Running Head: TUSKEGEE STUDY
Tuskegee Syphilis Study
Bosede Adedire, Sylvia Assiamah, Rachel Adejoh & Tracy Brooks
Coppin State University
Helene Fuld School of Nursing Family Nurse Practitioner
Ethics
NURS 500
Dr. Emmanuel Obiako
July 18, 2013
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There have been different documentations on historical research studies that involve
the use of human subjects; however, some of these studies have been flawed with violation of
ethical and moral principles. This paper explores and highlights the violations of one of such
research experiment, how it undermines what currently holds true in reference to research
guidelines and its impact in the establishment of several ethical codes and regulations. For the
purpose of this paper; the Tuskegee syphilis research study will be reviewed.
McCance, Huether, Brashers, and Rote
(2010) defines Syphilis “as an infectious
venereal disease caused by the spirochete Treponema pallidum, which is transmissible primarily
by sexual contact with infectious lesions, from mother to fetus in utero, via blood product
transfusion, and occasionally through breaks in the skin that come into contact with infectious
lesions” (p. 830). According to Porth, and Matfin, (2009) “untreated syphilis can progress
through series of stages which eventually lead to organ damage including the brain, nerves,
eyes, heart, blood vessels, liver, bones, and joints” (p. 389).
Syphilis was reportedly a prevalent but poorly-understood disease in the early 1930s,
much about the disease and its progression was unknown (Walker, 2009, para. 6). Report
indicates that “due to lack of familiarity with the disease many cases were incorrectly diagnosed
as syphilis” (Davis & Aroskar, 2011, p. 241). As the etiology of the disease evolved, it became
increasingly urgent to find a treatment or understand its long-term effects, because of the
findings that the disease itself could result in unwanted consequences if left untreated. In urgent
response to the outbreak of syphilis, (as cited by Levine, Williams, Kilbourne & Juarez, 2012)
the United States Public Health Service (PHS) carried out a surveillance that revealed prevalence
of syphilis in Macon County, Alabama. The PHS in response to surveillance result initiated a
program aimed at controlling the disease, a program funded by a benevolent organization for a
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two-year demonstration study in Macon County, Alabama “where 82% of the residents were
African-Americans, most of who were socioeconomically under privileged with little or no
access to health care” (Walker, 2009, para. 8).
The principal aim of the program was to determine the incidence of the disease in the
local population. From the study, (as cited by Levine, Williams, Kilbourne & Juarez, 2012)
results revealed that 36% of Macon County African-Americans had syphilis, which was far
higher than the national rate, concerned about the racial implications of this finding, the
sponsoring organization refused requests to support a follow-up project. Infected residents were
left to face the consequences of untreated syphilis (Appendix D).
However, the inability to provide funding for participant follow-up from previous study
led to a new study that aimed to examine the progression of untreated syphilis in AfricanAmericans in Macon County, Alabama. The new study originated what evolved into "The
Tuskegee Syphilis Study", a project that continued for forty years. In the study, a total of 616
participants were involved in the study with 399 with the disease and 217 without the disease as
control. The study participants were told they were going to be treated for ‘bad blood’. The
researchers (as cited by David, Green, & Kartz, 2012) sent out recruitment letters and postal
(Appendix B) indicating the last time for treatment option when in fact they were not treated but
only being used for a study to discover the progression of the disease if untreated.
The researchers were so fascinated by findings from this study that they continued with
the study even when a treatment was found for the disease. It was ensured that none of the study
participant was offered treatment even when they knew what their situation was. Study
participants were exposed to face the consequences of untreated syphilis, which is one of the
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reasons why the Tuskegee syphilis study has been reviewed by different scholars as a separate
study.
The Tuskegee syphilis study has been described in different literatures from diverse
point of view, as “unethical, racially motivated and manipulative in its research approach”
(David, Green, & Katz , 2012, para. 2;. Levine, Williams & Kilbourne, 2012, para. 6; Gupta,
2013, para. 8). In a study to explore the impact of past events on the willingness of African
Americans to participate in biomedical research or compliance with prescribed regimen, scholars
found out that the sequence of events in the Tuskegee syphilis study plays “a significant role in
reasons why some African Americans are not compliant with recommended care practices and
explains their reluctance to participate in medical research” (David, Green, & Katz , 2012, para.
