Feeding and Bleeding: The Institutional Banalization of Risk to Healthy Volunteers in Phase I Pharmaceutical Clinical Trials
- PMID:25914430
- PMCID: PMC4405793
- DOI: 10.1177/0162243914554838
Feeding and Bleeding: The Institutional Banalization of Risk to Healthy Volunteers in Phase I Pharmaceutical Clinical Trials
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.
Keywords: clinical trials; healthy volunteers; pharmaceuticals; phase I; risk.
References
- Abadie R. The Professional Guinea Pig: Big Pharma and the Risky World of Human Subjects. Duke University Press; Durham, NC: 2010.
- Batchelor S. [Accessed October 1, 2014];Feds May Track Sex Differences in Drug Reactions. Women’s eNews. 2002 Sep 15;http://womensenews.org/story/medicine/020915/feds-may-track-sex-differen...
- Beck U. From Industrial Society to the Risk Society: Questions of Survival, Social Structure and Ecological Enlightenment. Theory, Culture & Society. 1992;9(1):97–123.
- [Accessed April 7, 2012];Belmont Report. 1979http://ohsr.Od.Nih.Gov/guidelines/belmont.Html
- Borfitz D. Canada Scrambles to Reboot Sagging Clinical Trials Market. CenterWatch Monthly. 2011;18(12):1, 10–14.
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