grant writing for success

Ronald Margolis, Ph.D.National Institute of Diabetes, Digestive and Kidney Diseases

Amanda Boyce, Ph.D. National Institute of Arthritis and Musculoskeletal and Skin

DiseasesAlan Willard, Ph.D.

National Institute of Neurological Diseases and Stroke

2011 NIH Regional Seminars, Phoenix

Grant Writing for Success

Grant Writing for Success

“Anatomy” of Grant Process“Anatomy” of Grant Process

Program StaffProgram Staff Funding OpportunityFunding OpportunityAnnouncementAnnouncement

Funding OpportunityFunding OpportunityAnnouncementAnnouncement

Grant ApplicationGrant Application(R01, R03, R21,(R01, R03, R21,K01, K08, etc.)K01, K08, etc.)

Grant ApplicationGrant Application(R01, R03, R21,(R01, R03, R21,K01, K08, etc.)K01, K08, etc.)

NationalNationalAdvisoryAdvisoryCouncilCouncil

NationalNationalAdvisoryAdvisoryCouncilCouncil

Program Staff Program Staff Program Staff Program Staff

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Rev

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ResearcherResearcher

IdeaIdeaInstitutionInstitution

ResearcherResearcher

IdeaIdeaInstitutionInstitution

CSRCSRReferralReferral

and Review and Review

CSRCSRReferralReferral

and Review and Review

CollaboratorsCollaborators

Grant Writing for SuccessGrant Writing for Success

Writing the Application:Writing the Application: Start earlyStart early Seek advice from colleaguesSeek advice from colleagues Start with a good ideaStart with a good idea Talk to your NIH Program Official(s)Talk to your NIH Program Official(s) Use the NIH webpage (www.nih.gov)Use the NIH webpage (www.nih.gov) Remember review criteriaRemember review criteria Follow instructions carefullyFollow instructions carefully

What Determines Which What Determines Which Grants Are Funded?Grants Are Funded?

Scientific meritScientific merit

Program considerationsProgram considerations

Availability of fundsAvailability of funds

Components of a SuccessfulComponents of a SuccessfulGrant ApplicationGrant Application

Strong IdeaStrong Idea

Strong ScienceStrong Science

Strong ApplicationStrong Application

Principles of SuccessPrinciples of Success

Understand the peer review processUnderstand the peer review process Understand the agency missionUnderstand the agency mission

– Every IC is different!Every IC is different! Secure collaborators (mentors) to Secure collaborators (mentors) to

complement your expertise and experiencecomplement your expertise and experience– Don’t compete … Don’t compete … collaborate!collaborate!

Learn and practice the skills of writing Learn and practice the skills of writing applications for grant fundsapplications for grant funds

Understanding the MissionUnderstanding the Mission

Mission of each NIH IC is based and defined Mission of each NIH IC is based and defined in lawin law– Authorizations (create/continue an agency Authorizations (create/continue an agency

– periodic)– periodic)– Appropriations ($ for the agency – annual)Appropriations ($ for the agency – annual)

ICs establish specific research emphasesICs establish specific research emphases– Legislative missionLegislative mission– Current state of scienceCurrent state of science

Use the Web to find out!Use the Web to find out!

www.nih.govwww.nih.gov

Identifying NIH InitiativesIdentifying NIH Initiatives

Most NIH Institutes establish specific Most NIH Institutes establish specific research Initiatives and Prioritiesresearch Initiatives and Priorities

Funding Opportunity Announcements Funding Opportunity Announcements (FOAs)(FOAs)– Must respond to a FOA via Grants.govMust respond to a FOA via Grants.gov

NIH Guide for Grants and NIH Guide for Grants and ContractsContracts

Official publication listing NIH funding Official publication listing NIH funding opportunities and policy noticesopportunities and policy notices

– Request for Applications (RFA)Request for Applications (RFA)

– Program Announcements (PA, PAR, PAS)Program Announcements (PA, PAR, PAS)

– Request for Proposals (RFP)Request for Proposals (RFP)

– Notices (NOT)Notices (NOT) Published weeklyPublished weekly

NIH Guide for Grants and NIH Guide for Grants and ContractsContracts

http://grants.nih.gov/grants/guide/index.htmlhttp://grants.nih.gov/grants/guide/index.html

Identify NIH Funded GrantsIdentify NIH Funded Grants

See what Research Projects the See what Research Projects the NIH or any Institute has fundedNIH or any Institute has funded

Find Potential Collaborators for Find Potential Collaborators for your Projectyour Project

ReResearch search PPortfolio ortfolio OOnline nline RReporting eporting TTool (RePORT) ool (RePORT)

http://report.nih.gov/index.aspx

A searchable database of federally A searchable database of federally supported biomedical researchsupported biomedical research

Access reports, data, analyses, Access reports, data, analyses, expenditures, results of NIH supported expenditures, results of NIH supported research activitiesresearch activities

Identify, analyze IC research portfolios, Identify, analyze IC research portfolios, funding patterns, funded investigators:funding patterns, funded investigators:

• Identify areas with many or few funded projectsIdentify areas with many or few funded projects• Identify NIH-funded investigators and their Identify NIH-funded investigators and their

researchresearch• Identify potential mentors/collaboratorsIdentify potential mentors/collaborators

http://projectreporter.nih.gov/reporter.cfmhttp://projectreporter.nih.gov/reporter.cfm

NIH RePORTerNIH RePORTer

Application Development Application Development StrategyStrategy Act (Plan) Act (Plan)

WriteWrite

ThinkThink

So WHY Plan?So WHY Plan?

