Grant WritingGrant Writing

John Chae, MDJohn Chae, MDCase Western Reserve UniversityCase Western Reserve UniversityMetroHealth Medical CenterMetroHealth Medical Center2007 Annual Meeting of the AAP2007 Annual Meeting of the AAP

DisclaimerDisclaimer

I’ve never taken a “class” on I’ve never taken a “class” on grantsmanshipgrantsmanship

I’ve only written 5 unique NIH I’ve only written 5 unique NIH grants in my career (R29, three grants in my career (R29, three R01s and K24)R01s and K24)

However, each, except one, was However, each, except one, was funded the first timefunded the first time

““School of hard knocks”School of hard knocks”

OverviewOverview

NIHNIH People People Types of GrantsTypes of Grants K and R award StructureK and R award Structure Review criteriaReview criteria Comments on other mechanismsComments on other mechanisms Review ProcessReview Process What’s really important…What’s really important…

NIHNIH

Part of the Department of Health and Human ServicesPart of the Department of Health and Human Services Consists of 20 Institutes and 7 Centers: Each are Consists of 20 Institutes and 7 Centers: Each are

allocated a budgetallocated a budget Institutes: Institutes:

-Each institute has an identified domain and receives -Each institute has an identified domain and receives funding to support research in these domainsfunding to support research in these domains-Each institute make final funding decisions-Each institute make final funding decisions-Intramural and Extramural research -Intramural and Extramural research

CentersCenters-Several function similar to an Institute-Several function similar to an Institute-Several provide infrastructure predominantly-Several provide infrastructure predominantly-Several do both-Several do both

NIHNIH

Institutes of InterestInstitutes of Interest National Institute on Aging National Institute on Aging

(NIA)(NIA) National Institute of National Institute of

Arthritis and Arthritis and Musculoskeletal and Skin Musculoskeletal and Skin Diseases (NIAMS)Diseases (NIAMS)

National Institute of National Institute of Biomedical Imaging and Biomedical Imaging and Bioengineering (NIBIB)Bioengineering (NIBIB)

National Institute of Child National Institute of Child Health and Human Health and Human Development (NICHD)Development (NICHD)

National Institute of National Institute of Neurological Disorders and Neurological Disorders and Stroke (NINDS)Stroke (NINDS)

Centers of InterestCenters of Interest Center for Scientific Review Center for Scientific Review

(CSR)(CSR) National Center for National Center for

Complementary and Complementary and Alternative Medicine Alternative Medicine (NCCAM)(NCCAM)

National Center for National Center for Research Resource (NCRR)Research Resource (NCRR)

NIH Clinical Center (CC)NIH Clinical Center (CC) Comment: National Center Comment: National Center

for Medical Rehabilitation for Medical Rehabilitation Research (NCMRR)Research (NCMRR)

PeoplePeople

Scientific Review Administrator Scientific Review Administrator (SRA)-Review group specific(SRA)-Review group specific

Program Officers-Institute specificProgram Officers-Institute specific Grants manager-Institute specificGrants manager-Institute specific

Types of GrantsTypes of Grants

““Mechanisms”Mechanisms” R: Field or investigator initiated research R: Field or investigator initiated research

grantsgrants-R03: Small grants (2-yrs, $100K, 10 p -R03: Small grants (2-yrs, $100K, 10 p research plan)research plan)-R21: Exploratory grants (2-yrs, $350K, 15 p -R21: Exploratory grants (2-yrs, $350K, 15 p research plan)research plan)-R01: Traditional research grants (3 to 5-yrs, -R01: Traditional research grants (3 to 5-yrs, no $ limit, 25 page research plan)no $ limit, 25 page research plan)

K: Career awards (5-yrs, salary + $25-50K/yr, K: Career awards (5-yrs, salary + $25-50K/yr, 50 p)50 p)

T: Training grants T: Training grants F: FellowshipsF: Fellowships P: Program Project or Center grantsP: Program Project or Center grants

K-Award (K23)K-Award (K23)

Section I: Administrative DataSection I: Administrative Data Face pageFace page Description, performance sites, key Description, performance sites, key

personnelpersonnel Table of contentsTable of contents BudgetBudget Biographical sketchesBiographical sketches Other support (for mentors)Other support (for mentors) ResourcesResources

K-Award (K23)K-Award (K23)

Section II: Specialized InformationSection II: Specialized Information1.1.The candidate (25 pages)The candidate (25 pages)

