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Posted: Sep 07, 2011

Conference on building human subjects research oversight for nanomedicine products

(Nanowerk News) The University of Minnesota's Consortium on Law and Values in Health, Environment & the Life Sciences will host a groundbreaking conference on "Nanodiagnostics and Nanotherapeutics: Building Research Ethics & Oversight" from 8:30 a.m. to 4:45 p.m., on Monday, Sept. 26, 2011 in Minneapolis, MN.
The conference is supported by a grant from the National Human Genome Research Institute (NHGRI), National Institutes of Health (NIH). This grant funds a 2-year project that was convened to develop the first systematic and comprehensive recommendations on protecting human participants in research on nanomedicine products, including drugs, devices, and gene therapy using nano-vectors. University of Minnesota professor Susan M. Wolf, JD is the Principal Investigator. Co-Investigators include U of M professors Jeffrey McCullough, MD and Ralph F. Hall, JD, and Jeffrey Kahn, PhD, MPH, from Johns Hopkins University.
Nanomedicine research in human subjects is at the forefront of new challenges to research ethics posed by advanced technologies. Nanomedicine research raises significant questions about how to protect human subjects, especially in first-in-human (FIH) trials. But the challenges are even bigger--how to protect researchers, lab workers, bystanders who may be exposed to nanomaterials in the course of research, and the environment.
The September 26 conference will begin with an address by Mihail C. Roco, PhD, Senior Advisor for Nanotechnology at the National Science Foundation (NSF) and Founding Chair of the U.S. National Science and Technology Council (NSTC) Subcommittee on Nanoscale Science, Engineering and Technology (NSET). This will be followed by a keynote session on the translation of nanotherapeutics and nanodiagnostics to clinical practice presented by Samuel Wickline, MD, Washington University School of Medicine. Prof. Andrew Maynard, PhD, from the University of Michigan, will present on challenges posed by nanomedicine research in human subjects. The project investigators will present to conference attendees recommendations on human subjects research oversight for nanomedicine. A panel of experts, including John Howard, MD, MPH, JD, LLM, National Institute for Occupational Safety and Health (NIOSH), Centers for Disease Control and Prevention (CDC), U.S. Department of Health and Human Services (DHHS); Jerry Menikoff, MD, JD, MPP, Office for Human Research Protections (OHRP), DHHS; Prof. R. Alta Charo, JD, University of Wisconsin, Madison; and Warren Lux, MD, U.S. Environmental Protection Agency (EPA) will provide their reactions to the recommendations, before opening up the discussion to the audience. Afternoon break-out sessions will focus on defining the core risks of nanomedicine human subjects research, issues presented by first-in human research, approaches to human subjects protection, and oversight concerns beyond the human participant.
The Consortium on Law and Values in Health, Environment & the Life Sciences links together 19 University-wide centers, crossing nearly all colleges at the University of Minnesota. The Consortium performs groundbreaking research, develops cutting-edge programming, and trains new leaders in law, health, and the life sciences. For more information, visit
Source: University of Minnesota
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