You’re more likely to get …You’re more likely to get … A compelling scientific questionA compelling scientific question Appropriate NIH InstituteAppropriate NIH Institute Appropriate review committeeAppropriate review committee Adequate time to complete Adequate time to complete

– A major stress reducer!A major stress reducer!

……a better grant applicationa better grant application

Pre-Submission Planning Pre-Submission Planning TimelineTimeline

call NIH

Remember … Before you startRemember … Before you start

Talk to Program Staff at appropriate ICTalk to Program Staff at appropriate IC Read instructions for application formRead instructions for application form

– SF 424 R & RSF 424 R & R Know your audience Know your audience

– Which Integrated Review Group (IRG) is Which Integrated Review Group (IRG) is most likely to get your application?most likely to get your application?

Propose research about which you are Propose research about which you are passionatepassionate and totally committed to and totally committed to doingdoing

Good IdeaGood Idea

Does it address an important problem?Does it address an important problem? Will scientific knowledge be advanced?Will scientific knowledge be advanced? Does it build upon or expand current Does it build upon or expand current

knowledge?knowledge? Is it feasible …Is it feasible …

– to implement?to implement?– to investigate?to investigate?

Good GrantsmanshipGood Grantsmanship

Grant writing is a learned skillGrant writing is a learned skill– Writing grant applications, standard operating Writing grant applications, standard operating

protocols and manuals of procedures that get protocols and manuals of procedures that get approved are learned skills approved are learned skills

– Writing manuscripts that get published in Writing manuscripts that get published in peer reviewed journals is a learned skillpeer reviewed journals is a learned skill

Grantsmanship is a full time jobGrantsmanship is a full time job– Learn about the grant application processLearn about the grant application process


Searching NIH web sites is a good start Searching NIH web sites is a good start … … but follow up with personal contactbut follow up with personal contact

Contact NIH program staff Contact NIH program staff earlyearly Ask what information would help them Ask what information would help them

advise you about IC interest & advise you about IC interest & “goodness of fit”“goodness of fit”

Are there related FOAs?Are there related FOAs?


Collaborate with other Collaborate with other investigatorsinvestigators– Fill gaps in your Fill gaps in your

expertise and trainingexpertise and training– Add critical skills to Add critical skills to

your teamyour team ““Team Science” can be Team Science” can be

powerful powerful

Multiple Principal Multiple Principal InvestigatorsInvestigators

Single PI model does not always work well for Single PI model does not always work well for multi-disciplinary, collaborative researchmulti-disciplinary, collaborative research

Recognizes contributions of full teamRecognizes contributions of full team In place for most submissions to In place for most submissions to Grants.govGrants.gov Implications for “New Investigator” statusImplications for “New Investigator” status A complex issue – A complex issue – Talk to NIH program staff if Talk to NIH program staff if

you are considering multiple PIs !you are considering multiple PIs !

grants1.nih.gov/grants/multi_pi


Show your draft application to a Show your draft application to a colleaguecolleague

Show your draft application to a Show your draft application to a colleague who does not already know colleague who does not already know what you intend to dowhat you intend to do

Show your draft application to a Show your draft application to a colleague who is not your best friendcolleague who is not your best friend


Your draft reviewers need to Your draft reviewers need to understandunderstand– What you intend to doWhat you intend to do– Why you believe it is important to do Why you believe it is important to do – Exactly how you are going to do itExactly how you are going to do it

If they don’t get it, you must revise If they don’t get it, you must revise your applicationyour application

Leave enough time to make revisionsLeave enough time to make revisions

Good PresentationGood Presentation

Read the application instructions Read the application instructions carefullycarefully

Read the application instructions Read the application instructions carefullycarefully

Don’t forget … Don’t forget …

... ... read the application instructions read the application instructions carefullycarefully

3 Simple Steps:3 Simple Steps:


Good ideas, clearly presentedGood ideas, clearly presented Align your application with the new Align your application with the new

review guidelines to maximize impact:review guidelines to maximize impact:– SignificanceSignificance– InvestigatorInvestigator– InnovationInnovation– ApproachApproach– EnvironmentEnvironment

Developing a Strong Developing a Strong Research PlanResearch Plan

Specific AimsSpecific Aims

Grab the reader immediatelyGrab the reader immediately State long-term objectives AND State long-term objectives AND

expected impactexpected impact Explicitly state hypotheses and Explicitly state hypotheses and

research questionresearch question


Preliminary Studies/Progress ReportPreliminary Studies/Progress Report

How previous work -- by you, your team, How previous work -- by you, your team, and others -- leads to this studyand others -- leads to this study

Demonstrate your experience, Demonstrate your experience, competence and likelihood of continued competence and likelihood of continued successsuccess

Must flow logically from literature review Must flow logically from literature review and major themes of the problem areaand major themes of the problem area

ApproachApproach Does your plan flow logically from the Does your plan flow logically from the

literature review and prior studies?literature review and prior studies? How will each hypothesis be evaluated?How will each hypothesis be evaluated? Do your measures capture the variables Do your measures capture the variables

needed to test hypotheses? needed to test hypotheses? Why did you choose those measures?Why did you choose those measures? Methods and analyses must match Methods and analyses must match


