Strategies to optimize NIH Strategies to optimize NIH funding successfunding success

Cristina Cassetti, Ph.D.Cristina Cassetti, Ph.D.

Mark Mark ChallbergChallberg, PhD., PhD.

Program OfficersProgram Officers

Division of Microbiology and Infectious DiseasesDivision of Microbiology and Infectious Diseases

NIAIDNIAID

University of GeorgiaJanuary 16, 2009

Strategies to optimize NIH funding Strategies to optimize NIH funding successsuccess

•• Understand the NIH systemUnderstand the NIH system–– Extramural funding basicsExtramural funding basics–– Appropriate funding mechanismsAppropriate funding mechanisms–– Research resourcesResearch resources

•• Stay upStay up--toto--datedate–– Funding opportunitiesFunding opportunities–– Institutes research prioritiesInstitutes research priorities–– Change in funding policiesChange in funding policies

•• Improve your grant craftsmanshipImprove your grant craftsmanship

The National Institutes of HealthThe National Institutes of Health•• The National Institutes of Health (NIH), a part of the The National Institutes of Health (NIH), a part of the

U.S. Department of Health and Human ServicesU.S. Department of Health and Human Services, is the , is the primary Federal agency for conducting and supporting primary Federal agency for conducting and supporting medical research medical research

•• NIH traces its roots to 1887, when a oneNIH traces its roots to 1887, when a one--room room laboratory was created within the Marine Hospital laboratory was created within the Marine Hospital Service (MHS), predecessor agency to the U.S. Public Service (MHS), predecessor agency to the U.S. Public Health Service (PHS).Health Service (PHS).

•• $29B in Congressional Appropriations$29B in Congressional Appropriations and 18,000 and 18,000 employeesemployees

•• Mission: Mission: “Science in pursuit of fundamental knowledge about the nature and behavior of living systems and the application of that knowledge to extend healthy life and reduce the burdens of illness and disability.”

NIH Pursues its Mission by...NIH Pursues its Mission by...

•• Extramural research support (~85% of budget) Extramural research support (~85% of budget) for...for...–– Research by nonResearch by non--HHS scientists in universities & other HHS scientists in universities & other

research institutionsresearch institutions–– Training research investigatorsTraining research investigators–– Communicating biomedical informationCommunicating biomedical information

•• Intramural research (~10% of budget)Intramural research (~10% of budget)–– Conducted in Conducted in NIHNIH’’ss own laboratories own laboratories

Intramural Research: 10%

R&D Contracts: 10%

Research Centers: 10%

Other Research: 6%

All Other: 5%Research Mgmt & Support: 4% Research Project

Grants: 52%$15.165

Training: 3%

Source: http://www.nih.gov/about/director/budgetrequest/pressinfSource: http://www.nih.gov/about/director/budgetrequest/pressinfofy2008.pdfofy2008.pdf

FY08 President budget requestFY08 President budget requestTotal NIH budget Authority: $ 28.850 BTotal NIH budget Authority: $ 28.850 B

Office of the Director

National Instituteon Alcohol Abuseand Alcoholism

National Instituteof Arthritis andMusculoskeletal

and Skin Diseases

National CancerInstitute

National Instituteof Diabetes andDigestive and

Kidney Diseases

National Instituteof Dental andCraniofacial

Research

National Instituteon Drug Abuse

National Instituteof Environmental Health Sciences

National Instituteon Aging

National Instituteof Child Health

and HumanDevelopment

National Institute onDeafness and Other

CommunicationDisorders

National EyeInstitute

National HumanGenome Research

Institute

National Heart,Lung, and Blood

Institute

National Instituteof Mental Health

National Instituteof NeurologicalDisorders and

Stroke

National Instituteof General

Medical Sciences

National Instituteof Nursing Research

National Libraryof Medicine

Center for InformationTechnology

Center for Scientific Review

National Centerfor Complementary

and AlternativeMedicine

National Instituteof Allergy and

Infectious Diseases

FogartyInternational

Center

National Centerfor ResearchResources

Clinical Center

National Institute of Biomedical Imaging and Bioengineering

National Center on Minority Health and Health Disparities

No funding authority

NIH OrganizationNIH Organization

NIH Institutes & Centers (ICs)NIH Institutes & Centers (ICs)

•• Grants are funded by ICs (not by NIH centrally and not Grants are funded by ICs (not by NIH centrally and not by Study Sections)by Study Sections)

•• All grants are assigned to one primary IC for fundingAll grants are assigned to one primary IC for funding

•• Scientific Missions:Scientific Missions:–– Congress: statutory mission & scopeCongress: statutory mission & scope–– Institutes/Centers: define programs and set prioritiesInstitutes/Centers: define programs and set priorities

•• Budgets:Budgets:–– Congress: sets amountCongress: sets amount–– Institutes/Centers: allocate funds (e.g., investigatorInstitutes/Centers: allocate funds (e.g., investigator--initiated initiated

grants, research training, intramural research) & make awardsgrants, research training, intramural research) & make awards

Selected Institutes and CentersSelected Institutes and Centers

NIAIDNIAID National Institute of Allergy and Infectious DiseasesNational Institute of Allergy and Infectious Diseases

NCINCI National Cancer InstituteNational Cancer Institute

NIDDKNIDDK National Institute of Diabetes, Digestive and Kidney National Institute of Diabetes, Digestive and Kidney DiseasesDiseases

FICFIC Fogarty International CenterFogarty International Center

NIGMSNIGMS National Institute of General Medical SciencesNational Institute of General Medical Sciences

NHLBINHLBI National Heart Lung and Blood InstituteNational Heart Lung and Blood Institute

