Prudent Precaution in Clinical Trials of Nanomedicines

Journal of Law, Medicine and Ethics 40 (4):831-840 (2012)
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Abstract

Clinical trials of nanotechnology medical products present complex risk management challenges that involve many uncertainties and important risk-risk trade-offs. This paper inquires whether the precautionary principle can help to inform risk management approaches to nanomedicine clinical trials. It concludes that prudent precaution may be appropriate for ensuring the safety of such trials, but that the precautionary principle itself, especially in its more extreme forms, does not provide useful guidance for specific safety measures

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References found in this work

Toward understanding aspects of the precautionary principle.Carl F. Cranor - 2004 - Journal of Medicine and Philosophy 29 (3):259 – 279.
Balancing Uncertain Risks and Benefits in Human Subjects Research.Richard Barke - 2009 - Science, Technology, and Human Values 34 (3):337-364.
Ethics at Phase 0: Clarifying the Issues.Jonathan Kimmelman - 2007 - Journal of Law, Medicine and Ethics 35 (4):727-733.
The precautionary principle and the regulation of U.s. Food and drug safety.Ed Soule - 2004 - Journal of Medicine and Philosophy 29 (3):333 – 350.
Ethics at Phase 0: Clarifying the Issues.Jonathan Kimmelman - 2007 - Journal of Law, Medicine and Ethics 35 (4):727-733.

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