Grants 101: An Introduction Grants 101: An Introduction to NIH Grantsto NIH Grants

Lynn Clemow, Ph.D.Lynn Clemow, Ph.D.

    

OverviewOverview

Outline the organization of the National Outline the organization of the National Institutes of HealthInstitutes of Health

Program Announcements and RFAsProgram Announcements and RFAs Describe commonly-used grant Describe commonly-used grant

mechanismsmechanisms Application and Review ProcessApplication and Review Process

Structure of the NIHStructure of the NIH

Intramural ResearchIntramural Research Research done onsite by NIH scientistsResearch done onsite by NIH scientists 9% of the NIH budget9% of the NIH budget

Extramural Research – 82% of budgetExtramural Research – 82% of budget Research grantsResearch grants TrainingTraining R& D contractsR& D contracts

Research Management & SupportResearch Management & Support

NIH BudgetNIH Budget

Grants & Contracts

Intramural

Offices of: Women’s Health

AIDS Research - Disease Prevention

Behavioral & Social Science Research (OBSSR)

Institutes and Annual Budgets - Institutes and Annual Budgets - 20072007

National Cancer Institute – (NCI) $4.8 National Cancer Institute – (NCI) $4.8 billionbillion

National Institute of Allergy & Infectious National Institute of Allergy & Infectious Disease (NIAID) - $4.5 billionDisease (NIAID) - $4.5 billion

National Heart, Lung & Blood Institute National Heart, Lung & Blood Institute (NHLBI) $2.9 billion(NHLBI) $2.9 billion

National Institute of Diabetes and National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) Digestive and Kidney Diseases (NIDDK) - $1.85 billion- $1.85 billion

Institutes and Budgets - 2007Institutes and Budgets - 2007

National Institute of Neurological Diseases National Institute of Neurological Diseases and Stroke (and Stroke (NINDS) - $1.5 billion) - $1.5 billion

National Institute of Mental Health (National Institute of Mental Health (NIMHNIMH)- )- $1.4 billion$1.4 billion

National Institute on Aging (National Institute on Aging (NIANIA)- $1.04 )- $1.04 billionbillion

National Institute of Drug Abuse (National Institute of Drug Abuse (NIDANIDA) - ) - $1.0 billion$1.0 billion

Centers and BudgetsCenters and Budgets

NCCAMNCCAM - Complementary and Alternative - Complementary and Alternative Medicine - $121 millionMedicine - $121 million

NCMHDNCMHD – Minority Health & Health – Minority Health & Health Disparities - $190 millionDisparities - $190 million

NINR NINR – Nursing Research - $135 million– Nursing Research - $135 million

Other Federal EntitiesOther Federal Entities

Agency for Healthcare Research & Quality Agency for Healthcare Research & Quality (AHRQ)(AHRQ)

Centers for Disease Control & Prevention Centers for Disease Control & Prevention (CDC)(CDC)

Health Resources and Services Health Resources and Services Administration (HRSA)Administration (HRSA)

Grant Application OverviewGrant Application Overview 3 regular grant submission cycles every year 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, If a resubmission, due 1 month later (Mar, July,

Nov).Nov). Also special one-shot grant opportunities Also special one-shot grant opportunities

come up (Requests for Applications or RFAs) come up (Requests for Applications or RFAs) with very little notice. with very little notice.

Grant Submission RulesGrant Submission Rules

Prior to January, 2009, many grant Prior to January, 2009, many grant mechanisms could be re-submitted twice mechanisms could be re-submitted twice (i.e., total of 3 submissions), and that rule still (i.e., total of 3 submissions), and that rule still applies to grants submitted prior to 1/09applies to grants submitted prior to 1/09

As of January, 2009, new grants can only be As of January, 2009, new grants can only be re-submitted once (for a total of 2 re-submitted once (for a total of 2 submissions)submissions)

Grant BudgetsGrant Budgets

Budgets include:Budgets include: DIRECT COSTS: (GO TO THE PROJECT)DIRECT COSTS: (GO TO THE PROJECT)

Personnel costs (salary + ~36% fringe benefits rate) – Personnel costs (salary + ~36% fringe benefits rate) – specifying % effort for each personspecifying % effort for each person

EquipmentEquipment SuppliesSupplies Subject payments/ incentivesSubject payments/ incentives Travel (local mileage and conference travel)Travel (local mileage and conference travel)Each person and item needs to be justified in budget Each person and item needs to be justified in budget

justification section of grantjustification section of grant

Grant BudgetsGrant Budgets INDIRECT COSTS: (GO TO INSTITUTION)INDIRECT COSTS: (GO TO INSTITUTION)

Money goes to the institution to provide facilities and Money goes to the institution to provide facilities and administrative support to researchersadministrative support to researchers

Rate calculated by periodic negotiations between each Rate calculated by periodic negotiations between each institution and the Federal Government – at UMDNJ institution and the Federal Government – at UMDNJ currently 56% . currently 56% .

