Department of Human Development and Family Studies, Colorado State University, Fort Collins, CO, USA.
Department of Pediatrics, Section of Emergency Medicine, University of Colorado Denver, Aurora, CO, USA.
Pediatr Res. 2022 Apr;91(5):1156-1162. doi: 10.1038/s41390-021-01600-9. Epub 2021 Jun 4.
Obtaining informed consent for clinical research in the pediatric emergency department (ED) is challenging. Our objective was to understand the factors that influence parental consent for ED studies.
This was a cross-sectional survey assessing parents' willingness to enroll their children into an ED research study. Parents reporting a willingness to enroll in ED studies were presented with two hypothetical scenarios, a low-risk and a high-risk study, and then asked about decision influencers affecting consent. Parents expressing a lack of willingness to enroll were asked which decision influencers impacted their consent decision.
Among 118 parents, 90 (76%) stated they would be willing to enroll their child into an ED study; of these, 86 (96%) would consent for a low-risk study and 54 (60%) would consent for a high-risk study. Caucasian parents, and those with previous research exposure, were more likely to report willingness to participate. Those who would consent to the high-risk study cited "benefits that research would provide to future children" most strongly influenced their decision to agree.
ED investigators should highlight the benefits for future children and inquire about parents' previous exposure to research to enhance ED research enrollment. Barriers to consent in non-Caucasian families should be further investigated.
Obtaining consent for pediatric emergency research is challenging and this study identified factors influencing parental consent for research in EDs. Benefits for future children and parents' previous research experience were two of the most influential factors in parents' willingness to consent to ED research studies. These findings will help to improve enrollment in ED research studies and better our understanding of how to promote the health and well-being of pediatric patients.
在儿科急诊部（ED）进行临床研究获得知情同意是具有挑战性的。我们的目的是了解影响父母同意 ED 研究的因素。
这是一项横断面调查，评估父母愿意将其孩子纳入 ED 研究的意愿。报告愿意参加 ED 研究的父母被提供了两种假设情况，低风险和高风险研究，然后询问影响同意的决策影响因素。表示不愿意参加的父母被问及哪些决策影响因素影响了他们的同意决定。
在 118 名父母中，有 90 名（76％）表示愿意将孩子纳入 ED 研究；其中，86 名（96％）会同意低风险研究，54 名（60％）会同意高风险研究。白种人父母和有过研究经验的父母更有可能报告愿意参与。那些同意高风险研究的人表示，“研究将为未来的孩子提供的益处”对他们同意的决定影响最大。
ED 研究人员应强调研究对未来孩子的益处，并询问父母以前是否接触过研究，以增加 ED 研究的参与度。应进一步调查非白种人家属同意的障碍。
获得儿科急诊研究的同意具有挑战性，本研究确定了影响父母同意 ED 研究的因素。未来孩子的利益和父母以前的研究经验是父母愿意同意 ED 研究的两个最具影响力的因素。这些发现将有助于提高 ED 研究的参与率，并更好地了解如何促进儿科患者的健康和福祉。
