Tuskegee Syphilis Study & Ethical Implications



Tuskegee Syphilis Study & Ethical Implications Amber FranceConcordia UniversityTuskegee Syphilis Study & Ethical ImplicationsClinical research is designed to develop knowledge that improves the health of humans or increase the understanding of human biology (NIH, 2011). Having humans volunteer as participants makes it possible to conduct certain research, but it also places some people at risk for the good of others, making it possible to potentially exploit some volunteers. Ethical guidelines have been developed and put into place to protect both the patient volunteer and the integrity of science. These guidelines were developed in response to past studies, such as the Tuskegee Syphilis Study which unethically carried out research for 40 years. As a result, some influential codes of ethics and regulations, such as the Nuremberg Code and Belmont Report have been put in place to guide ethical clinical research. In the late 1800’s through the mid 1920’s many physicians began questioning the natural history of syphilis and whether treatment after the secondary stage was of value or if the disease would be better off untreated (Cobb, 1973). According to Cobb (1973) in the late 1920s and early 1930s there was a high incidence of syphilis among the black population, and many of those infected remained untreated. There was a lack of knowledge of the pathogenesis of syphilis and a long term study was deemed desirable to gain more knowledge on syphilis control. The Tuskegee Study of Untreated Syphilis in the Negro Male, otherwise known as the Tuskegee Syphilis Study, was done to record the natural history of syphilis in black males with hopes of justifying treatment programs for this population (Tuskegee University, 2013). The study took place in Macon County, Alabama on the campus of the Tuskegee Institute as a combined effort of the Public Health Service and Tuskegee Institute (CDC, 2013). The study was projected to last for 6 months but actually went on for 40 years. Six hundred poor and illiterate men were enrolled in the study, with 399 diagnosed with syphilis and 201 without as the control group (Tuskegee University, 2013). Researchers informed the men that they were participating in a study to treat for “bad blood.” According to Tuskegee University (2013) the term “bad blood” refers to a host of diagnosable ailments including anemia, fatigue, and syphilis. The CDC (2013) reports they were not given the proper treatments for their illness. Black men were enticed to participate in the study because they were given incentives including medical exams, transportation to and from clinics, meals on examination days, free treatment for other minor ailments, and guarantees that after their death their survivors would receive burial stipends (Tuskegee University, 2013). When the study began there were no known treatments for syphilis. In 1947 penicillin became the standard of treatment for syphilis and this treatment was withheld from the both the control and experimental group of the study. According to Cobb (1973) the study continued without offering treatment of penicillin to the subjects because the short and long term toxic effects were not well documented and possible risks to the patients from treatment outweighed their risks from the disease. On July 25, 1972 Jean Heller broke a story in the Associated Press revealing the study that had been going on while withholding penicillin treatment to the subjects (Tuskegee University, 2013). From 1932 to 1947, dozens of men had died and infected their loved ones with syphilis. As a result of this widespread public awareness of the study the Assistant Secretary for Health and Scientific Affairs developed an Ad Hoc Advisory Panel to review the study. The panel consisted of members from fields of medicine, law, religion, labor, education, health administration, and public affairs (CDC, 2013). The panel found that the men participated in the study freely, agreed to all examinations and treatments, but the scientific research protocol applied to human subjects was not followed (Tuskegee University, 2013). The men were never given an informed consent and were never told the actual name of the study, its purpose, or potential consequences. There was also no information given, or choice to quit the study, when penicillin was found to treat and cure syphilis in 1947. In November of 1972 the study was officially ended and declared ethically unjustified. In 1973 a class-action suit was filed on behalf of the men of the study and ended with a $9 million settlement to the study participants (Tuskegee University, 2013). As part of this class-action suit the US government promised to provide free medical and burial services to the survivors of the study and their families. As a result, the Tuskegee Health Benefit Program was established to provide these services (CDC, 2013). The program still exists today with 15 offspring currently receiving medical and health benefits. The Tuskegee Syphilis Study has left the black community scarred with distrust for the public health system (Thomas & Quinn, 1991). This scarring has led to issues today with HIV/AIDS prevention programs and the lack of use and trust from the black community. The Tuskegee Syphilis Study has proven to go against ethical standards of clinical research and has led to a greater understanding of ethical standards and informed consent. There are seven main principles that guide the conduct of ethical research: social and clinical value, scientific validity, fair subject selection, favorable risk-benefit ratio, independent review, informed consent, and respect for potential and enrolled subjects (NIH, 