Support for the Human Subjects Protection Program at UTH

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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.