6), the article concludes that the Tuskegee study was deceitful and sneaky in its approach and act
towards study participant. They describe the 40 year long research study as manipulative for
“exploiting hundreds of black sharecroppers with syphilis, following and studying these subjects
without their consent to be in the study, until their death” (David, Green, & Katz, 2012, para. 8).
Moreover, the Tuskegee syphilis study has long been blamed for the reason why some
African Americans are reluctant to participate in medical research studies. However, new
findings indicate that the unwillingness of African Americans to take part in research studies due
to events from the Tuskegee experiment does not appear to be a concern in today’s health care
practices and their willingness to participate in biomedical research studies (David & Arokar,
2011, para. 6, Levine, Williams & Kilbourne, 2012, para. 6). Bozeman, Slade, and Hirsch
(2009) added that the origination of many of the ethical codes and regulations that has been
instituted to protect human participants in research studies, has encouraged African Americans to
be inclined to participate in research studies (para. 8). Therefore, the potential fear of ethical
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violations such as those which occurred in the Tuskegee experiment is no longer a major
deciding factor for African Americans’ participation in research studies.
Likewise, other works explores reasons why the Tuskegee syphilis study was only on
black men in a low socio-economic group to demonstrate the effect of inequality and segregation
during the period. The study affirms that the Tuskegee study violates the moral framework of
beneficence, nomaleficence, autonomy, and justice. The article determines that the Tuskegee
study was racially motivated and confirms the effect of disparity of that period. Scholars
describes the study as being “racially motivated and deceitful by recruiting only black men into
the study without disclosing to them the nature of the study” (Walker, 2009, para. 6; David &
Arokar, p. 136) and what was required of participants.
Additionally, Ogungbure (2011) investigates ethical violations of the Tuskegee study and
its impact on present medical research, the article describes the study as unethical as it violates
human right principles, by coercing participants into the research study thereby violating their
rights of self- determination through coercion, deception and undisclosed data collection (para.
2). The study has also being fraught with infringement of currently known elements of ethical
research, and undermines the functions of the institutional review board (IRB). Levine, Williams
& Kilbourne (2012) added that the works of organizations such as the IRBs have been instituted
to ensure that research studies abide by ethical guidelines (para. 2), to make sure research studies
are free of ethical violations, especially those that involve human subjects to protect participant
safety in medical and scientific based research, such that the abuse of human subjects as it
occurred in the Tuskegee syphilis experiment is less likely to re-occur in today’s biomedical
research environment.
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Currently, there are a number of established ethical guidelines and regulations to guide
research studies. Though these guiding principles followed several unethical research studies,
including the Tuskegee syphilis experiment, however, appraisal of the sequence of events from
the study in light of existing regulations for research studies, the Tuskegee syphilis study is
flawed with violations of these ethical guidelines, among these violations are: the violation of
ethical principles for the protection of human subjects instituted in 1978; the Nuremberg code of
informed consent put in place in 1949, Health Insurance Portability and Accountability Act
(HIPAA) privacy rule and human right principles. “Infraction of ethical principles, human rights,
privacy rules and the established Nuremberg code has made the Tuskegee experiment an
unethical study” (Levine, Williams, Kilbourne & Juarez, 2012, para. 8).
The Tuskegee syphilis study started with recruitment letters (Appendix B, Figure 1)
mailed to potential study participants to enlist them in the study. The recruitment letter notified
participants of their ‘last chance’ to be treated for ‘bad blood’ with a ‘special treatment’. The
content of the recruitment letter and the approach used by the study researchers “to recruit
participants for the study has being described as coercive, deceptive and manipulative” (Gupta,
2013, para. 3). The content of the recruitment letter was misleading, because it failed to explain
the nature of the study, procedures involved in the study, disclosure of risks and benefits, and
also it did not provide participants with the right to make a voluntary decision to participate in
the study, which violates the Nuremberg code of voluntary informed consent.
Furthermore, the ‘use’ of human subjects in the study as indicated by unnecessary
medical procedures (Appendix C, Figure 1& 2) that had no benefits to study participants infringe
on ethical principles established by the National commission for the protection of human
subjects. Participant’s right for respect was violated by using their body unjustly for an
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experiment that had no benefits to them, but instead a high risk on their health, self-image and
ultimately death. The study undermines participants’ right for freedom from harm, exploitation
and failed to put into consideration the risk versus benefit ratio that the study had towards human
subject which violates the principle of beneficence. Burns & Grove (2011) describes beneficence
as an ethical principle which involves actions geared towards helping others (p. 58).
