Strengthening the oversight of human subjects research can be achieved through meaningful, ongoing education and efficient, """"""""user-friendly"""""""" information systems, as well as by addressing the specific needs of the individual IRBs. Case Western Reserve University (CWRU) and its affiliated hospitals, University Hospitals of Cleveland (UHC), MetroHealth System (MHS) and the Louis ,Stokes Cleveland Department of Veterans Affairs Medical Center (VAMC) have devoted considerable effort in each of these areas that can be built upon by the proposed project. To this end, the following specific aims are proposed: 1) expand training modules offered as part of ithe Continuing Research Education Program (CREC) to include more web-based modules for the intermediate and expert investigator as well as """"""""classroom"""""""" seminars/workshops that can be delivered at each institution, 2) develop and implement a web-based education and training database that will allow the institutions and investigators to keep track of Continuing Research Education credits, 3) upgrade the existing IRB database systems at each institution to meet their unique needs, 4) integrate these systems into a common web-based interface for access by investigators, 5) at UHC, develop a comprehensive plan for implementing a program for """"""""local context review"""""""" of protocols where the patient activity occurs in underdeveloped countries, 6) at MHS, relocate the IRB file room to a more secure location. These objectives will be accomplished primarily by acquiring additional expertise to work with existing IRB and information technology staff within each institution for a one year period. This supplemental, short-term staffing will greatly accelerate the efforts to date to develop and integrate these programs.
