black chapter of biomedical research

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