Human Subjects Research Enhancement and Outreach

The overall goal of this project is to strengthen human research protection at the University of Kentucky (UK) and five partner institutions: Florida International University (FlU), Morgan State University (MSU), New Mexico State University (NMSU), Northern Arizona University (NAU), and the University of Alaska Fairbanks (UAF). UK proposes two initiatives 1) to provide technical assistance and program enhancement to partners through resource sharing, professional development support, and mentoring and 2) to expand UK technology infrastructure by purchasing laptop computers to support Institutional Review Board (IRB) activities and by conducting assessment and initial implementation of an electronic protocol submission system. To address these two broad objectives, UK proposes the following Specific Aims: 1) to share resources and "best practices" with partners in the form of educational, assessment, and compliance tools, 2) to ensure effective partner implementation of shared resources through on-site mentoring and professional development support, 3) to facilitate UK IRB review of electronically maintained protocol records through purchase of laptop computers for IRB reviewers and staff, and 4) to develop the technology infrastructure at UK to support electronic submission of protocols to the IRB. Resources to be shared with the partner institutions include educational and policy materials, adverse-event reporting tools, quality improvement tools, and electronic submission assessment resources, all of which will significantly enhance institutional capacity to provide human research protection. In addition, there will be on-site mentored implementation of these shared resources, and representatives from the institutions will attend professional development programs. To develop human research protection technology infrastructure, UK will build on a current project to electronically archive alllRB records by providing computers to assist IRB members and staff with IRB review of archived records. UK also plans to develop an electronic protocol submission process by identifying, reviewing, and assessing currently available electronic protocol submission systems appropriate to UK's needs. Once a program has been selected, a development design consultant will perform a gap analysis and begin development of the web-based IRB system.