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

Abstract

Nonhuman animal research and phase I healthy-volunteer clinical trials are both critical components of testing the safety of investigational drugs as part of the development of new pharmaceuticals. In addition, these types of research share important structural features, as both take place in confinement and both use subjects that are dissimilar to the target population. By mobilizing a model-organism framework for phase I trials, we employ concepts and mechanisms typical to animal research to query gaps in the human subjects ethics and policy framework. By bringing these two research worlds together, we aim to illustrate how the model-organism framework can enhance healthy volunteers’ welfare during trials, improve research oversight, and more critically assess the science value of current phase I trials.

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

“…In five instances, the participants also noted that the bodily risks of the study were not worth the compensation, and this included the $11,000 study previously noted (n.b., the lowest paying study perceived as too physically risky was $1,260 and the average of the five was $6,130). For the purposes of this paper, we focus on economic decision making here rather than on risk, which we analyze elsewhere (Fisher et al 2019). 6.…”

"My Body is One of the Best Commodities": Exploring the Ethics of Commodification in Phase I Healthy Volunteer Clinical Trials

“…The majority of healthy volunteers are financially vulnerable individuals due to underemployment and membership in minority racial and ethnic groups (Cottingham and Fisher 2016;Monahan and Fisher 2015). They experience powerlessness in setting the terms of their exchange with phase I clinics as their payment for participation is not protected as a type of employment, even though many enroll serially and depend on clinical trial income to make ends meet (Walker, Cottingham, and Fisher 2018;Fisher and Walker 2019). To illustrate potential harmful consequences of these markets, past scandals in the commercial phase I industry include trials in which undocumented individuals were participating in rundown conditions and homeless alcoholics were recruited to test drugs in exchange for room, board, and pay (Evans, Smith, and Willen 2005;Cohen 1996).…”

Humans as Model Organisms

“…A s Jill Fisher and Rebecca Walker remind us in their article “Advancing Ethics and Policy for Healthy Volunteer Research through a Model Organism Framework,” in the January‐February 2019 issue of this journal, model organisms are “organisms on which much is known, and knowledge of which can be freely and easily accessed and used to study other organisms.” 1 In biomedical research, “model organism” almost exclusively refers to nonhuman organisms, and experiments involving model organisms almost exclusively benefit humans. The definition of model organism would be more descriptively accurate if it read instead, “ nonhuman organisms on which much is known, and knowledge of which can be freely and easily accessed and used to study human organisms.”…”