Dear Colleagues:
The UCSF Clinical and Translational Science Institute (CTSI)-Clinical Research Services (CRS) is undergoing a transformation in its financial model to better accommodate the marked increase in the demand for our services by an ever widening group of UCSF investigators.
For over 40 years, the NIH has provided infrastructure support for clinical and translational science through the former General Clinical Research Centers (GCRCs) at nominal, if any, cost to investigators. Currently, the growing popularity and demand for the CTSI-CRS’s quality services has simply outgrown the level of NIH support.
To continue to meet the ongoing commitments to our investigators and develop new services based on their evolving needs, we must develop and implement a different, more durable, funding model. Our transformation also aligns with the shift of the NIH’s expectations that the costs of clinical and translational research are borne in large part by individual grant awards supported by each NIH Institute/Center.
The CTSI-CRS goal is to establish a financial model that will allow the organization to continue to maintain existing high quality core services and develop new services to address emerging needs. For example, in response to investigator feedback, two new service cores are under development – the Clinical Research Coordinator Core and the Participant Recruitment Service. In addition, new IT systems will help improve efficiency and bring new tools and templates to support clinical research.
While some of our core services and sites have had a policy of cost recovery and many of our investigators have been engaged in this transition over the past several years, we have reached the point where we must fully transition all of our core services and investigators to the new model through a fair and transparent process. This will ensure our ability to maintain the high quality of services you have come to rely on, despite decreasing support from NIH coupled with escalating salary and benefits costs. For more details see the attached Guiding Principles for Cost Recovery developed by our Cost Recovery Task Force.
Many investigators have already adopted this fee-for-service model, have included CRS costs in their grants, and are paying for services. Now, for all grants submitted December 1, 2011 or after, costs for CRS services must be included in the budget. CRS staff will work with you to include costs for the services you plan to utilize in your budget proposal. If you are planning a competitive renewal of an existing clinical research study or submitting a new clinical research protocol, we will assist you and your staff to develop your budgets in line with our new cost recovery model. Please note that if you are presently conducting a research project in one of our eight CTSI-CRS sites every effort will be made to fulfill prior commitments to your on-going, funded research projects.
In your future plans for the use of CTSI-CRS services (e.g., nursing services, sample processing, bionutrition services, body composition/exercise physiology services, etc.), we offer the following resources and support for you and your research team.
- For assistance in preparing the CRS budget component of your new application/s to NIH, Industry or Non-Profits, or NIH competitive renewal applications, or if you have recently received a grant award and plan to use the CTSI-CRS, please call Cathleen Tierney at 415-476-9232 to discuss your budget and the funding available to support your research study.
- To facilitate your future research applications, samples of our standard letter of support are available online. A letter of support will be provided when the CRS budget has been finalized.
- For general assistance in accessing CRS services, please contact Leslie Mullin at 514-2292. She can provide you with information about available CRS services, direct you to core directors for more specific information, or connect you with the CRS nursing or medical director at the site where the work will be performed.
- More information on CTSI-CRS services
- A CRS cost recovery Frequently Asked Questions (FAQ) is enclosed for your reference.
As we provide proposal pricing to investigators we anticipate that gaps in funding, budgetary challenges, and special circumstances will be identified and addressed. We expect that support for unfunded studies and for underfunded investigator initiated studies will be needed. We will work with investigators to identify cost-containment strategies or other means of supporting these projects.
Utilization of CRS services is at an all-time high. The CRS has supported over 1,500 protocols over the past 5 years, including more than 325 protocols in 2010-11. This has resulted in notable scientific successes for UCSF. I sincerely look forward to your input, involvement and support as we embark on a new era of enhanced CTSI Clinical Research Services, to continue to facilitate and support your research endeavors and successes.
All the best,
C. William Balke, MD, Program Director
UCSF/CTSI-Clinical Research Services