FY 07 R01 Success rates for selected ICs FY 07 R01 Success rates for selected ICs

Funding Institute/Center

Activity Code

Number Reviewed

Number Awarded

Total Cost Awarded**

Success Rate**

NIAAA R01 378 101 $41,485,282 26.7%

NIA R01 1,152 255 $96,723,322 22.1%

NIAID R01 2,722 508 $193,290,793 18.7%

NIAMS R01 746 166 $60,156,786 22.3%

NCCAM R01 123 13 $4,107,401 10.6%

NCI R01 3,791 792 $276,862,315 20.9%

NIDA R01 1,146 256 $112,932,652 22.3%

NIDCD R01 497 165 $59,279,486 33.2%

NIDCR R01 429 104 $39,320,993 24.2%

NIDDK R01 2,089 498 $167,082,467 23.8%

NIEHS R01 530 111 $45,550,724 20.9%

NIGMS R01 3,024 999 $326,603,204 33.0%

NICHD R01 1,360 288 $114,275,124 21.2%

NHGRI R01 139 43 $18,394,944 30.9%

NHLBI R01 3,332 727 $345,604,599 21.8%

NIMH R01 1,697 402 $170,981,478 23.7%

NINDS R01 2,149 405 $148,646,985 18.8%

FIC R01 79 21 $3,405,364 26.60%

Research Portfolio Online Reporting Tool (RePORT)

Extramural Funding BasicsExtramural Funding Basics

Review & ProgramReview & ProgramReviewReview •• Center for Scientific Review (CSR)Center for Scientific Review (CSR)

•• Conducts independent peer review of grant Conducts independent peer review of grant applicationsapplications

•• Scientific Review AdministratorsScientific Review Administrators (SRAs) (SRAs) manage all review activitiesmanage all review activities

ProgramProgram •• 27 Institutes and Centers27 Institutes and Centers

•• Fund grantsFund grants

•• Program OfficersProgram Officers (aka Program Directors) (aka Program Directors) are responsible for an Instituteare responsible for an Institute’’s extramural s extramural activities in a scientific area, and manage all activities in a scientific area, and manage all the related grantsthe related grants

NIH Peer ReviewNIH Peer Review

••Mandated by Federal LawMandated by Federal Law

••Dual Review System:Dual Review System:

Initial ReviewInitial Review Secondary ReviewSecondary ReviewScientific Review GroupsScientific Review Groups National Advisory CouncilsNational Advisory Councils

•• Scientific meritScientific merit

•• Level of supportLevel of support

•• Duration of awardDuration of award

•• Endorse the initial scientific Endorse the initial scientific merit reviewmerit review

•• Evaluate relevance to NIH Evaluate relevance to NIH programs & prioritiesprograms & priorities

Initial Scientific ReviewInitial Scientific Review

•• All grant applications must undergo peer review for All grant applications must undergo peer review for scientific meritscientific merit

•• At NIH, review activities are separate and independent At NIH, review activities are separate and independent from funding and grants management activitiesfrom funding and grants management activities

•• Most reviews are conducted by the Center for Scientific Most reviews are conducted by the Center for Scientific Review (CSR)Review (CSR)

•• Most Institutes also have a review groupMost Institutes also have a review group

•• Scientific Review Officers (SROs) manage all review Scientific Review Officers (SROs) manage all review activitiesactivities

CSR Study SectionsCSR Study Sections

•• ~150 standing Study Sections that review ~150 standing Study Sections that review applications for:applications for:–– Research Grants (R01, PA)Research Grants (R01, PA)–– Postdoctoral FellowshipsPostdoctoral Fellowships–– Academic Research Enhancement Awards (AREA)Academic Research Enhancement Awards (AREA)–– Small Business Innovation Research GrantsSmall Business Innovation Research Grants

•• Standing study sections have 12 Standing study sections have 12 -- 24 members, 24 members, most from academiamost from academia

•• Managed by Scientific Review Officers (SROs)Managed by Scientific Review Officers (SROs)

Scientific Review OfficerScientific Review Officer

•• Trained scientist, usually a Ph.D., whose background is Trained scientist, usually a Ph.D., whose background is close to the expertise of the study sectionclose to the expertise of the study section

•• Manages study sections & the review process:Manages study sections & the review process:–– Performs administrative and technical review of applicationsPerforms administrative and technical review of applications–– Selects reviewersSelects reviewers–– Prepares summary statementsPrepares summary statements–– Provides information about study section recommendations to Provides information about study section recommendations to

Institutes and National Advisory Councils/BoardsInstitutes and National Advisory Councils/Boards

•• The main point of contact with applicants during the The main point of contact with applicants during the initial phase of peer review, until the conclusion of the initial phase of peer review, until the conclusion of the scientific review group meetingscientific review group meeting

Secondary Review:Secondary Review:National Advisory CouncilsNational Advisory Councils

•• Members: Members: –– Senior scientists with broad experienceSenior scientists with broad experience–– Members of the public with general knowledge of, Members of the public with general knowledge of,

and interest in, the IC's missionand interest in, the IC's mission

•• Perform second level of peer review of grant and Perform second level of peer review of grant and cooperative agreement applicationscooperative agreement applications

•• Provide advice and recommendations on matters Provide advice and recommendations on matters of significance to the policies, missions, and of significance to the policies, missions, and goals of the ICgoals of the IC

Program ManagementProgram Management

Managing the ScienceManaging the Science

•• WorkshopsWorkshops

•• InitiativesInitiatives–– Grants:Grants:

•• Program Announcement (PA)Program Announcement (PA)•• Request for Applications Request for Applications

