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Notable Events in the History of Human Subject Research

Notable Events in the History of Human Subject Research . CIP Course Lesson 1. Topics . Stanford Prison Study Guatemala Syphilis Studies Jewish Chronic Hospital Disease Study Tuskegee Syphilis Study Belmont Report The US FDA. An early study NAZI Research

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Notable Events in the History of Human Subject Research

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  1. Notable Events in the History of Human Subject Research CIP Course Lesson 1

  2. Topics Stanford Prison Study Guatemala Syphilis Studies Jewish Chronic Hospital Disease Study Tuskegee Syphilis Study Belmont Report The US FDA • An early study • NAZI Research • WillowbrookHepatitis Study • Milgram Obedience Study • Tearoom Trade Study • Radiation Experiments

  3. An earlier time…..

  4. Edward Jenner – founder of immunology - Founder of Immunology - Known for contribution to Small Pox eradication Hand of Mary Nelms, Milkmaid “On May 14, 1796, using matter from Nelms' lesions, he inoculated an 8-year-old boy, James Phipps. Subsequently, the boy developed mild fever and discomfort in the axillae. Nine days after the procedure he felt cold and had lost his appetite, but on the next day he was much better. In July 1796, Jenner inoculated the boy again, this time with matter from a fresh smallpox lesion. No disease developed, and Jenner concluded that protection was complete.” What are the ethical issues?

  5. NAZI Experiments

  6. NAZI Experiments NAZI Scientists conducted experiments on concentration camp victims: • Cold water • Altitude • Wounds • Nutrition • Sterilization What are the ethical issues? The NAZI experiments let to the Nuremberg trials and the Nuremberg Code

  7. Willowbrook State School, New York City Senator Robert Kennedy toured the institution in 1965 and proclaimed that individuals in the overcrowded facility were "living in filth and dirt, their clothing in rags, in rooms less comfortable and cheerful than the cages in which we put animals in a zoo" and offered a series of recommendations for improving conditions….

  8. Willowbrook State School Hepatitis Study • Started in 1955 by Dr. Sam Krugman • Children were intentionally infected with Hepatitis. • Parents consented to the child’s inclusion to have the child moved up on a waiting list • The study led to the use of gamma globulin for hepatitis A. What are the ethical issues?

  9. Stanley Milgram Obedience to Authority Study Please continue. The experiment requires that you continue. It is absolutely essential that you continue. You have no other choice, you must go on.

  10. What are the ethical issues?

  11. Laud Humpheys’ Tearoom Trade Study

  12. Tearoom Trade • A study of homosexual acts taking place in public places. • Investigator used deception to befriend participants. • Served as the “look-out” for homosexuals engaging in sex. • Copied license plate numbers and later went to participant’s home to conduct interview What are the ethical issues?

  13. Human Radiation Studies

  14. Human Radiation Studies • Soldiers were intentionally exposed to radiation • Children were exposed to radiation fortified foods • Cancer patients were exposed to radiation experiments What are the ethical issues?

  15. Stanford Prison Study • Volunteers were arrested in their home by police officers for “armed robbery.” • Prisoners were fingerprinted, stripped and doused with spray. • Other volunteers served as guards in the realistic “prison.” • Both prisoners and guards took on their roles and soon the prisoners became meek and the guards became sadistic. • The study was stopped as conditions deteriorated. What are the ethical issues?

  16. Jewish Chronic Disease Hospital Study In 1963, chronically ill and debilitated non-cancer patients at the Jewish Chronic Disease Hospital in New York were injected with live human cancer cells . Physicians did not inform the patients so as not to scare them, since it was believed that the cells would be rejected. What are the ethical issues?

