Irb Assignment - Tuskegee Syphilis

IRB Assignment

The Tuskegee Syphilis Study was a 40-year infamous unethical biomedical research study conducted by the United States Public Health Service and the Tuskegee Institute in Macon County, Alabama between 1932 and 1972. The Tuskegee Syphilis Study, also known as the Tuskegee Syphilis experiment, was a clinical research experiment that studied the natural advancement of untreated syphilis in four-hundred impoverished black men, who thought they were receiving free medical care for "bad blood", a common term used to describe different types of illnesses. The participants were enrolled without consent into the study and were never told they had syphilis. In fact, experimental spinal taps without anesthesia were conducted on participants, in order to study neurological effects of syphilis (Twenty Years After: The Legacy of the Tuskegee Syphilis Study, 1992). In exchange for the study, the human subjects were offered free medical care, free meals on examination days, and burial insurance (Centers for Disease Control & Prevention, n.d.). The Tuskegee scientists continued the study without treating the participants or informing them about penicillin, which in 1947 became a safe and effective standard antibiotic treatment for syphilis. The study continued until there was a leak to the Washington Star and the New York Times in 1972. As a result of the Tuskegee Syphilis study, more than one hundred of the infected men had perished by 1972, and many other individuals suffered from serious related syphilis related conditions, including many of the subject's wives and children which contracted the disease (Marsden & Melander, n.d.). Furthermore, in 1973 a class-action lawsuit was filed by the participants, and in 1974 a ten-million out-of-court settlement was reached, including lifetime medical benefits and burial services for all living participants and their families (Centers for Disease Control & Prevention, n.d.).

Most important, the Tuskegee Syphilis study led to the establishment of the National Research Act in 1974, which mandates the Institutional Review Board approval for all federal funded research involving human subjects (Twenty Years After: et. al., 1992). The IRB must approve and conduct ongoing annual reviews on any research involving human subjects. The IRB's goal is to ensure several requirements are satisfied during research, such as risk to subjects are minimized, selection of subjects are fair, informed consent is appropriately documented and requested by participants or legal representative, etc. The Tuskegee Syphilis study failed to reach IRB's requirements in ensuring the rights and welfare of the participants were being protected (Marsden & Melander, n.d.). Although, the panel that conducted a review of the study concluded that the human subjects freely participated in the study, they found that the study did not follow standard scientific research protocol and the subjects were put at risk. In fact, all of the participants were not offered the research procedure called informed consent and were not given the chance to quit the study or to take penicillin once it became available.

In addition, the Tuskegee Syphilis Study also led to the development

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