LawSeq: Building a Sound Legal Foundation for Translating Genomics into Clinical Application

 描述(由申请人提供)：位于明尼苏达大学和范德比尔特大学的为期3年的R01课程将召集一个由顶尖法律和科学专家组成的全国工作组，分析当前美国联邦和州关于翻译基因组学的法律、法规和指南，并就法律应该是什么产生共识建议，以优化基因组学成功地转化为临床应用。基因组学背后的规律目前还不清楚，人们对此知之甚少，也存在争议。由于这项技术现在正准备广泛的临床整合，法律学者需要与基因组学专家合作，建立所需的法律基础。尤其需要在四个领域开展工作：责任、测序和解释的质量、隐私和获得基因组结果的机会，以及澄清何时适用研究规则与临床规则的总体框架。这个项目的第一个目标是建立一个可搜索的公共在线数据库，包括州和联邦法规、法规、判例法，以及官方指导和标准，以及核心文献的注释书目--当前基因组学法律是什么的地图。该项目将使用既定的法律搜索方法和分析来构建数据库，与专业的网页设计公司合作，构建一个功能强大、耐用和免费的公共资源。我们将使用多种搜索方法来建立书目，将其发布在网上供免费访问。目标2是使用混合的方法来确定利益攸关方对法律的看法，并产生丰富的投入，为工作组的系统性进程提供信息，就支撑翻译基因组学的法律应该是什么产生共识建议。在一名资深社会科学家的领导下，该小组将使用改进的德尔菲法，征求工作组专家对问题优先事项的意见。为了系统地收集广泛的利益攸关方对问题和潜在解决方案的意见，该项目将使用简化的调查和面谈程序。我们将使用在线RedCap(Tm)调查来确定NIH资助的基因组学调查人员、法律顾问、行业代表、基因组学诊所主任、专业协会领导人和政府当局的观点。我们还将进行半结构化访谈，并对文字记录进行定性的内容分析，以更全面地收集法律顾问和政府当局样本的意见。根据这些丰富的投入，工作组将开展一个在法律和生物伦理方面行之有效的系统的分析和建立共识的进程。4个工作队中的每一个都将产生协商一致的建议，并向工作组全体成员报告，以便进行反馈和项目协调。我们将征求部分调查和访谈受访者以及其他专家读者对我们建议的反馈意见，并通过一个重要的公开会议征求意见。项目产品将包括：在线法律数据库和附注书目、工作队的4份具有共识分析和建议的文件、个别有针对性的文章、出版的经验分析、一次录像公开会议、一期同行评议期刊的专题讨论会，介绍项目出版物、在线获取我们的工作，以及广泛传播。

 DESCRIPTION (provided by applicant): This 3-year R01 based at the University of Minnesota and Vanderbilt University will convene a national Working Group of top legal and scientific experts to analyze current U.S. federal and state law, regulation, and guidance on translational genomics, and to generate consensus recommendations on what the law should be, to optimize successful translation of genomics into clinical use. The law underlying genomics is currently unclear, poorly understood, and contested. As this technology is now poised for wide clinical integration, legal scholars need to work with genomics experts to build the required legal foundation. Work is especially needed in 4 domains, the law of: Liability, Quality of sequencing and interpretation, Privacy & Access to genomic results, and the overarching Framework clarifying when research rules vs. clinical rules apply. Aim 1 of this project is to build a searchable public online Database of state and federal statutes, regulation, case law, plus official guidance and standards, and an Annotated Bibliography of core literature-a map of what current genomics law "is." The project will use established legal search methods and analysis to construct the Database, working with a professional web design firm to construct a highly functional, durable, and free public resource. We will use multiple search methods to build the Bibliography, posting it online for free access. Aim 2 is to use mixed methods to ascertain stakeholder views of the law and generate rich inputs to inform a systematic Working Group process generating consensus recommendations on what the law undergirding translational genomics should be. Led by a senior social scientist, the team will use a modified Delphi method to elicit views of Working Group experts on issue priorities. To systematically capture a wide range of stakeholder views on issues and potential solutions, the project will use a streamlined survey and interview process. We will use an online REDCap(tm) survey to identify the perspectives of NIH-funded genomics investigators, legal counsel, industry representatives, genomics clinic directors, professional society leaders, and government authorities. We will also conduct semi-structured interviews with qualitative content analysis of the transcripts to capture more fully the views of a sample of legal counsel and government authorities. Informed by these rich inputs, the Working Group will pursue a structured process of analysis and consensus building that is well-established in law and bioethics. Each of 4 Task Forces will generate consensus recommendations, reporting to the full Working Group for feedback and project coordination. We will seek feedback on our recommendations from a subset of survey and interview respondents plus other expert readers, and through a major public conference. Project products will include: the online legal Database and Annotated Bibliography, 4 Task Force papers with consensus analysis and recommendations, individual targeted articles, published empirical analyses, a videotaped public conference, a symposium issue of a peer-reviewed journal presenting project publications, online access to our work, and wide dissemination.