Lect10 Human Subjects: History

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Lect10 Human Subjects: History

  1. 1. Human subjects research: history. Phil 133 – Ethics in Science San José State University
  2. 2. Scientific research in Nazi Germany: <ul><li>Impact of extreme conditions (like those German soldiers might face) on human health </li></ul><ul><li>Better (more effective, more efficient) ways to kill enemy forces. </li></ul><ul><li>Research connected to Nazi racial theories. </li></ul>
  3. 3. Scientific research in Nazi Germany: <ul><li>A number of these questions seem to require experiments with human subjects. </li></ul><ul><li>The German government provided as many human subjects as scientists needed. </li></ul>
  4. 4. After Germany’s defeat: the Doctors’ Trial <ul><li>Defendants claimed their experiments were in the name of science, and that the knowledge could only be obtained through human experimentation. </li></ul><ul><li>Prosecution challenged these claims. </li></ul>
  5. 5. Doctors’ Trial prosecution: <ul><li>As physicians, the researchers had duties to experimental subjects (patients). </li></ul><ul><li>Researchers violated subjects’ right to free choice about whether to participate in research. </li></ul><ul><li>Researchers caused extreme harm (including death) to subjects. </li></ul>
  6. 6. Doctors’ Trial prosecution: <ul><li>“ The Nazi methods of investigation were inefficient and unscientific, and their techniques of research were unsystematic. ... The moral shortcomings of the defendants and the precipitous ease with which they decided to commit murder in quest of ‘scientific results’ dulled also that scientific hesitancy, that thorough thinking-through, that responsible weighing of every single step which alone can ensure scientifically valid results.” (91) </li></ul>
  7. 7. Public Health Service Tuskegee Syphilis Experiment: <ul><li>Launched in 1932. </li></ul><ul><li>Goal: to establish the effects of the spontaneous evolution of syphilis on black males. </li></ul><ul><li>Prior study of untreated syphilis in Norwegian men – why was another study needed? </li></ul><ul><li>Racial hypothesis (syphilis will take different courses in blacks and whites) </li></ul>
  8. 8. Public Health Service Tuskegee Syphilis Experiment: <ul><li>Experimental subjects: black men from Macon County, Alabama. </li></ul><ul><li>Study group: 412 men with syphilis </li></ul><ul><li>Control group: 204 men without syphilis </li></ul><ul><li>Measurements: physicals, blood tests, spinal taps, X-rays, postmortem autopsies. </li></ul>
  9. 9. Tuskegee Syphilis Experiment timeline: <ul><li>1932: study starts </li></ul><ul><li>1946: penicillin comes into wide medical use </li></ul><ul><li>1972: study ends </li></ul>
  10. 10. Evaluating the Tuskegee Experiment: <ul><li>1. Was it good science? </li></ul><ul><li>2. Was it ethical (judged by current standards)? </li></ul><ul><li>3. Was it ethical at the time? </li></ul>
  11. 11. Was it good science? <ul><li>Intended as a study of untreated syphilis. </li></ul><ul><li>But, early in the study, infected subjects did receive some treatment (less than usual doses of arsenic and mercury compounds). </li></ul><ul><li>No longer comparable to earlier Norwegian study. </li></ul><ul><li>Also, not clear how to interpret results of Tuskegee study on their own. </li></ul>
  12. 12. Was it good science? <ul><li>What was the point of studying the effects of untreated syphilis? </li></ul><ul><li>Contributed no useful knowledge about treatment. </li></ul><ul><li>Contributed no useful knowledge about prevention. </li></ul>
  13. 13. Was it ethical by current standards? <ul><li>Subjects not informed of purpose of study or risks (so couldn’t give informed consent). </li></ul><ul><li>Participation coerced (including economically). </li></ul><ul><li>No formal experimental protocol. </li></ul><ul><li>No consideration of harms to subjects. </li></ul><ul><li>Very little benefit to subjects. </li></ul>
  14. 14. Was it ethical by standards of the time? <ul><li>No requirement for “informed consent” in the 1930s. </li></ul><ul><li>Physicians felt they had a duty to be paternalistic. </li></ul><ul><li>But, giving treatment without consent was against medical ethics. </li></ul><ul><li>Common morality held that lying was wrong. </li></ul>
  15. 15. Vulnerable populations: <ul><li>Groups at special risk of being used by researchers as mere means to make knowledge, rather than treated as ends in themselves. </li></ul>

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