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Black Chapters of Biomedical Research
Weam Banjar; BDS., MS
General Directorate of Infection Control and Prevention- Ministry of Health
April 20/2015
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
1932
Tuskegee
Syphilis study
1945
End of WW II
1946
Nuremberg
Trial
1932
Tuskegee
Syphilis study
1945
End of WW II
1946
Nuremberg
Trial
Nuremberg
code
1948 1932
Tuskegee
Syphilis study
•Consent
•Fruitful results
•Foundation
•Do no harm
•Death/ disabling injury
•Risk
•Proper preparation
•Qualification
•Withdrawal
•Termination
1945
End of WW II
1946
Nuremberg
Trial
1950s
Thalidomide
disaster
1932
Tuskegee
Syphilis study
Nuremberg
code
1948
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
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
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
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
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
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
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
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
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
Acknowledgement:
• Prof. Ralph V. Katz
• Prof. Susan Reverby
• Prof. Mary Northridge
• Dr. Hail Alabdely
• Dr Hanan Hathout