Informed consent and genomic incidental findings: IRB chair perspectives.
It is unclear how genomic incidental finding (GIF) prospects should be addressed in informed consent processes. An exploratory study on this topic was conducted with 34 purposively sampled Chairs of institutional review boards (IRBs) at centers conducting genome-wide association studies. Most Chairs (96%) reported no knowledge of local IRB requirements regarding GIFs and informed consent. Chairs suggested consent processes should address the prospect of, and study disclosure policy on, GIFs; GIF management and follow-up; potential clinical significance of GIFs; potential risks of GIF disclosure; an opportunity for participants to opt out of GIF disclosure; and duration of the researcher's duty to disclose GIFs. Chairs were concerned about participant disclosure preferences changing over time; inherent limitations in determining the scope and accuracy of claims about GIFs; and making consent processes longer and more complex. IRB Chair and other stakeholder perspectives can help advance informed consent efforts to accommodate GIF prospects.
Program in Bioethics and Humanities, University of Iowa Carver College of Medicine, 500 Newton Road, Iowa City, IA 52242-1190, USA. christian-simon@uiowa.edu
Christian M
CM
Simon
Janet K
JK
Williams
Laura
L
Shinkunas
Debra
D
Brandt
Sandra
S
Daack-Hirsch
Martha
M
Driessnack
D030881:Disclosure / Q000941:ethics*; D028744:Ethics Committees, Research; D036281:Genetic Research / Q000941:ethics*; D055106:Genome-Wide Association Study / Q000941:ethics*; D007722:Health Knowledge, Attitudes, Practice; D006801:Humans; D007258:Informed Consent / Q000941:ethics*; D007407:Interviews as Topic; D012306:Risk