NIH Peer NIH Peer Review in the Review in the Population and Population and Social SciencesSocial Sciences

Center for Scientific ReviewNational Institutes of HealthU.S. Department of Health and Human Services

Scientific Review Administrator and Referral OfficerCenter for Scientific ReviewNational Institutes of Health

Charles N. Rafferty, Charles N. Rafferty, Ph.D.Ph.D.

Study SectionsStudy Sections Health Services Organization and Delivery

(HSOD) – reviews R01, R21, and R03 applications

Occupational Health and Safety SBIR/STTR

Referral IRGsReferral IRGs HOP, RPHB, BST, and DIGHOP, RPHB, BST, and DIG

OutlineOutline

Overview of NIH and Peer Overview of NIH and Peer ReviewReview

Application Receipt and Application Receipt and ReferralReferral

Initial Peer Review Process, Initial Peer Review Process, The Study SectionThe Study Section

GrantsmanshipGrantsmanship

PremisePremise

Understanding the peer review Understanding the peer review process will help you prepare a process will help you prepare a

successful grant application.successful grant application.

Success = AwardSuccess = Award

Dr. Brent StanfieldDr. Brent Stanfield

““Our work is critical Our work is critical because we know the result because we know the result of peer review is the of peer review is the primary factor determining primary factor determining which research NIH funds."which research NIH funds."

National Institutes of National Institutes of HealthHealth

Much of the Much of the biomedical biomedical research in the research in the United States is United States is supported by the supported by the Federal Federal Government, Government, primarily the primarily the National National Institutes of Institutes of Health (NIH)Health (NIH)

NIH Extramural Awarding NIH Extramural Awarding ComponentsComponents

National Cancer Institute (NCI)National Cancer Institute (NCI) National Heart, Lung, and Blood Institute (NHLBI)National Heart, Lung, and Blood Institute (NHLBI) National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) National Library of Medicine (NLM)National Library of Medicine (NLM) National Institute of Child Health and Human Development (NICHD)National Institute of Child Health and Human Development (NICHD) National Institute of Deafness and Other Communication Disorders National Institute of Deafness and Other Communication Disorders

(NIDCD)(NIDCD) National Institute of Environmental Health Sciences (NIEHS)National Institute of Environmental Health Sciences (NIEHS) National Institute of Neurological Disorders and Stroke (NINDS)National Institute of Neurological Disorders and Stroke (NINDS) National Institute on Aging (NIA)National Institute on Aging (NIA) National Institute of Allergy and Infectious Diseases (NIAID)National Institute of Allergy and Infectious Diseases (NIAID) National Institute of Arthritis and Musculoskeletal and Skin Diseases National Institute of Arthritis and Musculoskeletal and Skin Diseases

(NIAMS)(NIAMS) National Institute of Dental and Craniofacial Research (NIDCR)National Institute of Dental and Craniofacial Research (NIDCR) National Eye Institute (NEI)National Eye Institute (NEI) National Institute of General Medical Sciences (NIGMS)National Institute of General Medical Sciences (NIGMS) National Institute of Mental Health (NIMH)National Institute of Mental Health (NIMH) National Institute for Nursing Research (NINR)National Institute for Nursing Research (NINR) National Institute on Alcohol Abuse and Alcoholism (NIAAA)National Institute on Alcohol Abuse and Alcoholism (NIAAA) National Institute on Drug Abuse (NIDA)National Institute on Drug Abuse (NIDA) National Center for Complementary and Alternative Medicine (NCCAM)National Center for Complementary and Alternative Medicine (NCCAM) National Center for Research Resources (NCRR)National Center for Research Resources (NCRR) National Human Genome Research Institute (NHGRI)National Human Genome Research Institute (NHGRI) National Institute of Biomedical Imaging and BioengineeringNational Institute of Biomedical Imaging and Bioengineering (NIBIB) (NIBIB) Fogarty International Center (FIC) Fogarty International Center (FIC) National Center on Minority Health and Health DisparitiesNational Center on Minority Health and Health Disparities (NCMHD) (NCMHD)

A Typical Institute/CenterA Typical Institute/Center

Office of the ICOffice of the ICDirectorDirector

NationalNationalAdvisoryAdvisoryCouncilCouncil

Board ofBoard ofScientificScientific

CounselorsCounselors

ExtramuralExtramural

ScientificScientificProgramsPrograms

GrantsGrants ContractsContracts

IntramuralIntramural

LaboratoryLaboratoryStudiesStudies

ClinicalClinicalStudiesStudies

NIH Extramural NIH Extramural ProgramProgram

GrantGrant PatronPatron (assistance, encouragement)(assistance, encouragement)

