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.
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Mary-Rose Mueller (2005) studied this question.
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