For every dollar of direct costs (excluding large equipment For every dollar of direct costs (excluding large equipment purchases) UMDNJ gets an additional $.56.purchases) UMDNJ gets an additional $.56.

Usually indirect costs are given OVER AND ABOVE Usually indirect costs are given OVER AND ABOVE budget limits…. Usually ceilings apply only to direct costs.budget limits…. Usually ceilings apply only to direct costs.

How that money gets divided up within the institution varies How that money gets divided up within the institution varies a great deal from place to place. For many medical a great deal from place to place. For many medical schools, the dean/central admin. gets half, the department schools, the dean/central admin. gets half, the department gets half (in large depts., shared with the division and gets half (in large depts., shared with the division and investigator in some way for resources). investigator in some way for resources).

NIH Grant MechanismsNIH Grant Mechanisms T T - Institutional Research - Institutional Research TrainingTraining Grants Grants

(granted to institutions – grad students and post-(granted to institutions – grad students and post-docs appointed by institution) (e.g., NRSA)docs appointed by institution) (e.g., NRSA)

FF – – FellowshipsFellowships – Individual post-doc – Individual post-doc fellowships for research training in biomedical or fellowships for research training in biomedical or behavioral sciencebehavioral science

K K – Research – Research CareerCareer Development Awards Development Awards – to – to develop research scientists with clear potential develop research scientists with clear potential (can be early or later career, mentored or to (can be early or later career, mentored or to support mentoring) support mentoring)

Grant MechanismsGrant Mechanisms R – ResearchR – Research grants grants – Awarded to fund a specific – Awarded to fund a specific

objective or study in the area of the principal objective or study in the area of the principal investigator’s interest & competenceinvestigator’s interest & competence

P - Program GrantsP - Program Grants – awarded to more senior – awarded to more senior investigators only, funds a broad-based long-term investigators only, funds a broad-based long-term program of research, interacting projects with groups program of research, interacting projects with groups of investigators, often 3 or 4 projects and shared of investigators, often 3 or 4 projects and shared cores for stats, admin, training, instrumentation, etc. cores for stats, admin, training, instrumentation, etc. Tend to focus on mechanisms of disease.Tend to focus on mechanisms of disease.

P- Center GrantsP- Center Grants – – Senior investigators, research Senior investigators, research likely to have a more clinical focus, in response to I/C likely to have a more clinical focus, in response to I/C priorities. (MUPS center grant)priorities. (MUPS center grant)

Grant MechanismsGrant Mechanisms

SBIRSBIR – Grants made to small business – Grants made to small business concerns that have expertise to contribute concerns that have expertise to contribute to scientific mission of NIHto scientific mission of NIH

Small Business Technology Transfer Small Business Technology Transfer ((STTRSTTR) – to facilitate research between ) – to facilitate research between small businesses and research small businesses and research institutions.institutions.

Conference GrantsConference Grants

Career Development GrantsCareer Development Grants

Many K-award mechanisms:Many K-award mechanisms: Great career step, at whatever level.Great career step, at whatever level. Must devote Must devote >>75% effort to research in most75% effort to research in most Covers 75% base salary for up to 5 yearsCovers 75% base salary for up to 5 years For mentored mechanisms often want people to be with 5 years of end For mentored mechanisms often want people to be with 5 years of end

of training, though some career transition awards existof training, though some career transition awards exist

For early-career researchers, this kind of award is the “Holy Grail”.For early-career researchers, this kind of award is the “Holy Grail”. Protects the time and space to develop research skills, ideasProtects the time and space to develop research skills, ideas The project is usually of fairly limited scopeThe project is usually of fairly limited scope Can’t take any other NIH money for duration of awardCan’t take any other NIH money for duration of award Develops a track record with NIH funding.Develops a track record with NIH funding. The mentors and institutional resources are often key elements for The mentors and institutional resources are often key elements for

success success

Career Development AwardCareer Development AwardSome K grants are more basic-science focusedSome K grants are more basic-science focused K01 – Mentored research scientist awardK01 – Mentored research scientist award K02 – Independent scientist awardK02 – Independent scientist award K05 – Senior scientist awardK05 – Senior scientist award K07 – Academic career award - curriculum development focusK07 – Academic career award - curriculum development focusSome with more clinical scientist focus:Some with more clinical scientist focus: K08 – Mentored clinical scientist awardK08 – Mentored clinical scientist award K23 – Mentored patient-oriented research career development K23 – Mentored patient-oriented research career development

awardaward K24 - Mid-career investigator award in patient-oriented K24 - Mid-career investigator award in patient-oriented

research (must spend 25-50 % effort on pt-oriented research research (must spend 25-50 % effort on pt-oriented research There are many others…Important to note that each I/C uses There are many others…Important to note that each I/C uses

these mechanisms differently – important to checkthese mechanisms differently – important to check

