Exploitation in medical research: the enduring legacy of the Tuskegee syphilis study.

• Author: Yearby, Ruqaiijah

CONTENTS INTRODUCTION I. MEDICAL RESEARCH STUDIES INVOLVING CHILDREN: THE STRUCTURE AND HISTORY A. Structure of Medical Research Studies Involving Human Subjects B. The Belmont Report C. The Common Rule II. INCLUSION, EXPLOITATION, AND BIAS A. Inclusion B. Using Inclusion to Exploit C. Bias in Health Care 1. Structural Racial Bias 2. Institutional Racial Bias D. The Effect of Bias on Medical Research III. ENSURING JUSTICE IS FULFILLED A. Ending Exploitation: Human Development Approach 1. Theory 2. Human Development in the U.S. 3. Applying the Approach to U.S. Research B. Measuring Justice: Vulnerability and Equity Impact Assessment Tool 1. The VEIA 2. Applying the VEIA C. A New Regulatory Structure CONCLUSION INTRODUCTION

For forty years, the United States government allowed economically disadvantaged (1) African American men to be exploited in the name of research, although the research could not generate any benefit to society. (2) Specifically, from 1932 until 1972, government funded researchers enrolled economically disadvantaged African American men in the Tuskegee Syphilis Study to document the already known course of syphilis, which led to the men suffering sores, fever, hair loss, weight loss, headaches, paralysis, blindness, dementia, and death. (3) In exchange for free meals, medical exams, and burial insurance, the researchers promised the men that they would provide treatment for their "bad blood," which could include "anemic blood to muscle aches, general malaise, disorders such as parasitic infections, gonorrhea, syphilis, and other venereal diseases." (4) Not only did the researchers lie about the purpose of the study, but also they intentionally deprived these men of "demonstrably effective treatment in order not to interrupt the project, long after such treatment became generally available," causing the unnecessary disability and death of the men, their wives, and their children. (5) The study was not a therapeutic study because it was not testing a possible treatment of syphilis and blocked any access to treatment. (6) Additionally, the study was not a non-therapeutic study to attain generalizable knowledge because the medical community had already documented the disease process of syphilis. (7) Thus, there was nothing gained from the study other than exploiting economically disadvantaged minorities. (8)

The egregiousness of this study led to the creation and recognition of three Bioethical Principles: Respect for Persons (informed consent); (9) Beneficence (the best interest of the individual participating in the research based on a benefit-risk analysis); (10) and Justice (who participates in medical research and what benefit has to be given to groups who participate in medical research), (11) which govern all medical research studies conducted by or funded by the federal government, except for specified circumstances, like emergency settings. (12) Although these Bioethical Principles have the force of law, (13) medical research studies conducted by or funded by the federal government continue to exploit economically disadvantaged minorities by using them for participation in medical research studies for which there is no benefit.

Much of the work discussing the history and legacy of the Tuskegee Syphilis Study has focused on the violations of the Respect for Persons and Beneficence Principles. (14) The discussion has rarely focused on the Justice Principle that prohibits exploitation. (15) Exploitation is defined as the use of populations for research from which they will not benefit. (16) My Article begins to fill this void by critically analyzing the current limitations of the Justice Principle to address structural and institutional racial biases in health care, which allow economically disadvantaged minorities to be exploited in medical research studies as they were in the Tuskegee Syphilis Study. Using research conducted on economically disadvantaged minority children as an example, my Article shows how even after the creation of the Justice Principle and the passage of the civil rights laws, structural and institutional racial biases remain and have led to the continued exploitation of economically disadvantaged minorities in medical research studies.

Part I of the Article provides a descriptive overview of the purpose and structure of medical research studies and examines the parameters of the Justice Principle. Part II discusses the structural and institutional biases that prevent economically disadvantaged minority children from accessing health care and how this leads to their exploitation in medical research studies. Structural racial bias measures how nonrace based factors, such as the delivery of health care based on ability to pay, indirectly affects economically disadvantaged minority children's access to health care, whereas institutional racial bias focuses on the direct effects of institutional actions on economically disadvantaged minority children's access to health care. In Part III, I propose several ways to put an end to exploitation, a violation of the Justice Principle in medical research studies.