(RFA)(RFA)–– Contracts:Contracts:

•• Request for Proposals (RFP)Request for Proposals (RFP)

Managing Individual GrantsManaging Individual Grants

•• PrePre--AwardAward–– Advice on grant writingAdvice on grant writing–– Interpreting reviewerInterpreting reviewer’’s s

commentscomments–– Special Funding ActionsSpecial Funding Actions

•• Bridge/Interim FundingBridge/Interim Funding•• Select Pay/Exception FundingSelect Pay/Exception Funding•• Budget/Year AdjustmentBudget/Year Adjustment•• CoCo--fundingfunding

•• PostPost--AwardAward–– Monitor progressMonitor progress–– Supplemental fundingSupplemental funding

Program Officer Program Officer (a.k.a. Program Director, Administrator or Official)(a.k.a. Program Director, Administrator or Official)

•• Trained scientist or health professional, usually a Trained scientist or health professional, usually a Ph.D. or M.D., whose scientific background is Ph.D. or M.D., whose scientific background is close to the scope of the programclose to the scope of the program

•• Advocate for scientific area and steward of NIH Advocate for scientific area and steward of NIH funds:funds:–– Develops a comprehensive portfolio of grants and/or Develops a comprehensive portfolio of grants and/or

contracts addressing specific scientific and/or public contracts addressing specific scientific and/or public health objectiveshealth objectives

–– Identifies scientific gaps & opportunitiesIdentifies scientific gaps & opportunities–– Facilitates funding of grants & contractsFacilitates funding of grants & contracts–– Monitors progress of funded grants & contractsMonitors progress of funded grants & contracts

Grants Management SpecialistGrants Management Specialist

•• Responsible for the business and other nonResponsible for the business and other non--scientific scientific aspects of a portfolio of awarded grants:aspects of a portfolio of awarded grants:–– Evaluates grant applications for administrative content and Evaluates grant applications for administrative content and

compliance with statutes, regulations and guidelinescompliance with statutes, regulations and guidelines–– Assists applicants and grantees, interprets grants administratioAssists applicants and grantees, interprets grants administration n

policiespolicies

•• Calculates final award amount based on reviewers Calculates final award amount based on reviewers recommendations and institute policies recommendations and institute policies

•• Main point of contact for requests for postMain point of contact for requests for post--award award changeschanges–– Change of InstitutionChange of Institution–– Change of PIChange of PI–– NoNo--cost extension cost extension

You would like the NIH to fund You would like the NIH to fund your researchyour research

Now what?Now what?

1. Identify appropriate IC and 1. Identify appropriate IC and funding opportunityfunding opportunity

Computer Retrieval of Information Computer Retrieval of Information on Scientific Projects (CRISP)on Scientific Projects (CRISP)

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

Initiatives for GrantsInitiatives for Grants

ProgramProgram

AnnouncementAnnouncement(PA, PAS, PAR)(PA, PAS, PAR)

Request for Request for ApplicationsApplications

(RFA)(RFA)

ScienceScience BroadBroad FocusedFocused

Duration of Duration of initiativeinitiative

Varies; may be open for yearsVaries; may be open for years One time onlyOne time only

ReviewReview CSRCSR

butbut PAR reviewed by ICPAR reviewed by IC

ICIC

Receipt Receipt date(sdate(s)) Standard, 3/yearStandard, 3/year Special dateSpecial date

SetSet--aside $?aside $? NoNo

butbut PAS has setPAS has set--asideaside

YesYes

2. Identify Appropriate Grant 2. Identify Appropriate Grant MechanismsMechanisms

NIH Extramural FundingNIH Extramural Funding

GrantsGrants •• AssistanceAssistance

•• PI develops the research planPI develops the research plan

•• NIH not involved in the conduct of the researchNIH not involved in the conduct of the research

CooperativeCooperative

AgreementsAgreements

•• AssistanceAssistance

•• PI develops the research planPI develops the research plan

•• NIH has substantial involvement in carrying out the NIH has substantial involvement in carrying out the project's activities project's activities

R&D ContractsR&D Contracts •• ProcurementProcurement

•• NIH establishes plans, protocols, and detailed NIH establishes plans, protocols, and detailed requirementsrequirements

•• NIH monitors contract performance closelyNIH monitors contract performance closely

Grant MechanismsGrant MechanismsResearch ProjectsResearch Projects

R01R01 Research ProjectResearch Project

R03R03

R21R21

R15R15

R43, R44R43, R44

P01P01

Small Research Grant Small Research Grant

Exploratory/Developmental Grant Exploratory/Developmental Grant

Academic Research Enhancement Award Academic Research Enhancement Award (AREA) (AREA) Small Business Innovation Research Grant Small Business Innovation Research Grant (SBIR) (SBIR) Research Program Project Research Program Project

Small Research GrantsSmall Research Grants

R21R21 R03R03TitleTitle Exploratory / Developmental Exploratory / Developmental

Research Grant Research Grant Small Research GrantSmall Research Grant

Duration of supportDuration of support 2 years2 years 2 years2 years

Budget (direct costs)Budget (direct costs) Max. $200K/year, $275K totalMax. $200K/year, $275K total

ModularModular

Max $50K/yearMax $50K/year

ModularModular

Research planResearch plan 15 pages 15 pages 10 pages10 pages

Preliminary dataPreliminary data Not required but may be Not required but may be included if availableincluded if available

Not required, particularly for Not required, particularly for pilot or feasibility studies pilot or feasibility studies

