P. Kay Lund, PhD kay.lund@nih.gov

Henry Khachaturian, PhD hk11b@nih.gov

Division of Biomedical Research WorkforceOffice of the Director

National Institutes of Health

Writing an Effective K Application

BriefOverviewofGrantProcess

FOA

NIH

StudySectionandCouncilReviewInstitute/Center

CSRFeed

back&Revision

ProgramStaff

Department of Health and Human ServicesPart 1. Overview InformationNational Institutes of Health (NIH)Funding Opportunity TitleNIH Pathway to Independence Award (Parent K99/R00)PA-16-193

Award

Timeline for K Applications

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Review:

§ Jun/July

§ Oct/Nov

§ Feb/Mar

Council:

§ October

§ January

§May

AwardDate:

§ December

§ April

§ July

ReceiptDate:

§ Feb12(Mar12)

§ Jun12(Jul12)

§ Oct12(Nov12)

§ Supportprotectedtimeforintensive,supervisedcareerdevelopmentexperiencewithanexpectationforatransitiontoanindependentResearchIntensiveposition

§ K01ResearchScientist:Biomedicalorbehavioralsciences

§ K08ClinicalScientist: Individualswithclinicaldoctoraldegreespursuingtranslationalresearch—applicationofbasicresearchdiscoveriestowardthediagnosis,management,andpreventionofhumandisease

§ K23PatientOriented:InvestigatorscommittedtoPatient-OrientedResearch(POR– directinteractionwithhumansubjects;researchonmechanismsofhumandisease,therapeuticinterventions,clinicaltrials,anddevelopmentofnewtechnologies)

§ K99/R00PathwaytoIndependence:Facilitatesrapidtransitionfromamentoredpostdoctoralpositiontoindependentresearchposition

IndividualMentoredKAwards

Writing an Effective K Application

• StartEarly

• DevelopaStrategy

• PlanYourApplication

• ApplicationRequirement

• ReviewCriteria

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§ ThegeneralruleofthumbforaKawardistostartatleast3monthspriortotheapplicationduedate(orsooner)

§ Notifyyourrefereesearlyandgivethemplentyoftimetosubmitlettersofreference(ensuretheyhavecurrentCVandaimsofgrant)

§ Atleastamonthbeforeyouwanttoapply,you'llneedtogetanNIHCommonsaccount

§ Youwillalsoneedtoknowwhoisyourorganization'sAuthorizedOrganizationalRepresentative(AOR)

Start Early

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§ Assessyourcareersituationandneeds.

§ Findanexperiencedmentor(s)andcollaborators

§ Assesthefieldandthecompetition.SeewhatisbeingfundedbyNIH:ResearchPortfolioOnlineReportingTools(RePORT)

§ Whatareyourstrengthsandweaknesses?Canyoufillinanygapswithcollaboratorsorconsultants?

§ Findoutwhatresourcesandsupportyourorganizationhasandwhatadditionalsupportyouwillneed

Develop a Strategy (1 of 2)

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§ IsthereanaddedvaluetoyourreceivingaKaward?Whynotanotherfundingmechanisms?

§ Giveyourselfplentyoftimetowritetheapplication,atleastthreemonths(andsixmonthsforplanningandpreliminarydata)

§ Knowyourorganization'skeycontactsandinternalproceduresforelectronicapplication

§ CallanNIHProgramOfficertodiscussyouresearchtrainingneedsandcareerdevelopmentplans

Develop a Strategy (2 of 2)

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§ Coordinatetheapplicationwithyourmentor’sscheduleaKapplicationisacollaborationbetweenyouandyourmentor

§ Makesureyourplanningandfeedbackareadequatebyputtingtogetheryourownreviewcommittee

§ Afteryou'vesettledonaproject,draftashortdescriptionofyourspecificaimsanddiscussthesewiththecommittee

Plan Your Application

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§ Sharpenthefocusofyourapplication…avoidan“over-ambitious”project– butitshouldbenovelandsignificant!

