Overview of the NIH

1. Overview of the NIH Ralph Nitkin, Ph.D. - RN21E@NIH.GOV National Center for Medical Rehabilitation Research (NCMRR) Eunice K. Shriver National Institute of Child Health and Human Development (NICHD) National Institutes of Health (NIH)

2. The NIH is made up of 28 Institutes, Centers, Divisions: OD NIDA NCI NIEHS NEI NIGMS NHLBI NIMH NHGRI NINDS NIA NINR NIAAA NLM NIAID CIT NIAMS CSR NIBIB FIC NICHD NCCAM NIDCD NCMHD NIDCR NCRR NIDDK CC

3. Applying to the NIH Majority of funds go to investigator-initiated proposals - rather than responding to program initiatives Funding in any given area is largely driven by number of quality applications that NIH receives in that area NIH accepts proposals in three annual cycles, typically: early February, June, and October Electronic submissions – leave time to deal with it!!! From submission to funding: 9 months - probably more for revisions Support provided to institutions in name of investigator

4. Research Project Award: R01 • Investigator-initiated applications (majority of basic & clinical NIH funding) • Focus on specific set of aims • Budget: no boundaries but typically $200-300,000 per year (direct costs) • May request up to 5 years; • If funded, and productive, can later apply for “competitive renewal” for another years

5. Small Grants: R03 and R21 • R03: Pilot studies; feasibility studies • $50,000 (direct costs) per year for two years • R21: innovative research; high-risk; pushing the envelop; new methodology or technology; • $275,000 (direct costs) spread over two years Not renewable; may not be used to supplement already-funded projects

6. AREA (Academic Research Enhancement Award): R15 • Schools that have not been major recipients of NIH funding (< $3 million/yr) • Especially projects that engage undergraduate students • Up to 3 years, aggregate budgets up to $100,000 direct costs, Renewable http://grants.nih.gov/grants/funding/area.htm

7. Small Business Tech Transfer (STTR, R41/42) Small Business Innovation Res (SBIR, R43/R44) Innovative research, potential for commercialization • STTR (partnership: small business + academic): • Phase I: $100,000 (1 year) • Phase II: $500,000 (2 years) • SBIR (primarily at small business): • Phase I: $100,000 (6 months) • Phase II: $750,000 (2 years) http://grants.nih.gov/grants/Funding/sbir.htm

8. Midcareer Investigator Award in Patient-Oriented Research (K24) Mid-career (i.e., associate professor-level) clinical investigator Has grant-funding base Time and resources to become a better mentor for junior clinical investigators http://grants.nih.gov/grants/guide/pa-files/PA-09-037.html

9. Supplements to already-funded NIH research grants To add qualified individuals at any career level (high school through beginning investigator) who: • are from under-represented minorities • come from disadvantaged backgrounds • have disabilities • re-entering research after family obligations Contact NIH program director of funded grant http://grants.nih.gov/grants/guide/pa-files/PA-08-190.html

10. Special Research Initiatives • Program Announcements (PA) • Highlights Institute(s) interest in specific area, but no funds set aside • Request for Applications (RFA) • One-time limited set aside for applications in specific area

11. New and Early-Stage Investigators • NIH encouraging support for new investigators • “New investigator” status highlighted in the peer-review process • Extended paylines • Shortened review cycle • See NIH websites for specific policy New Investigator = never been PI on an R01 grant Early Career = New and within 10yrs of terminal research degree

12. Special Kinds of Grants for Engineers • BRG - Bioengineering Research Grant • Can be used for device development-may not need scientific hypotheses • BRP -Bioengineering Research Program • An industrial, multi-project collaborative program • NIH Bioengineering consortium: http://publicaccess.nih.gov/becon_redirect.htm

13. NIH Blueprint for Neuroscience • Cooperative effort among the 16 NIH Institutes and Centers that support neuroscience research • Basic and clinical neuroscientists • Development of new tools; training opportunities, • Neuroscience research initiatives • Resources (e.g., animal models, clinical tools, imaging, neuroinformatics, core facilities, cell/tissue/DNA banks; and gene and protein expression) http://neuroscienceblueprint.nih.gov/

14. How an Application becomes a Grant – or at least tries • 25,000 applications arrive at NIH Central: “Receipt and Referral” • Which Institute(s) support this area of research – should it get a top score? • Which study section has the most appropriate expertise? • You can attach a cover letter to suggest appropriate Institute(s) and/or study section assignments

