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Running Head: Tuskegee Syphilis Study
Tuskegee Syphilis Study
Tanya Staton
Concordia University
October 20, 2013
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Syphilis is an infectious disease that was once one of the leading causes of morbidity and
mortality in the early 20th century. Like AIDS today, there was social stigmatism attached with
the disease because it was sexually transmitted. Syphilis was left unreported at times and
information was scarce about the disease. In 1932, a clinical trial was conducted in Macon
County, Alabama that involved 600 black males. Out of the 600 participants there were 399
males that had syphilis and the others were non-infectious (cdc.gov). The study was put together
to observe the men and their symptoms while not receiving treatment during the course of the
disease. The investigators of the study did not ask the subjects for their permission to be studied
and information was never disclosed to the subjects on what the study was researching. The
name of the research trial was not even known to the participants. The researchers preyed on the
participants’ lack of education and lower socioeconomic status in order to persuade them to take
part in the study by telling them they had “bad blood” (Schneider, 2009). The medical slang "bad
blood" represented a number of ailments in the early 20th century; some examples included
anemia, fatigue and syphilis. The research participants were offered free medical exams, free
meals and burial insurance for their contribution to the study. To them it looked like the
government was offering them free healthcare and helping take care of them during the Great
Depression—a time when help was needed. Instead the government knew the research subjects
had syphilis and neglected to treat them properly. This clinical trial was called the “Tuskegee
Study of Untreated Syphilis in the Negro Male” (cdc.gov). The study took place over the course
of 40 years and is considered to be one of the most unethical human research trials to date in the
United States.
Syphilis is an infectious disease that is caused by the bacteria Treponema pallidum.
Syphilis is caused by a bacterium and because of this it can be easily treated with an antibiotic.
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The antibiotic most commonly used for treatment of syphilis is penicillin (webmd.com). When
the study began in 1932 there was no known cure for syphilis, but in the 1940s penicillin became
the standard course of treatment for the disease (Chadwick, 2002). Even with a known cure, the
participants of the Tuskegee Syphilis study did not receive treatment because investigators still
wanted to research how the infectious disease progressed. The subjects of the study were led to
believe they were being treated for whatever ailment they assumed they had, but instead they
were not receiving any significant treatment. Finally, in July 1972 after 40 years of trials, the
Washington Evening Star newspaper printed a story with the headline "Syphilis Patients Died
Untreated" (npr.org). After the story went to print, outraged citizens forced the Assistant
Secretary for Health and Scientific Affairs to develop an advisory panel to review the ongoing
research trial (cdc.gov). After reviewing data from the study the panel agreed to stop the study in
October of 1972, claiming that is was "ethically unjustified" (cdc.gov). The Tuskegee Syphilis
Study forever changed how human research trials were conducted and operated in the United
States and the National Research Act of 1974 was subsequently signed into law. Congress also
signed the Basic Health and Human Service Policy for Protection of Human Research Subjects
into law and the Department of Health, Education and Welfare initiated the adoption of the
National Commission for the Protection of Human Subjects of Biomedical and Behavioral
Research (cdc.gov).
The Tuskegee Syphilis Study could be labeled wrong on many levels. The investigators
withheld life-saving drugs from the participants. Syphilis is an intricate disease with primary,
secondary and tertiary stages (webmd.com). By the time penicillin was recognized to
successfully treat syphilis, the patients were probably already in the later stages of the disease,
making penicillin an ineffective course of treatment. The deception of the research study and
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failure to get informed consent is also a major fault of the research trial. Researchers designed
the study inadequately by only having black males as research participants. Syphilis is a disease
that can infect anyone, not just African American males. Because the investigators only singled
out black males to be human research participants, the Tuskegee Syphilis Study is not only
unethical but can also be viewed as racist. The exposé of the study brought about changes to the
methods researchers use to conduct human experiments. Congress passed The National Research
Act to establish guidelines for any research that was to be done on humans. These guidelines are
established to protect the participants and the investigators for future trials and to make sure
there would not be a repeat of an unethical study like what happened in Tuskegee (cdc.gov).
The National Research Act established the Belmont Report in 1979 to focus on ethical
principles and guidelines for the protection of human subjects of research (hhs.gov). The
Belmont Report contains three basic ethical principles: respect for persons, beneficence and
justice. Although the guidelines are clearly outlined, there are still challenges that can arise for
researchers when applying the Belmont principles. The principle of justice can be a challenge in
making sure participants are not picked differently based on a certain classification, i.e., race,
socioeconomic status or ease of availability (hhs.gov). Another key concern in human trials is
trying to avoid coercion and making sure compensation does not exceed an amount that might
persuade the research participants into the study. The main challenge with the principle of
beneficence meaning "to do no harm" is determining at what time risks prevail over benefits.
Trial investigators must also be aware of individual autonomy when choosing trial participants.
The individual must have the capacity to understand the benefits and dangers of the study which
they are consenting to. If an individual does not have the capacity to consent, then a legally
authorized representative must provide permission on their behalf.
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The Tuskegee Syphilis Trial neglected to properly acquire informed consent from the
individuals before researchers started the study. The Belmont Report also outlines rules and
regulations that must be followed involving informed consent for human research trials.
