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 has convened 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 widespread clinical integration, legal scholars need to help build the required legal foundation. Work is especially needed in 4 domains, the law of: LiabilityAccess to genomic results, Quality of sequencing and interpretation, and the overarching Framework clarifying when research rules versus clinical rules apply in translational genomics.

Aim 1 of this project is to build a searchable public online Database of state and federal statutes, regulation, case law, and official guidance, plus 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, and multiple search methods to build the Bibliography. The project team will work with a professional online-design firm to construct highly functional and easily accessed public resources.  

Aim 2 is to use mixed methods to generate rich inputs to inform a systematic Working Group process to generate consensus recommendations on what the law undergirding translational genomics should be.  The project will use a modified Delphi method to elicit views of Working Group experts on issue priorities. To capture a wide range of inputs from external stakeholders, the project will use a streamlined survey, interview, and outreach process. The team will use an online REDCap™ survey to identify the perspectives of investigators for NIH-funded translational genomics projects and their institutional legal counsel, plus semi-structured interviews with qualitative content analysis of the transcripts using NVivo software to capture the views of a subset of the investigators and legal counsel, plus genomics clinic directors, federal regulators, and state regulators in diverse states. The project team will also reach out to a wide range of additional identified stakeholders. 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 in our 4 issue areas of core concern, reporting to the full Working Group for feedback and project coordination. We will seek feedback on our recommendations from expert readers and through a major public conference. Project products will include: the online legal Database and Annotated Bibliography; 4 Task Force papers presenting consensus analysis and recommendations in our 4 domains of core concern; individual targeted articles; a videotaped public conference; a symposium issue of a peer-reviewed journal, collecting our publications; online access to our work; and wide dissemination.