§ Yourhypothesisshouldbetestableandaimsdoablewiththeresourcesyouarerequesting

§ Makesurethescaleofyourhypothesisandaimsfitsyourrequestoftimeandresources

§ Reviewerswillquicklypickuponhowwellmatchedyourresearchandcareerdevelopmentobjectivesare

Don't Propose Too Much

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§ CandidateQualifications,CareerGoalsandObjectives

§ Mentor(s),Collaborators,andConsultants

§ Institution’sEnvironmentandCommitmenttotheCandidate

§ SpecificAims§ ResearchStrategy

Application Requirements

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MakeLifeEasyforReviewers:§ Writeclearlyandconcisely§ Guidethereviewerswithgraphicsasmuchaspossible§ Labelallmaterialsclearly§ Makesurefiguresandlegendsarereadable§ Editandproof

KnowTheseReviewProblemsandSolutions:§ Writeacompellingargumentforwhyyourcareerwillbe

enhancedbyreceivingaKaward§ Writeforbothexpertsandnon-expertinyourfield

A Few Tips as You Write

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BiographicalSketch:§ PersonalStatement:YourresearchexperienceandotherqualificationsforthisKaward

§ ResearchSupport:Yoursandyourcolleaguesaccomplishmentsattestingtoqualificationsoftheresearchteam

Candidate’sBackground:§ CancoordinatewithinformationintheBiosketch,butmakesurekeyinformationisprovidedhere,evenifrepeatsBiosketch

Candidate’s Qualifications

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� ExplainanyneworenhancedresearchskillsyouwillgainasaresultoftheKaward

� Stressotheractivitiesthatwillenhanceyourresearchcareer,e.g.,courses,techniques

� Ifyouhavechangedresearchdirection,discussreasonsforthechange,andjustifyhowitwillhelpyoutodevelopyourresearchcareer

� Alwaysprovideacareerdevelopmenttimeline,includingplanstoapplyforsubsequentgrantsupport

� Careerdevelopmentcanincludeavisittoanotherlaboratory,tolearnnewtechnologiesorapproaches

NETWORKINGISGOOD!

Career Goals and Objectives

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� Eachmentormustexplainhowshe/hewillcontributetothedevelopmentofthecandidate.

� Discusstheresearchandalsootheractivities,e.g.,seminars,scientificmeetings,presentations

� Documentsourcesandamountsofanticipatedsupportforthecandidate’sresearchproject

� MentorshoulddiscusstheplansfortransitioningthecandidatetotheindependentinvestigatorstagebytheendoftheKaward- andconveyclearsupportforthepathwaytoindependence

� Providedetailsofpreviousexperienceasamentorandoutcomesofmentees

Mentor(s), Collaborators, Consultants

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� Documentastrong,well-establishedresearchprogramrelatedtothecandidate'sinterests

� Experiencedfaculty,facilitiesandresourcesavailableforthecandidate

� Opportunitiesforintellectualinteractions,e.g.,journalclubs,seminars,andpresentations

� Commitmenttothecandidate’scareerdevelopmentindependentoftheKaward

� Agreetoprovideadequateofficeandlabspace,timeandsupporttothecandidatefortheperiodofKaward

Institution’s Environment & Commitment

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Provideaclearstatementofeachaim’sobjectives,forexample:

§ Totestastatedhypothesis

§ Tocreateanoveldesign

§ Tosolveaspecificproblem

§ Tochallengeanexistingparadigm

§ Toaddressacriticalbarriertoprogressinthefield

§ Todevelopnewtechnology

Specific Aims of the Project

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§ TheresearchcomponentofaKapplicationshouldbedrivenbystronghypothesesratherthanadvancesintechnology.

§ Generally,aresearchprojectshouldaskquestionsthatproveordisproveahypothesisratherthanuseamethodtosearchforaproblemorsimplycollectinformation.

§ However,sometimesappliedresearchisimportanttodiscoverbasicbiologyordeveloporuseanewtechnology.

§ Developafocusedhypothesisthatincreasesunderstandingofanimportantbiologicprocess,healthordiseaserelatedissueandisbasedonastrongpremise(previousresearch,needforfurtherstudy).

A few Tips on the Hypothesis (1/2)

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§ Makesureyourideaisnottoobroad.Yourhypothesismustbetestableduringyour3to5yearawardwiththelevelofresourcesyouarerequesting.

§ Demonstratehowyourprojectfitsinandadvancesyourfield.Makethisexplicit.

§ Remember,methodsarethemeanstoperformyourexperiments.Yourexperimentalresultswillproveordisproveyourhypothesis.

§ Ifyouhavemorethanonehypothesis,chooseone- thatistestable,significantandinnovative.

