Risk and Emotion Among Healthy Volunteers in Clinical Trials

Abstract

Theorized as objective or constructed, risk is recognized as unequally distributed across social hierarchies. Yet the process by which social forces shape risk and risk emotions remains unknown. The pharmaceutical industry depends on healthy individuals to voluntarily test early-stage, investigational drugs in exchange for financial compensation. Emblematic of risk in late modernity, Phase I testing is a rich site for examining how class and race shape configurations of emotion and risk. Using interview data from 178 healthy trial participants, this article examines emotion and risk as mutually constituting processes linked to biographical context and social structure. Biographical events like economic insecurity and incarceration influence how risk is felt by providing comparative experiences of felt risk and felt benefits. Such events, in turn, are structured by class-based and racial inequalities, linking class and race positions to primary emotional experiences of risk.

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

“…9 Specifically, some healthy volunteers have voiced reservations about what they see as unacceptable risks of participation but nonetheless feel that the money offered is too good to refuse. 10 Second, in spite of frequent conflation between coercion and undue inducement in research oversight, 11 typical bioethical understandings of coercion insist that, unlike with undue inducement, genuine offers cannot coerce. Nonetheless, the socioeconomic conditions in which healthy volunteers choose to participate in clinical trials may evidence material threats to their well-being, such as those characterized by economic insecurity, race-based employment discrimination, histories of incarceration, and/or undocumented immigration.…”

“…The use of healthy volunteers in drug development has not generated a parallel imperative to consider translation from healthy participants to affected patients in spite of evidence that phase I participants are not representative of the general population in myriad ways. First, healthy volunteers are predominantly men in their 30s and 40s, 36 and the literature shows that there are sex-based differences that could lead to more drug exposure in women than in men. 37 This is particularly concerning given a government report that drugs that were removed from the market for safety concerns had disproportionately harmful effects on women.…”

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

“…Discontinuing a study means forfeiting a sizeable portion of the compensation that is reserved as a “completion bonus.” This payment structure helps to ensure that pharmaceutical companies get the data they are paying for by penalizing those participants who exercise their right to withdraw from the study. Additionally, temporal total institutions can encourage voluntary participation through the “reinventive” promise of the compensation, wherein individuals see clinical trials as a way to better their circumstances (see below and also Cottingham and Fisher 2016). Unlike reinventive institutions, however, it is not the institution’s doctrine that is the source of transformation.…”

“…Additionally, temporal total institutions can encourage voluntary participation through the "reinventive" promise of the compensation, wherein individuals see clinical trials as a way to better their circumstances (see below and also Cottingham and Fisher 2016). Unlike reinventive institutions, however, it is not the institution's doctrine that is the source of transformation.…”

“…Medical researchers typically lament the difficulty of recruiting minority participants to clinical trials (e.g., Paskett et al 2008;Shavers-Hornaday et al 1997), but Phase I trials enroll a disproportionate number of minorities (Fisher and Kalbaugh 2011). Specifically, Phase I participants in the United States are overwhelmingly represented by black men from low socioeconomic positions (Cottingham and Fisher 2016;. Healthy volunteers have been a largely understudied population, and researchers who have empirically examined these types of trial participants typically do not focus on the intersection of financial motivation to participate and the social context of profound racial and economic inequality in the United States (e.g., Grady et al 2017;Kass et al 2007).…”