Protection of Human Subjects of Biomedical and Behavioral Research - Essay Example

The Belmont Report The National Commission for the Protection of Human s of Biomedical and Behavioral Research was created in 1974 to investigate and develop guidelines for the ethical treatment of human medical and behavioral research subjects. The result was the Belmont report, which laid out the guidelines for human research. According to the National Institute of Health (NIH), "It is a statement of basic ethical principles and guidelines that should assist in resolving the ethical problems that surround the conduct of research with human subjects".

It determined the boundaries between research and treatment. It also offered guidelines for the ethical treatment of subjects, accurate risk appraisal, guidelines for the selection of subjects, and the definition of informed consent. The Belmont report was based on 3 ethical considerations. First, the patient's autonomy must be respected. In cases where a patient lacks autonomy such as incapacitation, measures must be taken to protect the individual. Second, efforts must be made to secure the patients well being.

The maxim of 'do no harm' must be respected and harm should not be inflicted for the sake of research. It is also recognized that research often involves risk and harm may be the ultimate result. The opportunity for benefits must be weighed against the risk. Lastly, there is the ethical question of who should bear the risk of medical research. The Tuskegee experiments on syphilis in the 1940s, "used disadvantaged, rural black men to study the untreated course of a disease that is by no means confined to that population" ("The Belmont Report").

The Belmont report recommends that the basis for patient selection should not be based on ".their compromised position, or their manipulability, rather than for reasons directly related to the problem being studied" ("The Belmont Report"). The issues of autonomy, do no harm, and subject selection are at the core of the Belmont report ethical considerations.Finally, subjects are entitled to informed consent. In cases of immaturity or mental incapability, other parties need to be consulted and informed.

The subjects must also be volunteers. There can be no coercion by outside threats and no inducements should be offered to those that are particularly vulnerable. It would not be ethical to offer a reduced sentence to a prison inmate to participate in risky medical research. The research must also be realistically evaluated for benefit/risk assessment. If the risk is too great and the benefit of obscure value, the research should be deemed unethical. The Belmont report is the guiding principles used today to conduct medical research on human subjects.