CooperativeCooperative PartnerPartnerAgreementAgreement (assistance but substantial(assistance but substantial program involvement)program involvement)

ContractContract PurchaserPurchaser (procurement)(procurement)

NIH Funding in FY 2004: By MechanismNIH Funding in FY 2004: By MechanismTotal = $27BTotal = $27B

Research Project Grants54%

Research Centers9%

Other Research Grants6%

Research Training3%

R&D Contracts10%

Research Management4%

Nat. Lib. Of Medicine1%

Cancer Prev. & Control

2%

Construction & Facilities

1%

Intramural Research10%

Over 80% of NIH funds support

extramural research.

NIH Peer ReviewNIH Peer Review

• Process of evaluation of NIH grant applications for scientific and program merit

• NIH uses dual review system

• Scientific Review Group or Study Section

• Institute/Center Program Review

Dual Review System for Grant ApplicationsDual Review System for Grant Applications

Second Level of ReviewSecond Level of ReviewCouncilCouncil

Assesses Quality of SRGAssesses Quality of SRG Review of Grant ApplicationsReview of Grant Applications Makes Recommendation toMakes Recommendation to Institute Staff on FundingInstitute Staff on Funding Evaluates Program PrioritiesEvaluates Program Priorities and Relevanceand Relevance Advises on PolicyAdvises on Policy

First Level of ReviewScientific Review Group Scientific Review Group

(SRG)(SRG) Provides Initial Scientific MeritProvides Initial Scientific Merit Review of Grant ApplicationsReview of Grant Applications Rates Applications and Makes Rates Applications and Makes

Recommendations for Recommendations for Appropriate Level of Support and Appropriate Level of Support and Duration of AwardDuration of Award

Review Process for a Review Process for a Research GrantResearch Grant

National Institutes of HealthNational Institutes of Health

Center for Scientific ReviewCenter for Scientific Review

Study SectionStudy Section

InstituteInstitute

Advisory Councils and BoardsAdvisory Councils and Boards

Institute DirectorInstitute Director

School or Other Research Center

School or Other Research Center

ResearchGrant Application

ResearchGrant Application

Submits Application

Allocates Funds

Initiates Research Idea

Conducts Research

Assigns to IC & IRG/ Study Section

Reviews for Scientific Merit

Evaluates for Relevance

Recommends Action

Takes final action

GROUPSGROUPS

CSR IRGsCSR IRGsStudy SectionsStudy Sections

Special Emphasis PanelsSpecial Emphasis Panels

INSTITUTESINSTITUTESScientific Review GroupsScientific Review Groups

Contract Review CommitteesContract Review Committees

APPLICATIONS REVIEWEDAPPLICATIONS REVIEWEDResearch ProjectsResearch Projects

Academic Research Academic Research Enhancement AwardsEnhancement Awards

Postdoctoral FellowshipsPostdoctoral FellowshipsSmall Business Innovation Small Business Innovation

ResearchResearchShared InstrumentationShared Instrumentation

Program ProjectsProgram ProjectsCentersCenters

Institutional Training GrantsInstitutional Training GrantsConference GrantsConference GrantsCareer AwardsCareer Awards

Types of Scientific Review GroupsTypes of Scientific Review GroupsWhere are Applications Reviewed?Where are Applications Reviewed?

Small GrantsSmall GrantsRFAsRFAsContractsContracts

Center for Scientific Center for Scientific Review (CSR)Review (CSR)

Focal Point for Initial Review at NIHFocal Point for Initial Review at NIH

•Central receipt point for PHS applications

•Referral to Institutes and to IRGs and Study Sections

•Review of most research and research training applications ..for scientific merit

Center Center forfor Scientific Scientific ReviewReview

ReferralReferral Central Receipt Point for most PHS Grant ApplicationsCentral Receipt Point for most PHS Grant Applications Institute Assignment (Potential Funding Component)Institute Assignment (Potential Funding Component) Assignment to Scientific Review Group in CSR or in an Assignment to Scientific Review Group in CSR or in an

InstituteInstitute

Scientific ReviewScientific Review More than 200 chartered study sections and regularly More than 200 chartered study sections and regularly

recurring special emphasis panels that review:recurring special emphasis panels that review: Research Grant ApplicationsResearch Grant Applications Postdoctoral Fellowship ApplicationPostdoctoral Fellowship Application Academic Research Enhancement Award Academic Research Enhancement Award