ApproachApproach

For clinical studies be explicit and thorough in For clinical studies be explicit and thorough in discussing discussing

– intervention or system to be studiedintervention or system to be studied

– target population target population

– inclusion and exclusion criteriainclusion and exclusion criteria

– independent and dependent variablesindependent and dependent variables

– all measures and instrumentsall measures and instruments

– power analysespower analyses


Some Common Miscues:Some Common Miscues:

Failure to …Failure to …

Document why the problem is importantDocument why the problem is important

Distinguish empirical findings from speculationDistinguish empirical findings from speculation

Critically analyze key themes in literatureCritically analyze key themes in literature

Consider alternative perspectives Consider alternative perspectives

Read, understand, and cite the crucial studiesRead, understand, and cite the crucial studies


Align with Review Align with Review CriteriaCriteria

1) Overall Impact (Address on Specific 1) Overall Impact (Address on Specific Aims page)Aims page)

2) The 5 core review criteria: 2) The 5 core review criteria: – SignificanceSignificance

– Investigator Investigator

– InnovationInnovation

– ApproachApproach

– EnvironmentEnvironment

http://grants.nih.gov/grants/guide/http://grants.nih.gov/grants/guide/notice-files/NOT-OD-09-025.htmlnotice-files/NOT-OD-09-025.html

http://grants.nih.gov/grants/guide/http://grants.nih.gov/grants/guide/notice-files/NOT-OD-09-025.htmlnotice-files/NOT-OD-09-025.html


OVERALL IMPACTOVERALL IMPACT

The likelihood for the project to exert a The likelihood for the project to exert a sustained, powerful influence on the sustained, powerful influence on the research field(s) involved: research field(s) involved: – in consideration of the following five core in consideration of the following five core

review criteria, and review criteria, and – additional review criteria (as applicable additional review criteria (as applicable

for the project proposed) for the project proposed)

Alignment of Application Format Alignment of Application Format with Scored Review Criteriawith Scored Review Criteria


SIGNIFICANCESIGNIFICANCE 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 be advanced? scientific knowledge be advanced? What will be the effect on concepts or What will be the effect on concepts or

methods that drive this field? methods that drive this field?


INVESTIGATORINVESTIGATOR Are the investigators appropriately trained Are the investigators appropriately trained

and well suited to carry out this work? and well suited to carry out this work? Is the work proposed appropriate to the Is the work proposed appropriate to the

experience level of the principal experience level of the principal investigator and other researchers? investigator and other researchers?

Does the investigative team bring Does the investigative team bring complementary and integrated expertise to complementary and integrated expertise to the project (if applicable)?the project (if applicable)?


INNOVATIONINNOVATION Does the project employ novel Does the project employ novel

concepts, approaches or methods? concepts, approaches or methods? Are the aims original and innovative? Are the aims original and innovative? Does the project challenge existing Does the project challenge existing

paradigms or develop new paradigms or develop new methodologies or technologies? methodologies or technologies?


APPROACHAPPROACH Are the conceptual framework, design, Are the conceptual framework, design,

methods, and analyses adequately methods, and analyses adequately developed, well-integrated, and developed, well-integrated, and appropriate to the aims of the project?appropriate to the aims of the project?

Does the applicant acknowledge Does the applicant acknowledge potential problem areas and consider potential problem areas and consider alternatives? alternatives?


ENVIRONMENTENVIRONMENT Does the scientific environment in which the Does the scientific environment in which the

work will be done contribute to the probability work will be done contribute to the probability of success? of success?

Do the proposed experiments take advantage Do the proposed experiments take advantage of unique features of the scientific environment of unique features of the scientific environment or employ useful collaborative arrangements? or employ useful collaborative arrangements?

Is there evidence of institutional support? Is there evidence of institutional support?


Be realistic … not overly ambitiousBe realistic … not overly ambitious Discuss potential problem areas Discuss potential problem areas Discuss possible solutionsDiscuss possible solutions

– Explain rationale for your decisions Explain rationale for your decisions Be explicitBe explicit Reviewers cannot read your mind … Reviewers cannot read your mind …

Don’t assume they know what you intendDon’t assume they know what you intend

Other Review ConsiderationsOther Review Considerations Human subjectsHuman subjects Animal care and useAnimal care and use Select agentsSelect agents Model organism sharing planModel organism sharing plan Data sharing planData sharing plan

Good ReviewGood Review

Get to the right review groupGet to the right review group Title, abstract, specific aims all point to the main Title, abstract, specific aims all point to the main

goals of your projectgoals of your project Attach a cover letter for the Center for Scientific Attach a cover letter for the Center for Scientific

Review Division of Receipt and Referral Review Division of Receipt and Referral – suggest IC and review group assignmentsuggest IC and review group assignment**– outline areas of key expertise needed for outline areas of key expertise needed for

appropriate reviewappropriate review– do not name specific reviewersdo not name specific reviewers

** Consult with Program Official Consult with Program Official

Understand the dynamics of peer review:Understand the dynamics of peer review: Reviewers will review many applicationsReviewers will review many applications Make your application easy to read and Make your application easy to read and

easy to understandeasy to understand The impact and significance should be The impact and significance should be

clear throughout the applicationclear throughout the application Convince them to be your advocateConvince them to be your advocate

– Get them on your side!Get them on your side!

