Informed consent – geïnformeerde
toestemming
Autonomy of involved subjects is the central principle: ‘self-determination’ Giving Informed Consent
implies optimal information
1 A HISTORY OF UNETHICAL RESEARCH
- Medical experiments by Nazi doctors during WW II
- Prisoners as research subjects in 20th century US
- Tuskegee Syphilis Study
1.1. THE TUSKEGEE STUDY OF UNTREATED SYPHILIS
- Study initiated in 1932 to last 6 to 9 months
- Subjects: Negro Males
- 399 with latent syphilis and 201 as control group.
- Purpose : collection of data on untreated syphilis
No information about the study. No IC
1.1.1.Historical infamy
- 399 Afro-Americans signed in for free medical service
- Men were told they had ‘bad blood’
- Disease followed without treatment; Purpose : collection of data on untreated syphilis
- No information about the study. No IC
- Penicillin – available since 1947
- Outcome:
- 28 men had died of syphilis
- 100 others were dead of related complications
- At least 40 wives had been infected
- 19 children had contracted the disease at birth
1.1.2.The Tuskegee experiment (Ctd)
- National Commission for the Protection of Human Subjects of Biomedical and Behavioral
Research (1974)
- The Belmont Report in 1979: ”respect for persons; beneficence; justice”
- Remarks by the president in apology for study done in Tuskegee. May 16, 1997 (15 min.
speech)
1.2. REVIEW OF THE HISTORY OF IC
From LEGAL point of view:
- Court case in 1914: New York Justice B. Cardoza: “Every human being of adult years and
sound mind has a right to determine what shall be done with his own body”
- Nuremberg Code in 1947: = 1st International code involving standards (10) for clinical
research practice. “The voluntary consent of the human subject is absolutely essential”
- Court case in 1957 “uninformed consent is not true consent”
- Declaration of Helsinki in 1964
toestemming
Autonomy of involved subjects is the central principle: ‘self-determination’ Giving Informed Consent
implies optimal information
1 A HISTORY OF UNETHICAL RESEARCH
- Medical experiments by Nazi doctors during WW II
- Prisoners as research subjects in 20th century US
- Tuskegee Syphilis Study
1.1. THE TUSKEGEE STUDY OF UNTREATED SYPHILIS
- Study initiated in 1932 to last 6 to 9 months
- Subjects: Negro Males
- 399 with latent syphilis and 201 as control group.
- Purpose : collection of data on untreated syphilis
No information about the study. No IC
1.1.1.Historical infamy
- 399 Afro-Americans signed in for free medical service
- Men were told they had ‘bad blood’
- Disease followed without treatment; Purpose : collection of data on untreated syphilis
- No information about the study. No IC
- Penicillin – available since 1947
- Outcome:
- 28 men had died of syphilis
- 100 others were dead of related complications
- At least 40 wives had been infected
- 19 children had contracted the disease at birth
1.1.2.The Tuskegee experiment (Ctd)
- National Commission for the Protection of Human Subjects of Biomedical and Behavioral
Research (1974)
- The Belmont Report in 1979: ”respect for persons; beneficence; justice”
- Remarks by the president in apology for study done in Tuskegee. May 16, 1997 (15 min.
speech)
1.2. REVIEW OF THE HISTORY OF IC
From LEGAL point of view:
- Court case in 1914: New York Justice B. Cardoza: “Every human being of adult years and
sound mind has a right to determine what shall be done with his own body”
- Nuremberg Code in 1947: = 1st International code involving standards (10) for clinical
research practice. “The voluntary consent of the human subject is absolutely essential”
- Court case in 1957 “uninformed consent is not true consent”
- Declaration of Helsinki in 1964
