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Research Ethics – A Short History

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

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Research Ethics – A Short History

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  1. Research Ethics – A Short History

  2. 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

  3. “Every treatment is an experiment” Sir William Osler • Committee on medical research Effective military medicine-better soldiers -1941(FDR) • August 19, 1947 Doctors’ Trial at the Nuremberg Tribunal • April 25, 1953 DNA: The secret of life • December 23, 1954 Renal transplantation • May 1960 Oral Contraceptives [Enovid FDA approved] • March 19, 1960 Chronic hemodialysis and the Seattle dialysis selection committee • December 3, 1967 1st heart transplantation • August 5, 1968 Harvard definition of brain death • July 26, 1972 The Tuskegee Revelations • July 25, 1978 Baby Louise Brown • 1974-78 US Congress establishes National Commission for the Protection of Human Subjects of Research • December 3, 1982 The Artificial Heart

  4. 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

  5. Nazi Experimentation included: • Starvation • Exposure to extreme cold and wet • Wounding and infection w/bacteria, glass, dirt,etc. • High altitude, compression chambers

  6. Nazi Experimentation (cont’d) • Malaria, TB • “Drinkable” sea water • Poisons • Genetic studies

  7. Nuremberg Doctors’ Trial • All 23 pleaded “not guilty” • 5 acquitted, 11 prison sentences, 7 death sentences

  8. 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

  9. WMA Declaration of Helsinki – 1964Ethical 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 clinician- investigators • Non-therapeutic research on human subjects emphasizes voluntariness and protection

  10. WMA Declaration of Helsinki Amended: 1975, 1983, 1989, 1996, 2000 http://ohsr.od.nih.gov/guidelines/helsinki

  11. 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

  12. 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

  13. Tuskegee – Recruiting • Free burial assistance ($50) & insurance – after autopsy (required) • Free transportation to and from exams • Free medicine and hot meals

  14. Tuskegee - Deceptions • Dx: “Bad Blood” • “therapeutic spinal taps” • Prevented from receiving penicillin tx – (not allowed to be drafted)

  15. 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

  16. Tuskegee - Outcomes • The National Commission for Protection of Human Subjects • Legacy of distrust and suspicion

  17. 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

  18. 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

  19. Belmont Applications • Consent: information, comprehensive, voluntariness • Risk/Benefit: To whom, for whom • Selection of subjects – vulnerable persons • Belmont, revisited, JAMA 2006, 296: 589-90

  20. Concluding Thoughts • Different targets (of research efforts), same concerns • Short-term vs. long term • Individual vs. community • Truth vs. loyalty • Justice vs. mercy

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