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儿童的知情同意及参与流感疫苗试验。

Informed consent by children and participation in an influenza vaccine trial.

作者信息

Lewis C E, Lewis M A, Ifekwunigue M

出版信息

Am J Public Health. 1978 Nov;68(11):1079-82. doi: 10.2105/ajph.68.11.1079.

Abstract

Two hundred thirteen school children, ages six to nine, were presented the opportunity to participate in an experimental trial of swine influenza vaccine. In non-directive question and answer sessions, all groups of children except one composed only of six year olds elicited all relevant information on the details of the trial and the associated risks and benefits. Forty-six per cent of the subjects declined to participate. Letters requiring informed consent of the parents were sent to the homes of the others. Almost 15 per cent of these parents agreed to their children's participation. In this setting, children initiate their own visits to the school nurse practitioner. A significant association was found between volunteering for the study and higher use of services (but not for medical reasons). Younger children and boys, regardless of their patterns of use, were less inclined to volunteer for the experiment.

摘要

213名6至9岁的学童获得了参与甲型H1N1流感疫苗试验的机会。在非指导性问答环节中,除了一组仅由6岁儿童组成的群体外,其他所有儿童组都了解到了关于试验细节以及相关风险和益处的所有相关信息。46%的受试者拒绝参与。要求家长知情同意的信件被寄到了其他孩子的家中。这些家长中近15%同意自己的孩子参与。在这种情况下,孩子们自行前往学校护士处就诊。研究发现,主动报名参与研究与更高的服务使用率(但并非出于医疗原因)之间存在显著关联。无论使用模式如何,年龄较小的儿童和男孩参与该试验的意愿较低。

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