Tuskegee Syphilis Study
Dr. Joseph Costa, D.H.Sc, PA-C
Health Policy and Management
MPH 525
Jessie McCarty
April 2013
Table of Contents
Chapter Page
1. Tuskegee Syphilis Study...... 2
2. Tuskegee Basics...... 3
3. What Went Wrong?...... 4
Informed Consent...... 4
Vulnerable Populations...... 4
Medical Profession Pursued...... 5
4. Personal Opinion...... 7
5. Basics of Research...... 8
Informed Consent...... 8
Individual Autonomy...... 9
Beneficence...... 9
6. Current Policies...... 11
Policies...... 11
Exceptions...... 11
7. Problems with Waving Consent...... 13
Flexibility...... 13
Vulnerable Populations...... 13
Ethical Dilemmas...... 14
8. Conclusion ...... 16
1
Chapter 1
Tuskegee Syphilis Study
Throughout the years, numerous research studies have taken place. In the United States, on a daily basis thousands of research studies are being conducted. Some of these studies will greatly influence science, while others will make little impact. Historically, some studies have been remembered not for the results, but for ethical dilemmas surrounding the study. The Tuskegee syphilis study is a prime example of a study which made many people aware of the ethical problems surrounding research. The Tuskegee syphilis study made the government begin to analyze how research was performed in the country, and the study opened many eyes to what changes needed to be made. Analyzing the Tuskegee syphilis study allows for one to understand what went wrong with the study and how this study lead to great changes in the world of research.
Chapter 2
Tuskegee Basics
A study regarding syphilis in men was started in 1932 in Tuskegee, Alabama (Presidential Commission for the Study of Bioethical Issues, 2012). This study would go on to be known as the Tuskegee syphilis study. The study focused on syphilis infections in African American men and the progression of syphilis in these men. Presidential Commission for the Study of Bioethical Issues (2012) stated,”When the Tuskegee syphilis studies began, many clinicians believed that a person’s race played a part in how they were affected by syphilis.” Therefore, African American men were specifically used in this study, believing syphilis infections were different in the African American race than Caucasian race.
In total, “600 men were enrolled in the study. Of this group 399, who had syphilis, were a part of the experimental group and 201 were controls subjects. “Most of the men were poor and illiterate sharecroppers form the country” (Tuskegee University, 2013). The men involved in the study were simply told they were being studied for ‘bad blood’ and never were actually informed of their diagnosis or what specifically was being studied. Even when antibiotics became available to treat the disease, the men were deprived of not only this knowledge, but the medication itself. Therefore, the men in the study were left with untreated syphilis in their bodies and some went on to die from complications. It was not until 1972, when The Associated Press printed a story regarding the Tuskegee study, that the Tuskegee research was revealed to the public and the ethical dilemmas arose. Eventually, in 1973, a lawsuit was filed for those men who participated, and their families, and more than $9million was awarded (Tuskegee University, 2013). The Tuskegee syphilis studyrevealed many ethical dilemmas and highlighted the need to truly define informed consent.
Chapter 3
What Went Wrong?
Looking back at the Tuskegee study, it is clear there were many aspects of the study that went wrong. In the end, men died from a disease because they were deprived of the known medication cure. The mistakes made in the study clearly showed the need for change in the process of research.
Informed Consent
One of the clearest mistakes made in this study was the lack of informed consent. Tuskegee University (2013) stated, “Researchers had not informed the men of the actual name of the study, i.e. ‘Tuskegee Study of Untreated Syphilis in the Negro Male,’ its purpose, and potential consequences of the treatment or non-treatment that they would receive during the study.” The men did consent to participating in a study and to a vague definition of the treatments and examinations (Tuskegee University, 2013). However, those studied “never knew of the debilitating and life threatening consequences of the treatments they were to receive… no choices given to the participants to quit the study when penicillin became available as a treatment and cure for syphilis” (Tuskegee University, 2013). Informed consent is supposed to include competence, disclosure, understanding, voluntariness, and then consent (Pantilat, 2008). It is clear to see the men in the study were not provide full disclosure and did not understand the details of the study.
Vulnerable Populations
A vulnerable population was also taken advantage of in this study. According to Tuskegee University (2013), “Most of the men were poor and illiterate sharecroppers from the county.” Therefore, if men were provided paperwork they would not have been able to fully comprehend it and it is likely they were not educated enough to understand what appropriate questions to ask if provided the opportunity. Many also question the influence of race in this study, since when the study was performed racism and discrimination was a very large problem, especially in the south. The presence of racism could be used to justify even calling African Americans, at the time, a vulnerable population. Parker and Alvarez (n.d) stated, “Those who lack the education,emotional maturity, or language and communication skills to understand and appreciate what isdisclosed to them during an informed consent process may also be vulnerable to inappropriate pressureto participate.” This statement explains the complex process of understanding what groups may be vulnerable.