Good ReviewGood Review

Lack of or weak impact Lack of or weak impact Significance not obvious or weakSignificance not obvious or weak

— Too ambitious, lacking focusToo ambitious, lacking focus— Unclear or flawed hypothesisUnclear or flawed hypothesis— Feasibility unsupportedFeasibility unsupported

Poor writingPoor writing Applicant track record weak or Applicant track record weak or

lacking appropriate expertiselacking appropriate expertise Approach flawedApproach flawed

Common Reasons Cited for Common Reasons Cited for a Weak Applicationa Weak Application

Strong significance to an important problem in Strong significance to an important problem in public health: IMPACT is highpublic health: IMPACT is high— High degree of novelty and innovationHigh degree of novelty and innovation

Strong track record by a well qualified Strong track record by a well qualified applicantapplicant

Clear rationaleClear rationale Relevant and supportive preliminary dataRelevant and supportive preliminary data Clear and focused approach that provides Clear and focused approach that provides

unambiguous resultsunambiguous results Careful attention to detailsCareful attention to details

— Fonts, clarity of data, error bars, spelling, Fonts, clarity of data, error bars, spelling, etcetc

Hallmarks of an Outstanding Hallmarks of an Outstanding Grant ApplicationGrant Application

How to assure that your grant How to assure that your grant gets funded?gets funded?

Good ideas, well presented always winGood ideas, well presented always win Think clearlyThink clearly Write clearlyWrite clearly Be complete but not verboseBe complete but not verbose Never lose sight of the significanceNever lose sight of the significance Point to the impactPoint to the impact Pay attention to detailsPay attention to details

Where Do I Get More Where Do I Get More Information?Information?

NIH homepage: NIH homepage: http://www.nih.gov/

NIDDK (or any Institute): NIDDK (or any Institute): http://www.niddk.nih.gov/

CSR website: CSR website: http://www.csr.nih.gov/

http://www.nih.gov/

http://www.niddk.nih.gov/

http://www.csr.nih.gov/

Additional supporting Additional supporting materialmaterial

Top 10 Top 10 Common Reviewer Common Reviewer

ConcernsConcerns

……..or How Not To ..or How Not To Get DINGED!Get DINGED!

# 1 Concern# 1 Concern

There is not a There is not a

CLEAR HYPOTHESIS, CLEAR HYPOTHESIS, oror

WELL DEFINED GOALSWELL DEFINED GOALS

Provide a focused hypothesis, objectivesProvide a focused hypothesis, objectives Describe the importance and relevance of your Describe the importance and relevance of your

problemproblem Be clear on how your project will move the Be clear on how your project will move the

field forwardfield forward

Grant 1Grant 1

HypothesisHypothesis: : The proposed research seeks to examine The proposed research seeks to examine the relationship between the relationship between neurotransmitter Aneurotransmitter A and and neurotransmitter Bneurotransmitter B signaling in B signaling in Brain Region of rain Region of InterestInterest and in vivo electrophysiological measures of and in vivo electrophysiological measures of BBrain ROIrain ROI output during the transition from chronic output during the transition from chronic morphine exposure to morphine withdrawal… morphine exposure to morphine withdrawal… additionally seeks to determine whether putative additionally seeks to determine whether putative Brain Brain ROIROI projection neurons exhibit altered basal and projection neurons exhibit altered basal and behaviorally-correlated firing profiles during these behaviorally-correlated firing profiles during these states… finally seeks to determine whether the states… finally seeks to determine whether the observed behavioral, neurochemical, and observed behavioral, neurochemical, and neurophysiological indices associated with morphine neurophysiological indices associated with morphine dependence and withdrawal are dependent on dependence and withdrawal are dependent on Neurotransmitter ANeurotransmitter A projections to the B projections to the Brain ROI.rain ROI.

Grant 1Grant 1

SA #1: SA #1: Examine alterations in BExamine alterations in Brain ROIrain ROI neurotransmitter Aneurotransmitter A and and neurotransmitter Bneurotransmitter B efflux in efflux in response to acute morphine challenge and response to acute morphine challenge and withdrawal in morphine-dependent ratswithdrawal in morphine-dependent rats

SA #2: SA #2: Examine alterations in Examine alterations in Brain ROIBrain ROI single-unit single-unit neuronal activity in response to acute morphine neuronal activity in response to acute morphine challenge…challenge…

SA #3: SA #3: Determine the sensitivity of withdrawal-Determine the sensitivity of withdrawal-associated associated neurotransmitter Aneurotransmitter A efflux, single unit efflux, single unit neuronal activity, and withdrawal-associated neuronal activity, and withdrawal-associated behaviors to lesions of the behaviors to lesions of the neurotransmitter A neurotransmitter A afferent inputsafferent inputs

Grant 1Grant 1

Reviewer Comments:Reviewer Comments:

1.1. This application appears to lack a hypothesis This application appears to lack a hypothesis driven from a specific mechanism.driven from a specific mechanism.

