Human subjects research at New England Medical Center and affiliated hospitals has expanded in recent years. To accommodate this expansion and ensure proper oversight of clinical research, a second institutional review board (IRB) was put in place. The administrative systems were also expanded in order to support two boards. One major component of the sytem still in need of upgrading and enhancement is the database that tracks ongoing studies. It was developed with a different set of needs than currently exist and must be upgraded to meet new requirements. The proposed enhancements will increase the automation of report generation, integrate the reporting of adverse events into the database and create on-line submissions for continuing renewal of research protocols. The data related to research involving human subjects is currently intertwined with other hospital data. This proposal includes a new computing platform to provide dedicated and secure storage for the enhanced database. The hardware will additionally lay the foundation for secure access to IRB systems by researchers from affiliated institutions. The proposed improvements for data storage, both format and platform, will allow for better oversight and protection of the safety and privacy of volunteers in clinical research.
