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CHILDREN IN MEDICAL RESEARCH: ETHICAL& POLICY CHALLENGES

儿童医学研究：道德

基本信息

批准号：
6660432
负责人：
Lainie Friedman Ross
金额：
$ 7.55万
依托单位：
UNIVERSITY OF CHICAGO
依托单位国家：
美国
项目类别：
财政年份：
2001
资助国家：
美国
起止时间：
2001-09-30 至 2004-09-29
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/6660432
关键词：
CHILDREN MEDICAL RESEARCH ETHICAL&POLICY

项目摘要

DESCRIPTION (provided by applicant): The research will explore the ethical and policy issues raised by the participation of children in medical research. The goals of this project are: 1) to show that the current safeguards are inadequate and that there are systemic breeches of research ethics standards; and 2) to motivate policy makers, health care analysts, and the leaders of medicine to change practice and policy regarding the participation of children in research Specifically, the broad objectives of the project are: 1) to examine the ethical issues raised by the participation of children in research, and the need to balance access and protection; 2) to assess the ethical and policy implications of the new national policies and commissioned reports regarding the participation of children in research; 3) to identify recent published pediatric research that supports the thesis that current policies and practices are inadequate protection of children-subjects; and 4) to make policy recommendations to re-equilibrate the balance between protection and access. The main outcome of the research will be a book that offers a sustained ethical and policy critique of current policies, guidelines, and statements. The book will be entitled: Children in Medical Research: An Ethical and Policy Challenge. The book is divided into five sections. Part I addresses the problem and the current solutions and includes a historical overview of the regulations of children in research and an analytical critique of current policies, regulations and guidelines. Part H is entitled Beecher Revisited and addresses current research controversies including a chapter on placebo-controlled clinical trials, research involving healthy children and "at risk" children, genetic research, and phase I cancer research. Part Ill addresses barriers to pediatric research and includes chapters on funding, recruitment, incentives, retention of subjects, and informed consent issues. Part IV addresses research on special populations including newborns and adolescents. Part V offers revised policy recommendations.

描述（由申请人提供）：该研究将探讨伦理和政策问题儿童参与医学研究。该项目的目标是： 1）表明目前的保障措施不充分，并且存在系统性违反研究伦理标准； 2) 激励政策制造商、医疗保健分析师和医学领导者改变实践关于儿童参与研究的政策具体而言，该项目的主要目标是：1）审查道德问题由于儿童参与研究以及平衡的需要而提出访问和保护； 2）评估道德和政策的影响关于参与的新国家政策和委托报告儿童参与研究； 3）确定最近发表的儿科研究支持当前政策和实践不足的论点保护儿童受试者； 4) 提出政策建议重新平衡保护和访问之间的平衡。主要成果为该研究将是一本提供持续道德和政策的书对当前政策、指导方针和声明的批评。这本书将是题为：医学研究中的儿童：道德和政策挑战。这本书分为五个部分。第一部分解决了问题和当前的解决方案，包括法规的历史概述儿童研究和对现行政策的分析批评，法规和指南。 H 部分的标题为“比彻重访”并阐述了地址当前的研究争议包括关于安慰剂对照的一章涉及健康儿童和“高危”儿童的临床试验、研究，基因研究和 I 期癌症研究。第三部分解决了障碍儿科研究，包括有关资助、招募、激励措施的章节，受试者的保留和知情同意问题。第四部分讨论研究针对包括新生儿和青少年在内的特殊人群。第五部分优惠修订的政策建议。