PROTECTING THE VULNERABLE:
THE TUSKEGEE SYPHILIS STUDY AND THE EVOLUTION OF INFORMED CONSENT IN THE TWENTIETH CENTURY
by Mariam Deria, BHSc. Candidate
Faculty of Health Sciences, University of Ottawa - Summer of 2006


  1. Acknowledgement
  2. Introduction
  3. Part I: The Birth of Consent (1900-1957)
  4. Part II: The Tuskegee Syphilis Study (1932-1972)
  5. Part II: Informed Consent Normative (1972-Present)
  6. Conclusion
  7. Endnotes

Acknowledgment:

This study was funded by the Geza Hetenyi Memorial Studentship for the Study of History of Medicine.


 

Introduction

The field of medicine experienced rapid change in the twentieth century. Numerous scholars and historians have found that many of these scientific developments were made at the expense of marginalized groups1. In the beginning decades of the twentieth century, American biomedical research generally proceeded with little or no effort toward informing subjects about the nature of experiments. The United States Public Health Service’s (USPHS) longitudinal observational study of the natural history of untreated syphilis in Tuskegee, Alabama was an especially infamous experiment. Current medical research protection guidelines were instigated by this history of the exploitation of vulnerable subjects.

According to Alexander Morawa, Austrian scholar and Professor of International Human Rights Law, there is no single approach to defining vulnerability despite extensive research and no consensus concerning what constitutes vulnerable populations2. Difficulties in defining vulnerability have prompted much discourse analysis, yet the concept of vulnerability remains obscure. The term “vulnerability” derives from the Latin vulnerare, which roughly translated means “to wound.” Contemporary usage of the term refers to a state of being "exposed to the risk of being attacked or harmed, either physically or emotionally."3

For the purposes of this paper, vulnerability is a term that describes groups of persons who may be more prone to abuse in the process of research, either because they are more likely to be coerced into participation, or more likely to fail to understand the full implications of involvement and as a result be deceived into participation. It does not reflect personal deficiency but structural social forces over which most individuals have little or no control. In this context, vulnerability will be considered a condition of some individuals—either intrinsic or situational or a combination of the two— which places them at a greater risk of being recruited in an ethically unsound research experiment.

The intention of this paper is to explore the contemporary meanings and relevance for our society of the legacy of the Tuskegee Syphilis Study, which was the longest non-therapeutic experiment on humans in the history of medicine, and was conducted by the U.S. Public Health Service from 1932 to 1972.4 This study has sparked widespread interest and debate since the story was exposed to the mainstream public in 1972. The study embodies not only the maltreatment of minorities in medical history, but also has implications for exploitation of any groups that may be vulnerable because of their race or socioeconomic status. This paper attempts to place the study in historical context and to trace the significance of the Tuskegee Study in relation to the evolution of informed consent, a medical guide to prevent the exploitation of vulnerable groups.

This report is divided into three parts. The first part will discuss the birth of basic consent in the beginning of the century. The second section will discuss the Tuskegee Study in the context in which the experiment occurred and outline how consent became ‘informed’ during this period. The third section will discuss the state of informed consent after the end of the experiment and how the study continues to influence informed consent in the present time. Finally, I will conclude with a discussion of the legacy of the Tuskegee study, which is still very much relevant today in many aspects of modern society.


 

Part I: Historical Context of Basic Consent (1900-1957):

Informed consent is a process through which patients authorize medical interventions or their involvement in research. The concept of informed consent evolved over the past century into a fundamental aspect of ethical medicine, shaped by the belief that people must be protected from being exploited at the hands of researchers. The necessity for patients to give explicit and informed permission for medical treatment suggests the role of patient autonomy in medicine.

According to American historian Martin Pernick, seeking consent in medical practice in the early twentieth century was intermittently recognized as important,5 although it was not necessarily informed or voluntary. Several court decisions in the first and second decades created a legal basis for consent in American law.6 These landmark cases explicitly examined the principles of consent to determine its nature and scope in medical interventions and have served as precedents that have formed the backbone of discussion about consent within the parameters of medical research.

Mohr Case (1905): The physician obtained his patient’s consent to complete an operation on her right hear. At some point in the course of the surgery, however, he opted to operate on the left ear instead because he believed that it was the source of hearing impairment. This decision led to further hearing loss and the patient sued her physician for negligence. The court found that the surgeon should have obtained the patient’s consent. The Judge concluded that “The free citizen’s first and greatest right, which underlies all others—is the right to himself.” The surgeon must not “violate without permission the bodily integrity of his patients by major operation without [their] consent or knowledge.”7 This case was particularly significant for the reason that it entrenched an individual's basic protection against unauthorized impositions and the basic right to be involved in the full decision process. Hence, the idea of consent was born.

