Policies for CTRC support of clinical research protocols conducted at University of Colorado Hospital (UCH) & Children’s Hospital Colorado (Excluding Industry-Initiated Protocols)
The National Center for Advancing Translational Sciences (NCATS), the branch of NIH supporting the CTSA program, is changing its policies for how CTSAs across the country will support clinical research. A Program Income System is being required by NCATS, which will change the funding model of research being conducted in our Clinical Translational Research Centers (CTRCs) at UCH and Children’s Hospital Colorado. Rather than providing services at no charge, we will switch to a subsidized fee-for-service model. To support investigators with limited or no funding, a CCTSI MicroGrant program will be launched to enable investigators to buy services (at subsidized cost) from the CTRCs. However, inpatient and outpatient CTRC facilities/room charges will continue to be provided at no cost to investigators. To accomplish this transition to the new model, we will phase in charges (at cost) for research nursing, nutrition, core laboratory tests, exercise testing, vascular imaging, etc. as per the description below, and begin the MicroGrant program described in the accompanying Policy. Please read the separate paragraphs below carefully for New Protocols, Currently Active and Approved Protocols, and Pending or Previously Awarded Grants. The CTRCs and the CCTSI are committed to providing the same high quality support for clinical research; we are merely changing the funding model for these services as required by NIH. Policies for the implementation of the Program Income System at the NJH and CU Boulder CTRCs will be forthcoming.
I. For CTRC Protocols approved by SARC after 2/25/2013:
Space: All protocols may utilize the inpatient and outpatient CTRC facilities at UCH and Children’s Hospital Colorado without a facility fee.
Research Nursing: CTRC Research Nursing will continue to be provided at no cost through 6/30/2015. Investigators will be responsible for paying research rates for CTRC Research Nursing services starting 7/1/2015.
Nutrition: CTRC Nutrition services will continue to be provided at no cost through 6/30/2014. Investigators will be responsible for paying research rates for CTRC Nutrition services starting 7/1/2014.
CTRC Core Laboratory Testing: Effective 7/1/2013, investigators will be responsible for paying research rates for CTRC Core Laboratory services.
Exercise testing, body composition, etc.: Effective 7/1/2013, investigators will be responsible for paying research rates for CTRC exercise testing, calorimetry, DXA and body composition analyses.
Echocardiography and Vascular Imaging: Investigators will continue to be responsible for paying research rates for CTRC Echocardiography and Vascular Imaging services.
Hospital Clinical Charges for Research: Effective 7/1/2013, investigators will be responsible for paying research rates for Hospital expenses (clinical laboratory charges, research pharmacy charges, radiology charges, specialized medical supplies and other clinical charges) incurred during the conduct of their studies on the CTRC Inpatient or Outpatient units.
Note: New CTRC MicroGrants can be used to pay for these services.
II. For Currently active and approved CTRC Protocols (prior to 2/25/2013):
Space: All protocols may continue to utilize the inpatient and outpatient facilities without a facility fee.
Research Nursing: CTRC Research nursing will continue to be provided at no cost through the stated end-date of original CTRC support or through 6/30/2015 (whichever comes first).
Nutrition: CTRC Nutrition services will continue to be provided at no cost through the stated end-date of original support or through 6/30/2015 (whichever comes first).
Current commitments for CTRC support will be honored up to $7,000/year until the stated end-date of original support or through 6/30/2015 (whichever comes first) for the following services:
CTRC core laboratory services
CTRC echocardiography & vascular imaging
CTRC exercise testing, indirect calorimetry, DXA and body composition analyses.
Hospital expenses (clinical laboratory charges, research pharmacy charges, radiology charges, specialized medical supplies and other clinical charges) incurred during the conduct of studies on the CTRC Inpatient or Outpatient units, up to a maximum of $7,000 per year.
Protocols continuing past 6/30/2015 will require individual negotiation with CCTSI leadership to determine the level of continuing direct support of hospital clinical expenses, nutrition, research nursing and echocardiography/vascular imaging services. It is the intent of the CCTSI to provide support to allow for completion of ongoing studies whenever possible.
III. For pending grants submitted to the funding agency prior to 2/25/2013 or previously awarded grants in which payment fees for CTRC services were not included in the grant budget:
Discussions between the investigator and the CTRC leadership will take place as soon as possible to determine the annual amount, duration and types of CTRC support that may be provided for the protocol. Investigators with pending grants or newly awarded grants that proposed using CTRC resources should notify the CTRC of these awards as soon as possible by emailing Tim Lockie, administrative director of the CCTSI.
IV. Funding to support CTRC protocols:
See separate CCTSI MicroGrants Policy for procedure to obtain these funds that can be used to pay for the CTRC expenses listed above.
V. CCTSI Grant Citations and Progress Reporting:
All investigators using any CTRC resources and services are required to cite the CCTSI UL1 grant as providing support for this research in all publications (see CCTSI citation language). Investigators are also required to submit Annual Progress Report information to the CCTSI in a timely fashion when requested by the CCTSI Administrative Core annually. Failure to do so may affect continued CCTSI support of the research project.
