4.3 Article

Ethical variability: Drug development and globalizing clinical trials

Journal

AMERICAN ETHNOLOGIST
Volume 32, Issue 2, Pages 183-197

Publisher

WILEY
DOI: 10.1525/ae.2005.32.2.183

Keywords

global pharmaceuticals; bioethics; clinical trials; human subjects; research ethics; governance; biological citizenship

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The rapid growth of pharmaceutical markets has Led to increased demands for human subjects for drug research, particularly in Low-income countries. For regulatory, economic, and even biological reasons, new populations are being pursued as human subjects for pharmaceutical trials. In this article I consider the evolution of commercialized clinical trials and ethical and regulatory environments as they contribute to a dramatic growth of human-subjects involvement in research. I focus on the operations of U.S.-based contract research organizations (CROs), which make up a specialized global industry focusing on human-subjects recruitment and research and the on ways in which they expedite drug testing to Low-income contexts. Specifically, I analyze how these transstate actors interact with regulatory authorities in the United States and how they recast international ethical guidelines as they organize trials for research subjects abroad. [global pharmaceuticals, bioethics, clinical trials, human subjects, research ethics, governance, biological citizenship].

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