ApplicationsApplications Small Business Innovation Research ApplicationsSmall Business Innovation Research Applications

Overall Timeframe from Overall Timeframe from Submission to Award Submission to Award

  There are three overlapping cycles per There are three overlapping cycles per year :year :

JAN FEB MAR APR MAY JUN JUL AUG SEP OCT NOV DEC JAN FEB MAR APR MAY JUN JUL

Review Council

Cycle 1Receipt

Referral Award

Review Council

Cycle 3ReceiptReferral Award

Review CouncilCycle 2

ReceiptAwardReferral

Grant Application Grant Application Receipt and Receipt and AssignmentAssignment

Applications Submitted to Applications Submitted to NIHNIH

Over 60,000 grant Over 60,000 grant applications are applications are submitted to NIH submitted to NIH each year, of which each year, of which 25-30% are funded25-30% are funded

Competing grant Competing grant applications are applications are received for three received for three review cycles per review cycles per yearyear

CSR Receipt and Referral: CSR Receipt and Referral: Central Receipt Point for Central Receipt Point for Applications Applications submitted to the Public Health submitted to the Public Health ServiceService

National Institutesof

Health

Substance Abuse andMental Health Services

Administration

CSRReceipt &ReferralCenters for

Disease Control

Food&

Drug

Agency for Health CarePolicy & Research

Office ofAssistant

Secretary forHealth

Applications are Applications are Assigned byAssigned by

Referral Officers:Referral Officers:

Professional scientists, Professional scientists, most of whom also serve most of whom also serve as scientific review as scientific review administrators of CSR administrators of CSR study sectionsstudy sections

Applications are Assigned Applications are Assigned to:to:

Scientific review groups based Scientific review groups based on:on:–Specific review guidelines for each Specific review guidelines for each scientific review groupscientific review group

Institutes based on:Institutes based on:–Overall mission of the InstituteOverall mission of the Institute–Specific programmatic mandates Specific programmatic mandates and interests of the Instituteand interests of the Institute

Assignment to Assignment to InstitutesInstitutes

Applications are referred to an Institute Applications are referred to an Institute or Center as the potential funding or Center as the potential funding component:component:

This assignment is based on a match This assignment is based on a match between the research proposed and the between the research proposed and the overall mission of the Institute or Centeroverall mission of the Institute or Center

Where applications are appropriate for Where applications are appropriate for more than one Institute or Center, multiple more than one Institute or Center, multiple assignments are madeassignments are made

Sample Application Sample Application NumberNumber

Individual Serial Individual Serial AmendedAmended Research Number Research Number GrantGrant

11 R01 R01 CA CA 123456123456 0101 A1A1

New National GrantNew National GrantApplication Cancer SupportApplication Cancer Support Institute YearInstitute Year

Special Referral IssuesSpecial Referral Issues

Investigators should write a cover letter Investigators should write a cover letter for their applications!for their applications! Referral Officers almost always honor Referral Officers almost always honor

investigator requests for Institute investigator requests for Institute assignments (funding) and CSR study section assignments (funding) and CSR study section assignments (review)assignments (review)

NIMH, NIAA, and NIDA review all health NIMH, NIAA, and NIDA review all health services and treatment research services and treatment research applications assigned to them for fundingapplications assigned to them for funding

All other investigator-initiated health All other investigator-initiated health services and treatment research services and treatment research applications are reviewed by CSRapplications are reviewed by CSR

Initial Review in CSRInitial Review in CSR

CSR Study SectionsCSR Study Sections Each CSR standing Each CSR standing

study section has 12-24 study section has 12-24 members who are members who are primarily from primarily from academiaacademia

CSR standing study CSR standing study sections convene face-sections convene face-to-face meetingsto-face meetings

As many as 60-100 As many as 60-100 applications are applications are reviewed by each study reviewed by each study sectionsection

Each study section is Each study section is managed by a Scientific managed by a Scientific Review AdministratorReview Administrator

CSR Review DivisionsCSR Review DivisionsDivision of Biologic

Basis of DiseaseElliot Postow, Ph.D.

ImmunologyIRG (IMM)

Calbert Laing, Ph.D.

AIDS and RelatedResearch IRG (AARR)

Ranga V. Srinivas, Ph.D.

Oncological SciencesIRG (ONC)

Syed Quadri, Ph.D.

Endocrinology, Metabolism, Nutrition and Reproductive

Sciences IRG (EMNR)Sooja Kim, Ph.D.

Infectious Diseases andMicrobiology IRG (IDM)

Alex Politis, Ph.D.

