The Tuskegee Syphilis Study - Term Paper Example

The Tuskegee Syphilis Study The Declaration of Helsinki by the WHO clearly states that in clinical trials involving humans the wellbeing of the subject should be of prime importance than the interest of science or society. This has been stated because at times in order to achieve the objectives of a study the investigators might overlook the welfare of the trial subjects thus jeopardizing their health in the process. According to ethical rules while comparing two treatment options the control group of the study must receive the best known treatment available while the study subjects are given a potential newer treatment. Only when there is no effective treatment available a placebo-controlled group can be used for the study. There have been several trials which have followed unethical means to realize study objective and have become textbook examples of unethical research study, one such study being the Tuskegee Study of Untreated Syphilis (Angell, 1997). The Tuskegee Study of Untreated Syphilis is widely considered as one of the most horrific studies in which the basic ethics of conduct has been totally disregarded. The study was based on the hypothesis that black and white people differed in their response to the disease. Before the study was initiated in 1928, the U.S Public Health Services (PHS) had already completed a study in Mississippi in which 25% of the participants who were all black had tested positive for the disease. The PHS intended to expand and continue the study in rural black population and set up a treatment program with aid from the Julius Rosenwald Fund. Though the study initially intended to improve the health of the African American population by providing doses of metals which was used to treat the disease during that period, the coming of the great depression drastically lowered the funds for the project. And it was then that the PHS decided to conduct a study based on the aforementioned hypothesis that racial variation plays a role in the effects of syphilis. The objective of the study was to compare the natural progression of syphilis in untreated poor African Americans who were followed up for a period of 40 years with a healthy control population who were free of the disease. While the initial study was designed to last for a year and where participants with syphilis were given minimal treatment which would have definitely not cured them, the extended study examined men with untreated syphilis over the 40 year period and in case they died during that period their bodies autopsied to study the exact course of the infection (Angell, 1997; Sugarman, 2002). The PHS took the cooperation of the Tuskegee Institute and since the institute was previously involved in syphilis treatment programs to local African Americans enrolling members from the black community was quite easy. In return the institute was promised employment for its doctors and nurses and aids for future studies. The PHS also recruited members from the church, community leaders and plantation workers with the promise of free treatment for the illness, food and transport and as the study was extended to perform autopsies on the infected men even burial stipends were offered to the family of the deceased (Research Ethics, n.d; Parker, n.d). Apart from the information that their blood was being tested for a variety of illnesses, the study participants were not informed about the disease, its mode of transmission and treatments offered and also whether they were actually infected with syphilis. Thus no form of informed consent was provided by the subject which is the first major ethical deviation in the study. The participants were denied the basic right to information and above all not informed that they had contracted a disease. They were merely treated as guinea pigs to realize the study objective which was to compare the natural history of syphilis in untreated men and compare the results with healthy male populations. As the study occurred at a time when the black population had no means to undergo any kind of medical treatment and hence enrolling participants was not a hindrance for this study. Moreover the iron and aspirin that were administered as placebos improved the general health of these individuals which gave them a sense of confidence and that the treatment offered indeed had some therapeutic potential (Sugarman, 2002). The researchers exploited the poverty of the participants and even performed spinal taps, a procedure which did not have any significance to the study and merely used to determine the presence of neuro-syphilis, as free treatment. Thus the entire study was carried out without any explanation of the nature of the study and its objectives to the participants (Research Ethics, n.d; Parker, n.d). As the study progressed the participants were denied any form of treatment, even after widespread use of penicillin as a promising treatment, as the objective of the study was to observe the natural course of the disease when left untreated. While the PHS offered the newly emerged penicillin treatment to syphilis infected individuals in its clinic, the study men were denied of even the older form of treatment with metals. Even after penicillin became the standard treatment for the disease and request from their draft boards to administer penicillin to the study participants, PHS ensured that the study subjects did not receive any form of treatment. Due to their uneducated background and since they were initially treated for sometime the study subjects believed that they had received enough treatment to control the disease. Thus the entire study did not bring about any benefit to the patient. During the course of the study paper were also presented and published in medical journals. The study, however, failed to uphold the ethical rules of clinical trials as proposed by the Nuremberg Code which laid emphasis on obtaining informed consent, voluntary participation by the study subjects and that no harm should be caused to the study participants. The developing world did not adhere