Maintaining NIH Funding
Joel E. Lavine, MDPhD Professor and Vice-Chairman (Research) Chief, Pediatric Gastroenterology, Hepatology, Nutrition Columbia University
Disclosure Consultant for: o o o o o
Millenium Synageva Biopharma Gilead Sciences Crosscare Ltd. Merck
Why You May Not Hear about Your Grant
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)
Well-Funded 2013 NIH Researchers in Pediatrics • Pediatric GI/Hepatology Rules! o o o o o o
NASPGHAN’s own Ron Sokol is #1 NASPGHAN’s own James Heubi is #13 NASPGHAN’s own Rob Squires is #14 NASPGHAN’s own David Perlmutter is #41 NASPGHAN’s own Joel Lavine is #46 Thus, Hepatology trumps GI
Awards For biomedical research, 2013 was a terrible year to have a great idea.
Paylines Past and Present
(e.g.) • K Awards o o o o o
K08 Mentored Clinical Scientist Development K12 Institutional Clinical Science Development K23 Mentored Patient-Oriented Research Career Development K24 Mid Career Investigator Award in Clinical Research K99 Pathway to Independence
• R Awards o o o o
R01 Research Project Awards R03 Small Grant Program (50K) R21 Exploratory/Developmental (275K/2y) R34 Clinical Trial Planning Grant
• U01 Awards Cooperative Agreements • P01 Program Projects • T32/F32 National Research Service Awards
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 o o o
Two years isn’t much time to complete a project Up to 20 months from R01 application to award R21 may not benefit early stage investigators Although preliminary data not required, funded ones have data
Receive and Review RFAs • Funding Opportunities o http://grants.nih.gov/grants/guide/search_results.htm?year=active&scop e= 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
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
Retain Your Study Subjects • Keep your subjects engaged with informational events and newsletters • Maintains addresses and phone numbers • Make it easy for them o o o o o
Transportation Hours Timeliness Costs Language and culture
Getting Renewed: Review Successful Grants and Summary Statements http://www.niaid.nih.gov/researchfunding/grant/pages/appsamples.aspx#rpindex
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
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
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
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 o o o o o
• • • • •
Annual progress report and final report Posting public data and depositing biospecimens Final invention statement and certification Federal financial report on eRA Commons IACUC and IRB renewals and approvals 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
Timelines for Funding Renewal
Staying funded
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 o o o
IACUC/IRB Other support Certificates in Human Subjects Protection Training for all personnel Embryonic Stem Cell Registry if ES cells used
• Almost all grant budgets are cut
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
Weathering the Storm • Industry grants • Collaborate • Institutional Bridging Grants • Subawards • Tincture of time