University of Minnesota professor and colleagues call on genomic researchers to make individual research results and findings available to human subjects
March 21, 2012
The debate over the return of individual research results (IRRs) and incidental findings (IFs) to participants in human subjects research has entered a new arena -- the brave new world of large-scale genetic and genomic research using biobanks and archived datasets. Together, these biobanks hold more than 300 million samples of human tissue. A special issue of the journal Genetics in Medicine offers more than 20 articles on this topic, including groundbreaking consensus recommendations in an article by University of Minnesota professor Susan M. Wolf and 25 colleagues from the United States and Canada. Science magazine calls the question of returning results to individuals “the most pressing issue in genetics today.”
This April 2012 issue is the result of a grant to University of Minnesota investigators from the National Human Genome Research Institute (NHGRI) at NIH. The principal investigator is Wolf, chair of the University’s Consortium on Law and Values in Health, Environment & the Life Sciences. Co-investigators include University of Minnesota professors Frances Lawrenz and Brian Van Ness.
“This article offers the first set of consensus recommendations on how to handle a huge problem in genomic research -- what to do with findings about individual research participants when those findings have high health importance. Indeed, some of these findings can make a life-or-death difference,” Wolf says. One example she points to is the discovery of a genetic variant in an individual that makes it dangerous for them to receive a certain drug or medication. “The tradition in research has been to maintain silence about individual findings, even when they have great health importance. Our paper calls instead for communicating important findings, while ensuring that researchers can continue to generate knowledge moving medicine and science forward. It is a difficult balancing act, but a crucially important one.”
In the consensus article, the authors recommend that biobanks take substantial responsibility for making sure that their research system, including the researchers feeding materials to the biobank and those using materials from it, addresses the IFs and IRRs return question unambiguously. If the biobank is able to identify individual specimen and data contributors, the authors advise that findings that are “analytically valid, reveal an established and substantial risk of a serious health condition, and are clinically actionable should generally be offered to consenting contributors.”
The article is now online at www.nature.com/gim/journal/vaop/ncurrent/full/gim201223a.html