2011). The seven principles are defined as follows:Social and clinical value: Research studies should be designed to answer a specific question and the answers should contribute to scientific understanding of health or improve ways of preventing, treating, or caring for people with a given disease. Scientific validity: Research is designed in which methods are valid and feasible, objectives are clear and scientific, and reliable practices, principles, and methods are being used. Fair subject selection: The primary basis of recruitment should be for fulfilling scientific goals of the study not on vulnerability, privilege, or other factors unrelated to the study.Favorable risk-benefit ratio: The research risk must be minimized and the benefits enhanced.Independent review: The research must be reviewed periodically by individuals not affiliated with the rmed consent: Individuals voluntarily agree to participate and are accurately informed of the purpose, methods, risks, benefits, and alternatives to research, they understand the information and how it relates to their clinical situation and interests, and they make the voluntary decision to participate. A proxy is required if the participant is a child, an adult with severe Alzheimer’s, an adult unconscious by head trauma, or someone of limited mental capacity. Respect for potential and enrolled subjects: All individuals must be respected (participant or not) by respecting confidentiality, their right to withdraw at any time, informing them of new research and changes in risk/benefits, monitoring their welfare and removal from study if necessary, and informing them of what was learned from the study. Some of the codes from which these seven principles have been derived from are the Nuremberg Code and the Belmont Report, both of which are crucial to in evaluating ethical standards for clinical research (NIH, 2011). The Nuremberg Code consists of 10 research ethics principles for human clinical trials (US Department of Health & Human Services, 2013). The ten principles include: 1) voluntary consent of human subjects, 2) the experiment must yield fruitful results for the good of society, 3) the experiment is based off of animal experimentation or natural history of disease to justify experiments anticipated results, 4) avoid all unnecessary physical or mental suffering, 5) no experiment can be conducted if death or disabling injury are known results, 6) degree of risk cannot exceed that determined by humanitarian importance of the problem to be solved, 7) preparations and accommodations must be made to ensure subjects are protected against injury, disability, or death, 8) experiment is conducted only by the highest scientifically qualified persons, 9) subjects can withdraw from the experiment at any time, and 10) the scientist must be prepared to terminate the experiment at any time if injury, disability, or death are foreseen as risk factors. Similar to the Nuremberg Code, the Belmont Report summarizes ethical principles for human clinical research. The Belmont Report consists of three main principles including respect for persons, beneficence, and justice (US Department of Health & Human Services, 2013). There are also three main areas of application including informed consent, assessment of risks and benefits, and selection of subjects. The first principle is respect for persons which includes treating individuals as autonomous agents and those with decreased autonomy are entitled to protection. This is applied through informed consent. As mentioned earlier informed consent is informing participants what to expect and contains three elements: information, comprehension, and voluntariness. Information should be given to participants on the purpose, methods, risks, benefits, and alternative methods. The information should be relayed in a manner in which the participants have full comprehension, and finally the participant must agree to voluntarily participate in the research free of coercion and undue influence. The second principle of the Belmont Report is beneficence, treating participants in an ethical manner by respecting their decisions and protecting them from harm and maximizing their benefits while minimizing harms (US Department of Health & Human Services, 2013). The application of this principle is through assessment of risks and benefits. The third principle is justice. This pertains to the selection of subjects. Selection of subjects must be unbiased and moral. Two levels of justice must be followed when selecting subjects. Social justice requires that subjects are chosen in a manner that justifies an order of preference to decrease burdens, such as adults before children. Individual justice requires that researchers choose subjects fairly and do not offer potential benefits to select certain populations. Vulnerable subjects should be protected from research. With the Tuskegee Syphilis Study significant ethical issues arose. With the study, subjects did not receive available treatment for the disease (Online Ethics Center, 2013). They were also misinformed regarding the nature of the study, both of which go against the Nuremberg Code and Belmont Report, now, of obtaining informed consent. If informed consent were obtained and the research followed ethical guidelines the study would not have been racist, violate human rights, and subjects would not have been solely selected from the vulnerable population. Much of the reason for the current ethical standards and guidelines were developed from this abuse of ethics. Having the Belmont Report and Nuremberg Code in place allows for ethical regulation and guidelines for human clinical investigations. Informed consent ensures that participants