Nanomedicine First-in-Human Research: Challenges for Informed Consent
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 823–830, Winter 2012
How to Cite
King, N. M. P. (2012), Nanomedicine First-in-Human Research: Challenges for Informed Consent. The Journal of Law, Medicine & Ethics, 40: 823–830. doi: 10.1111/j.1748-720X.2012.00710.x
- Issue published online: 3 JAN 2013
- Article first published online: 3 JAN 2013
Risks of harm, translational uncertainty, ambiguities in potential direct benefit, and long-term follow-up merit consideration in first-in-human research. Some nanomedical technologies have additional characteristics that should be addressed, including: defining and describing nanomedical interventions; bystander risks; the therapeutic misconception; and a decision-making context that includes both common use of nanomaterials outside medicine and persistent unknowns about the effects of nanosize. This paper considers how to address these issues in informed consent to first-in-human nanomedicine research.