Foundations of
Research
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7. Research Ethics: The Tuskegee Study
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© Dr. David J. McKirnan, 2014
The University of Illinois Chicago
McKirnanUIC@gmail.com
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Department of Health, Education, and Welfare. Public Health
Service.
Foundations of
Research
Tuskegee & the Natural History of Syphilis
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We will center our ethics discussion on the Tuskegee
study of the “Natural history” of untreated syphilis.
The aftermath of Tuskegee
led to many of the ethical
standard and procedures
in place today.
This includes reviewing the
ethical standards of all
studies through an
Institutional Review Board.
Participants in the Tuskegee Syphilis Study.
Department of Health, Education, and Welfare. Public Health Service. Health
Services and Mental Health Administration. Center for Disease Control.
Venereal Disease Branch (1970 - 1973).
Foundations of
Research
The Tuskegee study began as a
potentially important treatment trial.
Became a “Natural history” of untreated
syphilis
Natural History studies…

Monitor disease as it emerges & changes.
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Crucial to understanding disease progression
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Typically address:
 Natural progression in morbidity & mortality
 Individual differences in progression
 Variables that confer vulnerability / resistance to disease progression.
Data on African-American syphilis progression were limited
However, there were systematic Northern European data
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Foundations of
Research
Tuskegee & the Natural History of Syphilis
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Tuskegee addressed a serious public health problem:

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Around 1930, when the study began, the prevalence of
Syphilis in poor, rural Black men was extremely high;
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25% of African-American employees at a private Alabama
company tested positive for syphilis
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Prevalence in the 5 county rural area surrounding Macon,
Alabama ranged from 35% to 40%.
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For context, an infection rate of 5% or so is considered a
“syphilis outbreak” by the CDC today.
At study outset treatments were only marginally effective

Mercury was one of the earliest treatments, used extensively
in Europe from the Renaissance to the 1940s
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
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"A night in the arms of Venus leads to a lifetime on Mercury”.
The arsenic-derived drug Salvarsan was the treatment of
choice in 1930.
One “folk” treatment actually consisted of drinking kerosene (!).
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Foundations of
Research
A key figure in the study was Nurse Eunice Rivers,
the research nurse that recruited most of the
participants.
Miss Evers recruited men using personal
relationships, and by caring about their medical
status.
Participants were also attracted to free medical
exams and treatment for minor ailments, rides to
and from the clinics, meals, and provisions for
burial stipends paid to their survivors. The latter
was very important: it was stigmatizing for the
family to have a pauper’s funeral.
Nurse Rivers with a study participant.
Department of Health, Education, and Welfare. Public Health
Service, Center for Disease Control. Venereal Disease Branch
(1970 - 1973).
Nurse Rivers, as the only full-time employee of the study, was responsible for all day-today operations. Thus, she kept men in the study without treatment even when Penicillin
became widely available. She is often portrayed as a villain in the story, given her direct
role. However, this masks the much more important role of White investigators, none of
whom were from the South.
Her story, portrayed in the HBO film Miss Evers’ Boys, provides an overview of the study
and its moral and ethical failings.
Click the image for the Amazon release, or here for a (somewhat grainy) YouTube
version.
Foundations of
Research
Tuskegee & the Natural History of Syphilis
1928 – 1930: Tuskegee is begun as a prevalence and
treatment study
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Funding:

The Public Health Service (PHS, predecessor to the CDC)
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The Rosenwald Fund (An African-American development fund).
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Participants: primarily poor, uneducated, African-Americans.
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Stage 1: Prevalence study
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7,000 – 10,000 people tested;
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Syphilis prevalence = 36%
Stage 2: Treatment trial
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Salvarson & Mercury; Penicillin not yet used in general medicine.
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1,200 treated by 1930.
Thus, the eventual observational study was not even a true
natural history: treatment was provided in the early stages.
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Foundations of
Research
Tuskegee & the Natural History of Syphilis
1930 – 1932: The Depression slashes funding
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The treatment arm of the study is defunded.
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Rosenwald fund pulls out of the study
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Neither the PHS nor the State of Alabama have funds to
continue the study.
Men still followed by the Tuskegee Institute
 European data showed most
syphilis symptoms to be physical
rather than neurological.
 Tuskegee Investigators
hypothesized that symptoms
among African-Americans would
be predominantly neurological.
 Since no coherent theory would
predict this, it is a classic example
of “scientific racism”.
Department of Health, Education, and Welfare. Public Health Service.
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Foundations of
Research
Tuskegee & the Natural History of Syphilis
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1934: PHS funds the continuation of the Natural History
study. Participants: 600 poor, African-American sharecroppers

399 participants had syphilis at study outset.

