Enhancements for Human Subjects Protection

这项建议是对最初拨款的延伸，以加强对人类研究受试者的保护。在本申请中，我们提出以下具体目标： 1)扩大以初步资金启动的数据库整合项目，通过与目前正在开发的电子表格系统整合，将与IRB相关的数据自动输入; 2)创建一个基于网络的IRB表格和处理系统，包括新方案、持续审查、方案修改和不良事件报告; 3)使用可用于特定研究的宏开发电子知情同意书提交 英文和西班牙文的程序; 4)通过利用GCRC受试者倡导者和IRB合规工作人员提供关于知情同意过程和数据安全性和监测计划制定的额外培训，将我们的教育计划扩展到研究协调员和研究者; 5)与德克萨斯州其他医学中心（包括德克萨斯理工大学和北德克萨斯大学）合作，在达拉斯举办“人类研究保护最佳实践”研讨会; 6)扩大质量改进计划，以减少可能影响受试者安全的研究治疗错误和方案例外; 7)通过参加2003年12月在华盛顿，华盛顿特区举行的国家PRIM&R会议，扩大IRB主席和工作人员的知识。

This proposal is an extension of the initial grant to enhance the protection of human research subjects. In this application we propose the following specific aims: 1) To expand the database integration project started with the initial funding to include the automatic entry of IRB-related data through integration with an electronic forms system currently under development; 2) To create a web-based system for IRB forms and processing, including new protocols, continuing review, protocol modifications, and adverse event reporting; 3) To develop electronic consent form submission with macros available for specific research procedures in both English and Spanish; 4) To expand our education program to research coordinators and investigators by utilizing the GCRC subject advocate and IRB compliance staff to provide additional training on informed consent processes and development of data safety and monitoring plans; 5) To collaborate with other Texas medical centers including Texas Tech University and The University of North Texas to develop a workshop on "best practices in human research protection" to be held in Dallas; 6) To expand the Quality Improvement Program to include the reduction of research treatment errors and protocol exceptions that may impact subject safety; 7) To extend IRB chairs and staff knowledge through their participation in the national PRIM&R meeting in Washington, D.C. in December 2003.