Ethical Variability: An Anthropological Study of the Human Subjects Research Industry

FAIN: FA-50473-04

Adriana Petryna
University of Pennsylvania (New York, NY 10011-8871)

Accelerated drug development has occasioned a thriving global human subjects research industry. This projects considers the co-evolution of commercial environments for clinical research and ethical and regulatory environments as they contribute to a dramatic growth of human subjects involvement in research. Specifically, it focuses on the operations of North American contract research organizations (CRO's), and the ways in which they expedite drug development to low-income societies. I am especially concerned with how these trans-state actors interact with government regulatory institutions in the United States, and how they recast international ethical guidelines as they organize trials for research subjects abroad. Through multi-sited analysis, this work identifies the tactical role of ethics, or what I call ethical variability, in the regulation and oganization of commercial clinical trials. It elucidates how variability works in the interface of accelerated drug development, local public health crises, and international regulatory institutions. More broadly, it considers debates on changing social and moral contracts underpinning human research in globalized scientific settings. Applying insights from the humanities and social sciences, it moves beyond the current mood of mistrust of the research enterprise and enlarges the scope of debate on ethical responsibility in a fundamentally utilitarian sphere.

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