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Prof. Francis Shen Offers Insights on Neurolaw in ABA Journal

June 10, 2020

The American Bar Association Journal recently spotlighted Professor Francis Shen’s work in a feature story about investment in neurolaw. Professor Shen’s Neurolaw Lab at the University of Minnesota Law School studies a range of issues including dementia, brain injury, and the law. He is also leading research on the challenges raised by emerging neuroimaging technology and is an Affiliate Faculty Member in the Consortium. Read more at the ABA Journal website.  

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Gene Patent Policy Under Review by Congress

June 6, 2019

A new article in Wired by Megan Molteni describes potentially momentous changes in the legal status of gene patents. According to Molteni, "In 2013, the Supreme Court unanimously struck down patents on two human genes – BRCA1 and BRCA2 – associated with breast and ovarian cancers. Justice Clarence Thomas wrote for the court at the time that isolated DNA 'is a product of nature and not patent eligible.' The historic decision invalidated patents held by Myriad Genetics" and opened the way for companies like 23andMe to offer direct-to-consumer tests of BRCA and other genes. A new bill making its way through Congress would make "changes to several sections of the statutes covering patent law and [add] a provision that would nullify the Supreme Court’s exceptions." The congressional debate is driven by concerns that overly stringent patent rules are hindering US companies from creating potentially lucrative new diagnostic tools, allowing rivals like China to outpace American innovation. Hearings are currently underway to clarify the intention of the bill and ensure it effectively addresses industry concerns. Read the entire Wired article here, and one on the same topic from GenomeWeb here. For more information about genomics law and policy, visit the NIH-funded LawSeqSM website, created by the Consortium in collaboration with Vanderbilt University. 

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LawSeq Conference Videos Now Available

May 29, 2019

Videos of all sessions of the LawSeqSM conference are now available. This event brought together an eminent group of scientists, researchers, attorneys and clinicians on the campus of the University of Minnesota to grapple with gaps and areas of confusion in genomic law. The symposium was part of the LawSeqSM project, an NIH-funded effort to shape the future of law and policy to encourage the translation of genomic medicine ​from lab to clinic. View the conference videos here. A related resource is the LawSeqSM genomic law website, which includes a searchable database of relevant state and federal law as well as articles and commentaries to provide context. 

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International Germline Editing Commission Launched

May 22, 2019

The US National Academies of Science, Engineering and Medicine and the Royal Society of the UK have announced the formation of an expert group to develop a framework to guide scientists, clinicians and regulators in their use of human germline genome editing. According to the release, "The commission is the latest action from the international science community to address issues around human genome editing. It follows [last November's] Second International Summit on Human Genome Editing in Hong Kong," where scientist He Jiankui shocked attendees by revealing the birth of twins whose genomes had been edited. Germline editing is of particular concern because genetic changes will be passed down to future generations, greatly expanding the potential for disastrous, unanticipated outcomes. “'These revelations at the summit in Hong Kong underscore the urgent need for an internationally accepted framework to help . . . address the complex scientific and medical issues surrounding clinical use of germline genome editing,' said NAM President Victor J. Dzau and Royal Society Vice-President John Skehel, co-chairs of the commission’s international oversight board, in a joint statement." The law and policy related to clinical uses of genomic medicine are among the topics addressed in the LawSeqSM project, co-led by Consortium Chair Susan M. Wolf. Learn more about relevant, existing regulations here

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Science, Wired Feature LawSeq Conference

May 1, 2019

Two major media outlets have run coverage of last week's LawSeqSM conference and webcast, held on the University of Minnesota campus. Science Magazine focused on the difficulty of accurately interpreting genomic variants, and the legal liability claims that could result. The article quotes Prof. James Evans (University of North Carolina), a member of the LawSeqSM working group: “The genome is static, but our ability to analyze it and interpret it is undergoing dramatic change. We don’t understand most of these variants, nor their potential impact on health and diseases . . . and we change our minds a lot, which is kind of frightening for patients.” In Wired Magazine, the writer homed in on genetic privacy, including observations by Mark Rothstein (University of Louisville), also a member of the working group. He stated, “In the US we have taken to protecting genetic information separately rather than using more general privacy laws, and most of the people who’ve looked at it have concluded that’s a really bad idea." Rothstein contrasted US laws and policy with those of the European Union, where DNA is treated as personal data. The LawSeqSM conference is part of an NIH-funded project to map the law of genomics for translation from laboratory into clinical settings. Learn more about LawSeqSM here

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Research Ethics Conference Videos Now Available

April 1, 2019

The fourth annual University of Minnesota Research Ethics Conference, held on March 6, explored how big changes in rules and oversight are affecting researchers and research participants. Recordings of all sessions – including plenary talks by Carrie D. Wolinetz (National Institutes of Health), Pearl O'Rourke (Partners HealthCare, Harvard Medical School, All of Us Research Program) and Jeremy Wolfe (Harvard Medical School, Brigham and Women’s Hospital) – can be viewed here. Videos of most Consortium events are archived on our YouTube channel at z.umn.edu/ConsortiumYouTube.