to the code adding to which the subjects recruited in the study were mostly illiterates (Cash, 2007; The Ethics of Social Research, n.d). The declaration of Helsinki by the WHO in the year 1964, which was developed as an alternative to the Nuremberg code, laid strict emphasis on the importance of obtaining an informed consent following which the PHS framed its own guidelines for clinical trials which marked the beginning of what is more commonly now known as an IRB (institutional review boards). But even after the establishment of the code for ethical research by the USPHS none of its rules were followed for its own studies like the Tuskegee Study (The Ethics of Social Research, n.d). Further an article about the study was also published in the same year and the investigators were questioned by a physician named Peter Buxton regarding the ethics of the study and denial of effective treatment available to the study subjects. However the study did continue and the PHS merely arranged for a panel consisting of white physicians to decide on the course of the study. All the members except for one doctor were n favor of continuation of the study and they also added that obtaining an informed consent from people with very little education was practically impossible. But the study finally had to yield in to the negative publicity from the media which published an article about the patients being treated as guinea pigs and were left to die untreated, the information for which was provided by Buxton which led to its termination (Research Ethics, n.d; Parker, n.d). Thus the study is definitely an example of how the rules were bended for personal gains of certain institutions. It was definitely the moral responsibility of the conducting institute to ensure that the objective of a clinical study is towards achieving a positive research outcome and at the same time the welfare of all the subjects recruited for the study is taken care of. However in the Tuskegee Study both the above points have not been adhered to as neither did the study objective lead to a positive outcome and nor were the subjects treated in a right manner. The investigators had made poor decisions and were influenced by bigotry which has ultimately resulted in loss of faith among the African American community in clinical trial participation. There is still a sense of fear and suspicion among the black population and mistrust in the public health institutions (Research Ethics, n.d; The Ethics of Social Research, n.d). Hence following the Tuskegee Study all the regulations for participation of humans in clinical trials was changed by the National Research Act that was passes in 1974 which mandated that a national commission be created to look into the welfare of human subjects. Further the commission called for the establishment of an IRB in every institution and all the research conducted in the institution would have to be reviewed by the IRB before the study is initiated. The IRB also had a moral responsibility to ensure that the welfare of human subjects would be the first priority of any clinical research and hence all the regulatory procedures pertaining to human subjects in the study was adhered to and that an informed consent explaining the protocol in a language understood by the participant was obtained prior to the start of any study. And after obtaining an informed consent investigator should ensure that no deviation occurs in the study and the participant is treated according to what he has consented (The Ethics of Social Research, n.d). Additionally the participants should also be made aware of any risks involved, additional costs, circumstance under which the participants may be terminated, consequences if they decide to withdraw and dissemination of study findings. Apart from the informed consent the IRB would also look into the study objectives and most importantly the risk-benefit ratio in the study which directly pertains to the welfare of the study participants. Thus they constitute an important team in the assessment of the study and whether it would result in positive result outcomes both for the researcher, the study participants as well as for the future generation (Parker, n.d; Sugarman, 2002). It is also the responsibility of the study investigators to ensure the confidentiality of the study participants as some people may deem it to be important considering their future. Additionally this would also boost the participation rates and thus help to achieve the desired research results (Sugarman, 2002). In conclusion, the management of an institution has the sole responsibility of setting up the IRB and to make sure that no kind of prejudice is shown by the members of the IRB towards a particular study due to financial or other pressures as this would result in overlooking certain aspects of the study which may prove fatal as the study progresses. They also have to ensure that incidences such as death should be immediately reported to the federal agencies involved in the funding (The Ethics of Social Research, n.d). Hence, an establishment of such as regulatory body in every institute would help clinical studies carried out in humans follow the ethical code. References 1. Angell, M. (1997). The ethics of clinical research in the third world. The New England Journal of Medicine, 337(12), 847-849. 2. Research Ethics: The Tuskegee Syphilis Study. (n.d). Retrieved February 24, 2010, from http://www.tuskegee.edu/global/story.asp?s=1207598 3. Parker, L.S., & Alvarez, H.K. (n.d).The Legacy of the Tuskegee Syphilis Study. Retrieved February 24, 2010, from, http://www.asph.org/UserFiles/Module2.pdf 4. Cash, R.A. (2007). Research ethics involves continuous learning. Indian Journal of Medical Ethics, 4(2). Retrieved February 24, 2010, from http://www.issuesinmedicalethics.org/152cs82.html 5. Sugarman, J. (2002). Ethics in the Design and Conduct of Clinical Trials. Epidemiologic Reviews, 24(1), 54-58. 6. The Ethics of Social Research. (n.d). Retrieved February 24, 2010, from, http://www.sagepub.com/upm-data/6197_Chapter_3__Hesse_Biber_I_Proof_2.pdf Read More