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.1 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 patient- and research-participant-engagement in such debates (and in their resolution). In 2012, Geisinger began to lay the groundwork for a significant expansion of the MyCode 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 aim was 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.2 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 Institutional Review Board (IRB) and ultimately, Geisinger did indeed decide to return genomic results to that subset of MyCode participants whose sequenced genomes are found to contain one or more of the genetic variants on a defined list (based in part on the March 2013 clinical testing recommendations of the American College of Medical Genetics and Genomics3) and to integrate those clinically actionable results in genetically informed plans of care for these patient–participants. Soon after this decision, in early 2014, Geisinger announced an ambitious collaboration in genomics discovery with the Tarrytown, NY-based Regeneron Pharmaceuticals and embarked upon the anticipated expansion of MyCode—the current goal of which is to increase the ranks of patient–participants to at least 250,000 over five years. Against the backdrop of President Obama's recently announced Precision Medicine Initiative (PMI), which calls for the development of a one-million-participant cohort, Geisinger hopes to become a funded member of the PMI consortium and is considering a many-fold increase in the size of MyCode, inspired, in large measure, by rapid growth in the number of consented participants.4 Here we describe the development of the ethical rationale for returning genomic results to patient–participants in the MyCode Community Health Initiative with special attention to the aforementioned internal discussions, reflections and focus groups through which the institution sought to engage patient–participants.