Humphrey Institute of Public Affairs at University of Minnesota, USA.
J Law Med Ethics. 2009 Winter;37(4):546-86. doi: 10.1111/j.1748-720X.2009.00431.x.
The U.S. oversight system for genetically engineered organisms (GEOs) was evaluated to develop hypotheses and derive lessons for oversight of other emerging technologies, such as nanotechnology. Evaluation was based upon quantitative expert elicitation, semi-standardized interviews, and historical literature analysis. Through an interdisciplinary policy analysis approach, blending legal, ethical, risk analysis, and policy sciences viewpoints, criteria were used to identify strengths and weaknesses of GEOs oversight and explore correlations among its attributes and outcomes. From the three sources of data, hypotheses and broader conclusions for oversight were developed. Our analysis suggests several lessons for oversight of emerging technologies: the importance of reducing complexity and uncertainty in oversight for minimizing financial burdens on small product developers; consolidating multi-agency jurisdictions to avoid gaps and redundancies in safety reviews; consumer benefits for advancing acceptance of GEO products; rigorous and independent pre- and post-market assessment for environmental safety; early public input and transparency for ensuring public confidence; and the positive role of public input in system development, informed consent, capacity, compliance, incentives, and data requirements and stringency in promoting health and environmental safety outcomes, as well as the equitable distribution of health impacts. Our integrated approach is instructive for more comprehensive analyses of oversight systems, developing hypotheses for how features of oversight systems affect outcomes, and formulating policy options for oversight of future technological products, especially nanotechnology products.
美国对基因工程生物（GEOs）的监督体系进行了评估，以提出关于其他新兴技术（如纳米技术）监督的假设和经验教训。评估是基于定量专家征询意见、半标准化访谈和历史文献分析。通过跨学科的政策分析方法，融合法律、伦理、风险分析和政策科学观点，使用标准来确定 GEOs 监督的优缺点，并探讨其属性和结果之间的相关性。从这三个数据源中，我们提出了有关监督的假设和更广泛的结论。我们的分析为新兴技术的监督提出了一些经验教训：减少监督中的复杂性和不确定性对于减轻小型产品开发人员的财务负担至关重要；整合多机构管辖权，以避免安全审查中的空白和冗余；推进 GEO 产品接受度以实现消费者受益；严格和独立的上市前和上市后环境安全评估；早期公众投入和透明度以确保公众信心；以及公众投入在系统开发、知情同意、能力、合规、激励和数据要求以及促进健康和环境安全结果方面的严格性，以及公平分配健康影响方面的积极作用。我们的综合方法为更全面地分析监督体系、提出关于监督体系特征如何影响结果的假设以及制定未来技术产品（特别是纳米技术产品）监督的政策选择提供了有益的指导。
