1. ADDRESSING BAD RESEARCH Rels 300 / Nurs 330 23 October 2014

2. Miss Evers’ Boys 1. Note specific issues and dilemmas that arise in the story 2. Examine the key ethical choices made by health care providers and researchers: Which were ethical choices? Would you support them? Were there unethical choices? Would you challenge them? What information was withheld from the men and why? What specific harms and benefits resulted? 3. Do you believe that alternative courses of action would have been better? Can you suggest some alternatives? 4. What impact did the research have on the men and their families? 5. What did you find most challenging about this video? 6. How will this video contribute to your understanding and practice of being a health care provider? 7. What would you want potential viewers to be attentive to as they view the video themselves? What would you most want them to learn? 300/330 - appleby 2

3. The Tuskegee Syphilis Study 1932 to 1972, Macon County, Alabama 399 African American male sharecroppers recruited for a study on the natural progression of syphilis to death told that they were being treated for “bad blood” – this was how syphilis was known to them 201 African American men without syphilis also recruited all subjects were poor, black, largely illiterate, and had no access to regular medical care 300/330 - appleby 3

4. in 1943, penicillin emerged as an effective treatment for syphilis – this was not offered to the Tuskegee subjects benefits limited to free medicines, burial insurance, free hot meals on examination days, transport to and from hospital 300/330 - appleby 4

5. Evaluate the Tuskegee Study using the Nuremberg Code (1947) 1.Voluntary consent 2.Fruitful results for the good of society 3.Based on the results of animal experimentation and a knowledge of the natural history of the disease 4.Avoid all unnecessary physical and mental suffering and injury 5.No expectation of death or disabling injury 6.Degree of risk should never exceed the humanitarian importance of the problem to be solved 7.Protect the experimental subject against even remote possibilities of injury, disability, or death 8.Conducted only by scientifically qualified persons 9.Human subject should be at liberty to bring the experiment to an end 10.Scientist must terminate the experiment at any stage if there is a likelihood of injury, disability, or death 300/330 - appleby 5

6. President Clinton’s Apology, 1997 (http://clinton4.nara.gov/textonly/New/Remarks/Fri/19970516-898.html )http://clinton4.nara.gov/textonly/New/Remarks/Fri/19970516-898.html “The eight men who are survivors of the syphilis study at Tuskegee are a living link to a time not so very long ago that many Americans would prefer not to remember, but we dare not forget. “It was a time when our nation failed to live up to its ideals, when our nation broke the trust with our people that is the very foundation of our democracy… 300/330 - appleby 6

7. President Clinton with Syphilis Study participant Herman Shaw - May 16, 1997 “So today America does remember the hundreds of men used in research without their knowledge and consent… Men who were poor and African American, without resources and with few alternatives, they believed they had found hope when they were offered free medical care by the United States Public Health Service. They were betrayed. “Medical people are supposed to help when we need care, but even once a cure was discovered, they were denied help, and they were lied to by their government… “The American people are sorry -- for the loss, for the years of hurt. You did nothing wrong, but you were grievously wronged. I apologize and I am sorry that this apology has been so long in coming.” (http://clinton4.nara.gov/textonly/New/Remarks/Fri/19970516-898.html)http://clinton4.nara.gov/textonly/New/Remarks/Fri/19970516-898.html 300/330 - appleby 7

8. Tuskegee Legacy 1974 – US National Research Act National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research The Belmont Report Established 3 basic ethical principles: respect for persons beneficence justice 300/330 - appleby 8

9. The Belmont Report PRINCIPLE Respect for persons Individuals should be treated as autonomous agents Persons with diminished autonomy are entitled to protection. APPLICATION Informed consent Subjects, to the degree that they are capable, must be given the opportunity to choose what shall or shall not happen to them The consent process must include three elements: information, comprehension, and voluntariness. 300/330 - appleby 9

10. The Belmont Report PRINCIPLE Beneficence Human subjects should not be harmed Research should maximize possible benefits and minimize possible harms. APPLICATION Assessment of risks and benefits The nature and scope of risks and benefits must be assessed in a systematic manner. 300/330 - appleby 10

11. The Belmont Report PRINCIPLE Justice The benefits and risks of research must be distributed fairly. APPLICATION Selection of subjects There must be fair procedures and outcomes in the selection of research subjects 300/330 - appleby 11

12. The Belmont Report Full text can be found at: http://ohsr.od.nih.gov/guidelines/belmont.html http://ohsr.od.nih.gov/guidelines/belmont.html Significance of Belmont Report for the developing field of Bioethics? Respect for persons → Autonomy Beneficence – and risks / harms – Nonmaleficence Justice – fairness and equality 300/330 - appleby 12

13. Willowbrook State Mental Hospital for Children Staten Island, New York – mid 1950s 300/330 - appleby 13

14. http://www.museumofdi sability.org/newyork_tim eline_1960s.asp 300/330 - appleby 14

15. As the institutional population skyrocketed, admissions were suspended unless parents agreed to place their child in the hepatitis ward new children were deliberately infected with hepatitis to provide optimal control in the study parents were misled by exaggerations of the potential benefits of the study doctors claimed that the conditions were so unsanitary that the children would have developed hepatitis anyway 300/330 - appleby 15

16. Dr. Saul Krugman & Dr. Joan Giles: infectious disease specialists RESEARCH GOALS: to determine the natural history of viral hepatitis – its mode of infection and the course of the disease to test the effectiveness of gamma globulin in developing an inoculation against hepatitis Krugman & Giles collected serum specimens before exposure, during the incubation period, and several times post-infection 300/330 - appleby 16

17. “Therapeutic” Effect Drs. Krugman & Giles claimed that deliberately infecting the children was therapeutic because of their resulting immunity to hepatitis. the hepatitis strain was mild had optimum isolation facilities minimal exposure to other infectious diseases had consent from parents could withdraw consent before study was initiated in child significant scientific progress resulted from study 300/330 - appleby 17

18. As measured against Nuremberg Code: 1.Voluntary consent 2.Fruitful results 3.Results of animal experimentation 4.No unnecessary physical and mental suffering and injury 5.No death or disabling injury 6.Degree of risk less than humanitarian importance 7.Protect the experimental subject 8.Experiment conducted by scientifically qualified persons 9.Human subject can bring experiment to an end 10.Terminate experiment if evidence of injury, disability or death 300/330 - appleby 18

19. As measured against Belmont Report Principles Respect for persons Individuals should be treated as autonomous agents Persons with diminished autonomy are entitled to protection.Beneficence Human subjects should not be harmed Research should maximize possible benefits and minimize possible harms.Justice The benefits and risks of research must be distributed fairly. 300/330 - appleby 19

20. 1991 Symposium at the NYU School of Medicine honouring Dr. Saul Krugman “Dr. Krugman’s most important scientific achievements were in the unraveling of the mysteries of infectious hepatitis.” 300/330 - appleby 20