Download Bad Research

ADDRESSING BAD
RESEARCH
Rels 300 / Nurs 330
23 October 2014
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Miss Evers’ Boys
1.
2.
Note specific issues and dilemmas that arise in the story
Examine the key ethical choices made by health care providers and
researchers:
• Which were ethical choices? Would you support them?
• Were there unethical choices? Would you challenge them?
• What information was withheld from the men and why?
• What specific harms and benefits resulted?
3.
4.
5.
6.
7.
Do you believe that alternative courses of action would have been
better? Can you suggest some alternatives?
What impact did the research have on the men and their families?
What did you find most challenging about this video?
How will this video contribute to your understanding and practice of
being a health care provider?
What would you want potential viewers to be attentive to as they view
the video themselves? What would you most want them to learn?
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The Tuskegee
Syphilis Study
1932 to 1972, Macon County, Alabama
• 399 African American male sharecroppers recruited for a
study on the natural progression of syphilis to death
• told that they were being treated for “bad blood” – this
was how syphilis was known to them
• 201 African American men without syphilis also recruited
• all subjects were poor, black, largely illiterate, and had no
access to regular medical care
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• in 1943, penicillin emerged as an effective treatment for
syphilis – this was not offered to the Tuskegee subjects
• benefits limited to free medicines, burial insurance, free
hot meals on examination days, transport to and from
hospital
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Evaluate the Tuskegee Study using the
Nuremberg Code (1947)
1. Voluntary consent
2. Fruitful results for the good of
society
3. Based on the results of animal
experimentation and a knowledge
of the natural history of the
disease
4. Avoid all unnecessary physical
and mental suffering and injury
5. No expectation of death or
disabling injury
6. Degree of risk should never
exceed the humanitarian
importance of the problem to be
solved
7. Protect the experimental
subject against even remote
possibilities of injury,
disability, or death
8. Conducted only by
scientifically qualified
persons
9. Human subject should be at
liberty to bring the
experiment to an end
10. Scientist must terminate the
experiment at any stage if
there is a likelihood of injury,
disability, or death
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President Clinton’s Apology, 1997
(http://clinton4.nara.gov/textonly/New/Remarks/Fri/19970516-898.html )
“The eight men who are survivors
of the syphilis study at Tuskegee
are a living link to a time not so
very long ago that many
Americans would prefer not to
remember, but we dare not
forget.
“It was a time when our nation
failed to live up to its ideals,
when our nation broke the trust
with our people that is the very
foundation of our democracy…
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President Clinton with Syphilis Study
participant Herman Shaw - May 16, 1997
“So today America does remember the hundreds of men used in research
without their knowledge and consent… Men who were poor and African
American, without resources and with few alternatives, they believed they
had found hope when they were offered free medical care by the United
States Public Health Service. They were betrayed.
“Medical people are supposed to help when we need care, but even once a
cure was discovered, they were denied help, and they were lied to by
their government…
“The American people are sorry -- for the loss, for the years of hurt. You did
nothing wrong, but you were grievously wronged. I apologize and I am
sorry that this apology has been so long in coming.”
(http://clinton4.nara.gov/textonly/New/Remarks/Fri/19970516-898.html)
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Tuskegee Legacy
1974 – US National Research Act
• National Commission for the Protection of Human
Subjects of Biomedical and Behavioral Research
The Belmont Report
Established 3 basic ethical principles:
• respect for persons
• beneficence
• justice
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The Belmont Report
PRINCIPLE
Respect for persons
• Individuals should be
treated as autonomous
agents
• Persons with
diminished autonomy
are entitled to
protection.
APPLICATION
Informed consent
• Subjects, to the degree that
they are capable, must be
given the opportunity to
choose what shall or shall
not happen to them
• The consent process must
include three elements:
• information,
• comprehension, and
• voluntariness.
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The Belmont Report
PRINCIPLE
Beneficence
• Human subjects should
not be harmed
• Research should maximize
possible benefits and
minimize possible harms.
APPLICATION
Assessment of risks
and benefits
• The nature and scope
of risks and benefits
must be assessed in a
systematic manner.
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The Belmont Report
PRINCIPLE
APPLICATION
Justice
Selection of subjects
• The benefits and risks
• There must be fair
of research must be
distributed fairly.
procedures and outcomes
in the selection of research
subjects
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The Belmont Report
Full text can be found at:
http://ohsr.od.nih.gov/guidelines/belmont.html
Significance of Belmont Report for the developing field of
Bioethics?
• Respect for persons → Autonomy
• Beneficence – and risks / harms – Nonmaleficence
• Justice – fairness and equality
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Willowbrook State Mental Hospital for Children
Staten Island, New York – mid 1950s
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http://www.museumofdi
sability.org/newyork_tim
eline_1960s.asp
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As the institutional population
skyrocketed, admissions were
suspended unless parents agreed to
place their child in the hepatitis ward
• new children were deliberately
infected with hepatitis to provide
optimal control in the study
• parents were misled by
exaggerations of the potential
benefits of the study
• doctors claimed that the conditions
were so unsanitary that the children
would have developed hepatitis
anyway
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Dr. Saul Krugman & Dr. Joan Giles:
infectious disease specialists
RESEARCH GOALS:
• to determine the natural history
of viral hepatitis – its mode of
infection and the course of the
disease
• to test the effectiveness of
gamma globulin in developing
an inoculation against hepatitis
Krugman & Giles collected
serum specimens before
exposure, during the
incubation period, and several
times post-infection
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“Therapeutic” Effect
Drs. Krugman & Giles
claimed that deliberately
infecting the children was
therapeutic because of
their resulting immunity to
hepatitis.
• the hepatitis strain was mild
• had optimum isolation facilities
• minimal exposure to other
infectious diseases
• had consent from parents
• could withdraw consent before
study was initiated in child
• significant scientific progress
resulted from study
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As measured against
Nuremberg Code:
1.
Voluntary consent
2.
Fruitful results
3.
Results of animal experimentation
4.
No unnecessary physical and mental suffering and injury
5.
No death or disabling injury
6.
Degree of risk less than humanitarian importance
7.
Protect the experimental subject
8.
Experiment conducted by scientifically qualified persons
9.
Human subject can bring experiment to an end
10. Terminate experiment if evidence of injury, disability or death
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As measured against
Belmont Report Principles
Respect for persons
• Individuals should be treated as autonomous agents
• Persons with diminished autonomy are entitled to
protection.
Beneficence
• Human subjects should not be harmed
• Research should maximize possible benefits and
minimize possible harms.
Justice
• The benefits and risks of research must be distributed
fairly.
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1991 Symposium at the NYU School of Medicine honouring
Dr. Saul Krugman
“Dr. Krugman’s most
important scientific
achievements were in the
unraveling of the mysteries
of infectious hepatitis.”