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Copyright (c) 2017 Yale Journal of Health Policy, Law, and Ethics 
Yale Journal of Health Policy, Law, and Ethics

ARTICLE: Paying Research Participants: Regulatory Uncertainty, Conceptual Confusion, and a Path Forward

Winter, 2017

Yale Journal of Health Policy, Law & Ethics

17 Yale J. Health Pol'y L. & Ethics 61

Author

Emily A. Largent, J.D., Ph.D. * and Holly Fernandez Lynch, J.D., M.Bioethics **

Excerpt



Introduction
 
In the early days of 2016, news broke that six men had been hospitalized - one of whom was pronounced brain-dead - after a "serious accident" in the course of a drug trial conducted in France. 1 The men were all participants in a Phase I, or first-in-human, trial of BIA 10-2474, 2 a novel compound designed to treat "anxiety and motor disorders associated with Parkinson's disease, and chronic pain in people with cancer and other conditions." 3 Each participant had been paid .1,900 (about $ 2,060), "including travel expenses; in return, they agreed to stay at [the testing] facility in Rennes [France] for 2 weeks, swallow a drug on 10 consecutive days, undergo extensive medical tests, and provide at least 40 blood samples." 4 The amount of payment was widely reported in the wake of the tragedy, with the implication that the offer of payment, or the amount of payment, signaled that the trial itself was ethically questionable.

Clearly, something went terribly wrong in France. 5 Yet, if we focus on what was known at the time the offer of payment was made, rather than allowing retrospective judgments and suspicions about pecuniary incentives to cloud our ethical evaluations, was it acceptable to offer the research participants .1,900? And if it was not, why not?

Offers of payment made to research participants 6 have been described as "one of the more contentious ethical problems" facing institutional review boards (IRBs). 7 The U.S. federal regulations and the leading international codes ...
 
 
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