Unethical Issues In Research: An Historical Perspective

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Research Misconduct:
An Historical Perspective
of Unethical Practices
Andrea H. Jackson, Ph.D.
Assistant Dean
Howard University
Office of Research and the Graduate School
Responsible Conduct of Research (RCR) Workshop
Wednesday, October 19, 2005
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Informed Consent
African-American Slaves and Medical Experimentation
“…blacks were particularly easy targets, given their positions as
voiceless slaves or ‘free persons of color’ in a society sensitive to and
separated by race.” Todd L. Savitt (1982). “The Use of Blacks for
Medical Experimentation and Demonstration in the Old South”
Journal of Southern History, Vol. 48 (3):331-348.
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Nuremberg Codes (Nazi Concentration Camps)
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Injections with typhus fever
Injections of petroleum
Ice-cold vat baths
“Very few of the prisoners brought into this building to be used
in these ‘experiments’ came out alive.” --Buchenwald Reports
Secret Human Experiments
Plutonium Study (1947)
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Doctors injected plutonium into the leg of Elmer Allen, a
36-year-old African-American railroad porter.
Researchers analyzed tissue sample to determine the
physiological dispersion of plutonium.
They wanted to determine the lingering levels of plutonium
remaining in Allen’s body from the injection 26 years
earlier.
Secret Human Experiments
Willowbrook Study (Early 1960s)
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Willowbrook State School in Staten Island, NY conducted
research on vulnerable, mentally retarded children to better
understand the natural history of the highly infectious
hepatitis virus.
Only parents who agreed to the research were able to enroll
their children into Willowbrook.
Secret Human Experiments
Jewish Chronic Disease Hospital Study (1963)
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Studies were conducted at what is now the Interfaith Hospital
of Brooklyn
Unwitting, unsuspecting, and unconsenting patients were
monitored by doctors to determine the body’s ability to reject
cancer cells.
Doctors injected live cancer cells intravenously into patients
and watched for signs of neoplasia (new growth).
In reaction to this study, in 1966 the FDA issued clear
requirements for informed consent in research.
Secret Human Experiments
The Cincinnati Project (1966)
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The military’s aim was to determine how much radiation
military personnel could endure before becoming unable to
function effectively in combat.
Subjects were treated with high doses of radiation.
Amelia Jackson was treated with 100 rads of full-body radiation
(equivalent to 7,500 chest X-rays) and was never able to care for
herself after the treatment.
Secret Human Experiments
Oregon and Washington State Prisons (1963-71)
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The testicles of 67 inmates were exposed to X-rays to find out
the effects of radiation on sperm production.
Prisoners were not informed that exposure to radiation might
cause cancer, impotence, potential future birth defects or
forced vasectomies.
Beecher Article
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In 1966, Dr. Henry Beecher published an article in the
New England Journal of Medicine (NEJM) that
described 22 examples of unethical research conducted
and published by “reputable” researchers.
Until that time, it was believed that unethical research
was conducted only in Nazi prison camps.
The Tuskegee Syphilis Study (1932-1972)
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This study involved a large number of black males in
rural Alabama.
The subjects believed that they were receiving proper
medical treatment when, in fact, they received either
inadequate treatment or no treatment. At least 40 of
these subjects died during the study.
Summerlin Case (1973)
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Summerlin initially reported that tissue kept in organ
culture for a period of time could be transplanted
without rejection into another animal; he used tissues
from black mice and transplanted them into white
mice.
Summerlin used a felt tip pen to mark black patches on
the backs of white mice; the “patches” were later
discovered in the animal facility.
Veterans Administration (1999)
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In 1999, all research projects at the V.A. West Los
Angeles Medical Center were halted.
Allegations centered on the lack of consent from
patients.
Johns Hopkins Lead Paint Study (2001)
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Scientists were exploring the long-term effects of
exposure of children to lead paint.
Low income families were given housing with lead
paint but not informed.
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