Black chapter of biomedical research
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The document summarizes key events in the historical development of medical research ethics regulations and guidelines to protect human subjects, beginning with the 1932 Tuskegee Syphilis study. Major milestones included the 1946 Nuremberg Code, the 1964 Declaration of Helsinki, the 1974 National Research Act establishing regulatory oversight in the US, and the 1979 Belmont Report providing ethical principles. The history shows how abuses of human subjects led to increasingly stringent informed consent standards and review board oversight of research to prevent harm.
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Black chapter of biomedical research
- 2. Black Chapters of Biomedical Research Weam Banjar; BDS., MS General Directorate of Infection Control and Prevention- Ministry of Health April 20/2015
- 3. Objectives: • Understand the historical foundation of ethics and regulations that control research activities • Why do we need to protect human subjects in research • Highlight current ethical guidelines
- 5. 1945 End of WW II 1946 Nuremberg Trial 1932 Tuskegee Syphilis study
- 6. 1945 End of WW II 1946 Nuremberg Trial Nuremberg code 19481932 Tuskegee Syphilis study •Consent •Fruitful results •Foundation •Do no harm •Death/ disabling injury •Risk •Proper preparation •Qualification •Withdrawal •Termination
- 7. 1945 End of WW II 1946 Nuremberg Trial 1950s Thalidomide disaster 1932 Tuskegee Syphilis study Nuremberg code 1948
- 8. 1945 End of WW II 1946 Nuremberg Trial Nuremberg code 1948 1950s Thalidomide disaster 1962 Kefauver Amendment 1932 Tuskegee Syphilis study To ensure drug efficacy and greater drug safety
- 9. 1945 End of WW II 1946 Nuremberg Trial Nuremberg code 1948 1950s Thalidomide disaster 1962 Kefauver Amendment 1932 Tuskegee Syphilis study 1964 Declaration of Helsinki 1965 •Foundation •Review process •Informed consent •Qualification •Risk vs. benefits
- 10. 1945 End of WW II 1946 Nuremberg Trial Nuremberg code 1948 1950s Thalidomide disaster 1962 Kefauver Amendment 1932 Tuskegee Syphilis study 1964 Declaration of Helsinki 1965 Humphrey’s Study
- 11. 1945 End of WW II 1946 Nuremberg Trial Nuremberg code 1948 1950s Thalidomide disaster 1962 Kefauver Amendment 1932 Tuskegee Syphilis study 1964 Declaration of Helsinki 1965 Humphrey’s Study 1972-1973 Tuskegee Syphilis study- End
- 12. 1945 End of WW II 1946 Nuremberg Trial Nuremberg code 1948 1950s Thalidomide disaster 1962 Kefauver Amendment 1932 Tuskegee Syphilis study 1964 Declaration of Helsinki 1965 Humphrey’s Study 1972-1973 Tuskegee Syphilis study- End 1974 National Research Act •Committee creation •Drafted Belmont report
- 13. 1945 End of WW II 1946 Nuremberg Trial Nuremberg code 1948 1950s Thalidomide disaster 1962 Kefauver Amendment 1932 Tuskegee Syphilis study 1964 Declaration of Helsinki 1965 Humphrey’s Study 1972-1973 Tuskegee Syphilis study- End 1974 National Research Act 1979 Belmont report •Respect of person •Beneficence •Justice
- 14. 1945 End of WW II 1946 Nuremberg Trial Nuremberg code 1948 1950s Thalidomide disaster 1962 Kefauver Amendment 1932 Tuskegee Syphilis study 1964 Declaration of Helsinki 1965 Humphrey’s Study 1972-1973 Tuskegee Syphilis study- End 1974 National Research Act 1979 Belmont report 1981 45 CRF Part 46 1991 45 CRF Part 46, Subpart A •The common role
- 15. 1945 End of WW II 1946 Nuremberg Trial Nuremberg code 1948 1950s Thalidomide disaster 1962 Kefauver Amendment 1932 Tuskegee Syphilis study 1964 Declaration of Helsinki 1965 Humphrey’s Study 1972-1973 Tuskegee Syphilis study- End 1974 National Research Act 1979 Belmont report 1981 45 CRF Part 46 1991 45 CRF Part 46, Subpart A President Bill Clinton Apology 1997
- 16. 1945 End of WW II 1946 Nuremberg Trial Nuremberg code 1948 1950s Thalidomide disaster 1962 Kefauver Amendment 1932 Tuskegee Syphilis study 1964 Declaration of Helsinki 1965 Humphrey’s Study 1972-1973 Tuskegee Syphilis study- End 1974 National Research Act 1979 Belmont report 1981 45 CRF Part 46 1991 45 CRF Part 46, Subpart A President Bill Clinton Apology 1997
- 17. Acknowledgement: • Prof. Ralph V. Katz • Prof. Susan Reverby • Prof. Mary Northridge • Dr. Hail Alabdely • Dr Hanan Hathout