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与儿童参与临床研究相关的问题。

Issues related to children participating in clinical research.

作者信息

Knox Christina A, Burkhart Patricia V

机构信息

Kosair Children's Hospital, Louisville, KY, USA.

出版信息

J Pediatr Nurs. 2007 Aug;22(4):310-8. doi: 10.1016/j.pedn.2007.02.004.

Abstract

Research involving children is necessary to bridge the gap created by years of applying the findings of adult clinical trials to children. Given the mandate from the National Institutes of Health to include children in clinical trials, pediatric nurses will undoubtedly be asked to assist with pediatric research projects. Nurses working with children must consider the unique legal and ethical issues surrounding children as study participants. The purpose of this article is to examine issues related to children participating in clinical research. A review of pertinent literature is summarized, and practical approaches to the recommendations are discussed.

摘要

开展涉及儿童的研究对于弥合多年来将成人临床试验结果应用于儿童所造成的差距而言是必要的。鉴于美国国立卫生研究院要求将儿童纳入临床试验,儿科护士无疑会被要求协助开展儿科研究项目。照顾儿童的护士必须考虑到围绕儿童作为研究参与者所涉及的独特法律和伦理问题。本文旨在探讨与儿童参与临床研究相关的问题。总结了相关文献综述,并讨论了针对这些建议的实际方法。

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