Enhancement Of IRB Technology, Education and Facilities

加强IRB技术、教育和设施

• 批准号: 6591643
• 负责人: JOHN RICHARD SLADEK
• 金额: $ 25万
• 依托单位: UNIVERSITY OF COLORADO DENVER
• 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 2003-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6591643
• 关键词: Internet; biomedical facility; building /facility design /renovation; computer program /software; continuing education; health science research support; human rights; information systems; method development

Our proposed program will serve to enhance the infrastructure of this large multiple Institutional Review Board (IRB) serving the University of Colorado Health Sciences Center and our five affiliated institutions. Our long term goal is to establish a highly efficient and effective system of IRB review of protocols that provides accessible technical and educational support to investigators for human subject protection. Our specific aims are to 1) improve the quality of research protocols by developing an electronic protocol application that utilizes directed questions and routed follow-up questions 2) streamline administrative tracking and processing of protocols by improving the existing database 3) enhance the review process by use of electronic submission and review of protocols improving access to consultant or distant site reviewers, 4) strengthen Serious Adverse Event (SAE) review and monitoring by utilizing electronic SAE reporting which will allow for shared SAE review with Data Safety Monitoring Boards 5) enhance continuing education efforts by labelling investigators in the database with research topics in order to direct specific human subject protections education to them and 6) renovate space recently allocated in the IRB office to create an electronic IRB meeting room and additional storage space. In order to accomplish these specific aims, we will hire two additional information technology consultants to assist our database developer in making the necessary improvements to the database. LCD monitors and an LCD projector will be purchased to create the electronic meeting room. A new server and software will be purchased to support the higher web-based activity of the database proprosal. The database developer will work with the IRB director to create the electronic protocol application and laptops will be purchased for community members to participate in the electronic review of protocols. An electronic SAE form will be developed by the director, and a procedure for shared SAE review will be established with the local DSMBs. An electronic board room will be constructed in currently unrenovated space, which will include a table for the LCD monitors and an LCD projector with screen. Additional space will be rennovated to allow for storage of closed protocol files. This new comprehensive program will provide our institution with a higher level of quality, investigator participation and efficiency in review and oversight of human subject research.

我们提出的计划将旨在增强这项为科罗拉多大学健康科学中心和我们五个附属机构服务的大型多个机构审查委员会（IRB）的基础设施。我们的长期目标是建立对IRB协议的高效和有效效率的系统，为调查人员提供可访问的技术和教育支持，以寻求人类主题保护。我们的具体目的是1）通过开发电子协议应用程序来提高研究协议的质量，该应用程序利用有导题的问题和路由后续问题2）通过改进现有数据库来简化行政跟踪和处理协议的处理和处理协议3）通过使用电子提交和审查协议访问顾问或扩展现场或远处或远处或远处或远处或远处或远处的顾问或审查来增强审核过程 reviewers, 4) strengthen Serious Adverse Event (SAE) review and monitoring by utilizing electronic SAE reporting which will allow for shared SAE review with Data Safety Monitoring Boards 5) enhance continuing education efforts by labelling investigators in the database with research topics in order to direct specific human subject protections education to them and 6) renovate space recently allocated in the IRB office to create an electronic IRB meeting room and additional storage space.为了实现这些特定目标，我们将聘请两名其他信息技术顾问，以帮助我们的数据库开发人员对数据库进行必要的改进。将购买LCD监视器和LCD投影仪，以创建电子会议室。将购买新的服务器和软件以支持 数据库前提的较高基于Web的活动。数据库开发人员将与IRB主管合作创建电子协议应用程序，并将购买笔记本电脑，以供社区成员参与协议的电子审查。主管将开发电子SAE表格，并将与当地DSMBS建立共享SAE审查的程序。电子板房将在目前未经验证的空间中建造，其中包括LCD监视器的桌子和带屏幕的LCD投影仪。将重新编译的其他空间以允许存储封闭的协议文件。该新的综合计划将为我们的机构提供更高的质量，调查员 参与和效率对人类学科研究的审查和监督。