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

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Presentation on theme: "Grants 101: An Introduction to NIH Grants Lynn Clemow, Ph.D."— Presentation transcript:

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

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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 Research done onsite by NIH scientists 9% of the NIH budget 9% of the NIH budget  Extramural Research – 82% of budget Research grants Research grants Training Training R& D contracts R& D contracts  Research Management & Support

5 NIH Budget Grants & Contracts Intramural

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

7 Institutes and Annual Budgets  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  National Institute of Neurological Diseases and Stroke () - $1.5 billion  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) February 1 (+/- 2 weeks) June 1 (+/- 2 weeks) June 1 (+/- 2 weeks) October 1 (+/- 2 weeks) October 1 (+/- 2 weeks) If a resubmission, due 1 month later (Mar, July, Nov). 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 Personnel costs (salary + ~36% fringe benefits rate) – specifying % effort for each person Equipment Equipment Supplies Supplies Subject payments/ incentives Subject payments/ incentives Travel (local mileage and conference travel) 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 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%. 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. 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. 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). 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 % 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 / 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. 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 Total of $100,000 / year, 1 or 2 years

22 R-Series Grants  R01 – Research Project Grant Program To support a discrete, specific project 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) 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? Adequate pilot data? Scope of project? Scope of project? NIH grant deadline to shoot for? 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 Significance Investigators Investigators Innovation Innovation Approach Approach Environment 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 Significance Innovation Innovation Approach Approach Preliminary Studies for New ApplicationsPreliminary Studies for New Applications Progress Report for Renewal and Revision ApplicationsProgress 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 ScoreDescriptorAdditional Guidance on Strengths/Weaknesses  1ExceptionalExceptionally strong with essentially no weaknesses  2OutstandingExtremely strong with negligible weaknesses  3ExcellentVery strong with only some minor weaknesses  4Very GoodStrong but with numerous minor weaknesses  5GoodStrong but with at least one moderate weakness  6SatisfactorySome strengths but also some moderate weaknesses  7FairSome strengths but with at least one major weakness  8MarginalA few strengths and a few major weaknesses  9PoorVery 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 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 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


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