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Experimentality: On the Global Mobility and Regulation of Human Subjects Research
Author(s) -
Petryna Adriana
Publication year - 2007
Publication title -
polar: political and legal anthropology review
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.529
H-Index - 27
eISSN - 1555-2934
pISSN - 1081-6976
DOI - 10.1525/pol.2007.30.2.288
Subject(s) - outsourcing , transparency (behavior) , clinical trial , politics , offshoring , ethnography , political science , public relations , business , sociology , medicine , law , pathology , anthropology
The outsourcing and offshoring of clinical trials has generated an unprecedented global field of experimental activity. The geography of drug development and clinical trial participation is changing, but estimates of trials being carried out worldwide remain tentative at best. This essay charts the mobility of the clinical trials industry and its move into low‐ and middle‐income countries. It explores how subcontracted scientists and entrepreneurs who make up this industry interact with regulatory bodies in the United States and abroad, particularly in eastern Europe, where I carried out ethnographic research. The essay illuminates the scientific, economic, and regulatory mechanisms by which this experimentality takes form. It shows the transparency of this experimental enterprise and how it molds itself to international norms and national politics. There is a public policy vacuum with regard to how benefits and risks are being assessed in this new enterprise.