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| Home: Human Subjects : Regulations & Policies : Ethical Principles |
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Ethical
Principles (The Belmont Report) |
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The National Research Act created the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The Commission was charged setting forth the basic ethical principles underlying the acceptable conduct of research involving human subjects. The principles were presented in 1979 in a document called the Belmont Report, so named because the Commission met in the Belmont Room of the Smithsonian Institute. A summary is provided here, as well as a link to the full text. Summary of the Belmont Report The Belmont Report describes three fundamental principles:
Respect for persons involves recognition of the personal dignity and autonomy of individuals, and special protection of those persons with diminished autonomy. Respect for persons is manifested in the informed consent process in which potential subjects are provided information about the study in a manner comprehensible to them and then allowed to choose whether or not they wish to participate. Beneficence Beneficence entails an obligation to protect persons from harm by maximizing anticipated benefits and minimizing possible risks of harm. Beneficence requires that investigators and IRB members engage in an analysis of the risks and benefits to the subjects, making sure that anticipated risks are proportional to the potential benefits. Risk should be minimized as much as possible. Justice Justice requires that the benefits and burdens of research be distributed equitable. The principle of justice instructs us that subjects should not be chosen simply because they are available and easy to manipulate. In addition it requires that subjects who are likely to benefit from a study should not be excluded. The Belmont Report and the Federal Regulations For example, basic IRB review, as described in the federal regulations, must include the following questions:
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