Understanding of informed consent by parents of children enrolled in a genetic biobank

Abstract

Purpose: Prior research suggests that parents undervalue long-term risks associated with their children's participation in research studies. The primary aim of this study was to evaluate parental understanding of informed consent for a pediatric biobanking study. Methods: The study population included parents who provided consent for their child to participate in a study examining the genetic etiology of congenital cardiovascular malformations. Informed consent understanding was measured by adapting the Quality of Informed Consent assessment to our study. We evaluated possible predictors of individual Quality of Informed Consent items using generalized estimating equations. Results: A total of 252 individuals representing 188 families completed the study. The Quality of Informed Consent items best understood by parents included consent to participate in research, the main purpose of the study, and the possibility of no direct benefit. The items least understood by parents were those involving the indefinite storage of DNA, the possible risks of participation, and the fact that the study was not intended to treat their child's heart defect. Parent age and medical decision making by one versus both parents were frequent predictors of individual Quality of Informed Consent items. Conclusion: Parents overestimate personal benefit and underestimate the risks associated with their child's participation in a biobanking study. © 2014 American College of Medical Genetics and Genomics.