Experimentality

On the Global Mobility and Regulation of Human Subjects Research

Datos Bibliográficos

ID2480641
AutoresA Petryna (0000-0002-8952-7559)
Año2007
Volumen30
Número2
Páginas288-304
Fecha de publicación2007-11-01
Peer ReviewedSí
Open AccessSí
TipoARTICLE
RevistaPoLAR Political and Legal Anthropology Review (JOURNAL)
Identificadores de la revistaISSN: 1081-6976 • E-ISSN: 1555-2934
EditorialWiley (PUBLISHER • GB)
DOI10.1525/pol.2007.30.2.288
OpenAlexW2156448506
IdiomaEN
Citas recibidas32
Referencias citadas14

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

Biomedical Ethics and Regulation · Ethics in Clinical Research · Global Health and Surgery