Joel E. Lavine, MDPhD Professor and Vice-Chairman (Research) Chief, Pediatric Gastroenterology, Hepatology, Nutrition Columbia University

1. Maintaining NIH Funding
Joel E. Lavine, MDPhD
Professor and Vice-Chairman (Research)
Chief, Pediatric Gastroenterology, Hepatology, Nutrition
Columbia University

2. Disclosure
Consultant for:
o Millenium
o Synageva Biopharma
o Gilead Sciences
o Crosscare Ltd.
o Merck

3. Why You May Not Hear about Your Grant

4. Overview
• Current state of funding, applicants and paylines
• Types of NIH grants
• Receive and review RFAs
• Getting Ahead of the Grant
• Getting Renewed
• Managing/administration
• Competitive Renewals
• Carry-overs/No-cost Extensions
• Weathering the Storm(s)

5. Well-Funded 2013 NIH
Researchers in Pediatrics
• Pediatric GI/Hepatology Rules!
o NASPGHAN’s own Ron Sokol is #1
o NASPGHAN’s own James Heubi is #13
o NASPGHAN’s own Rob Squires is #14
o NASPGHAN’s own David Perlmutter is #41
o NASPGHAN’s own Joel Lavine is #46
o Thus, Hepatology trumps GI

6. NIH Budgets and Awards
For biomedical research, 2013 was a terrible year to have a great idea.

7. Paylines Past and Present

8. Types of NIH Grants (e.g.)
• K Awards
o K08 Mentored Clinical Scientist Development
o K12 Institutional Clinical Science Development
o K23 Mentored Patient-Oriented Research Career Development
o K24 Mid Career Investigator Award in Clinical Research
o K99 Pathway to Independence
• R Awards
o R01 Research Project Awards
o R03 Small Grant Program (50K)
o R21 Exploratory/Developmental (275K/2y)
o R34 Clinical Trial Planning Grant
• U01 Awards Cooperative Agreements
• P01 Program Projects
• T32/F32 National Research Service Awards

9. Should You Apply for an
R03 or R21?
• R03
o Only 50K direct/year
o No preliminary data needed
o Not a good idea because money limiting development of pilot
• R21 Pros
o Exploratory and high risk research (275K)
o To introduce novel scientific ideas, model systems, tools to advance biomedical
research
o To gather preliminary data for a future R01
• R21 Cons
o Two years isn’t much time to complete a project
o Up to 20 months from R01 application to award
o R21 may not benefit early stage investigators
o Although preliminary data not required, funded ones have data

10. Receive and Review RFAs
• Funding Opportunities
o http://grants.nih.gov/grants/guide/search_results.htm?year=active&scope=rfa
• Weekly NIH Funding Opportunities and Notices
o http://grants.nih.gov/grants/guide/WeeklyIndex.cfm
• Division Chiefs should review and distribute weekly
• Keep in touch with your adult GI/liver colleagues

11. Get Ahead of the Grant
• Costs incurred 90d pre-award
chargeable
• Work on aims once submitted
• Hiring staff is key for success
• Get the IRB approved
• Keep a registry for potential study
subjects

12. Retain Your Study Subjects
• Keep your subjects
engaged with informational
events and newsletters
• Maintains addresses and
phone numbers
• Make it easy for them
o Transportation
o Hours
o Timeliness
o Costs
o Language and culture

13. Getting Renewed:
Review Successful Grants and Summary Statements
http://www.niaid.nih.gov/researchfunding/grant/pages/appsamples.aspx#rpindex

14. Strategy for Staying Funded I
• Keep publishing
• Journal impact and prestige matters
• Be sure new topic is clearly distinct from already funded
work
• Use an offshoot of research for basis of another project
• Use collaborators for working in new directions
• Submit new and renewal applications at different times
• Have more than one application in the works

15. Strategy for Staying Funded II
• Consider applying for a smaller activity code
o Exploratory/developmental grant R21
o Need to check RFAs and PAs for these grants
• Look into multi-project grants
o U01 multicenter collaborative grants
o P01 grants
• Think about partnering for small business grants
• R56 bridging grant

16. No Doesn’t Always Mean No
• Other Institutes May Be Interested
• Council Decisions Consider Priorities as Well as
Paylines
• Discussion with Project Officers Useful
• Deferred Decisions with Fiscal Year Budgets

17. Managing Your Grant
• Fully read the “Notice of Award”
o Start and end dates
o Terms and conditions
o Fund amounts for each year
• Rules and Reporting Requirements
o Annual progress report and final report
o Posting public data and depositing biospecimens
o Final invention statement and certification
o Federal financial report on eRA Commons
o IACUC and IRB renewals and approvals
o Confirmation of institution’s reporting requirements on COI, data breach,
misconduct
• Changing specific aims or scope of research
• Approval for changing key personnel or practice sites
• Request More Time or Money
• Keep in Touch with Project Staff
• Pace Funds and keep your C&G Officer close

18. Timelines for Funding
Renewal
Staying funded

19. Delay in Receipt of Funds
• At the start of a fiscal year, there is no budget
• If there are human subjects or animal concerns
• If there is a complex activity code (e.g. a cooperative
agreement)
• For “Just-in-time” awards, be good or be gone
o IACUC/IRB
o Other support
o Certificates in Human Subjects Protection Training for all personnel
o Embryonic Stem Cell Registry if ES cells used
• Almost all grant budgets are cut

20. Carry-overs and NCE
• NoA includes terms and conditions for unobligated
balances and carry-over authority
o Doesn’t apply to U, T and P Awards
• No Cost Extension
o 12 months
o Scope of project remains the same
o Unobligated balance at end of grant period
o Request prior to project end date

21. Weathering the Storm
• Industry grants
• Collaborate
• Institutional
Bridging Grants
• Subawards
• Tincture of time