The Challenge of Nanomedicine Human Subjects Research: Protecting Participants,Workers,Bystanders,and the Environment

45 C.F.R. part 46 (2011).

21 C.F.R. parts 50, 56 (2012).

See Wolf S. M. and Jones C. M. , “Designing Oversight for Nanomedicine Research in Human Subjects: Systematic Analysis of Exceptional Oversight for Emerging Technologies,” Journal of Nanoparticle Research 13, no. 4 (2011): 1449–1465.

See NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (NIH Guidelines), March 2013, available at <http://oba.od.nih.gov/oba/rac/Guidelines/NIH_Guidelines_new.pdf> (last visited October 15, 2012), amending NIH Guidelines for Research Involving Recombinant DNA Molecules (NIH Guidelines) (October 2011), available at <http://oba.od.nih.gov/oba/rac/Guidelines/NIH_Guidelines.pdf> (last visited October 15, 2012).

See id.

Etheridge M. L. Campbell S. A. , and Erdman A. G. , “The Big Picture on Nanomedicine: The State of Investigational and Approved Nanomedicine Products,” Nanomedicine: Nanotechnology, Biology, and Medicine (forthcoming 2013).

See Fleege L. and Lawrenz F. , “An Empirical Examination of the Current State of Publically Available Nanotechnology Guidance Materials,” Journal of Law, Medicine & Ethics 40, no. 4 (2012): 751–762.

See Consortium on Law and Values, available at <http://www.lifesci.consortium.umn.edu/newsevents/conferences/nanodiagnanother/home.html> (last visited October 15, 2012).

Fatehi L. Wolf S. M. , and McCullough J. , “Recommendations for Nanomedicine Human Subjects Research Oversight: An Evolutionary Approach for an Emerging Field,” Journal of Law, Medicine & Ethics 40, no. 4 (2012): 751–750.

See, e.g., Mandel G. N. , “Regulating Emerging Technologies,” Law, Innovation & Technology 1, no. 1 (2009): 75–92; Marchant G. E. Sylvester D. J. , and Abbott K. W. , “What Does the History of Technology Regulation Teach Us about Nano Oversight?” Journal of Law, Medicine & Ethics 37, no. 4 (2009): 724–731.

National Nanotechnology Initiative (NNI), NNI Budget, available at <http://www.nano.gov/about-nni/what/funding> (last visited September 18, 2012).

See, e.g., Wagner V. Dullaart A. , and Bock A.-K. , “The Emerging Nanomedicine Landscape,” Nature Biotechnology 24, no. 10 (2006): 1211–1217.