Captive to the Clinic: Phase I Clinical Trials as Temporal Total Institutions

Abstract

This article develops the concept of temporal total institutions to describe how and why individuals voluntarily submit to highly-controlled and often dehumanizing environments. We focus empirically on Phase I clinical trials, which offer compensation to healthy people in exchange for testing investigational pharmaceuticals. Analyzing the experiences of 67 U.S. healthy volunteers, we illustrate how comparisons between Phase I trials and prison are salient to participants as they reflect on their confinement in research facilities and their interactions with other participants and research staff. We argue that conditions of contemporary economic insecurity and/or poverty facilitate the existence of coercive temporal total institutions by undermining voluntariness. Phase I clinics take advantage of the steady supply of individuals who will submit to the organization’s demands out of hope that the income gained will be transformative for their lives.

Healthy Volunteers’ Perceptions of the Benefits of Their Participation in Phase I Clinical Trials

“…This result is harder to explain; however, we interpret it as based in part on the fact that, of the racial and ethnic groups represented in our study, non-Hispanic Whites have the best chance of obtaining paid employment. Because many of the perceived future investment benefits were quite implausible “fantasies” (e.g., becoming millionaires), it is possible that individuals with less realistic opportunities for paid employment were more likely to entertain these hopeful narratives as a way of maintaining a positive vision for their future (Williams & Fisher, 2018). This is consistent with other findings, for instance, about the relatively high participation of poor and minority groups in lottery gambling, where “self-perceived social deprivation” can motivate regular lottery ticket purchases (Beckert & Lutter, 2013).…”

“…For example, the financial compensation might motivate individuals to sign up for a clinical trial, but this does not tell us how people perceive the economic benefits, which often need to be understood in light of participants’ specific sociodemographic contexts. Some studies indicate that many participants are dependent on clinical trial income to support their households (Cottingham & Fisher, 2016; Monahan & Fisher, 2015; Williams & Fisher, 2018), whereas others suggest that it is typically supplemental income to be used for consumer purchases and nonessentials (Tolich, 2010). Even less is known about what noneconomic benefits healthy volunteers might perceive from their enrollment in Phase I trials.…”

Speculating on precarious income: finance cultures and the risky strategies of healthy volunteers in clinical drug trials

“…While many healthy volunteers espouse a belief in the societal benefit of their trial participation (Fisher et al 2018b), it is nonetheless the financial compensation that motivates them to enroll and structures the system of 'clinical labor' (Cooper and Waldby 2014). While attention in the literature has concentrated on the 'professional' healthy volunteers who consider their drug trial participation to be a 'job' (Elliott 2008, Abadie 2010, they are not the majority of those who enroll in Phase I trials (Williams andFisher 2018, Fisher 2020). There are also those healthy volunteers who might see their clinical trial involvement as a one-time event as well as those who perceive of it as a long-term, intermittent source of income when they need it or as a revenue-generating economic activity 'for which one does not need to work' (Nyman et al 2013, p. 61, see also Nyman et al 2008, Beckert andLutter 2013).…”

Advancing Ethics and Policy for Healthy‐Volunteer Research through a Model‐Organism Framework

“…Our prior research suggests that these latter clinic configurations can result in overcrowding, and there are no external standards on how many participants can share the space. 29 …”

“…Our prior research suggests that these latter clinic configurations can result in overcrowding, and there are no external standards on how many participants can share the space. 29 Moderating the housing conditions are other factors, such as the comfort level of beds, chairs, and other furniture; access to windows; ambient room temperature; and poor-quality food. 30 Healthy volunteers routinely complain about how some clinics have thin mattresses, broken or inadequate furniture, windowless spaces, and distressingly cold rooms.…”