The Tuskegee syphilis study and violations of informed consent

Conflict Between Research and Ethics: The Tuskegee Syphilis Study

The Tuskegee syphilis study is probably the most famous series of medical experiments in U.S. history. Unfortunately, the reason that the study is so widely known is not because it led to ground-breaking advances in the treatment of syphilis, but because the study was conducted on human participants who had not given informed consent, and resulted in needless pain and suffering for most of those subjects. While it is commonly believed that the U.S. government infected the test subjects with syphilis, that belief is untrue. On the contrary, the government enlisted ill men in the study, did not identify the nature of their disease, and led them to believe that they were getting treatment, when they actually were not.

While it is tempting to completely condemn the Tuskegee syphilis study as an example of American racism, that would be a simplistic explanation of how the study occurred. In fact, the study began as an effort to justify treatment of syphilis in blacks. (Centers for Disease Control and Prevention, Home, 2008). In 1926, syphilis was identified as a major health concern, impacting 35% of the reproductive-aged population. (Centers for Disease Control and Prevention, Timeline, 2008). However, there was no antibiotic treatment developed for syphilis; on the contrary, in 1929 the government institutes an aggressive treatment program using mercury and bismuth, but the cure rate is less than 30%, the treatments are time consuming, and the side effects of the treatment could be toxic, even fatal. (Centers for Disease Control and Prevention, Timeline, 2008). After the market crashes, the powers that be determine that the cost of syphilis treatment in blacks is prohibitive and orders the end of the treatment program. However, the researchers decide to follow the men's health to demonstrate that untreated syphilis creates serious health problems, to show that the treatment is necessary. By 1935, the researchers were able to publish the first major paper about the effects of untreated syphilis. In 1936, the researchers decide to follow the men for life and ask the doctors in the community to join with them in preventing the men from receiving treatment. (Centers for Disease Control and Prevention, Timeline, 2008). In 1947, penicillin is found to cure syphilis, but the men are not offered penicillin and the study continues, despite ethical concerns, until 1972. In 1973, Congress held hearings about the study and the study participants filed a class-action lawsuit, which was settled in 1974 for $10 million. (Centers for Disease Control and Prevention, Timeline, 2008).

Patient consent

Obviously, the major ethical problem with the experiment is that the patients were not given sufficient information to give their informed consent to participate in the study. In the age of information, it may seem impossible to understand the depth of the ignorance the study participants had about their disease and about the appropriate treatments:

These men, for the most part illiterate sharecroppers from one of the poorest counties in Alabama, were never told what disease they were suffering from or of its seriousness. Informed that they were being treated for "bad blood," their doctors had no intention of curing them of syphilis at all...The data for the experiment was to be collected from autopsies of the men, and they were thus deliberately left to degenerate under the ravages of tertiary syphilis- which can include tumors, heart disease, paralysis, blindness, insanity, and death. (Brunner, 2008).

Most of these men had never been able to see a doctor, and they were happy to be receiving free medical care. Moreover, they did not know that they were not being treated; they were given an aspirin and led to believe that it was providing them with treatment for their disease. In fact, they were not even informed that they had syphilis; they were told that they had "bad blood" a term used in the area to describe a number of different diseases, one which was syphilis.

Potential roles of ethics committees

Today, it would be a clear violation of established ethics for anyone to perform an experiment like the Tuskegee experiment. In fact, in 1974, mostly in response to news of what had occurred at Tuskegee, the government enacted the National Research Act, which created the National Commission for the Protection of Human Subjects of Biomedical and Behavioural Research. That commission wrote the Belmont Report, which outlined three fundamental principles for human research: respect for persons, beneficence, and justice. (Office of Research Support, 2006). Respect for persons requires that researchers obtain informed consent, which means that subjects understand the study and voluntary choose to participate. However, even more important than that, experiments on humans must exhibit beneficence, which means that the risks to the subjects have to be proportional to the benefits, with risks minimized as much as possible. (Office of Research Support, 2006). The justice requirement means that the benefits and burdens of proposed research have to be distributed in an equitable manner. (Office of Research Support, 2006). Because the Tuskegee study violated all three of the Belmont Report's fundamental principles, the ethics committee would have no choice but to reject a similar research proposal. Moreover, while an ethics committee can propose revisions to make a study ethically sound, the flaws in the Tuskegee study were so profound that the necessary changes would alter the study beyond recognition.

Potential responsibilities of management

One of the most remarkable aspects of the Tuskegee study is that, of all the doctors, nurses, government officials, and other workers who knew about the study, no one called a halt to it. In fact, even though the first major paper about the study was openly criticized because of concerns that the men were not receiving treatment, that criticism did nothing to impact the course of the study. However, the study ended due to the actions of one whistle-blower, Jean Heller. Therefore, it is clear that, in the case of an experiment like the Tuskegee experiment, management's primary responsibility would be to take the necessary steps to end the experiment. Then, management would need to help the subjects find appropriate medical treatment and offer them appropriate reparations for their mistreatment.

Personal management approach

If confronted with a proposal for a study like the Tuskegee experiment, my personal management approach would have to go beyond merely rejecting the proposal. In this day and age, such a proposal would raise serious concerns about the ethics of the proposing researcher. I think that I would have to personally review any experiments conducted by that person, to assure myself that they did not contain the same types of ethical flaws. Furthermore, I would report the person to their appropriate governing body, so that they would at least be aware of the potential ethical problems that could be created by the researcher. If I were to enter into management and discover that one of the studies under me was being conducted in a manner like the Tuskegee study, I would not immediately end the study.

Instead, I would order that all study subjects be given effective medication to treat their disease and then end the study. One ethical question that I cannot answer is whether I would inform the patients that they had been subjected to years of useless treatments and then try to convince them that I was going to give them something that really works, or whether I would simply have them take an effective treatment as part of the ongoing study, and then order the study's termination. Needless to say, I would report the doctors involved to the appropriate ethics committees. Moreover, I think I would actually attempt to have them prosecuted for fraud, for using lies to induce the subjects to enter into and stay in the study, and for assault, for putting the patients through needless rounds of unnecessary medical tests.