R-Series GrantsR-Series Grants

SMALLER/ DEVELOPMENTAL GRANTSSMALLER/ DEVELOPMENTAL GRANTS: Used : Used in different ways by different I/Csin different ways by different I/Cs

R03 – Small grant program:R03 – Small grant program: May request up to 2 years of funding May request up to 2 years of funding

@$50,000 / year. Great for pilot data for larger @$50,000 / year. Great for pilot data for larger study.study.

R21 – Exploratory/developmental grantR21 – Exploratory/developmental grant:: May request up to 2 years for project, with May request up to 2 years for project, with

TOTAL of $275,000. Often used to develop and TOTAL of $275,000. Often used to develop and pilot test an intervention.pilot test an intervention.

R-Series GrantsR-Series Grants

SMALLER / DEVELOPMENTAL GRANTSSMALLER / DEVELOPMENTAL GRANTS R34R34 – – Clinical Trial Planning grant-Clinical Trial Planning grant-

project to prepare for a larger clinical trial, project to prepare for a larger clinical trial, (often R-18 or large R01) which generally (often R-18 or large R01) which generally is used to translate established scientific is used to translate established scientific findings into clinical practice.findings into clinical practice. Total of $100,000 / year, 1 or 2 yearsTotal of $100,000 / year, 1 or 2 years

R-Series GrantsR-Series Grants R01 – Research Project Grant ProgramR01 – 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 Need to have pilot & feasibility data and a team

with necessary expertise (preferably some of with necessary expertise (preferably some of whom have worked together before)whom have worked together before)

BudgetBudget: <$500,000 direct costs per year, up to : <$500,000 direct costs per year, up to 5 years5 years

Supplements and amendments are allowed.Supplements and amendments are allowed.

P-SeriesP-Series

Large program-projects or center grantsLarge program-projects or center grantsLed by senior investigators (supported by Led by senior investigators (supported by

collaborative interdisciplinary group)collaborative interdisciplinary group)Usually made up of 3-4 interacting projects Usually made up of 3-4 interacting projects

and several shared core functions and several shared core functions (biostatistics/ data management, (biostatistics/ data management, administration, training, instrumentation, administration, training, instrumentation, laboratories, etc.)laboratories, etc.)

Budgets usually $1.5 million/year for 5 years, Budgets usually $1.5 million/year for 5 years, goes up for competitive renewal every 5 goes up for competitive renewal every 5 yearsyears

Minority SupplementsMinority Supplements Trainees and junior investigators who are members of Trainees and junior investigators who are members of

under-represented minorities are eligible for special under-represented minorities are eligible for special minority supplements grants. minority supplements grants.

Generally propose a relatively simple additional measure Generally propose a relatively simple additional measure or research question to be added to the parent grant… or research question to be added to the parent grant… covers time at designated stipend levels.covers time at designated stipend levels.

Benefit to applicant: Great opportunity to get research Benefit to applicant: Great opportunity to get research experience and funding for that timeexperience and funding for that time

Benefit to project: an extra pair of hands that are free to Benefit to project: an extra pair of hands that are free to the project, sponsoring minority trainees viewed the project, sponsoring minority trainees viewed positively by NIHpositively by NIH

No specific deadlines for applications (usually ~ 5 pages No specific deadlines for applications (usually ~ 5 pages and admin. paperwork) – quick turnaround – 2 months. and admin. paperwork) – quick turnaround – 2 months. Issues in working with institutional HR, etc.Issues in working with institutional HR, etc.

Stimulus Plan (ARRA) FundingStimulus Plan (ARRA) Funding

Whole bunch of RFAs, used differently by I/Cs.Whole bunch of RFAs, used differently by I/Cs. Challenge Grants (RC-1) – Each I/C defines specific Challenge Grants (RC-1) – Each I/C defines specific

research aims. 12-page application format, research aims. 12-page application format, $500,000 per year x 2 years. $500,000 per year x 2 years.

