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New CTSI Resource Helps with NIH Study Record

April 22, 2019

A new online resource, developed by experts in the Clinicial and Translational Science Institute (CTSI) and the Department of Pediatrics, is now available to University of Minnesota clinical researchers, grant coordinators and others to help them save time when completing the National Institutes of Health Study Record, which is used to collect information on proposed human subjects research, clinical research, and clinical trials. The “Successfully Navigating the NIH Study Record” course is a curated collection of NIH instructions that take applicants step-by-step through the completion of the NIH Study Record. In addition, the resource offers answers to frequently asked questions, tips, and expert opinion about how to complete the Study Record. The resource is now available in the University of Minnesota’s Training Hub. CTSI is a Consortium member center. 

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Nanibaa Garrison

Increased Diversity Needed in Genomic Databases

April 18, 2019

An article in Nature describes the need for more diversity in genomic research. As of 2018, 78% of data use in genome-wide association studies (GWAS) were derived from people of European descent. Last November, the Consortium sponsored a conference, "Law, Genomic Medicine & Health Equity: How Can Law Support Genomics and Precision Medicine to Advance the Health of Underserved Populations?" Among the speakers was Nanibaa' Garrison (Seattle Children's, University of Washington). Prof. Garrison, a member of the Navajo Nation, works with Native American leaders to address ethical concerns about genetic research within tribal communities. View her presentation, along with a related one by Native scholar Spero Manson (University of Colorado Anschutz Medical Campus). The conference, held at Meharry Medical College, was co-sponsored by the Meharry-Vanderbilt Alliance, and the Minnesota Precision Medicine Collaborative.

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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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Amy Kircher

University Launches SPARC Research Collaborative

February 12, 2019

The University of Minnesota has created a new resource for faculty and staff who want to pursue research but need additional support. The Strategic Partnerships and Research Collaborative (SPARC) is made up of an interdisciplinary team with a proven track record of successful grants. They offer insights into writing proposals, putting together teams, and reviewing grant applications to maximize their likelihood of success. SPARC is led by Katey Pelican, PhD, DVM, Principal Investigator of the USAID One Health Workforce Project, and Amy Kircher (left), DrPH, Director of the Food Protection and Defense Institute (FPDI), a Consortium member. The SPARC innovation hub is designed to provide expertise and infrastructure to members of the University community and outside partners who want to pursue large and complex research projects. Learn more here.  

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Sharon F. Terry

Terry Recognized for Major Contributions to Precision Medicine

February 26, 2019

Sharon F. Terry, CEO of the Genetic Alliance, has received an award at the 10th annual Precision Medicine World Conference, held in Santa Clara, CA. She was recognized for "initiating the movement to build systems for individuals to access and share health data." Terry was a stay-at-home mom when she noticed some unusual spots on the sides of her daughter’s neck. Her two children were subsequently diagnosed with pseudoxanthoma elasticum (PXE), a rare, incurable and progressive disease. This devastating prognosis led Terry and her husband, Patrick – both non-scientists – on a quest to discover treatments. She went on to become the first-ever patient advocate to be recognized as a co-inventor on a gene patent, and has since served in leadership roles for many major organizations, including the federal All of Us Research Program. Ms. Terry was the featured speaker on a Consortium-sponsored webcast in late January; the topic was "Consumers in the Lead: Transforming Research and Health." Video of that webcast is available here

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Model of crystal structure for CRISPR-Cas9

CRISPR Babies Stun the World, Provoke Ethical Controversy

December 27, 2018

As 2018 comes to a close, one of the year's most startling scientific developments was the announcement of gene-edited twin girls born in China. While the promise and power of the technique known as CRISPR have long been known, scientists and policymakers have emphasized resisting the temptation to use it on human embryos. That is, however, precisely what He Jainkui did, as described in an article in Wired. He's attempt to contain the firestorm of criticism by proposing "a core set of fundamental human values to frame, guide and restrict clinical applications" of gene editing failed miserably, putting a point on the fact that "there are no actual international rules" for use of the technique. The primary ethical concern is limited understanding of the effects of so-called "germline editing," which is heritable and can be passed to future generations. Beyond doubts about the effects of CRISPR on the twin girls, Wired notes, "He’s research raises the spectre of gene-editing enhancements, designer babies if you will, such as making a person taller or smarter before birth," possibly heralding a new era of human-created genetic inequality. 

