Our proposed program will serve to enhance the infrastructure of this large multiple Institutional Review Board (IRB) serving the University of Colorado Health Sciences Center and our five affiliated institutions. Our long term goal is to establish a highly efficient and effective system of IRB review of protocols that provides accessible technical and educational support to investigators for human subject protection.
Our specific aims are to 1) improve the quality of research protocols by developing an electronic protocol application that utilizes directed questions and routed follow-up questions 2) streamline administrative tracking and processing of protocols by improving the existing database 3) enhance the review process by use of electronic submission and review of protocols improving access to consultant or distant site reviewers, 4) strengthen Serious Adverse Event (SAE) review and monitoring by utilizing electronic SAE reporting which will allow for shared SAE review with Data Safety Monitoring Boards 5) enhance continuing education efforts by labelling investigators in the database with research topics in order to direct specific human subject protections education to them and 6) renovate space recently allocated in the IRB office to create an electronic IRB meeting room and additional storage space. In order to accomplish these specific aims, we will hire two additional information technology consultants to assist our database developer in making the necessary improvements to the database. LCD monitors and an LCD projector will be purchased to create the electronic meeting room. A new server and software will be purchased to support the higher web-based activity of the database proprosal. The database developer will work with the IRB director to create the electronic protocol application and laptops will be purchased for community members to participate in the electronic review of protocols. An electronic SAE form will be developed by the director, and a procedure for shared SAE review will be established with the local DSMBs. An electronic board room will be constructed in currently unrenovated space, which will include a table for the LCD monitors and an LCD projector with screen. Additional space will be rennovated to allow for storage of closed protocol files. This new comprehensive program will provide our institution with a higher level of quality, investigator participation and efficiency in review and oversight of human subject research.
