Faculty Member in Center for Bioethics at University of Minnesota, USA.
J Law Med Ethics. 2009 Winter;37(4):659-84. doi: 10.1111/j.1748-720X.2009.00439.x.
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.
人类基因转移研究（“基因治疗”）的监督为监督人类参与者的纳米生物技术研究提供了一个重要的模型。基因治疗监督在国立卫生研究院的生物技术活动办公室及其重组 DNA 咨询委员会中增加了集中的联邦审查，以对研究人员机构中的人类受试者研究进行标准监督（由机构审查委员会和机构生物安全委员会进行，对于某些研究），并由人类研究保护办公室在联邦一级进行监督。食品和药物管理局的生物制品评价和研究中心同时监督人类基因转移研究，包括批准方案和监管产品。本文追溯了这一双重监督系统的发展；描述了该系统如何已经在解决基因转移中的纳米生物技术问题：根据公众意见、文献和初步专家意见评估基因治疗监督；并为纳米生物技术的监督提供了基因治疗监督经验的教训。
