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The Tuskegee experiment began in 1932, at that time there was no treatment for syphilis

(contagious venereal disease). Participants were recruited by the promise of free medical care, 600
African American men in Macon County, Alabama were enrolled in the project, which aimed to study
the full progression of the disease. Participants were primarily sharecroppers, and many had never
before visited a doctor.

These men were monitored by health workers but only given placebos such as aspirin and mineral
supplements, despite the fact that penicillin became the recommended treatment for syphilis in
1947 (15 years into the study). PHS researchers convinced local physicians in Macon County not to
treat the participants, and instead research was done at the Tuskegee Institute.

In order to track the disease’s full progression, researchers provided no effective care as the men
died, went blind or developed mental defects or experienced other severe health problems due to
their untreated syphilis.

PHS venereal disease investi gator in San Francisco named Peter Buxton leaked the story
to a reporter friend, who passed it on to a fellow reporter, Jean Heller of the Associated
Press. Heller broke the story in July 1972, prompti ng public outrage and forcing the
study to fi nally shut down.

By that ti me, 28 parti cipants had perished from syphilis, 100 more had passed away from
related complicati ons, at least 40 spouses had been diagnosed with it and the disease
had been passed to 19 children at birth.

Bioethical Violati ons;

1) Parti cipants were not fully informed about the study so they were not able to
make autonomous decision.
2) Nonmaleficence (Parti cipants were harmed because treatment was withheld aft er
it became treatment of choice)
3) Justi ce (only African American Males were recruited)
1) Justi ce (Prisoners were forced by the guards to parti cipate in the study)
2) Respect for autonomy (Parti cipants were not informed about the study)
3) Nonmaleficence (The prisoners did not have any benefi t by parti cipati ng in this
study, in fact it killed some of them)
4) Benefi cence (The parti cipants must be benefi ted by the study but in this case Dr
Strong carried out this trial for his own beneficence he wanted to prove that his
vaccine for cholera was superior to other)

Because of their poor health, low socioeconomic status, limited liberty and autonomy prisoners are
considered as a vulnerable population for research. Biomedical research on Prisoner-participants is
permitted by Risk-benefit analysis (Only when the benefit to the participants outweighs the potential
risk). Any study that offers no benefit to the participants should not be done (example; Testing of
cosmetic products).

The use of the term “vulnerable’’ in the context of human research protections does not refer to
susceptibility of harm, but rather the inability or a threat to the ability of an individual to give
voluntary informed consent. When some or all subjects are likely to be vulnerable to coercion or
undue influence the IRB must ensure that additional safeguards have been included in the
study to protect the rights and welfare of these subjects

1) People who are ill (dependent on clinician for care)


2) Pregnant women
3) Ethnic and Racial Minorities
4) Children
5) Elderly persons
6) Prisoners

Popole who are dependent on a clinician for care are vulnerable because of their poor health
condition and they maybe under influence of the clinician.

Pregnant women are considered as vulnerable population because of the involvement of third party
with a unique and inextricable relationship to the mother (the foetus) that maybe affected by
research and cannot give consent.

Certain racial and ethnic populations are considered as vulnerable because of their Socioeconomic
disadvantage and the lack of proper knowledge about their rights and they may be influenced.

Children are considered as vulnerable because their intellectual and emotional capabilities are
limited and therefore, they are legally incompetent to give valid informed consent

Elderly persons are considered because they are often economically vulnerable as their cost of care
may exceed their income and they may be influenced.
Prisoners are considered vulnerable because of their poor health, low socioeconomic status, limited
liberty and autonomy

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