Web Based System for Efficient and Thorough IRB Review

这个项目的目的是设计和实施一个电子路线和数据库系统，通过以下方式提高人体受试者审查过程的效率：1)使申请过程对调查员(S)更加友好；2)鼓励机构审查委员会成员进行更彻底的审查，同时缩短周转时间；3)改善调查员(S)和机构审查委员会之间的沟通；4)为合规审查过程、数据存储和检索提供额外的安全保障；5)通过使提交、批准通知、持续审查、项目结束和先决条件审查自动化，尽可能消除核准过程中的“人为错误” 在开设研究账户之前；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)创建评估人类受试者保护计划的计划，并将合规审查过程与赞助计划管理办公室的行政程序联系起来。 拟议的系统将有一个与安全服务器上的数据库连接的基于网络的界面。整个过程中的沟通将通过这个界面、电子邮件，并在受管制和必要时通过硬拷贝进行。该系统将由以下模块组成：1)首席调查员提交的提案/方案；2)科学审查；3)内部审查委员会审查；4)修改；5)继续审查和结束项目；6)对调查人员和内部审查委员会成员进行教育。特别注意系统安全、与校园内其他行政数据库的链接以及评估。

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.