Talk, Research Technology, and the Achievement of Human Subject “Status Passage”

Abstract

This article draws on field notes and interviews collected during an ethnographic study of the informed‐consent process in HIV/AIDS clinical trials to examine the movement of individuals from the status designation of patient to that of human subject of research. Its theoretical starting points are Glaser and Strauss's (1971) observation of the centrality of interaction to status passage and their conceptualization of status passage as social accomplishment. Insights from conversation and technology studies are applied to show that human subject status passage is facilitated through (1) the enlistment efforts of research professionals and patients, (2) the talk of participants on informed consent and protocol‐related matters, and (3) the placement of signatures on informed‐consent documents. The analysis reveals that human subject status passage is indeterminate, negotiated, and unmarked by ceremony and cultural symbols. The implications of these findings for future studies on status passage and informed consent in human research are considered.

Therapeutic Discourse Among Nurses and Physicians in Controlled Clinical Trials

“…The original work focused on AIDS clinical trials and also employed an ethnographic field research design. [10][11][12][13] As an interpretive method directed towards the understanding of natural processes and phenomena, 14 ethnographic field research concerns the actions, meaning and context of the subject under investigation. 15 The field setting for our study was an outpatient research unit lodged within the gastroenterology department of a large research-oriented medical center, where randomized, placebo-controlled HCV clinical trials sponsored by pharmaceutical companies were conducted.…”

The Work and Occupational Trajectories of Clinical Trials Research

“…Qualitative methods of data analysis, including coding, memo-writing, and categorization were utilized. A lengthy description of this study and methods is described elsewhere (Mueller, 2005). Strauss et al (1985) observe that trajectories are not always linear processes: they are often redirected and redrawn by various biological and social contingencies.…”

“…Recruiting or enlisting the participation of patients involved a complex set of activities. While I have described some of the characteristics of trial enlistment elsewhere (Mueller, 2003;2005), a somewhat detailed account is presented here.…”

“…As previously reported (Mueller, 2005), informed consent was accomplished through the actions and interactions of research workers and patients. The informed consent procedure took place as scheduled appointments.…”