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Sociol Health Illn. 2015 Jan;37(1):127-42. doi: 10.1111/1467-9566.12185.

Stopped hearts, amputated toes and NASA: contemporary legends among healthy volunteers in US phase I clinical trials.

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  • 1Department of Social Medicine and Center for Bioethics, University of North Carolina, North Carolina, USA.

Abstract

The first stage of testing new pharmaceuticals in humans is referred to as a phase I clinical trial. The purpose of these studies is to test the safety of the drugs and to establish appropriate doses that can later be given to patients. Most of these studies are conducted under controlled, in-patient conditions using healthy volunteers who are paid for their participation. To explore healthy volunteers' experiences in clinical trials, an ethnographic study was conducted at six in-patient phase I clinics in the USA. In addition to the observation of clinic activities (from informed consent procedures to dosing to blood draws), 268 semi-structured interviews were conducted, 33 with clinic staff and 235 with healthy volunteers. Drawing on this dataset, this article explores healthy volunteers' exchange of contemporary legends about phase I clinical trials. In addition to potentially scaring the listener and communicating distrust in the medical community, these incredible stories help participants cope with perceived stigma and establish a gradient of risk of trial participation, creating potential boundaries to their participation in medical research. The article argues that contemporary legends play a productive role in society, shaping how people view themselves and others and influencing their decisions about risky activities.

© 2015 The Author. Sociology of Health & Illness © 2015 Foundation for the Sociology of Health & Illness/John Wiley & Sons Ltd.

KEYWORDS:

clinical trials; contemporary legends; healthy volunteers; pharmaceuticals; phase I; safety

PMID:
25601069
[PubMed - indexed for MEDLINE]
PMCID:
PMC4406236
Free PMC Article
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