Regulation & oversight

News

Dome of US Capitol Building

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 logo stacked

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. 

News

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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Susan Wolf at podium for Research Ethics conference 2019

Annual Research Ethics Conference Examines Real-world Consequences of Policy Changes

March 7, 2019

Faculty, researchers, students and staff gathered in Coffman Theater on March 6 for the fourth annual, all-University Research Ethics Conference, Major Changes in Research Rules & Oversight: Making Progress or Creating New Problems? They were joined by several hundred webcast viewers. Three plenary speakers – Carrie D. Wolinetz of NIH, Pearl O'Rourke of Partners HealthCare Systems, Harvard Medical School and the All of Us Research Program, and Jeremy Wolfe of Harvard Medical School and Brigham and Women’s Hospital – each discussed an area of federal policy that has recently undergone changes. The final session was a panel of local experts who commented on the previous sessions and shared insights from their areas of specialty: Sue Abderholden (NAMI Minnesota) discussed the particulars of research participation of people with mental illness, Zubin Master (Mayo Clinic) raised bioethics questions about the new policies, particularly related to emerging areas like biohacking, and John E. Wagner (Masonic Cancer Center, Stem Cell Institute, University of Minnesota) described the practical challenges federal rules can present for researchers. The conference concluded with a lively question-and-answer period between panelists, plenary speakers and audience members. Videos of the conference can be viewed 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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Michael Imperiale

Video Now Available: Imperiale Describes Biosecurity Needs

March 18, 2019

On Feb. 28, Michael Imperiale (University of Michigan) shared the work of a committee he led that was tasked with outlining potential responses to new bioweapons. The lecture, which was part of the Consortium's series on Consumer-Driven and DIY Science, reviewed the recent history of US bioterrorism preparations, and described the opportunities and challenges presented by the emerging field of synthetic biology. Prof. Imperiale was joined by Michael Osterholm of CIDRAP, a Consortium member center, who added a policy perspective based on his expertise in infectious disease and public health. The moderator of the event, Amy Kircher of the Food Protection and Defense Institute (also a Consortium member), added insights from her experience as part of the national security apparatus. Video of the event is available here 

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Some Swedes are Early Adopters of Biohacking

November 7, 2018

According to a report from National Public Radio, "In Sweden, a country rich with technological advancement, thousands have had microchips inserted into their hands. The chips are designed to speed up users' daily routines and make their lives more convenient — accessing their homes, offices and gyms is as easy as swiping their hands against digital readers." On April 3, 2019, a free, public lecture and webcast will feature Prof. Lisa Ikemoto (UC Davis School of Law) discussing "Biohacking and Cyborg Rights." Her talk is part of this year's Consortium lecture series, "Consumer-driven and DIY Science," which will also feature Sharon Terry (Genetic Alliance) and Michael Imperiale (University of Michigan).

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Wolf, Evans Critique Recent National Academies' Return of Results Report

October 11, 2018

In an article appearing in the Oct. 12 issue of Science, Consortium Chair Susan M. Wolf and Barbara J. Evans of the University of Houston Law Center sound the alarm about a recent report from the National Academies of Sciences, Engineering, and Medicine. The Academies' report on "Returning Individual Research Results to Participants" makes recommendations on how to share research results and data with people who agree to participate in research studies and calls for problematic changes to federal law. In Science, Wolf and Evans argue that the Academies' recommendations are "rooted in confusion about the law." They maintain that "The Academies' report endorses the idea of participant access to results and data, but then builds daunting barriers. The report rejects established legal rights of access, two decades of consensus guidelines, and abundant data showing that participants benefit from access while incurring little risk. The report too often prefers paternalistic silence over partnership. . . . True progress on return of results requires accepting participants' established rights of access and respecting the value that participants place on broad access to their data and results. The next step is not to build barriers but to promote transparency." Read the entire Science article here

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Jessica Hellmann

IonE Among Recipients of NAFKI Challenge Grant

September 12, 2018

The National Academies of Sciences, Engineering and Medicine (NASEM) has awarded a NAFKI Challenge grant to a team including Jessica Hellmann (left) of the Insitute on the Environment and Bonnie Keeler of the Humphrey School of Public Affairs. The $500,000, two-year research project, “Institutionalizing Interdisciplinarity," will use sustainability science as the focus of an effort to create and model the infrastructure required to make research across multiple academic areas more common and effective. According to Prof. Hellmann, “Society needs science – and scientists – more than ever, because we need knowledge to confront our greatest societal and environmental challenges. But it takes a special kind of scientist, one who can work side by side with society, to bring about a better future. This project convenes the organizations and leaders who are creating and supporting this new kind of creator and doer. This group can change how science is done, why it is done, and for whom.” The Institute on the Environment (IonE) is a Consortium member, and represents the type of multidisciplinary research at the intersection of science and society the Consortium has pursued and supported since its founding in 2000.

