Beyond Human Subjects: Risk, Ethics, and Clinical Development of Nanomedicines
Version of Record 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 841–847, Winter 2012
How to Cite
Kimmelman, J. (2012), Beyond Human Subjects: Risk, Ethics, and Clinical Development of Nanomedicines. The Journal of Law, Medicine & Ethics, 40: 841–847. doi: 10.1111/j.1748-720X.2012.00712.x
- Issue online: 3 JAN 2013
- Version of Record online: 3 JAN 2013
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.