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

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.