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. DNA nanotubes have the potential to deliver compounds – such as nucleic acids – to the brain safely and efficiently, while aptamer-amphiphiles can detect milk with potentially ultrafast response time.
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

Kuzma J, Najmaie P, Larson J. Evaluating Oversight Systems for Emerging Technologies: A Case Study of Genetically Engineered Organisms. Journal of Law, Medicine & Ethics 2009;37(4):546-586. Download PDF (5.06 MB)
Johnson R. Commentary: Emerging Technologies Oversight: Research, Regulation and Commercialization. Journal of Law, Medicine & Ethics 2009;37(4):587-593. Download PDF (106.73 KB)
Paradise J, Tisdale AW, Hall RF, Kokkoli E. Evaluating Oversight of Human Drugs and Medical Devices: A Case Study of the FDA and Implications for Nanobiotechnology. Journal of Law, Medicine & Ethics 2009;37(4):598-624. Download PDF (1.79 MB)
Frankel MS. Commentary: Public Outreach by the FDA. Journal of Law, Medicine & Ethics 2009;37(4):625-628. Download PDF (81.46 KB)
Foote SB. Commentary: Evaluating Oversight of Human Drugs and Medical Devices. Journal of Law, Medicine & Ethics 2009;37(4):629-632. Download PDF (76.81 KB)
Choi JY, Ramachandran G. Review of the OSHA Framework for Oversight of Occupational Environments. Journal of Law, Medicine & Ethics 2009;37(4):633-650. Download PDF (1.41 MB)
Maynard AD. Commentary: Oversight of Engineered Nanomaterials in the Workplace. Journal of Law, Medicine & Ethics 2009;37(4):651-658. Download PDF (116.79 KB)
Wolf SM, Gupta R, Kohlhepp P. Gene Therapy Oversight: Lesson for Nanobiotechnology. Journal of Law, Medicine & Ethics 2009;37(4):659-684. Download PDF (356.46 KB)
Kahn JP. Commentary: Who's Afraid of the RAC? Lessons from the Oversight of Controversial Science. Journal of Law, Medicine & Ethics 2009;37(4):685-687. Download PDF (74.9 KB)
Paradise J, Wolf SM, Kuzma J, Kuzhabekova A, Tisdale AW, Kokkoli E, Ramachandran G. Developing U.S. Oversight Strategies for Nanoviotechnology: Learning from Past Oversight Experiences. Journal of Law, Medicine & Ethics 2009;37(4):688-705. Download PDF (706.77 KB)
Kimbrell GA. Governance of Nanotechnology and Nanomaterials: Principles, Regulation, and Renegotiating the Social Contract. Journal of Law, Medicine & Ethics 2009;37(4):706-723. Download PDF (335.86 KB)
Marchant GE, Sylvester DJ, Abbott KW. What Does the History of Technology Regulation Teach Us about Nano Oversight. Journal of Law, Medicine & Ethics 2009;37(4):724-731. Download PDF (143.36 KB)
Hogle LF. Science, Ethics, and the "Problems" of Governing Nanotechnologies. Journal of Law, Medicine & Ethics 2009;37(4):749-758. Download PDF (154.14 KB)
Priest SH. Risk Communication for Nanobiotechnology: To Whom, About What, and Why. Journal of Law, Medicine & Ethics 2009;37(4):759-769. Download PDF (187.68 KB)