The Belmont Report, according to the U.S. Department of Health and Human Services, was issued in 1978 by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The report is significant because it addresses the problems and describes basic ethical principles and important guidelines for research with human subjects.
The Belmont Report recognized that despite benefits, such as improved quality of life, longevity, and reduced morbidity, research on human subjects still posed challenging ethical and moral questions. The report underlined the difference between medical research and clinical practice, as the purpose of the former is to gain knowledge without bringing any benefits to the subjects of research, while the latter enhances health and well-being of the researched patients. The report does not make any specific recommendations for the Secretary of Health, Education, and Welfare, but rather requests its entire adoption by the Department.
The report noted that whereas the Nuremberg Code was drafted for ethical purposes, it did not address each potential scenario during research on human subjects, and thus, required additional principles to be established. The Belmont Report is, therefore, based on the principles of beneficence (i.e., nonmaleficence), justice, and respect for persons, which provide a basis for further research involving human subjects.
The principle of beneficence requires that researchers act to maximize well-being and benefits of human subjects, and at the same time, minimize risks and potential harm. In cases where risks are unavoidable, researchers should reduce them or find alternative means of research. The principle of justice refers to the fair and equal distribution of the benefits and the burdens of research. The principle of respect for persons demands that researchers perceive human subjects as autonomous and, as such, require the information about potential risks and benefits from the study, as well as the right for decision-making and voluntary involvement. The concept of informed consent comes from the principle mentioned above.