Schloendorff Case (1914): A patient authorized an abdominal examination under anaesthesia but explicitly requested that no surgery be performed. During the examination, the physician removed a fibroid tumour. Judge Benjamin Cardozo ruled that “Every human being of adult years and sound mind has a right to determine what should be done with his own body and a surgeon who performs an operation without his patient's consent commits an assault for which he is liable in damages.”8 This was a significant decision that further developed the principle of medical consent. This case focused on patient self-determination and the fact that physicians should not conduct medical interventions on patients without their consent, which later became the primary rationale for informed consent.

Nuremburg Code (1947): Not until the introduction of the Nuremburg Code did the notion of information become linked to consent. Historians have well documented the horrendous research doctors in Nazi Germany conducted in concentration camps during World War II, which included subjecting the victims to extreme temperatures, mutilating surgeries and deliberate infection with lethal pathogens.9 The revelation of these Nazi experiments sparked the development of the Nuremberg Code of 1947, which became “the first international normative framework regulating the standards of research clinical trials,”10 and consisted of ten basic principles to govern permissible medical experiments.

The first principle stated that:

The voluntary consent of the human subject was absolutely essential. The person involved should have legal capacity to give consent; should be so situated as to be able to exercise free power of choice, without the intervention of any element of force, deceit, or coercion; and should have sufficient knowledge and comprehension of the elements of the subject matter involved, as to enable him to make an understanding and enlightened decision.11

Research subjects now had a clear right to consent—voluntarily and with adequate information, or to refuse — hence, informed consent. More than a decade later the term “informed consent” was coined in Salgo vs. Leland Stanford Junior University (1957) and the definition expanded to include the necessity of providing “the nature, consequences, harms, benefits and alternatives” of a specific procedure or intervention.12

Each of the fifty-one original nations of the Charter of the United Nations accepted the code in principle, making it the first international document to promote voluntary involvement in medical research and informed consent.13 Although the United States also accepted the Nuremberg Code in principle, no mechanism existed to implement its provisions. The rights of American subjects, therefore, were not taken into consideration. According to American ethicist James F. Childress,

For many years the Nuremberg Code played virtually no role in ethical discussions, public policies, and legal decisions in the United States. It was effectively circumscribed and even marginalized in various ways. As formulated in the context of a criminal trial, it was considered a code for barbarians, the Nazis, who were guilty of brutal excesses, not a code for civilized researchers.14

American scholar Ruth Faden concluded that “the Code, at the time it was promulgated, had little effect on mainstream medical researchers engaged in human subject’s research,”15 which included the ongoing Tuskegee Syphilis study that had been initiated 15 years earlier.


 

Part II: Tuskegee Syphilis Study (1932-1972)

The introduction of more rigorous experimental methodology into medicine at the turn of the last century brought with it an increased demand for experimentation on human subjects. Many medical developments occurred as a result of World War II and the American government continued this trend by creating the National Institutes of Health (NIH) to provide funds for experimentation. Between 1945 and 1966, the NIH funded 2,000 research projects, but not one used informed consent.16

In order to appreciate the evolution of consent that emerged from the Tuskegee Study, it is first necessary to understand the historical context and to see how the men in the study were subject to exploitation. In the United States, health status was closely associated with socioeconomic status and race, and great disparities existed.17 During slavery and the segregation that resulted after the Civil War, Blacks were powerless subjects in medical experiments.18 The Tuskegee Study that documented the natural history of the sexually transmitted disease syphilis19 exploited the socio-economically deprived status of adult black males living within a racist, segregated society.

The Experiment:

The Tuskegee Syphilis Study was initiated with noble intentions. It was first pegged as the Julius Rosenwald Study and was initiated in 1928 in conjunction with the United States Public Health Services (USPHS), which wanted to determine the prevalence of syphilis among rural Blacks in the south and to explore the prospects for mass treatment. The researchers concluded that mass treatment could successfully be implemented. After the economy collapsed in the Great Depression of 1929, the study was discontinued; however, the USPHS decided to extend the study.

