With an overall goal of enhancing human research protection at the University of Kentucky (UK), the I Proposal project seeks to 1) expand the University's human subjects research mandatory education program land enhance the IRB orientation curricula, 2) strengthen the adverse event reporting system, and 3) augment Ithe existing quality assurance program. To address these three broad aims, the proposed program has been divided into three projects, which will each be lead by a dedicated project team. UK's current human research education program serves only key personnel on all NIH-funded projects and requires only initial training. The project seeks to extend UK's current use of Cynthia McGuire Dunn and Gary Chadwick's Protecting Study Volunteers in Research manual (1999) by purchasing 1,000 issues of the handbook and making the accompanying test available electronically. In addition, it will enhance UK's current education program by adopting supplemental curricula for human subjects researchers and IRB members and by developing an electronic system for documenting researchers' and IRB members' completion of initial and continuing training. Conflicting policies and reporting mechanisms make UK's existing adverse event reporting program confusing for investigators. The proposed adverse event reporting project will develop a uniform adverse event reporting policy and consolidated reporting forms, using an electronic submission format. These enhancements will simplify the reporting process, reduce delays, and enhance compliance. UK's Office of Research Integrity's Quality Improvement Program is currently limited to those studies that are selected for site review. This proposed project will expand the quality improvement/assurance efforts by developing an investigator self-assessment program, which will educate research staff and investigators on federal and University expectations and assist them in evaluating their own programs. Additionally, the proposed self-assessment program will include an on-line self-assessment tool/form and include a component to solicit feedback from subjects regarding the informed consent process and their participation. Each of the projects will be implemented and evaluated with the input of faculty researchers, IRB members, IRB professional staff, and consultants.
