1] Center for Innovation in Pediatric Practice, Nationwide Children's Hospital, Columbus, Ohio, USA [2] Present address: OhioHealth Research and Innovations Institute, Columbus, Ohio, USA.
Center for Cardiovascular and Pulmonary Research, Nationwide Children's Hospital, Columbus, Ohio, USA.
Genet Med. 2014 Feb;16(2):141-8. doi: 10.1038/gim.2013.86. Epub 2013 Jun 27.
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.
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.
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.
Parents overestimate personal benefit and underestimate the risks associated with their child's participation in a biobanking study.Genet Med 16 2, 141-148.
先前的研究表明，家长低估了其子女参与研究的长期风险。本研究的主要目的是评估父母对儿科生物库研究知情同意的理解。
研究对象包括为其子女参与一项研究提供同意的父母，该研究旨在探讨先天性心血管畸形的遗传病因。通过适应质量知情同意评估，来测量知情同意的理解。我们使用广义估计方程评估了个体知情同意项目的可能预测因素。
共有 252 名代表 188 个家庭的个体完成了这项研究。父母理解得最好的知情同意项目包括参与研究的同意、研究的主要目的以及没有直接受益的可能性。父母理解最差的项目涉及 DNA 的无限期储存、可能的参与风险，以及该研究并非旨在治疗其子女的心脏缺陷。父母的年龄和父母一方或双方做出医疗决策是个体知情同意项目的常见预测因素。
父母高估了个人获益，低估了其子女参与生物库研究的相关风险。遗传医学 16 卷 2 期，141-148 页。
