Grants 101: An Introduction to NIH Grants

1. Grants 101: An Introduction to NIH Grants Lynn Clemow, Ph.D.

3. Overview • Outline the organization of the National Institutes of Health • Program Announcements and RFAs • Describe commonly-used grant mechanisms • Application and Review Process

4. Structure of the NIH • Intramural Research • Research done onsite by NIH scientists • 9% of the NIH budget • Extramural Research – 82% of budget • Research grants • Training • R& D contracts • Research Management & Support

5. NIH Budget Intramural Grants & Contracts

6. Offices of: Women’s Health AIDS Research - Disease Prevention Behavioral & Social Science Research (OBSSR)

7. Institutes and Annual Budgets - 2007 • National Cancer Institute – (NCI) $4.8 billion • National Institute of Allergy & Infectious Disease (NIAID) - $4.5 billion • National Heart, Lung & Blood Institute (NHLBI) $2.9 billion • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) - $1.85 billion

8. Institutes and Budgets - 2007 • National Institute of Neurological Diseases and Stroke (NINDS) - $1.5 billion • National Institute of Mental Health (NIMH)- $1.4 billion • National Institute on Aging (NIA)- $1.04 billion • National Institute of Drug Abuse (NIDA) - $1.0 billion

9. Centers and Budgets • NCCAM - Complementary and Alternative Medicine - $121 million • NCMHD – Minority Health & Health Disparities - $190 million • NINR – Nursing Research - $135 million

10. Other Federal Entities • Agency for Healthcare Research & Quality (AHRQ) • Centers for Disease Control & Prevention (CDC) • Health Resources and Services Administration (HRSA)

11. Grant Application Overview • 3 regular grant submission cycles every year • February 1 (+/- 2 weeks) • June 1 (+/- 2 weeks) • October 1 (+/- 2 weeks) • If a resubmission, due 1 month later (Mar, July, Nov). • Also special one-shot grant opportunities come up (Requests for Applications or RFAs) with very little notice.

12. Grant Submission Rules • Prior to January, 2009, many grant mechanisms could be re-submitted twice (i.e., total of 3 submissions), and that rule still applies to grants submitted prior to 1/09 • As of January, 2009, new grants can only be re-submitted once (for a total of 2 submissions)

13. Grant Budgets Budgets include: • DIRECT COSTS: (GO TO THE PROJECT) • Personnel costs (salary + ~36% fringe benefits rate) – specifying % effort for each person • Equipment • Supplies • Subject payments/ incentives • Travel (local mileage and conference travel) Each person and item needs to be justified in budget justification section of grant

14. Grant Budgets • INDIRECT COSTS: (GO TO INSTITUTION) • Money goes to the institution to provide facilities and administrative support to researchers • Rate calculated by periodic negotiations between each institution and the Federal Government – at UMDNJ currently 56% . • For every dollar of direct costs (excluding large equipment purchases) UMDNJ gets an additional $.56. • Usually indirect costs are given OVER AND ABOVE budget limits…. Usually ceilings apply only to direct costs. • How that money gets divided up within the institution varies a great deal from place to place. For many medical schools, the dean/central admin. gets half, the department gets half (in large depts., shared with the division and investigator in some way for resources).

15. NIH Grant Mechanisms • T - Institutional Research Training Grants (granted to institutions – grad students and post-docs appointed by institution) (e.g., NRSA) • F – Fellowships – Individual post-doc fellowships for research training in biomedical or behavioral science • K – Research Career Development Awards – to develop research scientists with clear potential (can be early or later career, mentored or to support mentoring)

16. Grant Mechanisms • R – Research grants – Awarded to fund a specific objective or study in the area of the principal investigator’s interest & competence • P - Program Grants – awarded to more senior investigators only, funds a broad-based long-term program of research, interacting projects with groups of investigators, often 3 or 4 projects and shared cores for stats, admin, training, instrumentation, etc. Tend to focus on mechanisms of disease. • P- Center Grants – Senior investigators, research likely to have a more clinical focus, in response to I/C priorities. (MUPS center grant)