2.2. Enthusiasm … dampened by the lack of a Enthusiasm … dampened by the lack of a specific mechanismspecific mechanism

3.3. ……..the proposal begins to look more like a ..the proposal begins to look more like a collection of experiments where the collection of experiments where the applicants are simply listing experiments applicants are simply listing experiments according to their expertise in specific according to their expertise in specific techniquestechniques

4.4. …….overambitious nature of the project.overambitious nature of the project


The The specific aims specific aims do do NOT TEST NOT TEST the Hypothesis, orthe Hypothesis, or

the the specific aims specific aims DEPENDDEPEND on on results from previous aimsresults from previous aims

The best proposals are those with independent The best proposals are those with independent specific aims that address your hypothesis specific aims that address your hypothesis using different approachesusing different approaches

Grant 2Grant 2

HypothesisHypothesis: : The increase in The increase in brainbrain receptor receptor subunits after chronic morphine is an subunits after chronic morphine is an adaptation to reduced tonic adaptation to reduced tonic neurotransmitterneurotransmitter release in the release in the brain region of interestbrain region of interest and and elevates the threshold for opioid analgesia.elevates the threshold for opioid analgesia.

ObjectiveObjective: : Study is to design opioid-based pain Study is to design opioid-based pain relief paradigms with extended analgesic relief paradigms with extended analgesic efficacy and reduced risk of abuse. efficacy and reduced risk of abuse.

PurposePurpose: : To determine whether To determine whether thesethese brainbrain receptors are good targets for “anti-tolerance” receptors are good targets for “anti-tolerance” drugsdrugs

Grant 2Grant 2

SA #1: SA #1: Determine the anatomical location(s) of Determine the anatomical location(s) of chronic morphine-induced changes in chronic morphine-induced changes in brain brain receptorreceptor subunit levels subunit levels

SA #2: SA #2: Examine the role of Examine the role of brain receptor brain receptor subunitssubunits in opioid-induced behaviors other in opioid-induced behaviors other than analgesiathan analgesia

R01R01 Requested $225,000 direct costs / 5 yearsRequested $225,000 direct costs / 5 years

Grant 2Grant 2

Reviewer CommentsReviewer Comments::

1.1. Unfortunately, several of the experiments proposed do Unfortunately, several of the experiments proposed do not directly test the hypothesis and may or may not aid not directly test the hypothesis and may or may not aid in our further understanding of opioid tolerance.in our further understanding of opioid tolerance.

2.2. ..it is not clear whether such changes would correlate ..it is not clear whether such changes would correlate with anti-nociceptive functionwith anti-nociceptive function

3.3. ..there is a lack of preliminary data determining whether ..there is a lack of preliminary data determining whether such studies can be accomplished and whether any such studies can be accomplished and whether any significant changes can be measuredsignificant changes can be measured

4.4. ..the literature reports 15 to 20 different mechanisms ..the literature reports 15 to 20 different mechanisms demonstrating the inhibition of opioid anti-nociceptive demonstrating the inhibition of opioid anti-nociceptive tolerance, yet none of these are addressedtolerance, yet none of these are addressed

5.5. ..studies proposed in aim 2 lack rationale..studies proposed in aim 2 lack rationale


The proposal is The proposal is NOT MECHANISTIC,NOT MECHANISTIC, oror

NOT SCIENTIFICALLY RELEVANTNOT SCIENTIFICALLY RELEVANT

Do not propose correlative studies, propose Do not propose correlative studies, propose strong associationsstrong associations

Do not propose general observations, propose Do not propose general observations, propose specific manipulationsspecific manipulations

Grant 3Grant 3

HypothesisHypothesis: : Sustained electrical activity enhances Sustained electrical activity enhances neuronal neuronal process Xprocess X activity, targeting select proteins activity, targeting select proteins essential for synaptic vesicle essential for synaptic vesicle neurotransmitter neurotransmitter releaserelease and downregulating presynaptic output in and downregulating presynaptic output in neurotransmitter Aneurotransmitter A neurons neurons

ObjectiveObjective: : To define the cellular pathways initiated To define the cellular pathways initiated during periods of increased electrical activity to during periods of increased electrical activity to induce subsequent decreases in synaptic outputinduce subsequent decreases in synaptic output

ProposePropose: : Signal TransductionSignal Transduction pathway pathway 11 acts acts ultimately to phosphorylate and protect the key ultimately to phosphorylate and protect the key presynaptic targets of the presynaptic targets of the process X structureprocess X structure

Grant 3Grant 3

SA #1: SA #1: Investigate the interplay between Investigate the interplay between process process XX function and function and Signal Transduction 1Signal Transduction 1 signaling signaling in persistent in persistent neuronal plasticityneuronal plasticity

SA #2: SA #2: Validate roles for the Validate roles for the presynapticpresynaptic proteins proteins ABC1ABC1 and and ABC2ABC2 in persistent in persistent neuronal neuronal plasticityplasticity

R01R01 Requested $225,000 direct costs / 5 yearsRequested $225,000 direct costs / 5 years

Grant 3Grant 3Reviewer Comments:Reviewer Comments:

1.1. ..the investigator presents an unrealistically simplistic picture of ..the investigator presents an unrealistically simplistic picture of Signal Transduction 1Signal Transduction 1 signaling in neurons signaling in neurons

2.2. The general experimental design relies on correlative studies of The general experimental design relies on correlative studies of signaling systems that are highly complex, and which act at signaling systems that are highly complex, and which act at multiple levelsmultiple levels..