Division of Physiology and Pathology

Michael Martin, Ph.D.

Cardiovascular SciencesIRG (CVS)

Joyce Gibson, D.Sc.

Integrative, Functionaland Cognitive Neuroscience

IRG (IFCN)Christine Melchior, Ph.D.

Renal and Urological Sciences IRG (RUS)

Daniel McDonald, Ph.D.

HematologyIRG (HEME)

Joyce Gibson, D.Sc.

Digestive Sciences IRG (DIG)

Mushtaq Khan, Ph.D.

Division of Clinical andPopulation-Based Studies

Anita Miller Sostek, Ph.D

Surgical Sciences, Biomedical Imaging and Bioengineering

IRG (SBIB)Eileen Bradley, D. Sc.

Health of the Population IRG (HOP)

Robert Weller, Ph.D.

Risk, Prevention, and HealthBehavior IRG (RPHB)Michael Micklin, Ph.D.

Brain Disorders and ClinicalNeuroscience IRG (BDCN)

David Armstrong, Ph.D.

Behavioral & BiobehavioralProcesses IRG (BBBP)

Karen Sirocco, Ph.D

Division of Molecular and Cellular Mechanisms

Donald Schneider, Ph.D.

Biochemical SciencesIRG (BCS)

Zakir Bengali, Ph.D.

Bioengineering Sciences and Technologies IRG (BST)

Sally Amero, Ph.D.

Biology of Development and and Aging IRG (BDA)Sherry Dupere, Ph.D.

Biophysical and Chemical Sciences IRG (BPC)John Bowers, Ph.D.

Cell Development andFunction IRG (CDF)

Marcia Steinberg, Ph.D.

Genetic Sciences IRG (GNS)

Richard Panniers, Ph.D.

Molecular, Cellular and Developmental

Neuroscience IRG (MDCN)Carole Jelsema, Ph.D.

Respiratory Sciences IRG (RES)

Mushtaq Khan, Ph.D.

Musculoskeletal, Oral, and Skin Sciences IRG (MOSS)

Daniel McDonald, Ph.D.

Biobehavioral and Behavioral Biobehavioral and Behavioral Processes IRG (BBBP) Study Processes IRG (BBBP) Study SectionsSections BRLE – Biobehavioral Regulation, Learning and BRLE – Biobehavioral Regulation, Learning and

EthologyEthology MESH – Biobehavioral Mechanisms of Emotion, MESH – Biobehavioral Mechanisms of Emotion,

Stress and HealthStress and Health LCOM – Language and CommunicationLCOM – Language and Communication CP – Cognition and PerceptionCP – Cognition and Perception APDA – Adult Psychopathology and Disorders of APDA – Adult Psychopathology and Disorders of

AgingAging CPDD – Child Psychopathology and CPDD – Child Psychopathology and

Developmental DisabilitiesDevelopmental Disabilities MFSR – Motor Function, Speech, and MFSR – Motor Function, Speech, and

RehabilitationRehabilitation BBBP Small Business ActivitiesBBBP Small Business Activities

Health of the Population IRG Health of the Population IRG (HOP) Study Sections(HOP) Study Sections CLHP – Community-Level Health Promotion CLHP – Community-Level Health Promotion BGES – Behavioral Genetics and EpidemiologyBGES – Behavioral Genetics and Epidemiology SSPS - Social Sciences and Population StudiesSSPS - Social Sciences and Population Studies HSOD – Health Services Organization and DeliveryHSOD – Health Services Organization and Delivery BMRD - Biostatistical Methods and ResearchBMRD - Biostatistical Methods and Research ECD - Epidemiology of Chronic DiseaseECD - Epidemiology of Chronic Disease EPIC – Epidemiology of CancerEPIC – Epidemiology of Cancer ECDA – Epidemiology of Clinical Disorders and AgingECDA – Epidemiology of Clinical Disorders and Aging NSCF – Nursing Science: Children and FamiliesNSCF – Nursing Science: Children and Families NSAA – Nursing Science: Adults and Older AdultsNSAA – Nursing Science: Adults and Older Adults HOP Small Business ActivitiesHOP Small Business Activities

Risk Prevention and Health Risk Prevention and Health Behavior IRG (RPHB) Study Behavior IRG (RPHB) Study SectionsSections PDRP – Psychosocial Development, PDRP – Psychosocial Development,

Risk and PreventionRisk and Prevention PRDP – Psychosocial Risk and PRDP – Psychosocial Risk and

