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Black chapter of biomedical research
1.
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