Research ethics

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National Research Ethics Conferences Announced

February 2, 2017

On March 8th and 9th, 2017, the Consortium will present two related conferences on frontier issues in research ethics. Building on the sold-out Research with Human Participants conference held in December, 2015, the March events will bring together renowned speakers from a variety of disciplines to address how informed consent ethics and policy have developed over the past century and what tools are needed to improve patient and research protections going forward. Discussion will include recent changes to the Common Rule governing research, including changes on informed consent and broad consent. On March 8, an all-day conference and simultaneous webcast will address The Future of Informed Consent in Research and Translational Medicine. The morning of March 9 will kick off the University of Minnesota's first-ever Research Ethics Day with a half-day conference and webcast on The Challenges of Informed Consent. Research Ethics Day concludes in the afternoon with trainings and workshops designed to provide concrete, actionable and hands-on approaches to the everyday challenges of properly conducting research with human participants. To learn more and register, visit our conference website

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Final Version of Common Rule Announced

January 18, 2017

The long-awaited updated version of the Common Rule – the regulations safeguarding individuals who participate in research – was announced today by the US Department of Health and Human Services. The goal of the revision is to strengthen protections of research participants without adding undue administrative burdens for researchers, particularly in low-risk studies. The Common Rule revisions will inform the expert presentations at the Consortium's research ethics events on March 8-9, consisting of a national conference, "The Future of Informed Consent in Research and Translational Medicine" on March 8 and the University of Minnesota's "Annual Research Ethics Day" on March 9. These events will be webcast; for more information and to register, visit the Consortium's events page. The Annual Research Ethics Day on March 9 will conclude with in-person workshops and trainings on practical research topics. To learn more, visit z.umn.edu/researchtr

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Experts Explore the Opportunities and Perils of Patient-Led Medicine

December 7, 2016

Yesterday's Deinard Memorial Lecture on Law & Medicine was a fitting conclusion to a visionary series. Hundreds of attendees heard from a multidisciplinary panel on the fast-moving, emerging field of patient-led medicine. Prof. Jason Bobe (Mount Sinai School of Medicine) kicked things off by examining the obstacles to broad patient engagement in research, and shared his efforts to empower potential research participants through the Personal Genome Project and Open Humans. Ernesto Ramirez of Fitabase discussed the move toward gathering, analyzing and sharing personal data, and how that has both sparked patient-driven collaborations and led to the development of devices such as the "artificial pancreas," for those with Type 1 Diabetes. Prof. Kingshuk K. Sinha (Carlson School of Management, University of Minnesota) broadened the conversation to include business perspectives, such as supply-chain management, that can be used to increase access to new health-care products, and also highlighted some potential pitfalls of self-treatment, such as patients using unproven or dangerous approaches. Prof. Barbara Evans (University of Houston Law Center) wrapped up with remarks about the ways laws and regulations meant to protect patients have, in some cases, served as an obstacle to participation in research. An article about the event from the Minneapolis Star Tribune can be read here

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Health Disparities Training and Funding Opportunities

October 28, 2016

Prof. Kola Okuyemi, MD, MPH, has been awarded a $1.5M grant from the National Institutes of Health (NIH) to educate researchers about reducing cancer-related health disparities among underserved populations. Prof. Okuyemi, Director of the Program in Health Disparities Research, says these trainings are designed to "prepare predoctoral and postdoctoral trainees with the knowledge and skills necessary to conduct cancer-related health disparities intervention research." In related news, the Center for Healthy African American Men through Partnerships (CHAAMPS), a joint program of the University of Minnesota and the University of Alabama at Birmingham (UAB), has announced two funding opportunities: Pilot Projects (4-6 grants available to faculty from Minnesota, UAB, Johns Hopkins University, MD Anderson Cancer Center and UC Davis) and the Scholars Disparities Program (2-4 grants available to grad students, post-docs, medical residents, medical fellows and faculty at the same institutions). To learn more about deadlines, etc., click on the links above or contact Laurel Nightingale, MPH, MPP, CHAAMPS Collaborations Coordinator, at nigh0021@umn.edu.