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Wolf Describes Policy Solutions for Future of Genomic Medicine

December 11, 2018

The November/December issue of Minnesota Medicine features PDF icon an article by Consortium Chair Susan M. Wolf about the legal and regulatory underpinnings needed to advance genomic medicine. It is part of a special issue on the future of medicine, and provides an overview of the NIH-funded LawSeqSM project Wolf co-leads with Ellen Wright Clayton (Vanderbilt University) and Frances Lawrenz (University of Minnesota). LawSeqSM is dedicated to analyzing current US federal and state law and regulation on translational genomics. Results of the effort will be the development of consensus guidance on what the law should be, as well as the creation of a website aggregating the statutes, regulations and case law related to genomic medicine. The Minnesota Medicine article was co-authored by Kathryn Grimes, Communications Director for the Consortium.

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Lisa Ikemoto

Spotlight on Emerging Legal Approaches to Cyborgs, Biohacking

October 4, 2018

A recent Star Tribune profile of Frances Shen, JD, describes his work in neurolaw, a field he has pioneered. Prof. Shen, an affiliate member of the Consortium, focuses on the intersection of brain science, law and policy. In his research, he uses advances in scanning and other technology to better understand the connections between the brain and human behavior. He notes, “Seeing the world through brain circuitry is a really foundational shift, not just for law, but for policy. . . . A hundred years ago we just had to guess how the mind was working. And we still have to make a lot of guesses. But we know a lot more than we did . . . and it would be nice if the law caught up.” Another take on emerging technologies and the law will be presented by Lisa Ikemoto, JD, LLM (University of California, Davis) on April 3, 2019. Her lecture, "Biohacking and Cyborg RightS: Coping with Promise and Peril," will describe the work of citizen scientists and others who are working outside of academic and institutional labs to enhance human capacity. Prof. Ikemoto will examine the implications of "cyborg rights" for law and for defining the human. Her lecture is part of a series, Consumer-Driven and DIY Science. Learn more and register here

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Susanna Blumenthal

Blumenthal Honored with Named Professorship

May 9, 2018

Prof. Susanna Blumenthal has been appointed to a prestigious named professorship at the University of Minnesota Law School, assuming the title of the William L. Prosser Professor of Law on May 4. She is an affiliate faculty member of the Consortium and a scholar of American legal history who is the author of Law and the Modern Mind: Consciousness and Responsibility in American Legal Culture, which is "a thoughtful study of American law’s confrontation with insanity during the 19th century." (Los Angeles Review of Books). Consortium chair Susan M. Wolf also holds a named professorship in the Law School, endowed by Faegre Baker Daniels LLP, as well as the McKnight Presidential Professorhip of Law, Medicine & Public Policy.

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New Symposium on Informed Consent in Research and Genomics

April 25, 2018

The newest issue of the Journal of Law, Medicine & Ethics is a symposium guest edited by Consortium chair Susan M. Wolf, Ellen Wright Clayton and Frances Lawrenz, Principal Investigators on the LawSeqSM project. The title is "The Future of Informed Consent in Research and Translational Medicine;" it was inspired by last year's Consortium-sponsored research ethics conference. Both the conference and the journal issue look back at the evolution of informed consent since the historic Schloendorff case was decided more than 100 years ago. It was in that opinion Justice Benjamin Cardozo declared that a competent adult “has a right to determine what shall be done with his own body” in what is now regarded as the foundational statement of a patient's right to self-determination. Read the entire issue here

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Louise Slaughter

Louise Slaughter, Lead Author of GINA, Passes Away

March 20, 2018

New York representative Louise M. Slaughter died last week at the age of 88. She was trained as a microbiologist and was one of the longest-service members of the US House of Representatives. Among her many accomplishments was serving as lead author of the Genetic Information Nondiscrimination Act (GINA) of 2008. This landmark legislation protects individuals from genetic discrimination in health insurance and employment; it was designed to help ease discrimination concerns that might keep people from getting genetic tests that could benefit their health. The law also enables people to take part in research studies without fear that their DNA information might be used against them in health insurance or the workplace. According to Eric Green of the National Human Genome Research Institute (NHGRI), "We have truly lost a genomics champion. Louise Slaughter had the vision that GINA was needed to ensure continued advances in genetics and genomics research, especially for clinical applications — and she was completely right. Our research community will remember her commitment to these important social and ethical issues." GINA is among the laws that will be accessible via the website of the NHGRI-funded LawSeqSM project, for which Consortium chair Susan M. Wolf is Co-PI with Ellen Wright Clayton of Vanderbilt and Frances Lawrenz of the University of Minnesota. LawSeqSM is dedicated to building a legal foundation for translating genomics into clinical application; the website will go live in spring, 2018.