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Introduction
The Tuskegee syphilis study is the infamous clinical study of African Americans who had infections of syphilis in Tuskegee, Alabama. The United States Public Health Service conducted the research in conjunction with the Alabama State Board of Health for a period of four decades, from1932 to1972.
The clinical study consisted of 600 African Americans males of whom 399 had syphilis while 201 acted as a control groups. The study meant to find out the natural progression of syphilis as the infected subjects did not receive actual treatment of the disease but rather received heavy metal placebo.
According to Biber (2005), the head of the clinical research assured fellow researchers that, “…everyone is agreed that the proper procedure is the continuance of the observation of the Negro men used in the study with the idea of eventually bringing them to autopsy” (p.83).
Furthermore, the researchers deceived the subjects that their diagnosis showed they were suffering from ‘bad blood’ and they needed ‘special treatment’, which they were offering freely. Eventually, the Tuskegee syphilis study resulted into questionable medical research ethics.
Patient Consent
Medical ethics demands that in any scientific research project, human subjects must participate voluntarily and should consent to the contemplated research study. The case scenario of the Tuskegee syphilis study was against the medical research ethics because, the United States Public Health Service, and the Alabama State Board of Health researchers deceived the subjects to claim that they received consent from them to participate in the study.
Biber (2005) argues that, “at no time in the course of the project were subjects asked to give their consent to participate in the study or asked to volunteer … instead they were deceived into thinking that they were getting free treatment for a serious disease” (p.84). The subjects participated in the research study unknowingly as they thought they were receiving treatment freely from the government doctors.
For the human subjects to consent and participate in a scientific research project, they should be aware of the scope regarding the research so that they can make an informed decision whether to participate or not.
The subjects of the Tuskegee syphilis research did not receive any information about the intention of the research, only deceptions. According to Heintzelman (1996), “…it was never explained that the survey was designed to detect syphilis … subjects were never told they had syphilis, the course of the disease, or the treatment, which consisted of spinal taps” (p.25).
The recruitment letter of the subjects shows that, the Tuskegee Institute Hospital invited the subjects to the hospital claiming that they were suffering from a serious disease of ‘bad blood’ and the hospital was offering free ‘special treatment’ that could save their lives. Hence, the Tuskegee syphilis study elicits ethical issues regarding consent of the human subjects, which the research violated.
The Benefits of the Research
The Tuskegee syphilis study shaped the medical research ethics because it led to the formation of several bodies that regulate research projects, and protect the rights of the participants and the researchers as well. The aftermath of the Tuskegee syphilis study underscores the realization to protect the rights of the human subjects by the federal government in the 1960s. The federal government developed rules that regulate medical research practice and gave the Institutional Review Board (IRB) the mandate to apply the rules.
The Congress also in response to the Tuskegee syphilis study passed National Research Act (NRA), which provided the “National Institute of Health to set up Commission on Protection of Human Subjects of Biomedical and Behavioral Research Risks (CPHSBR)” (Alvino, 2003, p.897). These institutions protect the patients and the entire society from becoming victims of unethical biomedical researches.
The institutions that regulate the scientific projects have also benefited medical professionals in terms of ethics and enhanced the validity of the biomedical research outcomes. IRB has a sole mandate to review research proposals that entails human subjects and animal models before approving a project to proceed.
The IRB “…must determine whether the benefits of the study outweigh its risks, that consent procedures have been carefully carried out and no one group of individuals has been unfairly treated or left out of the potential positive outcomes of a given study” (Beyer, & Kass, 2002, p.248). The regulation of the research projects has enhanced credibility of the biomedical research and subsequent outcomes thus great benefits to both the patients and the medical professionals.
Potential Role of Institutions
Institutions that regulate and control scientific research have potential role of ensuring that research scientists comply with the stipulated code of ethics. “Every biomedical research project involving human subjects should be preceded by careful of the predictable risks in comparison with foreseeable benefits to the subjects or to others … the right to safeguard integrity of subject should be paramount” (Beecher, 2005, p.1356).
Institutions like the IRB should ensure that all biomedical research involving human subjects complies with the standard code of ethics that enhance human dignity. Tuskegee syphilis study occurred because institutions such as the IRB and CPHSBR were non-existent.
Institutions and ethical committees that regulate scientific research should not only protect the interests of the subjects, but also consider the integrity and credibility of the research findings. Many scientific researchers may claim to have adhered to the ethics and purport to have conducted novel research, yet they present concocted research findings.
“Researchers may be dishonest about who they are or what they are doing and thus use deception in order to conduct their research … and may even do out of their way to explain the research project as a cover story” (Beyer, & Kass, 2002, p.249).
Therefore, research-overseeing institutions like IRB should extend their role from, not only protecting the human subjects, but also the entire society against application of incredible scientific evidences that may harm the society.
Potential Responsibilities of Management
The management of the biomedical research projects requires strict compliance to the research ethics if at all the credibility of the findings is to be meaningful to the society. The Tuskegee syphilis study gives an important lesson that the management of the research determines its ethical bearing. The head of the research ordered other researchers to go against the ethics by deceiving the patients to become subjects of the study; that they were suffering from ‘bad blood’; and that they were receiving ‘special treatment’ for a serious disease.
Heintzelman (1996) argues that, “the moral integrity of the researcher is a critically important aspect of insuring that the research process and a researcher’s findings are trustworthy and valid” (p.27). Therefore, the research management has the responsibility of ensuring compliance with the research ethics and scientific principles in order to achieve credible scientific findings that can benefit the society.
Research ethics demand that the human subjects must consent and volunteer to participate in the scientific research. It is the function of the project management to ensure that subjects receive ethical treatment throughout the process of the research. With respect to the Tuskegee syphilis study, if I were in power, I would have attributed the research mess to the management of Tuskegee Institute Hospital for they allowed other researchers to use their facility and patients to conduct unethical scientific research.
The letter of recruitment shows how the researchers employed unethical means of deception to lure helpless patients into ‘special treatment’ where they subjected them to torture rather than treatment. For the best management of scientific research project, special laboratories and research centers are necessary so that different levels of management authorities and instructional bodies can have real time monitoring of the ongoing projects.
Conclusion
The Tuskegee syphilis study, which took a period of four decades researching on the progression of untreated syphilis on human subjects, elicited sharp reactions regarding medical research ethics. The ethicists question remains whether it was ethical for the medical researchers to deceive patients that they were treating a disease when they were only making observations on the progression of the disease.
The patients became subjects of the research unknowingly due to the deception, for the researchers did not inform them concerning diagnosis or prognosis of their condition. Following this case scenario, it emerged that without ethics, researchers would continue with unethical research projects that do not only harm the subjects, but also the society.
References
Alvino, L. (2003). Who Is Watching The Watchdogs? Responding To the Erosion of Research Ethics by Enforcing Promises. Columbia Law Review, 103(36), 893–924.
Beecher, H. (1966). Ethics and Clinical Research. New England Journal of Medicine, 65, 1354–1360.
Beyer, C., & Kass, N. (2002). Human Rights, Politics, and Reviews of Research Ethics. Lancet, 246–251.
Biber, H. (2005). The Ethics of Social Research: The Tuskegee Syphilis Study. The Qualitative Paradigm, 23, 83-116.
Heintzelman, C. (1996). Human Subjects and Informed Consent: The legacy of the Tuskegee Syphilis Study. Scholars: Research, Teaching, and Public Service, 4(6), 23–29.
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