Ruqaiijah Yearby (Case Western) on “The Enduring Legacy of the Tuskegee Syphilis Study”…

Ruqaiijah Yearby  (Case Western)

Ruqaiijah Yearby  (Case Western)

Exploitative medical research is a somewhat challenging phenomenon to describe economically.  To the extent subjects do not get paid at all, like the enslaved women experimented upon to create modern gynecology, using Black folks to come up with cures for diseases is an example of how the externalities and transaction costs of society are asymmetrically and disproportionately borne by Black folks.  Asymmetrical Transaction Costs.  The enduring legacy of the Tuskegee Experiments perhaps discourages Black folks from fully engaging with the health marketplace, as both professionals and patients.  This would represent asymmetrically imperfect market competition, or perhaps asymmetrical market rationality. - DreSmith

Introduction:

For forty years, the United States government allowed economically disadvantaged African American men to be exploited in the name of research, although the research could not generate any benefit to society. 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. 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.” 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. The study was not a therapeutic study because it was not testing a possible treatment of syphilis and blocked any access to treatment. 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. Thus, there was nothing gained from the study other than exploiting economically disadvantaged minorities.

The egregiousness of this study led to the creation and recognition of three Bioethical Principles: Respect for Persons (informed consent); Beneficence (the best interest of the individual participating in the research based on a benefit-risk analysis); and Justice (who participates in medical research and what benefit has to be given to groups who participate in medical research), which govern all medical research studies conducted by or funded by the federal government, except for specified circumstances, like emergency settings. Although these Bioethical Principles have the force of law, 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. The discussion has rarely focused on the Justice Principle that prohibits exploitation. Exploitation is defined as the use of populations for research from which they will not benefit. 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 non-race 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. 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. 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.

 

Table of Contents:

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

 

Conclusion:

Professor Patricia King, one of the drafters of the Belmont Report, noted, “[d]espite common recognition that ‘the Tuskegee Study is America's metaphor for racism in medical research,’ there has been inadequate attention paid to race, either in the sense of negative and differential treatment or in terms of pervasive scientific racism, in the construction of bioethics in the United States.” Specifically, neither researchers nor those who regulate medical research studies take into account structural and institutional racial biases that prevent vulnerable populations, such as economically disadvantaged minority children, from accessing health care, making them vulnerable to exploitation in medical research studies that promise access to health care. Thus, economically disadvantaged minority children continue to be exploited in medical research studies that do not provide a benefit to the population from which they originated.

As Carol Levine notes, “[t]here [has been] no resolution of the conflict between American society's failure to provide basic healthcare and HIV/AIDS prevention programs to poor communities of color--a matter of social justice-- and the potential coerciveness of using research participation as an entry into the health care system.” Hence, the time has come to put an end to this exploitation by enforcing the Justice Principle to prevent the use of all children, but especially economically disadvantaged minority children, in medical research studies for which they will not receive a benefit. This will only happen if the Justice Principle stands for more than inclusion. The Justice Principle must be a measurable standard that ensures fairness, equity, and the right of children to reach their full health potential without interference. Otherwise, children will continue to be sacrificed for the benefit of an unworthy society.