INTRODUCTION: Return of Research Results: What About the Family?

437 When work began on return of results in genomic research about a decade ago, few thought about the family. The question of whether researchers owed participants a duty to offer back individual results and incidental findings of potential health importance was vexing enough. At that point researchers customarily refrained from offering results to participants. If consent forms said anything at all about return of results, it was often to clarify that no results would be offered back.1 In 2005, the University of Minnesota’s Consortium on Law and Values began a project funded by the National Human Genome Research Institute (NHGRI) at the National Institutes of Health (NIH) to examine the question of how incidental findings should be managed in genetic and genomic research.2 By this point, imaging researchers had recognized and documented the inevitability of incidental findings, including in neuroimaging research using MRI to image the brain. In imaging research, the “unidentified bright object” that could signal a mass or the obvious arterial malformation was hard to ignore in reading the scans. The imaging research community was hard at work developing classification schemes for incidental findings and protocols for ascertaining which findings required clinical attention, and deciding how to communicate these findings to research participants and their physicians. The genetics and genomics research community lagged behind. Our project took the progress made in the imaging context as a starting point for developing consensus recommendations cutting across imaging, genetic, and genomic research.3 Others soon took up this difficult problem as well.4 What made this problem difficult was that it erupted in the research sphere, where investigators were committed to seeking generalizable knowledge. Yet incidental findings discovered in the course of research were troubling because of their potential implications in the clinical sphere, where clinicians were committed to advancing the well-being of individual patients.5 Researchers wondered whether they had responsibilities to recognize and even hunt for these incidental findings, and then responsibilities to alert the research participant to permit clinical evaluation. After all, they were researchers not clinicians, operating with limited research budgets to seek group results for population benefit. And if they had responsibilities to recognize, analyze, and offer back incidental findings of potential clinical concern, they probably also had duties to evaluate and offer back individual results on variables under study when those research results signalled clinical concerns. Analyzing return of results and incidental findings has proven enormously challenging, requiring empirical research, new philosophical analysis, legal scrutiny, attitudinal research, and innovation in research design and clinical practice. Over time, the debate has broadened to include the question of whether genomic biobanks and other large collections of data and specimens to fuel research across the globe have responsibilities as well to address the potential for findings of health importance to the source individual. Thanks to NHGRI funding for a follow-up project,6 the Consorintroduction Return of Research Results: What About the Family?