3.3. The anticipated outcomes are discussed only superficially and The anticipated outcomes are discussed only superficially and assume only that the experiments will turn out to support the assume only that the experiments will turn out to support the investigator’s hypothesis…many outcomes can be imaginedinvestigator’s hypothesis…many outcomes can be imagined

4.4. The paradigms still place the neurons in unnatural (non-The paradigms still place the neurons in unnatural (non-physiological) environments for extraordinarily long periods of physiological) environments for extraordinarily long periods of time....this model system (cultured cells) reduces the time....this model system (cultured cells) reduces the significance of the project because the relevance to more significance of the project because the relevance to more realistic neuronal networks remains unclearrealistic neuronal networks remains unclear

5.5. ..experiments have been added which are outside the technical ..experiments have been added which are outside the technical expertise of the investigator and for which preliminary data are expertise of the investigator and for which preliminary data are not in handnot in hand

Grant 4Grant 4

Hypothesis: Hypothesis: Combined Treatment A/BCombined Treatment A/B group will have a group will have a greater reduction in substance use and better greater reduction in substance use and better outcomes three months after study entry, and lower outcomes three months after study entry, and lower HIV risk from drug or sexual behaviorsHIV risk from drug or sexual behaviors

Purpose: Purpose: Examine the utility of a Examine the utility of a Combined Treatment Combined Treatment A/BA/B protocol in the [ protocol in the [hospitalhospital] emergency department ] emergency department with persons at risk for drug addiction and its with persons at risk for drug addiction and its associated health consequencesassociated health consequences

SA #1: SA #1: Determine the impact of a Determine the impact of a Combined Treatment Combined Treatment A/BA/B protocol on substance use, HIV risk reduction, protocol on substance use, HIV risk reduction, health care utilization, and health status among health care utilization, and health status among persons at moderate or high risk for substance abuse persons at moderate or high risk for substance abuse seeking treatment in a [seeking treatment in a [hospitalhospital] emergency ] emergency departmentdepartment

Grant 4Grant 4


1.1. The initial model of care is not different from the The initial model of care is not different from the current practice….thus, it is not clear that this current practice….thus, it is not clear that this Combined Treatment A/B protocolCombined Treatment A/B protocol will have an impact will have an impact of identifying new patients who need counseling.of identifying new patients who need counseling.

2.2. ..the significance of this ..the significance of this Combined Treatment A/BCombined Treatment A/B application is compromised by the failure to integrate application is compromised by the failure to integrate the intervention into existing practice.the intervention into existing practice.

3.3. The recruitment process is not based on a uniform The recruitment process is not based on a uniform screening protocol (lack of specifics on subject screening protocol (lack of specifics on subject recruitment, interview process, support personnel, recruitment, interview process, support personnel, follow-up strategy).follow-up strategy).


This application is not This application is not APPROPRIATEAPPROPRIATE for the for the

GRANT MECHANISMGRANT MECHANISM

A R21 is NOT a R01A R21 is NOT a R01 A Career Development Award (K) is NOT a A Career Development Award (K) is NOT a

Research Project Grant (R)Research Project Grant (R)

Grant 5Grant 5

Hypothesis: Hypothesis: Amphetamine-induced Amphetamine-induced Behavior ABehavior A targets targets Transcription Factor XTranscription Factor X to dendritic structures such to dendritic structures such as the spines of pyramidal cells or the dendrites of as the spines of pyramidal cells or the dendrites of interneurons of the interneurons of the Brain ROIBrain ROI

SA #1: SA #1: Amphetamine-induced Amphetamine-induced Behavior ABehavior A alters alters Transcription Factor XTranscription Factor X immunoreactivity in immunoreactivity in pyramidal neurons and/or interneuronspyramidal neurons and/or interneurons

SA #2: SA #2: Amphetamine-induced Amphetamine-induced Behavior ABehavior A targets targets Transcription Factor XTranscription Factor X to dendrites and spines that to dendrites and spines that receive excitatory synapsesreceive excitatory synapses

Grant 5Grant 5


1.1. This proposal ……is somewhat novel, This proposal ……is somewhat novel, although mainly in the sense that no one although mainly in the sense that no one previously has examined this issue before in previously has examined this issue before in the the Brain ROIBrain ROI. However, in essence this . However, in essence this question reflects more of an incremental question reflects more of an incremental advance in our knowledge as opposed to the advance in our knowledge as opposed to the novel ideas targeted by the R21 mechanism.novel ideas targeted by the R21 mechanism.


The proposal is The proposal is

OVERLY AMBITIOUSOVERLY AMBITIOUS

Set realistic goals for the budget and project Set realistic goals for the budget and project period you proposeperiod you propose


PRELIMINDARY DATA PRELIMINDARY DATA is lackingis lacking

Include preliminary data for all aimsInclude preliminary data for all aims Use preliminary data to show knowledge of Use preliminary data to show knowledge of

methods and data analysesmethods and data analyses But DO propose more than just confirming But DO propose more than just confirming

preliminary resultspreliminary results


I’m not sure that the I’m not sure that the Investigator can do the Investigator can do the

PROPOSED EXPERIMENTSPROPOSED EXPERIMENTS

Don’t propose what you can’t doDon’t propose what you can’t do Include Collaborators and Consultants on Include Collaborators and Consultants on

your projectyour project Describe the value of datasets and Describe the value of datasets and

experimental modelsexperimental models


The The backgroundbackground section is section is MISSING KEY MISSING KEY publications and publications and

experimental findingsexperimental findings

Thoroughly describe the literature, especially Thoroughly describe the literature, especially controversies, controversies, butbut

