EVALUATION OF NIH IMPLEMENTATION OF SECTION 491

该项目的目标是评估目前的方案， 全面的方式。 该项目旨在解决以下六个问题 问题： 问题1：目前的人类受试者保护计划 其设计和运行实现了其初衷，即保护 充分保护生物医学和生物技术所涉人类的权利和福利， 行为研究 问题2：是否有可信的证据表明与过去的调查结果相比发生了变化 研究人员的知识、态度和行为研究 关于保护人类受试者的权利， 这是1981年推出的一项计划。 问题3：目前的设计是否有具体的特点， 该计划，如果得到纠正，将有可能提高性能， 该计划，无论是通过减少其成本和负担，或减少 发生严重问题的可能性？ 问题4：有哪些方法和程序，包括 前几个委员会的建议， 似乎有能力提高充分性和效率， 获得和记录受试者知情同意的过程？ 问题5：是否有IRB监督方法， 有效地实现了计划的目标。 问题6：在方案的哪个领域， 政府似乎需要提高绩效？ 这些问题的答案将提供给：1）联邦政策制定者; 2)该系统和相关政府的联邦管理人员支持 研究活动; 3）研究的执行者，包括研究 调查人员和负责问责的机构官员 来实施这个计划。 需要这些信息来确保 方案的合理性，并根据以下情况提出方案修订建议： 业绩的证据。

The objective of this project will be to assess the present program in a comprehensive way. This project is intended to address the following six questions: Questions 1: Does the Human Subjects Protection Program in its current design and operation fulfill its original intent which was to protect adequately the rights and welfare of humans involved in biomedical and behavioral research? Questions 2: Is there credible evidence of a change from findings of past studies in knowledge, attitudes and behavior among research investigators regarding the protection of the rights of human subjects which can be attributed to the program introduced in 1981? Question 3: Are there specific features in the current design of the program, which, if corrected, would be likely to improve the performance of the program, either by reducing its cost and burden, or reducing the likelihood of serious problems occurring? Question 4: What methods and procedures, including changes stemming from the recommendation of the earlier commissions, have been adopted which appear to be capable of improving the adequacy and efficiency of the process of obtaining and documenting informed consent of subject? Question 5: Are there IRB oversight methods which appear to be especially effective in meeting the objectives of the Program? Question 6: In what area of the program, does action by the Government appear to be needed to improve performance? Answers to these questions will be provided to : 1) Federal policy makers; 2) the Federal managers of the system and of related government supported research activities; 3) the performers of research, including both research investigators and the institutional officials charged with accountability for implementing the program. The information is needed to ensure the soundness of the program and to recommend program revisions in the light of evidence on performance.