Macon County was chosen as the location for the study because it was found to have the highest syphilis rate at 35 percent. The purpose of this study was to look at the natural history of the disease because “99 percent of this group was entirely without previous treatment,” and it was believed that this kind of study, “could not be duplicated elsewhere in the world.”20

The Tuskegee Study became an observational study of over 399 Black men with latent untreated syphilis, with an additional 201 Black men serving as controls, to document racial differences in the clinical manifestations of syphilis.21 The men were recruited under the impression that they were patients of a medical intervention and were being treated for their “‘bad blood,’ a local idiom that encompassed syphilis as well as some anemias,” and were enticed with offers of free medical examinations and special free treatments.22

Eunice Rivers, a Black nurse, served as the liaison between the men and the government officials. Although the doctors involved in the study changed regularly, she remained a constant in the experiment for the duration of the forty years. Her primary roles were to help recruit the subjects, deal with their problems, and secure their autopsies upon death. Her sense of healing focused on the care giving role and her camaraderie with the men, rather than treating the syphilis. She rationalized her role in the experiment with the belief that these men were better off in the study because of their access to free medical examinations and pain killers.23

The study actively kept the men away from treatment, even after penicillin became widely used for the treatment of syphilis in 1950s.24 In February of 1969, the PHS decided to continue the study and to continue to deny the men antibiotic treatment even though penicillin had become established as the standard treatment for syphilis, because it assumed that the disease was far too advanced for it to be treated.25 Associated Press reporter Jean Heller broke the story on July 25, 1972 on the front-page of the New York Times and the study stopped at once:

For forty years the United States Public Health Service had been conducting a study of the effects of untreated syphilis on black men in Macon County, Alabama, in and around the county seat of Tuskegee. The Tuskegee study, as the experiment had come to be called, involved a substantial number of men: 399 who had syphilis and an additional 201 who where free of the disease chosen to serve as controls. All the syphilitic men were in the late stage of the disease when the study began.26

Over the course of the forty years, dozens of subjects had died of syphilis, and hundreds more had suffered complications and infected their wives and partners who in turn had infected their children.27 Three-fourths of the participants died from complications of syphilis and only seventy-four participants were still living at the time the study was exposed.28 In August 1972, an ad hoc committee found the study to have been “ethically unjustified” and argued that penicillin should have been given to the men.29

On 23 July 1973, Fred Gray, a civil rights attorney, filed a 1.8 billion dollar class action suit against the government. The lawsuit alleged the study had violated rights guaranteed to the men under the “Fifth, Ninth, Thirteenth, and Fourteenth Amendments of the Constitution of the U.S. and the Alabama Constitution of 1901.” The case never went to trial and the U.S. government agreed to a settlement of $10 million dollars, giving $37,500 to the living syphilitics and $15,000 to the families of the deceased.30 In May of 1997, President Clinton made a public apology to the surviving men and their families.31 The study has come to represent not only the abuse of Blacks in medical history, but also the potential for exploitation of any group that may be vulnerable because of ethnicity, race, gender, or social class.

The Tuskegee Syphilis Study exploited the disadvantaged status of 400 poor, predominantly illiterate Black sharecroppers from a poverty-ridden community. In the beginning of the study malnutrition was common, and most of the subjects were living in rural poverty in shacks with dirt floors, no plumbing, and poor sanitation.32 It was well documented that there were high levels of “mortality, morbidity, illiteracy, poverty and insufficient food and clothing.”33 Doctors were only available to the wealthy since fees for consultation were between $2.50 and $3.00, and rural calls sometimes amounted to $12.00 due to distance and accessibility.34 Considering that pay was typically $3.00- $4.00 a week, this was a heavy burden on these poor families that were already heavily damaged by the Great Depression.35 As one man described, “you gotta have the money on the table or you just lies here and dies.”36

The researchers sought people who had never been treated by a physician, and given their background, the men were eager to participate in this so-called treatment plan because of the prospect of seeing a free doctor. The canvassers told the men that they were sick and they promised free care. They were not told about the experiment; instead they were told they were being treated for bad blood. To preserve their interest, they gave the men non-effective drugs. Under this illusion of treatment, the study provided the men with placebos, tonics, aspirins, free lunch and burial insurance.37

These men were vulnerable because of the legacy of oppression and slavery, and their impoverished status made them eager to accept the material benefits of participating in the study. It did not occur to these people to ask what the researchers were trying to find or about the treatment they would be receiving. They submitted to the researchers without understanding and agreeing to the risks and harms involved with the study. The men were deceived into “consenting” to the experiment, which was anything but informed.

