Research ethics


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Stay Updated on Consortium Resources and Activities!

February 2, 2018

Every year, the Consortium sponsors leading national programs, undertakes cross-disciplinary research and provides grants to support scholarship on the societal implications of the life sciences. We also connect our 19 member centers and affiliate faculty with national and international collaborators to create a vibrant community of thinkers and policymakers. To stay up to date on our offerings and news, sign up for our email list. And don't forget to follow us on Facebook and Twitter!  


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." 


Logo for Petrie Flom Center, Harvard Law School

Genomic Screening: What's Age Got to Do with It?

December 18, 2017

A new post on the Bill of Health blog discusses new research that looks at whether upper age limits should be established for population-based preventive genomic screening. These types of limits are used in other clinical screenings on the assumption that older individuals wouldn't see clinical benefits. The authors of the paper used data from the GeneScreen study to look at how age issues were perceived and valued by researchers and participants. Their findings? "While clinical benefits of preventive genomic screening for older adults are debatable, our respondents perceived a range of benefits of screening in both clinical and research settings. Researchers and clinicians should carefully consider decisions about whether to exclude older adults and whether to provide information about benefits and risks across age groups."


A film still of Audrey Hepburn wearing a red dress

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


Prof Susan M. WOlf

Wolf Joins TOPMed Advisory Panel

November 30, 2017

The National Heart, Lung, and Blood Institute (NHLBI) has appointed Consortium Chair Susan M. Wolf to the External Advisory Panel for the Trans-Omics in Precision Medicine (TOPMed) Program, which is dedicated to the advancement of heart, lung, blood, and sleep precision medicine. Since its launch in 2014, TOPMed has supporting whole genome sequencing and other omics platforms such as metabolomics and proteomics; the project researchers expect to have achieved a total of 150,000 whole genome sequences by the end of 2018. Research conducted on such a scale raises importance governance questions, including how best to ensure the privacy of participants' health data when it's shared with the broader research community. Prof. Wolf is a renowned expert on genomic privacy, having led several research studies that established the legally and ethically preferred methods to manage research findings from biobanks. The External Advisory Panel will provide the NHLBI Director and staff with expert guidance on TOPMed, with the goal of applying systems biology to drive the future of precision medicine. 


Nanibaa’ A. Garrison

Navajo Nation Reconsiders Ban on Genetic Research

October 16, 2017

An article in Nature News and Comment discusses a growing interest in genetic research within the Navajo Nation. DNA studies were banned in 2002 because of concerns about the misuse of genetic materials. Now, tribal leaders "increasingly see genetic research as a tool to improve medical care for the 174,000 residents of their sprawling reservation, which is roughly the size of Scotland." Consortium collaborator Nanibaa’ Garrison, PhD, a member of the Navajo Nation who is a professor at the University of Washington School of Medicine, is among those helping develop the new policy. She indicates the plan is likely to address types of research that will be allowed, who will have access to genetic information, and who will provide oversight. Prof. Garrison has written widely on genetics, with a focus on health conditions prevalent in American Indian communities, such as type 2 diabetes. She is author or co-author of two articles on related topics that were published in a special symposium of the Journal of Law, Medicine and Ethics; here's a link to that issue, for which Consortium chair Susan Wolf was one of the editors.


Medical tech carrying cooler

Susan Wolf on the Ethics of GTEx

October 13, 2017

Nature News and Comment​ has just published an article about an National Institutes of Health (NIH)​-funded study on gene expression that's intended to create "a 'Google Maps' of the body, according to Kristin Ardlie of the Broad Institute of MIT and Harvard​. The study, known as GTEx, is collecting data from the tissues of deceased donors and has the goal of plugging "a gap in the search for the genetic origins of disease." Laura Siminoff, a bioethicist at Temple University​, has studied whether the families of donors truly understood the possible implications of participating in the study, and suggested that "some form of genetic counseling should be made part of the informed consent process for similar projects." Regarding the lack of a plan to return GTEx results to families, Consortium Chair Susan M. Wolf noted in the article, “'A standing policy of simply "we will not return results" is becoming less and less common.' She noted that studies such as GTEx should plan to enable families to be identified if researchers discover, for instance, a mutation that dramatically increases the risk of cancer for relatives who inherit it."


