Stopped Hearts, Amputated Toes, and NASA: Contemporary Legends among Healthy Volunteers in Phase I Clinical Trials

• In Event: 346 - Regular Session. Sociology of Science 1

Abstract

The first stage of testing new pharmaceuticals in humans is referred to as Phase I clinical trials. 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. The majority 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 dedicated Phase I, in-patient units in the United States (two in the East, two in the Midwest, and two in the West). In addition to observation of clinic activities (from informed consent procedures to blood draws to dosing), 268 semi-structured interviews were conducted, 33 with clinic staff and 235 with healthy volunteers. Drawing on this larger dataset, this article explores healthy volunteers’ exchange of contemporary legends about Phase I clinical trials. These incredible stories can scare the listener, manifest distrust in the medical community, provide advice to minimize risk, and form the basis of a shared community. The article argues that the circulation of contemporary legends provides an outlet for volunteers’ residual anxiety about their participation in medical research.

Author

• Jill A. Fisher, University of North Carolina-Chapel Hill