Protecting Human Research Subjects as Human Research Workers
Holly Fernandez Lynch
Petrie-Flom Center, Harvard Law School
March 1, 2013
The Future of Human Subjects Research Regulation, I. Glenn Cohen and Holly Fernandez Lynch, eds., MIT Press (Spring 2014) (Forthcoming)
As described by the Department of Health and Human Services, the changes proposed to the Common Rule in the July 2011 ANPRM were primarily intended to enhance protections for human subjects while reducing burden on researchers. However, due to a continued view of human subjects research as an exceptional endeavor that ought to be governed by exceptional rules, the government and interested stakeholders have failed to take this once-in-two-decade opportunity to consider some enhanced protections that could be appropriately imported from a potentially unexpected but analogous setting – the workplace.
In this chapter, I flesh out the analogy between human subjects in clinical research and traditional workers in order to demonstrate several ways in which their differential treatment is problematically inconsistent, with a focus on areas in which subjects are less stringently protected than their counterparts in customary workplace environments. In particular, I argue that in some cases, human research subjects might actually be eligible for employment law protections without any regulatory change, and that 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.
[The ideas presented in this chapter are fleshed out more fully in my longer article, Human Research Subjects as Human Research Workers, available here:http://ssrn.com/abstract=2296100]
Number of Pages in PDF File: 24
Keywords: human subjects research, common rule, ANPRM, employment/labor law
Date posted: April 2, 2013 ; Last revised: February 6, 2014