Research ethics

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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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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.

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Ketamine Study, Performed Without Patient Consent, Raises Alarms

June 25, 2018

An article in the Minneapolis Star Tribune describes concerns over a program in which paramedics from Hennepin Healthcare administer the sedative ketamine when responding to reports of extremely aggressive or agitated people. The newspaper obtained a draft report that examined the protocol, which was apparently driven by a study "which began last August, requires no consent from patients whose data can be used for research, but gives the subject the option to opt out afterward." The report alleges that in some cases, police encouraged or directed use of the drug. Representatives of Hennepin Healthcare explain that ketamine and and other sedatives "can be a lifesaving tool when paramedics encounter people showing signs of 'excited delirium,' a condition when severe agitation can lead to death." However, "a recent paper published by the hospital [noted that] 57 percent of study patients given ketamine required intubation — inserting a tube in the throat to help deliver oxygen." According to Carl Elliott, who is on the faculty of the Center for Bioethics, a Consortium member, “If I were asked to consent to this study in advance, I would refuse. I would never want to be in this study. And yet they’re describing it to people like it’s so uncontroversial that they can enroll them without even asking them.”

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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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MobileELSI Explores Ethical Issues in Health Research with Mobile Devices

May 17, 2018

Patient-led medicine, powered by mobile technology like smartphones and wearable fitness trackers, is transforming health research. While these new tools have powerful potential, some of this research is not subject to federal regulations, raising quandaries about how to ensure adherence to independent review, informed consent and privacy standards. A new NIH-funded project, MobileELSIwill develop and disseminate recommendations for the ethical conduct of this emerging research. It's led by Consortium collaborators Mark Rothstein (University of Louisville), Charlisse Caga-anan (National Cancer Institute) and John Wilbanks (Sage Bionetworks); Consortium chair Susan M. Wolf is serving on the Working Group. The Consortium hosted an event, How Patients Are Creating Medicine's Future, in Dec. 2016, featuring four experts in the field; video can be viewed here

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MPMC, Mille Lacs Band Partner to Reduce Lung Cancer Disparities

May 11, 2018

An article in the Brainerd Dispatch describes a new collaboration between members of the Minnesota Precision Medicine Collaborative (MPMC) and the Mille Lacs Band of Ojibwe; together, they will "investigate aspects of lung cancer and nicotine metabolism from commercial tobacco use that may be unique to the American Indian populations in Minnesota." As part of this effort, researchers will conduct two pilot studies, one on the rate of nicotine metabolism in members of the Band and one on a new approach to lung cancer treatment and early detection. Pamala Jacobson, one of the leaders of MPMC, emphasizes the need for researchers to take the time to establish authentic, honorable working relationships within communities affected by health disparities. "For precision medicine approaches to be effective, we have to know how to apply this exciting new science to all populations, not just healthcare systems in metropolitan areas or those serving high income patients," said Jacobson. "Conducting the needed research and implementing precision medicine to benefit the health of American Indians and other minority populations is a priority." In addition to Prof. Jacobson, Consortium chair Susan M. Wolf is also an MPMC leader. To learn more, click here.

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