Rethinking Research Ethics: The Case of Postmarketing Trials

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Science  04 May 2012:
Vol. 336, Issue 6081, pp. 544-545
DOI: 10.1126/science.1216086

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From the Nuremberg Code onward, the core mission of human subjects research ethics has been to protect study participants from infringements motivated by a zeal for medical progress. However, with individuals, clinicians, and policymakers increasingly dependent on scientific information for decision-making and with vast social resources invested in developing and utilizing the fruits of research, actors have powerful incentives to coopt research for narrow ends. Contemplated revisions to human subjects research ethics policies in the United States (1) and existing policy in Canada (2) and the United Kingdom (3) fail to capture harms that, although they may not threaten participants, nonetheless undermine the social value of research. This is illustrated by postmarketing (phase IV) research. As a corrective, research ethics should focus on safeguarding the integrity of research as a critical component of an evidence-driven, health information economy.