The continuous search for methods to improve the safety and effectiveness of human research has led to several new recommendations and guidelines from organizations at the national level. The recognition of the importance of these guidelines, and the rapid growth of human research at the Cincinnati Children's Hospital Medical Center compels us to put in place a robust and user-friendly research compliance initiative. A new Research Compliance Program (RCP), directed by Frederick Samaha, M.D., has now been formed at the Cincinnati Children's Hospital Research Foundation. The RCP will have oversight responsibilities of the Review Board, Radiation Safety Committee, Scientific Misconduct Committee, Institutional Biosafety Committee, Conflict of Interest Committee, and a Research Advocate Program for patients. The purpose of this grant application is to request funds to set up a comprehensive web-based information system that will allow investigators to complete online forms, access the status of their submissions, and view the appropriate training areas. The proposed system will provide a """"""""back-end"""""""" data-base that will enable Committee members to retdeve and understand the data needed to monitor the status of a particular protocol. The transparency of the system to the end user will help to ensure compliance, as well as providing the Director with the necessary tools to monitor """"""""real-time"""""""" compliance. This application is for a second year of funding. The purpose of year two is to complete the implementation of the systems mentioned above and to share these systems with the Tri-Health Medical Group that has not previously been funded by the first grant. The sharing of electronic systems will allow Tri-Health to upgrade their research compliance program.
