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Keeping Pace with the Science: Project Paves Way for Genomic Law

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Precision medicine is playing an increasingly important role in health care, bringing new possibilities to cancer treatment, rare disease diagnosis, cardiac care, and more through the use of genetic tools. Unfortunately, law and policy lag behind the rapid development of these tools, leaving many aspects of their use unclear, poorly understood, and contested.

University of Minnesota researchers are among those helping to map and shape the law around genomics. The LawSeq project, based cooperatively at the U of M and Vanderbilt University and funded by the National Institutes of Health, convened a national working group of top legal and scientific experts over the last three years to compile, collect, and analyze current federal and state laws and regulations on translational genomics. The project set out to provide guiding resources and build a solid foundation for the clinical integration of genomics tools.

LawSeq’s co-principal investigators are Susan Wolf, JD, chair of the U’s Consortium on Law and Values in Health, Environment, & the Life Sciences; Frances Lawrenz, PhD, associate vice president for research and professor of educational psychology in the College of Education and Human Development; and Ellen Wright Clayton, MD, JD, professor of law, health policy, and pediatrics at Vanderbilt University.

While many domains of law are separated from one another and rooted in longstanding (or even ancient) practices, Wolf said genomics law is different—it straddles many domains and therefore can’t rely on past precedent to guide it going forward.

“These are incredibly fast-moving, newly emerging technologies and patterns of analysis and clinical care,” she said. “What should law be doing? What should our regulators be doing?”

Among the many questions at hand are whether doctors are adequately trained to interpret genetic testing, when doctors might be liable for errors interpreting the implications of a test, and what privacy protections are in place for patients undergoing whole-genome sequencing, which maps out a person’s complete DNA.

The LawSeq project aims to solve these and other legal and policy issues in genomic medicine by focusing on four areas: liability protections, ensuring test quality, preserving patient access to test results and privacy, and clarifying the boundaries between research and clinical uses of DNA.

“How far we’ve come in moving from genetics, the study of single genes or small groups of genes, to genomics, where now we’re talking about and seeing integrated into clinical care the very large-scale analysis of the human genome,” Wolf said. “This is a huge challenge for law and policy.”

To help guide the law forward, the LawSeq project research team developed an online resource that includes searchable databases of relevant federal and state laws, along with secondary sources selected primarily from journals and professional society publications, to provide an entry point into the state of genomics law. The resource will be maintained and updated going forward.

Bringing the Experts Together

On Thursday, April 25—which happened to also be “National DNA Day”—the Consortium on Law and Values brought together top legal and scientific experts from across the country to grapple with gaps and areas of confusion in genomic law.

At the LawSeq Conference, the researchers, scientists, attorneys, bioethicists, and health care providers who made up the LawSeq working group recommended guidelines in genomic law for attendees to respond to and critique. Their goal was to help build a legal and policy foundation around genomics that would encourage the translation of genomic medicine from lab to clinic, allowing precision medicine to fulfill its massive potential to improve human health.

Ultimately, LawSeq’s working group will inform the development of law, policy, professional guidelines, and other resources that will help align fast-emerging genomic medicine with safe and ethical patient care.

Videos of all conference sessions will be available soon. Contact consortm@umn.edu to receive a notification when they are posted.

Kevin Coss

Kevin Coss

Kevin is a writer with the Office of the Vice President for Research.

coss@umn.edu

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