Building an Ethical Foundation for First-in-Human Nanotrials
Washington University in Saint Louis - School of Law
Journal of Law, Medicine and Ethics, Vol. 40, No. 4, 2013
Washington University in St. Louis Legal Studies Research Paper No. 14-02-08
Novel nanomedical interventions require human testing to evaluate their safety and effectiveness. To establish a proper evidentiary basis for human trials, nanomedical innovations must first be subjected to animal and other laboratory testing. But it is uncertain whether the traditional laboratory approaches to safety evaluation will supply adequate information on nanotechnology risks to humans. This uncertainty, together with other features of nanomedical innovation, heightens the ethical challenges in conducting first-in-human nanotrials.
Accepted Paper Series
Date posted: March 1, 2014
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