Participants were told they are simply receiving medical treatment, not
that they are in a research study
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Incentives for participation: medical care, meals, burial insurance.
 Not being buried as a pauper was culturally very important
 Of course men could only qualify for the insurance if they literally stayed in
the study for the rest of their lives!

Infected men not told they had syphilis.
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The cohort was recruited and
maintained by a local AfricanAmerican, Nurse Evers.

Nurse Evers cultivated personal
relationships with participants, and
drives them to their medical visits.
Eunice Evers speaking to study participants.
Department of Health, Education, and Welfare. Public Health Service.
Foundations of
Research
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Tuskegee & the Natural History of Syphilis
1943: Penicillin becomes generally available.
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Alexander Fleming had first identified Penicillin in 1929.
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The treatment potential of Penicillin was recognized in 1939.
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Larger scale production begun by the U.S. War Production
Board (WPB) in 1943, to treat “venereal disease”.
Tuskegee participants not informed that treatment is available
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One rationalization was that
penicillin may not be effective for
longer-standing syphilis.
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There was no clear theoretical
rationale for this assumption
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The assumption – later proved
false – was not tested by giving the
Tuskegee men treatment.
Treatment was given only when the
study was stopped.
Department of Health, Education, and Welfare. Public Health Service.
Foundations of
Research
Tuskegee & the Natural History of Syphilis
1950s - 1960s; Multiple papers published in Medical
Journals describe the study.
Few or no ethical questions posed to PHS or the journals
1963
1956
1935
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Foundations of
Research
Tuskegee & the Natural History of Syphilis
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1965: Dr. Irwin Schatz sends a letter to PHS (then CDC)
“I am utterly astounded by the fact that physicians allow patients
with a potentially fatal disease to remain untreated when effective
therapy is available.”
 CDC files the letter, noting it was the first such letter received.
 No reply was written.
1966: Dr. Peter Buxtun writes CDC after reviewing
published articles on Tuskegee
 Buxtum invited to CDC to discuss the study.
 CDC does not change its policy or stop the study.
1968: Buxtun again writes CDC
 Committee formed to investigate the study.
 CDC again does not change policy or stop the study.
Foundations of
Research
Tuskegee & the Natural History of Syphilis
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1972: Buxtun discusses the study with a reporter from the
Associate Press.
 Jean Heller writes an explosive columns for the Washington
Star (now Washington Post) and New York Times.
1972: Secretary of Health & Human Welfare
(now Health & Human Services) convenes a panel
 … in response to the Washington Star
report, not from communication from CDC.
 Describes himself as “shocked” and
“horrified”.
1973: Sen. Ted Kennedy begins congressional hearings.
 Congress hears about the study for the first time, despite 40
years of government funding for it.
 The study ends and remaining participants given penicillin.
Foundations of
Research
Tuskegee & the Natural History of Syphilis
1975; Class action suit brought by surviving members
of the cohort.
1980s; HIV / AIDS re-invokes prospect of unethical
research or treatment
 Incidence of HIV infections skewed toward AfricanAmericans & other minorities
 Search for vaccines & treatments
raises the prospects of racist or
unequal treatment.
1997; Presidential apology
 Bill Clinton apologizes to the 8
remaining cohort members.
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Foundations of
Research
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Core ethical issues in Tuskegee
No informed consent
 Key issue: Research was presented as Clinical care

Refusal of treatment
 …not informed when Penicillin became available
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Coercive enrollment & retention
 Deception: Patients unaware they were in a research study
• personal relationships with Nurse Evers
 Exploitation:
• vulnerability of uneducated, poor men with a
disease
 Primary incentive was burial $, which would require lifetime
participation

Co-opted population members:
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Local African-American Medical Personnel were key players
on the research and study team.
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Ethical Principles stemming from Tuskegee aftermath:
Foundations of
Research
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Include participants of all races & both genders in study
cohorts
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Members of the target population included on research
team & design boards
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Barring a compelling reason to exclude groups.
Note: African-Americans were on the research and outreach
teams in Tuskegee
Facilitate access to an intervention to the entire
population
 Cannot withhold “Standard of Care”.
 Standard of Care shifted during the Tuskegee study – from
Salvarson to penicillin – but study procedures did not.
 Research must contribute to population being studied
 Communicate research results
 Develop applied programs or interventions
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Ethical Principles stemming from Tuskegee aftermath:
Foundations of
Research

