Satisfy IRB Code and Rule Criteria

Satisfy IRB Code & Rule Criteria

The literature has identified the manner and form by which conduct of the Tuskegee Syphilis Study and the Milgram Study have violated the provisions of the Institutional Review Board (IRB) policies and standards. In an effort to clarify how the Tuskegee Syphilis Study and the Milgram Study might have complied with the Institutional Review Board (IRB) policies, this analysis proceeds as follows. For the main deviations from IRB policies identified, alternative procedures and safeguards that do reflect compliance with IRB policies and standards are identified and discussed. A caveat is relevant: realistically, changes to the research protocols would, in effect, render the research useless. Unfortunately, the experimental design 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

The following sections of IRB were violated by the research. 46.103; 46.110; 46.111; 46.116; 46.1167, 46.118; 46.119. No reasonable or useful adaptations to the research have been suggested in the literature. I suggest that, instead of proposing how to alter this research, that good models of research using human subjects be reviewed. A foundation of the IRB is the provision of informed consent. Specifically, §46.109IRB calls for a review of the research that to ensure that the standards of informed consent are being met. The language regarding the information contained in the consent agreement is further delineated by the regulation, as follows:

§46.109IRB 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.

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 that was withheld from the subjects, which could be construed to meaningfully add to protection of their rights and welfare as subjects, included the following: (1) The true nature of the study was withheld from the subjects. To whit: the study was intended to compare the medical outcomes of black men suffering from syphilis to that 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; the result was that the disease did, in fact, spread to others (Jones, 1993). (4) The subjects were "treated" with aspirin, medication that is not effective against their disease (Jones, 1993). (5) The subjects were enticed to allow painful and potentially dangerous spinal-taps through the suggestion that they were getting free treatment that would only be available for a short 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 were 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 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 the military doctors (Jones, 1993).

In order to be compliant with the IRB policies regarding informed consent, the subjects in the experiment would need to have been informed about each of the deviations listed above. Doubtless, the experiment would not have gone forward under those conditions -- a conclusion that did not escape the doctors and institutions involved. Moreover, the IRB specifically requires that risks to subject be minimized in research.

§46.111 Criteria for IRB approval of research

(1) Risks to subjects are minimized.

Not by the farthest stretch of the imagination could this standard be achieved as the experiment was constructed. Further, no re-design of the experiment -- short of research that did, in fact, provide alternative and effective treatments to the subjects suffering from syphilis -- could conceivably be compliant with IRB policies.