Informed consent in pediatric research.
Informed consent in pediatric research.
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儿科研究的知情同意。
DOI：
10.1017/s0963180104134063
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发表时间：
2004
期刊：
影响因子：
--
通讯作者：
Ross,LainieFriedman
中科院分区：
文献类型：
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作者：
Ross,LainieFriedman
纽伦堡法典（1946年）的第一条原则要求受试者知情同意。直到1964年《赫尔辛基宣言》才涉及到代理同意。美国关于儿童参与研究的同意的政策在将近二十年（1983年）之后才在管理受试者参与研究的联邦法规的D子部分中最终确定。2000年10月，通过了《儿童健康法》。第十章要求卫生与公众服务部部长根据D子部分对条例进行审查，并“考虑任何必要的修改，以确保充分和适当地保护参与研究的儿童，并向国会报告部长的调查结果”。在这篇文章中，我提供了一个简短的概述，目前在儿科研究中的知情同意要求，其中包括父母的许可和儿童的同意的要求。然后，我检查这些要求的道德基础;当前的政策是否符合这些道德基础;如果不符合，应该如何修改这些政策。阅读本文的早期版本。本文题为“父母许可”的部分是基于一篇社论：罗斯LF。需要多少父母同意孩子参与医学研究？美国儿科学会，生物伦理学通讯部分，2002年5月：1，4。罗斯博士对儿童研究的研究是由美国国立卫生研究院资助（NLM 1 G13 LM 07472 -01）。
The first principle of the Nuremberg Code (1946) requires the informed consent of the subject. Proxy consent was not addressed until the Declaration of Helsinki (1964). U.S. policies regarding consent for the participation of children in research would not be finalized for almost two more decades (1983) in subpart D of the federal regulations that govern the participation of subjects in research. In October 2000, the Children's Health Act was passed. Title X required the Secretary of the Department of Health and Human Services (DHHS) to conduct a review of the regulations under subpart D and “to consider any modifications necessary to ensure the adequate and appropriate protection of children participating in research, and report the findings of the Secretary to Congress.” In this article, I provide a brief overview of the current informed consent requirements in pediatric research, which include requirements for parental permission and the child's assent. I then examine the moral bases for these requirements; whether the current policies are consistent with these moral foundations; and if not, how the policies ought to be modified.I would like to thank Walter Glannon, Ph.D., for reading an earlier version of this paper. The section of this paper entitled “Parental Permission” is based on an editorial: Ross LF. How many parents should be needed to consent to a child's participation in medical research? American Academy of Pediatrics, Section on Bioethics Newsletter May 2002:1, 4. Dr. Ross's research on children in research is funded by an NIH Grant (NLM 1 G13 LM07472-01).