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Article
Informed consent and genomic incidental findings: IRB chair perspectives
Journal of empirical research on human research ethics
  • C. M. Simon
  • Janet K. Williams, University of Iowa
  • L. Shinkunas
  • D. Brandt
  • Sandra Daack-Hirsch, University of Iowa
  • Martha Driessnack, University of Iowa
Document Type
Article
Peer Reviewed
1
Publication Date
12-1-2011
NLM Title Abbreviation
J Empir Res Hum Res Ethics
PubMed ID
22228060
DOI of Published Version
10.1525/jer.2011.6.4.53
Abstract

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.

Published Article/Book Citation
Journal of empirical research on human research ethics, 6:4 (2011) pp.53-67. DOI:10.1525/jer.2011.6.4.53.
Disciplines
Citation Information
C. M. Simon, Janet K. Williams, L. Shinkunas, D. Brandt, et al.. "Informed consent and genomic incidental findings: IRB chair perspectives" Journal of empirical research on human research ethics Vol. 6 Iss. 4 (2011) p. 53 - 67 ISSN: 1556-2654
Available at: http://works.bepress.com/sandra_daack-hirsch/45/