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 the education programs and information technology (IT) associated with the human subject protection system at CWRU and its affiliated hospitals, 2) share this education program and its computerized documentation system with other Northeast Ohio institutions including John Carroll University (JCU), Cleveland State University (CSU), and Kent State University (KSU), 3) create a multi-institutional advisory committee to harmonize the review of tdals involving functional electrical stimulation (FES), and 4) provide for additional IRB-specific needs such as local context review procedures and support for community members. These objectives will be accomplished by acquiring additional expertise and resources (e.g., programming professionals, computer hardware and software, travel funds) that will supplement existing IRB and IT staff and resources within each institution for a one year period. This supplemental, short-term staffing and much needed equipment and travel funds will greatly accelerate the efforts to date to develop and integrate these programs and to extend them to other institutions in the Northeast Ohio region.
