Support for the Human Subjects Protection Program at UTH

该提案有两个目标。第一个是支持德克萨斯大学休斯顿健康科学中心(UTHSC-H)实施电子IRB协议和跟踪系统。HSREP第一年提供的支持已用于评估和购买互联网研究信息系统(IRIS)IRB协议管理系统(iMedRIS数据公司)。IRIS系统的实施将包括开发基础设施/技术，以支持以计算机为基础的电子协议提交和审查、协议跟踪和安全记录保留。还将利用支持将电子礼仪管理系统纳入针对调查人员、管理员和IRB成员的持续教育方案。该计划的第二个主要目标将是开发一种 UTHSC-H IRB与德克萨斯南方大学、普莱里维尤农工大学和德克萨斯大学布朗斯维尔三所地区机构IRB之间的合作项目。该计划的目标将是共享人类受试者研究的教育计划，促进互惠的咨询资源，特别是在人类受试者研究中文化敏感问题的领域，并分享在HSREP主持下开发的IRB电子数据管理系统的技术。在1年的获奖期后，该机构将为参与研究支持委员会办公室的技术和外展计划的人员提供持续支持，该办公室支持我们的机构审查委员会。所要求的系统将为9所学校和运营单位提供服务 UTHSC-H是世界上最大、最全面的学术健康中心之一。外展方案将导致建立一个区域机构网络，合作开发最佳资源，以开展符合道德和负责任的人体研究方案。所要求的系统将是我们综合计划的一部分，该计划的总体目标是通过适当的研究设计和规划来强调对人类主体的保护，以防止错误，同时提高研究本身的质量。该计划将在UTHSC-H研究执行副总裁的指导下进行。

There are 2 goals to the proposal. The first is to support implementation of an electronic IRB protocol and tracking system at the University of Texas Health Science Center at Houston (UTHSC-H). Support from the first year of the HSREP has been used to evaluate and purchase an Internet Research Information System (iRIS) IRB Protocol Management System (iMedRIS Data Corporation). The implementation of the iRIS system will include the development of infrastructure/technology to support computer-based electronic protocol submission and review, protocol tracking and secure records retention. Support will also be used to incorporate the electronic protocol management system into the ongoing educational programs for investigators, administrators and IRB members. The second major goal of the program will be to develop a collaborative program of interaction between the UTHSC-H IRB with the IRB's of three regional institutions, Texas Southern University, Prairie View A&M University and the University of Texas Brownsville. The goals of this program will be to share educational programs in human subjects research, to facilitate reciprocal consultative resources particularly in the areas of culturally sensitive issues in human subjects research, and to share the technologies for electronic IRB data management systems developed under the auspices of this HSREP. After the 1 year award period, the institution will provide ongoing support for personnel involved in both the technology and outreach programs of the Office of Research Support Committees, which supports our Institutional Review Board. The requested system will serve the 9 schools and operating units of UTHSC-H, one of the largest and most comprehensive academic health centers in the wodd. The outreach program will lead to the establishment of a network of regional institutions collaborating to develop optimal resources for the conduct of ethical and responsible programs of human subjects research. The requested system will be part of our comprehensive program which has the overall goals of emphasizing the protection of human subjects through proper research design and planning to prevent errors, while simultaneously improving the quality of the research itself. The program will be under the direction of the Executive Vice President for Research of the UTHSC-H.