Slide2Tuskegee syphilis study (1932-1972) qSyphilis is a sexually transmitted infectious disease. qIn 1933, the U.S Public Health Service in Macon country, Alabama, managed a study on Syphilis. qThe experiment's name comes from the Tuskegee Institute, the black university founded by Booker T. Washington.
Slide3Location qTuskegee study was conducted in province of America in Alabama. qIt is situated in South Eastern region of the country.
Slide4Study Clinicians qDr. Taliaferro Clark, formed the study group. qDr. Eugene Dibble, Head of John Andrew Hospital. qDr. Oliver C. Wenger. qDr. Raymond H. Vonderlehr, on-site Director. qNurse Eunice Rivers
Slide5Study Details qThe subjects were studied for 6-8 months, then treated with contemporary methods including Salvarsan, mercurial ointments, and bismuth. qThe Tuskegee University-affiliated hospital effectively loaned the PHS its medical facilities. qPatients received free physical examinations at Tuskegee University, free rides to and from the clinic, hot meals on examination days, and free treatment for minor ailments.
Slide6Study Details qOut of the 600 low income African-American males, 399 with latent syphilis and 201 males without disease as controls were enrolled in the study. qContinuing effects of the Stock Market Crash of 1929 and the beginning of the Great Depression led the Rosenwald Fund to withdraw its offer of funding. qNo funding implied end of the study, therefore study directors issued a final report. qThe Tuskegee study group decided to salvage their work and perform a prospective study equivalent to the Oslo Study.
Slide8Study Details qMany patients were lied to and given placebo treatments so that researchers could observe the progression of the fatal disease. qIn 1934, the Tuskegee Study published its first clinical data, and issued their first major report in 1936,prior to the discovery of penicillin as treatment for syphilis. qBy 1947 penicillin had become standard therapy for syphilis. qThe subjects were prevented from participating in Syphilis eradicative campaigns, thus depriving chance for cure.
Slide9Study Termination and Aftermath qIn 1972 the Tuskegee Study was brought to public and national attention by Peter Buxtun (whistleblower), who gave information to the “Washington Star” and the “New York Times”. qPeter Buxtun wrote letter to the director of Venereal Disease Division showing concern for the ethics and morality of the Tuskegee Study. qIn 1968 William (Bill) Carter Jenkins, founded and edited ‘The Drum’, a newsletter, where he called for the end of the study. But did not succeed
Slide10Study Termination and Aftermath qFinally Peter Buxtun broke the story first in the Washington Star on July 25,1972 and the following day in the New York Times. qA congressional hearing was held by Senator Edward Kennedy. qThe CDC and PHS appointed an advisory committee who reviewed the study as medically unjustified and ordered its termination. qAfter end of study,28 men had died of syphilis,100 were dead of related complications,40 of their wives had been infected, and 19 of their children had been born with congenital syphilis. qA class action lawsuit was filed where the U.S. government paid $9 million.
Slide11Study Termination and Aftermath q"The United States government did something that was wrong—deeply, profoundly, morally wrong. It was an outrage to our commitment to integrity and equality for all our citizens... clearly racist." qPresident Clinton's apology for the Tuskegee Syphilis Experiment to the eight remaining survivors, May 16, 1997 with these sentences.
Slide12Aftermath qThe Tuskegee Syphilis Study was in violation of all three requirements proposed by the Judiciary: qThe voluntary consent of the person on whom the experiment is to be performed must be obtained, qThe danger of each experiment must be previously investigated by animal experimentation, qThe experiment must be performed under proper medical protection and management.
Slide13National Research Act qDue to the publicity from the Syphilis Study, the National Research Act was signed on 12 July,1974. qThe National Research Act created the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. qThe Commission charge was to identify the basic ethical principles and to accordingly develop guidelines to be followed.
Slide14National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research qCarrying out its charge, the Commission prepared the Belmont Report in 1979. qThe Belmont Report is a statement of basic ethical principles and guidelines that provide “an analytical framework to guide the resolution of the ethical problems arising from research with human subjects.” qThe framework of the Belmont Report is presented under three heads: boundaries between practice and research; basic ethical principles, and applications.
Slide15Belmont Report qThe report was created on April 18, 1979 and gets its name from the Belmont Conference Center where the document was drafted. qReport was created by the former United States Department of Health, Education, and Welfare (Health and Human Services). qThe Belmont Report attempts to summarize the basic ethical principles identified by the Commission in the course of its deliberations.
Slide16Ethical Principles & Guidelines for Research Involving Human Subjects 1.1- Respect for persons: q Individuals should be treated as autonomous agents. q Individuals with diminished autonomy are entitled to protection. 2- Beneficence: q Do not harm. qMaximum possible benefits, and minimize potential harms. 3- Justice: qFair distribution of burdens and benefits of research.