RevisionsRevisions 22 11

Competing Competing continuationcontinuation

NoNo NoNo

Funding OpportunityFunding Opportunity PAPA--0606--181181 PAPA--0606--180180

Academic Research EnhancementAcademic Research EnhancementAward (AREA) (R15)Award (AREA) (R15)•• Support small research projects in academic settings that Support small research projects in academic settings that

have not been major recipients of NIH research grant have not been major recipients of NIH research grant funds funds

•• Goals: Goals: –– support meritorious researchsupport meritorious research–– strengthen the research environment of the institutionstrengthen the research environment of the institution–– expose students to researchexpose students to research

•• Budget: up to $150,000/year direct costs plus applicable Budget: up to $150,000/year direct costs plus applicable indirect costsindirect costs

•• Time: Up to three yearsTime: Up to three years

AREA EligibilityAREA Eligibility

•• NOT eligible if institution received NIH grants NOT eligible if institution received NIH grants totaling > $3M/year in totaling > $3M/year in ≥≥ 4 of the last 7 years.4 of the last 7 years.

•• Eligibility is determined at the time of Eligibility is determined at the time of application.application.

•• NIH Contact:NIH Contact:Denise Russo, Ph.D.Denise Russo, Ph.D.301301--451451--79727972drusso1@mail.nih.govdrusso1@mail.nih.gov

Training & Career DevelopmentTraining & Career Development

SeriesSeries ProgramProgram ExamplesExamples

F30,31F30,31 PrePre--docdoc

K08K08 Research training (for MD, DO, DVM, Research training (for MD, DO, DVM, etc.)etc.)

K23K23 PatientPatient--oriented research trainingoriented research training

K22K22 TransitionTransition

K99/R00K99/R00 Pathway to IndependencePathway to Independence

KK Career Development AwardsCareer Development Awards

FF FellowshipsFellowshipsaka aka KirschsteinKirschstein Individual Individual National Research Service National Research Service Awards (NRSA)Awards (NRSA)

F32F32 PostPost--docdoc

K02K02 Newly independentNewly independent

Cooperative Research Partnership Cooperative Research Partnership Grants (U01)Grants (U01)

•• To support translational researchTo support translational research

•• Encourages collaborations between academia Encourages collaborations between academia and industryand industry

•• No budget limit, up to 5 years of supportNo budget limit, up to 5 years of support

•• Substantial Involvement of Program StaffSubstantial Involvement of Program Staff

•• Occasionally issued by institutes with interest in Occasionally issued by institutes with interest in product developmentproduct development–– NIAID yearly NIAID yearly RFAsRFAs on BIOD product development on BIOD product development

NIH DirectorNIH Director’’s New Innovator Awards New Innovator Award•• To support unusually creative new investigators with highly innoTo support unusually creative new investigators with highly innovative vative

research ideas at an early stage of their career when they may lresearch ideas at an early stage of their career when they may lack the ack the preliminary data required for an R01 grant.preliminary data required for an R01 grant.

•• Deadline: Jan 16, 2009 for preDeadline: Jan 16, 2009 for pre--applicationapplication

•• Eligibility for FY 2009:Eligibility for FY 2009:–– New investigator: never been the PI on an R01 or equivalent granNew investigator: never been the PI on an R01 or equivalent grant t –– Received most recent doctoral degree or completed medical internReceived most recent doctoral degree or completed medical internship and ship and

residency in 1999 or later. Limited exceptions for delays in resresidency in 1999 or later. Limited exceptions for delays in research career earch career –– Have an independent research position by September 19, 2009Have an independent research position by September 19, 2009–– No citizenship or residency requirementsNo citizenship or residency requirements

•• Unique ApplicationUnique Application–– 1010--page essay replaces the traditional 25page essay replaces the traditional 25--page page ““Research PlanResearch Plan””–– Budget: up to $300,000 direct costs/ year for up to5 yearsBudget: up to $300,000 direct costs/ year for up to5 years–– Expect to make 24 awards in FY 2009. Competing renewals not be Expect to make 24 awards in FY 2009. Competing renewals not be allowed. allowed.

•• RFARFA--RMRM--0909--003003

Opportunities for nonOpportunities for non--U.S. CitizensU.S. Citizens

•• Generally, PIs and other personnel supported by NIH research graGenerally, PIs and other personnel supported by NIH research grants are nts are not required to be U.S. citizensnot required to be U.S. citizens

•• Some NIH programs/mechanisms have a citizenship/residence requirSome NIH programs/mechanisms have a citizenship/residence requirement, ement, which will be stated in the PA or RFA. Typically:which will be stated in the PA or RFA. Typically:–– U.S. citizen U.S. citizen –– NonNon--citizen U.S. national citizen U.S. national –– Lawfully admitted for permanent residence.Lawfully admitted for permanent residence.

•• Most programs with citizenship requirements involve Career DevelMost programs with citizenship requirements involve Career Development opment (K(K--series) and Research Training (Fseries) and Research Training (F--series, Diversity Supplements)series, Diversity Supplements)

•• A notable exception is the K99/R00 program: citizenship or permaA notable exception is the K99/R00 program: citizenship or permanent nent residence is not requiredresidence is not required

•• The appropriate citizenship/residence status is required when thThe appropriate citizenship/residence status is required when the award is e award is made, not when the application is submittedmade, not when the application is submitted

Diversity SupplementsDiversity Supplements

•• Administrative supplements to existing grantsAdministrative supplements to existing grants–– Most R, P and U grants eligibleMost R, P and U grants eligible–– R03 and R21 R03 and R21 are not eligibleare not eligible

•• Diversity targetsDiversity targets–– UnderUnder--represented racial and ethnic groupsrepresented racial and ethnic groups–– Persons with disabilitiesPersons with disabilities–– Persons from socially, culturally, economically, or educationallPersons from socially, culturally, economically, or educationally disadvantaged y disadvantaged

backgrounds that have inhibited their ability to pursue a careerbackgrounds that have inhibited their ability to pursue a career in healthin health--related related research. research.