Additionally, the group of medical professionals (Appendix A), the researchers involved
with the Tuskegee study was supposed to honor the principle of beneficence by conducting
research that was medically beneficial to the subjects and not otherwise. Nonetheless, this
principle was violated when the researchers failed to defend the rights of the subjects and
knowingly put them in harm’s way, which also undermines important professional virtues of
compassion and violates the principle of nomaleficence.
Another highlight of ethical principle violated by the Tuskegee study is the principle of
justice. Beauchamp and Childress (2009), define justice as “fair, equitable and appropriate
treatment in light of what is owed or due to persons” (p. 241), although there exists abundant
theories of what constitutes justice, however, “fairness and equal treatment are strong objectives
when it comes to research involving human subjects” (Bozeman, Slade & Hirsh, 2009, para. 6).
Beauchamp and Childress (2009) added that objectivity involves “fair, equitable, and appropriate
dealings determined by justified norms that structure the terms of social interactions” (p. 241).
However, the Tuskegee study participants “received unfair treatments by being pressured into a
harmful study due to their low socio-economic background and vulnerability” (Walker, 2009,
para. 6) which makes them susceptible to a study that defiles social interaction.
Similarly, research samples were collected with no privacy (Appendix
C), and no
confidentiality, in the presence of other people which violates subjects right to privacy to
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determine the general circumstances under which their information or health status should be
handled. Ogungbure (2011) explained that “participants were abused physically and mentally by
research investigators through series of unnecessary medical procedures done on these subjects,
use of placebos without participants’ being well-informed of treatment, data collections from
study subjects involved periodic blood draws and spinal taps”(para. 3), hurtful procedures which
had no value to their treatment. These procedures violate the moral principle of non-maleficence.
Furthermore, in accordance with the principle of non-maleficence, medical researchers
have an obligation not to induce any form of harm to research subjects, “a duty that emphasizes
above all do no harm” (Beauchamp & Childress, 2009, p. 149). In addition, the Tuskegee
experiment investigators violated this principle by withholding standard treatment for syphilis
from study subjects, even when penicillin was discovered (Appendix D) as treatment for
syphilis. Even more disturbing is the fact that “a few men who questioned the study's nontherapeutic protocol were “warned of the dangers of taking Penicillin” (Walker, 2009, para. 6).
As the study progressed, participant’s mortality and morbidity were recorded over the period
which was an indication to research investigators the level of risk involved in the study.
However, they continued with the study, an instance that indicates a violation of the Nuremberg
code which specifies to stop a study if a casualty results. By the time the study ended in 1972,
“out of the 399 original research subjects, 28 had died as a direct result of syphilis, with 100
more dying due to complications of syphilis” (Davis, Green & Katz, 2012, para. 4). The events
from the study experiment paved way for the establishment of rules that guides research studies.
The implication of the Tuskegee syphilis experiment for the current laws and regulation
for research studies, especially as it relates to human subjects cannot be over emphasized. The
nature of the study has a profound significance in the institutions of current procedures used in
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biomedical and research studies. There are numerous codes and regulations guiding the use of
human subjects in research today, such as the Nuremberg Code instituted in1949 to guide the use
of human subjects; the National Commission for the protection of human subjects of biomedical
and behavioral research established in 1978 to guide principle of respect for persons, beneficence
and justice. Declaration of Helsinki in1964 was established to ensure therapeutic benefit of
scientific study to the subjects, or for the future. IRB was instituted to ensure protection of
human subject. Also, the Department of health education and welfare regulations (DHEW)
mandates rules to guide the use of subjects with diminished autonomy. The subsequent
guidelines and regulations that results from the impact of the Tuskegee study has enforced the
need to have all research studies be screened by IRBs to protect human rights and welfare, to
ensure consent is voluntary and subjects are well informed about the benefits and risks involved
in a study.
