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Title: Building an Ethical Foundation for First-in-Human Nanotrials
Date: 12/2012
  Link to Journal Abstract
Abstract: 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 FIH nanotrials.
Non-technical Summary: 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 FIH nanotrials.
Content Emphasis Peer Reviewed Journal Article
Exposure Or Hazard Target Mammalian
Exposure Pathway Other/Unspecified
Method Of Study Other
Paper Type Commentaries
Particle Type Other/Unspecified
Production Method Engineered
Risk Exposure Group General Population
Target Audience Technical Research
Public Policy
Citation: The Journal of Law, Medicine & Ethics, 40(4): 802-808 (Winter 2012)
Publication: The Journal of Law, Medicine & Ethics
Author: Dresser R
Volume: 40
Number: 4
Pages: 802-808
     


Last updated on February 19, 2013
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This work is supported in part by the Nanoscale Science and Engineering Initiative of the National Science Foundation
under NSF Award Number EEC-0118007.

 		 
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