Feeding and Bleeding: The Institutional Banalization of Risk to Healthy Volunteers in Phase I Pharmaceutical Clinical Trials
Science, Technology, and Human Values 40 (2):199-226 (2015)
Abstract
Phase I clinical trials are the first stage of testing new pharmaceuticals in humans. The majority of these studies are conducted under controlled, inpatient conditions using healthy volunteers who are paid for their participation. This article draws on an ethnographic study of six phase I clinics in the United States, including 268 semistructured interviews with research staff and healthy volunteers. In it, I argue that an institutional banalization of risk structures the perceptions of research staff and healthy volunteers participating in the studies. For research staff, there are three mechanisms by which risk becomes banal: a perceived homogeneity of studies, Fordist work regimes, and data-centric discourse. For healthy volunteers, repeat study participation contributes to the institutional banalization of risk both through the process of desensitization to risk and the formation of trust in the clinics. I argue that the institutional banalization of risk also renders invisible ethical concerns about exploitation of underprivileged groups in pharmaceutical research.My notes
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Citations of this work
“Paid to Endure”: Paid Research Participation, Passivity, and the Goods of Work.Erik Malmqvist - 2019 - American Journal of Bioethics 19 (9):11-20.
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Avoiding Exploitation in Phase I Clinical Trials: More than (Un)Just Compensation.Matt Lamkin & Carl Elliott - 2018 - Journal of Law, Medicine and Ethics 46 (1):52-63.
To report or not to report: Exploring healthy volunteers' rationales for disclosing adverse events in Phase I drug trials.Lisa McManus & Jill A. Fisher - 2018 - AJOB Empirical Bioethics 9 (2):82-90.
Picking and Choosing Among Phase I Trials: A Qualitative Examination of How Healthy Volunteers Understand Study Risks.Jill A. Fisher, Torin Monahan & Rebecca L. Walker - 2019 - Journal of Bioethical Inquiry 16 (4):535-549.
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