Navigating the Alphabet Soup of the NIH

Transcription

1 Navigating the Alphabet Soup of the NIH Yolonda L. Colson, MD PhD Associate Professor of Surgery Division of Thoracic Surgery Brigham and Women s Hospital Harvard Medical School

2 Disclosures: No Disclosures

3 The Start of the Alphabet FUNDING OPPORTUNITY ANNOUNCEMENTS (FOA) Parent Announcement (PA) often Institute or Center (IC)-specific Non-specific, investigator initiated unsolicited areas of research Any topic within NIH mission Institute or Center (IC)-specific PA are funding priority reminders PA renewed every 3 yrs if still a priority Standard dates for submission Study Section Review through Centers for Scientific Review (CSR) No set-aside $, so funding depends on overall paylines If aligned with IC-specific PA can fund high priority grants below payline

4 The Start of the Alphabet RFA Request for Applications Proposals focused on specific problem or scientific need Often one-time request with a single specific due date All applications reviewed by the same committee Special Emphasis Panel (Scientific Review Group or SRG) Panel formed for single review not standing study section Resubmissions go to Study Section, cannot go back to Special Emphasis Panel Set aside dollar amount or number of awards stated Competition dependent on number of applications and targeted $

5 What Type of Grant? Stage of Career and Eligibility Training Fellow New Independent Investigator (Early Stage Investigator or ESI) Established Investigator Ability to Establish Independence Do you have Preliminary Data? What Do You Need the Funding For? 4-5 years of full research support Salary support with some funds for initial research Collection of initial preliminary data only Conference Is Your Proposal Part of a Group of Inter-related Projects Is Success Dependent on all Projects Being Funded

6 Early Stage Investigator (ESI) New Investigator: Completed last research degree or residency in last 10 years No prior substantial, competing NIH grant ESI bonus only considered for R01 paylines Must be ESI or transition to ESI for some mechanisms: Pathway to Independence Awards (K99/R00) NIH Director s New Innovator Award New Investigators with highly innovative research ideas Qualifications & proposal reviewed by multi-phase editorial board Innovation, Creativity and Impact more than preliminary data 5-yr budget requested for up to $300k/yr Minimum PI effort of 25% Total # awards for ENTIRE NIH in 2013 is ~ 33!

7 NIH Grant Mechanisms R series: Research Grants RO1: Research Project Grant Program Typical NIH funded lab mechanism Usually ~$250k/yr for up to 5 years (4 years as of 2014) Modular budget via $25,000 modules, rather than detailed Typically awarded less than $250k/yr Need permission if >$500k in any year Yearly progress reports (non-competing renewal) Submit competing renewal 1-2 years before end of grant Competes in Study Section with other RO1s (new & old) No mandatory PI effort commitment Eligible for supplements etc Qualifies for ESI bonus

8 NIH Grant Mechanisms RO3: Small Grant Program Limited research scope pilot or feasibility studies Self-contained research projects Development of new technology Preliminary data or analysis of existing data or database Usually < $50k/yr for up to 2 years Non-renewable Usually NOT good mechanism for new investigator Limited funds Short duration

9 NIH Grant Mechanisms R21: Exploratory/Developmental Research Grant Awards Early Stages of Project Development, Higher Risk Less or ~no preliminary data Still very competitive (so preliminary data always helps) Development of new technology Preliminary data or analysis of existing data or database Only 2- yr grant so commonly for feasibility or pilot with goal of future longer-term funding -- R01 etc. Combined 2 year budget usually $275k Much debate about utility for new investigators More $$ but still short time period

10 NIH Grant Mechanisms R41/42: Small Business Technology Transfer (STTR) and R43/44: Small Business Innovative Research (SBIR) Stimulate scientific and technologic innovation via cooperative R & D between small business concern and research institution STTR: PI may be employed by business or research institute May require formal appointment to business Be aware of Conflict of Interest policies at your institution SBIR: funding in for-profit institution, PI employed by business Milestones Outlined for Each of 3 Phases Phase I Establish feasibility ~ $150k, usually 1 yr Phase II full R & D effort for 2 years ~ $ 1 million Phase III Commercialization, STTR funds cannot be used These grants are from separate set-aside funds targeted for these programs so funding level is higher (i.e. lower payline)

11 R Award Funding Fiscal Year R Award Number of Applications Reviewed Number of Applications Awarded Success Rate* Total Funding 2013 Percentile Pay Line 2012 New R01 24,637 3, % $1,592,528,845 NCI 7th 2012 Renewal R % $690,983, R03 2, % $47,758, R21 13,743 1, % $422,632,904 NHLBI ~ 6 th ESI 20 th NCI Priority score > 25 NHLBI - NA NCI 7 th NHBLI ~ 6th *Reviewed grants that ultimately received funding during that year. Note: Success rate is different than payline which is based on ranking of priority score.

