Regulation & oversight

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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." 

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Jeffrey Kahn

Are Bioethicists Keeping Pace with Rapid Changes in Gene Editing?

January 17, 2018

Jeffrey Kahn, Director of the Berman Institute of Bioethics at Johns Hopkins University, joined Minnesota Public Radio host Kerri Miller today to discuss innovations in gene editing and the consequences that must be considered as it moves into clinical application. New tools like CRISPR are much more targeted than past gene therapies; molecular biology now allows the precoding of both the material and the location affected by genetic change. This raises thorny ethical questions: could these techniques go beyond curing diseases to creating genetic enhancements that could make someone stronger or faster? Could gene editing be used to advance eugenics, by making it possible to change someone's skin color? Will the benefits be widely available, or only help the wealthy and powerful? What does it mean to disabled if we have the ability to wipe out conditions like Down syndrome? Rapid advancements in gene therapy and the development of technologies that are more powerful than originally expected means carefully considered policy and clinical approaches must be put in place. Listen to the whole conversation here. Before joining Johns Hopkins, Prof. Kahn was Director of the Center for Bioethics at University of Minnesota. 

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MERS virus

NIH Lifts Ban on Making Lethal Viruses

December 21, 2017

The National Insitutes of Health (NIH) has ended "a moratorium imposed three years ago on funding research that alters germs to make them more lethal," according to the New York Times. The goal of such research is to better understand the mechanisms that drive pathogens to mutate and become deadly; the new guideline requires the germ pose a "serious health threat" and that the research be done in a highly secure lab. The Times article notes, "There has been a long, fierce debate about projects — known as 'gain of function' research — intended to make pathogens more deadly or more transmissible." The ban on such reseach was put in place after an incident in which lab workers at the Centers for Disease Control (CDC) were accidentally exposed to anthrax. Michael T. Osterholm, Director of the Center for Infectious Disease Research and Policy (CIDRAP), a Consortium member, is quoted in the article. He believes this type of work could be done safely, but wanted restrictions on what would be published, noting "if someone finds a way to make the Ebola virus more dangerous, I don’t believe that should be available to anybody off the street who could use it for nefarious purposes. . . . We want to keep some of this stuff on a need-to-know basis."

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A Prolific Gender Studies Researcher's Outcomes Questioned

December 14, 2017

According to an article in Ars Technica, "Psychologist Nicolas Guéguen's large body of research is the kind of social psychology that demonstrates, and likely fuels, the Mars vs. Venus model of gender interactions, with its assertions, for example, that men consider women wearing red to be more attractive. But it seems that at least some of his conclusions are resting on shaky ground. Since 2015, a pair of scientists, James Heathers and Nick Brown, has been looking closely at the results in Guéguen's work. What they've found raises a litany of questions about statistical and ethical problems. In some cases, the data is too perfectly regular or full of oddities, making it difficult to understand how it could have been generated by the experiment described by Guéguen." In addition to identifying questionable research outcomes, Heathers and Brown learned that some of Guéguen's methodologies put female researchers in sexualized situations. These types of concerns are central to Research Integrity and Trustworthy Science, a conference that will be held on the University of Minnesota campus on March 8. Eminent, nationally-known presenters will address data fabrication, selective data reporting, predatory journals and concerns about the reproducibility of scientific findings. To learn more and register for free in-person or webinar attendance, click here

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Whole brain scan

Should Older Judges and Politicians be Evaluated for Dementia?