Include participants of all races & both
genders in study cohorts

Members of the target population included
on research team & design boards

Facilitate access to an intervention to the
entire population
 Research must contribute to population
being studied
James Jones’ Bad Blood is an excellent
history and ethical overview of
Tuskegee and other studies, with
particular relevance to the HIV/AIDS
epidemic.
Click the image for Amazon.com
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Foundations of
Research
Ethics procedures stemming from Tuskegee
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Informed consent
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Non-coercive enrollment & retention
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Led to the 1979 Belmont Report
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Indirectly to core elements of the “Common Rule”.
Ethical review & monitoring
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Led to establishment of the Federal Office for Human
Research Protections (OHRP)
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Led to laws requiring Institutional Review Boards (IRBs)
 All Federally funded research must be reviewed and monitored
by a local IRB
 Most institutions (e.g., UIC) require IRB approval of all
research, federally funded or not.
Foundations of
Research

SUMMARY
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Begun – and should have remained – a natural history of
participants’ response to treatment.
Had the virtue of being conducted by a local institution –
Tuskegee Institute – with African-American Investigators & staff.
Became a wholly unethical no-treatment history.
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Tuskegee study begin as a potentially valuable trial
of treatment outcomes
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Tuskegee Study: Overview
Based on spurious – and racist – scientific reasoning about
differences between Africans and Caucasians
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Investigators took advantage of participants economic and
social vulnerability to exploit and harm them.
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Note: Tuskegee participants were not actually given syphilis;
they were not given treatment.
Tuskegee led to many of our research norms and
institutional controls.
Foundations of
Research
Quiz
 European data showed most syphilis symptoms to be
physical rather than neurological.
 Tuskegee Investigators hypothesized that symptoms among
African-Americans would be predominantly neurological.
This is an example of:
A = Expanding a hypothesis to a new study
B = A change in theory
C = Scientific racism
D = Tailoring a hypothesis to a specific culture
This is potentially correct – the hypothesis did change for poor
African-Americans – although it was not based on a clear scientific
rationale.
Rather, it derived from racist stereotypes about African-American
intelligence.
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Foundations of
Research
Quiz
 European data showed most syphilis symptoms to be physical
rather than neurological.
 Tuskegee Investigators hypothesized that symptoms among
African-Americans would be predominantly neurological.
Why was this hypothesis an example of scientific racism?
A = It involved an underprivileged group
B = It had no theoretical or empirical rationale
C = It was in the context of a coercive study
D = It was never communicated to the participants
Each of these unethical features may have stemmed from a racist
disregard for the men in the study.
The key is that any hypothesis – particularly regarding racial
differences – must have a scientific basis.
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Foundations of
Research
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Quiz
Which of these was not an unethical feature of the study:
A = Syphilis was not that important a health threat
to the population under study.
B = A lack of informed consent
C = Coercive enrollment and retention practices
D = Refusal of effective treatment
Syphilis was endemic to that population,
and with no treatment was an important
health threat.
The unethical features were in the
conduct of the study, not the topic.
Foundations of
Research
Quiz
Which of these was not an unethical feature of the study:
A = Participants were not given their diagnosis.
B = There was no institutional ethical review.
C = The study did not contribute to the population
being studied.
D = Members of the target population were not
included in the research team.
Even though a recommendation stemming from Tuskegee was
that members of the study group be part of the investigative team,
the Tuskegee study did have key African-American staff.
The unethical features were in the conduct of the study, not the
topic.
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Foundations of
Research
Quiz
Which of these was not an important consequence of
reactions to the Tuskegee study?
A. Informed consent
B. Non-coercive enrollment & retention procedures
C. Led to the 1979 Belmont Report
D. Defunding of research targeting only African-Americans
E. Ethical review & monitoring / Institutional Review Boards
(IRBs).
Each of these core ethical procedures either stemmed from or were
institutionalized in the aftermath of Tuskegee.
Research targeting one cultural group must have a clear scientific
basis, but is certainly not prohibited.
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