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. The University of Tennessee Health Science Center is aware of the need for these enhancements and is requesting support for the development of an Office of Compliance and Data and Safety Management for research involving human participants. It is expected that this office would interface closely with all four of the UTHSC's IRBs, however, the primary aim is to provide independent oversight of research involving human subjects with the goal of improving participant safety.
The specific aims of the application would be: (a) to create an Office of Compliance and Data and Safety Management, (b) hire a Director of Compliance and Data and Safety Management, (c) hire and train research associates for each of the UTHSC medical units, (d) Utilize the competing infrastructure which has been put in place by the Vice Chancellor for research to develop monitoring, training, and educational programs. The budget requested would only provide sufficient funding for approximately half of the salaries of the proposed personnel for the first year of operation of the Office of Compliance and Data and Safety Management. The rest of the funding for the first year, as well as all expenses associated with the office (supplies, equipment, travel 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 subiects research.