Medical Profession Pursued
Although the participants were suffering from not get treatment for syphilis, the medical profession continued to pursue the study. One reason they may have continued to pursue the study was simply because many did not feel there was a risk of getting caught since the participants were generally poor and uneducated. Also, the study was not being performed to injure anyone, but to simply study participants. Therefore, many in the medical profession most likely did not think they were doing anything wrong since they were not causing direct harm. Parker and Alvarez (n.d) explained the study “was not an experiment in the sense that an intervention was tested. Its initial methodologyinvolved collecting data to trace the course of a disease in members of a population and the prevalenceof the disease in that population.” Many in the medical profession felt that simply withholding a new medication for treatment was not a source of intentional harm.
The medical profession also pursued the study because the results of the study would be helpful to understand syphilis and how the disease affected African Americans. Without performing the study, it would have been very hard to understand this disease and the specific effects of the disease on a specific race. Many could argue the study was not performed with the intention to harm a vulnerable group but, the lack of informed consent and full disclosure, did lead to harm and even fatalities.
Chapter 4
Personal Opinion
In my personal opinion, there are many aspects of this study I would have changed. By far, the greatest error made was the lack of informed consent. Sure, the participants agreed to be in a study. However, not informing them about having syphilis, and not providing them with Penicillin when it became available as a treatment, was not fully disclosing information to the participants. Full disclosure would have led to lives being saved and helped control the spread of the disease to others. Informed consent is necessary and it is not enough to just get consent to involve a participant in the study. Those involved must be told the details about the study and the possible benefits and risks of being in the study.
Knowing those picked to be in the study were poor and typically uneducated, I would have made sure issues with the vulnerability of this population were addressed and that implied consent was fully understood. Also, if I wanted to focus on African American men, I would have chosen men throughout the country with syphilis, and not just those in the rural, south who were poor and uneducated. This would have not only made for less bias in the study and broadened the applicability of the study, but it would have decreased the ability to say the study was performed only on a specific vulnerable group.
Overall, this study needed informed consent and also autonomy and beneficence. There was a lack of respect and caring from the researchers and the participants were left to suffer, and even to die, without knowing there was a treatment. The study was not performed with respect for human life or the quality of human life.
Chapter 5
Basics of Research
Research is conducted with many intricate concepts of research kept in mind. These concepts of research include topics such as informed consent, individual autonomy, and beneficence. One must truly understand these concepts in order to understand research which has already been performed, and understanding these topics will help to perform research safely and correctly in the future.
Informed Consent
Informed consent is perhaps one of the most important concepts of research, especially when looking at what went wrong in the Tuskegee research. Informed consent is not a simple concept only applying that the person involved in research has consented to being in research. The concept of informed consent involves respect and beneficence. “Respect for persons requires that subjects, to the degree that they are capable, be given the opportunity to choose what shall or shall not happen to them. This opportunity is provided when adequate standards for informed consent are satisfied” (U.S. Department of Health and Human Services [HHS], 1979).
Informed consent involves competence, disclosure, understanding, voluntariness, and then consent (Pantilat, 2008). HHS (2013) explained getting consent involves, “disclosing to potential research subjects information needed to make an informed decision, facilitating the understanding of what has been disclosed, and promoting the voluntariness of the decision about whether or not to participate in the research.” Informed consent “must be legally effective and prospectively obtained” (HHS, 2013). Requiring consent shows respect for those in the research and “the requirement to obtain the legally effective informed consent of individuals before involving them in research is one of the central protections provided for under the HHS” (HHS, 2013). Informed consent not only allows for individual autonomy, but shows beneficence as well.
Individual Autonomy
Individual autonomy is a very important concept to understand when performing research or when attempting to understand research which has already been performed. Pantilat (2008) defined autonomy as, “the personal rule of the self that is free from both controlling interferences by others and from personal limitations that prevent meaningful choice. Autonomous individuals act intentionally, with understanding, and without controlling influences.” An individual is autonomous when he or she is truly making decisions without being told, or influenced, about how to make the decisions. Individual autonomy is important because it gives individuals a sense of control. Also, in research autonomy is important because research is often performed to see how individuals act and behave without being greatly influenced. Pantilat (2008) stated, “respect for autonomy includes respecting an individual’s right to self-determination as well as creating the conditions necessary for autonomous choice.” Having respect for individual autonomy is necessary with research.
