The University of Missouri-Columbia is implementing its newly developed online database management system for human subjects research activities (elRB). This was funded through the 2002 NIH Human Subjects Research Enhancement program to meet the growing demand to more efficiently manage the review process and the reporting and monitoring needs of the human subjects research community. The 2002 project has been implemented successfully and ahead of schedule. The elRB currently allows electronic submission of applications, continuing review reports, amendments, adverse events, and other project-related activities. Investigators can review the status of their projects online along with IRB requirements and comments. Reporting functions allow for tracking of projects and monitoring review times. Additional online functions include document storage and upload leading to less handling of paper. In March 2003, MU hosted the Midwest Consortium to demonstrate the elRB system. The 2003-04 project proposed here will enhance the electronic educational system, develop a customized quality assurance system to facilitate existing elRB processes, and offer a shareware product for collaborative IRBs via three specific aims: ? Aim 1: Enhance the existinq human subiects and HIPAA traininq modules and develop recertification modules. A new, case-based, interactive recertification training site will incorporate actual projects. These modules will be accessible to the IRB community and collaborative sites. ? Aim 2: Develop an efficient, automated quality assurance monitorinq system, elRB is a flexible database capable of supporting our information needs. The requested funds will develop full-scale reporting capacity. ? Aim 3: Develop a shareware educational system that can interface with cooperatin.q IRBs and institutions. The MU IRB serves as an advisor to minority IRBs who conduct research under the jurisdiction of MU. This proposal will provide a venue whereby collaborating IRBs can benefit from MU's educational and quality assurance monitoring resources. User manuals will be developed for the elRB.