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'Sensory Santa' for Kids with Autism Will Help Find Participants for SPARK Study

December 13, 2018

The Center for Neurobehavioral Development, a Consortium member, is using an unusual partner  Santa Claus  to raise awareness of SPARK, the largest autism genetics study in the nation. According to a story from Minnesota Public Radio (MPR), the Center is hosting a Sensory Friendly Santa event this coming Saturday, Dec. 15, from noon-4. Dr. Suma Jacob, who helped organize the event, notes, "It varies for different individuals but one way to describe [sensory sensitivity] is that some people can hear almost every noise around them and have a difficult time blocking it out. . . . Our Santa has worked with kids with autism and other developmental disabilities. Santa will be mindful to wait for the child to approach instead of taking the lead." Dr. Jacobs leads the University of Minnesota SPARK team, and explains that one goal of the event is to let families know about the study and how they can participate. According to MPR, "As part of the study, children will be able to give saliva samples instead of having their blood drawn, which can often be especially traumatic for children with sensory sensitivities."

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Prof. Consuelo H. Wilkins

"Law, Genomic Medicine & Health Equity" Event Tackles Policy Needs

December 3, 2018

On Thursday, Nov. 29 a group of eminent scholars and researchers convened at Meharry Medical College in Nashville to evaluate the current state of precision medicine and how access to it can be improved. Conference presenters shared a wide-ranging array of information about obstacles and solutions to delivering genomic medicine in clinical settings, with a particular focus on policies to promote health equity. The event, which involved several dozen in-person attendees and 200 webcast viewers, concluded with a talk by Consuelo H. Wilkins (Meharry-Vanderbilt Alliance). Prof. Wilkins described her work with the federal All of Us Research Program, for which she serves as head of the Engagement Core. She emphasized the need to address the underrepresentation of minority populations in research, as well as mistrust and limited genomic literacy. One of the important takeaways from Prof. Wilkins' talk was the need to reframe the benefits to research participants of collaborating in studies, from returning results to returning value – that is, information these communities find useful. The event was presented by the Meharry-Vanderbilt Alliance, Vanderbilt University Medical Center, the Consortium, and the Minnesota Precision Medicine Collaborative. A special symposium based on the conference will be published in and issue of Ethnicity & Disease guest edited by Marino Bruce (Vanderbilt University), Vence L. Bonham (National Human Genome Research Institute - NHGRI) and Consortium Chair Susan M. Wolf (University of Minnesota). Video of conference sessions will be posted in the next 10 days; to receive notification, please email consortm@umn.edu

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Groundbreaking Case Hinges on Family Genetic Privacy, Access

November 26, 2018

Doctors at a London hospital are being sued "because they failed to tell [a woman] about her father’s fatal hereditary disease before she had her own child," according to the Guardian. "The woman discovered – after giving birth – that her father carried the gene for Huntington’s disease, a degenerative, incurable brain condition. Later she found out she had inherited the gene and that her own daughter, now eight, has a 50% chance of having it. The woman. . .  says she would have had an abortion had she known about her father’s condition, and is suing the doctors who failed to tell her about the risks she and her child faced. It is the first case in English law to deal with a relative’s claim over issues of genetic responsibility." Much of the groundwork for US legal and policy approaches to these complicated issues can be found in a symposium, "Should We Offer Genomic Research Results to a Participant's Family, Including After the Participant's Death?" edited by Consortium Chair Susan M. Wolf, Barbara A. Koenig (UCSF) and Gloria M. Petersen (Mayo Clinic). The symposium grew out of an NIH-funded grant, "Disclosing Genomic Incidental Findings in a Cancer Biobank: An ELSI Experiment," for which Wolf, Koenig and Petersen served as Principal Investigators. 

