How Geisinger made the case for an institutional duty to return genomic results to biobank participants

To return or not to return the results of genomics research: that has been the question at the crux of an ongoing debate spawned by the increasingly rapid evolution of genomics. Like many debates, this one arises from conflicting perspectives on broader concerns: for example, the purported distinction between research and patient care, the relationship between health care institutions and the communities they serve, and the role of patientand research-participant-engagement in such debates (and in their resolution). In 2012, Geisinger began to lay the groundwork for a significant expansion of theMyCode Community Health Initiative, a research platform comprised not only of a biobank established five years earlier but also of the clinical data collected in the electronic health records of the biobank's patient–participants and of the investigations made possible by these resources. Advances in genomic knowledge, coupled with steady decreases in sequencing costs, supplied the immediate context for this effort, which also entailed extensive internal discussion and patient–participant engagement focused on the ethical question, should Geisinger return clinically actionable results of genomics research to MyCode's patient–participants whose sequenced genomes yield such results? In convening the internal discussions, the aimwas to enlist organizational leaders, clinicians, and investigators in a process of ethical analysis and reflection for the purpose of identifying what obligations, if any, Geisinger has toward its patient–participants with regard to the return of results. Through engagement with the patient–participants, nearly 100 of whom were convened through focus groups described below, the aim was to solicit their views on the very same question. After the focus groups, the views of the engaged participants were clear: they overwhelmingly favored the return of results. Additional discussions were then held with leadership, researchers and Geisinger's