Essay: Consent and the Tuskegee Study

From 1932 to 1972, scientists working for the United States Government withheld treatment to participants in studies conducted to assess the effects of syphilis in African-American males. Doctors had been looking for treatments for syphilis in African-American males when the government decided that they would fund this study for the Tuskegee Hospital.
Early treatments involved the application of Mercury rubs, Litman oil, and other various treatments. The participants of the Tuskegee Study were further told they had bad blood and were not told that they had syphilis. Syphilis is a disease that, untreated, causes destruction between the cartilaginous joints. Study participants were, furthermore, promised this treatment to cure their bad blood, or syphilis, not for research purposes. (Thomas 1-2,)
As time progresses, the government decided to pull their funding of the Tuskegee study. They decided that the study was not as valuable as they had hoped it would be, but they decided that they would renew funding if those conducting the study would meet certain criteria that the government imposed. Government officials stipulated that funding would only be continued if a pure sample of African-American males who were untreated were used to conduct the study. The government officials wanted to use the untreated group of African-American men because they wanted to see how syphilis, when left untreated, affected the African-American males. (Thomas 1-2,)
The doctors from Tuskegee argued that this was racist . To defend their case, government officials cited a case when this was done on Caucasian males. They wanted to conduct the same type of study that had been done with Caucasian males with African-American males in Tuskegee. (Thomas 1-2,)
After doctors agreed to the conditions stipulated by Government agents providing funding, study participants were given a different story about the purpose of the study.
A second consent form was sent to participants in the Tuskegee study. This second form explained that this was their last chance to participate in this study. It was further explained that, without this treatment, they might not survive their “bad blood”. Participants in the Tuskegee study were also told that they were not allowed to seek other treatments, such as penicillin, to cure them from syphilis. (Thomas 1,20)
Three factors have made the Tuskegee study infamous. First, and most important, was the issue of consent. The lack of treatment and forced participation, study participants were told that they could not be removed from the study unless they were dead. This paper focusses on consent none of the study participants understood the study – none of the participants really understood what the term bad blood meant, for example. By using the simplified term, “bad blood” study participants were lead to believe that their disease was not necessarily something that was harmful ‘ they believed that they were being treated only for something called bad blood. (Thomas 1, 20)
Elements of consent – 4 pages
Contract law
The notion of consent is well understood by people who work on contract law. Contract law stipulates that three conditions must be true in order for a contract to be valid: an offer, acceptance and consideration. (“contract.”)
An offer is a proposal which may involve an exchange of money as in a sale. One party might offer to sell a good or a service to another party for a sum of money. In order for a contract to be formed, participating parties must reach mutual assent (also called a meeting of the minds). Mutual assent is typically reached through offer and an acceptance which does not vary the offer’s terms, which is known as the ‘mirror image rule’. Consideration is something of value given by a promissor to a promisee in exchange for something of value given by a promisee to a promissor. (“contract.”)
Deception/discrimination
The Tuskegee case is not an isolated case. The Canadian Federal Government and Canadian scientists carried out studies on aboriginal children without the consent of those children or their families Willows (2013) argues that the federal government, scientists, bureaucrats, and university researchers carried out studies on mineral supplements and processed foods on starving and malnourished individuals. (iii) The people who carried out the studies exploited the human suffering that they observed to further their own professional interests. Aboriginal children at residential schools were denied supplements, milk, and dental care and were subjected to medical and dental examinations, blood tests, and intelligence and aptitude tests. At one residential school, children were fed fortified flour not approved for the general Canadian population and they experienced worsening anemia. (Willows iii) None of the studies resolved the malnutrition, hunger, or suffering of the children or community members. The federal government funded the research and, had approved the nutritional experiments (Willows iii). Fairchild and Bayer (1999) describe the Tuskegee study as being deceptive, exploitative and inhuman. The study was deceptive because individuals were lured into the study by making them feel it was their only option. The researchers exploited study participant’s and the socialy vulnerability when recruiting. (921) Most seriously, the Tuskegee researchers deprived subjects of treatment to further the study’s goals (Fairchild, Bayer 919)
Physicians who honour the notion of consent would never do what the Tuskegee researchers did to their study participants. Ramsey (1970) for example, doctors make decisions about the best thing to do and how to explain treatment options to the client . Good physicians inform their clients about what may happen because too much uncertainty was considered bad. (Cassell 16) Not providing full information to a patient diagnosed with a terminal illness could be harmful because the patient might lapse into hopelessness. In another example a surgeon gave a patient with inoperable stomach cancer false hope about the seriousness of the patient’s condition!!! The patient died months later. A few days before dying he was heard saying, ‘Sometimes lately I think maybe I’m not getting better.’) (Cassell 16)
Informed consent
The rules around informed consent have been clearly stated but the notion of informed consent is sometimes misunderstood Collier (2011) clearly states that informed consent is a requirement of treatment.’You shall not treat a patient without the informed consent of the patient or his or her lawful surrogate except in narrowly defined emergencies.’ (79). This does not tell the whole story. The principle of informed consent, for example, places requirements on both doctors and patients. Doctors are required to meet four conditions in order for consent to be truly informed. First, doctors are required to provide patients with sufficient information about diagnosis, prognosis, and treatment options so that an informed decision can be made by a patient. Second, doctors must not lie to patients or withhold information that patients might find important when making decisions. Third, doctors must establish that information provided has been understood or not. Finally, doctors must not coerce or pressure patients to accept a particular treatment. (Collier 79).
