CHILDREN IN MEDICAL RESEARCH: ETHICAL& POLICY CHALLENGES

描述(由申请人提供)： 这项研究将探讨 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，而且有 研究伦理标准的系统性障碍；和2)推动政策 制造商、医疗保健分析师和医学界领袖改变做法 特别是关于儿童参与研究的政策， 该项目的主要目标是：1)审查伦理问题 由于儿童参与研究而提出的，以及需要平衡 获取和保护；2)评估《公约》的伦理和政策影响 关于参与的新的国家政策和委托编写的报告 参与研究的儿童；3)确定最近发表的儿科研究 支持当前政策和做法不充分的论点 保护儿童--主题；以及4)提出政策建议 重新平衡保护和准入之间的平衡。其主要成果是 这项研究将是一本提供持续的伦理和政策的书 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：伦理和政策挑战。这个 这本书分为五个部分。第一部分解决了问题和 当前解决方案，并包括对以下法规的历史概述 儿童参与研究和对当前政策的分析批评， 条例和指导方针。H部分题为Beecher Revisted and Address 目前的研究争议包括关于安慰剂对照的一章 临床试验，涉及健康儿童和高危儿童的研究， 基因研究和I期癌症研究。第11部分解决以下障碍 儿科研究，包括关于资金、招聘、激励、 受试者的保留和知情同意问题。第四部分：研究 针对特殊人群，包括新生儿和青少年。第五部分提供 修订后的政策建议。

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.