Through the Looking Glass: Reflections of a Research Ethicist or The Collapse of Science and Ethics?...
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![Page 1: Through the Looking Glass: Reflections of a Research Ethicist or The Collapse of Science and Ethics? Michael Goodyear Department of Medicine, Queen Elizabeth.](https://reader035.fdocuments.net/reader035/viewer/2022062519/56649e965503460f94b9a468/html5/thumbnails/1.jpg)
Through the Looking Glass:
Reflections of a Research Ethicistor
The Collapse of Science and Ethics?
Michael Goodyear
Department of Medicine,Queen Elizabeth II Health Sciences Centre,
Dalhousie University, Halifax,Nova Scotia, Canada
MSMR Waltham MA, June 2006
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Alice was sitting curled up in a corner of the great arm-chair, half talking to herself and half asleep
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Learning Objectives
• I: How Did We Get Here From There?
• II: Where are We Now?
• III: Lessons from TGN1412
• IV: Moving Forward
Summary
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“The aim of science is not to open a door to infinite wisdom but to set a limit to infinite error”Brecht B. The Life of Galileo (Leben des Galilei) 1943
Bertolt Brecht (1898 –1956)
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Part I
How Did We Get Here From There?
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We All Know Where We Have Come From
Or Do We?
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History
• Human experimentation since time immemorial– Generally more vulnerable populations
• Prisoners, slaves, patients
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History
• Thomas Percival (1740-1804) Medical Ethics: a Code of Institutes and Precepts Adapted to the Professional Conduct of Physicians and SurgeonsRussell, London 1803
Adopted by AMA 1847, modified many times
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History
• Claude Bernard (1813-1878)
– Must have potential benefit
– Prisoners not considered human
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History
• William Osler (1849-1918)
– Consent
– Animal experimentation
• George Bernard Shaw (1856-1950)
– “Human Guinea Pigs” (1913)*
*Disclaimer: No Guinea Pigs were harmed in this production
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History
• Germany– Prussian regulations 1900– Third Reich 1931
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Nürnberg
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Nuremberg CodeNuremberg Code 19471947
Trials of war criminals before the Nuremberg military tribunals under Control Council Law, No 10, Vol 2. Washington DC: US Government Printing Office, 1949: 181.
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Nuremberg Code 1947
1. Voluntary Consent Essential2. Must Yield Valid Results3. Based on Animal Experiments4. Avoid Physical and Mental Suffering5. Avoid Injury6. Risk Proportional to Benefit7. Subjects Must be Protected8. Qualified Investigators9. Voluntary Withdrawal10. Must be Terminated if Necessary
Top Secret
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Nuremberg Code 1947
3. The experiment should be so designed and based on the results of animal experimentation and a knowledge of the natural history of the disease or other problem under study, that the anticipated results will justify the performance of the experiment.
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(1)The voluntary consent of the person on whom the experiment is to be performed must be obtained
(2)The experiment must be performed under proper medical protection and management.
(3)(3)The danger of each experiment must be The danger of each experiment must be previously investigated by previously investigated by animal animal experimentationexperimentation
American Medical AssociationJudiciary Council
December 10th, 1946
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David Rothman PhDDirector, Center for the Study of Society and MedicineColumbia College of Physicians and Surgeons
Strangers at the Bedside: A history of how law and bioethicstransformed medical decision makingNY Basic Books 1991
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“Neither the horrors described at the Nuremberg trial nor the ethical principles that emerged from it had a significant impact on the American research establishment” because they did not seem “directly relevant to the American Scene”
Rothman p. 62
LF Ross
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“To most Americans, however, Nuremberg addressed madness, not medicine”
Shapiro HT.Waggoner Lecture, U MichiganDec 5 2001Ethical Considerations in Research on Human Subjects:A Time for Change…Again
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Nürnberg, Germany
Tuskegee, Alabama
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Tuskegee, AlabamaTuskegee, Alabama(1932 – 1972)(1932 – 1972)
RIPRIP
“I don’t know what they used us for. I ain’t never understood the study”
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1965
Are humans used as guinea pigs not told?
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(1904-1976)
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“What seem to be breaches of ethical conduct in experimentation are by no means rare, but are almost, one fears, universal”
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“No physician is justified in placing science or the public welfare first and his obligation to the individual, who is his patient or subject, second”
“No doctor, however great his capacity or original his ideas, has the right to choose martyrs for science or for the general good” Maurice Pappworth
Pappworth M.H. Human Guinea Pigs Penguin 1967, p.27
L Swartz
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The Dark Side
• Willowbrook Hepatitis Study• Jewish Hospital Cancer Study• Tearoom Trade Study• Wichita Jury Study• Milgram Obedience Study• San Antonio Contraceptive Study• Radiation Studies• etc…………..
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…and the Light
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Belmont Report1979
Ethical Principles and Guidelines for the Protection of Human Subjects of Research
The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research
April 18, 1979
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So We Fixed it?
Right?
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Advisory Committee on Human Radiation Experiments (1994-5)
Human Radiation ExperimentsAssociated with the
U.S. Department of Energyand Its Predecessors
(1944 – 1974)
X-Files?
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Unfortunately, however, the government's conduct with respect to some research performed in the past has left a legacy of distrust
1.
We did find evidence of some serious problems in the conduct …of human research today
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We realize, however, that regulations and policies are no guarantee of ethical conduct
2.
It is essential that the research community come to increasingly value the ethics of research involving human subjects as central to the scientific enterprise
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The revision of regulations that govern human research (and) professional ethics are necessary, but are not sufficient, means to needed reform. Of at least equal import is the development of a more common understanding among the public of research involving human subjects
3.
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Some of what is regrettable about the past happened… because we
as citizens let it happen
Let the lessons of history remind us all that the best safeguard for the future is an informed and active citizenry
4.
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