17. Grant Mechanisms • SBIR – Grants made to small business concerns that have expertise to contribute to scientific mission of NIH • Small Business Technology Transfer (STTR) – to facilitate research between small businesses and research institutions. • Conference Grants

18. Career Development Grants Many K-award mechanisms: • Great career step, at whatever level. • Must devote >75% effort to research in most • Covers 75% base salary for up to 5 years • For mentored mechanisms often want people to be with 5 years of end of training, though some career transition awards exist For early-career researchers, this kind of award is the “Holy Grail”. • Protects the time and space to develop research skills, ideas • The project is usually of fairly limited scope • Can’t take any other NIH money for duration of award • Develops a track record with NIH funding. • The mentors and institutional resources are often key elements for success

19. Career Development Award Some K grants are more basic-science focused • K01 – Mentored research scientist award • K02 – Independent scientist award • K05 – Senior scientist award • K07 – Academic career award - curriculum development focus Some with more clinical scientist focus: • K08 – Mentored clinical scientist award • K23 – Mentored patient-oriented research career development award • K24 - Mid-career investigator award in patient-oriented research (must spend 25-50 % effort on pt-oriented research There are many others…Important to note that each I/C uses these mechanisms differently – important to check

20. R-Series Grants SMALLER/ DEVELOPMENTAL GRANTS: Used in different ways by different I/Cs • R03 – Small grant program: May request up to 2 years of funding @$50,000 / year. Great for pilot data for larger study. • R21 – Exploratory/developmental grant: May request up to 2 years for project, with TOTAL of $275,000. Often used to develop and pilot test an intervention.

21. R-Series Grants SMALLER / DEVELOPMENTAL GRANTS • R34 – Clinical Trial Planning grant- project to prepare for a larger clinical trial, (often R-18 or large R01) which generally is used to translate established scientific findings into clinical practice. • Total of $100,000 / year, 1 or 2 years

22. R-Series Grants • R01 – Research Project Grant Program To support a discrete, specific project Need to have pilot & feasibility data and a team with necessary expertise (preferably some of whom have worked together before) • Budget: <$500,000 direct costs per year, up to 5 years • Supplements and amendments are allowed.

23. P-Series Large program-projects or center grants Led by senior investigators (supported by collaborative interdisciplinary group) Usually made up of 3-4 interacting projects and several shared core functions (biostatistics/ data management, administration, training, instrumentation, laboratories, etc.) Budgets usually $1.5 million/year for 5 years, goes up for competitive renewal every 5 years

24. Minority Supplements • Trainees and junior investigators who are members of under-represented minorities are eligible for special minority supplements grants. • Generally propose a relatively simple additional measure or research question to be added to the parent grant… covers time at designated stipend levels. • Benefit to applicant: Great opportunity to get research experience and funding for that time • Benefit to project: an extra pair of hands that are free to the project, sponsoring minority trainees viewed positively by NIH • No specific deadlines for applications (usually ~ 5 pages and admin. paperwork) – quick turnaround – 2 months. Issues in working with institutional HR, etc.

25. Stimulus Plan (ARRA) Funding Whole bunch of RFAs, used differently by I/Cs. • Challenge Grants (RC-1) – Each I/C defines specific research aims. 12-page application format, $500,000 per year x 2 years. • Administrative Supplements – Again, each I/C defines use of these supplements, many institutes gave these primarily to new investigators • Announcements still emerging • Very high level of special reporting and tracking of funds

26. GRANT DEVELOPMENT PROCESS • Get an idea, discuss with colleagues, mentors • Think about appropriate grant mechanisms • Adequate pilot data? • Scope of project? • NIH grant deadline to shoot for? • Develop sample size estimates & project timeline – and budget flows from those • Develop budget and budget justification, consult with administrator regarding budget details, has to be in early. • Develop grant application

27. New NIH Grant Scoring Domains • OVERALL IMPACT (Summary score) • SCORED REVIEW CRITERIA: • Significance • Investigators • Innovation • Approach • Environment

28. Grant Outline / Formatting • For R01 – 12 pages of science for the project. • For R21 and some other mechanisms – shorter format (6 pages)

