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Human Research Subjects As Human Research Workers Yale Journal of Health Policy, Law, and Ethics Volume 14 Issue 1 Article 3 2015 Human Research Subjects As Human Research Workers Holly Fernandez Lynch Harvard Law School Follow this and additional works at: https://digitalcommons.law.yale.edu/yjhple Part of the Health Law and Policy Commons, and the Legal Ethics and Professional Responsibility Commons Recommended Citation Holly Fernandez Lynch, Human Research Subjects As Human Research Workers, 14 YALE J. HEALTH POL'Y L. & ETHICS (2015). Available at: https://digitalcommons.law.yale.edu/yjhple/vol14/iss1/3 This Article is brought to you for free and open access by Yale Law School Legal Scholarship Repository. It has been accepted for inclusion in Yale Journal of Health Policy, Law, and Ethics by an authorized editor of Yale Law School Legal Scholarship Repository. For more information, please contact [email protected]. Fernandez Lynch: Human Research Subjects As Human Research Workers YALE JOURNAL OF HEALTH POLICY, LAW, AND ETHICS XIV:1 (2014) Human Research Subjects As Human Research Workers Holly Fernandez Lynch ABSTRACT: Biomedical research involving human subjects has traditionally been treated as a unique endeavor, presenting special risks and demanding special protections. But in several ways, the regulatory scheme governing human subjects research is counter-intuitively less protective than the labor and employment laws applicable to many workers. This Article relies on analogical and legal reasoning to demonstrate that this should not be the case; in a number of ways, human research subjects ought to be fundamentally recast as human research workers. Like other workers protected under worklaw, biomedical research subjects often have interests that diverge from those in positions of control but little bargaining power for change. Bearing these important similarities in mind, the question becomes whether there is any good reason to treat subjects and protected workers differently as a matter of law. With regard to unrestricted payment, eligibility for a minimum wage, compensation for injury, and rights to engage in concerted activity, the answer is no and human subjects regulations ought to be revised accordingly. * Executive Director, Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics, Harvard Law School. J.D./M.Bioethics, University of Pennsylvania. My thanks to Glenn Cohen, Einer Elhauge, Carl Elliott, Jonathan Jay, Sophia Lee, Paul Lombardo, Kristin Madison, Michelle Meyer, Collin O'Neill, Ben Roin, Benjamin Sachs (HLS), Benjamin Sachs (NYU), Seema Shah, Jeff Skopek, and Patrick Taylor for very helpful comments and discussion. Thanks also to participants in the 2012 Harvard Law School Health Law Policy Workshop; the Petrie-Flom Center 2012 Conference on The Future of Human Subjects Research Regulation; and the American Society of Law, Medicine, and Ethics 2012 Health Law Professors Conference. Finally, thank you to Jordan Baehr and Afroditi Giovanopoulou, who provided research assistance, and the excellent editors of the Yale Journal of Health Policy, Law, and Ethics. 122 Published by Yale Law School Legal Scholarship Repository, 2015 1 Yale Journal of Health Policy, Law, and Ethics, Vol. 14 [2015], Iss. 1, Art. 3 HUMAN RESEARCH SUBJECTS AS HUMAN RESEARCH WORKERS TABLE OF CONTENTS INTRODUCTION ................................................... 125 I. LEGAL AND ETHICAL REQUIREMENTS FOR HSR ............ 130 II. RESEARCH PARTICIPATION AS A JOB......................... 132 A. THE BIOETHICISTS ............................................... 132 1. HEALTHY SUBJECTS AND AVOIDING EXPLOITATION . ............... 133 2. EQUATING SUBJECT PAYMENT WITH A WAGE............ .............. 137 3. ANALYSIS .......................................... .............. 139 B. LEGAL BACKGROUND............................................. 142 1. EMPLOYEES AND EMPLOYERS............................... 142 2. THE EMPLOYMENT STATUS OF HUMAN RESEARCH SUBJECTS.............. 144 3. ANALYSIS .................................................... 148 III. CLARIFYING THE ANALOGY AND ITS SCOPE ................. 149 A. WHY NOT APPLY WORKLAW DIRECTLY TO SUBJECTS? . .. .. 149 B. SHARED CONCERNS OF SUBJECTS AND PROTECTED WORKERS ............... 151 1. DIVERGENT INTERESTS ......................................... 151 2. BARGAINING POWER, COLLECTIVE ACTION, AND EXPLOITATION........ 152 3. DEMOCRATIC DEFICITS, DEPENDENCY, AND THE NEED FOR PROTECTION ........................................................ 153 C. WEAKER ANALOGY, SAME PROTECTIONS ........................... 154 IV. LEVELING SUBJECTS UP TO WORKERS ....................... 156 A. PAYMENT .............................................. ......... 156 1. PAYMENT CEILING ............................................. 