Beauchamp and Childress (2001) further explain that true understanding takes place only after people have acquired pertinent information and have justified relevant beliefs about the nature and consequences of their actions. Such understanding need not be complete, because a grasp of central facts is generally sufficient.(Varelius 207-208) In some cases, a person’s lack of awareness of even a single risk or missing fact can deprive him or her of adequate understanding. To illustrate insufficient understanding, Beauchamp and Childress describe the case of a patient who had consented to undergoing prostate surgery without knowing that sterilization is an inevitable outcome of that procedure (Varelius 208). Assuming that the patient wanted to remain fertile, when he consented to undergo the prostate surgery, not knowing that the operation would make him sterile meant that he had acted against his own plan. The patient believed that he was acting in accordance with his plan but his understanding was mistaken. Beauchamp and Childress argue that the patient did not act autonomously because of the one misunderstanding he held about the possible results of the operation (Varelius 208).
Roberts (2014) argues that a clinical treatment or research study will discuss personal benefit or that a clinical researcher will always act in the best interests of the client/participant. This would then distort the values of the autonomous choice of the individual. Finally, some beliefs and psychological defenses that emerge, dealing with an overwhelming illness may be a barrier to considering alternative treatment.(706)
Taylor (2010) argues that a healthcare provider who fails to provide a patient with information that is pertinent to a treatment decision does not undermine a patient’s autonomy, because a patient’s medical decision can be fully autonomous despite lack of knowledge relevant to the treatment. Taylor further argues that a healthcare provider who fails to secure a patient’s informed consent to treatment is morally culpable for negligence. Taylor argues that autonomy is a property of persons, that autonomy, in his words, ‘admits of degrees’ meaning that . , and that the actions of autonomous persons are not subject to the direction of others. (Varelius 209)
A slave’s actions, for example, are subject of his master, and a soldier’s actions are subject of his superiors directions, but the actions of autonomous persons (a patient in this case) are not subject to the direction of others (health care providers). For Taylor a person make autonomous decision based on if it meets one of three criteria:
1. The information on which a decision is based has not been affected by another person with the goal of making the patient to make a particular (kind of) decision, or, if a decision has been affected, the person is aware. (Varelius 209)
2. the person is pleased with the decision-making process used to make the decision as being his or her decision-making procedure for making the type of decision; (Varelius 209)
3. if the person decides to use a decision-making process that is not the same their own but is satisfied with it being their own, then decision-making is autonomous.(Varelius 209)
The morality of the study
To assess the morality of the Tuskegee Study, we must consider the Belmont Report. Belmont outlined aesthetic guidelines and tells us what we can and cannot do while we are studying/researching. Sims argues that if these guidelines are broken then the study must be stopped, because, if the study continues, it would be immoral. The main components of the Belmont Report were to Ensure the study was approved by an Internal Review Board (IRB), to ensure that informed consent was obtained from study participants, to ensure that study participants understood the full extent of the experiment and, if not, would contact the study coordinator, to ensure that the study participants were not coerced into participating in the experiment by means of threatening or bullying, to be careful of other effects of the clinical trial that were not mentioned, and to report other effects to the proper study coordinator, to support study participant’s privacy, particularly to keep the identities and motivations of study participants confidential, and to ensure that all study participants obtained, at the very least, a minimal level of care as determined by their condition.( Sims,173-174)
As the study progresses nurses and doctors working at the Tuskegee Hospital felt uneasy about what they were doing, but they continued with the treatment though they knew how poorly they were treating Afro-American male study participants. the Tuskegee study was immoral but continued based on practices that the government laid out.
Discussion of consent to the Tuskegee Study
Taylor (2009) Beauchamp and Childress (2001) make a valid point about how informed consent was obtained. Their observations would indicate that the researches responsible for the Tuskegee Study did not formally and fairly inform participants about the details of the study. (Varelius 208-209).This oversight harmed participants and went against the values articulated by Belmont. This was most harmful because government stipulated that participants were not allowed to exit the study to seek other treatments. (Varelius 208-209).
Ramsey (Cassell 16), Willows (iii), Fairchild, Bayer(919-921), and Roberts (706) focus on the role and the harm brought about by deception. Doctors working on the Tuskegee study put their own best interests ahead of the best interests of the study participants by now allowing study participants to make an informed decision.
As Contract law also gives us some insight into the role informed consent should play in any relationship. The three conditions that should have been met at Tuskegee were not met so the doctors had no right to stop study participants requesting or obtaining treatment from some other place(“contract.”).
In Willows study of the treatment of Canadian aboriginals in residential schools, we saw that the Aboriginals had rights and are allowed to use them at any time to allow them the best possible life and well being, Research conducted with young Aboriginal students showed evidence of of malnutrition and incidents in which anorginal students were not reated properly. To address those problems Canada’s Aborginals have been demanding their rights as determined under various Treaties and Acts and demanding that they be treated like human beings!!!! (Willows iii)