The Tuskegee Syphilis Experiment

Erin Buell

Concordia University

Health Policy and Management

MPH 525

Hollie Pavlica

February 22, 2015

THE TUSKEGEE SYPHILIS EXPERIMENT1

The Tuskegee Syphilis Experiment

  1. List at least three examples of unethical decisions made by the researchers conducting the Tuskegee Syphilis Study.

There were many blatant examples of unethical treatment throughout the 40 year span of the Tuskegee experiment. One example is that the decision makers did not give the men truthful information about the blood tests, which was paternalistic in nature and did not allow complete autonomy in the decision making of the men to be in the program. They were told that the blood samples were simply a test for “bad blood,” which was a general term of the day that included common ailments such as fatigue, and anemia, as well as syphilis (Tuskegee University, n.d.). In all codes of ethics, the foundation of truth-telling is emphasized as a component of respect for a person (Burke & Friedman, 2011).

The experiment also breached the ethical component of beneficence. The principle of beneficence is the treatment of people with actions of kindness and charity. In terms of public health practice, beneficence means that the health professional has apositive duty to the public and that they will do all that is possible for the people served (Burke & Friedman, 2011). The experiment was conducted without consideration of the health of the men who tested positive for syphilis, did not work to prevent the spread of the disease, and did not provide treatment even when penicillin was accepted as effective medical intervention in 1945(Centers for Disease Control and Prevention [CDC], n.d.). In fact, in the 27 years between the introduction of penicillin as a treatment and the end of the experiment, the participants were neither informed of their condition nor provided the medication.

Respect for persons in ethical practice involves the respect for individual autonomy. This ethical backbone supports that one person will treat another in a way that allows them to be self-governing (Burke & Friedman, 2011). In order to be able to be self-governing, an individual must not be coerced, misinformed, or otherwise constrained (Burke & Friedman, 2011). This includes the consideration of many factors that may present interference of a person being able to make an informed decision. In the case of the Tuskegee experiment, many of the men were not able to read. Their illiteracy was not addressed to help the men and their families understand the process. A flagrant example of the experiment not allowing for proper autonomy is epitomizedin comments from Dr. Sidney Olansky, the director of the experiment from 1950-1957. Olansky stated that “The fact that they were illiterate was helpful too, because they couldn’t read the newspapers. If they were not, as things moved on they might have been reading newspapers and seen what was going on.”Olansky further admitted that it was not clear that the men understood what they were told, or if they were told the truth in efforts to gain their participation(Thomas, 2000, para. 14).

  1. List three ways you would have changed the way this study was run and why?

To consider how a professional in public health may have changed the way the study was run, it is important to look at the different points in history in which any specific decisions were made. To consider how I might have made a difference in the conduction and outcome of the study, I would have utilized the information, key events, and influential figures of the day. In 1930 when the Tuskegee study began, societal and cultural norms, effects of the Great Depression, medical knowledge, and the exploration of ethics and public health affected the decisions that were made to conduct the experiment. Prior to the onset of the experiment, efforts to improve Black economic development were initiated by Booker T. Washington and his supporters, including Julius Rosenwald (CDC, n.d.). By the mid 1920’s, the identification of syphilis as an impediment to health was considered, and efforts in treatment were funded andexplored (CDC, n.d.). However, when funding cuts during the onset of the Depression threatened the continuation of study of the disease, a decision was made to follow the men that were left untreated. The hope was that it could be proven that funding was indeed necessary for treatment programs (CDC, n.d.).At the very onset of the Tuskegee syphilis trials, however, honesty should have been integral to the implementation and to the offerings among the men involved. Cultural inequities between Blacks and Whites were vast at that time in history, and undoubtedly ignorance, norms, and prejudice would have had an effect on communication tactics. In the minds of many, the inequity of the races may have justified paternalistic practices.However, such prominent figures as Eleanor Roosevelt, who was involved in the National Association for the Advancement of Colored People(Stanford University, n.d.), could have given strength to any White leader to voice the truth to the Black men that were asked to participate in the study. These men and their families should have been told that the study was regarding syphilis, and whether or not they had the disease. Men were also led to believe that spinal tests were treatments, when in fact they were diagnostic tools for the study (Thomas, 2000). This likely would have made it more difficult for men to step forward to participate, but it would have avoided a tremendous ethical breach.

