The National Research Act (1974) created the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The Commission set forth the basic ethical principles underlying the acceptable conduct of research involving human subjects (this act was a direct result of the ethical violations inherent in the Tuskeegee Study
). The principles of the National Research Act 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.
Respect for Persons
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 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 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.