Research ethics

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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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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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National Institutes of Health Announces Adoption of SMART IRB

March 24, 2017

Multisite clinical trials are a powerful way to drive the discovery of new therapies, but ensuring that the health and privacy of study participants are protected across multiple Institutional Review Boards (IRBs) has slowed things down in the past. Today, the NIH reached a major milestone: all of their Clinical and Translational Science Awards program sites have agreed to a new authorization agreement, SMART IRB. The agreement – whose acronym stands for Streamlined, Multisite, Accelerated Resources for Trials IRB – "will enable all participating study sites to rely on the ethics review of one IRB for each study, making it possible to initiate multisite studies within weeks instead of months. For patients waiting to enroll in a study, this could make a life-saving difference." Among the signatories on the agreement is Consortium member the Clinical and Translational Science Institute (CTSI).

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Patient-led Medicine Symposium on Harvard Bill of Health Blog

March 6, 2017

A symposium published today on Bill of Health, a blog edited by the Petrie-Flom Center at Harvard Law School, expands on discussions held at the Consortium's Deinard Memorial Lecture last December, "How Patients Are Creating Medicine’s Future." The Deinard lecture featured four speakers – Ernesto Ramirez of Fitabase, Jason Bobe of the Mount Sinai School of Medicine, Barbara Evans of the University of Houston Law Center, and Kingshuk K. Sinha of the Carlson School of Management at the University of Minnesota. The Bill of Health symposium provides commentary on their lectures and further reflections on the ways citizen science and wearables are transforming both health care and medical research. A video of the entire Deinard lecture can be viewed here

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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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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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