The purpose of the experiment was the specific effort to study the natural progression of untreated syphilis, and how the effects of syphilis might differ between Blacks and Whites. A total of 600 men were chosen for the study. Most were impoverished, uneducated sharecroppers. Of the men chosen, 201 did not have syphilis. The remaining 399 subjects were in the second stage of the disease, and while they did not know what their illness was, they were promised medical care, food, and other benefits in exchange for participation (Thomas, 2000). What ensued was the unethical positioning of the health of these men, their sexual function, and the health of their intimate partners against the objectifying of human beings for the purpose of medical experimentation. A more ethical approach would have been to offer clinical trials for treatment, and provide education to both White and Black populations that were affected with the disease and closely monitor the results. This would have lessened the racial bias that affected the study, and would have established better data in which to learn of the progression, spread, and cure of the disease. Unfortunately, in the early years of the study, the common treatment involved mercury and bismuth, which did not prove effective in curing the disease, and was toxic in nature (CDC, n.d.). Therefore, while this approach may have been more ethically sound, history would have undoubtedly carried forward a message of poor outcome.

There were several points in the forty-year study in which interventions should have been put into place to stop the experiment. The Henderson Act of 1943 required testing and treatment for venereal disease, but the Tuskegee study continued. In 1945, penicillin was validated as appropriate and effective treatment, but the participants of the study were not informed or treated. During the draft for World War II, 250 of the infected men were given exemptions by Public Health Service to receive treatment so that they could remain in the study (Information Please, n.d.). These were missed opportunities for health workers and others involved in the study to inform the participants, become whistle blowers, provide treatment, and prevent the spread of disease.

  1. Name five of the essential elements of informed consent and discuss whether any of those were met with the Tuskegee Syphilis Study participants?

The United States Department of Health and Human Services (DHHS) outlines specific points regarding essential elements of informed consent. Among this list of elements are the specifications that the subjects be informed that the study involves research, be informed of the purposes of the research, be given a description of any foreseeable risks or discomforts to the subjects, be provided the expected duration of the subject’s participation, and be given a disclosure of appropriate alternative procedures or courses of treatment, if any, that may be of advantage to the subject (U.S. Department of Health and Human Services,[DHHS]n.d.[a]).

As the subjects were mostly unable to read, they were provided information about the study through verbal communication.It is important to note that the subjects were not told that they were part of a study or any research project, but only that they were being given treatment. There appears to be no specific evidence that shows that the subjects comprehended what they were told, or that there was consistency of information given to different groups and individuals recruited for the study. At a very minimum, because the subjects were offered burial costs, it might be argued that the element of informed consent regarding the duration of the experiment was established if the intent of that offering was that the study was expected to continue until death of the subject.

  1. Are there any scenarios where informed consent is not needed? If so, describe three of them.

Informed consent is not always appropriate or necessary. This would include the event of an emergency, in which there is not time or ability to communicate process of care in a timely manner with which to administer it (Burke & Friedman, 2011). The Institutional Review Board (IRB)of DHHS can determine whether a project can waive some or all of the elements of informed consent (DHHS, n.d. [a]). Examples might include projects that the IRB finds to be of benefit to the public and carries minimal or no risk to the subjects, or where the lack of informed consent will not adversely affect the rights and welfare of the subjects (DHHS, n.d.). The Tuskegee study has been accused of consideration of the subjects to be no more than that of laboratory animals(Thomas, 2000). If that was the general attitude of the Public Health Services of the day, it is likely that informed consent was not a consideration among many.

  1. What are the three core principles of the Belmont Report?

The Belmont Report was createdby the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research in 1978 and has been adopted as a statement, rather than as a list of specific recommendations of legislative action, for the treatment of subjects in biomedical and behavioral research(DHHS, n.d.[b]).The three core ethical principles of this report are respect for persons, beneficence, and justice. Respect for persons includes the requirement to acknowledge a person’s autonomy and to protect those who have diminished autonomy. Beneficent actions include those that maximize benefit while minimizing harm and that only utilize humans in research when there is likelihood of benefit. The principle of justice is the requirement to treat people fairly and equitably, and that subjects are not used for the purpose of research through any systematic selection process based on a person’s or group’s easy availability or manipulability,or compromised position that are not specific to the problem being studied (Bryn Mawr College, n.d.).

  1. What does individual autonomy mean and who does it specifically protect? Was the principle applied appropriately in the Tuskegee study?

Individual autonomy protects individual freedom through respect of a person’s judgment. Autonomy reflects the capabilities of a person to make choices based on personal goals and opinions, unless those choices are deemed to be detrimental to another. In many cases, however, an individual is not capable of the self-determination that supports autonomy. The ability to understand the choices are conditional upon such things as age and maturity, intelligence, and language, as well as deficiencies caused by such elements as mental illness or disability. In the case of the Tuskagee project, autonomy was prevented from several perspectives. The men in the study were prompted to participate primarily through promises of medical care, food, transportation to medical facilities, and cost coverage for burial expenses, but not from decisions of the full extent of self-determination. In addition, these men were not able to read. Had they been given contracts, written information, or newspapers with updates on the treatment of syphilis, they would not have been able to make decisions based upon the information. Autonomy as a basis of decision making cannot be made if the information is not given or is not understood (Burke & Friedman, 2011).