Administrative Supplements – Again, each I/C Administrative Supplements – Again, each I/C defines use of these supplements, many institutes defines use of these supplements, many institutes gave these primarily to new investigatorsgave these primarily to new investigators

Announcements still emergingAnnouncements still emerging Very high level of special reporting and tracking of Very high level of special reporting and tracking of

fundsfunds

GRANT DEVELOPMENT GRANT DEVELOPMENT PROCESSPROCESS

Get an idea, discuss with colleagues, mentorsGet an idea, discuss with colleagues, mentors Think about appropriate grant mechanismsThink 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 – Develop sample size estimates & project timeline – and budget flows from thoseand budget flows from those

Develop budget and budget justification, consult with Develop budget and budget justification, consult with administrator regarding budget details, has to be in administrator regarding budget details, has to be in early.early.

Develop grant applicationDevelop grant application

New NIH Grant Scoring New NIH Grant Scoring DomainsDomains

OVERALL IMPACT OVERALL IMPACT (Summary score)(Summary score) SCORED REVIEW CRITERIASCORED REVIEW CRITERIA::

SignificanceSignificance InvestigatorsInvestigators InnovationInnovation ApproachApproach EnvironmentEnvironment

Grant Outline / FormattingGrant Outline / Formatting

For R01 – 12 pages of science for the For R01 – 12 pages of science for the project.project.

For R21 and some other mechanisms – For R21 and some other mechanisms – shorter format (6 pages)shorter format (6 pages)

Grant OutlineGrant Outline Introduction (for resubmission only, 1 page)Introduction (for resubmission only, 1 page) Specific Aims (1 page)Specific Aims (1 page)

Research StrategyResearch Strategy SignificanceSignificance InnovationInnovation ApproachApproach

• Preliminary Studies for New ApplicationsPreliminary Studies for New Applications• Progress Report for Renewal and Revision ApplicationsProgress Report for Renewal and Revision Applications

References References Human Subjects issues, Environment, etcHuman Subjects issues, Environment, etc

Page limits apply to these sections

Grant OutlineGrant Outline

Also need to include:Also need to include: Budget/ budget justificationBudget/ budget justification Any subcontract paperwork, if including co-Any subcontract paperwork, if including co-

investigators from other institutioninvestigators from other institution Biosketches (4-page limit) for investigators Biosketches (4-page limit) for investigators

and main staff peopleand main staff people Letters of supportLetters of support Administrative pages with info on PI, Administrative pages with info on PI,

investigators, and institutioninvestigators, and institution

Grant SubmissionGrant Submission

Have to get internal sign-offsHave to get internal sign-offsFinancial disclosure from each investigatorFinancial disclosure from each investigatorGrants office, financial review of budgets.Grants office, financial review of budgets.Admin. sign-off from departments, facilitiesAdmin. sign-off from departments, facilitiesSubmissions done electronically in almost all Submissions done electronically in almost all

cases at this time… to grants.gov via cases at this time… to grants.gov via grants officegrants office

Grant Review ProcessGrant Review Process Sent to Center for Scientific Review, directed to Sent to Center for Scientific Review, directed to

an I/Can I/C Assigned to a Study Section (can request Assigned to a Study Section (can request

specific assignment)specific assignment) Can submit 3 pages of supplemental data/ info Can submit 3 pages of supplemental data/ info

prior to review.prior to review. Reviewed ~ 4 months later when Study Section Reviewed ~ 4 months later when Study Section

meetsmeets After study section meets (usually a few days) After study section meets (usually a few days)

get score, summary statement follows within 30 get score, summary statement follows within 30 days.days.

ScoringScoring Approximately half of grants don’t get Approximately half of grants don’t get

scored and are not discussed at the study scored and are not discussed at the study section meeting. So you get reviews, but section meeting. So you get reviews, but no discussion and no overall priority no discussion and no overall priority score.score.

New scoring system gives reviewers’ New scoring system gives reviewers’ ratings of each scoring criteriaratings of each scoring criteria

Scored grants (and grant elements) are Scored grants (and grant elements) are rated from 1 - 9:rated from 1 - 9:1 = perfect score; 9 = worst possible score1 = perfect score; 9 = worst possible score

