This project is focused at accomplishing three specific aims in improving the accountability of research involving human subjects from compliance, record keeping, tracking and education of researchers and IRB staff (members and office staff) whether the research engages live human subjects, their records or tissue samples or social and behavioral and epidemiological research conducted with or without subject identifiers. The three main specific aims are as follows: 1. To improve and migrate the current innovative and robust, but non-user friendly human subjects research database to a more state-of-the-art version of R:Base program that is more efficient and less cumbersome in terms of data entry and tracking methods at the same time the database can be used by password protected remote users to monitor the progress of their projects and respond to the requirements of the IRB including adverse event reporting on a real time basis. This improvement and migration of database will be done by R:Base experts. 2. The second objective of this study is to create an internal university community-based regulatory and ethics research forum (UCREF) using the same paradigms and expertise of Drexel University's Math Forum that is serving over half a million individuals interested in mathematics. UCREF features will include a library of regulatory and ethics documents with embedded help links, frequently asked questions sections, and the ability to ask questions of an expert. Registration for the site will be required, giving different levels of permission to investigators and coordinators. Investigators will be guided in accurately characterizing the regulatory requirements for their studies, so that they will be able to prepare for the proper levels of review and submit appropriately prepared documents. 3. The final objective of this RFA is to establish a dedicated server that not only supports the updated R-Base and its functions, but also assists medical, social and behavioral scientists to conduct confidential and encrypted educational, identifiable and anonymous surveys keeping the subject identity and the information confidential. The specifics aims of this RFA are critical for the Institution at this juncture for the responsible conduct of human subjects research and to protect the rights and welfare of research participants with dignity and respect.
