, MPH, Consultant to the National Commission

Dorothy Height, Ph.D. (Commissioner)

Albert R. Jonsen, Ph.D. (Commissioner)

Miriam Kelty, Ph.D. (Commission Staff)

Patricia King, J.D. (Commissioner)

Karen Lebacqz, Ph.D. (Commissioner)

Bonnie M. Lee, B.A. (Commission Staff)

Robert Levine, Ph.D. (Consultant to Commission)

Charles R. McCarthy, Ph.D. (NIH Liaison to Commission)

Barbara Mishkin, J.D. (Commission Staff)

Rep. Paul Rogers (U.S. Congress)

Donald Seldin, MD., Commissioner, National Commission

Stephen Toulmin, Ph.D., National Commission

LeRoy Walters, Ph.D. (Commission Staff)

Michael Yesley, J.D. (Commission Staff)

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Last revised: November 13, 2008

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