As genetic and genomic researchers have relied more heavily on biobanks and archived data sets, there has been increasing concern and ongoing debate over the disclosure of individual results and incidental findings of research participants and DNA donors. KIE Senior Research Scholar Henry S. Richardson, with Principal Investigator Susan M. Wolf and 24 others, participated in a study funded by the National Institutes of Health on “Managing incidental findings and research results in genomic research involving biobanks and archived data sets” and recently published, on March 15, 2012, a consensus article with the same title in the journal Genetics in Medicine.
As a result of the study, Wolf and her colleagues recommend that biobanks should play an important part in developing a system for managing individual research results and incidental findings. The authors specifically conclude 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 authors also identify four core responsibilities for biobank research systems, including the responsibility to clarify the criteria for evaluating findings, and ten concrete recommendations for biobanks, researchers, and others as they move forward to implement the study’s findings and address this issue of growing concern.
In addition to the consensus article, Genetics in Medicine has published other related articles and commentaries, including a separate article by Dr. Richardson, coauthored with Mildred K. Cho, Ph.D., Associate Director of the Center for Biomedical Ethics at Stanford, on February 23, 2012, entitled “Secondary researchers’ duties to return incidental findings and individual research results: a partial-entrustment account”.