NEW SCORING CRITERIANEW SCORING CRITERIAScoreScore DescriptorDescriptor Additional Guidance on Strengths/WeaknessesAdditional Guidance on Strengths/Weaknesses 11 ExceptionalExceptional Exceptionally strong with essentially no weaknessesExceptionally strong with essentially no weaknesses 22 OutstandingOutstanding Extremely strong with negligible weaknessesExtremely strong with negligible weaknesses 33 ExcellentExcellent Very strong with only some minor weaknessesVery strong with only some minor weaknesses 44 Very GoodVery Good Strong but with numerous minor weaknessesStrong but with numerous minor weaknesses 55 GoodGood Strong but with at least one moderate weaknessStrong but with at least one moderate weakness 66 SatisfactorySatisfactory Some strengths but also some moderate weaknessesSome strengths but also some moderate weaknesses 77 FairFair Some strengths but with at least one major weaknessSome strengths but with at least one major weakness 88 MarginalMarginal A few strengths and a few major weaknessesA few strengths and a few major weaknesses 99 PoorPoor Very few strengths and numerous major weaknessesVery few strengths and numerous major weaknesses

Minor Weakness: An easily addressable weakness that does not substantially lessen impactMinor Weakness: An easily addressable weakness that does not substantially lessen impactModerate Weakness: A weakness that lessens impactModerate Weakness: A weakness that lessens impactMajor Weakness: A weakness that severely limits impactMajor Weakness: A weakness that severely limits impact

The final overall impact/priority score: The final overall impact/priority score: AverageAverage of OVERALL IMPACT/PRIORITY SCORES OF of OVERALL IMPACT/PRIORITY SCORES OF REVIEW PANEL MEMBERS to REVIEW PANEL MEMBERS to one decimal point and multiplying by tenone decimal point and multiplying by ten. Thus, the new . Thus, the new scores range from 10-90 in whole numbers. scores range from 10-90 in whole numbers.

PERCENTILESPERCENTILES Also get a percentile rankAlso get a percentile rank Percentile lets you compare your grant’s score to the Percentile lets you compare your grant’s score to the

likely payline (cutoff percentile score). The lower the likely payline (cutoff percentile score). The lower the percentile and the score, the better. Fundable % percentile and the score, the better. Fundable % scores generally published every year by the I/C scores generally published every year by the I/C

Example: Score : 21, 11%Example: Score : 21, 11% Payline: 15% - grant is nearly sure to Payline: 15% - grant is nearly sure to be be

fundedfundedCan’t be absolutely sure until the Council meets (3 Can’t be absolutely sure until the Council meets (3

times/year) and confirms payline.times/year) and confirms payline.Later: Notice of Grant Award is issued (that’s the actual Later: Notice of Grant Award is issued (that’s the actual

money)money)

Paylines DifferPaylines Differ Year by year, given level of NIH budgetYear by year, given level of NIH budget Institute by Institute – depends on budget level Institute by Institute – depends on budget level

and their long-term commitmentsand their long-term commitments Depending on the Investigator – Advantage Depending on the Investigator – Advantage

given to new investigators (sometimes get extra given to new investigators (sometimes get extra 5% points). People who have had K awards or 5% points). People who have had K awards or small R grants are still considered “new”small R grants are still considered “new”

At some I/Cs, if you get close to the payline, can At some I/Cs, if you get close to the payline, can submit a 5-page response to the reviewers and submit a 5-page response to the reviewers and undergoes administrative reviewundergoes administrative review

ResubmissionResubmission Need to carefully digest the reviews and decide Need to carefully digest the reviews and decide

how best to respond.how best to respond. May need to strengthen background, study May need to strengthen background, study

rationale, details of methods, statistical analysis rationale, details of methods, statistical analysis plan, adjust budget, or collect additional pilot dataplan, adjust budget, or collect additional pilot data

May just need to highlight things you originally May just need to highlight things you originally wrote, but didn’t emphasizewrote, but didn’t emphasize

Always best to be clear that you are being Always best to be clear that you are being responsive to feedbackresponsive to feedback

Great to get advice from Program Officer assigned Great to get advice from Program Officer assigned to your grant once you get score – they were to your grant once you get score – they were generally in the room when it was discussedgenerally in the room when it was discussed

ResubmissionResubmission You have up to 2 years to resubmit…. Most often done You have up to 2 years to resubmit…. Most often done

sooner.sooner. Deadline usually a month later than regular intervals, but Deadline usually a month later than regular intervals, but

check about special mechanismscheck about special mechanisms Sooner rather than later is the general rule, but totally worth Sooner rather than later is the general rule, but totally worth

it to wait a cycle and collect pilot data if feasibility is it to wait a cycle and collect pilot data if feasibility is questioned.questioned.

You have 1 additional page up front to respond directly to You have 1 additional page up front to respond directly to the reviewers’ comments, and mark other revisions in body the reviewers’ comments, and mark other revisions in body of grantof grant

Generally goes back to the same study sectionGenerally goes back to the same study section Especially important to get the response right when only 1 Especially important to get the response right when only 1

resubmission is allowedresubmission is allowed