M odels of Consent to Return of Incidental Findings in

July-August 2014 Genomic research—including whole genome sequencing and whole exome sequencing— has a growing presence in contemporary biomedical investigation. The capacity of sequencing techniques to generate results that go beyond the primary aims of the research—historically referred to as “incidental findings”—has generated considerable discussion as to how this information should be handled—that is, whether incidental results should be returned and, if so, which ones. We previously reported strong support among genomic researchers for the return of medically actionable data and substantial support for offering participants findings related to reproductive choices, pharmacogenetics, and highly penetrant disorders without available clinical interventions. Others have reported comparable results, and a number of expert groups have taken similar positions. Participants in genetic research are reportedly extremely interested in receiving most classes of genetic findings. Important questions remain to be answered about how incidental findings may be identified and returned to research participants. Some genomic studies involve the interrogation of large parts of the genome, making identification of incidental findings quite likely. However, in many sequencing studies, data can be filtered selectively, permitting investigators to control the extent to which incidental findings are likely to be identified. Whether genomic researchers will ultimately be deemed to have an obligation to search for certain categories of incidental findings and how extensive those categories may be remain undetermined. Similarly uncertain is the extent to which participants will be able to choose Models of Consent to Return of Incidental Findings in Genomic Research