The primary objective of this project is development of an Institutional Review Board (IRB) process management system -- HIRBERT: Harvard IRB Electronic Reporting Tool -- with a common technology platform that will serve the University's three independent IRB's by facilitating and automating the protocol approval process. We envision HIRBERT as a highly flexible multi-user system that will replace three stand alone legacy systems. Development of a single system will allow for standardization of IRB data across the University without sacrificing the distinct needs of each office. It will also allow for a coordination of IRB activity not previously available. At the conclusion of the project HIRBERT will support and enable an automated approval process; allow for direct entry of application and renewal data by IRB administrative staff; support and enable agenda, minutes, letters and notification templates; strengthen and streamline the continuing review process; and link compliance and IRB processes. It will provide the IRB offices with the ability to meet University, study, investigator and sponsor reporting needs and current and anticipated federal reporting requirements. HIRBERT will provide the University with an infrastructure upon which to build a Web-based electronic protocol submission process for investigators. It will greatly reduce the burdensome administrative demands on the IRB staff thereby enabling them to devote more attention to substantive protection issues.
