Feeding and Bleeding

The Institutional Banalization of Risk to Healthy Volunteers in Phase I Pharmaceutical Clinical Trials

Datos Bibliográficos

ID5337294
AutoresJill A Fisher (0000-0002-9487-1493, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA, autor de correspondencia)
Año2015
Volumen40
Número2
Páginas199-226
Fecha de publicación2015-03-01
Peer ReviewedSí
Open AccessSí
TipoARTICLE
RevistaScience Technology & Human Values (JOURNAL)
Identificadores de la revistaISSN: 0162-2439 • E-ISSN: 1552-8251
EditorialSAGE Publications Inc (PUBLISHER)
DOI10.1177/0162243914554838
PMID25914430
PMCIDPMC4405793
OpenAlexW2014105707
IdiomaEN
Citas recibidas17
Referencias citadas48

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

Clinical trial · Ethnography · Participant observation · Perception · Political science · Psychiatry · Public relations · Qualitative research · Research ethics · Social science · Sociology · Biomedical Ethics and Regulation · Ethics in Clinical Research · Medicine · Pharmaceutical industry and healthcare · Psychology