NIRT: Evaluating Oversight Models for Active Nanostructures and Nanosystems: Learning from Past Technologies in a Societal Context

纳米结构跨学科研究团队(NIRT)奖是对积极的纳米结构和纳米系统(ANN)征集(NSF 05-610)以及与长期纳米科学和工程进步相关的社会和教育问题的主题的回应。设计用于生物系统或从生物分子(包括仿生纳米结构界面)衍生纳米材料的纳米技术应用正在增加。这些应用大有可为，但缺乏对纳米技术监管模型的严格分析。政府机构、研究人员和工业界正在积极努力解决什么样的监督方案适用于不同种类的纳米技术的问题。该项目通过评估6种历史监督模式确定了在发展对纳米技术的监督方面需要解决的关键问题：药物、设备、基因转移、食品供应中的基因工程生物、工作场所的化学品和环境中的化学品。该项目汇集了来自明尼苏达大学的多学科研究人员和高级人员，他们在纳米技术研究和开发、公共政策、法律、卫生、环境、经济和生物伦理学方面具有优势，并将涉及代表一系列观点的外部合作者。项目组将整合分析方法和评估标准，以历史和比较的方式评价这些监督模式，并将整合研究结果，为纳米技术的新应用汲取经验教训。该项目将分3个阶段进行：(1)通过(A)收集文献，(B)制定评估标准，(C)应用标准，以及(D)比较6种模式的发展、属性和结果，对6种历史监管模式进行评估；(2)将模式映射到纳米技术，以使工作组就可行的纳米技术监管模式达成共识；(3)通过情景分析，研究建议如何适用于特定的纳米产品，邀请反馈，并公开介绍建议，以完善关于纳米产品监管的建议。项目团队将提供关于监督评估的新思维，融合法律、生物伦理学和公共政策方法的理论、方法和想法，为政策制定者、决策者、研究人员、行业、患者、研究对象、消费者和公众提供指导。该项目将首次对与纳米技术有关的6项关键技术的监督模式进行综合评估。该项目的产品将包括：(1)出版个人撰写的分析6种历史监督模式的论文；(2)出版审查6种模式的监督模式的比较工作；(3)出版小组撰写的关于纳米技术监督经验教训的共识文件；(4)通过硬拷贝和丰富的网上资源广泛传播政策分析和规范性监督建议；(5)在明尼苏达大学主办一次公开会议，提交文件并征求公众反馈；以及(6)由调查人员在外部会议上介绍项目工作。这些产品将推动对纳米技术监督机制的讨论，主动确定关切和问题。该项目及其产品将引起研究人员、科学家、联邦机构、企业利益相关者、律师、学者、法官、立法者、政策制定者和普通公众的兴趣。该项目将为研究生和专业学生提供与项目团队互动、进行研究、参加小组会议和参加有针对性的研讨会的机会。休伯特·H·汉弗莱公共事务学院将举办一系列研讨会，作为本科生和研究生的课程选项，并与法学院和其他项目交叉注册。PIS还将努力将这一项目与K-12社区的科学教育需求联系起来。

This Nanostructure Interdisciplinary Research Team (NIRT) award is in response to the Active Nanostructure and Nanosytems (ANN) solicitation (NSF 05-610) and the theme of Societal and Educational Issues Associated with Long-Term Nanoscale Science and Engineering Advances. Nanotechnology applications designed for use in biological systems or in which nanomaterials are derived from biological molecules (including biomimetic nanostructured interfaces) are increasing. These applications hold great promise, yet rigorous analysis of models for nanotechnology oversight is lacking. Government agencies, researchers, and industry are actively struggling with the question of what oversight schemes are appropriate for different sorts of nanotechnology. This project identifies key issues to address in developing oversight for nanotechnology by assessing 6 historical oversight models: for drugs, devices, gene transfer, genetically engineered organisms in the food supply, chemicals in the workplace, and chemicals in the environment. The project brings together a multidisciplinary group of Investigators and Senior Personnel from the University of Minnesota, with strengths in nanotechnology research and development, public policy, law, health, environment, economics, and bioethics and will involve outside collaborators representing a range of perspectives. The project team will integrate methods of analysis and criteria for assessment to evaluate these oversight models using a historical and comparative approach and will integrate findings to glean lessons for emerging applications of nanotechnology. This project will proceed in 3 phases: (1) evaluation of 6 historical oversight models by (a) collecting the literature, (b) developing assessment criteria, (c) applying the criteria, and (d) comparing the development, attributes, and outcomes of the 6 models; (2) mapping the models onto nanotechnology to achieve Working Group consensus on workable oversight models for nanotechnology; and (3) refining the recommendations on oversight for nanoproducts through scenario analysis examining how the recommendations would apply to specific nanoproducts, invited feedback, and public presentation of the recommendations. The project team will provide fresh thinking on oversight assessment, blending theory, methods, and ideas from legal, bioethics, and public policy approaches to offer guidance to policymakers, decisionmakers, researchers, industry, patients, research subjects, consumers, and the public. This project will provide the first integrative assessment of oversight models of 6 key technologies germane to nanotechnology. Products of this project will include (1) publication of individually authored papers analyzing the 6 historical oversight models; (2) publication of comparative work examining oversight models across the 6 models; (3) publication of a group-authored consensus paper on lessons for nanotechnology oversight; (4) wide dissemination of policy analysis and normative oversight recommendations through hard-copy and rich web-based resources; (5) a public conference hosted at the University of Minnesota to present papers and seek public feedback; and (6) presentation of project work by Investigators at outside conferences. The products will advance discussion of oversight mechanisms for nanotechnology, proactively identifying concerns and issues. The project and its products will be of interest to researchers, scientists, federal agencies, corporate stakeholders, lawyers, academics, judges, legislators, policymakers, and the general public. The project will provide opportunities for graduate and professional students to interact with the project team, undertake research, attend group meetings, and participate in targeted workshops. A workshop series will be developed as a course option for both undergraduates and graduate students within the Hubert H. Humphrey Institute of Public Affairs, with cross-registration from the Law School and other programs. The PIs will also endeavor to link this project with science education needs in the K-12 community.