Technology for Electronic Submission of IRB Protocols

Tulane University Of Louisiana, New Orleans LA

Investigators

Abstract

This application represents the institutional response from Tulane University to the Human Subjects Research Enhancements Award Program (RFA OD-02-003). This award was created by the NIH to provide interim support for institutional activities to strengthen oversight of human subjects research at institutions that receive significant NIH support for clinical research. The overall goal of this application is to obtain an award for development of technology to further enhance electronic management of IRB (Institutional Review Board) functions including initial protocol submission, IRB reviewer activities and IRB meeting management. We plan to work toward this goal in conjunction with ProlRB Plus, Inc., the developer of our current IRB software. The Tulane Health Sciences IRB reviews approximately 300 new protocols, 1000 items of miscellaneous correspondence and 1800 serious adverse event reports annually. ProlRB Plus, Inc., Tampa, FL is a software development company with experience in creating IRB-specific software which is currently in use at over 60 US institutions. The proposed collaboration will combine Tulane's IRB and regulatory expertise with the software programming expertise of ProlRB Plus., Inc. Successful collaboration will result in a product which can be made available to other research institutions for the purpose of strengthening protections offered by the IRB process. SPECIFIC AIMS: 1.) To collaborate with ProlRB Plus., a software development company, to develop and test expanded capatilities of the ProlRB Plus electronic management software. The expanded capabilities will be: (a) to allow online submission of new protocols from investigators to the IRB; (b) to allow online review of protocols and related correspondence by IRB members; (c) to allow online access to study files for IRB members and authorized investigators. 2.) To provide laptop computers for all IRB members so that during meetings, all members have online access to study documents, study history and reviewer comments.