•• Training levelTraining level–– Students: high school through graduateStudents: high school through graduate–– PostPost--docsdocs–– Faculty members who will participate in the ongoing research proFaculty members who will participate in the ongoing research project. ject.

•• All NIH Institutes and Centers participate in this programAll NIH Institutes and Centers participate in this program

Research ResourcesResearch Resources

•• Research tools and services for research Research tools and services for research communitycommunity–– Reagents, clones, model organisms, genomic tools, Reagents, clones, model organisms, genomic tools,

bioinformatics tools and databases, sequencing services, bioinformatics tools and databases, sequencing services, cell lines, antibodies, recombinant proteins, clinical cell lines, antibodies, recombinant proteins, clinical specimensspecimens

•• Examples:Examples:–– NIAID: http://www3.niaid.nih.gov/research/resources/NIAID: http://www3.niaid.nih.gov/research/resources/–– NCI: NCI: http://http://resresources.nci.nih.gov/index.cfmresresources.nci.nih.gov/index.cfm–– NIGMS: http://NIGMS: http://www.nigms.nih.govwww.nigms.nih.gov/Initiatives/Models//Initiatives/Models/

3. Identify Appropriate Study 3. Identify Appropriate Study SectionSection

Study section selectionStudy section selection

•• CSR webpage (CSR webpage (http://cms.csr.nih.gov/http://cms.csr.nih.gov/))–– Integrated review groups (Integrated review groups (IRGsIRGs))–– Individual SS and rostersIndividual SS and rosters

•• Talk to SROTalk to SRO

•• Specify desired expertise or study section Specify desired expertise or study section on application cover letter on application cover letter

4. Submission, Review & 4. Submission, Review & AwardAward

The Grant Review CyclesThe Grant Review Cycles

Cycle IIICycle III

Cycle IICycle II

Cycle ICycle I $$CouncilCouncilReviewReviewReceipt & ReferralReceipt & Referral

JanJan FebFeb MarMar AprApr

Receipt & ReferralReceipt & Referral

MayMay JunJun JulJul AugAug

Receipt & ReferralReceipt & Referral

SepSep

ReviewReview

OctOct NovNov DecDec

CouncilCouncil

JanJan

ReviewReview

FebFeb MarMar

$$

AprApr

CouncilCouncil

MayMay JunJun

$$

JulJul

Feb 5 Jun 5 Oct 5

http://grants.nih.gov/grants/funding/submissionschedule.htm

Appl. deadlinesfor new R01s

ReviewReview CouncilCouncil

CouncilCouncilReceipt & ReferralReceipt & Referral

Start registration toeCommons 2-4 weeks before submission

Obtain softwareAdobe Reader 8.1.3or higher

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

Center for Scientific ReviewCenter for Scientific Review

•• Central processing point for most PHS grant Central processing point for most PHS grant applications (Office of Receipt and Referral)applications (Office of Receipt and Referral)

•• Matches grant applications withMatches grant applications with–– Funding Funding IC(sIC(s))–– Initial review groupInitial review group

•• Conducts initial scientific merit review of most Conducts initial scientific merit review of most research applications submitted to the NIHresearch applications submitted to the NIH

Assignment to InstitutesAssignment to Institutes

•• CSR refers applications to an IC as the potential CSR refers applications to an IC as the potential funding componentfunding component

•• The research proposed is matched to the The research proposed is matched to the mission of the ICmission of the IC

•• Where applications are appropriate for more Where applications are appropriate for more than one IC, multiple assignments are madethan one IC, multiple assignments are made

•• The assigned IC(s) will further assign the The assigned IC(s) will further assign the application to a Programapplication to a Program

Assignment to a Scientific Review Assignment to a Scientific Review Group (SRG)Group (SRG)•• Standing Study Section:Standing Study Section:

When the subject matter of the application When the subject matter of the application matches the referral guidelines for the study matches the referral guidelines for the study sectionsection

•• Special Emphasis Panel (SEP):Special Emphasis Panel (SEP):–– When the subject matter does not fit into any Study When the subject matter does not fit into any Study

SectionSection–– When assignment of an application to the most When assignment of an application to the most

appropriate study section would create a conflict of appropriate study section would create a conflict of interest.interest.

–– For special mechanisms (e.g., fellowships, For special mechanisms (e.g., fellowships, SBIRsSBIRs))

Initial ReviewInitial Review

•• Reviewer PreparationReviewer Preparation–– CritiqueCritique–– Preliminary scorePreliminary score

•• Committee MeetingsCommittee Meetings–– FormatFormat

•• Traditional faceTraditional face--toto--faceface•• TelephoneTelephone•• VideoVideo•• Asynchronous Electronic Discussions (AED)Asynchronous Electronic Discussions (AED)

–– ActionsActions•• DiscussionDiscussion•• Independent scoringIndependent scoring

Review Criteria (Research Project Grants)Review Criteria (Research Project Grants)•• SignificanceSignificance

–– Does the study address an important problem? How will scientifiDoes the study address an important problem? How will scientific c knowledge or clinical practice be advanced?knowledge or clinical practice be advanced?

•• ApproachApproach–– Are design and methods wellAre design and methods well--developed and appropriate? Are problem developed and appropriate? Are problem

areas addressed?areas addressed?

•• InnovationInnovation–– Are there novel concepts or approaches? Are the aims original Are there novel concepts or approaches? Are the aims original and and

innovative?innovative?