Support your views and ideasSupport your views and ideas Be sure you have found key referencesBe sure you have found key references

Grant 6Grant 6

Objective: Objective: Study is designed to revise and evaluate Study is designed to revise and evaluate Intervention Model AIntervention Model A for homeless adolescents for homeless adolescents

Purpose: Purpose: Intervention Model A has been thoroughly Intervention Model A has been thoroughly developed and standardized for adults, but not as developed and standardized for adults, but not as well for adolescents, and certainly not within well for adolescents, and certainly not within existing services. This will be a stage I, early existing services. This will be a stage I, early treatment development project, with the aim of treatment development project, with the aim of refining refining Intervention Model AIntervention Model A for homeless for homeless adolescentsadolescents

Grant 6Grant 6

SA #1: SA #1: Refine the existing Refine the existing Intervention Model AIntervention Model A [for adults][for adults] program to develop an integrated program to develop an integrated Intervention A and Intervention A and Intervention BIntervention B treatment program for homeless adolescents treatment program for homeless adolescents presenting symptoms of substance use disorders and self-presenting symptoms of substance use disorders and self-injury/suicidality injury/suicidality

SA #2: SA #2: Examine the feasibility of delivering the Examine the feasibility of delivering the new Integrated new Integrated Intervention programIntervention program within the context of the [ within the context of the [currently currently usedused] youth ] youth InterventionIntervention program recently developed …. for program recently developed …. for homeless adolescentshomeless adolescents

SA #3: SA #3: Conduct a pilot study, comparing Conduct a pilot study, comparing the new Integrated the new Integrated Invention programInvention program to Treatment-as-Usual in a randomized to Treatment-as-Usual in a randomized two group repeated measures design, assessing clients two group repeated measures design, assessing clients enrolled in [enrolled in [the currently usedthe currently used] homeless adolescent ] homeless adolescent Intervention Intervention program who are experiencing substance program who are experiencing substance abuse use disorder symptoms and suicidality/self-injurious abuse use disorder symptoms and suicidality/self-injurious behaviorsbehaviors

Grant 6Grant 6Reviewer CommentsReviewer Comments::

1.1. ..the application does not provide a balanced, critical ..the application does not provide a balanced, critical review of review of Intervention Model AIntervention Model A with substance-abusing with substance-abusing adults, and why this approach would, in turn, be adults, and why this approach would, in turn, be promising with homeless youthpromising with homeless youth

2.2. ..there is an almost complete absence of focus on ..there is an almost complete absence of focus on substance abuse or the integration of substance abuse or the integration of Intervention Intervention Model AModel A [ [previouslypreviously] adapted for this problem] adapted for this problem

3.3. Other more serious design problems include different Other more serious design problems include different assessment schedules, attendance burden, and assessment schedules, attendance burden, and discharge rules between the two conditionsdischarge rules between the two conditions

4.4. ..inclusion criteria …are extremely broad…would seem ..inclusion criteria …are extremely broad…would seem to introduce enormous heterogeneity to the sample to introduce enormous heterogeneity to the sample selectedselected

5.5. What is not well-specified in the application is how the What is not well-specified in the application is how the team will decide if the results of the trial warrant the team will decide if the results of the trial warrant the move to a large efficacy trial.move to a large efficacy trial.


Experimental details,Experimental details,alternative approaches, or alternative approaches, or

interpretation of data interpretation of data are are INADEQUATELY DESCRIBEDINADEQUATELY DESCRIBED

Don’t assume the reviewers know the methodsDon’t assume the reviewers know the methods Provide other experimental directions you Provide other experimental directions you

might use should you encounter problemsmight use should you encounter problems Show the reviewers that you have thought Show the reviewers that you have thought

about your research planabout your research plan


The Proposal is The Proposal is

NOT RELEVANT NOT RELEVANT to the to the MISSION MISSION of the Instituteof the Institute

Don’t try to make your application FIT Don’t try to make your application FIT the Mission of a particular Institutethe Mission of a particular Institute

Funded ApplicationsFunded Applications

Good Grant 1Good Grant 1

Hypothesis: Hypothesis: Chronic drugChronic drug exposure upregulates exposure upregulates the expression of the expression of Factor XFactor X, which triggers and , which triggers and sustains the exocytotic trafficking and surface sustains the exocytotic trafficking and surface expression of functional expression of functional Receptor AReceptor A

Purpose: Purpose: To investigate the molecular mechanisms To investigate the molecular mechanisms for for FactorFactor XX-induced -induced Receptor AReceptor A trafficking trafficking


SA #1: SA #1: Determine the signaling pathways mediating Determine the signaling pathways mediating FactorFactor XX-induced R-induced Receptor Aeceptor A trafficking trafficking

SA #2: SA #2: Determine Determine Factor XFactor X involvement in involvement in drugdrug-induced -induced Receptor AReceptor A trafficking trafficking

SA #3: SA #3: Determine the synaptic sites of Determine the synaptic sites of Receptor AReceptor A trafficking and trafficking and Receptor A-BReceptor A-B interactions interactions

SA #4: SA #4: Determine the behavioral significance of Determine the behavioral significance of emergent emergent Receptor AReceptor A and behavioral and behavioral Receptor A-BReceptor A-B interactionsinteractions

Good Grant 1Good Grant 1Reviewer CommentsReviewer Comments::

1.1. Strengths are numerous and include novel and Strengths are numerous and include novel and innovative hypotheses, sound experimental design innovative hypotheses, sound experimental design using multidisciplinary approaches, a highly using multidisciplinary approaches, a highly qualified investigator and research team, and a qualified investigator and research team, and a high likelihood of meaningful findingshigh likelihood of meaningful findings

2.2. Strengths include the significance of the central Strengths include the significance of the central hypothesis, the well-designed experimental plan, hypothesis, the well-designed experimental plan, supportive preliminary data ….supportive preliminary data ….

