IRB Compliance: Tuskegee and Milgram Study Violations

Introduction

The literature has identified the manner and form by which the conduct of the Tuskegee Syphilis Study and the Milgram Study violated the provisions of Institutional Review Board (IRB) policies and standards. In an effort to clarify how each study might have complied with IRB policies, this analysis identifies alternative procedures and safeguards that would reflect such compliance. A caveat is relevant: realistically, changes to the research protocols would, in effect, render the research useless. The experimental design of each study required deceit and obfuscation of the actual research procedures. In effect, and in each case, the research should never have been conducted.

Tuskegee Syphilis Study IRB Violations

The following sections of the IRB Code of Federal Regulations were violated by the Tuskegee Syphilis Study: §46.103, §46.110, §46.111, §46.116, §46.117, §46.118, and §46.119. No reasonable or useful adaptations to the research have been identified in the literature. Rather than proposing how to alter this research, it is more productive to consider good models of research involving human subjects.

A foundation of the IRB framework is the provision of informed consent. Specifically, §46.109 calls for a review of research to ensure that the standards of informed consent are being met. The language regarding the information required in the consent agreement is further delineated by the regulation:

§46.109(b): An IRB shall require that information given to subjects as part of informed consent is in accordance with §46.116. The IRB may require that information, in addition to that specifically mentioned in §46.116, be given to the subjects when in the IRB's judgment the information would meaningfully add to the protection of the rights and welfare of subjects.

Informed Consent Failures in the Tuskegee Study

In the Tuskegee Syphilis Study, research subjects were not fully informed; therefore, the subjects could not give consent as it is understood under the law. The information withheld from the subjects—which could be construed to meaningfully add to the protection of their rights and welfare—included the following:

(1) The true nature of the study was withheld from the subjects. Specifically, the study was intended to compare the medical outcomes of Black men suffering from syphilis to those of white men (Jones, 1993). (2) Although the doctors conducting the research knew that the subjects had syphilis, they did not identify the disease; moreover, the subjects were led to believe they were suffering from a "bad blood" condition rather than syphilis (Jones, 1993). (3) The subjects were not told that the disease they had was contagious, with the result that the disease did, in fact, spread to others (Jones, 1993). (4) The subjects were "treated" with aspirin, a medication that is not effective against syphilis (Jones, 1993).

(5) The subjects were enticed to allow painful and potentially dangerous spinal taps through the suggestion that they were receiving free treatment available only for a limited time (Jones, 1993). (6) The fact that post-mortem autopsies were planned for every subject was concealed by the researchers (Jones, 1993). (7) When campaigns to eradicate venereal disease became available in the county, the subjects were prevented from participating (Jones, 1993). (8) When penicillin—an established cure for syphilis—became available, the subjects were deliberately denied the medication (Jones, 1993). (9) When 250 of the men joined the military and received a diagnosis of syphilis, they were exempted by the U.S. Public Health Service from the treatment ordered by military doctors (Jones, 1993).

Conclusion

Both the Tuskegee Syphilis Study and the Milgram Study represent profound violations of the ethical principles governing human subjects research. The specific IRB provisions violated—including requirements for informed consent, risk minimization, and respect for participant well-being—were not incidental breaches but were structurally integral to how each study was designed. No reasonable adaptation has been identified that would render either study compliant with IRB and federal human subjects protections without simultaneously rendering the research itself meaningless. The inescapable conclusion is that neither study should have been conducted as it was.

References

American Psychological Association. (2010). Ethical principles of psychologists and code of conduct (003-066X). Washington, DC: American Psychological Association.

Code of Federal Regulations. (2009). Title 45: Public Welfare. Department of Human Services, Part 46. Protection of Human Subjects.

Jones, J. H. (1993). Bad blood: The Tuskegee syphilis experiment: History, facts, bad blood, bad science. New York, NY: Free Press.

Milgram, S. (1963). Behavioral study of obedience. Journal of Abnormal and Social Psychology, 67(4), 317–378.