List at least three examples of unethical decisions made by the researchers conducting the Tuskegee Syphilis Study.
Starting with not explaining the true nature of the study, the researchers conducting the Tuskegee Syphilis Study (TSS) made many unethical decisions. The test subjects were told that they were receiving medical treatment for “bad blood”, but those few who recognized their condition and attempted to seek help from outside the study were prevented from doing so (Brunner, n.d.). After 1943, penicillin became available as a safe, highly effective cure; participants were not treated for the disease because the researchers determined it would not be beneficial in the advanced stages of the disease and would interfere with the study’s objective (Tuskegee University, 2015). Additionally, no informed consent was obtained and the study was racially biased (Rosenthal, 2000).
Was it possible to accomplish the study goals conducting the study in an ethical manner?
Some ethicists affirm that it is unfair to judge the TSS researchers using contemporary values and beliefs. In the early 1930s, it would not have been unusual for members of that segregated society to have believed that the TSS was a justifiable and moral project (National Academy of Engineering, 2015). Some historians argue that the ethical problem regarding treatment is unclear because the prepenicillin treatments for syphilis were highly toxic (National Academy of Engineering, 2015). The original intent was controlling venereal disease in the rural South; the residents of Macon County were African-Americans, most of them lived in poverty and had never seen a doctor (Brunner, n.d.). The initial objective of this study was to determine the incidence of the disease in the local population, while training both white and African-American physicians and nurses in its treatment; an ethically sound objective (Brunner, n.d.). The study evolved into a racially biased and unethical disaster when the goal of the new study was to examine the progression ofuntreatedsyphilis in African-Americans (Tuskegee University, 2015).
What three things would you have changed in the way this study was run. Explain why (e.g., what ethical code was violated, who was hurt and how, did it cost too much, etc.)
I would have treated the participants and stopped the study when penicillin was available as a treatment. I would have developed the study to assist all races with syphilis in Macon County and I would have discussed the objective with the potential participants to obtain their consent. Finally, I would have allowed individuals to stop participating at anytime. All of these changes are related to the ethical code set up in the Nuremburg Code and the Belmont Report (Brunner, n.d.). The principles of autonomy, beneficence and justice were ignored. The violations of these codes hurt the participants, their families, the community and the relationship of researcher to subject for future studies. The TSS cost the research community greatly in regard to the loss of respect and trust (Tuskegee University, 2015).
Name five of the essential elements of informed consent and discuss whether any of those were met with the Tuskegee Syphilis Study participants?
According to the U.S. Department of Health and Human Services (1998) informed consent must contain the following elements;
a statement that the study involves research
an explanation of the purposes of the research
the expected duration of the subject's participation
a description of the procedures to be followed
identification of any procedures which are experimental
a description of any reasonably foreseeable risks or discomforts to the subject
a description of any benefits which may reasonably be expected from the research
a statement describing how confidentiality of records identifying the subject will be maintained
an explanation as to whether any compensation will be provided
an explanation of whom to contact for answers to pertinent questions about the research
a statement that participation is voluntary, refusal to participate will involve no penalty or loss of benefits entitled and the subject may discontinue participation at any time without penalty or loss of benefits
In the TSS, most of the above elements were disregarded. In regard to number one, participants were not aware they were even enrolled in a research study (Brunner, n.d.). For the second component, the subjects were deceived about the purpose of the study (National Academy of Engineering, 2015). The third element was discussed to be a life-long commitment; regrettably the researchers forgot number 12 that individuals could leave the study at anytime and used coercive techniques to keep participants in the study (National Academy of Engineering, 2015). Number seven, the benefits, was probably the most emphasized aspect of the study to the subjects, while number six, the risks, were unethically hidden from them (Rosenthal, 2000).
Are there any scenarios where informed consent is not needed? If so, describe three of them.
The U.S. Department of Health and Human Services’ (1998) require researchers to obtain an informed consent unless (1) the research is exempt under 45 CFR 46.101(b); (2) the IRB finds that informed consent can be waived (45 CFR 46.116(c) or (d)); or (3) the IRB finds the research meets the requirements of the HHS Secretarial waiver under 45 CFR 46.101(i) that permits a waiver of the general requirements for obtaining informed consent in a limited class of research in emergency settings. Some examples of exemptions are when research is conducted in commonly accepted educational settings; involves the use of educational testing results; includes the collection of existing data, documents, records, pathological specimens, or diagnostic specimens and for taste and food quality evaluation and consumer acceptance studies (U.S. Department of Health and Human Services, 1998).
What are the three core principles of the Belmont Report?
In 1979, the Ethical Principles and Guidelines for the Protection of Human Subjects of Research, was published which is commonly referred to as The Belmont Report (National Academy of Engineering, 2015). As a well-developed ethical framework, this document surveys the issues associated with the use of human beings as the subjects of research (National Academy of Engineering, 2015). Defining the limit between customary therapeutic practice and experimental research, the Belmont report is a guide in the evaluation of the ethical research (National Academy of Engineering, 2015). The three core principles are respect for persons, beneficence and justice (National Academy of Engineering, 2015).
What does individual autonomy mean and who does it specifically protect? Was the principle applied appropriately in the Tuskegee study?
Autonomy is essential in ethical research because it protects the individual’s right to choose; it is the acknowledgement that humans can govern themselves and can be empowered to make their own decisions (Burke & Friedman, 2011, p. 91). This principle was not applied in the TSS; researchers specifically did not inform participants of their right to choice and even went as far as to block them from seeking outside treatment (National Academy of Engineering, 2015).