•• InvestigatorsInvestigators–– Is the team of investigators appropriately trained?Is the team of investigators appropriately trained?

•• EnvironmentEnvironment–– Does the scientific environment contribute to the probability ofDoes the scientific environment contribute to the probability of success? Are success? Are

there unique features of the scientific environment or subject pthere unique features of the scientific environment or subject populations?opulations?

•• Overall EvaluationOverall Evaluation–– An application need not be strong in all categories to be judgeAn application need not be strong in all categories to be judged likely to d likely to

have a major scientific impact. have a major scientific impact.

Communicating Review ResultsCommunicating Review Results

•• The Summary StatementThe Summary Statement–– Summary of Review DiscussionSummary of Review Discussion–– Essentially Unedited CritiquesEssentially Unedited Critiques–– Budget RecommendationsBudget Recommendations–– Administrative NotesAdministrative Notes–– Priority Score and Percentile RankingPriority Score and Percentile Ranking

•• Feedback from Program OfficerFeedback from Program Officer

•• Applicant retrieves Applicant retrieves pdfpdf from eRA Commonsfrom eRA Commons

Paylines & Funding DecisionsPaylines & Funding Decisions

•• ICs Set PaylinesICs Set Paylines–– Based on available funds and expected Based on available funds and expected

number of applications & their budgetsnumber of applications & their budgets–– Rigid or flexibleRigid or flexible

•• Initiatives & Special ActionsInitiatives & Special Actions–– Public health needsPublic health needs–– Scientific gaps & opportunitiesScientific gaps & opportunities

Congratulations, you got an award!Congratulations, you got an award!•• Awards are made to institutions, not PIsAwards are made to institutions, not PIs

•• Requests for changes postRequests for changes post--award have to be submitted award have to be submitted from PI, through their grant officefrom PI, through their grant office

•• Yearly progress reportsYearly progress reports

•• Can request supplements for:Can request supplements for:–– minority students or minority students or postdocpostdoc–– broken pieces of equipmentbroken pieces of equipment–– Unanticipated expenses that impair your ability to perform the Unanticipated expenses that impair your ability to perform the

researchresearch

•• Submit a competing renewal at least 1 year before the Submit a competing renewal at least 1 year before the end of your grantend of your grant

•• Can carry over unspentCan carry over unspent--grant funds for one year beyond grant funds for one year beyond the end of the grant (nothe end of the grant (no--cost extension)cost extension)

Strategies to optimize funding Strategies to optimize funding successsuccess

Strategies to optimize NIH funding Strategies to optimize NIH funding successsuccess

•• Now that you understand the NIH systemNow that you understand the NIH system–– Find the right Institute, ProgramFind the right Institute, Program–– Choose the best funding mechanismChoose the best funding mechanism–– Find the right study sectionFind the right study section

•• Stay upStay up--toto--datedate–– Funding opportunitiesFunding opportunities–– Institutes research prioritiesInstitutes research priorities–– Change in funding policiesChange in funding policies

•• Improve your grant craftsmanshipImprove your grant craftsmanship

Target the right combination of Target the right combination of Institute, Program, Grant Institute, Program, Grant Mechanism, Study SectionMechanism, Study Section

Institute Research PrioritiesInstitute Research Priorities•• Institute websitesInstitute websites

–– Research fundingResearch funding•• OpportunitiesOpportunities

–– Concepts for future initiativesConcepts for future initiatives

•• Some Some ““Hot TopicsHot Topics”” in the Division of in the Division of MicrobiologyMicrobiology–– Mechanisms of DrugMechanisms of Drug--resistanceresistance–– MalariaMalaria–– TBTB–– Pandemic InfluenzaPandemic Influenza–– Emerging Infectious DiseasesEmerging Infectious Diseases–– Vaccine SafetyVaccine Safety

NIH Guide for Grants & ContractsNIH Guide for Grants & Contracts

http://grants.nih.gov/grants/guide/

Identify and Talk to your Potential Identify and Talk to your Potential Program OfficerProgram Officer

•• Institute web sitesInstitute web sites——Description of Description of extramural programsextramural programs

•• Ask your colleagues, mentor, competitorsAsk your colleagues, mentor, competitors

Match Institute and Grant Match Institute and Grant MechanismMechanism

EarlyEarly--Career Grant MechanismsCareer Grant MechanismsSeriesSeries ProgramProgram ExamplesExamples

F30,31F30,31 PrePre--docdoc

K08K08 Research training (for MD, DO, DVM, etc.)Research training (for MD, DO, DVM, etc.)

K22K22 TransitionTransition

K99/R00K99/R00 Pathway to IndependencePathway to Independence

R01R01 Research projectResearch project

R03, R21R03, R21 Small grantsSmall grants

Special ProgramsSpecial Programs DP2DP2 New Innovator AwardNew Innovator Award

RR Research GrantsResearch Grants

KK Career Development AwardsCareer Development Awards

FF FellowshipsFellowshipsaka aka KirschsteinKirschstein Individual Individual National Research Service Awards National Research Service Awards (NRSA)(NRSA)

F32F32 PostPost--docdoc

K02K02

R15R15

Newly independentNewly independent

Academic Research Enhancement Award Academic Research Enhancement Award (AREA)(AREA)

