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CTSA

Clinical Service Core Policy

Clinical Service Core Policy for the IIMS-FIRST Program

The Frederic-Bartter Institutional Resource to Support Translation (FIRST) Program has been constituted under the Institute for the Integration of Medicine & Science (IIMS) to support translational clinical science among the facilities of the IIMS Institutional partners. This mission will be supported through a Cost-Leveraging Policy of the IIMS. The FIRST Program has three Clinical Research Units (sites) with a limited capacity 4th component which is mobile.

  1. The Bartter Research Unit (BRU) is an inpatient/outpatient adult unit located within the Bartter Center on unit 7.A in the VA-hospital.
  2. The Children’s Health Advocacy Research and Treatment (CHART) Center is a pediatric inpatient/outpatient unit located at CHRISTUS Santa Rosa Children’s Hospital.
  3. The FIRST Outpatient Research Unit (FORU) – an outpatient unit located at 3939 Medical Drive.
  4. The FIRST - Mobile Unit to support other clinical sites in and around the South Texas Medical Center.

Purpose of Cost-Leveraging

The Clinical and Translational Science Award (CTSA) program grant to the UT-Health Science Center has created the IIMS in order to develop and maintain resources to support translational research on campus. Because resources are limited, the IIMS will prioritize resource support based upon the:

  • Significance, novelty, and potential impact of the science for transformative clinical outcomes
  • Protection of human subjects, research ethics
  • Strength of the study protocol, including design, power, feasibility, and strength of investigator team
  • Potential use of participant resources, and leveraged resources, cost recovery
  • Potential contribution to career development of junior clinical/translational scientists
  • Likelihood of future NIH or other competitive funding

Under the IIMS, the FIRST Program is mandated to leverage resources to sustain and enhance clinical research resources to support translational research. For the FIRST Program, "cost leveraging" means that the costs of conducting Phase I, II, III, and IV clinical studies will be shared between the CTSA Program grant and the local clinical investigators variously funded through alternative sources. Below we describe the plans and process for cost-leveraging in translational clinical research.

OVERVIEW of Cost-Leveraging

The IIMS-FIRST program will provide facilities, equipment, and staff resources to support a variety of clinical studies at various clinical research sites throughout the IIMS and its clinical partners in the community. Through a Single Point Of Contact, investigators may request use of these facilities, equipment, and staff resources to support their planned research. Upon this request, a FIRST Program administrative review will estimate the costs of all study procedures and visits involving FIRST Program resources and a negotiated "cost-minus discount" will be applied to those expenses based upon availability of resources, IIMS priorities, and the availability of alternative funding sources. Under this plan, basic clinical facilities and nursing or research staff support may be available at up to fully discounted rates depending on IIMS priorities, but selected services may be available only at little or no discount, again depending on IIMS priorities and available resources. IIMS priorities are to support high quality translational research conducted by both senior and junior investigators in a rigorous manner compliant with regulatory authorities. Priorities also take into account the alternative funding sources available to investigators including whether or not funding is provided by the federal government, private foundation, or private corporate interests.

MECHANISM of Cost-Leveraging

Any research studies expected to share in the costs of conducting that research will be required to identify an account number which will be charged for services provided at the negotiated rate. If the account is a UT-Health Science Center account, the account will be charged monthly by interdepartmental transfer (IDT) for services rendered. If the account is located outside of the UT-Health Science Center, then an invoice will be issued to the host institution. All revenue will be deposited into a FIRST Program Cost Recovery Account and will be reinvested in program resources to enable further extension of support to other clinical studies.

The costs of services provided to investigators will be negotiated and mutually agreed upon prior to any final study approval for support by the FIRST Program. These costs are designed to be competitive and/or discounted based upon IIMS priorities. Charges against the study account will be assessed only after satisfactory delivery of services.

Priorities to guide the overall level of discount under the Clinical Service Core Policy include 5 graded steps based on IIMS Resource priorities (see Table 1) where for top priority, the estimated costs are discounted up to 100% (i.e., free resource support at no cost). Although the overall discount level represents a target that the FIRST Program would strive to support, it should be appreciated that not all services will necessarily receive the same overall discount. Investigator’s studies receiving existing GCRC discounted support as of June 1, 2008, will continue to receive that same level of FIRST Program support until May 1, 2009, after which the IIMS priority guidelines will be applied.

 
Priority Number Overall Discount Description
1 ≤ 100% IIMS supported studies (either pilot studies or studies submitted by IIMS Clinical Scholars)
2 ≤ 75% Grants and contracts from NIH or other Federal Agency
3 ≤ 50% Exploratory or novel small pilot studies conducted to generate preliminary data for subsequent NIH or other Federal grants and contracts
4 ≤ 25% Private Foundation or selected Industry-sponsored (private corporate funding source) studies
5 0% Most Industry-sponsored studies or any other studies which may strain FIRST Program resources

The list of procedures supported by the FIRST Program and projected costs for 2008 are provided in the appended FIRST Program Procedure List.