Simon Christian M, Williams Janet K, Shinkunas Laura, Brandt Debra, Daack-Hirsch Sandra, Driessnack Martha
Program in Bioethics and Humanities, University of Iowa Carver College of Medicine, 500 Newton Road, Iowa City, IA 52242-1190, USA.
J Empir Res Hum Res Ethics. 2011 Dec;6(4):53-67. doi: 10.1525/jer.2011.6.4.53.
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.
目前尚不清楚在知情同意过程中应如何处理基因组偶然发现（GIF）的相关事宜。针对这一主题，对34名在开展全基因组关联研究的中心有目的地抽样选取的机构审查委员会（IRB）主席进行了一项探索性研究。大多数主席（96%）表示不了解当地IRB关于GIF和知情同意的要求。主席们建议，同意过程应涉及GIF的可能性及研究披露政策；GIF的管理与随访；GIF的潜在临床意义；GIF披露的潜在风险；参与者选择不披露GIF的机会；以及研究人员披露GIF的责任期限。主席们担心参与者的披露偏好会随时间变化；在确定关于GIF的声明范围和准确性方面存在固有局限性；以及使同意过程变得更长、更复杂。IRB主席和其他利益相关者的观点有助于推进知情同意工作，以适应GIF的相关情况。