Small Grant Awards (FY2007)Small Grant Awards (FY2007)R21 R03

Institute/Center Number

ReviewedNumber Awarded

SuccessRate

Number Reviewed

Number Awarded

SuccessRate

NIAAA 274 61 22.3% 44 11 25.0%

NIA 614 120 19.5% 234 42 17.9%

NIAID 1,308 306 23.4% 240 44 18.3%

NIAMS 271 46 17.0% 229 34 14.8%

NCI 2,039 277 13.6% 433 154 35.6%

NIDA 366 90 24.6% 180 42 23.3%

NIDCD 117 21 17.9% 107 31 29.0%

NIDCR 342 59 17.3% 101 25 24.8%

NIDDK 1,111 109 9.8% 84 24 28.6%

NIBIB 503 87 17.3% 71 17 23.9%

NIEHS 226 23 10.2% 44 12 27.3%

NEI 231 40 17.3% 16 3 18.8%

NIGMS 207 25 12.1% 0 0

NICHD 595 90 15.1% 530 114 21.5%

NHLBI 797 91 11.4% 6 0 0.0%

NIMH 455 83 18.2% 287 49 17.1%

NINR 128 36 28.1% 40 7 17.5%

NINDS 955 156 16.3% 151 31 20.5%

NCRR 54 13 24.10% 0 0

A Tale of Two K AwardsA Tale of Two K Awards

K22K22 K99/R00K99/R00

NIAID NIAID Research Research Scholar Development Scholar Development AwardAward

NIH Pathway to NIH Pathway to Independence AwardIndependence Award

PostPost--docdoc

IndependentIndependent 2 years2 years 22--3 years3 years

NIAID favors 2NIAID favors 2

IndependentIndependent $150K (yr 1)$150K (yr 1)

$100K (yr 2)$100K (yr 2)

~$165K ($249K less ~$165K ($249K less ~50% F&A)~50% F&A)

PostPost--docdoc

Length of supportLength of support 0 years0 years 11--2 years2 years

NIAID favors 1NIAID favors 1

Annual funding levelAnnual funding level

(direct costs)(direct costs)

$0$0 ~$89K ($90K less ~$89K ($90K less ~8% F&A)~8% F&A)

Citizenship required?Citizenship required? YesYes NoNo

K22 & K99 Applications for FY08K22 & K99 Applications for FY08

K22K22 K99K99

InstituteInstitute ReceivedReceived FundedFunded ReceivedReceived FundedFunded

NCI 115

62

4

3

227

139 54 (39%)

NIGMS

48 (42%)

19 (31%)

2

2 (67%)

134 23 (17%)

NIAID 91 7 (7.7%)

NHLBI 120 47 (39%)

NINDS 96 26 (27%)

NIH Total 111 (49%) 1043 332 (31%)

Study section selectionStudy section selection

•• CSR webpage (CSR webpage (http://cms.csr.nih.gov/http://cms.csr.nih.gov/))–– Integrated review groups (Integrated review groups (IRGsIRGs))–– Individual SS and rostersIndividual SS and rosters

•• Talk to SROTalk to SRO

•• Specify desired expertise or study section Specify desired expertise or study section on application cover letter on application cover letter

Stay upStay up--toto--datedate

NewslettersNewsletters

•• NIH Extramural Nexus (Office of NIH Extramural Nexus (Office of Extramural Research)Extramural Research)http://grants1.nih.gov/grants/nexus.htmhttp://grants1.nih.gov/grants/nexus.htm

•• NIAID Funding NewsNIAID Funding Newshttp://http://www.niaid.nih.gov/ncn/newsletters/www.niaid.nih.gov/ncn/newsletters/default.htmdefault.htm

Changing grant policiesChanging grant policies

•• Change in Change in ““New PINew PI”” policy (Oct 08)policy (Oct 08)–– Add EarlyAdd Early--Stage Investigators (ESI)Stage Investigators (ESI)–– An ESI is a New Investigator who is within 10 years An ESI is a New Investigator who is within 10 years

of completing his/her terminal research degree or is of completing his/her terminal research degree or is within 10 years of completing medical residency (or within 10 years of completing medical residency (or the equivalent).the equivalent). By encouraging By encouraging ESIsESIs to apply for to apply for NIH support, the NIH hopes to accelerate the NIH support, the NIH hopes to accelerate the transition to an independent scientific career with transition to an independent scientific career with substantive NIH research grant support.substantive NIH research grant support.

•• Encourage new and Encourage new and ESIsESIs to apply for R01sto apply for R01s

Changes to Peer ReviewChanges to Peer Reviewhttp://grants1.nih.gov/grants/guide/noticehttp://grants1.nih.gov/grants/guide/notice--files/NOTfiles/NOT--ODOD--0909--023.html023.html

•• January 2009 Due Dates January 2009 Due Dates (for potential FY2010 (for potential FY2010 funding) funding) –– New NIH Policy on Resubmissions (ONE revisionNew NIH Policy on Resubmissions (ONE revision——no A2s)no A2s)

•• May 2009 Review MeetingsMay 2009 Review Meetings (for potential FY2010 (for potential FY2010 funding)funding)–– 99--Point Scoring System Point Scoring System –– Enhanced Review Criteria Enhanced Review Criteria –– Formatted Reviewer Critiques Formatted Reviewer Critiques –– Scoring of Individual Review Criteria Scoring of Individual Review Criteria –– Clustering of New Investigator Applications During Review Clustering of New Investigator Applications During Review

•• January 2010 Due Dates January 2010 Due Dates (for potential FY2011 (for potential FY2011 funding)funding)–– Shorter Applications for R01s and Other Mechanisms Shorter Applications for R01s and Other Mechanisms –– Restructured Applications to Align with Review Criteria Restructured Applications to Align with Review Criteria

Improve GrantsmanshipImprove Grantsmanship

NIH Regional Seminars on Program NIH Regional Seminars on Program Funding & Grants Administration Funding & Grants Administration •• TwoTwo--day seminars coveringday seminars covering

–– The application and review processThe application and review process–– Federal regulations and policiesFederal regulations and policies–– Current areas of special interest or concernCurrent areas of special interest or concern

•• Appropriate forAppropriate for–– Grants administratorsGrants administrators–– Researchers new to NIHResearchers new to NIH–– Graduate students. Graduate students.

