Loyola University Chicago Stritch School of Medicine has markedly increased its biomedical research activity over the past decade. There has been a parallel rise in clinical trial actiivity also, and the recent formation of a clinical trials office promises to further accelerate human subjects research. The almost tenfold increase in research funding has placed tremendous pressures on our research infrastructure-especially in maintaining effective functioning of the IACUC and the IRB. Survey data made available from an Integrated Advanced information Management Systems planning grant has explicitly identified the urgent need for a campus-wide research comprehensive data base with a compliance component for effective IRB functioning. The School of Medicine will develop a web-based portal to serve as the foundation of an electronic research administration (ERA) system. A web based portal pilot project that allows on-line education, testing and certification of clinical investigators, implemented about a year ago on the medical center campus, has been enthusiastically embraced by our faculty and underscores the utility of a research portal system. The ERA will provide capability for on-line enhancements of IRB function including, among others, generation of a uniform application process with simultaneous creation of an executive summary, investigator prompts for heeding critical ethical and consent issues, summaries of current and prior adverse events, all prior committee minutes related to amendments and enrollment summaries. A senior programming analyst, utilizing existing infrastructure that includes Allaire's ColdFusion (v5.0) and a Microsoft SQL (v7.0) for database services, will be needed for development of the portal and the ERA. There are two independent IRBs at Loyola University Chicago. The second one is sited on the Lakeside campuses about 20 miles from the medical center. A collaborative IRB enhancement with the Lakeside IRB is planned. The School of Nursing is located on the latter campus and has dual IRB submission requirements. There is a potential for conflicting reviews in this situation. A videoconferencing enhancement will allow simultaneous discussion and reciprocal exchange of expertise of these nursing protocols. Two computers, a laptop and a video camera are the only requirements for this enhancement.