3.3. ..the rationale for the studies are clearly ..the rationale for the studies are clearly delineated, appropriate controls are in place, delineated, appropriate controls are in place, scope of the studies is appropriate, and there is … scope of the studies is appropriate, and there is … complete discussion of possible limitations of complete discussion of possible limitations of some approaches and how findings will be some approaches and how findings will be interpretedinterpreted


ObjectiveObjective: : To use … conceptual and statistical To use … conceptual and statistical models to address challenges in the development of models to address challenges in the development of practical strategies for measuring the quality of practical strategies for measuring the quality of communitycommunity treatmenttreatment programs programs

PurposePurpose: : To extend previous approaches to casemix To extend previous approaches to casemix adjustment for performance measurement, and the adjustment for performance measurement, and the feasibility of valid outcomes-based performance feasibility of valid outcomes-based performance measurement systems for measurement systems for community treatmentcommunity treatment..


SA #1: SA #1: Test whether Treatment Program A Test whether Treatment Program A demonstrates efficacy under experimental conditions demonstrates efficacy under experimental conditions relative to community-based care programs, can be relative to community-based care programs, can be translated to a set of community-based care programs, translated to a set of community-based care programs, and is effective relative to a set of community-based and is effective relative to a set of community-based care programscare programs

SA #2: SA #2: Identify program features associated with good Identify program features associated with good client outcomes which might serve as indicators of the client outcomes which might serve as indicators of the quality of community-based treatment programsquality of community-based treatment programs

SA #3: SA #3: Identify candidate quality indicators appropriate Identify candidate quality indicators appropriate for assessing the performance of community-based for assessing the performance of community-based care programs in serving key client subgroupscare programs in serving key client subgroups

Good Grant 2Good Grant 2Reviewer CommentsReviewer Comments::

1.1. The evaluation of Treatment Program A .. in real world The evaluation of Treatment Program A .. in real world settings, and the examination of efficacy, settings, and the examination of efficacy, translational, and effectiveness outcomes in a single translational, and effectiveness outcomes in a single study represents a highly significant endeavor.study represents a highly significant endeavor.

2.2. ..the approach to aim 1 is elegant..the approach to aim 1 is elegant

3.3. The study has the potential to address a major gap in The study has the potential to address a major gap in treatment services research, and to guide diffusion of treatment services research, and to guide diffusion of research-based practices to real world settingsresearch-based practices to real world settings

4.4. The solid design and measurement aspects of the The solid design and measurement aspects of the study and the innovative analytical approach ..make study and the innovative analytical approach ..make this an exciting application with the potential for high this an exciting application with the potential for high impact on the fieldimpact on the field

Three Simple Rules to Three Simple Rules to remember when planning, remember when planning,

writing and submitting writing and submitting your applicationyour application

DO NOT DO NOT write the application write the application for yourself for yourself

unless you are going to fund it unless you are going to fund it yourself.yourself.

You You MUSTMUST convince convince the the entireentire review committee review committee

and the funding agency.and the funding agency.

# 1

Reviewers are never wrong.Reviewers are never wrong. Reviewers are never right.Reviewers are never right.

They simply provide an assessment They simply provide an assessment of material that you provided of material that you provided

in your application.in your application.

Don’t take it personally!Don’t take it personally!

# 2 # 2

The comments in the summary The comments in the summary statement only list some of the statement only list some of the weaknesses… not all of the weaknesses… not all of the weaknesses.weaknesses.

When you revise your application use When you revise your application use the time as an opportunity to improve the time as an opportunity to improve the entire application.the entire application.

# 3 # 3

More Web Resources

Funding Opportunities - sites with Funding Opportunities - sites with important information:important information:

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http://grants.nih.gov/grants/welcome.htm#introduction

http://deainfo.nci.nih.gov/funding.htm

http://deainfo.nci.nih.gov/extra/extdocs/grantrevprocess.htm

http://www.niaid.nih.gov/ncn/grants/default.htm

http://www.niaid.nih.gov/ncn/grants/charts/default.htm

http://www.niaid.nih.gov/ncn/glossary/default.htmhttp://www.niaid.nih.gov/ncn/glossary/default.htm

grants1.nih.gov/grants/grant_tips.htm

grants.nih.gov/grants/glossary.htm

http://www3.cancer.gov/admin/gab/links.htm

deainfo.nci.nih.gov/consumer.htm

deainfo.nci.nih.gov/extra/extdocs/gntapp.htm

www.niaid.nih.gov/ncn/grants/

http://era.nih.gov/

https://commons.era.nih.gov/commons/

http://era.nih.gov/virtualschool/http://era.nih.gov/virtualschool/

grants2.nih.gov/grants/policy/nihgps_2003

http://era.nih.gov/ElectronicReceipt/

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era.nih.gov/ElectronicReceipt/training.htm

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