A.A. Candidate backgroundCandidate backgroundB.B. Career goals and objectives: Career goals and objectives: Scientific biographyScientific biographyC.C. Career development/training Career development/training activity during award periodactivity during award periodD.D. Training in the responsible Training in the responsible conduct of researchconduct of research

K-Award (K23)K-Award (K23)

2. Statement by Sponsor, Co-Sponsor(s), 2. Statement by Sponsor, Co-Sponsor(s), Consultants and ContributorsConsultants and Contributors

3. Environment and Institutional 3. Environment and Institutional Commitment to CandidateCommitment to Candidate

A.A. Description of Institutional Description of Institutional EnvironmentEnvironment

B.B. Institutional commitment to Institutional commitment to candidate’s research career development: candidate’s research career development: 75% protected research time75% protected research time

K-award (K23)K-award (K23)

4. Research Plan4. Research PlanA.A. Specific AimsSpecific AimsB.B. Background and SignificanceBackground and SignificanceC.C. Preliminary studies/progress reportPreliminary studies/progress reportD.D. Research design and methodsResearch design and methodsE. E. Human Subjects ResearchHuman Subjects ResearchF.F. Vertebrate AnimalsVertebrate AnimalsG.G. Select Agent ResearchSelect Agent ResearchH.H. Literature CitedLiterature CitedI.I. Consortium/contractual arrangementsConsortium/contractual arrangementsJ. J. Resource SharingResource Sharing

A-D: 25 pages

K23 Review CriteriaK23 Review Criteria

Candidate:Candidate:-Quality of the candidate’s academic and clinical record-Quality of the candidate’s academic and clinical record-Potential to develop as an independent clinical -Potential to develop as an independent clinical researcher focusing on patient oriented research (POR)researcher focusing on patient oriented research (POR)-Commitment to a career in POR-Commitment to a career in POR

Career Development Plan:Career Development Plan:-Likelihood that the plan will contribute substantially to -Likelihood that the plan will contribute substantially to the scientific development of the candidatethe scientific development of the candidate-Appropriateness of the content and duration of the -Appropriateness of the content and duration of the proposed didactic and research phases of the awardproposed didactic and research phases of the award-Consistency of the career development plan with the -Consistency of the career development plan with the candidate’s career goals and prior research experiencecandidate’s career goals and prior research experience-Quality of the proposed training in responsible conduct -Quality of the proposed training in responsible conduct of researchof research

K23 Review Criteria K23 Review Criteria (cont’)(cont’) Research Plan:Research Plan:

““Reviewers recognize that an individual with Reviewers recognize that an individual with limited research experience is less likely to be limited research experience is less likely to be able to prepare a research plan with the able to prepare a research plan with the breadth and depth of that submitted by a more breadth and depth of that submitted by a more experienced investigator. Although it is experienced investigator. Although it is understood that K23 applications do not understood that K23 applications do not require the level of detail necessary in regular require the level of detail necessary in regular research grant applications, a fundamentally research grant applications, a fundamentally sound research plan must be provided. In sound research plan must be provided. In general, less detail is expected with regard to general, less detail is expected with regard to research planned for the later years of the research planned for the later years of the award, but the application should outline the award, but the application should outline the general goals of these years.”general goals of these years.”

K23 Review Criteria K23 Review Criteria (cont’)(cont’) Research Plan (cont’)Research Plan (cont’)

-Appropriateness of the plan to the stage of research -Appropriateness of the plan to the stage of research development and as a vehicle for developing the development and as a vehicle for developing the research skills as described in the career development research skills as described in the career development planplan-Scientific and technical merit of the research question, -Scientific and technical merit of the research question, design and methodologydesign and methodology-Relevance of the proposed research to the candidate’s -Relevance of the proposed research to the candidate’s career objectivescareer objectives-Adequacy of the plan’s attention to including both -Adequacy of the plan’s attention to including both genders and minority subjects in projects involving genders and minority subjects in projects involving human subjectshuman subjects-Adequacy of plans for including children as appropriate -Adequacy of plans for including children as appropriate for scientific goals of the research, or justification for for scientific goals of the research, or justification for exclusionexclusion

K23 Review Criteria K23 Review Criteria (cont’)(cont’) MentorMentor

-Appropriateness of mentor’s research qualifications in the -Appropriateness of mentor’s research qualifications in the area of applicationarea of application-Quality and extent of mentor’s proposed role in providing -Quality and extent of mentor’s proposed role in providing guidance and advice to the candidateguidance and advice to the candidate-Previous experience in fostering the development of -Previous experience in fostering the development of researchersresearchers-History of research productivity and support-History of research productivity and support

