TY - JOUR
T1 - Informed consent and genomic incidental findings
T2 - IRB chair perspectives
AU - Simon, Christian M.
AU - Williams, Janet K.
AU - Shinkunas, Laura
AU - Brandt, Debra
AU - Daack-Hirsch, Sandra
AU - Driessnack, Martha
PY - 2011/12
Y1 - 2011/12
N2 - 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.
AB - 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.
KW - Genomic incidental findings
KW - Informed consent
KW - Institutional review board
UR - http://www.scopus.com/inward/record.url?scp=84862911210&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=84862911210&partnerID=8YFLogxK
U2 - 10.1525/jer.2011.6.4.53
DO - 10.1525/jer.2011.6.4.53
M3 - Review article
C2 - 22228060
AN - SCOPUS:84862911210
SN - 1556-2646
VL - 6
SP - 53
EP - 67
JO - Journal of Empirical Research on Human Research Ethics
JF - Journal of Empirical Research on Human Research Ethics
IS - 4
ER -