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.

我们提议的计划将有助于加强这个大型多机构审查委员会(IRB)的基础设施，该委员会为科罗拉多大学健康科学中心和我们的五个附属机构服务。我们的长期目标是建立一个高效和有效的IRB方案审查系统，为研究人员提供可获得的技术和教育支持，以保护人类主体。我们的具体目标是1)通过开发利用定向问题和发送的后续问题的电子协议应用程序来提高研究协议的质量2)通过改进现有的数据库来简化协议的行政跟踪和处理3)通过使用电子提交和协议审查来加强审查过程，改善与顾问或远程站点的联系 4)通过利用电子严重不良事件报告加强严重不良事件审查和监测，这将允许与数据安全监测委员会共享严重不良事件审查5)加强继续教育努力，在数据库中标记研究主题，以便对调查人员进行具体的人类主体保护教育；6)翻新IRB办公室最近分配的空间，以创建一个电子IRB会议室和额外的存储空间。为了达到这些具体目标，我们将额外聘请两名信息技术顾问，协助我们的数据库开发人员对数据库进行必要的改进。将购买液晶显示器和一台液晶投影仪来创建电子会议室。将购买新的服务器和软件以支持 数据库代理的基于Web的活跃度较高。数据库开发人员将与IRB主任合作创建电子协议应用程序，并将为社区成员购买笔记本电脑，以参与协议的电子审查。主任将制定一份电子SAE表格，并将与当地DSMB建立共享SAE审查的程序。将在目前尚未翻修的空间内建造一个电子板房，其中将包括一张放LCD显示器的桌子和一台带屏幕的LCD投影仪。将更新额外的空间，以便存储已关闭的协议文件。这一新的综合计划将为我们的机构提供更高水平的质量，调查员 参与和监督人类主题研究的审查和效率。