Human Subjects Research Enhancements at Harbor-UCLA REI

Harbor-UCLA REI 的人类受试者研究增强

• 批准号: 6591498
• 负责人: Gail V Anderson
• 金额: $ 13.44万
• 依托单位: LUNDQUIST INSTITUTE FOR BIOMEDICAL INNOVATION AT HARBOR-UCLA MEDICAL CENTER
• 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 2003-09-11
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6591498
• 关键词: biomedical facility; clinical research; computer data analysis; computer program /software; data management; drug screening /evaluation; ethics; health science research support; human rights; information systems

The Human Subjects Research Enhancements at Harbor-UCLA REI program is intended to strengthen the protection of human research subjects at Harbor-UCLA REI by improving the data collection and tracking processes and by implementing a long term program to ensure accreditation of the programs of the IRB's at REI. Specifically, the program identifies three major areas for improvement: (a) Development of Infrastructure/technology for computer tracking of human subjects protocols, secure record retention, electronic protocol submission. (b) Development of system to permit the "cradle to grave" monitoring of investigational drugs on campus (c) Implementation of an accreditation system to ensure continuing adherence to high standards of human subjects oversight The first two enhancements will permit closer tracking of research protocols, including monitoring investigational drugs. The first enhancement will also permit the IRB's and their support arm, the Compliance Office, to automate a number of essential but labor- and time-intensive operations, such as preparation of agendas, minutes and investigator memos, as well as establishing a direct link to the study sites for real time communication of IRB decisions and reporting of adverse events. The third component, by initiating regular accreditation, will permit the IRB/Compliance operations to be continually upgraded and maintained at the industry standard level for protection of human study volunteers.

港湾-加州大学洛杉矶分校的人类研究增强计划旨在通过改进数据收集和跟踪过程以及实施一个长期计划来确保IRB在REI的计划的认证，从而加强对港湾-加州大学洛杉矶分校的人类研究对象的保护。具体地说，该计划确定了三个主要的改进领域： (A)开发用于计算机跟踪人体受试者议定书的基础设施/技术， 安全记录保留、电子协议提交。 (B)建立系统，允许对研究药物进行“从摇篮到坟墓”的监测 校园 (C)执行认证制度，以确保继续遵守人类主体监督的高标准 前两项改进将允许更密切地跟踪研究方案，包括监测研究药物。第一项改进还将允许IRB及其支持机构，即遵从性办公室，自动化一些基本但耗费人力和时间的操作，如编写议程、会议纪要和调查员备忘录，以及建立与研究地点的直接联系，以便实时传达IRB的决定和报告不良事件。第三个部分，通过启动定期认证，将允许IRB/合规业务不断升级，并保持在保护人类研究志愿者的行业标准水平。