Human Experimentation

Basic scientific research often requires research on human subjects and/or materials drawn from human beings. In addition, basic research often leads to clinical applications that require further research regarding their safety and efficacy. Physicians may try innovative therapeutic approaches if justified by the patient’s condition and if the patient voluntarily consents to the treatment after being properly informed. Such research often gives rise to ethical dilemmas, and must be reviewed by an IRB. [Source: Brody, BA, The Ethics of Biomedical Research: An International Perspective (New York: Oxford University Press, 1998).]

Often involved in these ethical dilemmas are issues of informed consent, benefits and burdens (including risks), and surrogate decision-making. According to the Ethical and Religious Directives,

No one should be the subject of medical or genetic experimentation even if it is therapeutic, unless the person or surrogate first has given free and informed consent. In instances of non-therapeutic experimentation, the surrogate can give this consent only if the experiment entails no significant risk to the person’s well-being. Moreover, the greater the person’s incompetence and vulnerability, the greater the reasons must be to perform any medical experimentation, especially non-therapeutic (n. 31).

In addition to this Directive, there are several documents that have been created in response to horrendous violations of human rights in the use of human research subjects. One example of such violations of human rights is the Tuskegee Syphilis Study (1932-1972), in which 400 African-American males known to have syphilis were given a placebo without their knowledge or consent, so that researchers for the U.S. Public Health Service could determine just how lethal syphilis was if not treated [See: Devettere, R. Practical Decision Making in Healthcare Ethics: Cases and Concepts (Washington, DC: Georgetown University Press, 1995), 398-400]. The Helsinki Declaration, the Nuremberg Code, and the Belmont Report are all documents intended to explicitly govern human experimentation. (See also the Office for Human Research Protections.)

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