159 2. MINIMUM WAGE .............................................. 163 3. UNEMPLOYMENT .............................................. 165 B. CARE AND COMPENSATION FOR INJURY ............................ 166 1. SCOPE, NEED, AND BURDEN..................................... 170 2. COVERED HARM AND CAUSATION ......................... 173 3. FUNDING, TORT PREEMPTION, AND ADDITIONAL CONCERNS............... 175 123 https://digitalcommons.law.yale.edu/yjhple/vol14/iss1/3 2 Fernandez Lynch: Human Research Subjects As Human Research Workers YALE JOURNAL OF HEALTH POLICY, LAW, AND ETHICS XIV:1 (2014) 4. UNPAID SUBJECTS .................................... ..... 177 C. WORKING CONDITIONS AND INSPECTIONS .............. .......... 179 D. COLLECTIVE BARGAINING AND UNIONS ....................... 181 V. OUTSTANDING OBJECTIONS ................................ 191 CONCLUSION ...................................................... 193 124 Published by Yale Law School Legal Scholarship Repository, 2015 3 Yale Journal of Health Policy, Law, and Ethics, Vol. 14 [2015], Iss. 1, Art. 3 HUMAN RESEARCH SUBJECTS As HUMAN RESEARCH WORKERS INTRODUCTION In the early 1930s, a physician named William Osler Abbott was working to develop a new technique for rapidly intubating the human intestine. He swallowed the tubes himself until he "was sick of the sight of them" and worked out some aspects of the technique using hospital patients. Eventually, however, he realized the need to experiment on healthy human subjects., Abbott planned to offer two dollars a day to anyone willing to take the job, and expected no difficulty recruiting at the height of the Depression. However, relief administrators refused to refer anyone for this type of work. Abbott lamented that "[i]n that day of poverty, destitution and collapsing homes, not one solitary subject did I ever get through the very agencies that were apparently striving to find jobs, to make jobs, to beg jobs of any kind for hungry men." Abbott also failed to recruit "beggars," "tramps, vagrants, and the unemployed," all of whom recoiled at the work once it was described to them. Eventually, he enlisted the help of a "black janitor on the hospital floor," offering a finder's fee for every healthy subject brought in "appearing sober" and fasting, and finally had some success.2 As he prepared to exhibit the intubation technique at a medical conference, however, Abbott faced an unexpected problem: his subjects went on strike, seeking more money. At the eleventh hour, he managed to recruit new volunteers from a class of medical students, "a shipment of scab labor . that would have made any factory foreman green with envy." Then, "the National Labor Relations Board being as yet unborn," Abbott "had the pleasure of indulging in a little old-fashioned capitalism. We fired the whole lot of [strikers], lock, stock and barrel. The exhibit went off like clockwork."3 Thereafter, Abbott began advertising in newspapers, which generated enough interest that he was able to have his pick from among the applicants, most of whom volunteered for financial reasons.4 Abbott's encounters are in many ways from a different time, but much of what he describes could apply equally well to biomedical research involving human subjects today: advertisements, payment for participation, and recruitment based on physical characteristics and willingness to cooperate. One key feature, however, stands in stark contrast. Abbott clearly viewed his subjects as workers and their research participation as a type of job. But this view of the subject has never taken hold. Today, researchers, ethicists, and regulators generally see subjects as a class unto themselves - a class in need of special protection as a 1 W. Osler Abbott, The Problem of the Professional Guinea Pig, 68 TRANSACTIONS AM. CLINICAL & CLIMATOLOGICAL Ass'N 1, 1 (1957). 2 Id. at 2-3. 3 Id. at 4. 4 Id. at 6-8. 125 https://digitalcommons.law.yale.edu/yjhple/vol14/iss1/3 4 Fernandez Lynch: Human Research Subjects As Human Research Workers YALE JOURNAL OF HEALTH POLICY, LAW, AND ETHICS XIV:1 (2014) result of a history of research scandal and other supposedly unique characteristics, such as the nature of subjects' vulnerability, motivation, and risk taking. As a result, the protections offered to many traditional workers under U.S. labor and employment law (hereinafter, "worklaw") have been treated as completely separate from and exclusive of the regulatory scheme governing clinical research. And although that regulatory scheme, and the thrust of research ethics in general, is heavily focused on subject protection, some traditional workers - usually those satisfying the legal definition of "employee" - receive a number of legal protections that research subjects do not. In recent years,
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