The University of Texas Medical Branch at Galveston, The University of Texas Health Center at Tyler and the University of Houston - Clear Lake propose to collaboratively develop and implement a comprehensive education and training program for biomedical and socio-behavioral science researchers and to establish tools to link areas of institutional research compliance, the IRB and other processes to strengthen the overall protection of human research subjects. There will be two parts to the education and training program. The first will involve development of a web based human research protection information center with a historical prospective and educational material and hyperlinks intended to provide a knowledge base on the ethical considerations and procedures for performing human subject research. The second part will involve development and implementation of a multi-faceted, web-based education and training program that can be utilized by the three collaborating institutions. In order to link areas of institutional research compliance, the IRB and other processes, it will be necessary to implement and utilize databases to track research protocol modifications, continuing review and adverse events, and will also be used to document compliance issues, as well as insure that the research protocol is followed. Ideally, the database will track the protocol through its entire life cycle. Our intent with the education and training program is to convey the critical importance of a profound commitment to carefully designed, ethically sound, and appropriately conducted human subject research studies. A goal of all institutions is to expand their respective research programs. In so doing, it is necessary to increase awareness of human subject protection issues, policies and procedures. Educational initiatives for investigators, administrators and IRB members are in need of expansion. This project will enhance our respective Institutions' resources and knowledge for protecting human subjects and provide an education and training program that conveys the Institutions' attitude and philosophy of profound commitment to carefully designed, ethically sound, and appropriately conducted human subject research.