Beneficence
Just as individual autonomy is important in research, beneficence is also a necessary part of quality research. Pantilat (2008) defined beneficence as “an action that is done for the benefit of others. Beneficent actions can be taken to help prevent or remove harms or to simply improve the situation of others.” Whereas autonomy is granted to the individual in research, beneficence is an action performed by the researchers themselves. Beneficence helps to ensure those involved in the research are not being purposefully harmed and are aware of the dangers of research. Pantilat (2008) also stated those with beneficence “prevent and remove harms, and weigh and balance possible benefits against possible risks of an action. Beneficence can also include protecting and defending the rights of others, rescuing persons who are in danger, and helping individuals with disabilities.” Beneficence is very important to ensure to make those participating in research feel safe and respected.
Chapter 6
Current Policies
Understanding some of the basic concepts of research, such as individual autonomy, beneficence, and consent, one can understand how these concepts can be complex and why policies have been created to make these concepts more clear. Specifically, the concept of consent has been misunderstood and taken advantage of in the past. The Tuskegee study showed a lack of respect and understanding of the concept of informed consent. Therefore, policies regarding individual consent have been created.
Policies
In 1974, “The National Research Act (Pub. L. 93-348) was signed into law, there-by creating the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research” (HHS, 1979). This act helped enforce the importance of individual consent and autonomy. Also, the act helped stress the importance of ethicalprinciples and helped define what consent really involves. Many current federal regulations have stemmed from this act, such as Title 45, Part 46 which deals with public welfare and protection of human subjects. HHS (2013) stated, “The HHS regulations at45 CFR part 46for the protection of human subjects in research require that an investigator obtain thelegally effective informed consentof the subject.” These federal policies define the concept of consent, as aforementioned, and stress the federal mandate requiring consent.
Exceptions
Although informed consent is typically required, there are scenarios when it is not needed. Consent can only be waived if researchers can prove “no more than minimal risk to the subjects” (HHS, 2013). Also, HHS (2013) stated the researchers must show “the waiver or alteration will not adversely affect the rights and welfare of the subjects, the research could not practicably be carried out without the waiver or alteration, and the subjects will be provided with additional pertinent information after participation.” Consent cannot simply be waived based on the preference of the researchers and instead, must be shown to be waived for a necessary reason.
Some reasons for excluding consent include research performed in emergency settings and research which could not be performed if consent was required (HHS, 2013). HHS (2013) also stated reasons for excluding consent includes research being performed for “public benefit or service programs, procedures for obtaining benefits or services under those programs, possible changes in or alternatives to those programs or procedures, or possible changes in methods or levels of payment for benefits or services under those programs.” Even in these situations where consent is not required, there must be adequate proof of no additional harm to participants and reason justifying why consent was not needed.
Chapter 7
Problems with Waving Consent
As explained, there are situations when consent is not required. Obviously, these policies allow for researchers to have some type of flexibility instead of requiring consent in every single case. Although not always requiring consent can lead to more precise and accurate results from research, not requiring consent can also potentially lead to problems.
Flexibility
Anytime rules are provided some flexibility, people will take advantage of these situations. For example, knowing consent can be waived in emergency research, many researchers could try labeling situations as emergencies to simply avoid getting informed consent. Many of the other exclusions for consent could also be taken advantage of in similar ways. However, knowing there are rules even in those exclusion situations, such as avoiding harm to the patient regardless of consent, helps to prevent repeat situations such as the Tuskegee situation.
Vulnerable Populations
Although rules are in place even when consent is waived, there still will be problems with waiving consent. As aforementioned, some researchers may try to label research in a way to avoid having to get consent. Also, the participants may not be aware of the consequences of not being consented in exclusion cases and therefore, may be taken advantage of. Special considerations must be taken, especially when waiving consent, to vulnerable populations. Vulnerable populations can include children, cognitive impairments, pregnant women, fetuses, prisoners, and those who do not speak the language (University of California-San Francisco [UCSF], 2012). There are special legal requirements in how to get consent from these vulnerable populations and when consent can be waived in these vulnerable populations. Unfortunately, the process of waiving consent for this population can be taken advantage of. Because those in vulnerable populations are often not able to express consent, or approval or disapproval of situations, many people may ignore their needs and rights. Therefore, the legal requirements are very important in regards to this population. However, many people may try to still take advantage of these vulnerable populations despite the legal requirements simply because those in the vulnerable populations may not complain.