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Patients' Rights - Medical Experimentation

consent research study informed

Medical progress and medical experimentation have always gone hand in hand, but patients' rights have sometimes been ignored in the process. Sometimes patients are completely unaware of the experimentation. Experimentation has also taken place in settings in which individuals may have extreme difficulty asserting their rights, such as in prisons, mental institutions, the military, and residences for the mentally disabled. Legitimate experimentation requires informed consent that may be withdrawn at any time.

Some of the more notorious and shameful instances of human experimentation in the United States in the twentieth century include a 1963 study in which terminally ill hospital patients were injected with live cancer cells to test their immune response; the TUSKEGEE SYPHILIS STUDY, begun before WORLD WAR II and continuing for 40 years, in which effective treatment was withheld from poor black males suffering from syphilis so that medical personnel could study the natural course of the disease; and a study where developmentally disabled children were deliberately infected with hepatitis to test potential vaccines.

Failure to obtain informed consent can arise even when consent has ostensibly been obtained. The California Supreme Court ruled in 1990 that a physician must disclose preexisting research and potential economic interests that may affect the doctor's medical judgment (Moore v. Regents of the University of California, 51 Cal. 3d 120, 793 P. 2d 479). The case involved excision of a patient's cells pursuant to surgery and other procedures to which the patient had consented. The surgery itself was not experimental; the experimentation took place after the surgery and other procedures. The cells were used in medical research that proved lucrative to the doctor and medical center.

Patients in teaching hospitals are frequently asked to participate in research. Participants do not surrender legal rights simply by agreeing to cooperate and validly obtained consent cannot protect a researcher from NEGLIGENCE.

In hospitals, human experimentation is typically monitored by an institutional review board (IRB). Federal regulation requires IRBs in all hospitals receiving federal funding. These boards review proposed research before patients are asked to participate and approve written consent forms. IRBs are meant to ensure that risks are minimized, the risks are reasonable in relation to anticipated benefits, the selection of subjects is equitable, and informed consent is obtained and properly documented. Federal regulations denominate specific items that must be covered when obtaining informed consent in experimental cases. IRB approval never obligates a patient to participate in research.

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