Support for the Human Research Protection Program

支持人类研究保护计划

• 批准号: 6591407
• 负责人: PETER J DAVIES
• 金额: $ 25万
• 依托单位: UNIVERSITY OF TEXAS HLTH SCI CTR HOUSTON
• 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/6591407
• 关键词: Internet; computer program /software; computer system hardware; data management; experimental designs; health science research analysis /evaluation; health science research support; training

This application requests support for a web-based IRB protocol and tracking system. The system will provide for the electronic submissions of protocols; all subsequent investigator, IRB, and institutional actions; management of all IRB activities; integration of interfaces with other institutional units; tracking and generation of reports for both internal and external use; and archiving and permanent retention of protocols and related records. Funds are requested for software and hardware, personnel for initial implementation and training, and information technology (IT) support personnel during the year of the award. After the 1-year award period, the institution will provide ongoing support for IT personnel needs of the Office of Research Support Committees, which supports the Committee for the Protection of Human Subjects (CPHS) that serves as our Institutional Review Board (IRB). The requested system will serve the 9 schools and operating units of The University of Texas Health Science Center at Houston (UTHSC-H), one of the largest and most comprehensive academic health centers in the world. In FY 2001, the UTHSCH-H had total research expenditures of approximately $120 million, of which 56% involved human subjects. The requested system will be part of our comprehensive program which has the overall goals of emphasizing the protection of human subjects through proper research design and planning to prevent errors, rather than after-the-fact audits and sanctions, while simultaneously improving the quality of the research itself. The program will be under the direction of the Executive Vice President for Research of the UTHSC-H.

该应用程序请求支持基于 Web 的 IRB 协议和跟踪系统。该系统将提供以电子方式提交方案；所有后续调查员、IRB 和机构行动；管理所有 IRB 活动；与其他机构单位的接口整合；跟踪和生成供内部和外部使用的报告；方案和相关记录的归档和永久保存。奖项当年需要为软件和硬件、初始实施和培训人员以及信息技术 (IT) 支持人员提供资金。 1 年奖励期结束后，该机构将为研究支持委员会办公室的 IT 人员需求提供持续支持，该办公室支持人类受试者保护委员会 (CPHS) 作为我们的机构审查委员会 (IRB)。所请求的系统将为德克萨斯大学休斯顿健康科学中心 (UTHSC-H) 的 9 所学校和运营单位提供服务，该中心是世界上最大、最全面的学术健康中心之一。 2001财年，UTHSCH-H的研究总支出约为1.2亿美元，其中56%涉及人类受试者。所请求的系统将成为我们综合计划的一部分，该计划的总体目标是通过适当的研究设计和规划来强调对人类受试者的保护，以防止错误，而不是事后审计和制裁，同时提高研究的质量研究本身。该计划将在 UTHSC-H 的研究执行副总裁的指导下进行。