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Nanobot in bloodstream

Chemistry Nobel Prize Goes to Nanotech Scientists

October 5, 2016

Three scientists have been awarded the 2016 Nobel Prize in Chemistry for their work on designing tiny machines "a thousand times thinner than a strand of hair," according to the BBCJean-Pierre Sauvage (Strasbourg University), Fraser Stoddart (Northwestern University) and Bernard Feringa (University of Groningen) will share the prize, which is worth approximately $930,000. Nanotechnology – "the creation of structures on the scale of a nanometer, or a billionth of a meter," as described in the New York Times – could be used to precisely deliver pharmaceuticals within the human body and may lead to entirely new therapeutic approaches. Consortium Chair Susan M. Wolf has led significant efforts, funded by the National Science Foundation and National Institutes of Health, to determine the best way to protect human beings who participate in nanotechnology research. Two major symposia evaluated oversight models using a historical and comparative approach and produced the first systematic, comprehensive recommendations on how to protect human participants in nanotech research. To see all the Consortium's work on nanotechnology, click here

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New Rules: Researchers Must Publish Results of All Clinical Trials

September 19, 2016

In a step toward greater transparency, the US Department of Health and Human Services (HHS) has announced that, going forward, researchers funded by the National Institutes of Health (NIH) must report the design and results of all clinical trials, whether successful or not. An article in Nature describes the new rules, which are designed to reduce the number of clinical trials that aren't reported; a 2013 study found that approximately half the time, trial results aren't published if they have unfavorable results. The article notes, "Under the new rule, trials must be registered on ClinicalTrials.gov within 21 days of enrolling their first patient — researchers can no longer wait for the results of their trails to report their data." For the first time, those who don't adhere to the guidelines can be penalized by having their funding withdrawn. Bioethicist Jennifer Miller of New York University’s Langone Medical Center praises the change, noting "You need a clear law so you can have clear compliance." 

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Feud Over Parkinson's Drug Trial Reveals Power of Gatekeepers

August 31, 2016

A dispute between Dr. Charbel Moussa, a scientist at Georgetown University, and the Michael J. Fox Foundation (MJFF) has exposed some challenges of conducting independent drug research in collaboration with a major advocacy group. An article in STAT outlines the conflict, noting that the MJFF-funded Phase 2 trial based on Moussa's previous research "was supposed to begin in October, but Fox and the Georgetown team had a bitter falling out, and it’s unclear whether Georgetown will be able to obtain the medicine from its manufacturer so that the study can proceed. [MJFF], meanwhile, is moving forward on its own, and has established a separate group to study the same drug." The article provides a glimpse into unusually public discord within the world of high-stakes research. In a statement, MJFF states the conflict with Dr. Moussa and his team is a result of differences of opinion regarding the design and execution of the study, citing "the limitations of open-label clinical trials in Parkinson's, which have been shown to be disproportionately affected by placebo response." Leigh Turner, a professor at Consortium member the Center for Bioethics, is quoted in the STAT article, saying funders and journal editors should "be above reproach in their handling of insider information. [Turner cautions] 'You have these gatekeeper moments, where it is possible to take advantage of positions like that, to gobble up as much information as possible, and repurpose it for your own advantage.'"

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National Academies Call for Halt to Common Rule Update

June 29, 2016

The National Academies of Sciences, Engineering, and Medicine (NASEM) have issued a call for the withdrawal of the Notice of Proposed Rulemaking (NPRM), which is intended to update the federal guidelines for research with human participants, also known as the Common Rule. In the view of the National Academies, the NPRM "is marred by omissions, the absence of essential elements, and a lack of clarity," an opinion shared by many scientific groups. In its place, NASEM suggests a national commission be appointed to issue a "course correction" that will update the rules without increasing regulatory burdens or diminishing the effectiveness of human subjects research. An article in Science describes the debate and the initial response by a Department of Health and Human Services spokesperson, who notes they've "received more than 2,100 public comments" on the NPRM and will "take all public comments seriously" as they develop the final rule.

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Legacy of Tuskegee Syphilis Experiment Revelations: Reduced Life Expectancy for Black Men

June 14, 2016

Since it was revealed in 1972, the Tuskegee Study of Untreated Syphilis in the Negro Male has been considered among the most egregious violations of research ethics during the 20th century. The study began in 1932; for 40 years, researchers passively monitored hundreds of adult black males with syphilis, despite the availability of effective treatment. The study was funded by the US Public Health Service (PHS), and only concluded when PHS employees alerted journalists, having been ignored or rebuffed by their employer. A newly published paper outlines the tragic legacy: "the historical disclosure of the study in 1972 is correlated with increases in medical mistrust and mortality and decreases in both outpatient and inpatient physician interactions for older black men." The authors of the study estimate "life expectancy at age 45 for black men fell by up to 1.4 years in response to the disclosure, accounting for approximately 35% of the 1980 life expectancy gap between black and white men." At last December's Consortium-sponsored Research with Human Participants conference, Prof. Vanessa Northington Gamble, MD, PhD (George Washington University) discussed her work as Chair of the federal committee that obtained an official apology for the study from President Bill Clinton in 1997 -- view her talk here

