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重新思考儿科同意:从要求到理想状态。

Rethinking pediatric assent: from requirement to ideal.

作者信息

Unguru Yoram, Coppes Max J, Kamani Naynesh

机构信息

Division of Hematology/Oncology, Center for Cancer and Blood Disorders, Children's National Medical Center, Washington, DC 20010-2970, USA.

出版信息

Pediatr Clin North Am. 2008 Feb;55(1):211-22, xii. doi: 10.1016/j.pcl.2007.10.016.

Abstract

Physician-investigators are required to obtain informed consent from adult participants in their studies. Inclusion of children in research legally requires informed permission of a child's parent or guardian. It is increasingly recognized that a child need not assume a passive role when included in research, but that his or her active involvement should be sought, as expressed by the child's assent to partake in clinical research. This article briefly explores the history of assent and the central role of assessing a child's understanding of research and preference for participating in decisions related to their care, as necessary components of meaningful assent.

摘要

医生-研究人员必须获得其研究中成年参与者的知情同意。将儿童纳入研究在法律上需要获得儿童父母或监护人的知情许可。人们越来越认识到,儿童在被纳入研究时不必扮演被动角色,而应寻求其积极参与,正如儿童同意参与临床研究所表达的那样。本文简要探讨了同意的历史,以及评估儿童对研究的理解和参与与其护理相关决策的偏好的核心作用,这些是有意义同意的必要组成部分。

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