Seton Hall University School of Law, USA.
J Law Med Ethics. 2009 Winter;37(4):688-705. doi: 10.1111/j.1748-720X.2009.00441.x.
The emergence of nanotechnology, and specifically nanobiotechnology, raises major oversight challenges. In the United States, government, industry, and researchers are debating what oversight approaches are most appropriate. Among the federal agencies already embroiled in discussion of oversight approaches are the Food and Drug Administration (FDA), Environmental Protection Agency (EPA), Department of Agriculture (USDA), Occupational Safety and Health Administration (OSHA), and National Institutes of Health (NIH). All can learn from assessment of the successes and failures of past oversight efforts aimed at emerging technologies. This article reports on work funded by the National Science Foundation (NSF) aimed at learning the lessons of past oversight efforts. The article offers insights that emerge from comparing five oversight case studies that examine oversight of genetically engineered organisms (GEOs) in the food supply, pharmaceuticals, medical devices, chemicals in the workplace, and gene therapy. Using quantitative and qualitative analysis, the authors present a new way of evaluating oversight.
纳米技术的出现，特别是纳米生物技术的出现，带来了重大的监督挑战。在美国，政府、工业界和研究人员正在争论哪种监督方法最合适。已经参与监督方法讨论的联邦机构包括美国食品和药物管理局（FDA）、美国环境保护署（EPA）、美国农业部（USDA）、职业安全与健康管理局（OSHA）和美国国立卫生研究院（NIH）。所有这些机构都可以从评估旨在监管新兴技术的过去监督工作的成败中吸取教训。本文报告了由美国国家科学基金会（NSF）资助的旨在吸取过去监督工作经验教训的工作。本文从比较五个监督案例研究中提供了一些见解，这些案例研究考察了对食品供应、药品、医疗器械、工作场所化学品和基因治疗中基因工程生物（GEO）的监督。作者使用定量和定性分析，提出了一种评估监督的新方法。
