The broad objectives of this supplemental proposal to RFA OD-02-003 are: 1)To enhance the web-based infrastructure of an expanded Louisville Institutional Review Board Consortium (LIRBC) to protect and monitor the participation and safety of human subjects in research; and 2)To expedite the Institutional Review Board (IRB) process by maximizing opportunities for electronic interface between investigators and the IRB, increase meeting preparedness of the IRB, and improve the processing of applications. The LIRBC is comprised of University of Louisville, Jewish Hospital Inc., Norton Healthcare, Inc, University Medical Center, Inc., Bellarmine University, Spalding University and the Louisville Department of Veterans Affairs Medical Center. The LIRBC members will have access to all components of the system.
Aim 1 is to obtain and implement a secure web-based electronic protocol submission management system. This system will include an IRB application, protocol submission, a serious adverse event reporting system, a continuing review, management of correspondence and documentation of education in human subject protections. Additional documentation may be attached to protocol information via electronic files to give IRB members and IRB staff easy access to all research-related materials. Access to this information will be multi-tiered to ensure the privacy and security of research-related documentation. Individuals will be able to access files and data based on their roles and responsibilities as they relate to research and research oversight.
Aim 2 will assess the impact of electronic file sharing of IRB meeting materials.
This aim will test the hypothesis that a secure web-based electronic protocol submission management system will allow the expanded LIRBC collaboration to improve member preparedness and protection of human subjects in research in all participating institutions. A pre- and post-survey of the LIRBC members will be conducted to measure member preparation time, meeting time, self-assessed !member preparedness at meetings, and perceived enhancement of human subject protections.
