(Press-News.org) Karen J. Maschke, a research scholar at The Hastings Center, is coauthor of a consensus article that explicitly outlines "significant new responsibilities" for biobanks concerning the return of incidental findings and individual research results to people whose biospecimens were used in genetic and genomic studies.
The consensus paper addresses the growing ethical debate over the responsibility of researchers and biobanks – repositories of human biospecimens, such as blood and tissue – to inform biospecimen contributors about findings in genetic or genomic research that reveal their risk of disease or that could affect their reproductive choices. The debate has intensified with the burgeoning research on the genetic underpinnings of disease and human traits.
The consensus paper concludes that biobanks "should set the rules for the overall process of recognizing (and subsequently analyzing and returning)" incidental findings and individual research results to contributors. Among the recommendations is that biobanks should offer to return findings that "reveal an established and substantial risk of a serious health condition" and "are clinically actionable, meaning that the return of findings of health importance allows the contributor or contributor's clinician to take action with significant potential to prevent or alter the course of the condition or to alter its treatment."
In addition, the paper recommends that biobanks may offer to return results that are not "actionable" if they meet other criteria, including that they "reveal an established and substantial risk of likely health or reproductive importance or personal utility to the contributor and return is likely to provide net benefit from the contributor's perspective."
Maschke, whose research focuses on ethical issues in research involving human subjects, is editor of IRB: Ethics & Human Research, a Hastings Center journal. "The consensus group identified the ethical underpinnings of biobanks' responsibilities regarding the return of individual genetic results to research participants," she said. "In doing so, it established a valuable framework that biobanks, institutions, researchers, and funders should use in determining what results to return and in managing the return of results in a biobank research system."
###The consensus report was the result of a two-year study funded by the National Institutes of Health. The paper appears in Genetics in Medicine.
Consensus guidelines: Return of results to participants in genomics research
2012-03-26
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