Disease PreventionDisease Prevention BMIO – Behavioral Medicine BMIO – Behavioral Medicine

Interventions and OutcomesInterventions and Outcomes SPIP - Social Psychology, Personality SPIP - Social Psychology, Personality

and Interpersonal Processesand Interpersonal Processes RPHB Small Business ActivitiesRPHB Small Business Activities

Scientific Review Scientific Review AdministratorAdministrator

Designated Federal Official Performs administrative and

technical review of applications Selects reviewers Manages study sections Prepares summary statements Provides requested information

about study section recommendations to Institutes and National Advisory Councils/Boards

Selection of Peer Selection of Peer ReviewersReviewers

Non-Doctoral

Scientific Community

Non-Research

ResearchCapability

Active and ProductiveResearchers

Criteria For Selection of Peer ReviewersCriteria For Selection of Peer Reviewers

Demonstrated Scientific ExpertiseDemonstrated Scientific Expertise Doctoral Degree or EquivalentDoctoral Degree or Equivalent Mature Judgment Mature Judgment Work Effectively in a Group ContextWork Effectively in a Group Context Breadth of PerspectiveBreadth of Perspective ImpartialityImpartiality Interest in ServingInterest in Serving Adequate Representation of Women Adequate Representation of Women

and Minority Scientistsand Minority Scientists

Review of Research Review of Research GrantsGrantsREVIEW CRITERIA:REVIEW CRITERIA:

SignificanceSignificance ApproachApproach InnovationInnovation InvestigatorInvestigator EnvironmentEnvironment

__________________ Protection of Human SubjectsProtection of Human Subjects Inclusion of Women, Minorities, and ChildrenInclusion of Women, Minorities, and Children Animal Welfare/BiohazardsAnimal Welfare/Biohazards

Overall Evaluation & Score Reflects Impact on FieldOverall Evaluation & Score Reflects Impact on Field

Review Criteria Review Criteria (continued)(continued) Significance: Significance: Does the study address an important Does the study address an important

problem? How will scientific knowledge be problem? How will scientific knowledge be advanced? What are the societal benefits?advanced? What are the societal benefits?

Approach: Approach: Are design and methods well-developed Are design and methods well-developed and appropriate? Are problem areas addressed?and appropriate? Are problem areas addressed?

Innovation: Innovation: Are there novel concepts or approaches? Are there novel concepts or approaches? Are the aims original and innovative?Are the aims original and innovative?

Investigator: Investigator: Is the investigator appropriately Is the investigator appropriately trained?trained?

Environment: Environment: Does the scientific environment Does the scientific environment contribute to the probability of success? Are there contribute to the probability of success? Are there unique features of the scientific environment?unique features of the scientific environment?

Additional Review Criteria – Additional Review Criteria – Amended Applications (Most Amended Applications (Most Mechanisms)Mechanisms)

Adequacy of response to the Adequacy of response to the previous reviewprevious review

Degree of overall Degree of overall improvement of the revised improvement of the revised applicationapplication

Scientific Review Group or Scientific Review Group or Study Section ActionsStudy Section Actions

Scored, Scientific Merit Scored, Scientific Merit Rating (priority scores and Rating (priority scores and percentiles)percentiles)

Unscored (lower half)Unscored (lower half)

DeferralDeferral

Not recommended for Not recommended for further considerationfurther consideration

Priority Priority Scores/Percentile RankScores/Percentile Rank

For each study section, For each study section, applications in the upper applications in the upper half are scored from 1.0-half are scored from 1.0-3.0, with 1.0 the best 3.0, with 1.0 the best score score

Individual scores are Individual scores are averaged and multiplied averaged and multiplied by 100 to give the final by 100 to give the final priority scorepriority score• Percentile ranking is calculated based on results of current

plus past two meetings

Summary StatementSummary Statement Once applications are reviewed, the results Once applications are reviewed, the results

are documented by the SRA in a summary are documented by the SRA in a summary statement and forwarded to the Institute (and statement and forwarded to the Institute (and the PI) where a funding decision is made: the PI) where a funding decision is made:

The summary statement contains:The summary statement contains:

Overall Resume and Summary of Review DiscussionOverall Resume and Summary of Review Discussion Essentially Unedited CritiquesEssentially Unedited Critiques Priority Score and Percentile RankingPriority Score and Percentile Ranking Budget RecommendationsBudget Recommendations Administrative NotesAdministrative Notes

What Determines What Determines Which Awards Are Which Awards Are Made?Made?

