The Belmont Report & research on human subjects

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Back in the early 1970s in the United States, a very long syphilis study was completed. The study involved sharecroppers in Tuskegee, Alabama. The study became public, and, without going into details, the manner in which the study was conducted included many severe ethical issues. Indeed, the effect of this study on the public trust of healthcare studies is still being felt today. Outcry resulted in new legislation – the National Research Act of 1974. One outcome of this legislation was creation of the National Commission, which met for many years to discuss the issues of the Tuskegee study and other study design matters.
The National Commission created a document called the Belmont Report. The Belmont Report was named after the Belmont Convention Center in Maryland, which was where many of the ideas in the report were formalized. The Belmont Report was released in 1978 and continues to be referenced today.
The Belmont Report included three ethical principles. (1) – respect for persons. A key idea is that study subjects are autonomous agents whose participation is voluntary. (2) – beneficence. Researchers must respect study subjects’ decisions and protect the subjects from harm. Beneficence is a stronger idea than just caring for the subjects. Beneficence implies that taking care of the subjects is the direct responsibility of the researchers. (3) – justice. Justice addresses the benefits and burdens of the research and how the study subjects share in the benefits and burdens.
The Belmont Report also lists three applications or practices that follow from the three ethical principles. (1) – informed consent. Subjects must be properly informed for them to provide meaningful consent. Compensation for the subjects should be fair without undermining the voluntary nature for participation. (2) – assessment of risks & benefits. Risks and benefits should be determined based not only on the probability of a given outcome (good or bad) but also the magnitude of the outcome. (3) – subject selection. Researchers should not take advantage of a subject’s availability. All of these principles and applications were violated during the Tuskegee study, and other, lesser known studies as well. Proper use of these principles and applications helps to ensure that human research is performed in an ethical manner.