Enhancement of IRB Education & Technology

加强IRB教育

• 批准号: 6781663
• 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 2005-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6781663
• 关键词: computer assisted instruction; computer program /software; continuing education; education evaluation /planning; educational resource design /development; ethics; experimental designs; health related legal; health science research support; informed consent; training

Our proposed program will serve to improve the quality of education and 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 education in human subject protections by the creation of a comprehensive online tutorial for investigators; 2) improve the quality of continuing education for investigators by creating a series of online topical tutorials; 3) improve the quality of IRB Member education by creating educational programs available in online tutorial; 4) provide these online tutorials to affiliate IRBs within the University of Colorado system to improve consistency between IRBs; 5) Continue enhancement of the COMIRB database to support the development of electronic protocol submission. A major advantage of these new tutorials is that they include the expansion of case studies that will be tailored to individual disciplinary needs such as pediatrics since our current case studies deal with adults. Another major advantage of this program is that IRB member training, virtually unavailable in electronic format now, will be utilized widely by our large IRB and the CU System IRBs to enhance a consistent application and understanding of the federal regulations. In order to accomplish these specific aims, we will work with two co-investigators who have previously developed technology in the creation of online tutorials. Dr. Allan Prochazka who was previously a Co-chair in COMIRB and has extensive expertise in both ethics and human subject protections, will develop the educational modules for investigators, IRB members, and continuing education. Dr. Laurie Shroyer has become an expert in the technological aspects of creating these online tutorials. We also will utilize an Information Technology consultant to assist our database developer in continuing the necessary improvements to the database. A new computer will be established as an additional workstation for updating the current system. A laptop computer will be purchased for presentations of our system to other IRBs and in training investigators in the use of the electronic protocol submission process. We believe this comprehensive program will provide our institution with a higher level of quality, investigator participation and efficiency in review and oversight of human subject research.

我们提出的计划将有助于提高教育质量，并加强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的大型多机构审查委员会 (IRB) 的基础设施。我们的长期目标是建立一个高效且有效的 IRB 方案审查系统，为研究人员提供易于获得的技术和教育支持，以保护人类受试者。我们的具体目标是 1) 通过为研究者创建全面的在线教程来提高人类受试者保护方面的教育质量； 2）通过打造系列在线专题教程，提高研究者继续教育质量； 3) 通过创建在线教程中提供的教育计划来提高 IRB 会员教育的质量； 4) 向科罗拉多大学系统内的附属 IRB 提供这些在线教程，以提高 IRB 之间的一致性； 5) 继续增强COMIRB数据库以支持电子方案提交的发展。这些新教程的一个主要优点是，它们包括案例研究的扩展，这些案例研究将根据儿科等个人学科的需求进行定制，因为我们当前的案例研究涉及成人。该计划的另一个主要优点是，IRB 成员培训目前几乎无法以电子格式提供，我们的大型 IRB 和 CU 系统 IRB 将广泛利用，以增强一致的应用程序和 了解联邦法规。 为了实现这些具体目标，我们将与两位先前开发过的联合研究人员合作 创建在线教程的技术。 Allan Prochazka 博士曾任 COMIRB 联合主席，在伦理和人类受试者保护方面拥有丰富的专业知识，他将为研究人员、IRB 成员和继续教育开发教育模块。 Laurie Shroyer 博士已成为创建这些在线教程的技术方面的专家。我们还将聘请信息技术顾问来协助我们的数据库开发人员继续对数据库进行必要的改进。将建立一台新计算机作为额外的工作站，用于更新当前系统。将购买一台笔记本电脑，用于向其他 IRB 演示我们的系统，并培训调查人员使用电子方案提交流程。我们相信，这一综合计划将为我们机构提供更高水平的人类受试者研究审查和监督质量、研究者参与度和效率。