Scientific meritScientific merit

Program considerationsProgram considerations

Availability of fundsAvailability of funds

GrantsmanshipGrantsmanship

Steps in preparing a successful Steps in preparing a successful grant applicationgrant application

There is no grantsmanship There is no grantsmanship that will turn a bad idea that will turn a bad idea into a good one, but……..into a good one, but……..

There are many ways to There are many ways to disguise a good one.disguise a good one.

William Raub, Past Deputy Director, NIH

The NIH Grant CultureThe NIH Grant Culture

Bio-Medical ModelBio-Medical Model Randomized Clinical Trial as gold Randomized Clinical Trial as gold

standardstandard Evidence basedEvidence based Underlying Conceptual ModelUnderlying Conceptual Model Emphasis on OutcomesEmphasis on Outcomes Need for MeasurementNeed for Measurement

Step One – ScopingStep One – Scoping

Identify possible research projectsIdentify possible research projects Use web-based NIH data-bases and Use web-based NIH data-bases and

resourcesresources Identify candidate NIH Institutes/CentersIdentify candidate NIH Institutes/Centers Identify candidate NIH grant initiativesIdentify candidate NIH grant initiatives

Program announcement (PA)Program announcement (PA) Request for applications (RFA)Request for applications (RFA) Investigator initiated applicationInvestigator initiated application

Review NIH grant application procedures – Review NIH grant application procedures – PHS 398 InstructionsPHS 398 Instructions

Step Two – Make NIH Step Two – Make NIH ContactsContacts Confer with NIH Program DirectorsConfer with NIH Program Directors

Assess the “fit” to the Institute/CenterAssess the “fit” to the Institute/Center Find out what’s new – PAs and RFAsFind out what’s new – PAs and RFAs Decide on mechanism – Decide on mechanism – e.g.e.g., RO1, R03, , RO1, R03, R21R21

Find collaboratorsFind collaborators Identify review issues – Dos and Don’tsIdentify review issues – Dos and Don’ts Define product and focus applicationDefine product and focus application

Types of GrantsTypes of Grants

R01 – Research ProjectsR01 – Research Projects R03 – Small Research GrantsR03 – Small Research Grants R21 – Exploratory/Developmental GrantsR21 – Exploratory/Developmental Grants R13 –R13 – Conference GrantsConference Grants R41/R42 – Small Business Technology R41/R42 – Small Business Technology

Transfer Grants Phase I/IITransfer Grants Phase I/II K-Awards – Career DevelopmentK-Awards – Career Development F-Awards - FellowshipsF-Awards - Fellowships P01 – Research Program ProjectsP01 – Research Program Projects http://deainfo.nci.nih.gov/flash/awards.htmhttp://deainfo.nci.nih.gov/flash/awards.htm

NIH Grant NIH Grant MechanismsMechanisms

R01R01 Traditional investigator-initiated grant Traditional investigator-initiated grant

< $500K/yr, 3-5 yrs. Need approval if more than < $500K/yr, 3-5 yrs. Need approval if more than $500K for any year of the grant$500K for any year of the grant

R03R03 Small Grant Small Grant

< $100K for 2 yrs< $100K for 2 yrs

R21R21 (NCI) Exploratory/Developmental Grant (NCI) Exploratory/Developmental Grant

< $275K for 2 yrs< $275K for 2 yrs

R13R13 Conference GrantsConference Grants

amount dependent on score, timeliness, budget, NIH amount dependent on score, timeliness, budget, NIH interestinterest

NIH Opportunities for NIH Opportunities for Young Young InvestigatorsInvestigators

National Research Service Individual Fellowship National Research Service Individual Fellowship (F32)(F32)

Mentored Research Scientist Development Award Mentored Research Scientist Development Award (K01)(K01)

Independent Scientist Award Independent Scientist Award (K02)(K02) Mentored Clinical Scientist Development Award Mentored Clinical Scientist Development Award

(K08)(K08) Small Grant Small Grant (R03)(R03) Academic Research Enhancement Award Academic Research Enhancement Award (R15)(R15) Exploratory/Developmental Grant Exploratory/Developmental Grant (R21)(R21)

Step 3 Develop Your Step 3 Develop Your IdeaIdea Review literatureReview literature Generate preliminary dataGenerate preliminary data Enlist collaborators, include letters Enlist collaborators, include letters

of commitmentof commitment Review successful grant applications Review successful grant applications

of other colleaguesof other colleagues

The “Top Ten” ListThe “Top Ten” List

1.1. Read and re-read the program announcementRead and re-read the program announcement

2.2. Assemble a strong research teamAssemble a strong research team

3.3. Use the strongest study design possibleUse the strongest study design possible

4.4. If you have not been on a study section, confer with If you have not been on a study section, confer with someone who hassomeone who has

