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.