November 20, 2017

In a talk last week sponsored by Harvard Law School's Petrie-Flom Center for Health Law Policy, Biotechnology and Bioethics, Prof. Francis Shen, JD, PhD, raised the question of how to grapple with powerful people who show signs of dementia. According to an item from WBUR, a public radio station in Boston, Shen's central point was that "politicians, who have huge advantages as incumbents, and federal judges, who serve for life, tend to stay on the job well past typical retirement ages. Yet we know that some cognitive decline with age is normal, and that the risk of dementia skyrockets as we get older. So it's reasonable to conclude that some judges and politicians are no longer up to their tasks." Shen is a Consortium affilate faculty member who specializes in neurolaw; he's currently a fellow at Petrie-Flom. Ultimately, Shen recommended a middle way, one that doesn't involve mandatory retirement ages for elected officials and judges but also doesn't ignore the social risks of their cognitive decline. Read the entire article here

News

Pollution from factory

Ramaswami-led Research May Mean Cleaner Air for Cities

November 6, 2017

Air pollution in urban environments causes many premature deaths each year, and that number will grow as urban populations increase. Anu Ramaswami, PhD, led an international research team that recently published a study showing that using the heat generated from industrial processes for heating and cooling other buildings would result in fewer pollutants being generated by cities. The study used new models and data sets representing 637 Chinese cities to quantify, for the first time on this scale, the potential benefits of such energy and materials exchanges. Prof. Ramaswami is Director of the Center for Science, Technology, and Environmental Policy, a Consortium member. The study was published in the journal Nature Climate Change; an article about this research also appears on the Office of the Vice President for Research Inquiry blog.

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Klass Weighs in on Proposed Pipeline Project

October 27, 2017

Plans for a replacement pipeline called Enbridge Line 3 is roiling conversations across Northern Minnesota. According to an article in the Duluth News Tribune, the state's "Public Utilities Commission (PUC) has to weigh the adequacy and reliability of energy supplies, decide which forecasts to trust and — if it is to approve the project — be convinced there's no better alternative." Prof. Alexandra Klass, a Consortium affiliate member, is quoted; she notes, "The position the state is taking is yes, having a new pipeline will be more efficient for Enbridge's business operations, but that's not saying it's needed for the state and citizens of Minnesota." Klass is a professor at the University of Minnesota Law School who specializes in energy and the environment. Earlier this week, protests caused the cancellation of a St. Cloud public hearing on the pipeline; to learn more, click here.

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Deborah Swackhamer

Swackhamer to Speak on Scientific Integrity and the EPA

October 10, 2017

This Friday, Oct. 13, Deborah Swackhamer, PhD (Professor Emerita, Humphrey School of Public Affairs and School of Public Health), will discuss the federal advisory committees mandated to oversee the quality and scope of the science used by the US Environmental Protection Agency (EPA). Her talk is called "Scientific Integrity in the Balance: What's at Stake?" and will be held in 105 Cargill at 3 pm on the St. Paul campus; a remote webcast is also available here (registration required). Dr. Swackhamer is a past Chair of the EPA Science Advisory Board, and is the current Chair of the Board of Scientific Counselors, and will share first-hand knowledge of how these committees have done their work, and how they are currently being used by the new Administration. This seminar is particularly timely in light of yesterday's announcement by EPA chief Scott Pruitt that his agency is taking formal steps to repeal a rule limiting greenhouse-gas admissions that was put in place under the Obama administration. From 2002-2014, Prof. Swackhamer was the director of the Water Resources Center, a Consortium member. 

Publication

News

Nanowarming in an alternating magnetic field

U Researchers Develop New Nanotech to Improve Transplant Outcomes

August 23, 2017

A team led by University of Minnesota researchers has developed a new method for thawing frozen tissue that may enable long-term storage and subsequent viability of tissues and organs for transplantation. The method, called nanowarming, prevents tissue damage during the rapid thawing process that would precede a transplant. The U of MN has long been a leader in organ transplants – 2017 marks the 50th anniversary of the world's first pancreatic transplant, in 1967. According to the study's co-author, Prof. Michael Garwood, PhD, of the University of Minnesota Dept. of Radiology, "Prior to the development of [this nanowarming technology, called] SWIFT, no imaging technique had been capable of quantifying high concentrations of iron-oxide #nanoparticles in tissues non-invasively." Consortium Chair Susan M. Wolf led the team that developed the oversight guidelines for nanotechnology research with human participants; learn more about those here.

