Human Subjects Research Enhancements Program

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iThis proposal for human subjects research enhancements addresses the dramatically increased requirements for human subject protection and data safety and monitoring resulting from both (a) American Health Foundation's increasing focus on clinical research and (b) increasing regulatory and ethical requirements for patients' rights and protections as well as education for researchers. Our plan consists of three components, each designed to improve our ability to guarantee data security and safety and patient confidentiality in future multi-site AHF studies, a number of which are in the planning stages. They are: ? Equipment to facilitate IRB activities such as teleconferencing and training in IRB procedures, through installation of a videoconferencing Team Station at AHF's Naylor Dana Institute in Valhalla - Facilitating a tracking system for monitoring and coordinating adverse event reporting, through purchase and installation of "Oracle Clinical," a software package that supports design, management and analysis of clinical trials. ? Providing an improved means to coordinate the activities of collaborating IRBs that allow for the interchange of information and approval of consent forms used in multiple institutions, through provision of (a) remote access to the AHF computer network and (b) design and implementation of the AHF Intranet.