The Expanded Louisville Institutional Review Board Conso

扩大路易斯维尔机构审查委员会委员会

• 批准号: 6778993
• 负责人: Nancy C Martin
• 金额: $ 10万
• 依托单位: UNIVERSITY OF LOUISVILLE
• 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 2006-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6778993
• 关键词: Internet; computer system design /evaluation; health science research support; information display; information dissemination; information retrieval; university

The broad objectives of this supplemental proposal to RFA OD-02-003 are: 1)To enhance the web-based infrastructure of an expanded Louisville Institutional Review Board Consortium (LIRBC) to protect and monitor the participation and safety of human subjects in research; and 2)To expedite the Institutional Review Board (IRB) process by maximizing opportunities for electronic interface between investigators and the IRB, increase meeting preparedness of the IRB, and improve the processing of applications. The LIRBC is comprised of University of Louisville, Jewish Hospital Inc., Norton Healthcare, Inc, University Medical Center, Inc., Bellarmine University, Spalding University and the Louisville Department of Veterans Affairs Medical Center. The LIRBC members will have access to all components of the system. Aim 1 is to obtain and implement a secure web-based electronic protocol submission management system. This system will include an IRB application, protocol submission, a serious adverse event reporting system, a continuing review, management of correspondence and documentation of education in human subject protections. Additional documentation may be attached to protocol information via electronic files to give IRB members and IRB staff easy access to all research-related materials. Access to this information will be multi-tiered to ensure the privacy and security of research-related documentation. Individuals will be able to access files and data based on their roles and responsibilities as they relate to research and research oversight. Aim 2 will assess the impact of electronic file sharing of IRB meeting materials. This aim will test the hypothesis that a secure web-based electronic protocol submission management system will allow the expanded LIRBC collaboration to improve member preparedness and protection of human subjects in research in all participating institutions. A pre- and post-survey of the LIRBC members will be conducted to measure member preparation time, meeting time, self-assessed !member preparedness at meetings, and perceived enhancement of human subject protections.

RFA OD-02-003的这一补充提案的广泛目标是：1）增强基于网络的基础设施，扩展了路易斯维尔机构审查委员会（LIRBC），以保护和监控人类受试者在研究中的参与和安全； 2）通过最大限度地提高调查人员与IRB之间电子界面的机会，增加IRB的满足准备并改善应用程序的处理，以加快机构审查委员会（IRB）流程的加快。 LIRBC由路易斯维尔大学，犹太医院公司，诺顿医疗保健公司，大学医学中心，贝拉明大学，斯波丁大学和路易斯维尔退伍军人事务医疗中心。 LIRBC成员将可以访问系统的所有组件。 AIM 1是获得并实施一个安全的基于Web的电子协议提交管理系统。该系统将包括IRB申请，协议提交，严重的不良事件报告系统，持续的审查，对人类主题保护中教育的信件的管理和文档。其他文档可以通过电子文件附加到协议信息，以使IRB成员和IRB员工易于访问所有与研究相关的材料。访问此信息将是多层的，以确保与研究相关的文档的隐私和安全性。个人将能够根据其与研究和研究监督有关的角色和职责访问文件和数据。 AIM 2将评估IRB会议材料的电子文件共享的影响。该目标将检验以下假设：一个安全的基于Web的电子协议提交管理系统将允许扩展的LIRBC协作，以改善所有参与机构研究中人类受试者的成员准备和保护。 LIRBC的前后调查 会员将进行衡量成员准备时间，会议时间，自我评估 ！会议上的成员准备，并认为对人类主题保护的增强。