12 NIH Grant Mechanisms P series: Program Project and Center Grants Research Program Projects (P01) Multi-project Research Application with common theme Involves several independent investigator projects and associated core and administrative resources Each Project is essentially an RO1 which is supports and is supported by the other Projects Each project must support well-defined research goal Strong PO1 can be good mechanism to get new investigator funded PO1 does not get ESI bonus however

13 NIH Grant Mechanisms K series: Career Development Awards (Dr. Kirschestein) Mentored grants for collection of preliminary data in a supervised research environment ~2 mentors with sufficient independent research support to cover costs of proposed research not covered by K award Standard application dates 3-5 yrs of support for Salary + Fringe, supplies & research expenses Salary capped at ~ $75-100k/yr plus fringe OFTEN REQUIRES 50-75% TIME COMMITMENT! Varies by Institute so check this Indirect $ only at 8% (rather than >60 70 % for RO1 funding) Look for Combined programs: see TSFRE-NCI, TSFRE-NHLBI Additional matching funds for CT surgeons awarded K grants Unique PA for minority applicants or for interest in aging

14 NIH Grant Mechanisms K08 - Mentored Clinical Scientist Research CDA Support and protected time for MDs in biomedical or behavioral research, can be translational i.e. Health-related research that does not directly involve patients K23 - Mentored Patient-Oriented Research CDA Support and protected time for MDs in patient-oriented research i.e. Human subjects research with IRB etc use of human tissues Exemption 4 not included Mechanisms of human disease, therapeutic interventions, clinical trials, new technologies Budget for either mechanism: NCI: Salary $100k + fringe/yr; Supplies etc $30k/yr NHLBI: Salary $75k + fringe/yr; Supplies etc $25k/yr May not hold concurrent AHA Scientific Development Grant etc Confirm required time commitment with individual institute

15 NIH Grant Mechanisms K99/R00 NIH Pathway to Independence (PI) Program Transitional Career Award from postdoc to competing for R01 Outstanding candidates < 5 yrs of clinical or research doctorate Do not have tenure track assistant professor position Call NIH to clarify if thinking of this mechanism Phase I: 1-2 yrs mentored research support ($90k/yr) Need designated mentor Phase II: 3 yr transition to independent support (< $249 K/yr) Contingent on securing independent research position Tenure track assistant professor or equivalent Still requires commitment of 75% of full-time effort Expectation to compete successfully for R01 during Phase II

16 K Award Funding Fiscal Year K Award NIH Institute / Center Number of Applications Reviewed Number of Applications Awarded Success Rate* Total Funding 2012 K08 NCI % $3,464, K08 NHLBI % $3,211, K08 Activity Total % $23,254, K23 NCI % $687, K23 NHLBI % $2,635, K23 Activity Total % $31,820, K99 NCI % $3,089, K99 NHLBI % $4,121, K99 Activity Total % $21,549,955 *Reviewed grants that received funding. Note: Success rate is different than payline.

17 NIH Grant Mechanisms T and F series: Training and Fellowship Grants T32 (institution program) and F32 (individual applicant) Stipend and small research allowance to help defray expenses during training Pre and postdoctoral applicants Stipend based on PGY level Health insurance, supplies, equipment, books, travel all allowed Up to 3 years support for postdoctoral Full time effort during residency years Individual sponsor for F32

18 Summary Grant Duration (yrs) Funding Limits/yr R01 4 ~ 250k* New 14.9% R k 19.9% R k (275k total) 14.4% STTR/SBIR 1 then 2 150k (phase I) 1,000,000 (phase II) K08/K k 30-40% * Special request if over $500k for any year Success Rate (Different than payline!) STTR I/II: 20.3%/39.4% SBIR I/II: 15.6%/39.9%

19 Q39. An Early Stage Investigator (ESI) can be within 10 years of completing their residency and have had a prior K award? a. No, ESI status is lost with a K award b. No, 10 years is too long to be a new investigator c. Yes prior training grants do not impact ESI status

20 Q40. If you do not have preliminary data you should... a.submit an R01 grant and outline what data you will generate with funding b.consider applying for a K series (K08 or K23) or other Foundation Grant with a senior mentor/sponsor c.make up really good data from the literature

21 Q41. Which grant mechanism requires a significant 50-75% dedicated research time commitment? a. R01 b. R21 c. P01 d. Career Development Grants such as K08/K23

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