Factors influencing parental consent in pediatric clinical research
Factors influencing parental consent in pediatric clinical research
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DOI：
10.1542/peds.111.5.1037
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发表时间：
2003-05-01
期刊：
影响因子：
8
通讯作者：
Shapiro, GG
中科院分区：
文献类型：
--
作者：
Rothmier, JD;Lasley, MV;Shapiro, GG
背景。虽然以前的研究已经关注了成人和健康受试者参加临床试验的动机，但在儿童临床研究中，影响父母同意的因素知之甚少，因为受试者自己不同意。本研究旨在确定在儿科临床试验中影响家长同意的一组因素。这可能使研究人员能够确定临床试验中特定吸引人方面的子集，这些方面将促进参与，同时也将需要进一步考虑的伦理问题暴露出来。从1999年7月到1999年9月，44位目前参与临床哮喘研究的儿童的父母或监护人完成了关于允许他们的孩子参加临床试验的动机的问卷调查。然后用李克特数值量表对这些回答进行评分。父母最重要的动机是更多地了解孩子的病情。第二重要的是帮助医学知识的动机。免费用药可及性与家庭收入呈负相关。虽然在儿童哮喘研究中存在利他动机，但大多数家长/监护人同意他们的孩子更多地了解他们孩子的哮喘。获得免费药物在低收入家庭中比在高收入家庭中更为重要。
Background. Although previous studies have looked at the motivation behind enrollment in clinical trials of adults and healthy subjects, little is known about the factors influencing parental consent in pediatric clinical studies where the subjects themselves do not provide consent.Objective. This study was conducted to define a group of factors that impact parental consent in the pediatric clinical trial. This may allow investigators to identify a subset of specific appealing aspects of clinical trials that will promote participation while also bringing ethical issues to light that may require further consideration.Methods. Forty-four parents or guardians of children currently participating in clinical asthma research completed questionnaires from July 1999 to September 1999 pertaining to motives for allowing their child to participate in clinical trials. The responses were then rated on a Likert numerical scale.Results. The most important motive for parents is learning more about their child's illness. Next important was the motive of helping medical knowledge. Availability of free medication was negatively correlated with family income.Conclusions. Although altruistic motives are present in pediatric asthma research, most parents/guardians gave consent for their child to learn more about their child's asthma. Access to free medication was more important in families with lower incomes than in families with higher incomes.