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The confluence of the Mississippi and Minnesota rivers

Gulf "Dead Zone" Highlights Downstream Effects of Polluted Water from the Upper Midwest

August 7, 2017

Improving water quality throughout Minnesota has been the focus of ongoing efforts by organizations like the Water Resources Center (WRC), a Consortium member. An article from Minnesota Public Radio lays out potential solutions, referring to a recent report by the WRC "that recommends strategies like better regulation of farm drainage systems and moving away from planting corn and soybeans to perennial crops." Fertilizers like nitrogen and phosphorus from Midwestern farm fields wash into the Mississippi River and other watersheds, causing contamination. Road salt and golf course runoff are also among the culprits. One dramatic outcome is this summer's largest-ever "dead zone" downstream in the Gulf of Mexico, an area the size of New Jersey "where water doesn't have enough oxygen for fish to survive," according to NPR. Don Scavia, a researcher at the University of Michigan, "describes it as a kind of hidden environmental disaster. 'You know, it's 8,000 square miles of no oxygen. That can't be good!'" One example of an effective solution that Scavia points to is mandatory limits on nutrient pollution in Chesapeake Bay, which have helped the bay begin to recover since being put in place in 2010. 

Conference

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Texas Law Allows Unproven Stem Cell Interventions

June 30, 2017

A Texas bill has been signed into law allowing "clinics and companies. . . to offer people unproven stem cell interventions without the testing and approval required under federal law," according to Science Magazine. The act grants legal status to practices that are already widespread; Leigh Turner, a professor at Consortium member the Center for Bioethics notes, "you could make the argument that — if [the new law] was vigorously enforced — it’s going to put some constraints in place." However, he continues, "it would really be surprising if anybody in Texas is going to wander around the state making sure that businesses are complying with these standards." The law, which takes effect Sept. 1, sanctions a much broader set of therapies than federal rules allow. Read the entire article here

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Underwater research drone

Consortium Scholar Reveals Potential, Pitfalls of New Ocean Research Technology

June 21, 2017

New observational technologies are greatly complicating oceanographic research, even as they present tantalizing opportunities. Because they are less expensive and more networked than ship-based measurements, remotely operated vehicles like undersea drones and satellites can provide an unprecedented amount of data while democratizing the research process. However, these new tools also challenge existing maritime codes such as the United Nations Convention on the Law of the Sea. During the 2015-2016 academic year, Geography, Environment and Society PhD candidate Jessica Lehman was awarded a Consortium Research Grant to explore how these new technologies have become entangled in questions of territory, information-sharing, and politics. Lehman notes, “Concerns about global environmental crises such as climate change push scientists to collect more data and make it freely available online, but nations are concerned that these data may compromise their sovereignty, from military operations to fisheries development. To address these concerns, we can’t make assumptions about relationships between security and new technologies; we have to follow them into the world and see what they are actually doing.” Her Consortium-funded research informed her dissertation, which evaluated the interfaces between geopolitics and international oceanographic science. Lehman is currently an AW Mellon Postdoctoral Fellow in the Center for the Humanities at the University of Wisconsin, Madison; to learn more about her research, click here.  

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LawSeq logo corrected Dec 2016

ELSI Congress Tackles the Big Questions on Genomics and Society

June 9, 2017

Earlier this week, the 4th annual conference of the National Human Genome Research Institute (NHGRI) Ethical, Legal and Social Implications (ELSI) Research Program was held in Farmington, CT. This year's focus was the many ways genomics is rapidly becoming a fixture in our lives, from prenatal genetic screening to the genetic testing of women with family histories of breast cancer. Physicians, geneticists, genetic counselors, social scientists and lawyers from academia, government and industry brought new insight and perspectives to debates over new and emerging data. Consortium Chair Susan M. Wolf, JD, moderated and presented during a session on a new, NHGRI-funded grant entitled "LawSeq: Building a Sound Legal Foundation for Translating Genomics into Clinical Application." The panelists – Gary Marchant (Sandra Day O'Connor College of Law, Arizona State University), Amy McGuire (Baylor College of Medicine, University of Texas), and Ellen Wright Clayton (School of Law, Vanderbilt University) – are all PIs and collaborators on the grant. The speakers identified areas of agreement and disagreement, and suggest pathways to advance law and policy to support the optimal use of genomics. For more information, visit the ELSI Congress website.

