= 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 [[UnitedStates/EthicsLaw/HumanSubjectResearch|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 [[UnitedStates/EthicsLaw/InformedConsent|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 [[UnitedStates/EthicsLaw/TuskegeeStudy|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 [[UnitedStates/CodeOfFederalRegulations|Federal Register]] the year after. After significant amendments, these requirements were reworked into the [[UnitedStates/EthicsLaw/CommonRule|Common Rule]] by the [[UnitedStates/DepartmentOfHealthAndHumanServices|Department of Health, Education, and Welfare]] (HEW). ---- CategoryRicottone