EVALUATION OF NIH IMPLEMENTATION OF SECTION 491

该项目的目标将是评估目前的方案 综合的方式。本项目旨在解决以下六个问题 问题： 问题1：人类受试者保护计划目前 设计和运营实现了它的初衷，即保护 充分保障人类在生物医学和医疗领域的权利和福利 行为研究？ 问题2：有可信的证据表明与过去的调查结果不同吗？ 研究人员的知识、态度和行为调查 关于保护人类主体的权利，可以是 归因于1981年推出的计划？ 问题3：在目前的设计中有没有什么具体的特点 计划，如果得到纠正，很可能会提高 该计划，要么通过降低成本和负担，要么减少 发生严重问题的可能性？ 问题4：哪些方法和程序，包括产生变化的方法和程序 前几个委员会的建议已获通过，其中 似乎能够提高 获取和记录受试者知情同意的过程？ 问题5：IRB有没有特别特别的监督方法 是否有效地实现了计划的目标？ 问题6：在计划的哪个领域， 政府似乎需要改善业绩？ 这些问题的答案将提供给：1)联邦政策制定者； 2)系统和相关政府的联邦管理人员得到支持 研究活动；3)研究的执行者，包括两项研究 调查人员和被控问责的机构官员 用于实施该计划。需要这些信息以确保 计划的稳健性，并根据以下情况建议计划修订 关于表现的证据。

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.