IRB Information and Education System

IRB 信息和教育系统

• 批准号: 6591960
• 负责人: ANTHONY J INFANTE
• 金额: $ 14.92万
• 依托单位: UNIVERSITY OF TEXAS HLTH SCIENCE 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 2005-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6591960
• 关键词: Internet; clinical research; computer program /software; computer system design /evaluation; continuing education; data management; education evaluation /planning; health science research support; informatics; information systems; informed consent; training

The objective of this project is to provide the Institutional Review Board (IRB) of the University of Texas Health Science Center at San Antonio with appropriate tools to manage the activities of the IRB and to provide appropriate training to the research community on the protection of human beings in research. The increased regulatory environment and workload expansion has not allowed the IRB to have a viable management tracking system nor to provide state of the art educational programs for the user community. An IRB Informatics Support system will be developed into which all protocols will be entered and tracked via web-enabled database. In addition, education programs will be created for the use of the database. Finally, a web-based educational course will be developed for clinicians and research nurses. The purpose of the course is to provide an overview of human subject use regulation, IRB protocol review and approval processes, development of appropriate protocols and informed consent forms, and other subjects relevant to human subject usage.

该项目的目的是向圣安东尼奥的德克萨斯大学健康科学中心机构审查委员会(IRB)提供适当的工具，以管理IRB的活动，并向研究界提供关于在研究中保护人类的适当培训。监管环境的增加和工作量的扩大使IRB无法拥有可行的管理跟踪系统，也无法为用户社区提供最先进的教育计划。将开发一个IRB信息学支持系统，所有协议都将通过联网数据库输入和跟踪。此外，还将为数据库的使用创建教育方案。最后，将为临床医生和研究护士开发一个基于网络的教育课程。该计划的目的是 本课程将概述人类受试者使用规则、IRB方案审查和批准过程、制定适当的方案和知情同意书，以及与人类受试者使用相关的其他主题。