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DNA graphic with doctors in the middle

Fine Print in DNA Kits May Hold Some Surprises

May 25, 2017

A report from the NBC affiliate in Boston sheds light on an aspect of mail-in DNA kits that may surprise some users: when you sign the paperwork to obtain the results, you're often granting a "perpetual, royalty-free, world-wide, transferable license" for the data. The company in this example is Ancestry, but in an interview Glenn Cohen of Harvard Law School's Petrie-Flom Center noted "that kind of language is probably buried into the informed consent or the forms you sign almost every time you've donated blood or had a blood test." In a statement, Ancestry said they will "not share DNA data with third party marketers, employers or insurance companies," and they allow users to delete their DNA results and/or ask the company destroy the sample from which the results were derived. They also store your DNA without your name. However, these policies are not included in the contract users of Ancestry DNA are required to sign. Consumer protection attorney Joel Winston is quoted in Slate saying “Even if you’ve never used Ancestry.com, but one of your genetic relatives has, the company may already own identifiable portions of your DNA.” Issues related to shared family genomics and privacy have been explored by Consortium Chair Susan M. Wolf and her co-investigators, resulting in a major symposium on the subject. 

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Rorschach graphic

Common Rule Revisions Applauded by Some Social Scientists

May 22, 2017

The latest revision to the Common Rule released in January exempted studies using "benign behavioral interventions" – such as those typically used by social scientists – from the level of oversight required for medical research with human participants. This news was welcomed by some who have long chafed against what they see as excessive scrutiny of their studies. In an article about the changes, the New York Times reports about an op ed published in the Chronicle of Higher Education; in it, co-authors Richard A. Shweder, an anthropologist, and Richard E. Nisbett, a psychologist, celebrate the easing of oversight, noting "Socrates himself would probably roll over in his grave if he knew about the hoops his academic heirs in the humanities, law, and the social sciences have been jumping through." However, famous studies like the Milgram and Stanford prison experiments demonstrate the extremes to which social science research can go. Tracy Arwood, assistant vice president for research compliance at Clemson University, notes: "Researchers tend to underestimate the risk of activities that they are very comfortable with," particularly when conducting experiments and publishing the results is critical to the advancement of their careers. Read the entire New York Times article here

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Doctor with patients and tablet computer

Research Ethics Videos Available

April 19, 2017

Videos are now available for sessions held during the two research ethics conferences presented at the University of Minnesota on March 8 and 9, 2017. At these events, researchers, policymakers, bioethicists, patient advocates and other stakeholders explored best practices for research with human participants. The conferences are The Future of Informed Consent: A Century of Law, Ethics & Innovation (March 8) and The Challenges of Informed Consent in Research with Children, Adolescents & Adults (March 9). The videos are posted at z.umn.edu/researchethicsvideos for free public access.

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FDA Approves Direct-to-Consumer Genetic Tests

April 6, 2017

In a turnaround for the Food and Drug Administration (FDA), the agency has announced it will "allow a company to sell genetic tests for disease risk directly to consumers," according to the New York Times23andMe, a private genomics and biotechnology company based in Mountain View, California, pioneered products to allow customers to learn about their genome without the involvement of a doctor, genetic counselor or other health care professional. There are two levels of test offered; the default will only include the gene variants that could lead to the development of 10 rare conditions such as factor XI deficiency, Gaucher disease type 1 and celiac disease. For the genes associated with illnesses such as Parkinson's and Alzheimer's, there is a separate track that includes access to genetic counselors. An attempt by 23andMe to offer similar direct-to-consumer tests in 2013 was quashed by the FDA because of concerns about how patients might misinterprete potentially bad news without professional guidance. However, according to Dr. Robert C. Green, a Consortium collaborator who has researched the matter, studies since then have "there is some potential for distress, but it is much, much smaller than was anticipated.” Read the entire article here