Research Ethics –
A Short History
Quiz
• “Every treatment is an experiment”
Author?
• Committee on medical research – 1941(FDR)
Goals?
• August 19, 1947
• April 25, 1953
• December 23, 1954
• May 1960
• March 19, 1960
• December 3, 1967
• August 5, 1968
• July 26, 1972
• July 25, 1978
• 1974-78
• December 3, 1982
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“Every treatment is an experiment”
Committee on medical research
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August 19, 1947
April 25, 1953
December 23, 1954
May 1960
March 19, 1960
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December 3, 1967
August 5, 1968
July 26, 1972
July 25, 1978
1974-78
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December 3, 1982
Sir William Osler
Effective military medicine-better soldiers
-1941(FDR)
Doctors’ Trial at the Nuremberg Tribunal
DNA: The secret of life
Renal transplantation
Oral Contraceptives [Enovid FDA approved]
Chronic hemodialysis and the Seattle dialysis
selection committee
1st heart transplantation
Harvard definition of brain death
The Tuskegee Revelations
Baby Louise Brown
US Congress establishes National
Commission for the Protection of Human
Subjects of Research
The Artificial Heart
The Doctors’ Trial at Nuremberg, 1947
• The United States of America vs. Karl Brandt, et al
• The first of 12 trials
• 23 defendants – all medial doctors accused of
involvement in Nazi human experimentation
Nazi Experimentation included:
• Starvation
• Exposure to extreme cold and wet
• Wounding and infection w/bacteria, glass,
dirt,etc.
• High altitude, compression chambers
Nazi Experimentation (cont’d)
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Malaria, TB
“Drinkable” sea water
Poisons
Genetic studies
Nuremberg Doctors’ Trial
• All 23 pleaded “not guilty”
• 5 acquitted, 11 prison sentences, 7 death
sentences
The Nuremberg Code –
Directives for Human Experimentation
• 10 points
• Voluntary consent, ability to withdraw
• Goals – constraints
http://ohsr.od.nih.gov/guidelines/nuremberg
www.jewish.virtuallibrary.com
WMA Declaration of Helsinki – 1964
Ethical Principles for Medical Research Involving
Human Subjects
• Basic Principles – 10
(consent, proportionality, integrity)
• Medical Research Combined with Clinical Care
(clinical research)
dual goals: cure of this patient & acquisition of
new medical knowledge
potential conflict:
potential conflicts of interest for clinicianinvestigators
• Non-therapeutic research on human subjects
emphasizes voluntariness and protection
WMA Declaration of Helsinki
Amended: 1975, 1983, 1989, 1996, 2000
http://ohsr.od.nih.gov/guidelines/helsinki
Three (U.S.) Revelations – 1960’s
• Sloan-Kettering researchers implanted cancer
cells in skin of aged, debilitated and unknowing
patients in Jewish Chronic Disease Hospital
• NYU School of Medicine researchers infected
750-800 profoundly retarded children (IQ<20)
at Willowbrook State Hospital with hepatitis
virus - ? Consent, coercion
• Tuskegee Revelations
Tuskegee Syphilis Study
• 1932-1972
• US Public Health service: venereal disease section
• Goal: study of (untreated) syphilis, incidence and
outcome in Macom County, AL.
• Subjects: 339 syphilitic A.A. men, 201 non-syphilitic
A.A. men
• Pre-penicillin tx: arsenic and mercury.
Jean Heller, “Syphilis victims in U.S. study went untreated for 40 years.” NYT
7/26/72
Tuskegee – Recruiting
• Free burial assistance ($50) & insurance – after
autopsy (required)
• Free transportation to and from exams
• Free medicine and hot meals
Tuskegee - Deceptions
• Dx: “Bad Blood”
• “therapeutic spinal taps”
• Prevented from receiving penicillin tx – (not
allowed to be drafted)
Tuskegee Outcome
• NYT reported 7/26/72 – Ended study
• 74 men alive
• 28 men died of syphilis, 100 died of relation
complications, 40 wives were infected, 19
children were born with congenital syphilis
• Presidential apology, 1997
Tuskegee - Outcomes
• The National Commission for Protection of
Human Subjects
• Legacy of distrust and suspicion
The Belmont Report – April 18, 1979
• National Commission for Protection of Human
Subjects of Research
3 sections:
• Boundaries between practice and research
• Basic ethical principles (3)
• Applications
http://ohsr.od.nih.gov/guidelines/belmont
Belmont - Principles
• Autonomy – respect for persons
• Beneficence – do good, minimize harm
• Justice – fairness, deserts
-special groups: children, prisoners,
homeless or otherwise disadvantaged
Nonmaleficence – added later
Belmont Applications
• Consent: information, comprehensive,
voluntariness
• Risk/Benefit: To whom, for whom
• Selection of subjects – vulnerable persons
• Belmont, revisited, JAMA 2006, 296: 589-90
Concluding Thoughts
• Different targets (of research efforts), same
concerns
• Short-term vs. long term
• Individual vs. community
• Truth vs. loyalty
• Justice vs. mercy