Informed consent contains three elements: information, comprehension and voluntariness
(hhs.gov). The research participants must be given sufficient information regarding the study and
what it will entail. The research investigator must also present the material in a matter that is not
confusing and can be easily understood by the individual. The risks and benefits that might arise
must be clearly stated and the participants must be aware that they can withdraw from the trial at
any point without a loss of benefit. There are cases where incomplete disclosure is justified. If
incomplete disclosure is truly necessary for the research, there must only be minimal risks
involved to the subject and a plan for debriefing subjects must be established (hhs.gov).
There are also scenarios where informed consent can be waived. The most common is
during an emergency care scenario. If informed consent was to be waived for a particular
research study then the International Review Board (IRB) and the investigators would have to
examine multiple variables before allowing the study to continue. The IRB are required
committees by the Health and Human Services. They are established to safeguard the rights and
welfare of human subjects (hhs.gov). The IRB might approve a wavier if they can find and
document that:
(1) The research involves no more than minimal risk to the subjects;
(2) The waiver or alteration will not adversely affect the rights and welfare of the
subjects;
(3) The research could not practicably be carried out without the waiver or alteration;
and
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(4) Whenever appropriate, the subjects will be provided with additional pertinent
information after participation.
In my opinion, waiving consent forms for any research trial is a bad idea. The biggest problem
would be legal ramifications. If there is no written and legal documentation that a participant
agreed to engage in research then what happens if a problem does arise? The question of when to
waive consent is another problem. Some people might view the trial coordinators as taking
advantage of the human subjects if they provide consent forms for one demographic but not for
another. The Tuskegee Syphilis Study proved that backlash can occur without informed consent.
Informed consent also helps with the validity of the research study by making sure researchers
uphold ethical standards.
From an ethical standpoint, researchers should have stopped the trial, but from a clinical
standpoint I can see why the investigators would want to keep the study going and why it would
have probably continued to bear valid results. Like I stated previously, syphilis is very complex
and each stage has different symptoms and contagious qualities. When the study began in the
1930s, there was little information about the bacterium that caused syphilis and the severity of
symptoms that occurred in later stages. The investigators wanted to provide groundbreaking
research on an infectious disease that plagued many people. Being able to see what happens to
the body from the point of infection to death can sway researchers to exclusively focus on the
science and not the morality of the study.
There are things I would have changed about this study had I been the lead investigator. I
would have been upfront and honest about the study and I would not have tried to deceive or
withhold important information form the research participants. However, I can see why
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researchers withheld information. Researchers conducted the study during the Great Depression
and funding was probably limited. I am sure the study would not have been possible had there
not been enough participants to begin with, so the researchers probably withheld information to
allow the study to move forward. I also would have changed the study design by changing how
the research participants were selected and by including a blend of the population instead of just
a focus on African American males. I understand why the investigators chose the population they
did. There were numerous black males in the area that were infected and, due to economic
hardships, they could be easily persuaded into the study. However, a well-designed research
study has a mix of the population. Including other races and genders also avoids research studies
from being racially motivated. Since some of the males were already known to be infected with
syphilis and some were not I would have designed the study to be a case-control study. I would
have examined the men to see if there was already a link between the exposed versus the nonexposed.
In 1973, Congress held hearings to decide compensation for the participants that were
enrolled in the study. Congress established the Tuskegee Health Benefit Program in 1974 to pay
for medical care and burial expenses for the study participants and their families. In 1997, 25
years after the study had ended, President Bill Clinton finally gave a national apology to the
families that were affected. Eight years later the last Tuskegee Syphilis Study patient died
(cdc.gov). The study has had a lasting impact on the way research trials are viewed, interpreted
and conducted on humans. People are hesitant to participate in human research studies after what
happened in Tuskegee, especially in the African American population. Human trials play a vital
role in clinical research but there needs to be respect and trust between the investigator and the
participant. The Tuskegee Study of Untreated Syphilis in the Negro Male resulted in wonderful
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legislation in regards to research ethics and standards, but unfortunately some of the best
legislation is created due to horrendous events. President Clinton best summarized the study
when he said "The United States government did something that was wrong—deeply,
profoundly, morally wrong. It was an outrage to our commitment to integrity and equality for all
our citizens” (cdc.gov).
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Tuskegee Syphilis Study
References
Schneider, MJ. (2011). Introduction to Public Health (3rd edition). Sudbury, MA: Jones &
Bartlett
Center for Disease Control and Prevention. (2013). U.S. Public Health Service Syphilis Study at
Tuskegee. Retrieved from http://www.cdc.gov/tuskegee/timeline.htm
Chadwick, A. (2002) Remembering Tuskegee. Retrieved from
http://www.npr.org/programs/morning/features/2002/jul/tuskegee/
Center for Disease Control and Prevention. (2013). How Tuskegee Changed Research Practices .
Retrieved from http://www.cdc.gov/tuskegee/after.htm
U.S. Department of Health and Human Services. (2013). The Belmont Report. Retrieved from
http://www.hhs.gov/ohrp/humansubjects/guidance/belmont.html
U.S. Department of Health and Human Services. (2013). Informed Consent – FAQs. Retrieved
from http://answers.hhs.gov/ohrp/categories/1566
Web Md. (2011). Syphilis-Topic Overview. Retrieved from http://www.webmd.com/sexualconditions/tc/syphilis-topic-overview