Web Based System for Efficient and Thorough IRB Review

基于网络的系统，用于高效、彻底的 IRB 审查

• 批准号: 6591442
• 负责人: JAMES R BLOEDEL
• 金额: $ 10万
• 依托单位: IOWA STATE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2002
• 资助国家: 美国
• 起止时间: 2002-09-01 至 2003-09-11
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6591442
• 关键词: computer network; data management; education; health science research support; information systems; online computer; telecommunications

The purpose of this project is to design and implement an electronic routing and database system that will improve the efficiency of the human subjects review process through: 1) making the application process more user-friendly for the investigator(s); 2) encouraging a more thorough review by the Institutional Review Board (IRB) members while shortening the turn around time; 3) improving the communication between the investigator(s) and the IRB; 4) providing additional security for the compliance review process, data storage and retrieval; 5) eliminating as much as possible the "human error" from the approval process by automating the submission, notification of approval, continuing review, project closure and review of the prerequisites before research accounts are opened; 6) providing additional education opportunities for the investigators, key personnel and support staff, 7) creating programs to evaluate the human subjects protection programs and link the compliance review process to administrative processes in the Office of Sponsored Programs Administration. The proposed system will have a web-based interface to a database that resides on a secure server. Communication throughout the process will be through this interface, e-mails, and, where regulated and necessary, through hard copies. This system will consist of the following modules: 1) principal investigator submission of the proposal/protocol; 2) scientific review; 3) IRB review; 4) modification; 5) continuing review and closure of a project; and 6) education of investigators and IRB members. Special attention is paid to system security, linkage with other administrative databases on campus, and assessment.

该项目的目的是设计和实施一个电子路由和数据库系统，该系统将通过以下方式提高人类受试者审查过程的效率：1）使申请过程对研究人员更加用户友好； 2）鼓励机构审查委员会（IRB）成员进行更全面的审查，同时缩短转折时间； 3）改善研究者与IRB之间的沟通； 4）为合规审查过程，数据存储和检索提供其他安全性； 5）尽可能多地消除批准过程中的“人为错误”，自动化提交，批准通知，持续审查，项目封闭和对先决条件的审查 在开放研究帐户之前； 6）为调查人员，关键人员和支持人员提供更多的教育机会，7）创建计划以评估人类受试者保护计划，并将合规性审查过程与赞助计划管理办公室的行政流程联系起来。 所提出的系统将具有位于安全服务器上的数据库的基于Web的接口。在整个过程中的通信将通过此接口，电子邮件以及通过硬副本进行调节和必要的情况。该系统将包含以下模块：1）提案/协议的主要研究人员提交； 2）科学评论； 3）IRB审查； 4）修改； 5）继续审查和关闭项目； 6）调查人员和IRB成员的教育。特别注意系统安全性，与校园中其他行政数据库的联系以及评估。