Specifically, I suggest that the Justice Principle be redefined to include the Human Development Approach that requires researchers to provide a benefit to the population from which the research subjects originated that alleviates some of the populations' underlying problems, such as lack of access to health care. This type of benefit is required because oftentimes either the researcher's institution or the researcher's actions have caused some of the underlying problems, such as lack of access to health care. (17) To measure whether the research fulfills the Human Development Approach and provides a benefit that alleviates some of the underlying problems, researchers should be required to use the Vulnerability and Equity Impact Assessment (VEIA) tool, which I have created based on the Health Equity Impact Assessment tool. (18) Using the VEIA, a newly created Board of Children would be responsible for approving all medical research studies seeking U.S. government funding that plan to use children. The Board would use the VEIA to determine if the research would exploit economically disadvantaged minority children in violation of the redefined Justice Principle.

Redefining the Justice Principle to include the Human Development Approach, implementing the VEIA, and creating a Board to review all medical research studies using children will prevent economically disadvantaged minority children from being exploited in medical research studies for the benefit of an unworthy society.

1. MEDICAL RESEARCH STUDIES INVOLVING CHILDREN: THE STRUCTURE AND HISTORY

   There are two types of medical research studies involving human subjects: non-therapeutic and therapeutic. (19) Regardless of the type of medical research study, all studies using children entail risk of psychological and physical harm, as well as the possibility of stigma. In fact, countless children have suffered harm as a result of participating in medical research studies, often without any benefit to children. (20) However, economically disadvantaged minority children have been and continue to be overrepresented in medical research studies that do not provide a benefit to economically disadvantaged minority children. (21) This violates the Justice Principle.

   The Justice Principle was created by incorporating social justice into scientific endeavors to protect populations from being exploited. In 1979, the first, discussion of the Justice Principle in medical research studies appeared in the United States Belmont Report. (22) This report--mandated by the United States Congress--not only defined the Justice Principle, but also provided the framework for which to apply the principle to medical research studies. (23) Since the codification of the Belmont Report in 1986, (24) the Justice Principle has been applied to all medical research studies conducted by or funded by the federal government, except in emergency settings, as a means to protect vulnerable populations, such as economically disadvantaged minority children from being exploited. (25)

   1. Structure of Medical Research Studies Involving Human Subjects

      A non-therapeutic medical research study is conducted to obtain generalizable scientific knowledge. (26) This research is done to learn more "about the subjects' disorder or condition, which is of vital importance for the understanding or amelioration of the subjects' disorder or condition." (27) An example of non-therapeutic research is the Kennedy Krieger lead study. (28)

      In the 1990s, Kennedy Krieger Institute researchers investigating cheap lead abatement techniques partnered with landlords to partially abate lead tainted housing in Baltimore, Maryland. (29) In order to test the efficacy of the abatement procedures, the researchers--in collaboration with the landlords--ensured that only families with healthy children lived in the lead tainted housing by agreeing to pay for lead abatement procedures if the landlords rented to families with young children. (30) Although the information given to parents "implied that the study was protecting their children from lead damage and promised to inform parents of any hazards," (31) the study was non-therapeutic (32) because it was conducted to find out more "about the subjects' disorder or condition which is of vital importance for the understanding or amelioration of the subjects' disorder or condition...." (33)

      A therapeutic medical research study tests a vaccine, drug, or medical device for the treatment of a disease. (34) An example of a therapeutic medical research study is the testing of HIV/AIDS drugs. There are five phases of therapeutic medical research studies: Phase 0, I, II, III, and IV. (35) Using drug medical research studies as an example, each phase is discussed below.

      In a Phase 0 drug study, research is conducted using at most ten people and...