5.5. Be sure to document the innovations(s)Be sure to document the innovations(s)

6.6. Document strong access to the study populationDocument strong access to the study population

7.7. Make sure the writing, organization, & grammar are as Make sure the writing, organization, & grammar are as tight as possible (write, re-write…read, re-read)tight as possible (write, re-write…read, re-read)

8.8. Seek reviews from experienced peers before Seek reviews from experienced peers before submissionsubmission

9.9. Make careful use of the summary statementMake careful use of the summary statement

10.10. Persevere and don’t take rejection personallyPersevere and don’t take rejection personally(Source: Ross Brownson 1/13/2004)

Step 4 Writing the Step 4 Writing the ApplicationApplication Clear, concise writing styleClear, concise writing style Be focusedBe focused Don’t rushDon’t rush Critique, critique, and critique again Critique, critique, and critique again Follow up with NIH program directors Follow up with NIH program directors

before and after reviewbefore and after review

Step 5 Preparing the Step 5 Preparing the ApplicationApplication

Follow instructions – PHS 398Follow instructions – PHS 398 Never assume that reviewers “know what you Never assume that reviewers “know what you

mean”mean” Refer to literature thoroughlyRefer to literature thoroughly Present a clear rationale for the proposed Present a clear rationale for the proposed

work work Make sure that the experimental approach is Make sure that the experimental approach is

thorough and detailedthorough and detailed Include well-designed tables and figuresInclude well-designed tables and figures Anticipate human subject issuesAnticipate human subject issues

General Design IssuesGeneral Design Issues

Will it work? Will it work? Supporting preliminary dataSupporting preliminary data Valid InstrumentsValid Instruments Pilot dataPilot data Reality check – subject burdenReality check – subject burden Will compliance rate(s) be adequateWill compliance rate(s) be adequate

Methodological IssuesMethodological Issues

Sampling MethodsSampling Methods Power CalculationsPower Calculations Theoretical-based InterventionTheoretical-based Intervention CompliancesCompliances Data Acquisition and ManagementData Acquisition and Management Participant Training and MonitoringParticipant Training and Monitoring Data AnalysisData Analysis

Human Subjects IssuesHuman Subjects IssuesFour criteriaFour criteria

Risks*Risks* ProtectionsProtections Benefits to subjects and othersBenefits to subjects and others Importance of knowledgeImportance of knowledge

Data Safety and Monitoring Plan for clinical trialsData Safety and Monitoring Plan for clinical trials Exemptions applicableExemptions applicable Inclusion plansInclusion plans

Minorities, women, children, Minorities, women, children,

*Risks include the possibility of physical, psychological, or social injury *Risks include the possibility of physical, psychological, or social injury resulting from research.resulting from research.

More Human Subject IssuesMore Human Subject Issues

Recruitment and informed consentRecruitment and informed consent Vulnerable populationsVulnerable populations IncentivesIncentives Informed ConsentInformed Consent

ParticipationParticipation Use of informationUse of information Future analysisFuture analysis

http://ohrp.osophs.dhhs.gov/humansubjects/guidance/45cfr46.htm

Step 6 Submit the Step 6 Submit the applicationapplication Include cover letter

Request Institute assignment for funding Request study section assignment for review Indicate potential conflicts Suggest expertise but not reviewers by name

Multiple Institute assignments acceptable Institute or CSR review predetermined (you can’t

choose) Meet submission deadlines

If late, ask for exception and provide reason Weather, health, study section activities Exceptions never granted prior to submission

Step 7 Monitor Review Step 7 Monitor Review ProcessProcess Contact Scientific Review Administrator for Contact Scientific Review Administrator for

information and to express any concernsinformation and to express any concerns TimingTiming Institute assignmentsInstitute assignments Study section assignmentStudy section assignment

Provide input about needed expertise - Do Not Provide input about needed expertise - Do Not Suggest Reviewers by Name!Suggest Reviewers by Name!