•• Two per yearTwo per year

•• http://http://grants.nih.gov/grants/seminars.htmgrants.nih.gov/grants/seminars.htm

Successful Grant WritingSuccessful Grant Writing

•• Your application as a whole must convince Your application as a whole must convince the assigned reviewers to be your the assigned reviewers to be your enthusiastic advocates.enthusiastic advocates.

•• Write for a scientist who knows the field Write for a scientist who knows the field generally.generally.

•• Make the reviewerMake the reviewer’’s job easy: provide all s job easy: provide all necessary information (but no more!) in a necessary information (but no more!) in a clear, wellclear, well--reasoned presentation.reasoned presentation.

Basic GrantsmanshipBasic GrantsmanshipResearch ObjectivesResearch Objectives

•• Address critical issues with the potential to Address critical issues with the potential to significantly advance the fieldsignificantly advance the field

•• HypothesisHypothesis--drivendriven

•• Amount of work appropriate for time Amount of work appropriate for time requestedrequested

•• Aims interrelated but not sequentially Aims interrelated but not sequentially dependentdependent

Basic GrantsmanshipBasic GrantsmanshipPresentationPresentation

•• Provide all background information needed to Provide all background information needed to understand the importance of the work, to understand the importance of the work, to substantiate the hypotheses, and to justify the substantiate the hypotheses, and to justify the approaches.approaches.

•• Interpret and summarize for the reviewer.Interpret and summarize for the reviewer.

•• Demonstrate careful and critical thinking in Demonstrate careful and critical thinking in assessing your own work and that of others.assessing your own work and that of others.

•• Writing should be clear, succinct and informative.Writing should be clear, succinct and informative.

•• Figures should be useful and intelligible.Figures should be useful and intelligible.

NetworkingNetworking

•• Have colleagues critique the application before Have colleagues critique the application before submissionsubmission–– Choose people willing to put in the time and to Choose people willing to put in the time and to

provide a candid critiqueprovide a candid critique–– Allow enough time for them to do the job and for you Allow enough time for them to do the job and for you

to make changesto make changes

•• Know your Program Officer and SRA and call Know your Program Officer and SRA and call with questions or for advicewith questions or for advice

•• If at first you donIf at first you don’’t succeedt succeed……call your Program call your Program Officer!Officer!

Unsuccessful: Program HelpUnsuccessful: Program Help

General AdviceGeneral Advice Notes from reviewNotes from review

Analyze critiques to identify main Analyze critiques to identify main issues that need to be addressedissues that need to be addressed

Bridge/Interim Bridge/Interim (R56)(R56)

One year funding for applications One year funding for applications likely to receive a fundable score likely to receive a fundable score after revisionafter revision

Select Select Pay/ExceptionPay/Exception

Some ICs can fund a limited Some ICs can fund a limited number of applications beyond number of applications beyond their paylinetheir payline

Interim Support (R56 awards)Interim Support (R56 awards)

•• Institute Bridge AwardsInstitute Bridge Awards–– Policies vary among the different Institutes; contact your Policies vary among the different Institutes; contact your

Program OfficerProgram Officer–– Typically awards oneTypically awards one--year at the requested amount for an year at the requested amount for an

unsuccessful R01 applicationunsuccessful R01 application–– May be available to both new and established investigatorsMay be available to both new and established investigators

•• NIH DirectorNIH Director’’s Bridge Awardss Bridge Awards–– To support established investigators To support established investigators –– Competing renewal R01 applicationCompeting renewal R01 application–– Unfunded but close to the payline for the assigned InstituteUnfunded but close to the payline for the assigned Institute–– PI has less than $400,000 in other support (total costs) from alPI has less than $400,000 in other support (total costs) from all l

sourcessources–– One year award, up to $500,000 One year award, up to $500,000 –– $89.6 million available in FY 2008$89.6 million available in FY 2008

NIH Financial OutlookNIH Financial Outlook

Taxpayer Support for NIHTaxpayer Support for NIH

0

5

10

15

20

25

30

35

1940

1945

1950

1955

1960

1965

1970

1975

1980

1985

1990

1995

2000

2005

Fiscal Year

NIH

App

ropr

iatio

n (b

illio

ns)

R01 Spending IncreaseR01 Spending Increase

2

3

4

5

6

7

1996 1998 2000 2002 2004 2006

Fiscal Year

Tota

l R01

Aw

ards

($

billi

ons)

10

15

20

25

30

35

NIH

Bud

get (

$bill

ions

)

R01 SpendingNIH Budget

NIH Budget ↑ 98%R01 $ ↑ 82%

Growth on Growth on allall frontsfronts

NIH NIH BudgetBudget BRDPIBRDPI Grant Grant

BudgetsBudgets InvestigatorsInvestigators

+ 18%+ 18% + 22%+ 22%

+ 17%+ 17%+ 13%+ 13%

+ 30%+ 30%

+ 15%+ 15%

19981998--20032003 + 98%+ 98%

20032003--20062006 + 5%+ 5%

For additional informationFor additional information

Cristina Cassetti, Ph.D.Cristina Cassetti, Ph.D.

Email: Email: ccassetti@niaid.nih.govccassetti@niaid.nih.gov

Mark Mark ChallbergChallberg, , Ph.DPh.D

Email: Email: mchallberg@niaid.nih.govmchallberg@niaid.nih.gov