According to historians’ Thomas Benedeck and Jonathan Erlen, numerous reasons justified the study’s inception in 1932.38 Syphilis was a major public health problem worthy of study that appeared to be more prevalent in the Black population. Statistics helped propagate negative racial assumptions, which helped justify the initiation of the study. Data collected in a survey begun in 1926 of twenty-five communities across the United States indicated that the incidence of syphilis among patients under observation was 4.05 cases per 1,000 of population, the rate for whites being 4 per 1,000, and that for “Negroes,” 7.2 per 1,000. In 1930, Macon County had 27,000 residents, 82.4 percent of which were Blacks.39

Richard Shweder, cultural anthropologist from the University of Chicago, contended that the study emerged out of a progressive public health movement that was concerned with the health of the Black population to show that syphilis could be controlled even in rural areas of the South.40 Caucasian syphilitics had already been studied in Oslo, Norway, and so it made sense to do a study on the Black population. Dr. Joseph Earle Moore of the Venereal Disease Clinic of the Johns Hopkins University School of Medicine stated, “Syphilis in the Negro is in many respects almost a different disease from syphilis in the white."41 This idea was further supported by the discovery that Blacks had unique diseases such as sickle cell anaemia.42

The racial climate of American society at the study’s inception placed these men in a situation where they were not able to provide free and informed consent to participate in research. It also explains why the men were not consulted or told they were participating in a research study. According to historian Allan Brandt, the racial assumptions at the beginning of the study affected the perception of syphilis, which included deeply held opinions about the relationship between race, sexuality and the disease.43 The study was formulated and directed within mainstream assumptions regarding Blacks and venereal disease: the premises that they were innately carnal in nature, promiscuous, lustful and would not seek or continue treatment shaped the study.44 It was believed that “The Negro race in America was in the throes of a degenerative evolutionary process, the lowest species in the Darwinian hierarchy . . . particularly prone to disease, vice and crime [and] census data predicted the virtual extinction the Negro in the 20th century.”45 Other rationalizations for the study included the ideas that “Gray mater of the negro brain [was] at least 1000 years behind that of white races [and] his genital organs were overdeveloped, making him particularly prone to venereal diseases.”46

The aforementioned ideas formed the core of medical opinion concerning Blacks and syphilis in the early twentieth century, which contributed to the neglect of the government officials running the experiment to obtain the consent from the men in the study. In the meantime, literature on informed consent began to emerge in the late 1950s, and according to Ruth Faden, it was notable for the absence of discussion on the relationship between consent and class, gender, and race or ethnicity.47 The phrase ‘informed consent’ first appeared in American medical literature in the late 1950s and 1960s. From 1930 to 1956, scholars were able to find only nine published articles linking issues of consent and patient authorization in this literature.48


 

Part III: Informed Consent becomes Normative (1972 to the Present)

Historians typically consider the patient’s rights movement as one of the phenomena emerging out of a synthesis of social changes in the late1950s and 60s that influenced the protection of individual rights against medical paternalism.49 As racial segregation and discrimination became increasingly difficult to justify, the changing atmosphere helped to fuel civil unrest. Blacks began to mobilize and challenge their status in American society in a movement that reached its peak between 1955 and 1965.50 In Brown v. Board of Education (1954) the Supreme Court eliminated the “separate but equal’ doctrine of Plessy v. Ferguson (1896) and ruled to abolish segregation in public schools.51 Congress passed the Civil Rights Act of 1964 and the Voting Rights Act of 1965, which put a legal end to Jim Crow Laws,52 and secured basic civil rights for all Americans, regardless of race. The Civil Rights movement created more of a conscience about the need for informed consent.53 The revelation of the Tuskegee Syphilis Study led to intense efforts to protect vulnerable human subjects and a policy shift emphasized the protection of vulnerable human subjects and the necessity for informed consent. New legislation addressed the need for guidelines that were larger in scope than the Nuremberg Code.54

The Belmont Report:

Jay Katz argues that it was not until the 1970s that physicians had meaningful discussions with patients about choices and alternatives.55 According to historian Susan Lederer, “no laws that governed human research were enacted until 1974, on the heels of public disclosures about the Tuskegee Syphilis Study.”56 Due to public pressure, the National Research Act of 1974 was passed in the United States Congress to create the National Commission for the Protection of Human Subjects of Biomedical and Behavioural Research. The Commission was composed of a multidisciplinary group of scientists, ethicists, and policy experts. According to Brady, one of the commissioners, “There was a broad effort to make [it] a representative group… we contacted a wide variety of organizations, professional societies in medicine, in ethics, and in other areas.”57 The Commissions’ mandate was to identify the basic ethical principles that should underlie the conduct of biomedical research involving human subjects and to develop guidelines which should be followed to assure that such research be conducted in accordance with those principles.58

