Human Research Protections Program Enhancements

人类研究保护计划的增强

• 批准号: 6591427
• 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 2003-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6591427
• 关键词: clinical research; education; health science research support; information systems; informed consent; online computer; telecommunications

The aim of this project is to develop enhancements to UCSD's current Human Research Protections Program (HRPP) infrastructure and educational offerings that improve the quality and effectiveness of human subjects protections. Included are specific enhancement projects that fall into four major conceptual areas relevant to the protection of human research participants: 1) HRPP program operations; 2) communications and coordination among offices and programs involved in research; 3) enhanced education for researchers performing research involving human subjects; and 4) advancing the state of the art in recognizing and managing impaired decisional capacity among potential research volunteers. Program operations will be enhanced by creating a paperless IRB submission and review infrastructure associated with a state of the art electronic document management system. Communications and coordination enhancements will focus on a new online Adverse Event reporting system that automatically notifies relevant administrative offices and makes available the details about Adverse Events as soon as those events are reported. Educational enhancements will include both educational events for researchers and IRB members, and enhancement of current web-based educational content. Assessing and obtaining informed consent in subject populations with impaired decisional capacity will be the focus of a multimedia development project. Each of the proposed enhancement projects is designed to conform to both the spirit and letter of RFA OD-02-003, in that each will create "lasting enhancements to the quality assurance capacities of the institution and its investigators to support and monitor the use and safety of human subjects in clinical research."

该项目的目的是改进加州大学圣地亚哥分校目前的人类研究保护计划（HRPP）基础设施和教育产品，以提高人类受试者保护的质量和有效性。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相关的四个主要概念领域：1)HRPP计划的运作；2)各研究单位、项目间的沟通协调；3)加强对从事涉及人类研究的研究人员的教育；4)提高识别和管理潜在研究志愿者决策能力受损的技术水平。通过建立无纸化的IRB提交和审查基础设施，以及先进的电子文件管理系统，将加强项目运作。加强沟通和协调将侧重于新的在线不良事件报告系统，该系统可自动通知相关人员