  17. Wichita Jury Bugging 1950s - University of Chicago researchers involved the taping of jury deliberations in criminal cases. The study was in response to concerns that juries were being unduly influenced by showmanship rather than the facts of the case. Though the judge and the attorneys involved were aware of the taping, the juries were not informed as researchers believed it would affect their behavior. Gene Therapy Study at University of Pennsylvania In 1999, Jesse Gelsinger died while a participant in a gene therapy research study at the University of Pennsylvania. After his death, information divulged led Jesse's father to believe that Jesse and his family were not fully informed of the risks involved in the research. Death of a Healthy Volunteer at Johns Hopkins 200 - a 24 year old female employee at Johns Hopkins inhaled hexamethonium as a research volunteer.She became ill and died. The investigation revealed that the consent form failed to adequately describe the research procedures to be followed, or failed to identify procedures which were experimental, and failed to adequately describe the reasonably foreseeable risks and discomforts of the research. The researchers failed to follow the protocol, failed to report unanticipated problems in an initial subject, and continued to involve additional subjects before the symptoms in the first subject were resolved and reported to the appropriate entities.

  18. Guatemala Syphilis Studies

  19. Guatemala Syphilis Studies • Occurred in 1946-1948 but not discovered until. • Funded by PHS. • Prisoners, soldiers, and mental health patients in Guatemala were intentionally infected with syphilis and other diseases for medical experiments with antibiotics. • President Obama apologized to the Guatemalan people. What are the ethical issues?

  20. Tuskegee Syphilis Study

  21. An Invitation to treatment?

  22. Tuskegee Syphilis Study • Funded by Public Health Service • Objective was to study the lifespan of syphilis. • Enrolled African American sharecroppers who were infected with syphilis. • The men were never treated and were told they had “bad-blood.” • Information about the study became public in 1972. • Congress reaction by requiring DHHS to develop regulations. • Congress formed the National Commission for the Study of Ethical Problems in Research.

  23. The Belmont Report and Federal Regulations for the Protection of Human Subjects

  24. Belmont Report • Respect for Persons • Beneficence • Justice

  25. 45 CFR 46 • Referred to as: The Common Rule, OHRP Regulations, HHS Regulations • Applies to human subject research funded or supported by DHHS • Includes requirements for: • Institutional Review Boards (IRBs) • Informed consent • Children, Prisoners, Pregnant Women, Fetuses (added at later dates)

  26. The US FDA

  27. 1938The Federal Food, Drug, and Cosmetic (FDC) Act of 1938 is passed by Congress, containing new provisions: Extending control to cosmetics and therapeutic devices. Requiring new drugs to be shown safe before marketing-starting a new system of drug regulation. Eliminating the Sherley Amendment requirement to prove intent to defraud in drug misbranding cases. Providing that safe tolerances be set for unavoidable poisonous substances. Authorizing standards of identity, quality, and fill-of-container for foods. Authorizing factory inspections. Adding the remedy of court injunctions to the previous penalties of seizures and prosecutions. Under the Wheeler-Lea Act, the Federal Trade Commission is charged with overseeing advertising associated with products otherwise regulated by FDA.

  28. 1962Thalidomide, a new sleeping pill, is found to have caused birth defects in thousands of babies born in western Europe. News reports on the role of Dr. Frances Kelsey, FDA medical officer, in keeping the drug off the U.S. market, arouse public support for stronger drug regulation.Kefauver-Harris Drug Amendments passed to ensure drug efficacy and greater drug safety. For the first time, drug manufacturers are required to prove to FDA the effectiveness of their products before marketing them. Consumer Bill of Rights is proclaimed by President John F. Kennedy in a message to Congress. Included are the right to safety, the right to be informed, the right to choose, and the right to be heard

  29. 1962 FDA Regulations Enacted FDA and the Department of Health and Human Services revise regulations for human subject protections, based on the 1979 Belmont Report, which had been issued by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The revised rules provide for wider representation on institutional review boards and they detail elements of what constitutes informed consent, among other provisions. 21 CFR 50 – Informed Consent and protections for Children 21 CFR 56 - Institutional Review Boards

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