Informed consent and genomic incidental findings: IRB chair perspectives

Christian M. Simon, Janet K. Williams, Laura Shinkunas, Debra Brandt, Sandra Daack-Hirsch, Martha Driessnack

Research output: Contribution to journalReview article

31 Scopus citations

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.

Original languageEnglish (US)
Pages (from-to)53-67
Number of pages15
JournalJournal of Empirical Research on Human Research Ethics
Volume6
Issue number4
DOIs
StatePublished - Dec 2011

Keywords

  • Genomic incidental findings
  • Informed consent
  • Institutional review board

ASJC Scopus subject areas

  • Social Psychology
  • Education
  • Communication

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    Simon, C. M., Williams, J. K., Shinkunas, L., Brandt, D., Daack-Hirsch, S., & Driessnack, M. (2011). Informed consent and genomic incidental findings: IRB chair perspectives. Journal of Empirical Research on Human Research Ethics, 6(4), 53-67. https://doi.org/10.1525/jer.2011.6.4.53