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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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Critics Call for Large Sepsis Study to be Shut Down

September 25, 2018

Sepsis is a very serious illness — of the million Americans who get the disease each year, up to 30 percent will die. A large, National Institutes of Health (NIH)-funded government trial of sepsis treatments, called Clovers, is currently under attack. According to the New York Times, "In a letter to the federal Office for Human Research Protection, representatives of Public Citizen’s Health Research Group compared the study, called Clovers, to 'an experiment that would be conducted on laboratory animals.” The Times recounts, "At issue is whether patients participating in Clovers are being given treatment that deviates from usual care — so much so that lives may be endangered by the research. Participants are only enrolled for 24 hours, but the first hours of treatment are critical for survival. . . . Scientists leading the study note that treatment is not hard and fast, and insist that all participants are getting medical care that 'falls within the range of usual care.'” The Consortium is nationally recognized for its work on patient rights and research ethics in clinical trials; among our contributions are major, national conferences bringing together top policymakers, scholars and researchers to grapple with thorny issues of consent, capacity and conflicts of interest. To learn more and view videos from these conferences, visit our YouTube channel.

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Brain with Alzheimers

Alzheimer's Research Uses Innovative Clinical Design, Precision Medicine Tools

September 5, 2018

Recent research has raised hopes that new drugs can help slow or reverse the symptoms of Alzheimer's disease. While promising breakthroughs abound in this arena, what distinguishes the development of one of these drugs, BAN2401, was the clinical trial's "adaptive design." That approach "ensured that when new subjects were recruited, they were more likely to be assigned to arms of the trial that showed the greatest promise," according to the Los Angeles Times. Advocates for adaptive design note it can make clinical trials more flexible, efficient and ethical because it makes effective treatments more readily available to patients. Critics are concerned that such adaptation opens the door to biased studies. To read a recent symposium on challenges to the conduct of high-quality laboratory research, click here. The other promising drug, Anavex 2-73, was developed using precision medicine approaches. "Researchers [focused on studying a small group of] Alzheimer’s patients who bear a few 'actionable genetic variants.'" These variants were identified by genomic sequencing intended to find participants most likely to have a positive response to the drugs. On Nov. 29, the Consortium is co-sponsoring a free, public conference and webcast, "Law, Genomic Medicine & Health Equity" that will discuss some of the implications of precision medicine for traditionally underserved populations; co-sponsors are the Meharry-Vanderbilt Alliance, Vanderbilt Health, and the Minnesota Precision Medicine Collaborative. The event will be held at Meharry Medical College in Nashville, TN; to learn more and register, click here

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FDA Complaint on MN Ketamine Research Conducted Without Patient Consent

July 25, 2018

The advocacy group Public Citizen has filed a complaint with the FDA and Office for Human Research Protections about trials conducted at Hennepin Healthcare (formerly Hennepin County Medical Center), in which paramedics used the sedative ketamine to treat "prehospital agitation." The letter is signed by dozens of bioethicists and medical experts, including Carl Elliott and Leigh Turner of the University of Minnesota Center for Bioethics, a Consortium member. According to reporting in the Washington Post, during the 4-year study "paramedics used either the anesthetic ketamine or a different powerful drug to sedate patients. . . . Patients or caregivers were not asked for permission to participate, and they were informed only later that they had become part of a medical experiment." Previous research, also conducted by Hennepin Healthcare, demonstrated that ketamine frequently causes complications that require patients by intubated. Regarding the recently halted study that was the catalyst for the complaint, Leigh Turner notes, “Even if there’s a case for using these drugs, there’s a case for being very judicious about when to use it.” He also expressed concern about the danger of the study influencing decisions by paramedics: “That’s going to lead to a reduction in the scope of clinical judgment, where EMS doesn’t have the full array of medications. The study is playing a role in which medication people get,” Turner said.