Belmont Report

The Belmont Report was produced by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. It outlines the ethical principles guiding regulations.

Description

The Belmont Report identifies the guiding ethical principles for human subject research.

1. Respect for Persons
   • Individuals should be treated as autonomous agents
   • Individuals with diminished autonomy are entitled to protection
2. Beneficence
   • Typically formulated as one of...
     • Do not harm.
     • Maximize possible benefits and minimize possible harms.
3. Justice
   • Typically formulated as one of...
     • to each person an equal share
     • to each person according to individual need
     • to each person according to individual effort
     • to each person according to societal contribution
     • to each person according to merit

The immediate applications for these principles are:

• Requiring informed consent

  • Must include information about all risks
  • Information must be conveyed in a manner appropriate for the subject's ability to understand
  • Must be voluntary
• Assess risks against benefits
  • Brutal and inhumane research is unallowable
  • Risks must be minimized, including by considering alternative research methods that risk fewer subjects or pose comparatively less risk to subjects
  • When risk is severe, it must be justified (usually by demonstrating benefits to the specific subject, or the manifest consent of the subject)
  • Risks to vulnerable populations must be minimized, including by considering alternative research methods that exclude them
  • Risks and benefits must be outlined in the informed consent process
• Selection of subjects
  • Even if subjects are selected and treated fairly, unjust distributions of risks and/or benefits can be realized
  • Subjects for research that involves risks should be recruited from less burdened populations

History

The Belmont Report was largely precipitated from the fallout of the Tuskegee Study.

The National Research Act of 1974 established the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The members of this commission were:

• Kenneth John Ryan, M.D., chief of staff of Boston Hospital for Women (chair)
• Joseph V. Brady, Ph.D., professor of Behavioral Biology at Johns Hopkins University
• Robert E. Cooke, M.D., president of Medical College of Pennsylvania
• Dorothy I. Height, president of National Council of Negro Women
• Albert R. Jonsen, Ph.D., associate professor of Bioethics at University of California at San Francisco
• Patricia King, J.D., associate professor of Law at Georgetown University Law Center
• Karen Lebacqz, Ph.D., associate professor of Christian Ethics at Pacific School of Religion
• David W. Louisell, J.D., professor of Law at University of California at Berkeley
• Donald W. Seldin, M.D., professor and chairman of Department of Internal Medicine at University of Texas at Dallas
• Eliot Stellar, Ph.D., provost of the University and professor of Physiological Psychology at University of Pennsylvania

• Robert H. Turtle, LL.B., attorney of !VomBaur, Coburn, Simmons & Turtle

The commission produced the Belmont Report in 1978 to summarize their findings. It was published in the Federal Register the year after.

After significant amendments, these requirements were reworked into the Common Rule by the Department of Health, Education, and Welfare (HEW).

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