29. Grant Outline • Introduction (for resubmission only, 1 page) • Specific Aims (1 page) • Research Strategy • Significance • Innovation • Approach • Preliminary Studies for New Applications • Progress Report for Renewal and Revision Applications • References • Human Subjects issues, Environment, etc Page limits apply to these sections

30. Grant Outline Also need to include: • Budget/ budget justification • Any subcontract paperwork, if including co-investigators from other institution • Biosketches (4-page limit) for investigators and main staff people • Letters of support • Administrative pages with info on PI, investigators, and institution

31. Grant Submission Have to get internal sign-offs Financial disclosure from each investigator Grants office, financial review of budgets. Admin. sign-off from departments, facilities Submissions done electronically in almost all cases at this time… to grants.gov via grants office

32. Grant Review Process • Sent to Center for Scientific Review, directed to an I/C • Assigned to a Study Section (can request specific assignment) • Can submit 3 pages of supplemental data/ info prior to review. • Reviewed ~ 4 months later when Study Section meets • After study section meets (usually a few days) get score, summary statement follows within 30 days.

33. Scoring • Approximately half of grants don’t get scored and are not discussed at the study section meeting. So you get reviews, but no discussion and no overall priority score. • New scoring system gives reviewers’ ratings of each scoring criteria • Scored grants (and grant elements) are rated from 1 - 9: 1 = perfect score; 9 = worst possible score

34. NEW SCORING CRITERIA Score Descriptor Additional Guidance on Strengths/Weaknesses • 1 Exceptional Exceptionally strong with essentially no weaknesses • 2 Outstanding Extremely strong with negligible weaknesses • 3 Excellent Very strong with only some minor weaknesses • 4 Very Good Strong but with numerous minor weaknesses • 5 Good Strong but with at least one moderate weakness • 6 Satisfactory Some strengths but also some moderate weaknesses • 7 Fair Some strengths but with at least one major weakness • 8 Marginal A few strengths and a few major weaknesses • 9 Poor Very few strengths and numerous major weaknesses Minor Weakness: An easily addressable weakness that does not substantially lessen impact Moderate Weakness: A weakness that lessens impact Major Weakness: A weakness that severely limits impact The final overall impact/priority score: Average of OVERALL IMPACT/PRIORITY SCORES OF REVIEW PANEL MEMBERS to one decimal point and multiplying by ten. Thus, the new scores range from 10-90 in whole numbers.

35. PERCENTILES • Also get a percentile rank • Percentile lets you compare your grant’s score to the likely payline (cutoff percentile score). The lower the percentile and the score, the better. Fundable % scores generally published every year by the I/C • Example: Score : 21, 11% Payline: 15% - grant is nearly sure to be funded Can’t be absolutely sure until the Council meets (3 times/year) and confirms payline. Later: Notice of Grant Award is issued (that’s the actual money)

36. Paylines Differ • Year by year, given level of NIH budget • Institute by Institute – depends on budget level and their long-term commitments • Depending on the Investigator – Advantage given to new investigators (sometimes get extra 5% points). People who have had K awards or small R grants are still considered “new” • At some I/Cs, if you get close to the payline, can submit a 5-page response to the reviewers and undergoes administrative review

37. Resubmission • Need to carefully digest the reviews and decide how best to respond. • May need to strengthen background, study rationale, details of methods, statistical analysis plan, adjust budget, or collect additional pilot data • May just need to highlight things you originally wrote, but didn’t emphasize • Always best to be clear that you are being responsive to feedback • Great to get advice from Program Officer assigned to your grant once you get score – they were generally in the room when it was discussed

38. Resubmission • You have up to 2 years to resubmit…. Most often done sooner. • Deadline usually a month later than regular intervals, but check about special mechanisms • Sooner rather than later is the general rule, but totally worth it to wait a cycle and collect pilot data if feasibility is questioned. • You have 1 additional page up front to respond directly to the reviewers’ comments, and mark other revisions in body of grant • Generally goes back to the same study section • Especially important to get the response right when only 1 resubmission is allowed