IRB perspectives on obligations to disclose genetic incidental findings to research participants

Abstract

Purpose Researchers’ obligations to disclose genetic incidental findings (GIFs) have been widely debated, but there has been little empirical study of IRBs’ engagement with this issue. Methods: This article presents data from the first extensive (n=796) national survey of IRB professionals’ understanding of, experience with, and beliefs surrounding GIFs. Results: Most respondents had dealt with questions about GIFs (74%), but only a minority (47%) felt prepared to address them. Although a majority believed that there is an obligation to disclose GIFs (78%) there is still not consensus about the supporting ethical principles. Respondents generally did not endorse the idea that researchers’ additional time and effort (7%) and lack of resources (29%) were valid reasons for diminishing a putative obligation. Most (96%) supported a right not to know, but this view became less pronounced (63%) when framed in terms of specific case studies. Conclusions: IRBs are actively engaged with GIFs, but have not yet reached consensus. Respondents were uncomfortable with arguments that could be used to limit an obligation to return GIFs. This could indicate that IRBs are providing some of the impetus for the trend towards returning GIFs, although questions remain about the relative contribution of other stakeholders.