15. Also Institute Peer-review Although R01 applications are generally reviewed in the centralized “Center for Scientific Review” (CSR), study sections within Institutes generally review: RFAs and other one-time solicitations Training & career-development applications R03s & other specialized support mechanisms Institute study sections function similar to the peer-review panels of CSR

16. Application gets assigned to a Study Section Study section has about two dozen reviewers, plus ad hoc expertise as needed Scientific Review Officer (SRO): Checks applications for administrative issues Makes reviewer assignments Avoids conflicts of interest (positive/negative) Typical workload for a study section: 50-80 applications per round

17. Prior to the Review Meeting Each application assigned to three reviewers: Sometimes, additional outside opinions sought Prior to the meeting, assigned reviewers prepare detailed written critiques focusing on strengths and weaknesses for each of the five NIH review criterion: Significance, Investigator(s), Innovation, Approach, and Environment Note: review criteria re-oriented to shift emphasis from methodological details to potential scientific impact Assigned reviewers score applications on each of the five review criteria, using new NIH scale 1-9 (whole numbers only). Old NIH scale was 1-5

18. NIH Review Criteria • Individual criterion scores in each domains: • Significance: important problem? Effect on the field? • Investigator: Appropriately trained? Appropriate experience? • Innovation: Potential to shift thinking? Novel concepts, approaches or methods? Aims original and innovative? Refinement, improvement or new application of approaches? • Approach: Conceptual framework, design, methods, and analyses? Discussed potential problems and alternative strategies? Benchmarks for success? • Environment: Adequate scientific environment(s)? Adequate institutional support? Unique features, subject populations? • Also: Protection of human subjects; Inclusion of women, minorities, and children; vertebrate animal research; • Renewal or revision?

19. At the Review Meeting • Applications are reviewed in rank order through the upper half; remaining applications are not discussed* • *Do not receive a formal impact/priority score, but get benefit of full written critiques and the five criterion scores • Also, applications from new investigators clustered together • Discussion of applications (~15-20’ each): • 3 assigned reviewers highlight strengths and weaknesses • Rest of committee joins in discussion • Each member votes overall impact: 1 (exceptional) – 9 (poor) • Impact scores averaged and multiplied by 10 (thus 10 - 90) • To normalize scoring across study sections, • impact/priority scores translated to percentile ranking

20. Meanwhile, back at the Institutes . . . Applications get a second level of review from Institute Councils, but are rarely discussed individually Each NIH Institute has limited amount of funds to support investigator-initiated research applications: Generally fund by percentile ranking, occasionally making minor adjustments right around funding line Outcomes:  Award notice !!!!  Revise ?!?  Back to the drawing board Talk to your Program official! Now only one amended application will be allowed

21. Useful NIH Websites NIH Home page: www.nih.gov CRISP (searchable database of all NIH-funded grants): www.commons.cit.nih.gov/crisp/ [search by topic or by institution/locale] Center for Scientific review (study section descriptions and rosters): www.csr.nih.gov BECON (NIH Bioengineering Consortium): www.becon.nih.gov/becon.htm

22. You are encouraged to contact NIH staff • Locate possible “program officials” through Institute websites • As an introduction, email your abstract and “specific aims” pages • Discuss potential grant mechanisms, funding initiatives, study section assignments • Later, program official can help interpret your summary statement • But funding decisions are largely driven by the priority score you get from study section

23. Program Official • Primary point of contact prior to submission and again after summary statement is released • As introduction, email “specific aims” page • Discuss potential grant mechanisms, funding initiatives, and study section assignments • Later, can help interpret summary statement • But funding decisions are largely driven by the priority score you get from peer review • If funded, Program staff administers the grant (e.g., progress reports, subsequent adjustments)

24. Scientific Review Officer • Associated with a particular study section – (usually located in the Center for Scientific Review) • But also SROs within NIH Institutes, to review training, career development, pilot grants, and most RFAs • SRO is the primary point of contact once the application has been submitted to the NIH and up to the release of the summary statement • SRO oversees the review process: recruits and assigns reviewers; checks for completeness of application, necessary certifications, conflicts of interest • Monitors the actual review meeting and later prepares the summary statement