Feeding and Bleeding: The Institutional Banalization of Risk to Healthy Volunteers in Phase I Pharmaceutical Clinical Trials

TitleFeeding and Bleeding: The Institutional Banalization of Risk to Healthy Volunteers in Phase I Pharmaceutical Clinical Trials
Publication TypeJournal Article
Year of Publication2015
AuthorsFisher, JA
JournalScience, Technology & Human Values
Date Published2015
Publication Languageeng
ISBN Number01622439
KeywordsClinical , ethnographic , healthy , Medical , Pharmaceuticals , phase , research , RISK , United , Volunteers
AbstractPhase I clinical trials are the first stage of testing new pharmaceuticals in humans.  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. The author argues 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. The author argues that the institutional banalization of risk also renders invisible ethical concerns about exploitation of underprivileged groups in pharmaceutical research. 
NotesFisher, Jill A. 1; Affiliation: 1: University of North Carolina at Chapel Hill, Chapel Hill, NC, USA jill.fisher@unc.edu; Source Info: Mar2015, Vol. 40 Issue 2, p199; Subject Term: CLINICAL trials; Subject Term: MEDICAL research; Subject Term: ETHNOGRAPHIC analysis; Subject Term: VOLUNTEERS; Subject Term: RESEARCH; Subject Term: UNITED States; Author-Supplied Keyword: clinical trials; Author-Supplied Keyword: healthy volunteers; Author-Supplied Keyword: pharmaceuticals; Author-Supplied Keyword: phase I; Author-Supplied Keyword: risk; NAICS/Industry Codes: 541712 Research and Development in the Physical, Engineering, and Life Sciences (except Biotechnology); Number of Pages: 28p; Document Type: Article; Full Text Word Count: 10759