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关于儿童参与研究的同意信息及家长决策的差异回忆。

Differential recall of consent information and parental decisions about enrolling children in research studies.

作者信息

Boccia Maria L, Campbell Frances A, Goldman Barbara D, Skinner Martie

机构信息

Graduate Programs in Counseling, Gordon-Conwell Theological Seminary, 14543 Choate Circle, Charlotte, NC 28273, USA.

出版信息

J Gen Psychol. 2009 Jan;136(1):91-108. doi: 10.3200/GENP.136.1.91-108.

Abstract

In the present simulation research, the authors examined the relations between the type of information that low-income parents (N = 116) recalled from informed-consent materials and their hypothetical decision to enroll a child in a clinical study. The authors gave parents or guardians of Head Start children information about a medical protocol involving high risk and significant potential benefit to child participants. Differential recall of the various categories of information (procedures, benefits, risks and costs, rights, and other) showed that relative to all consent information conveyed to them, participants recalled most about procedures and least about their child's rights as a study participant. Relative to their own recall, they also recounted most about procedures, slightly more about benefits than risks, and least about research rights. The pattern of recall differed among those who agreed to enroll and those who declined. The ratio of recalled risks to benefits predicted enrollment decisions.

摘要

在当前的模拟研究中,作者考察了低收入父母(N = 116)从知情同意材料中回忆出的信息类型与他们让孩子参加临床研究的假设性决定之间的关系。作者向开端计划儿童的父母或监护人提供了一份关于一项医疗方案的信息,该方案对儿童参与者有高风险和显著的潜在益处。对各类信息(程序、益处、风险和成本、权利及其他)的不同回忆表明,相对于传达给他们的所有同意信息,参与者对程序的回忆最多,而对其孩子作为研究参与者的权利回忆最少。相对于他们自己的回忆,他们对程序的叙述也最多,对益处的叙述比对风险的叙述略多,而对研究权利的叙述最少。同意参加和拒绝参加的人的回忆模式有所不同。回忆出的风险与益处的比例预测了参与决定。

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