Environment and Institutional SupportEnvironment and Institutional Support-Institution’s commitment to the scientific development of the -Institution’s commitment to the scientific development of the candidatecandidate-Adequacy of facilities and the availability of appropriate -Adequacy of facilities and the availability of appropriate educational opportunitieseducational opportunities-Quality and relevance of the environment for scientific and -Quality and relevance of the environment for scientific and professional developmentprofessional development-Institution’s commitment to an appropriate balance of -Institution’s commitment to an appropriate balance of research and clinical responsibilitiesresearch and clinical responsibilities

K23 Review Criteria K23 Review Criteria (cont’)(cont’) Budget: Evaluate the justification Budget: Evaluate the justification

of the requested budget in of the requested budget in relation to career development relation to career development goals and research aimsgoals and research aims

Human Subjects: Assess risks and Human Subjects: Assess risks and benefits and data and safety benefits and data and safety monitoring planmonitoring plan

Gender/Minority/Children Gender/Minority/Children inclusioninclusion

R AwardsR Awards

Same as K-award but without the Candidate sectionSame as K-award but without the Candidate section Primary focus in the research plan:Primary focus in the research plan:

A.A. Specific AimsSpecific AimsB.B. Background and SignificanceBackground and SignificanceC.C. Preliminary studies/progress reportPreliminary studies/progress reportD.D. Research design and methodsResearch design and methodsE. E. Human Subjects ResearchHuman Subjects ResearchF.F. Vertebrate AnimalsVertebrate AnimalsG.G. Select Agent ResearchSelect Agent ResearchH.H. Literature CitedLiterature CitedI.I. Consortium/contractual arrangementsConsortium/contractual arrangementsJ. J. Resource SharingResource Sharing

A-D: 25 pages

R-award CriteriaR-award Criteria

Significance: Significance: -Does this study address an important -Does this study address an important problem?problem?-If the aims are achieved, how will -If the aims are achieved, how will scientific knowledge or clinical practice scientific knowledge or clinical practice be advanced?be advanced?-What will be the effect of these studies -What will be the effect of these studies on the concepts, methods, technologies, on the concepts, methods, technologies, treatments, services, or preventive treatments, services, or preventive interventions that drive the field? interventions that drive the field?

R-award Criteria R-award Criteria (cont’)(cont’) Approach:Approach:

-Are the conceptual or clinical -Are the conceptual or clinical framework, design, methods, and framework, design, methods, and analyses adequately developed, well-analyses adequately developed, well-reasoned and appropriate to the aims reasoned and appropriate to the aims of the project?of the project?

-Does the applicant acknowledge -Does the applicant acknowledge potential problem areas and consider potential problem areas and consider alternative tactics?alternative tactics?

R-award Criteria R-award Criteria (cont’)(cont’) Innovation:Innovation:

-Is the project original and innovative?-Is the project original and innovative?-Does the project challenge existing -Does the project challenge existing paradigms or clinical practice; address paradigms or clinical practice; address an innovative hypothesis or critical an innovative hypothesis or critical barrier to progress in the field?barrier to progress in the field?-Does the project develop or employ a -Does the project develop or employ a novel concept, approaches, novel concept, approaches, methodologies, tools, or technologies methodologies, tools, or technologies for this area?for this area?

Other MechanismsOther Mechanisms

R03: Small grantR03: Small grant-$50K/yr, 2 yrs-$50K/yr, 2 yrs-Pilot studies, 10 page Research Plan-Pilot studies, 10 page Research Plan-Preliminary study not needed-Preliminary study not needed

R21: Exploratory grantR21: Exploratory grant-$350K over 2 yrs-$350K over 2 yrs-High risk, potential high yield-High risk, potential high yield-Preliminary study not needed-Preliminary study not needed-15 page Research Plan-15 page Research Plan

Review ProcessReview Process

Dual level processDual level process Scientific ReviewScientific Review

-Received by the -Received by the Center for Scientific ReviewCenter for Scientific Review (CSR)(CSR)-CSR assigns the grant to a -CSR assigns the grant to a Scientific Review Groups (SRG)Scientific Review Groups (SRG), , AKA “Study Section”AKA “Study Section”

*Musculoskeletal Rehabilitation*Musculoskeletal Rehabilitation*Function, Integration, Rehabilitation Sciences *Function, Integration, Rehabilitation Sciences