Define beneficence. Was this principle adhered to in the Tuskegee study? Explain your answer.
Research involving human subjects should do no intentional harm; this is the principle of beneficence (National Academy of Engineering, 2015). Burke and Friedman (2011) define it as acting in charity and kindness (p.91). The TSS is difficult to analyze through the ethics glasses of the 21st century. In the 1930’s,syphilis was a wide-spread and poorly-understood disease; due to the lack of understanding many cases were incorrectly diagnosed (National Academy of Engineering, 2015). In fact, when the study began 36% of the Macon County’s African-American population had syphilis, which was far higher than the national rate (National Academy of Engineering, 2015). The only available treatments at the commencement of the study involved the use of dangerous poisons like arsenic and mercury, sometimes resulting in the death of those treated (National Academy of Engineering, 2015). All of the participants received medical care for decades which would have not been available to them due to economic and social factors (National Academy of Engineering, 2015). Eunice Rivers, an African-American nurse from the Public Health Service supervised the study (National Academy of Engineering, 2015). Her assessment of the study speaks of the ethical adherence of the principle of beneficence, “ …the men in the study were better off because they received superior medical care for ailments other than syphilis than the vast majority of African-Americans in Macon County” (National Academy of Engineering, 2015).
What does respect for persons mean and how is it applied in research? Was it applied in the Tuskegee study? Explain your answer.
Respect for personsis a principle with four elements; autonomy, truth-telling, confidentiality and fidelity (Burke & Friedman, 2011, p. 91). It is applied to research to protect the participants and recognize their ability to make choices with full understanding of the consequences (Burke & Friedman, 2011, p. 91). In the TSS these elements were not applied. Unfortunately, the research subjects were kept in the dark about the true intent of the study, they were deceived about the treatment for “bad blood” and they were never given the chance to make an informed choice (National Academy of Engineering, 2015).
What is the Nuremburg Code? What was it inspired by? What are the core elements in it?
At the end of World War II, the atrocities committed by Nazi doctors in the name of medical experimentation were revealed during the Nuremberg war crimes trials (Rosenthal, 2000). This raised international consciousness about the need for a standard for medical research (Rosenthal, 2000). National and international guidelines for human research projects were long overdue. In 1947, the Nuremberg Code was drafted by an international panel of experts on medical research, human rights, and ethics (National Academy of Engineering, 2015). The 10 core elements concentrate on the requirement for voluntary consent of the human subject, the weighing of the anticipated potential humanitarian benefits of a proposed experiment against the risks to the participant, the qualifications of the researcher and the freedom to stop or quit the study at anytime (U.S.Department of Health and Human Services, 2005).
Name what went right in the Tuskegee study. Which aspects of it could be replicated today, following the Nuremberg Code,the Declaration of Helsinki, and the Belmont Report?
The Nuremberg Code, the Belmont Report and the Declaration of Helsinki serve as models for public and private research and to professional organizations that voluntarily chose to adopt guidelines for research involving human subjects (U.S.Department of Health and Human Services, 2005). Following these rules, certain aspects of the TSS could be replicated today as a public health initiative to study and treat sexually transmitted diseases in a specific area. Specifically, public health officials could serve the underserved community with healthcare resources and education while obtaining data on prevalence, effective treatments and cultural attitudes towards sexually transmitted diseases. Other characteristics of the TSS should never be replicated today due to the harm caused by the TSS. The World Medical Association Declaration of Helsinki declares that in research involving human subjects, “The health of [the] patient will be [the] first consideration,” and the International Code of Medical Ethics asserts that, “A physician shall act in the patient's best interest when providing medical care.” (59th WMA General Assembly, 2008)
59th WMA General Assembly. (2008, October). Declaration of Helsinki: Ethical Principles for Medical Research Involving Human Subjects. Retrieved June 17, 2015, from http://www.wma.net/en/30publications/10policies/b3/17c.pdf
Brunner, B. (n.d.). The Tuskegee Syphilis Experiment. Retrieved June 19, 2015, from http://www.infoplease.com/spot/bhmtuskegee1.html
Burke, R., & Friedman, L. (2011). Essentials of management and leadership in public health. Burlington, MA: Jones & Bartlett Learning.
National Academy of Engineering. (2015). Case Study 3: The Tuskegee Syphilis Study. Retrieved June 19, 2015, from http://www.onlineethics.org/Education/precollege/scienceclass/sectone/chapt4/cs3/28724 .aspx
Rosenthal, B. (2000). The Tuskegee Syphilis Study. Retrieved June 19, 2015, from http://www.history.ucsb.edu/faculty/marcuse/classes/33d/projects/medicine/The%20Tusk egee%20Syphilis%20Study.htm
Tuskegee University. (2015). About the USPHS Syphilis Study. Retrieved June 16, 2015, from http://www.tuskegee.edu/about_us/centers_of_excellence/bioethics_center/about_the_usp hs_syphilis_study.aspx
U.S. Department of Health and Human Services. (1998). Informed Consent. Retrieved June 19, 2015, from http://www.hhs.gov/ohrp/policy/consent/
U.S.Department of Health and Human Services. (2005, November 5). The Nuremberg Code. Retrieved June 20, 2015, from http://www.hhs.gov/ohrp/archive/nurcode.html