Disclosure of Incidental Research Findings in Genomic Research – A Study of Institutional Review Board Chairs' and Members' Perspectives

Genomic research with human subjects raises complicated questions about the management of incidental or secondary findings. These are research results that have potential clinical significance, but are unrelated to the specific research question being asked. There is an active debate about the circumstances (if any) under which there is an obligation to return incidental findings. Questions about the disclosure of results become more complicated as the number of results generated increases, which is precisely what is likely to occur as whole exome and genome sequencing (WES/WGS) technologies begin to replace targeted genetic research techniques. The ethical obligation to return individual results remains unsettled, and while there are emerging positions, there is no final consensus on this issue in the research ethics literature. In the absence of an ethical consensus, and without definitive regulatory guidance, many IRBs are struggling with review of next-generation sequencing research. This paper will present data from a qualitative study of IRB members' views about the management and disclosure of incidental research findings in the context of genomic sequencing protocols. The study involved one-time in-depth semi-structured interviews with IRB chairs and members that have reviewed next-generation sequencing research protocols. These interviews incorporate carefully developed vignettes that describe a variety of research types and procedures for disclosure of results. An examination of such views and an understanding of the normative foundations behind them are useful foundations for the formulation of policy and guidance on this subject.