SubcommitteeSubcommittee-Each SRG managed by a -Each SRG managed by a Scientific Review Administrator Scientific Review Administrator (SRA)(SRA)-Most SRG are not aligned with an Institute, but some are-Most SRG are not aligned with an Institute, but some are-Peers, independent investigators for the most part-Peers, independent investigators for the most part

Council ReviewCouncil Review-Institute specific-Institute specific-Peers, program officers-Peers, program officers

Review ProcessReview Process

1-5 (1=outstanding)1-5 (1=outstanding)-No specific instructions on how to weigh -No specific instructions on how to weigh each criterioneach criterion-Reviewer’s overall impression-Reviewer’s overall impression

Priority score: Rating of intrinsic scientific Priority score: Rating of intrinsic scientific merit of the proposed research (100-500)merit of the proposed research (100-500)

Percentile: the relative rank of each priority Percentile: the relative rank of each priority score (along a 100.0 percentile band) among score (along a 100.0 percentile band) among the scores assigned by a particular study the scores assigned by a particular study sectionsection

Streamlining: Up to half of proposals are Streamlining: Up to half of proposals are unscored (bottom half of applicants, ~priority unscored (bottom half of applicants, ~priority score 3.0 or higher)score 3.0 or higher)

What really matters…What really matters…

I will assume that you have a greatI will assume that you have a great ideaidea mentormentor institutioninstitution

What really matters…What really matters…

Communicate!Communicate! Write in EnglishWrite in English Learn to write!Learn to write! Use correct Use correct

grammargrammar Use correct spellingUse correct spelling Keep it simple and Keep it simple and

clearclear Don’t try to impressDon’t try to impress Write to a scientists Write to a scientists

who is not in your who is not in your fieldfield

Remember, the Remember, the reviewers are:reviewers are:

Spending 6-10 hrs Spending 6-10 hrs per K-award per K-award applicationapplication

FatiguedFatigued Grumpy and irritableGrumpy and irritable Not easily impressedNot easily impressed Poorly paidPoorly paid Working above and Working above and

beyond their regular beyond their regular workwork

What really matters…What really matters…

FormatFormat Remember, reviewers are spending Remember, reviewers are spending

hrs reviewing grants, their eyes are hrs reviewing grants, their eyes are red and glassy and they are fatiguedred and glassy and they are fatigued

They need to see!They need to see! Follow instructionsFollow instructions Watch marginsWatch margins Arial 11 or largerArial 11 or larger Include pictures and diagrams; a sea Include pictures and diagrams; a sea

of letters tend to merge into a blurof letters tend to merge into a blur

What really matters…What really matters…

Read other people’s grants:Read other people’s grants: Knutson R21: Knutson R21: 153, 11%153, 11% Chae single site R01Chae single site R01

-Initial submission: -Initial submission: 273, 49.4%273, 49.4%

-A1: -A1: 170, 16.7%170, 16.7%

-A2: -A2: 130, 1.0%130, 1.0% Chae multi-site R01: Chae multi-site R01: 135, 3.1%135, 3.1%

What really matters…What really matters…

Start earlyStart early Give yourself at least 4-mo to Give yourself at least 4-mo to

write a R-award (~2 hrs/day)write a R-award (~2 hrs/day) For a K-award, start earlier to For a K-award, start earlier to

identify a mentor, establish a identify a mentor, establish a training plan, research plan etctraining plan, research plan etc

Get it done earlyGet it done early

What really matters…What really matters…

Have others read your applicationHave others read your application Independent investigators with a track record Independent investigators with a track record

of successof success Members of study sectionsMembers of study sections Remember, it takes approximately 8 hrs to Remember, it takes approximately 8 hrs to

review a K-awardreview a K-award Don’t give it to your colleague last minute; Don’t give it to your colleague last minute;

give them at least 2-wksgive them at least 2-wks Have a thick skin; they are trying to help you, Have a thick skin; they are trying to help you,

not humiliate younot humiliate you Take their feedback seriouslyTake their feedback seriously

What really matters…What really matters…

After you receive your score…After you receive your score… Review your summary statement with Review your summary statement with

your mentor your mentor Follow up with your program officer Follow up with your program officer Determine whether you’re in the Determine whether you’re in the

fundable rangefundable range Determine whether the grant has Determine whether the grant has

merit for resubmission merit for resubmission Try, try again…Try, try again…

SummarySummary

NIH structureNIH structure People to knowPeople to know Types of GrantsTypes of Grants K and R Award StructureK and R Award Structure Review criteriaReview criteria Comments on other mechanismsComments on other mechanisms Review ProcessReview Process How to write…How to write…