San Diego Regional IRB Enhancements

该项目的目的是将加州大学圣地亚哥分校人类研究保护计划(HRPP)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高效和有效保护。包括与保护人类研究参与者相关的三个主要概念领域的具体增强项目：1.将加州大学圣迭戈分校根据最初的IRB增强赠款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.创建一个在线多LRB提交程序，使在一个以上地点进行研究的研究人员能够与圣地亚哥地区的多个IRB进行单点互动；以及3.创建专注于在儿科人群中进行研究的新教育资源。这些项目既符合RFA 0D-03-007的精神，又符合RFA 0D-03-007的规定，其中包括：发展计算机跟踪的基础设施/技术 人类受试者协议、安全记录保留、电子协议提交“、”在参与多中心临床试验时协调多个IRBs活动的系统的开发“以及”为研究人员、管理人员和IRB成员开发临床研究的安全和道德行为的教育倡议“。这些项目设计的明确目的是”与进行人类受试者研究但没有得到HSREP支持的其他机构接触“。

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."