This project produced the first systematic and comprehensive recommendations on how to protect human participants in research on nanodiagnostics and nanotherapeutics, including drugs, devices, and gene therapy using nano-vectors. Research in nano-medicine is burgeoning, with research on human participants under way, but current research ethics and oversight have not yet adequately addressed key concerns including uncertainty about how to assess risks. The project group used normative, empirical, and policy analysis to evaluate current approaches to nanomedicine research ethics and oversight and generated much-needed recommendations on ethics standards and oversight processes.
09/30/09 to 07/31/12
- Susan M. Wolf, JD (Consortium on Law and Values in Health, Environment & the Life Sciences)
- Jeffrey McCullough, MD (Dept. of Laboratory Pathology)
- Ralph Hall, JD (Law)
- Jeffrey Kahn, PhD (Center for Bioethics)
- A national conference on "Nanodiagnostics and Nanotherapeutics: Building Research Ethics and Oversight."
- "Recommendations for Nanomedicine Human Subjects Research Oversight, An Evolutionary Approach for an Emerging Field" for researchers, research universities and institutions, private industry, NIH, FDA, OHRP, policymakers, and stakeholders including research participants themselves.
- A symposium published in the Winter 2012 issue of the Journal of Law, Medicine & Ethics.