In 1979, the Commission drafted the Belmont Report, which expanded the definition of informed consent by stressing the need for vulnerable individuals to be protected. In the preamble, it discussed the importance of the concept of vulnerability in research ethics. Directly influenced by the Tuskegee Syphilis study, the Belmont Report expanded and developed informed consent to include the protection of the exploited and vulnerable.

Unlike the Nuremberg Code, which presented only proposals, the Belmont Report established essential ethical principles relevant to all research involving human subjects.59 The two that were most important with regards to informed consent were:

Respect for Persons: This principle acknowledged the dignity and autonomy of individuals, and required that certain subject populations [vulnerable] be provided with additional protections when providing informed consent to participation in research.

Justice: This principle required that subjects be treated fairly. Certain individuals or classes of individuals such as financially impoverished people should not be systematically selected, as was the case in the Tuskegee Study.

According to Barbara Mishkin, a senior staff member of the commission, the minutes from the meetings were sent to members of the public, allowing citizens to address the commission on any issues under consideration. Letters received form the public were included in the agenda and distributed to the commissioners before each meeting, allowing the public to participate in the process of developing public policy. This in turn enhanced the credibility of the product.60 The Nuremberg Code contained only recommendations, but the Belmont Report's principles were codified in American law, which meant that its principles by law were to be strictly followed in medical research with the intent to protect vulnerable subjects from the hands of researchers.

Canadian Regulations (1993):

The conclusion of the Tuskegee Syphilis Study and the formation of the Belmont Report prompted closer inspection of clinical research and the development of ethical guidelines for the protection of research participants around the world. As a consequence, research ethics guidelines, codes and regulations were further developed in Canada. The first attempt to introduce control of research ethics in Canada occurred in 1978. Both the Medical Research Council (MRC) and the Social Sciences and Humanities Research Council (SSHRC) issued guidelines based on the Belmont Report.61

The direct influence of the Tuskegee Syphilis Study is still visible in other Canadian research regulations because the Belmont Report continued to form the basis of these documents developed to protect human rights in research. The Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans was developed within this framework. Published in 1993, this document addressed the issues of free and informed consent of research subjects. In the preamble, it stated that “despite the Nuremberg Code and other human rights protections in place at the time, some research undertaken after World War II, such as the Tuskegee Syphilis Study, raised ethical concerns . . . . As a consequence, research ethics guidelines, codes and regulations were further developed in many countries, including Canada.”62 It is clear, therefore that the study was instrumental in developing informed consent legislation in Canada.

The revelation of the Tuskegee Study also caused a marked increase in discussion of informed consent. Using its computerized retrieval system, the National Library of Medicine had identified 272 citations on informed consent between January 1970 and April 1974. In the next two years, the NLM catalogued an additional 403 citations and between July 1977 and July 1982, an additional 403 citations. Another computerized literature retrieval system, which includes journals in the domains of law, philosophy, theology and the social sciences, identified between 300 and 400 citations on informed consent every year in the period 1974 to 1979.63 At the same time, word of informed consent began to spread in the classroom. The topic was presented to many medical students starting in the 1970s, with the majority of medical students reporting instruction in medico-legal matters by 1978.64 In a survey conducted in 1982, over 75 percent of physicians self-reported that they always or usually explained to their patients the risks and alternatives for treatments, although patients credited their physicians with complete disclosure only 68 percent of the time.65 The overall impression, however, is that interest in informed consent exploded after exposure of the Tuskegee Study in 1972.


 

Conclusion

The concept of informed consent grew in importance during the course of the century. Documented abuse of research subjects led to the codification of informed consent requirements for clinical research. The Tuskegee Syphilis Study marked the beginning of the modern era in the protection of vulnerable human subjects in biomedical research and sparked the evolution of informed consent. Based on the early landmark legal cases, the concept was developed through an incremental process, was catalyzed by the Tuskegee Syphilis Study and eventually led to the development of the doctrine of informed consent. This has since become a basic tenet of medical research ethics, helping to ensure a person’s self-determination and providing some protection to marginalized groups that are susceptible to exploitation. Informed consent places the onus on the medical researcher to ensure that the consent of research participants is given freely and is fully informed.

