Ethical variability: Drug development and globalizing clinical trials

被引:130
作者
Petryna, A [1 ]
机构
[1] New Sch Univ, Grad Fac Polit & Social Sci, Dept Anthropol, New York, NY 10003 USA
关键词
global pharmaceuticals; bioethics; clinical trials; human subjects; research ethics; governance; biological citizenship;
D O I
10.1525/ae.2005.32.2.183
中图分类号
Q98 [人类学];
学科分类号
030303 ;
摘要
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].
引用
收藏
页码:183 / 197
页数:15
相关论文
共 93 条
[1]  
ALDEN E, 2004, FINANCIAL TIMES 0610, P3
[2]  
Anderson Warwick., 2003, CULTIVATION WHITENES
[4]   The ethics of clinical research in the Third World [J].
Angell, M .
NEW ENGLAND JOURNAL OF MEDICINE, 1997, 337 (12) :847-849
[6]   World Medical Association Declaration of Helsinki Ethical Principles for Medical Research Involving Human Subjects [J].
JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION, 2013, 310 (20) :2191-2194
[7]  
[Anonymous], 2000, TANNER LECT HUMAN VA
[8]  
[Anonymous], 1999, Against Relativism: Cultural Diversity and the Search for Ethical Universals in Medicine
[9]  
[Anonymous], CRITICAL EVENTS ANTH
[10]  
[Anonymous], 2000, Living and Working with the New Medical Technologies