A few Tips on the Hypothesis (2/2)

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Significance:§ Provideanexplanationoftheimportanceoftheproblemyouaretryingtostudy

§ Explainhowyourproposedstudywillimprovescientificknowledge,technicalcapability,orclinicalpracticeinoneormorefields

§ Discusshowexistingconcepts,methods,technologies,treatments,orinterventionsmaybeimpactediftheproposedaimsareachieved

Research Strategy (1 of 3)

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Innovation:§ Provideanexplanationonhowyourproposedresearchprojectmaychallengeorimprovecurrentresearchorclinicalpracticeparadigms

§ Describeandfullydiscussanynoveltheoreticalconcepts,approaches,methodologies,orinterventionsthatmaybedevelopedorused

§ Describeanyadvantageoverexistingapproaches,methodologies,instrumentation,orinterventions

Research Strategy (2 of 3)

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Approach:§ Describethemethodologyandanalysestobeusedto

accomplishthespecificaimsoftheproject.

§ Discusspotentialproblems,alternativestrategies,andbenchmarksforsuccessanticipatedtoachievetheaims

§ Forearlystagesofdevelopment,describestrategiestoestablishfeasibilityandmanagehigh-riskaspectsoftheproposedwork

§ Payattentiontorigorousexperimentaldesign– powercalculations,sufficientN,biologicalvariables,appropriatestatisticaltestsandauthenticationofreagents

Research Strategy (3 of 3)

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§ DiscussthefivecomponentsoutlinedintheNIHPolicy:§ (1)Format,(1)SubjectMatter,(3)FacultyParticipation,(4)Duration,and(5)Frequency

§ Istheplanappropriateforyourcareerstage,andwillitenhanceyourunderstandingofethicalissuesrelatedtoresearch?

§ DocumentanypriorparticipationinRCRtrainingand/orproposeplanstoreceiveadditionalinstruction

Responsible Conduct of Research

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ScoredReviewCriteria:Ø CandidateØ CareerDevelopmentPlan,Goalsand

ObjectivesØ ResearchPlan(IncludesreviewofScientific

Premise,rigorousexperimentaldesign,biologicalvariables)

Ø Mentor(s),Consultants(s),Collaborator(s)Ø EnvironmentandInstitutionalCommitmentto

theCandidate

Career Award Review Criteria (1 of 5)

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Candidate:

§ Research,academicand/orclinicalrecord

§ Commitmentandpotentialtodevelopasanindependentandproductiveresearcher

§ Qualityoflettersofreference

CareerDevelopmentPlan,GoalsandObjectives:

§ Contributesubstantiallytothescientificdevelopmentofcandidate

§ Content,scope,phasing,anddurationoftheplaninthecontextofpriorexperience

Career Award Review Criteria (2 of 5)

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ResearchPlan:

§ Scientificandtechnicalmeritoftheresearchquestion,designandmethodology

§ Strongpremise,rigorousexperimentaldesignandstatisticalanalyses,unbiasedapproach,addressesrelevantbiologicalvariables(e.g.sex)

§ Relevanceoftheproposedresearchtothecandidate‘scareerobjectives

§ Istheresearchplanappropriatetothestageofresearchdevelopmentandfordevelopingtheresearchskillsdescribedinthecareerdevelopmentplan

Career Award Review Criteria (3 of 5)

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Mentor(s),Consultants(s),Collaborator(s):

§ Qualifications,funding,andstatementbyMentor(s),collaborators,and/orConsultants

EnvironmentandInstitutionalCommitmenttotheCandidate:

§ Assurancethatminimum75%effortwillbedevotedtoresearchandrelatedactivities

§ Capablefacultyandresearchfacilities

§ Assurancethatinstitutionintendsforthecandidatetobeanintegralpartofitsresearchprogram

Career Award Review Criteria (4 of 5)

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AdditionalReviewCriteria:§ ProtectionofHumanSubjects§ InclusionofWomen,Minorities,andChildren§ CareandUseofVertebrateAnimals§ BiohazardsAdditionalReviewConsiderations:§ ResponsibleConductofResearch§ SelectAgents§ Authenticationofkeybiologicalorchemicalresources

§ ResourceSharingPlans§ BudgetandPeriodofSupport

Career Award Review Criteria (5 of 5)

About Grants

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http://grants.nih.gov/grants/about_grants.htm

GrantsBasics

GrantsProcessOverview

PlanYourApplication

HowtoApply

Receipt&Referral

PeerReview

Pre-AwardProcess

Post-AwardMonitoringandReporting

KeeptheJoyinResearchWritingaGrantisFun

TraineesandMenteesprovideaScientificFamilyForever

THANKYOU!QUESTIONS?

RigorinKAwardApplicationandReview