Identify possible conflicts of study section reviewers Identify possible conflicts of study section reviewers – – e.g.e.g., professional, personal, financial, institutional, professional, personal, financial, institutional

Be mindful that NIH review administrators are Be mindful that NIH review administrators are typically managing multiple meetings involving typically managing multiple meetings involving about 100 applications per roundabout 100 applications per round

Step 8 Post Review Step 8 Post Review FollowupFollowup Contact Program Director for information Contact Program Director for information

and guidanceand guidance Discuss outcome of merit peer reviewDiscuss outcome of merit peer review

Review summary statementReview summary statement What the scores mean (Institute ranking)What the scores mean (Institute ranking) Strengths and weaknessesStrengths and weaknesses Recommendations for improvementRecommendations for improvement

Discuss Institute program prioritiesDiscuss Institute program priorities Likelihood of fundingLikelihood of funding Next stepsNext steps

Most Common ProblemsMost Common Problems

Lack of new or original ideasLack of new or original ideas Absence of an acceptable scientific rationaleAbsence of an acceptable scientific rationale Lack of experience in the essential methodologyLack of experience in the essential methodology Questionable reasoning in experimental approachQuestionable reasoning in experimental approach Uncritical approachUncritical approach Diffuse, superficial, or unfocused research planDiffuse, superficial, or unfocused research plan Lack of sufficient methodological detailLack of sufficient methodological detail Lack of knowledge of published relevant workLack of knowledge of published relevant work Unrealistically large amount of workUnrealistically large amount of work Uncertainty concerning future directionsUncertainty concerning future directions

SummarySummary

Keys To SuccessKeys To Success Find collaborators and mentors who are Find collaborators and mentors who are

experienced in writing and winning NIH grantsexperienced in writing and winning NIH grants

Make contact with NIH scientific staff at Make contact with NIH scientific staff at appropriate stages of the review/award cycleappropriate stages of the review/award cycle Institute/Center Program AdministratorsInstitute/Center Program Administrators

Scientific Review AdministratorsScientific Review Administrators

Recognize that NIH peer review has a special Recognize that NIH peer review has a special culture based on standing study sections culture based on standing study sections composed of senior academic researchers composed of senior academic researchers with long histories of service and expectations with long histories of service and expectations of style, academic rigor, and hypothesis-based of style, academic rigor, and hypothesis-based researchresearch

Good Luck!Good Luck!

If at first you don’t succeed –If at first you don’t succeed –

Revise and resubmitRevise and resubmit

Contact InformationContact Information

Charles N. Rafferty, Ph.D.Charles N. Rafferty, Ph.D.Scientific Review AdministratorScientific Review AdministratorHealth of the Population IRGHealth of the Population IRGCenter for Scientific ReviewCenter for Scientific ReviewNational Institutes of HealthNational Institutes of Health6701 Rockledge Drive, MSC 7770, Room 6701 Rockledge Drive, MSC 7770, Room 31723172Bethesda, MD 20892 (20817 for overnight Bethesda, MD 20892 (20817 for overnight mail)mail)301-435-3562301-435-3562301-480-3962 fax301-480-3962 faxraffertc@csr.nih.govraffertc@csr.nih.govhttp://www.csr.nih.govhttp://www.csr.nih.gov

NIH Information NIH Information SourcesSources

Information on the World Wide Information on the World Wide WebWebSelected Sites of InterestSelected Sites of Interest National Institutes of Health (http://www.nih.gov)National Institutes of Health (http://www.nih.gov)

Office of Extramural Research Office of Extramural Research (http://www.nih.gov/grants/oer.htm)(http://www.nih.gov/grants/oer.htm)

Grants Policy Grants Policy (http://www.nih.gov/grants/policy/policy.htm)(http://www.nih.gov/grants/policy/policy.htm)

Center for Scientific Review (http://www.csr.nih.gov)Center for Scientific Review (http://www.csr.nih.gov)

Referral and Review (http://www.csr.nih.gov/refrev.htm)Referral and Review (http://www.csr.nih.gov/refrev.htm)

CSR Study Section Rosters CSR Study Section Rosters (http://www.csr.nih.gov/committees/rosterindex.asp)(http://www.csr.nih.gov/committees/rosterindex.asp)

Review Group Meeting Dates Review Group Meeting Dates (http://www. (http://www. csr.nih.gov/committees/meetings/ssmeet1.asp)csr.nih.gov/committees/meetings/ssmeet1.asp)

CSR Reorganization News CSR Reorganization News (http://www.csr.nih.gov/review/reorgact.asp)(http://www.csr.nih.gov/review/reorgact.asp)

CSR Web Site: CSR Web Site: http://www.csr.nih.govhttp://www.csr.nih.gov

News and EventsNews and Events

Resources for Resources for ApplicantsApplicants

Study Section Study Section InformationInformation

Employment Employment OpportunitiesOpportunities

Contact InformationContact Information

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