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. 


Female runner with wearable fitness tracker

Addressing Ethical, Legal, and Social Issues (ELSI) in Unregulated Health Research Using Mobile Devices (MobileELSI)

To date, there has been very little study of the ethical and legal issues surrounding unregulated health research performed by "citizen scientists." A three-year grant from the National Institutes of Health will enable a team of 30 researchers from leading research institutions, health technology developers, and patient advocates to consider a wide range of issues, including the various types of mobile health research platforms, the potential applicability of various federal and state laws regulating research, possible models of self-regulation, and specific measures from online consent to integrating privacy protection in health apps.


Map marker with My Training text

CTSI Launches New Training Tool for Research with Human Participants

September 25, 2017

The Clinical and Translational Science Institute (CTSI), a Consortium member, has launched a new web-based training tool for University of Minnesota clinical research professionals who work with human participants, and their supervisors. The Human Research Training website is a free, easy-to-use tool to help these researchers identify and maintain the appropriate training, certification, credentials, and immunizations. “Previously there wasn’t a systematic way to identify what research training was necessary or a system to track and maintain training compliance,” said Megan Hoffman, CTSI Workforce Development Program Manager, Clinical Translational Research Services. “This tool provides the linking and connectivity between U Learn and Moodle in one spot — it works to provide training uniformity across our vast research enterprise. The tool doesn’t add to the training requests, it simply tracks them in one place.”



Registration is Open for Mini Bioethics Academy

September 20, 2017

The Center for Bioethics, a Consortium member, is hosting a three-part Mini Bioethics Academy that will explore issues at the intersection of ethics, science and society. The series kicks off on Oct. 11 with a session on the effect of meaningless work on our health and lives, presented by affiliate faculty member Christopher Michaelson (Opus College of Business, University of St. Thomas). On Oct. 18 the topic will be food justice and bioethics, with Michelle Horovitz and Princess Titus (Appetite For Change). The final seminar, on the ethics of environmentally responsible health care, will be held on Oct. 25; the speaker will be affiliate faculty member Andrew Jameton (emeritus, University of Nebraska Medical Center). The Academy is open to anyone interested in learning more about bioethics; attendees can choose to come to all three sessions or select those that are of interest. Learn more and register here


Prof. J. Neil Henderson

$10 Million Gift Will be Used to Found Native American Health Center

September 13, 2017

An anonymous donor has given $10 million to the Medical School at University of Minnesota, Duluth, which will be used to build on the school's already strong foundation in Native American health. According to the Duluth News Tribune, "In any given year, Native Americans comprise about 10 percent of the university's medical school class. . . . Moreover, the six faculty members at the school's Duluth campus who are Native American comprise about a quarter of all Native Americans on medical school faculties in the entire country. Only about 1 percent of the nation's doctors are Native American." Among those UMD faculty members is Prof. J. Neil Henderson, PhD, an enrolled member of the Choctaw Nation. He notes that the private gift, which has very few stipulations attached to it, could fund portions of research not covered by federal grants. Prof. Henderson spoke at the Consortium-sponsored research ethics conference last March, on the inter-cultural aspects of working with American Indian institutional research boards when conducting research. You can see his talk here.


Red glass double helixes

Is it Clinical Care? Is it Research? Navigating the Difference in Genomic Medicine

