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1932 US Public health Service and Tuskegee institute, Macon county, Alabama
METHODOLOGY: > 600 rural black men were enrolled; 399 with syphilis and
201 healthy black men
1947 penicillin had become standard therapy for syphilis but participants withheld
penicillin, information about it, and were prevented from accessing syphilis
treatment programs
1972 Results: Of the 399 patients : only 74 of the test subjects were alive, 28
had died of syphilis, 100 were dead of related complications, 40 of their wives
had been infected and 19 of their children were born with congenital syphilis.
This led to bioethics reforms in the US 1979 Belmont Report and the establishment of
the Office of Human Research Protection.
federal laws and regulations requiring Institutional Review Board for the protection of
human subjects in studies
May 16, 1997: Public apology from U.S. President Clinton (CNN);
The study was conducted without the benefit of patients' informed consent.
The men thought they were receiving free health care from the U.S. Government
The consent of the subjects for spinal taps was obtained by depicting the diagnostic
test as a "special free treatment.
The men were never told they had syphilis but they were told that they were being
treated for "bad blood", a local term for various illnesses
Objectives
Nuremberg Code of 1947: 10 principles that became the first documented code of
ethics for human research
2. The experiment should be such as to yield fruitful results for the good of society.,
unprocurable by other methods or means of study, and not random and unnecessary in
nature.
4. conducted as to avoid all unnecessary physical and mental suffering and injury.
6.The degree of risk to be taken should never exceed that determined by the humanitarian
importance of the problem to be solved by the experiment.
7. Proper preparations should be made and adequate facilities provided to protect the
experimental subject.
9. During the course of the experiment, the human subject should be at liberty to bring
the experiment to an end
10. During the course of the experiment, the scientist in charge must be prepared to
terminate the experiment at any stage, if continuation of the experiment is likely to result
in injury, disability, or death to the experimental subject.
Historical background
Jewish Chronic Dis. Hosp. injection of live cancer cells into elderly patients
to minimize the possibility of exploitation participants are not merely used but are treated
with respect while they contribute to the social good.
refraining from obstructing their actions unless they are clearly detrimental to others
Participants enter into the research voluntarily and with adequate information
6. Informed consent
7. Respect for Enrolled subjects
Emmanual E. What makes Clinical research Ethical. JAMA may 24/31 2000 Vol 283 No
20
1. SOCIAL OR SCIENTIFIC VALUE
Evaluation of a treatment, intervention or theory that will improve health and well being
or increase knowledge
2. SCIENTIFIC VALIDITY
Vulnerable Subjects
Children
Laboratory assistants
Medical students
Ethnic minorities
3 condition
No 20
5. INDEPENDENT REVIEW
-assures members of the society that people enrolled in trials will be treated ethically and not
benefit from the misuse of other human beings.
6. INFORMED CONSENT
Provision of information:
> purpose
> procedures
so that the individual understands this information and can make a voluntary decision
whether to enroll and continue to participate
Access to intervention
3. Psychological/emotional distress
5. Loss of privacy
6. Loss of time
7. Monetary costs ( transpo, child care, time from work)