  1. Define beneficence. Was this principle adhered to in the Tuskegee study? Explain your answer.

Beneficence refers to the specification that potential benefits for individuals and to society be maximized in the effort that potential harms can beminimized (Coughlin, 2008). The moral obligation of beneficence includes that one cannot readily treat another with kindness and charity if goodness does not outweigh risk. However, if an action is not considered morally just to the individual, the greater good is not justified(Burke & Friedman, 2011). In the Tuskegee study, we should argue that the individual good was sacrificed for an interpretation of the greater good, which does not satisfy the rules of beneficence. Many individuals were subjected to spinal injections, were denied diagnosis and treatment, and unintentionally exposed their intimate partners to a preventable disease. The conductors of the study held the belief that this was in an the effort to study the effects of syphilis in the Black population, but the risks do not outweigh the benefits.

  1. What does respect for persons mean and how is it applied in research? Was it applied in the Tuskegee study? Explain your answer.

Respect for persons might be looked at as the umbrella over autonomy, beneficence, non-maleficence, and justice (Coughlin, 2008). Professional public health practices must consider the application of respect for persons in every professional ethics matter in that health professionals are in the position to identify, to contribute to, and to clarify the fundamental ethical aspects of the work done in epidemiology and biomedical research (Coughlin, 2008). Respect was largely ignored in the Tuskegee project. Autonomy and beneficence were not sufficiently considered throughout the 40 year project and it is clear that respect for persons wasnot adequatelyconsidered.

  1. What is the Nuremberg Code? What was it inspired by? What are the core elements in it?

The Nuremberg Code was developed in 1947 in the aftermath of Nazi research on uninformed prisoners in concentration camps. Human participants had unwittingly been victims of medical experiments that led to many permanent disabilities or death. Subsequently, twenty-three physicians and administrators were charged for willing participation in war crimes against humanity (Claremont Graduate University, 2015).As a result of these heinous acts, the ethical principle of informed consent became known as teh Nuremberg Code. The Nuremberg Code specified that any person involved as a human subject for research or experimentation should have legal capacity to give consent, and should be able to exercise free power of choice without force, fraud, fear, deceit, coercion, or duress (Claremont Graduate University, 2015). Furthermore, the subject should be able to comprehend the elements of the matter and research process to the extent that an informed decision can be made (DHHS, n.d.[c]). Core elements of the Nuremberg Code include that it is the responsibility as well as the duty of the individual or entity who initiates, directs, or engages in the experiment to ascertain the quality of the consent (DHHS, n.d.[c]). In addition, any experiment utilizing human subjects must be for the promotion of good, and must be shown to not be attainable through any other course of study, nor to be random or unnecessary (DHHS, n.d.[c]).

  1. Name what went right in the Tuskegee study. Which aspects of it could be replicated today, following the Nuremberg Code, the Declaration of Helsinki, and the Belmont Report?

It is difficult to name what may have gone right in the Tuskegee study. However, it is worth remembering that there were the physicians, considered liberal in the era, that were supportive of the efforts to study syphilis and other venereal diseases, and had intentions to understand how to prevent and eradicate the disease in the early part of the twentieth century. Through the course of history we learn from our mistakes and from those who speak up about such things as ethical treatment. The studies that have occurred in the aftermath of abhorrent treatments as happened in Nuremberg, Helsinki, and Macon County, have shaped codes of ethics across decades. However, we should heed warning that not all human beings are above taking advantage of those with lesser capabilities to be autonomous, and that there are those who may utilize paternalism to the degree of unfairness, maleficence, and injustice, even when law provides protection against such action. Furthermore, it is important to recognize that while the Nuremberg Code was created to create ethical guidelines for the utilization of humans in bio-research, and to protect autonomy and respect of persons, it came into existence 25 years before the Tuskegee project was finally forced to end. Cultivating and promoting ethical conduct is an ongoing process that will change with social, cultural, economic, and medical progressions through time. The lessons learned from poor and unethical treatment of humans and mistakes in judgment,will continue to be made through ignorance and blind obedience, social and leadership pressures or other influences. The study and practice of ethics needs to stay current with education, advocacy,and perseverance.