Gene Therapy Oversight: Lessons for Nanobiotechnology

Authors

  • Susan M. Wolf,

    1. McKnight Presidential Professor of Law, Medicine & Public Policy; Faegre & Benson Professor of Law; Professor of Medicine; and Faculty Member in the Center for Bioethics at the University of Minnesota.
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  • Rishi Gupta,

    1. Holds an M.S. in Applied Physics from the University of Texas at Dallas and a J.D. from the University of Minnesota Law School. He is currently an Associate at Fish and Richardson PC. in Dallas, Texas.
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  • Peter Kohlhepp

    1. Received his J.D. from the University of Minnesota Law School in May 2009. He is currently an Associate at Carlson, Caspers, Vandenburgh and Lindquist in Minneapolis.
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Abstract

Oversight of human gene transfer research (“gene therapy”) presents an important model with potential application to oversight of nanobiology research on human participants. Gene therapy oversight adds centralized federal review at the National Institutes of Health's Office of Biotechnology Activities and its Recombinant DNA Advisory Committee to standard oversight of human subjects research at the researcher's institution (by the Institutional Review Board and, for some research, the Institutional Biosafety Committee) and at the federal level by the Office for Human Research Protections. The Food and Drug Administration's Center for Biologics Evaluation and Research oversees human gene transfer research in parallel, including approval of protocols and regulation of products. This article traces the evolution of this dual oversight system; describes how the system is already addressing nanobiotechnology in gene transfer: evaluates gene therapy oversight based on public opinion, the literature, and preliminary expert elicitation; and offers lessons of the gene therapy oversight experience for oversight of nanobiotechnology.

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