Incidental findings

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DNA helix plus family genomic map

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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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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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. 

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New Paper from eMERGE Network Challenges ACMG Return of Results Recommendations

January 11, 2016

Last week's Journal of the American Medical Association (JAMA) includes a paper from the Electronic Medical Records and Genomics (eMERGE) Network that presents important new information on the interpretation of gene variants. Using a Big Data approach to electronic health records, eMERGE found evidence that having a potentially harmful genetic variant for two life-threatening disorders does not always translate into developing the actual diseases. An article in STAT explores the significance of the eMERGE findings, featuring short essays by three renowned scholars: Ellen Wright Clayton of Vanderbilt University, Michael Murray of Geisinger Health System and Consortium chair Susan M. Wolf. In her piece, Wolf discusses the JAMA paper in the context of recommendations on return of results regarding incidental findings by the American College of Medical Genetics (ACMG); she previously published an article on her concerns with those recommendations in the Annual Review of Human Genetics. On a related note, the Consortium hosted Prof. Rex Chisholm, PhD, of the eMERGE Network last spring; you can view his lecture here

News

First Consensus Recommendations Published on Sharing Individuals’ Genomic Findings with Family

October 19, 2015

An NIH-funded, blue-ribbon project group has just published the first consensus recommendations on a question that has vexed researchers for serveral years: Should researchers share an individual study participant’s private results with family members who may share a genetic risk? A new special issue of the Journal of Law, Medicine & Ethics grapples with these real-world dilemmas and presents recommendations to guide researchers confronted with them. The symposium is an outgrowth of a multi-year National Institutes of Health (NIH)-funded grant and was edited by the grant's principal investigators: Susan M. Wolf, JD, University of Minnesota; Barbara A. Koenig, PhD, RN, University of California, San Francisco; and Gloria M. Petersen, PhD, Mayo Clinic College of Medicine. Prof. Wolf says, “What makes these issues so challenging is current bioethics, law, and research rules focus on protecting individuals, but genetics is about families.” The guidelines are the beginning of an important, national policy conversation, one that will have a major impact on the future of genomics in U.S. health care. View a PDF of the consensus recommendations here. 

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Wolf SM, Lawrenz FP, Nelson CA, Kahn JP, Cho MK, Clayton EW, Fletcher JG, Georgieff MK, Hammerschmidt D, Hudson K, Illes J, Kapur V, Keane MA, Koenig BA, LeRoy BS, McFarland EG, Paradise J, Parker LS, Terry SF, Van Ness B, Wilfond BS. Managing Incidental Findings in Human Subjects Research: Analysis and Recommendations. Journal of Law, Medicine & Ethics 2008;36(2):219-248. Download PDF (415.08 KB)

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Nature  magazine masthead

Susan Wolf in Nature on Precision Medicine Data-sharing Challenges

September 3, 2015

An article in Nature outlines some of the dilemmas facing the NIH-funded Precision Medicine Initiative when it comes to deciding how much genetic data about disease risk will be shared with an expected one million participants in the project. While medical treatments tailored to individual genomes promise to be powerful health care tools, the floods of data unleashed by such an enterprise raise vexing questions about unexpected findings and patients' ability to interpret that information. Despite those qualms, as Consortium chair Susan M. Wolf notes, “We’re past the era when scientists can simply take specimens, generate data with great health importance, and decline to offer any of that data back to people.”

Symposia