Consensus guidelines: Return of individual results to participants in genomics research
- Date : 30 Mar 2012
- Topic : Bioethics, legal and economic issues
A new consensus article 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 states that biobanks "should set the rules for the overall process of recognizing (and subsequently analysing 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."
Karen J Maschke, a research scholar at The Hastings Center, is coauthor of a consensus article and editor of IRB: Ethics & Human Research, a Hastings Centre journal. Her research focuses on ethical issues in research involving human subjects. She said that the consensus group 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 USA National Institutes of Health. The paper appears in Genetics in Medicine.
Thank you for rating!
You have already rated this page, you can only rate it once!