August 31, 2017

A working group of the Clinical Sequencing Exploratory Research (CSER) Consortium has published the first-ever study describing new approaches to a crucial question: how should genomics investigators handle the increasingly blurry boundary between research and clinical practice? The article, "Navigating the Research-Clinical Interface in Genomic Medicine" appeared in Genetics in Medicine, which is published by ACMG. A new blog post by Consortium Chair Susan M. Wolf, JD and Wylie Burke, MD, PhD (Department of Bioethics and Humanities at the University of Washington) describes the results of CSER's empirical research. A 22-item survey was administered to investigate how investigators were conceptualizing and navigating the research-clinical interface. The results were striking: most of the studies describe a merger of research and clinical care. According to Wolf and Burke, "This challenges the conventional wisdom that while clinical care benefits patients, research seeks only generalizable knowledge." CSER encompasses nine National Institutes of Health (NIH)-funded projects driving the translation of genomic sequencing into clinical care; among these are grants for which Consortium Chair Susan M. Wolf serves as a co-Principal Investigator: Disclosing Genomic Incidental Findings in a Cancer Biobank (with Gloria Petersen of Mayo Clinic and Barbara Koenig of UCSF) and LawSeq: Building a Sound Legal Foundation for Translating Genomics into Clinical Application (with Ellen Wright Clayton of Vanderbilt and Frances Lawrenz of the University of Minnesota). Prof. Wolf was the lead author on the Genetics in Medicine article. 



Doug Yee, Masonic Cancer Ctr director, and his wife, Janet Yee.

Chainbreaker Bike Ride Raises Money for Cancer Research

August 15, 2017

On August 12th and 13th, 1000 cyclists raised more than $1 million during the first-ever Chainbreaker ride, sponsored by Consortium member the Masonic Cancer Center (MCC). Routes were in increments of 25, 50, 100 and 180 miles, and wound through the south and west metro; those riding longer distances connected with the Cannon Valley Trail and eventually ended up in Excelsior. 400 volunteers supported the riders, helping with logistics, providing food and beverages, and cheering on participants. MCC Director Douglas Yee and his wife, Janet Yee, rode their tandem bike the entire 180 miles, raising more than $8000 between the two of them. Chainbreaker is modeled after a very successful event founded at Ohio State University, which has raised $130 million dollars for cancer research in the past 8 years, including $20 million dollars last year alone. Next year's Minnesota Chainbreaker is planned for summer, 2018. 


Cells edited using CRISPR

Study is First to Use CRISPR to Repair an Embryonic Mutation

August 2, 2017

The New York Times and other news outlets are reporting a major milestone in genetic engineering: the successful editing of genes in human embryos to repair a "common and serious disease-causing mutation." A new study published in Nature describes the research performed by a team led by biologist Shoukhrat Mitalipov of Oregon Health & Science University. Since the discovery of the CRISPR gene-editing method, scientists and ethicists have been discussing the opportunities and challenges presented by the procedure. Robin Lovell-Badge, a professor of genetics at the The Francis Crick Institute in London noted “You could certainly help families who have been blighted by a horrible genetic disease.” On the other hand, Consortium collaborator Henry Greely of the Center for Law and the Biosciences at Stanford University notes ethical concerns related to "so-called germline engineering, which refers to changes made to embryo that are inheritable. 'If you’re in one camp, it’s a horror to be avoided, and if you’re in the other camp, it’s desirable,' Dr. Greely said. 'That’s going to continue to be the fight, whether it’s a feature or a bug.'" Read the entire article here



Prof. Heidi Rehm of Harvard Medical, lecturing

Rehm Calls for Open Data Sharing to Improve Genomic Interpretation

July 24, 2017

In an article published in Genetics in Medicine, Heidi L. Rehm, Director of the Laboratory for Molecular Medicine at Partners Healthcare Personalized Medicine and Associate Professor of Pathology at Harvard Medical School, calls for the sharing of variant interpretations to advance medicine and improve patient care. Reviewing the progress made over the past five years by ClinVar and other major studies, she highlights the strides than can be made when multiple laboratories collaborate on evaluating the significance of individual genes, assigning categories consistently, and allowing peer review. To that end, Rehm lays out five recommendations for regulators, agencies, providers, laboratories and others. Rehm is a frequent Consortium collaborator – she wrote a major article on improving genomic laboratory practices with Consortium Chair Susan M. Wolf and others. She also spoke about her work to define standards for the interpretation of genomic variants at a lecture hosted by the Consortium in 2015; video of that talk is available here