Participation of children in clinical research - Factors that influence a parent's decision to consent
Participation of children in clinical research - Factors that influence a parent's decision to consent
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DOI：
10.1097/00000542-200310000-00012
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发表时间：
2003-10-01
期刊：
影响因子：
8.8
通讯作者：
Malviya, S
中科院分区：
文献类型：
--
作者：
Tait, AR;Voepel-Lewis, T;Malviya, S
背景：鉴于美国国立卫生研究院和其他机构倡议将儿童纳入研究，了解影响儿童参与的因素非常重要。本研究旨在确定影响家长决定同意孩子参与临床研究的因素。 方法：本调查研究由 505 名家长组成，他们已被联系以获得允许其孩子参加大型三级儿童医院临床麻醉或手术研究的许可。无论父母是否同意（同意者，n = 411）或拒绝（不同意者，n = 94）他们的孩子参与研究，他们都有机会完成一份调查问卷，以获取有关影响他们决定的因素的信息。结果：同意者在决策中表现出较少的不确定性，对医疗系统更加信任，对研究有更多的了解，并且认为寻求同意的环境比不同意者的压力更小。同意的预测因素包括低感知风险、家长阅读同意文件的程度、同意文件的特征、家长理解、感知研究的重要性以及感知的益处。结论：通过制定策略来改进研究信息的披露方式并确保父母真正了解情况，确定影响父母允许孩子参加临床研究的决定的因素将非常重要。
Background: Given the initiatives of the National Institutes of Health and other agencies to include children in research, it is important to understand the factors that influence their participation. This study was designed to identify factors that influence parents' decisions to consent to their child's participation in clinical research.Methods: This survey study consisted of 505 parents who had been approached for permission to allow their child to participate in a clinical anesthesia or surgery study at a large tertiary care children's hospital. Regardless of whether the parents consented to (consenters, n = 411), or declined (nonconsenters, n = 94) their child's participation in a study, they were offered the opportunity to complete a questionnaire eliciting information regarding factors that had influenced their decision.Results: Consenters exhibited less uncertainty in their decision making, were more trusting of the medical system, had greater understanding of the research, and believed that the environment in which consent was sought was less pressured than nonconsenters. Predictors of consent included low perceived risk, degree to which the parent read the consent document, characteristics of the consent document, parental understanding, perceived importance of the study, and perceived benefits.Conclusions: Identification of factors that influence parents' decisions to allow their child to participate in a clinical research study will be important by way of developing strategies to improve the manner in which study information is disclosed and to ensure that parents are truly informed.