Clinical Translational Research Center: Funding for New Projects Eric Kleerup Version 2/17/12 1

2 Clinical Translational Research Center Operations Committee Eric Kleerup, Chair John Adams Tony Butch Lin Chang Michael Irwin Ron Mitsuyasu Isidro Salusky

3 New Model for UCLA CTRC 3-Bed Inpatient CTRC (RRMC) 36 bed-days per month Inpatient scatter support High-risk outpatient visits 23-Hour Outpatient CTRC (CHS) M-F 1 weekend/month Dietitian & Kitchen Community Nurse (48 hours/month) Future continuous inpatient units at NPI, VA and/or SM-UCLA Hospital Sleep Center Continuous Inpatient Unit at Harbor-UCLA Harbor-UCLA Special Dietary Kitchen Community (CERP) Nursing, specimen processing, phlebotomy, dietary, currier, participant transportation Clinical Translational Research Laboratory

Group 1 Resources: CTRC Nursing and Nutrition Research Nursing support (CHS 23-Hour Unit) hourly nursing based on intensity of subject contact Supplemental Research Nursing support (RRMC 6W Inpatient unit)hourly nursing based on intensity of subject contact. Routine (1:4) nursing is included in the Hospital overnight rate Nutrition (Research Nutritionist and meals) Metabolic diets of different levels of complexity including controlled feeding studies Anthropometry measures, bioelectrical impedance analysis, resting energy expenditure by indirect calorimetry, and CPX testing Collection, analysis, coding and reporting of dietary intake data 4

Group 2 Resources: Inpatient Overnight Stays (RRMC) Three dedicated beds on 6 West Includes basic nursing care Current Hospital charge $ /night 5

Group 3 Resources: Patient Care Supplied Outside the CTRC Clinical Translational Research Lab Department of Pathology Adjacent to CTRC Currently 150 common tests for research Will source suppliers including the Hospital lab for other tests Not for inpatient (RRMC) stays Other Ancillary Services purchased from the Hospital Inpatient clinical labs, Radiology, Cardiac, PFT etc. 6

Group 4 Resources: Other Costs CTRC Other Costs Extensive/off site training of personnel needed for protocol Non-CTRC Other Costs Pharmacy dispensing and set-up Parking 7

8 Model for Transition: Non-Profit Grants Funded 9/1/12-12/31/15 CTSI Grant YearPI Charges 6/1/11-2/29/120% 3/1/12-2/28/135% 3/1/13-2/28/1410% 3/1/14-2/28/1515% 3/1/15-2/29/1620% 3/1/16-beyond50%

9 CTRC Subsidy Plan: Grants Funded after 1/1/16 CTRC Subsidy Limits Prior GCRC Limits Group 1: CTRC Labor (Nursing and dietary) 50% $50,000 10% direct cost PI grant Group 2: Inpatient Hospital Stays 50% $50,000 20% direct cost PI grant $30,000-60,000 Group 3: Clinical Translational Research Lab & Hospital Ancillary 50% $6,000 10% direct cost PI grant Median $3,000 IQR $1,050-6,000 Max $21,500 Group 4: NIH “Other Costs” Category 0% $0

10 Model for Transition: New Grants Funded 9/1/12-12/31/15 Duration of Grant Funding Start Date5 Year4 Year3 Year2 Year1 Year 9/1/12- 12/31/1223%16%11%9%6% 1/1/13- 12/31/1331%27%19%14%11% 1/1/14- 12/31/1439%36%32%23%16% 1/1/15- 12/31/1546%45%43%39%29% 1/1/16-continuing50%

11 Model for Transition: Grants Funded Before 9/1/12 Grant End DatePI Cost from 6/1/11- End of Grant CTRC Transition Funding CTRC Standard Funding 6/1/11-12/31/110%50% 1/1/12-12/31/121%49%50% 1/1/13-12/31/134%46%50% 1/1/14-12/31/147%43%50% 1/1/15-12/31/159%41%50% 1/1/16-12/31/1613%37%50% 1/1/17-8/31/1719%31%50%

12 Additional Subsidies New Investigators–20% NIH definition, as PI or Co-PI on parent grant CTSI Translational Research Cluster grants–10%

Funding Limits: Per Project 13 Resource TypeLimit as Percent of Direct Costs Absolute $ Limit per Calendar Year Group 1 (CTRC Labor)10%$50,000 Group 2 (Inpatient Stay)20%$50,000 Group 3 (CTRL and Hospital Ancillary) 10%$6,000 Group 4 (NIH “Other Costs”) 0%$0

Direct Cost Limits Percent of project limits doubled for Oppenheimer seed grants and CTSI Research Education, Training and Career Development Program (CTSI-ED), R21 (exploratory/developmental) and R03 (if pilot) K23 grants may use both salary and research support components to calculate limits Program project grants and Clinical Trials consortium grants use the portion of direct costs attributed to the particular project. Sub-contracts use the UCLA specific portion 14

Annual Review Utilization/Activity Changes in plan, protocol, expectations Reports from OSMB/DSMB and IRB renewal Review from Nursing and other service providers Review from Investigator regarding problems/difficulties Recognition of support in publications 15