To Return or Not to Return? IRB Perspectives on Obligations to Return Genetic Incidental Findings to Research Participants

Abstract

Purpose: Whether researchers have an obligation to disclose genetic incidental findings (GIFs) to research participants has been widely debated but has lacked empirical data. This is the first extensive national examination of IRB professionals’ understanding, experience, and beliefs surrounding GIFs in the context of genomic sequencing. Methods: We conducted a cross-sectional online survey of 796 individuals sampled from Public Responsibility in Medicine and Research (PRIM&R) about background and experience with GIFs and ethical reasoning supporting or diminishing an obligation to disclose. Results: Most participants have had experience dealing with GIFs (74%), but less than half (47%) felt well prepared to evaluate a plan for managing them. Respondents generally agreed (78%) that researchers have some obligation to disclose GIFs. The top-cited ethical principles were a duty to warn (84%), respect for autonomy (80%), and beneficence (79%). While a majority believed that the obligation could be undermined by inadequate clinical or analytical validity (72%) or inadequate clinical utility (66%), respondents disagreed that researchers’ additional time and effort (87%) and participants’ imperfect understanding of genetics (70%) were valid reasons for non-disclosure. Almost all (96%) indicated it is definitely or probably acceptable for a participant to elect not to receive any GIFs. This view, however, became less pronounced (63%) when applied to specific case studies. Conclusion: Most IRBs are actively dealing with GIFs but feel only moderately prepared to do so. A majority believes there is sometimes or always an obligation to disclose and that duty to warn, autonomy, and beneficence are guiding forces in this obligation. Respondents generally rejected instrumental and paternalistic concerns as valid reasons for non-disclosure.