Regulation & oversight

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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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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

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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. 

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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." 

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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

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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. 

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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. 

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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