Healthy Volunteers’ “Informed” Study Participation: The Influence of Social Networks on Knowledge about and Identity in Phase I Clinical Trials

Jill Fisher, PhD

Assistant Professor of Social Medicine
Center for Bioethics
University of North Carolina at Chapel Hill

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 talk draws on an ethnographic study of six phase I clinics in the United States, including 268 semi-structured interviews with research staff and healthy volunteers. It examines the concept of informed consent in Phase I trials by attending to the exchange of information that happens not only between the researchers and healthy volunteers but also among the healthy volunteers themselves. It problematizes notions of what information is most important to healthy volunteers as they consider the risks and benefits of participation in Phase I trials.