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

Principal investigator(s)

Susan M. Wolf, JD (University of Minnesota) 
Ellen Wright Clayton, MD, JD (Vanderbilt University)
Frances Lawrenz, PhD (University of Minnesota)

Read an article in Science, Return of Results and Data to Study Participants, by LawSeqSM Co-PI Susan M. Wolf and Working Group member Barbara J. Evans. This is the authors' version of the work. It is posted here by permission of the AAAS for personal use, not for redistribution. The definitive version was published in Science 362, (2018), doi: 10.1126/science.aav0005.

This innovative 3-year project, based cooperatively at the University of Minnesota and Vanderbilt University, has convened a national Working Group of top legal and scientific experts to analyze current US federal and state law and regulation on translational genomics and to generate consensus guidance on what the law should be. The federal Precision Medicine Initiative (PMI) aims to use genomics and other analyses to accelerate development of more powerful and tailored treatments for cancer and other diseases. Yet federal and state genomics law is unclear and poorly understood, presenting a major obstacle to progress. 

The project team will build a searchable online database of relevant law and an annotated bibliography for free public access, systematically collect and analyze a range of stakeholder inputs, convene a national public conference, and publish analyses and recommendations to help shape the law to support genomic medicine.

Project outcomes include: 

  • A resource-rich website that includes searchable databases of relevant federal and state laws and secondary sources;
  • Consensus recommendations on what genomics law should be in four key domains (liability, quality, privacy & access, and framework);
  • Publications by Working Group members offering further targeted analyses;
  • Empirical analyses of perceived legal issues facing genomics;
  • A national conference at the University of Minnesota on the law of genomics with archived videos available for free public access;
  • A national conference at Meharry Medical College on how law can support health equity in genomic medicine with archived videos for free public access;
  • A 2018 symposium in the Journal of Law, Medicine & Ethics on “The Future of Informed Consent in Research & Translational Medicine"; 
  • A 2019 symposium to be published in Ethnicity and Disease on “Law, Genomic Medicine & Health Equity: How Can Law Support Genomics and Precision Medicine to Advance the Health of Underserved Populations?; and
  • A 2020 symposium to be published in the Journal of Law, Medicine & Ethics on “LawSeqSM: Building a Legal Foundation for Translating Genomics Into Clinical Application.

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