Research involving human participants at the University of Chicago is conducted under a single comprehensive Multiple Project Assurance. One MPA indicates an institutional culture and obligation that research with human subjects conforms to the highest ethical standards and protections regardless of the discipline. Research programs at the University of Chicago are diverse and complex: from the most invasive and high risk clinical studies to benign surveys of less than minimal risk. The University of Chicago supports 5 IRBs serving Biomedical-biological sciences/University of Chicago Hospitals (3 IRBs), the School of Social Service Administration/Chapin Hall Center for Children IRB, and the Social & Behavioral Sciences IRB, which supports all other disciplines involved in human research. Collectively these IRBs are responsible for over 2500 active protocols, new and continuing reviews, and over 1600 hundred amendments to existing protocols/year. We believe that strengthening the oversight of human subjects research protections at The University of Chicago can best be achieved by significantly improving the information systems that support the IRBs and by providing new tools for investigators that will significantly improve the quality of the protocols they submit to the IRB, particularly for clinical research. With NIH funding, we propose to make significant and sustainable improvements in our human research protection program. Our objectives are: (1) Improve the quality of investigator-initiated protocols with a web-based protocol development tool informed by regulation, policy and institutional procedures; (2) Transfer data and records from legacy systems to new IRB information and management systems already in development at the University; and (3) Provide IRB administrators with workstation tools that can fully and efficiently deploy the benefits of the new systems.
