The University of Tennessee Health Science Center (UTHSC) has increased its NIH funding by over 100% in the past three years. This has put a strain on the University's entire research infrastructure. More so than any other area, research involving human participants has come under increasing scrutiny over the past several years. As a result, such research has demanded heightened oversight, greater protections for research subjects, and increased education for key personnel involved in the design and implementation of human trials. This application addresses the needs of UTHSC in this important area. In this application, The University of Tennessee Health Science Center is is requesting continuing support for the development of an Office of Human Subject Protections. This office was established last year through the support of our application entitled """"""""UTHSC Human Subjects Research Enhancement Program"""""""", 1S07RR018172. This office is interfaced closely with all four of the UTHSC's IRBs in Memphis, Chattanooga and Knoxville and the GCRC on the Memphis campus. However, the primary aim is to provide independent oversight of research involving human subjects with the goal of improving participant safety. The continuing specific aims of this application would be: (a) to create an Office of Human Subject Protections, (b) hire a Director of Human Subject Protections, (c) hire and train research associates for each of the UTHSC medical units, (d) Utilize the computing infrastructure which has been put in place by the Vice Chancellor for Research to develop monitoring, training and educational programs (e) Work closely with the research compliance offices of four affiliated hospitals in Memphis so that they might also benefit form this human subjects enhancement program The budget requested would only provide sufficient funding for approximately half of the salaries of the proposed personnel for this second year of operation of the Office of Human Subject Protections. The rest of the funding for the second year, as well as all expenses associated with the office (supplies, equipment, and other) will be provided by the Office of the Vice Chancellor for Research (PI of this application). Continued funding of this office is also guaranteed past the funding period. The purpose of this application is to specifically address UTHSC's needs to hire professional personnel to perform monitoring and educational services for the IRB as well as for staff and faculty involved in human subjects research.
