Human Subjects Research Enhancements Program

这项赠款建议旨在完成改进程序的制定， 加强和促进对参与研究的人类受试者的保护， 监督在本人类受试者研究增强计划第一年启动的所有临床研究活动沿着。此外，我们正在与南卡罗来纳州农村的Beaufort-Jasper-汉普顿社区卫生中心的专业人员分享我们的程序，技术，仪器和知识，为贫困，少数民族人口提供服务，这些机构没有资格获得这笔赠款。我们的具体目标仍然是：（1）建立必要的设备，以促进IRB的活动，并通过视频会议工作站完成IFCP纽约校区，IFCP瓦尔哈拉校区和南卡罗来纳州的Beaufort-Jasper-汉普顿卫生中心的连接，（二）通过支持开展临床试验的新软件包，促进不良事件监测和协调跟踪系统以及（3）通过提供对IFCP计算机网络的远程访问和开发新的IFCP内联网，改善所有合作机构的IRB活动的协调。在该赠款第一年提供的财政支助下，在实现这些目标方面取得了重大进展。将赠款延长到第二年的支持将使这些目标得以实现，并建立一个自我维持的系统，同时扩大这些新资源的范围，通过地区卫生中心帮助南卡罗来纳州贫困的农村少数民族人口。IFCP和南卡罗来纳州正在进行的合作将通过为该资助计划的第二年提供资金来完成保护人类受试者的升级程序而得到极大的加强。

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.