When the Tuskegee Study is understood as an illustrative history of vulnerable individuals being mistreated due to social and economic disempowerment, it helps to explain the atmosphere of distrust that continues to surround medical research conducted on minority groups. Despite informed consent protections, the contemporary legacy of the Tuskegee Study is visible in the day-to-day interactions between health care providers and recipients, notably in the doctor-patient relationship. Aside from the direct suffering experienced by the men and their families in the experiment, the Tuskegee Study continues to contribute to suspicion among Blacks by negatively affecting their participation in research trials. They are also less likely to donate organs, and often avoid seeking routine medical treatment or preventative care. The Tuskegee Study also generated racist views around AIDS in the Black community, ranging from the notion that AIDS is a plot to exterminate black people to the idea that needle exchange programs fuel a drug epidemic disproportionately affecting Black neighborhoods.66 A national poll survey conducted for Emory University's Institute of Minority Health Research in 1997 stated that

[Seventy-four] percent of blacks believed they were very likely or somewhat likely to be used by doctors as guinea pigs without their consent. [Eighteen] percent said they believed H.I.V. was an engineered microbe, and nearly one in ten said AIDS was part of a plot to kill blacks.67

This paper is a starting point for deeper consideration and analysis of the limitations of informed consent. The Tuskegee Study played a crucial role in causing Americans to rethink the ethics of human experimentation. According to historian Joel Howell, however, studies like these serve as powerful examples of why and how medical history ought to be an essential part of every clinician’s education.68 As the lingering results of Tuskegee demonstrate, protecting patients’ interests in decision-making processes cannot be fully realized through legal initiatives alone. Rather, it requires respectful discourse with patients, and awareness on the part of physicians of the historical legacy that human experimentation has left.


 

Endnotes

  1. Susan Lederer, “Children as Guinea Pigs: Historical Perspectives,” Accountability in Research: Policies and Quality Assurance, 10, no. 1 (2003): 1.

  2. Alexander H. E. Morawa, “Vulnerability as a Concept in International Human Rights Law,” Journal of International Relations and Development 6, no. 2 (2003): 139.

  3. “Vulnerable,” Oxford Encyclopedic English Dictionary, http://oed.com/ (accessed July 9, 2006).

  4. James H. Jones, Bad Blood: The Tuskegee Syphilis Experiment (New York: Free Press, 1981), 1.

  5. Martin S. Pernick, “The patient's role in medical decision making: a social history of informed consent in medical therapy,” in Making Health Care Decisions: A Report on the Ethical and Legal Implications of Informed Consent in the Patient-Practitioner Relationship, President's Commission for Study of Ethical Problems in Medicine and Biomedical and Behavioral Research, 3 1-25.

  6. Ruth R. Faden and Tom L. Beauchamp, in collaboration with Nancy M.P King, A History and Theory of Informed Consent (New York: Oxford University Press, 1986), 120.

  7. Faden and Beauchamp, A History and Theory of Informed Consent, 121-122.

  8. Faden and Beauchamp, A History and Theory of Informed Consent, 123-124.

  9. “The Nuremburg Trails: the Doctors Trial,” University of Missouri- Kansas City School of Law, http://www.law.umkc.edu/faculty/projects/ftrials/nuremberg/NurembergDoctorTrial.html (accessed June 20, 2006).

  10. Jason P. Lott, “Module Three: Vulnerable/Special Participant Populations,” Developing World Bioethics, 5, no. 1 (2005): 34.

  11. “The Nuremburg Code,” http://www.hss.gov/ohrp/references.nurcode.htm (accessed June 10, 2006).

  12. Faden and Beauchamp, A History and Theory of Informed Consent, 125-128.

  13. Office of the Vice President for Research, Auburn University, “Historical, Ethical and Legal Foundations for the Protection of Human Subjects in Research,” http://www.auburn.edu/research/vpr/ohs/history/history.htm (accessed June 20, 2006).

  14. James F. Childress, “Nuremberg's Legacy: Some Ethical Reflections,” Perspectives in Biology and Medicine, 43 no. 3(2000): 349.

  15. Ruth R. Faden, Susan E. Lederer , J. E. Lederer, and Juan D. Moreno, “U.S. Medical Researchers, the Nuremberg Doctors Trial, and the Nuremberg Code,” Journal of the American Medical Association, 276 no. 20(1996): 1668.

