The Belmont Report begins by recognizing that while research involving human subjects has produced important social benefits including reduced morbidity, greater longevity and improved quality of life, this research has also posed challenging and troubling ethical questions. The report also explicitly distinguishes clinical practice and medical research. The purpose of clinical practice is to enhance the well-being of the patient by using interventions for which there is an expectation for success. On the other hand, the purpose of medical research is to gain new knowledge; research involves testing hypotheses and drawing conclusions through experiments from which research subjects may or may not derive benefits. Notably, clinical practice and medical research often occur in the same setting. However, subjects in the clinical setting may not recall that they are participating in a research study (Riecken, H. and Ravich, R., 1982). It is important for research subjects to be informed of and understand these differences (American College of Physicians, 2005).
The Belmont Report also recognizes that the Nuremberg Code and later codes were drafted to assure the ethical conduct of human subjects research. However, these codes consist primarily of rules for conducting research that do not address every potential research scenario (e.g., a scenario that the rules do not cover or conflict with each other). To address these deficiencies of the codes, the authors of the Belmont Report describe three prima facie ethical principles for conducting human subjects research that provide a basis on which specific rules may be established, appraised and interpreted. These three principles are respect for persons, beneficence (nonmaleficence) and justice.
The principle of respect for persons requires that investigators acknowledge that individual human research subjects are autonomous (the word autonomy derives from the Greek autos for ''self'' and nomos for ''rule'') agents with the right of self-determination (Beauchamp, T. and Childress J., 2001). The centrality of informed consent in research derives from this principle. Informed consent consists of three elements: (a) adequate information regarding the research study and its potential risks and benefits and subject understanding of the information; (b) subject decision-making capacity; and (c) subject voluntary involvement (i.e., without coercion). Respect for persons is maximized when the elements of informed consent are fully realized. Notably, not every person is capable of self-determination. Hence, this principle also requires that investigators protect subjects with diminished autonomy (e.g., due to impaired decision making capacity) from exploitation and harm.
The principle of beneficence requires that investigators act to secure the well-being of human research subjects, maximize benefits and minimize risks and harm. The Belmont Report, however, recognizes that the goal of avoiding harm may, in fact, require that research be done to determine what is harmful and what is beneficial and, hence, may involve exposing research subjects to risks. The dilemma for investigators is to determine when benefits should be forgone because of risks and when benefits should be sought despite the risks. Research protocols should be designed in ways that maximize benefit while at the same time minimizing harm. Proposed research questions must also be worth answering. Research studies involving human subjects, even those involving minimal risk, are not justifiable if the research does not generate scientifically valid and worthy new knowledge. Hence, proper study design and methods are not only scientific, but also ethical, obligations.
The Belmont Report also declares that: (a) inhumane treatment of human subjects is never morally justified;
(b) investigators should determine if human subjects are necessary and, if so, the risks should be reduced to those necessary or alternative means used to reach the research objective; (c) if the research involves risk of harm, the risk should be justified; (d) the appropriateness of involving vulnerable populations in research should be demonstrated; and (e) risks and benefits should be clearly stated in informed consent documents.
The principle of justice refers to the equitable distribution of the benefits and burdens of research. Injustice occurs when one receives (or is denied) benefits or when one bears (or does not bear) burdens without good reason. Applied to research involving human subjects, the benefits and burdens of participating in research should be distributed fairly. In fact, the Belmont Report explicitly notes the legacy of unjust prior research studies (and specifically mentions the Tuskegee study) in which the burdens of being research subjects fell primarily upon disadvantaged (e.g., poor) persons, while the benefits of improved healthcare was realized primarily by privileged patients.
Instead, the selection of research subjects should be based on the needs of the study. Furthermore, publicly-funded research should not unduly involve individuals who will not likely benefit from therapeutic innovations that derive from the research, and when such research results in therapeutic innovations, the innovations should not provide advantages only to those who can afford them.
General applications of the three prima facie ethical principles described in the Belmont Report are described in Table 7.2.
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