Enhancements for Human Subjects Protection

这项建议是对最初拨款的延伸，以加强对人类研究对象的保护。在本申请中，我们提出了以下具体目标： 1)扩大从初始资金开始的数据库整合项目，包括通过与目前正在开发的电子表格系统整合，自动录入与IRB有关的数据； 2)建立以网络为基础的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)开发电子同意书提交，并提供宏供特定研究使用 英文和西班牙文的程序； 4)将我们的教育计划扩展到研究协调员和调查人员，利用GCRC主题倡导者和IRB合规工作人员提供有关知情同意程序和制定数据安全和监测计划的额外培训； 5)与包括德克萨斯理工大学和北得克萨斯大学在内的其他德克萨斯医学中心合作，开发一个将在达拉斯举行的“人类研究保护最佳实践”研讨会； 6)扩大质量改进计划，以包括减少可能影响受试者安全的研究处理错误和方案例外； 7)通过参加2003年12月在华盛顿举行的全国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.