  16. Jessica Kiefer, “The History and Importance of Informed Consent in Clinical Trials,” http://serendip.brynmawr.edu (accessed June 3, 2006).

  17. Vanessa N. Gamble and Deborah Stone. “U.S. Policy on Health Inequities: the Interplay of Politics and Research,” Journal of Health Politics, Policy and Law 31, (2006): 93-126.

  18. Vernellia R. Randall, “Slavery, Segregation and Racism: Trusting the Health Care System Ain’t Always Easy! An African American Perspective on Bioethics,” http://academic.udayton.edu (accessed July 28, 2006).

  19. Syphilis is caused by the bacterium Treponema pallidum that is communicated through direct contact with a syphilitic sore. See The Myth of Syphilis: The Natural History of Treponematosis in North America, ed. Mary Lucas Powell and Della Collins Cook (Gainesville: University Press of Florida, 2005).

  20. Allan M. Brandt, “Racism and Research: The Case of the Tuskegee Syphilis Experiment,” in Tuskegee's Truths: Rethinking the Tuskegee Syphilis Study, ed. Susan M. Reverby (Chapel Hill: University of North Carolina Press, 2000), 29.

  21. Susan M. Reverby, “More than a Metaphor: An Overview of the Scholarship of the Study,” in Tuskegee's Truths: Rethinking the Tuskegee Syphilis Study, ed. Susan M. Reverby (Chapel Hill: University of North Carolina Press, 2000), 1.

  22. Brandt, “Racism and Research,” 24.

  23. Susan M. Reverby, “Rethinking the Tuskegee syphilis study– Nurse Rivers, Silence, and the Meaning of Treatment,”in Tuskegee's Truths: Rethinking the Tuskegee Syphilis Study, ed. Susan M. Reverby (Chapel Hill: University of North Carolina Press, 2000), 372-373.

  24. Brandt, “Racism and Research,” 15.

  25. Brandt, “Racism and Research,” 28.

  26. Jean Heller, “Syphilis Victims in the U.S. Went Untreated for 40 years,” in Tuskegee's Truths: Rethinking the Tuskegee Syphilis Study, ed. Susan M. Reverby (Chapel Hill: University of North Carolina Press, 2000), 116-117.

  27. Jonathan Peterson, “Close-up: Tuskegee experiment’s legacy is the spread of suspicion,” The Seattle Times, May 16, 1997, http://archives.seattletimes.nwsource.com/web/index.html (accessed June 29, 2006).

  28. Jones, Bad Blood, 154.

  29. Ad Hoc Tuskegee Syphilis Panel, “Selections from the Final Report,” in Tuskegee's Truths: Rethinking the Tuskegee Syphilis Study, ed. Susan M. Reverby (Chapel Hill: University of North Carolina Press, 2000), 166.

  30. Jones, Bad Blood, 177-217.

  31. William J. Clinton, “Remarks,” in Tuskegee's Truths: Rethinking the Tuskegee Syphilis Study, ed. Susan M. Reverby (Chapel Hill: University of North Carolina Press, 2000), 574-577.

  32. Thomas Parran, “Shadow on the Land: Syphilis, the White Man’s Burden,” in Tuskegee's Truths: Rethinking the Tuskegee Syphilis Study, ed. Susan M. Reverby (Chapel Hill: University of North Carolina Press, 2000), 63.

  33. “Charles S. Johnson, “The Shadow of the Plantation,” in Tuskegee's Truths: Rethinking the Tuskegee Syphilis Study, ed. Susan M. Reverby (Chapel Hill: University of North Carolina Press, 2000), 56.

  34. Johnson, “The Shadow of the Plantation,” 49.

  35. Claudia D Johnson, “Interview: Growing Up Black in the 1930s in McCulleys Quarters Alabama” http://library.thinkquest.org/12111/mculley.html (accessed June 21 2006).

  36. Johnson, “The Shadow of the Plantation,” 50.

  37. Reverby, “Rethinking the Tuskegee Syphilis Study,” 372.

  38. Thomas G. Benedek and Jonathan Erlen, “The Scientific Environment of the Tuskegee Study of Syphilis, 1920-1960, Perspectives in Biology and Medicine 43 no. 1 (1999), 1-30.

  39. A.W. Fourtner, C.R. Fourtner and C.F. Herreid, “Bad Blood: A Case of the Tuskegee Syphilis Project,” July 10, 2005, http://ublib.buffalo.edu/libraries/projects/cases/blood.htm (accessed July 20, 2006).