are well informed of the overall experience they will be encountering, describes the benefits and risks, confidentiality, and voluntary withdraw at any time (US Department of Health & Human Services, 2013). Informed consent also ensures autonomy, beneficence, and justice. Participants must be given all information pertaining to the study in order to make an informed decision on whether or not to participate (University of Minnesota, 1998). Autonomy also protects vulnerable populations such as children, elderly, mentally ill, and prisoners. Beneficence is an action that protects others and prevents or removes harms (UCSF, 2013). Physicians must practice beneficence by having the obligation to prevent and remove harms, and conduct risk/benefit assessments. Many times conflicts can occur between patient autonomy and beneficence and with informed consent the patient can make an autonomous decision. In an emergency situation informed consent does not have to be obtained if the result is life or death. A doctor must practice beneficence and save an individual’s life. In clinical research informed consent can only be waived if:Public Service (both are met):Research could not practically be carried out without the waiver,Research conducted by state or local government to study, evaluate, or examine public benefit or service programs, procedures for obtaining benefits or services under those programs, changes or alternatives to those programs, or changes in methods of payment for benefits or services for those programsResearch in Emergency SettingsGeneral Research (all four met):Research involves no more than minimal risk to subjects,Research could not practically be carried out without the waiver,No informed consent does not change the rights or welfare of the subjects,Subjects will be provided with additional pertinent information as it arises (US Department of Health & Human Services, 2013). In any other situation informed consent must be obtained. Waiving informed consent for any other reason than those stated would not be ethically acceptable by the Nuremberg Code or the Belmont Report. Without having ethical standards in place and providing subjects with informed consent there is no legal obligation to ethically conduct practice. The Tuskegee Syphilis Study is a perfect example as to why informed consent must be used. If the subjects were bound by informed consent they would have been given all the treatment options as they arose and would have been able to opt out at any time. They also would have known why they were participating in the research and what the perspective outcomes would be. If informed consent was no longer required, subjects would be subjected to harm simply because they would not know what to ask. The researchers may believe they are doing no harm, but each person knows their clinical history better than the researcher would to know if they were making an informed decision on participation. The vulnerable population would also not be protected and researchers could handpick their subjects. With informed consent and ethical guidelines information must be given in an accurate and comprehendible manner. The vulnerable population is often times at risk for being unable to comprehend information well and therefore deceptively chosen for the study. Informed consent and the codes of ethics are in place and have been developed as a result of past abuses, thus should not be tampered with to further research. Research can be conducted in an ethical manner to get desired results. The Tuskegee Syphilis Study could have been conducted in a much more ethical manner. In order to ethically study the natural history of syphilis and effects of treatment all categories of humans should have been asked to participate in the study. If they specifically wanted to study the black population, informed consent should have been given. The researchers should have informed the participants what they were studying and the possible risks and benefits of participating the study. They also should have informed participants of penicillin treatments when they became available and allowed those who wanted to withdraw to receive those treatments do so. There wasn’t necessarily anything wrong with the research itself, but the way the research was conducted was unethical and unjustified. With the use of informed consent this could have been valid research. This study, among others, is an important reason why informed consent is necessary for future human clinical research and why ethical guidelines must be followed. Resources(1998). Informed Consent Overview. University of Minnesota. Retreived from (2011). Ethics in Clinical Research. NIH. Retrieved from (2013, September 24). US Public Health Service Syphilis Study at Tuskegee. CDC. Retrieved from (2013). About the USPHS Syphilis Study. Tuskegee University. Retrieved from (2013). The Nuremberg Code. US Department of Health & Human Services. Retrieved from (2013). The Belmont Report. US Department of Health & Human Services. Retrieved from (2013). Informed Consent Waivers. US Department of Health & Human Services. Retrieved from (2013). Autonomy vs. Beneficence. UCSF. Retrieved from (2013). Case Study 3: The Tuskegee Syphilis Study. Online Ethics Center. Retrieved from Cobb, W.M. (1973). Tuskegee Syphilis Study. Journal of the National Medical Association; 65(4):315-348. Retrieved from Thomas, S.B. & Quinn, S.C. (1991). Public Health Then and Now: The Tuskegee Syphilis Study, 1932 to 1972: Implications for HIV Education and AIDS Risk Education Programs in the Black Community. American Journal of Public Health; 81(11):1498-1505. Retrieved from ................
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