Beyond Human Subjects: Risk, Ethics, and Clinical Development of Nanomedicines

Journal of Law, Medicine and Ethics 40 (4):841-847 (2012)
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Abstract

Clinical testing of nanomedicines presents two challenges to prevailing, human subject-centered frameworks governing research ethics. First, some nanomedical applications may present risk to persons other than research subjects. Second, pressures encountered in testing nanomedicines may present threats to the kinds of collaborations and collective activities needed for supporting clinical translation and redeeming research risk. In this article, I describe how similar challenges were encountered and addressed in gene transfer, and sketch policy options that might be explored in the nanomedicine translation arena

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10.1111/j.1748-720x.2012.00712.x

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RAC Oversight of Gene Transfer Research: A Model Worth Extending?Nancy M. P. King - 2002 - Journal of Law, Medicine and Ethics 30 (3):381-389.
Medical research, risk, and bystanders.Jonathan Kimmelman - 2005 - IRB: Ethics & Human Research 27 (4):1.

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