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On April 18, 1979, basic ethical principles for the protection of human research subjects were published in the Federal Register of the United States. They are contained within what is known as the Belmont Report. Both the principles and the report endure, intact.
These principles of human research ethics are concisely approximated as follows:
- Respect for Persons - autonomy (self-determination) whenever possible and suitable protections for those of diminished autonomy (compromised self-determination)
- Beneficence - maximize positive health or well-being-related results (benefit) and minimize the magnitude and probability of harm (risk) – which includes deciding when the benefits justify the risk and when the risk does not justify the benefits
- Justice - fairness in selection of human research subjects (justifiable distribution of research burden).
In addition to the principles, per se, the report also discusses issues related to their application, such as: (1) boundaries between research (both biomedical and behavioral) and routine practice (medical or behavioral), (2) matters inherent to the process of informed consent, such as suitable information, comprehension, and voluntariness, (3) role of risk-benefit assessment in decisions about appropriate research participation, and (4) matters concerning determination of just selection for participation by: (a) individuals (e.g., unfair inclusion or exclusion) and (b) social groups (e.g., one group bears the research burden while another benefits or a more burdened group is selected over one less burdened where both stand to benefit equally from the knowledge to be derived).
 As an aside, although simultaneously applied, each of the three cited principles is unique unto itself. Conflicts can arise when the application of each results in dissimilar conclusions. These conflicts are called ethical dilemmas. Review bodies that apply these principles (e.g., within the framework of applicable rules, like 45 CFR 46), are left to consider the appropriate priority weight for each. Hence, respect for each principle results in both thoughtful application of each and balancing between them.
(01-29-07)
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