title: Gene therapy oversight: lessons for nanobiotechnology.
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.
authors.affiliation: Faculty Member in Center for Bioethics at University of Minnesota, USA.
authors.forename: Susan M
authors.initials: SM
authors.lastname: Wolf
authors.forename: Rishi
authors.initials: R
authors.lastname: Gupta
authors.forename: Peter
authors.initials: P
authors.lastname: Kohlhepp
mesh_terms: D026683:Advisory Committees; D032921:Consensus; D004274:DNA, Recombinant / Q000266:history; D017277:Drug Approval; D018014:Gene Transfer Techniques; D015316:Genetic Therapy / Q000266:history / Q000331:legislation & jurisprudence*; D033161:Government Regulation / Q000266:history; D049673:History, 20th Century; D006801:Humans; D053758:Nanoparticles; D036103:Nanotechnology / Q000331:legislation & jurisprudence*; D009316:National Institutes of Health (U.S.); D019982:Organizational Case Studies; D017712:Peer Review, Research; D011050:Policy Making; D011639:Public Opinion; D012196:Review Literature as Topic; D052416:Targeted Gene Repair / Q000331:legislation & jurisprudence; D013673:Technology Assessment, Biomedical; D014481:United States; D014486:United States Food and Drug Administration
chemical_list: D004274:DNA, Recombinant