Human Research Subjects as Human Research Workers

Abstract

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.

For love and money: the need to rethink benefits in HIV cure studies

“…To the contrary, it may ‘brib[e] people to become commodities’ 31. Research participation is appropriately analogised to unskilled, yet essential labour 32. In the context of unskilled labour people are generally permitted to sell their bodily services, even when that exposes them to risks.…”

“…31 Research participation is appropriately analogised to unskilled, yet essential labour. 32 In the context of unskilled labour people are generally permitted to sell their bodily services, even when that exposes them to risks. It should be 'no more worrisome to commodify a person's labor as a research subject than to commodify a person's labor in other contexts, which happens all the time'.…”

Differential payment to research participants in the same study: an ethical analysis

“…Note that this complaint need not rely on accepting the notion that research participation is, in fact, analogous to work,20 but instead suggests a more basic desire to fairly acknowledge participants’ inputs to research, however conceived. On that basis, this objection fails.…”

“Paid to Endure”: Paid Research Participation, Passivity, and the Goods of Work

“…Nonetheless, the professional guinea pigs' perspective is gaining increasing scholarly support. A number of bioethicists, philosophers, anthropologists, and legal scholars have proposed conceiving of and regulating participation in phase I trials as a form of work (Abadie 2010;Dickert and Grady 1999;Lemmens and Elliott 1999;Lynch 2014;Phillips 2011;VanderWalde and Kurzban 2011;Walker, Cottingham, and Fisher 2018). 1 This would enable participants to claim higher payment, but also to enjoy a range of other rights and benefits available to workers.…”

“…Let me also specify what I mean by a "work model." While regulating research participation as work could amount to different things, I take the model to consist of the following widely proposed elements: a right to a minimum wage, a right to organize into unions and engage in collective bargaining, a right to a safe workplace, and a right to adequate care and compensation in case of injury (Anderson and Weijer 2002;Lemmens and Elliott 1999;Lynch 2014). 2 Importantly, these rights are not intended to replace already established research regulations since that would weaken subject protections in important respects, but rather to be added to existing protections as a way of "leveling up" subjects to the status of workers (Lynch 2014).…”