The broad, long-term objectives of this proposal are: 1) To enhance the web-based infrastructure of the Louisville Institutional Review Board (LIRB) Consortium to protect and monitor the use and safety of human subjects in clinical research; and 2) To expedite the IRB review process by maximizing opportunities for electronic interface between investigators and the IRB, while simultaneously increasing the preparedness of IRB members at meetings as well as improving the processing of applications among the consortium members. The LIRB is made up of University of Louisville, Jewish Hospital Healthcare Inc., Norton Healthcare, Inc, and the University Medical Center, Inc.
Aim 1 is to develop and implement secure web-based forms for electronic submission of three IRB documents: 1) an IRB application, 2) a Serious Adverse Event form, and 3) a Progress Report/Continuation Request form. All three web-based forms will interface with an Oracle database and be accessible via all four institutional websites.
Aim 2 is to test, at one IRB committee site (20 IRB members), the impact of electronic file sharing of IRB meeting materials (member packets) on IRB review process time and IRB member preparedness. Hardcopies of all submission materials will be scanned into PDF files and placed in an administratively secure area on the University of Louisville website (user ID and password needed) to give IRB members easy electronic access to documents and reviewer forms.
This aim will test the hypothesis that electronic management of IRB documents will expedite the IRB review process and increase the preparedness of IRB members at meetings. To test this hypothesis, a pre- and post-Web-based system survey of the IRB members at one site will be conducted to measure the outcomes of member preparation time, meeting time, and self-assessed member preparedness at meetings. Greater member preparedness should tmean a faster and better IRB review process and improved protection of human subjects in clinical research.