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Genomic Research Privacy Recommendations in the News

May 18, 2016

An article in the Huffington Post by Robert C. Green, MD, MPH (Harvard, Brigham and Women's Hospital) outlines the conclusions reached by a team of researchers led by Consortium chair Susan M. Wolf, JD; Gloria Petersen, PhD (Mayo) and Barbara Koenig, PhD, RN (UCSF). Their charge: to make recommendations regarding the disclosure of genomic incidental findings to family members of research participants. The national working group for the project included Green and other eminent scholars. Thus far, the study has produced consensus recommendations; a published symposium; and a public conference

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Controversy Erupts on Informed Consent for Biospecimens

May 16, 2016

A new proposal by the Obama administration would require scientists who work with human biospecimens to obtain consent from patients prior to using them in research, even when all personal information is removed. The proposed change is part of the revision of the Common Rule, the federal law used to govern research with human participants, which is currently under review. In effect, the new policy would broaden the definition of "human subject" to include tissues, blood, and urine. Some scientists, medical device manufacturers, and advocacy groups are concerned about the chilling effect this could have on research, including the Precision Medicine Initiative. Bioethicists have raised issues about plans to offer new forms of consent, with Consortium collaborator Ellen Wright Clayton, MD, JD, of Vanderbilt University questioning whether those could be effective: “The idea that this informed consent will be in any way meaningful I think is illusory.” Read an article about the debate from STAT here

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Prof. Wolf Lectures on Genomics and Public Health

May 11, 2016

Consortium Chair Susan M. Wolf, JD, lectured yesterday at Boston University's School of Public Health. Her topic was the current status of legal and ethical guidelines, as well as the development of best practices, related to translational genomics – issues given greater urgency in light of the federal Precision Medicine Initiative, which launched last year. For more than a decade, Prof. Wolf has led groundbreaking research on return of results (RoR) from genomic testing to research participants, patients, and their families. In her talk at Boston University, she delved into the public health implications of RoR and identified areas needing further study, including the blurring of boundaries between research and clinical applications of genomic scans; difficulties with properly interpreting gene variants; and the need to augment unrepresentative or inadequate data sets to insure they represent well vs. unwell populations and reflect gender and ethnic diversity. Video of the lecture and the following Q&A can be viewed here.  

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Course on Community-based Participatory Research Announced

April 15, 2016

Starting Sept. 12, a course in Community-based Participatory Research (CBPR) will be offered to graduate students and community practitioners who want to know more about this powerful approach to understanding and addressing health and social disparities. Each Monday from 4-6, the class will explore the purpose and applications of CBPR; partnership formation and maintenance; issues of power, race, class, and social justice; conflict resolution; ethical issues; and CBPR's relationship to cultural and community knowledge systems. Please note this course can either be taken for academic credit (tuition costs apply) or for free by community practitioners seeking a certificate. 

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Sophia Vinogradov

New Psychiatry Department Head Appointed

April 4, 2016

The University of Minnesota has hired a new leader for its Department of Psychiatry. Dr. Sophia Vinogradov, a schizophrenia researcher who has recently served as vice chair of the psychiatry department at the University of California, San Francisco School of Medicine, will start in August. New leadership for the department is one of several steps being taken to address issues raised in external reviews of the University’s protection of human research participants. Dr. Vinogradov replaces interim department head Dr. Mark Paller, senior associate dean of the Medical School, who has led the department since last August when Dr. Charles Schulz resigned. Learn more in articles from the Star Tribune, Pioneer Press, and Minnesota Daily.

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Emily Scholtes

New Research on Calculating the Cost of Return of Incidental Findings

March 15, 2016

The latest issue of the Minnesota Law Review features an article growing out of work by Legal Project Assistant Emily Scholtes on the Consortium's NIH-funded grant, Disclosing Genomic Incidental Findings in a Cancer Biobank. The article is entitled "Incorporating Cost into the Return of Incidental Findings Calculus: Defining a Responsible Default for Genetics and Genomics Researchers." Ms. Scholtes has collaborated with Consortium chair Susan M. Wolf, JD, on a number of projects; she is a 3L at the University of Minnesota Law School, and is also editor-in-chief of volume 100 of the journal.