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Human Subjects Research RegulationPerspectives on the Future$
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I. Glenn Cohen and Holly Fernandez Lynch

Print publication date: 2014

Print ISBN-13: 9780262027465

Published to MIT Press Scholarship Online: January 2015

DOI: 10.7551/mitpress/9780262027465.001.0001

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Protecting Human Research Subjects as Human Research Workers

Protecting Human Research Subjects as Human Research Workers

(p.327) 21 Protecting Human Research Subjects as Human Research Workers
Human Subjects Research Regulation

Holly Fernandez Lynch

The MIT Press

Clinical 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 chapterargues that this should not be the case. In some instances, human research subjects might actually be eligible for employment law protections without any regulatory change, but in others, they ought to be “leveled-up” to worker-type protections. Thus, clinical research subjects should at the very least not face regulatory limits on how much they may be paid for participation and should be entitled to no-fault compensation for research-related injury. Efforts to more fully integrate their perspective into the research endeavor, similar to the role of labor negotiations, should also be explored.

Keywords:   Labor and employment law, Payment, Study-related injury, Analogical reasoning

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