Ethical variability: Drug development and globalizing clinical trials by Adriana Petryna, New School University

Published in American Ethnologist  Volume 32 Number 2 May 2005 Globalizing_Clinical_Trials (download pdf)

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.