Human subjectsprot


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Why human subject protection, past abuse

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Human subjectsprot

  1. 1. Protection of Human Subjects Institutional Review Board IRB
  2. 2. Hippocratic Oath: <ul><li>physicians must help patients and do no harm </li></ul><ul><li>4th Century B.C.: </li></ul>
  3. 3. Tuskegee <ul><li>1932: Syphilis experiments begin in Tuskegee, Alabama; not widely acknowledged until 40 years later </li></ul>
  4. 4. Tuskegee <ul><li>Tuskegee Syphilis Study was a 40-year project administered by the US Public Health Service in Macon County, Alabama.. </li></ul>
  5. 5. Tuskegee <ul><li>The American Government promised 400 men free treatment for bad blood which had become an epidemic in the county </li></ul>
  6. 6. Tuskegee <ul><li>The study sample was made up of poor African American men who were told that they had &quot;bad blood&quot;. </li></ul><ul><li>The treatment was never given to the men and was in fact withheld. </li></ul>
  7. 7. Tuskegee <ul><li>These men did not receive standard treatment for syphilis even when penicillin was available later during the study. </li></ul>
  8. 8. Tuskegee <ul><li>The Tuskegee Study symbolized the medical misconduct and blatant disregard for human rights that takes place in the name of science </li></ul>
  9. 9. Tuskegee <ul><li>The investigators were not mad scientists; rather they were government physicians, respected men of science, who published their reports of the study in medical journals </li></ul>
  10. 10. Tuskegee <ul><li>Tuskegee was way back in the early 1930’s </li></ul><ul><li>Violation of People, Human Subjects, was not possible in modern times like the 1960’s. Right? </li></ul>
  11. 11. Willowbrook Study <ul><li>From 1963 to 1966, the study involved a group of children diagnosed with mental retardation, who lived at the Willowbrook State Hospital in Staten Island, New York </li></ul>
  12. 12. Willowbrook hepatitis <ul><li>These innocent children were deliberately infected with the hepatitis virus </li></ul>
  13. 13. Willowbrook hepatitis <ul><li>The mentally retarded children were fed extracts of stools from infected individuals </li></ul><ul><li>later subjects received injections of more purified virus preparations.. </li></ul>
  14. 14. Willowbrook hepatitis <ul><li>Investigators defended the injections by pointing out that the vast majority of them acquired the infection anyway while at Willowbrook </li></ul><ul><li>(sounds like a good place) </li></ul>
  15. 15. Willowbrook hepatitis <ul><li>and it would be better for them to be infected under carefully controlled research conditions </li></ul><ul><li>(can rationalization can get any weaker) </li></ul>
  16. 16. Institutional Review Board (IRB) <ul><li>1. risk to subjects are minimized </li></ul><ul><li>2. risk to subjects are reasonable in relation to anticipated benefits, </li></ul><ul><li>3. selection of subjects is equitable, i.e. fair </li></ul><ul><li>4. informed consent is sought form each subject or his/her legally authorized </li></ul><ul><li>representative, </li></ul>
  17. 17. IRB continued <ul><li>5. informed consent is appropriately documented, </li></ul><ul><li>6. when appropriate, the research plan makes provisions for monitoring data collection, </li></ul><ul><li>7. privacy and confidentiality of research subjects is appropriately protected, and </li></ul><ul><li>8. when some or all of the subjects are likely to be vulnerable to coercion or undue </li></ul><ul><li>influence, additional safeguards have been included. </li></ul>
  18. 18. Cleveland Chiropractic College <ul><li>IRB committee here at Cleveland, both KC and LA faculty members </li></ul><ul><li>Approves all college research for human subject protection </li></ul>
  19. 19. <ul><li>Two examples of research experiments that would not be approved by an IRB committee today. </li></ul><ul><li>However, both show us something about </li></ul><ul><li>how and who were may be. </li></ul>
  20. 20. The Milgram experiment <ul><li>a seminal event because of what it taught us about ourselves. . . </li></ul><ul><li>We have the courage to do what is right in the face of authority telling us to do otherwise. </li></ul>
  21. 21. Milgram experiment <ul><li>was series of social psychology experiments conducted by psychologist Stanly Milgram of Yale University </li></ul>
  22. 22. <ul><li>The study measured the willingness of study participants to obey an authority figure who instructed them to perform acts that conflicted with their personal conscience. </li></ul>
  23. 23. <ul><li>The experiments began in July 1961, three months after the start of the trial of Nazi war criminal Adof Eichmann in Jerusalem. </li></ul><ul><li>Milgram devised the experiments to answer this question: &quot;Could it be that Eichmann and his million accomplices in the Holocaust were just following orders? Could we call them all accomplices? </li></ul>
  24. 24. <ul><ul><li>Subjects were instructed to ask questions of another subject, actually an actor, who was part of the experiment. </li></ul></ul><ul><ul><li>When the “other subjects” answered incorrectly the subject was told to administer an electric shock. </li></ul></ul>
  25. 26. <ul><li>The subjects did administer the shock </li></ul><ul><li>As the actor continued to give an incorrect answer the intensity of the shock was increased. </li></ul><ul><li>Although the actor was screaming in pain and begging for mercy the subject continued to administer the shock </li></ul>
  26. 27. <ul><li>The generator has 30 switches in 15 volt increments, each is labeled with a voltage ranging from 15 up to 450 volts. Each switch also has a rating, ranging from &quot;slight shock&quot; to &quot;danger: severe shock&quot;. The final two switches are labeled &quot;XXX&quot;. </li></ul>
  27. 28. <ul><li>The &quot;teacher&quot; automatically is supposed to increase the shock each time the &quot;learner&quot; misses a word in the list. Although the &quot;teacher&quot; thought that he/she was administering shocks to the &quot;learner&quot;, the &quot;learner&quot; is actually a student or an actor who is never actually harmed. The drawing of lots was rigged, so that the actor would always end up as the &quot;learner.&quot; </li></ul>
  28. 29. <ul><li>Ultimately 65% of all of the &quot;teachers&quot; punished the &quot;learners&quot; to the maximum 450 volts. No subject stopped before reaching 300 volts! </li></ul>
  29. 30. One more from 1971 <ul><li>Stanford Prison Experiment </li></ul><ul><li>Dr. Philip Zimbardo </li></ul><ul><li>Psychology study of human response to captivity </li></ul>
  30. 31. <ul><li>http:// =1KXy8CLqgk4 </li></ul>
  31. 32. <ul><li>undergraduate college students randomly assigned to roles of prisoners or guards </li></ul><ul><li>mock prison in the basement of the psychology building </li></ul>
  32. 33. Dark Side of Human Nature <ul><li>prisoners and guards rapidly adapted to their roles </li></ul><ul><li>*one third of the guards displayed sadistic tendencies </li></ul><ul><li>*prisoners emotionally traumatized </li></ul><ul><li>*only 1 of 50 observers objected </li></ul><ul><li>experiment stopped early </li></ul>