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TUSKEGEE SYPHILIS STUDY

PREPARED BY
Bosede Adedire, Rachel Adejoh, Sylvia Assiamah and Tracy Brooks

Coppin State University
July 18, 2013

CONTENT OUTLINE
Background of study
What is syphilis?
Case study
Literature review
Exhibit 1- Analysis of study violations
of
Nuremberg codes
 Exhibit 2- Analysis of study violations




of ethical and moral
principles
 Exhibit 3- Analysis of study violations
of other ethical codes
 Demonstration of study events to the
evolution of current laws guiding use

Warning!
Be advised this presentation
may contain explicit and
disturbing graphics.
Thank you!

BACKGROUND
 Syphilis was prevalent in the early
1930s, disease and its progression
was unknown
 As the disease evolved , it
prompted an urgent need to study
disease progression more
 Public Health Service (PHS) carried
vigorously
out a surveillance that revealed
widespread of syphilis in Macon
Alabama
 County,
Initiation of a program aimed at
controlling the disease
 A two-year demonstration study in
Macon County, Alabama
 Study result from demonstration
brought the study to an abrupt end

Macon County, Alabama

WHAT IS SYPHILIS?

 Syphilis is an infectious venereal disease caused
by the spirochete Treponema pallidum. Transmissible primarily by:
 Sexual contact with infectious
lesions
 Mother to fetus in utero
 Via blood product transfusion
Signs and Symptoms
 Chancre
 Skin rash
 Flu-like symptoms
Untreated syphilis can eventually lead to organ damage including
 The brain
 Nerves
 The heart
 Blood vessels, liver, bones, and
joints

THE CASE
Faces of Tuskegee team
 Due to lack of funding to follow-up with
treatment, another study was initiated to
study the progression of syphilis in the
people that already got the disease.
 The origination of this study started what is
now known as the Tuskegee Syphilis Study
 616 participants, 399 with disease and 217
as control group
 No stated ethical guidelines for research study
 Order of events in study

Literature
Review..

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.
 Literature explores the impact of past events on the willingness of African Americans to
participate in biomedical research
 Sequence of events in the Tuskegee syphilis study has been
blamed for reasons why African Americans are reluctant
to participate in medical research. But scholars found out
it does not appear to be a major factor today.
 Also, researchers concludes Tuskeegee
syphilis study violates moral and ethical
principles .

terature Review cont..

Walker, C. A. (2009). Lest we forget: The Tuskegee experiment.
Journal of
Theory Construction and Testing. pp. 5-6. Press.

 Article investigates reasons why the Tuskegee study was only on
black men in a low socio-economic group to demonstrate the
effect of inequality and segregation during the period
 Findings concludes that the Tuskegee study
was racially motivated and confirms the
effect of disparity of that period.

 Affirms that the Tuskegee study violates the
moral framework of beneficence,
nonmaleficence, autonomy, and justice

terature Review cont…
Gupta, U. (2013). Informed consent in clinical research: Revisiting few concepts and
areas. Perspectives in Clinical Research, 1, 26-32.
 Study evaluate procedures used by study researchers to conduct
the study including the quality of information given to study
participants and how it meets subject’s understanding.
 Concludes participants were not provided
with adequate information to give proper
consent
 Article asserts that the Tuskegee syphilis
study violates ethical principles

Exhibit A - Analysis of study violations

o VIOLATIONS
 CODES VIOLATED
o Recruitment letter used vague and
  unclear words to lure participants
study
o into
Researchers
exploited unsuspecting

Recruitment Letter

participants who were illiterates and
uneducated sharecroppers
o Tuskegee syphilis experiment was meant to
study untreated syphilis progression in
human, not designed to yield any fruitful
results
o Participants were not allowed to leave the
study when they ‘wanted out’

 Nuremberg codes

Some study subjects

Exhibit B - Analysis of study violation Cont..
o VIOLATIONS
 CODES VIOLATED

o Experiment involved
unnecessary spinal taps and
blood draws
o Study continues when
treatment to disease was found

 Nonmaleficence

Use of placebos without participants consent

 Principle of respect for persons
o Study continues when
treatment to disease was found

 Beneficence

Exhibit C - Analysis of study violations cont...
o VIOLATIONS
 CODES VIOLATED

Risk involved in study outweighs its benefit

 Beneficence
o Scientist not ready to terminate experiment
even when they knew participants could end
up with consequences of untreated syphilis
which could cause harm, organ damage,
or death
o disability
Study continues
even when number of
participants death were reported
 Nonmaleficence

Demonstration of study events to the evolution of
current laws guiding use of human subjects in
research
Regulatory bodies institutionalized to ensure instituted policies are
implemented in research studies to minimize harm to participant's
mental or physical wellbeing
 Research protocols to be reviewed by an independent
committee prior to initiation and research with humans, need
to be based on results from laboratory animals and
experimentation
 Current knowledge of ethical obligations mandates a study to
stop or come to an end if fatality or any forms of harm results
 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.
 National commission for the protection of human subjects of
biomedical and behavioral research mandates rules to guide the
use of subjects with diminished autonomy
 Researchers are now obligated to provide and improve the quality
information to subjects and to make sure that subjects are
competent enough to comprehend such information.

Questions??

References
Beauchamp, L., & Childress, F., (2009). Principles of Biomedical
Ethics.
(5thed.).
York:
University
Press
 Bozeman,
B.,New
Slade,
C., Oxford
& 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.
in Clinical
Research,
26-32.
Retrieved
fromTuskegee
Levine,Perspectives
S., & Williams,
C., Kilbourne,
A.,1, &
Juarez,
P. D.(2012).
http://www.picronline.org/article.asp?issn=2229redux:
Evolution of legal mandates for human experimentation.
Journal of Health
3485;year=2013;volume=4;issue=1;spage=26;epage=32;aulast=Gupta
Care for the Poor and Underserved 23(4), 104-125. The Johns Hopkins

References
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.
Porth, C. & Matfin, G. (2009). Pathophysiology: Concepts of altered
health states