  40. Richard A. Shweder, “The Idea of Moral Progress: Bush versus Posner versus Berlin,” 29-55 http://www.ed.uiuc.edu/EPS/PES-yearbook/2003/shweder.pdf#search=%22Richard%20A.%20 Shweder.%20The%20Idea%20of%20Moral%20Progress%20%22/ (accessed June 6, 2006).

  41. Jones, Bad Blood, 106.

  42. Keith Wailoo, Drawing Blood: Technology and Disease Identity in Twentieth Century America (Baltimore: Johns Hopkins University Press, 1997), 134-61.

  43. Reverby, “Rethinking the Tuskegee Syphilis Study,” 368.

  44. Brandt, “Racism and Research,” 16-18.

  45. Brandt, “Racism and Research,” 16-18.

  46. Brandt, “Racism and Research,” 16-18.

  47. Faden and Beauchamp, A History and Theory of Informed Consent, 94.

  48. Faden and Beauchamp, A History and Theory of Informed Consent, 86.

  49. Amy L. Fairchild, "Leprosy, Domesticity, and Patient Protest: The Social Context of a Patients' Rights Movement in Mid-Century America," Journal of Social History, 39 no. 4 (2006):1004-1043.

  50. “Civil Rights Movement,” http://www.africanamericans.com/CivilRightsHistoryIndex.htm (accessed August 2, 2006).

  51. Supreme Court of The United States, “Civil Rights: Brown v. Board of Education 347 U.S. 483 (1954)” http://www.nationalcenter.org/brown.html (accessed August 2, 2006).

  52. Jim Crow laws were state and local legislation enacted in the Southern states of the United States between 1876 and 1964 that required racial segregation in all public facilities. See New York Life, “The History of Jim Crowe” http://www.jimcrowhistory.org/. (accessed August 15, 2006).

  53. Roseanne B. Prats. “History of Ethics Commitees,” 3, http://ec.hcahealthcare.com/CPM/ClinicalEthicsManual.doc (accessed July 28, 2006)

  54. National Institutes of Health, “Guidelines for the Conduct of Research Involving Human Subjects” http://www.nihtraining.com/ (accessed June 25, 2006).

  55. Jay Katz, The Silent World of Doctor and Patient, (New York: Free Press,1984), 3-4.

  56. Susan Lederer, “The Tuskegee Syphilis Study in the Context of American Medical Research,” in Tuskegee's Truths: Rethinking the Tuskegee Syphilis Study, ed. Susan M. Reverby (Chapel Hill: University of North Carolina Press, 2000), 268.

  57. Patricia C. El-Hinnawy “Oral History of the Belmont Report and the National Commission for the Protection of Human Subjects of Biomedical and Behavioural Research: Interview with Duane Alexander, M.D.” July 9, 2004. http://www.hhs.gov/ohrp/docs/InterviewAlexander.doc (accessed June 17, 2006).

  58. National Commission on the Protection of Human Subjects of Biomedical and Behavioural Research, “The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research,” http://ohsr.od.nih.gov/guidelines/belmont.html (accessed June 6, 2006).

  59. National Commission, “The Belmont Report.”

  60. Barbara Mishkin, “Law and Public Policy in Human Studies Research,” Perspectives in Biology and Medicine 43, no.3 (2000), http://muse.jhu.edu/ (accessed June 29, 2006).

  61. Douglas Kinsella, “Research Ethics Boards: A Historical Background,” http://www.chrcrm.org/main/modules/pageworks/index.php?page=015&id=11 (accessed July 14, 2006).

  62. “Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans,” http://www.ncehr-cnerh.org/english/code_2/ (Accessed May 28, 2006).

  63. Faden and Beauchamp, A History and Theory of Informed Consent, 95.

  64. Faden and Beauchamp, A History and Theory of Informed Consent, 96.

  65. Faden and Beauchamp, A History and Theory of Informed Consent, 99.

  66. Joel D. Howell, “Trust and the Tuskegee Experiments,” in Clio in the Clinic: Doctors' Stories of Using History in Medical Practice, ed. Jacayln Duffin (New York: Oxford University Press, 2005), 213-226.

  67. David France, “Challenging the Conventional Stance on AIDS,” New York Times, December 22, 1998, http://query.nytimes.com (accessed July 15, 2006).

  68. Howell, “Trust and the Tuskegee Experiments,” 213-226.


©2006, Mariam Deria, BHSc.