3 Overview Outline the organization of the National Institutes of Health Program Announcements and RFAsDescribe commonly-used grant mechanismsApplication and Review Process
4 Structure of the NIH Intramural Research Research done onsite by NIH scientists9% of the NIH budgetExtramural Research – 82% of budgetResearch grantsTrainingR& D contractsResearch Management & Support
6 Offices of: Women’s Health AIDS Research Disease PreventionBehavioral & Social Science Research (OBSSR)
7 Institutes and Annual Budgets - 2007 National Cancer Institute – (NCI) $4.8 billionNational Institute of Allergy & Infectious Disease (NIAID) - $4.5 billionNational Heart, Lung & Blood Institute (NHLBI) $2.9 billionNational 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 billionNational Institute of Mental Health (NIMH)- $1.4 billionNational Institute on Aging (NIA)- $1.04 billionNational Institute of Drug Abuse (NIDA) - $1.0 billion
9 Centers and BudgetsNCCAM - Complementary and Alternative Medicine - $121 millionNCMHD – Minority Health & Health Disparities - $190 millionNINR – 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 yearFebruary 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 1/09As 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 personEquipmentSuppliesSubject payments/ incentivesTravel (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 researchersRate 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 MechanismsT - 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 scienceK – Research Career Development Awards – to develop research scientists with clear potential (can be early or later career, mentored or to support mentoring)
16 Grant MechanismsR – Research grants – Awarded to fund a specific objective or study in the area of the principal investigator’s interest & competenceP - 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 MechanismsSBIR – Grants made to small business concerns that have expertise to contribute to scientific mission of NIHSmall 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 mostCovers 75% base salary for up to 5 yearsFor mentored mechanisms often want people to be with 5 years of end of training, though some career transition awards existFor early-career researchers, this kind of award is the “Holy Grail”.Protects the time and space to develop research skills, ideasThe project is usually of fairly limited scopeCan’t take any other NIH money for duration of awardDevelops 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 focusedK01 – Mentored research scientist awardK02 – Independent scientist awardK05 – Senior scientist awardK07 – Academic career award - curriculum development focusSome with more clinical scientist focus:K08 – Mentored clinical scientist awardK23 – Mentored patient-oriented research career development awardK24 - Mid-career investigator award in patient-oriented research (must spend % effort on pt-oriented researchThere are many others…Important to note that each I/C uses these mechanisms differently – important to check
20 R-Series GrantsSMALLER/ DEVELOPMENTAL GRANTS: Used in different ways by different I/CsR03 – 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.
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 projectNeed 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 yearsSupplements 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 SupplementsTrainees 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 timeBenefit to project: an extra pair of hands that are free to the project, sponsoring minority trainees viewed positively by NIHNo 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 investigatorsAnnouncements still emergingVery high level of special reporting and tracking of funds
26 GRANT DEVELOPMENT PROCESS Get an idea, discuss with colleagues, mentorsThink about appropriate grant mechanismsAdequate pilot data?Scope of project?NIH grant deadline to shoot for?Develop sample size estimates & project timeline – and budget flows from thoseDevelop 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:SignificanceInvestigatorsInnovationApproachEnvironment
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 StrategySignificanceInnovationApproachPreliminary Studies for New ApplicationsProgress Report for Renewal and Revision ApplicationsReferencesHuman Subjects issues, Environment, etcPage limits apply to these sections
30 Grant Outline Also need to include: Budget/ budget justification Any subcontract paperwork, if including co-investigators from other institutionBiosketches (4-page limit) for investigators and main staff peopleLetters of supportAdministrative pages with info on PI, investigators, and institution
31 Grant Submission Have to get internal sign-offs Financial disclosure from each investigatorGrants office, financial review of budgets.Admin. sign-off from departments, facilitiesSubmissions done electronically in almost all cases at this time… to grants.gov via grants office
32 Grant Review ProcessSent to Center for Scientific Review, directed to an I/CAssigned 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 meetsAfter study section meets (usually a few days) get score, summary statement follows within 30 days.
33 ScoringApproximately 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 criteriaScored grants (and grant elements) are rated from 1 - 9:1 = perfect score; 9 = worst possible score
34 NEW SCORING CRITERIAScore Descriptor Additional Guidance on Strengths/Weaknesses1 Exceptional Exceptionally strong with essentially no weaknesses2 Outstanding Extremely strong with negligible weaknesses3 Excellent Very strong with only some minor weaknesses4 Very Good Strong but with numerous minor weaknesses5 Good Strong but with at least one moderate weakness6 Satisfactory Some strengths but also some moderate weaknesses7 Fair Some strengths but with at least one major weakness8 Marginal A few strengths and a few major weaknesses9 Poor Very few strengths and numerous major weaknessesMinor Weakness: An easily addressable weakness that does not substantially lessen impactModerate Weakness: A weakness that lessens impactMajor Weakness: A weakness that severely limits impactThe 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/CExample: Score : 21, 11%Payline: 15% - grant is nearly sure to be fundedCan’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 commitmentsDepending 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 ResubmissionNeed 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 dataMay just need to highlight things you originally wrote, but didn’t emphasizeAlways best to be clear that you are being responsive to feedbackGreat 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 ResubmissionYou have up to 2 years to resubmit…. Most often done sooner.Deadline usually a month later than regular intervals, but check about special mechanismsSooner 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 grantGenerally goes back to the same study sectionEspecially important to get the response right when only 1 resubmission is allowed