San Diego Regional IRB Enhancements

圣地亚哥地区 IRB 增强功能

• 批准号: 6778759
• 负责人: EDWARD W HOLMES
• 金额: $ 25万
• 依托单位: UNIVERSITY OF CALIFORNIA, SAN DIEGO
• 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/6778759
• 关键词: clinical research; computer network; data management; education; health related legal; health science research support; information systems; informed consent; online computer; telecommunications

The aim of this project is to transfer technology and capabilities developed by the University of California, San Diego's Human Research Protections Program (HRPP) to other institutions in the San Diego region in order to facilitate the efficient and effective protection of research subjects. Included are specific enhancement projects that fall into three major conceptual areas relevant to the protection of human research participants: 1. To transfer computerized IRB systems developed at UCSD under the original IRB enhancement grant program to San Diego Children's Hospital and Health Center; 2. To create an online multi-lRB submission process that enables investigators conducting research at more than one site to have a single point of interaction with multiple IRBs in the San Diego region; and 3. To create new educational resources focused on the conduct of research in pediatric populations. These projects address both the spirit and letter of RFA 0D-03-007, including "development of infrastructure/technology for computer tracking of human subjects protocols, secure records retention, electronic protocol submission," "Development of systems for coordinating activities of multiple IRBs when participating in multi-center clinical trials," and "Development of educational initiatives for investigators, administrators and IRB members in the safe and ethical conduct of clinical research." The projects are designed with the express purposes of "reaching out to other institutions that conduct human subjects research but do not receive HSREP support."

该项目的目的是将加州大学圣地亚哥分校人类研究保护方案开发的技术和能力转让给圣地亚哥地区的其他机构，以促进对研究对象的有效保护。其中包括具体的增强项目，这些项目属于与保护人类研究参与者有关的三个主要概念领域：1。将加州大学圣地亚哥分校根据原始IRB增强资助计划开发的计算机化IRB系统转移到圣地亚哥儿童医院和健康中心; 2.创建在线多IRB提交流程，使在多个研究中心开展研究的研究者能够与圣地亚哥地区的多个IRB进行单点交互;以及3.创建新的教育资源，重点是在儿科人群中进行研究。这些项目符合RFA 0 D-03-007的精神和文字，包括“计算机跟踪基础设施/技术的开发 人类受试者方案、安全记录保留、电子方案提交”、“开发参与多中心临床试验时协调多个IRB活动的系统”和“为研究者、管理人员和IRB成员制定临床研究安全和道德行为的教育计划。这些项目的设计目的是“与其他进行人类受试者研究但不接受HSREP支持的机构联系”。"