Prudent Precaution in Clinical Trials of Nanomedicines
Article first published online: 3 JAN 2013
© 2012 American Society of Law, Medicine & Ethics, Inc.
The Journal of Law, Medicine & Ethics
Special Issue: SYMPOSIUM 1: Nanodiagnostics and Nanotherapeutics: Building Research Ethics and Oversight
Volume 40, Issue 4, pages 831–840, Winter 2012
How to Cite
Marchant, G. E. and Lindor, R. A. (2012), Prudent Precaution in Clinical Trials of Nanomedicines. The Journal of Law, Medicine & Ethics, 40: 831–840. doi: 10.1111/j.1748-720X.2012.00711.x
- Issue published online: 3 JAN 2013
- Article first published online: 3 JAN 2013
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.