Publication

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Why is DTC Genetic Testing Booming Despite a Lack of Privacy Protections?

June 21, 2018

An article published in Slate as part of their Future Tense project provides a valuable overview of the current state of privacy protections for those who use direct-to-consumer (DTC) genetic tests: "There’s a basic asymmetry at work in genetic testing: It takes just a few minutes to put some spit into a vial, sign a few disclosure forms, and pop your saliva in the mail. But that little bit of spit can yield volumes of deeply intimate data about your body. As Undark Magazine has reported in the past, that information can last for decades. It can be subpoenaed in court. It can be stolen. And it can be bundled and sold as a commodity. . . . Unlike genetic data collected in a hospital, the information that direct-to-consumer tests gather about you is not subject to the Health Insurance Portability and Accountability Act, or HIPAA, which places restrictions on how health care providers can share information about patients. State laws offer some regulations, but they vary widely from state to state." DTC genetic tests are among the topics being studied as part of the LawSeqSM project, for which Consortium chair Susan M. Wolf is one of the PIs; Barbara J. Evans (University of Houston Law Center), a member of the LawSeqSM working group, is quoted in the article. Learn more about the project here.

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Logo for Petrie Flom Center, Harvard Law School

Bill of Health Symposium Describes How to Improve Reproducibility

May 29, 2018

The Petrie-Flom Center of Harvard Law School has posted a symposium based on last March's national conference on research integrity and trustworthy science. The conference was the third annual all-University research ethics event, and was sponsored by the Office of the Vice President for Research, the Consortium and the Masonic Cancer Center. The symposium is introduced by Consortium Chair Susan M. Wolf and features perspectives by Prof. John P.A. Ioannidis (Stanford University), Prof. Barbara A. Spellman (University of Virginia) and Prof. C.K. Gunsalus (National Center for Professional and Research Ethics - NCPRE & University of Illinois). Videos of plenary talks and all conference sessions are available here

Publication

News

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. 

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Al Levine at podium, Research Integrity Conference 2018

Consortium-led Conference Charts a Path Toward Greater Research Integrity

March 15, 2018

In a recent KARE 11 interview, Consortium Chair Susan M. Wolf discussed current challenges to research integrity and described how they can be addressed. The news report hints at a larger set of issues that threaten to slow advances in knowledge and undermine the public’s trust in science. Last week, at the Research Integrity and Trustworthy Science conference, national experts in biomedicine, the social sciences, law, ethics, and more converged at the University of Minnesota to grapple with pressing research problems, including researcher misconduct, inadequate education of new researchers, predatory journals that fail to perform thorough peer review and oversight lapses. An article in Inquiry, the blog of the University of Minnesota Office of the Vice President for Research (VP Allen Levine is pictured), describes the conference proceedings and delves into the plenary sessions, which highlighted how research ethics rely on three parties: researchers, academic journals, and research institutions. Video of this year's sessions are available here. Information on previous annual Research Ethics conferences can be found here, here and here.  

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New Articles from Wolf, Evans on Genomics Research Ethics, Patient Rights

January 23, 2018

Two recently published articles, one written by Consortium Chair Susan M. Wolf and the other by LawSeqSM Working Group member Barbara J. Evans, grapple with important issues in genetic research ethics. The Wolf article, "The Continuing Evolution of Ethical Standards for Genomic Sequencing in Clinical Care: Restoring Patient Choice," outlines the complexities of setting policy to guide the management of incidental or secondary findings. She argues that the leading professional society for medical geneticists in the US, the American College of Medical Genetics and Genomics (ACMG), needs to change their current guideline to reflect empirically-based research on patient preferences regarding informed consent. In her commentary "HIPAA’s Individual Right of Access to Genomic Data: Reconciling Safety and Civil Rights," Prof. Evans applies the lens of civil rights law to a patient's right to view their own laboratory test results. Wolf and Evans are two of the most eminent legal scholars working on genomics research ethics; they were among the co-authors of the influential paper "Return of Genomic Results to Research Participants: The Floor, the Ceiling, and the Choices In Between."