Web Based System for Efficient and Thorough IRB Review

本项目的目的是设计和实施一个电子路由和数据库系统，通过以下方式提高人类受试者审查过程的效率：1）使申请过程对研究者更加用户友好; 2）鼓励机构审查委员会（IRB）成员进行更彻底的审查，同时缩短周转时间; 3）改善研究者与IRB之间的沟通; 4）为合规性审查过程、数据存储和检索提供额外的安全性; 5）通过自动化提交，批准通知，持续审查、项目结束和先决条件审查 在研究账户开立之前; 6）为研究者、关键人员和支持人员提供额外的教育机会，7）创建评估人类受试者保护计划的计划，并将合规性审查过程与申办项目管理办公室的管理过程联系起来。 拟议的系统将有一个与安全服务器上的数据库的网络接口。整个过程中的沟通将通过这一界面、电子邮件以及在规定和必要的情况下通过硬拷贝进行。该系统将包括以下模块：1）主要研究者提交的提案/方案; 2）科学审查; 3）IRB审查; 4）修改; 5）项目的持续审查和关闭;以及6）研究者和IRB成员的教育。特别注意系统的安全性，与校园内其他行政数据库的链接和评估。

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.