Human Subjects Research Enhancements Program

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This grant proposal seeks to complete the development of improved procedures to monitor, enhance and facilitate the protection of human subjects involved in research and to strengthen oversight of all clinical research activities along the lines that were initiated in the first year of this Human Subjects Research Enhancement Program. In addition, we are sharing our procedures, techniques, instrumentation and knowledge gained with the professionals of the Beaufort-Jasper-Hampton Community Health Centers in rural South Carolina, serving an indigent, minority population and are institutions which are not eligible to be awarded this grant. Our specific aims continue to be: (1) To establish the equipment necessary to facilitate IRB activities, and to complete the linking of the IFCP NYC campus, the IFCP Valhalla campus and the Beaufort-Jasper-Hampton Health Centers in South Carolina through videoconferencing teamstations, (2) To facilitate a tracking system for monitoring and coordinating adverse events through a new software package that supports the conduct of clinical trials and (3) To improve coordination of IRB activities at all the collaborating institutions by providing remote access to the IFCP computer network and by developing a new IFCP intranet. Significant progress has been made towards achieving these objectives with the financial support provided by the first year of this grant. Extending the grant for a second year of support will enable these objectives to come to fruition and to create a selfsustaining system, while extending the outreach of these new resources to aid the impoverished, rural minority population of South Carolina through their regional health centers. The ongoing collaborations of IFCP and South Carolina will be greatly strengthened by the completion of upgrading procedures for protection of human subjects by funding the second year of support of this grant program.