Nanotechnology Research Ethics and Oversight

This 2-year project used breakthrough DNA nanotechnology to engineer and evaluate materials to address major health challenges and food system issues. We propose to use aptamer-amphiphiles as DNA nanotubes to target and treat Alzheimer’s disease and brain tumors, and as sensors to detect food allergens such as milk.
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.
This project aimed to identify oversight models for nanotechnology by assessing 6 historical oversight models: for drugs, devices, gene transfer, genetically engineered organisms in the food supply, chemicals in the workplace, and chemicals in the environment. The project brought together a multidisciplinary group of Investigators and senior personnel from the University of Minnesota, with strengths in nanotechnology research and development, public policy, law, health, environment, economics, and bioethics and involves outside collaborators representing a range of perspectives.

Related Publications

Fatehi L, Wolf SM, McCullough J, Hall R, Lawrenz F, Kahn JP, Jones C, Campbell SA, Dresser RS, Erdman AG, Haynes CL, Hoerr RA, Hogle LF, Keane MA, Khushf G, King NMP, Kokkoli E, Marchant G, Maynard AD, Philbert M, Ramachandran G, Siegel RA, Wickline S. Recommendations for Nanomedicine Human Subjects Research Oversight: An Evolutionary Approach for an Emerging Field. Journal of Law, Medicine & Ethics 2012;40(4):716-750. Download PDF (3.36 MB)
Fleege L, Lawrenz F. An Empirical Examination of the Current State of Publically Available Nanotechnology Guidance Materials. Journal of Law, Medicine & Ethics 2012;40(4):751-762. Download PDF (449.15 KB)
Hall RM, Sun T, Ferrari M. A Portrait of Nanomedicine and Its Bioethical Implications. Journal of Law, Medicine & Ethics 2012;40(4):763-779. Download PDF (387.03 KB)
Khushf G, Seigel RA. What is Unique About Nanomedicine: The Significance of the Mesoscale. Journal of Law, Medicine & Ethics 2012;40(4):780-794. Download PDF (326.98 KB)
Maurer-Jones MA, Haynes CL. Toward Correlation in In Vivo and In Vitro Nanotoxicology Studies. Journal of Law, Medicine & Ethics 2012;40(4):795-801. Download PDF (382.95 KB)
Dresser R. Building an Ethical Foundation for First-in-Human Nanotrials. Journal of Law, Medicine & Ethics 2012;40(4):802-808. Download PDF (203.81 KB)
Hogle LF. Concepts of Risk in Nanomedicine Research. Journal of Law, Medicine & Ethics 2012;40(4):809-822. Download PDF (306.63 KB)
King NMP. Nanomedicine First-in-Human Research: Challenges for Informed Consent. Journal of Law, Medicine & Ethics 2012;40(4):823-830. Download PDF (196.66 KB)
Marchant GE, Lindor RA. Prudent Precaution in Clinical Trials of Nanomedicines. Journal of Law, Medicine & Ethics 2012;40(4):831-840. Download PDF (239.63 KB)
Kimmelman J. Beyond Human Subjects: Risk, Ethics, and Clinical Development of Nanomedicines. Journal of Law, Medicine & Ethics 2012;40(4):841-847. Download PDF (179.83 KB)
Resnik DB. Responsible Conduct in Nanomedicine Research: Environmental Concerns Beyond the Common Rule. Journal of Law, Medicine & Ethics 2012;40(4):848-855. Download PDF (202.92 KB)
Ramachandran G, Howard J, Maynard A, Philbert M. Handling Worker and Third-Party Exposures to Nanotherapeutics During the Clinical Trails. Journal of Law, Medicine & Ethics 2012;40(4):856-864. Download PDF (232.96 KB)
Ramachandran G, Wolf SM, Paradise J, Kuzma J, Hall Kokkoli E, Fatehi L. Recommendations for Oversight of Nanobiotechnology: Dynamic Oversight for Complex and Convergent Technology. Journal of Nanoparticle Research 2011;13(4):1345-1371. Download PDF (339.75 KB)
Wang J, Asbach C, Fissan H, Hülser T, Kuhlbusch TAJ, Thompson D, Pui DYH. How Can Nanobiotechnology Oversight Advance Science and Industry: Examples From Environmental, Health and Safety Studies of Nanoparticles (Nano-EHS). Journal of Nanoparticle Research 2011;13(4):1373-1387. Download PDF (1.13 MB)