In essence, researchers are now obligated to provide adequate information to subjects
and to make sure that subjects are competent enough to comprehend such information. They are
also obligated to give subjects full disclosure of the nature of the study, duration of the study, the
benefit versus risk and the right to withdraw at any time without penalty or fear of undue
controlling influence. Moreover, the impact of the Tuskegee experiment has been demonstrated
through current knowledge of ethical obligations which mandates a study to stop or come to an
end if fatality or any forms of harm results. An instance of these events is the asthma study in
Johns Hopkins University that results in death of one of the participants and the study was
brought to an abrupt end with the death of one participant. Basically, the Tuskegee experiment
has reinforced the need to enforce necessary guidelines in research studies that involves human
subjects. According to the United States Department of Health and Human Services (DHHS), “a
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human subject in research is a living individual about whom a research investigator obtains data”
(Gupta, 2013, para. 2). Research agents are currently required to follow defined protocols in
conducting research experiments, these ethical guidelines that govern the use of human subjects
in research are detailed regulations put in place to protect subjects from abuses.
Regulatory bodies were institutionalized to ensure that instituted policies are
implemented to minimize harm to participant's mental or physical wellbeing. The Nuremberg
Code emphasized the concept that ‘the voluntary consent of the human subject is absolutely
essential’, the emphasis that was placed on individual consent in the Nuremberg Code was aimed
at keeping participants informed of the risk-benefit outcomes of experiments. Likewise, other
guidelines in protection of human subjects include the principles that “research protocols be
reviewed by an independent committee prior to initiation and that research with humans be based
on results from laboratory animals and experimentation” (Levine, Williams & Kilbourne, 2012,
para. 6).
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References
Beauchamp, L., & Childress, F. (2009). Principles of Biomedical Ethics.
(5thed.). New York: Oxford University Press
Bozeman, B., Slade, C., & Hirsch, P. (2009). Ethics in research and practice. American Journal
of Public Health, 99, 1549-1556.
Burns, N., & Grove, S.K. (2011). Understanding nursing research. (5th ed).
Saunders Elsevier
Davis, A.J., & Aroskar, M. A. (2011). Ethical dilemmas and nursing practice. (5th ed).
Pearson Publishers
Davis, L., Green, B., & Katz, R. V. (2012). Influence of scary beliefs about the Tuskegee
syphilis study on willingness to participate in research. ABNF Journal, 23, 59-62.
Gupta, U. (2013). Informed consent in clinical research: Revisiting few concepts and areas.
Perspectives in Clinical Research, 1, 26-32. Retrieved from
http://www.picronline.org/article.asp?issn=22293485;year=2013;volume=4;issue=1;spage=26;epage=32;aulast=Gupta
Levine, S., & Williams, C., Kilbourne, A., & Juarez, P. D.(2012). Tuskegee
redux: Evolution of legal mandates for human experimentation. Journal of Health
Care for the Poor and Underserved 23(4), 104-125. The Johns Hopkins University
McCance, K., Huether, S., Brashers, V., & Rote, N. (2010). Pathophysiology: The
Biologic Basis for Disease in Adults and Children (6th ed.). Missouri: Mosby Inc.
Ogungbure, A. (2011). The Tuskegee syphilis study: Some ethical reflections. Thought and
Practice: A Journal of the Philosophical Association of Kenya (PAK), 3(3), 75-92.
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Porth, C. & Matfin, G. (2009). Pathophysiology: Concepts of altered health states
(8th ed.). Philadelphia: J.B. Lippincott-Raven.
Walker, C. A. (2009). Lest we forget: The Tuskegee experiment. Journal of
Theory Construction and Testing. pp. 5-6. Press.
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Appendix A
Faces of Tuskegee Syphilis Experiment Team
Dr. Taliaferro Clark
Dr. Oliver C. Wenger
Dr. Eugene Dibble
.
Dr. Raymond H. Vonderlehr
Dr. John R. Heller
Nurse Eunice Rivers
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Appendix B
Figure 1: Tuskegee Study Participant Recruitment Letter
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Figure 2: Tuskegee Recruitment Postal
Figure 3: Group of Tuskegee experiment test subjects
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Appendix C
Figure 1:
Blood sample taken as part of the
Tuskegee syphilis study
Spinal tap carried out on one of the
study participants
Figure 2: Doctor attending to one of the Tuskegee study participant
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Figure 3: Pharmaceutical display of syphilis treatment, though not made available to study
subjects.
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Appendix D
Figure 1: One of the participant with result of untreated syphilis
Figure 2: Another participant with result of untreated syphilis
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Figure 3: Some illustration of consequences of untreated syphilis
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