CHILDREN IN MEDICAL RESEARCH: ETHICAL& POLICY CHALLENGES

描述（由申请人提供）： 这项研究将探讨的伦理和政策问题所提出的 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是不够的， 研究伦理标准的系统性违反; 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 该项目的主要目标是：1）研究道德问题 儿童参与研究所提出的问题，以及需要平衡 获取和保护; 2）评估 新的国家政策和委托编写的关于 研究中的儿童; 3）确定最近发表的儿科研究， 支持目前的政策和做法是不够的论点 （四）提出政策建议， 重新平衡保护和获取之间的平衡。的主要成果 这项研究将是一本书，提供一个持续的道德和政策， 对现行政策、指导方针和声明的批评。这本书将 题为“医学研究中的儿童：伦理和政策挑战”。的 本书分为五个部分。第一部分解决了这个问题， 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性批评， 条例和准则。H部分题为《比彻再访》， 目前的研究争议，包括一章安慰剂对照 临床试验，涉及健康儿童和“高危”儿童的研究， 基因研究和第一阶段癌症研究第三部分讨论了 儿科研究，包括章节的资金，招聘，奖励， 保留受试者和知情同意问题。第四部分涉及研究 包括新生儿和青少年在内的特殊人群。第五部分提供 修订政策建议。

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.