Highlights of Unethical Research Studies Conducted in the United States
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Research Study – Hyman vs. Jewish Chronic Disease Hospital case
Focus of study- Doctors injected cancer-ridden aged and senile patients with their own cancer cells to study the rejection response.
Ethical principle violated- Informed consent was not obtained. There was no indication that the study was reviewed and approved by an ethics committee. The two physicians claimed they did not wish to evoke emotional reactions or refusals to participate by informing the subjects of the nature of the study (Hershey & Miller, 1976).
Research study- Ivory Coast, Africa, AIDS/AZT case
Focus of study- In a study supported by the US government and conducted in the Ivory Coast, Dominican Republic, and Thailand, some pregnant women infected with HIV were given placebo pills rather than AZT, a drug known to prevent mothers from passing on the virus. Babies were in danger of contracting HIV unnecessarily.
Ethical principle violated- Subjects who consented to participate and randomized to the control group were denied access to a medication regimen with a known benefit. This violates a subjects’ right to fair treatment and protection (French, 1997; Wheeler, 1997).
Research study- Midgeville, Georgia, case
Focus of study- Investigational drugs were used on mentally disabled children without first obtaining the opinion of a psychiatrist.
Ethical principle violated- There was no review of the study protocol or institutional approval of the program before implementation (Levine, 1986).
Research study- Tuskegee, Alabama, Syphilis Study
Focus of study- For 40 years the US Public Health Service conducted a study using two groups of poor black male sharecroppers. One group included those who had untreated syphilis; the other group was judged to be free of the disease. Treatment was withheld from the group having syphilis even after penicillin became available and accepted as effective treatment. Steps were taken to prevent the subjects from obtaining it. Researchers wanted to study the untreated disease.
Ethical principle violated- Many subjects who consented to participate were not informed about the purpose and procedures of the research. Others were unaware that they were subjects. The degree of risk outweighed the potential benefit. Withholding of known effective treatment violates the subjects’ right to fair treatment and protection from harm (Levine, 1986).
Research study- San Antonio Contraceptive Study
Focus of study- This study examined side effects of oral contraceptives in 76 impoverished Mexican-American women who were randomly assigned to an experimental group receiving birth control pills or a control group receiving placebos. Subjects were not informed about the placebo and pregnancy risk; 11 subjects became pregnant, 10 of whom were in the placebo control group.
Ethical principle violated- Informed consent principles were violated; full disclosure of potential risk, harm, results, or side effects was not evident in the informed consent document. The potential risk outweighed the benefits of the study. The subjects’ right to fair treatment and protection from harm was violated (Levine, 1986).
Research study- Willowbrook Hospital Study
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Focus of study- Mentally incompetent children (n = 350) were not admitted to Willowbrook Hospital, a residential treatment facility, unless parents consented to their children being subjects in a study examining the natural history of infectious hepatitis and the effect of gamma globulin. Children were deliberately infected with the hepatitis virus under various conditions. Some received gamma globulin; others did not.
Ethical principles violated- The principle of voluntary consent was violated. Parents were coerced to consent to their children’s participation as research subjects. Subjects or their guardians have a right to self-determination—that is, they should be free of constraint, coercion, or undue influence of any kind.
Research study- UCLA Schizophrenia Medication Study
Focus of study- The study examined the effects of withdrawing psychotropic medications of 50 patients being treated for schizophrenia; 23 subjects suffered severe relapses after their medication was stopped. The study’s goal was to determine if some schizophrenics might do better without medications that had deleterious side effects.
Ethical principles violated- Although subjects signed an informed consent, they were not informed how severe their relapses might be, or that they could suffer worsening symptoms with each recurrence. Informed consent principles violated; full disclosure of potential risk, harm, results, or side effects was not evident in informed consent form. Potential risks outweighed the study’s benefits. The subjects’ right to fair treatment and protection from harm was violated (Hilts, 1995).
In 1973 the first set of proposed regulations on the protection of human subjects were published. The most important provision was a regulation mandating that an institutional review board must review and approve all studies. In 1974, the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research was created. A major charge brought forth by the commission was to identify the basic principles that should underlie the conduct of biomedical and behavioral research involving human subjects and to develop guidelines to ensure that research is conducted in accordance with those principles (Amdur & Bankert, 2011). Three ethical principles were identified as relevant to the conduct of research involving human subjects: the principles of respect for persons, beneficence, and justice (Box 13.1). Included in the report called the Belmont Report, these principles provided the basis for regulations affecting research (National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, 1978).