NIH Peer Review inNIH Peer Review in
the Population andthe Population and
Social SciencesSocial Sciences
Center for Scient...
Scientific Review Administrator
and Referral Officer
Center for Scientific Review
National Institutes of Health
Charles N....
OutlineOutline
• Overview of NIH and Peer ReviewOverview of NIH and Peer Review
• Application Receipt and ReferralApplicat...
PremisePremise
Understanding the peer review process willUnderstanding the peer review process will
help you prepare a suc...
Dr. Brent StanfieldDr. Brent Stanfield
““Our work is criticalOur work is critical
because we know the resultbecause we kno...
National Institutes ofNational Institutes of
HealthHealth
Much of theMuch of the
biomedical researchbiomedical research
in...
NIH Extramural Awarding ComponentsNIH Extramural Awarding Components
• National Cancer Institute (NCI)National Cancer Inst...
A Typical Institute/CenterA Typical Institute/Center
Office of the ICOffice of the IC
DirectorDirector
NationalNational
Ad...
NIH Extramural ProgramNIH Extramural Program
GrantGrant PatronPatron
(assistance, encouragement)(assistance, encouragement...
NIH Funding in FY 2004: By MechanismNIH Funding in FY 2004: By Mechanism
Total = $27BTotal = $27B
Research Project
Grants
...
NIH Peer ReviewNIH Peer Review
• Process of evaluation of NIH grant
applications for scientific and program merit
• NIH us...
Dual Review System for Grant ApplicationsDual Review System for Grant Applications
Second Level of ReviewSecond Level of R...
Review Process for a Research GrantReview Process for a Research Grant
National Institutes of HealthNational Institutes of...
GROUPSGROUPS
CSR IRGsCSR IRGs
Study SectionsStudy Sections
Special Emphasis PanelsSpecial Emphasis Panels
INSTITUTESINSTIT...
Center for Scientific Review (CSR)Center for Scientific Review (CSR)
Focal Point for Initial Review at NIHFocal Point for ...
CenterCenter forfor Scientific ReviewScientific Review
• ReferralReferral
• Central Receipt Point for most PHS Grant Appli...
Overall Timeframe fromOverall Timeframe from
Submission to AwardSubmission to Award
  There are three overlapping cycles p...
Grant ApplicationGrant Application
Receipt and AssignmentReceipt and Assignment
Applications Submitted to NIHApplications Submitted to NIH
• Over 60,000 grantOver 60,000 grant
applications areapplicatio...
CSR Receipt and Referral:CSR Receipt and Referral:
Central Receipt Point for ApplicationsCentral Receipt Point for Applica...
Applications are AssignedApplications are Assigned
byby
Referral Officers:Referral Officers:
Professional scientists, most...
Applications are Assigned to:Applications are Assigned to:
• Scientific review groups based on:Scientific review groups ba...
Assignment to InstitutesAssignment to Institutes
Applications are referred to an Institute orApplications are referred to ...
Sample Application NumberSample Application Number
Individual Serial AmendedIndividual Serial Amended
Research NumberResea...
Special Referral IssuesSpecial Referral Issues
• Investigators should write a cover letter forInvestigators should write a...
Initial Review in CSRInitial Review in CSR
CSR Study SectionsCSR Study Sections
• Each CSR standing studyEach CSR standing study
section has 12-24 memberssection has...
CSR Review DivisionsCSR Review Divisions
Division of Biologic
Basis of Disease
Elliot Postow, Ph.D.
Immunology
IRG (IMM)
C...
Biobehavioral and BehavioralBiobehavioral and Behavioral
Processes IRG (BBBP) Study SectionsProcesses IRG (BBBP) Study Sec...
Health of the Population IRG (HOP)Health of the Population IRG (HOP)
Study SectionsStudy Sections
• CLHP – Community-Level...
Risk Prevention and Health BehaviorRisk Prevention and Health Behavior
IRG (RPHB) Study SectionsIRG (RPHB) Study Sections
...
Scientific Review AdministratorScientific Review Administrator
• Designated Federal Official
• Performs administrative and...
Selection of Peer ReviewersSelection of Peer Reviewers
Non-Doctoral
Scientific Community
Non-Research
Research
Capability
...
Criteria For Selection of Peer ReviewersCriteria For Selection of Peer Reviewers
• Demonstrated Scientific ExpertiseDemons...
Review of Research GrantsReview of Research Grants
REVIEW CRITERIA:REVIEW CRITERIA:
• SignificanceSignificance
• ApproachA...
Review Criteria (continued)Review Criteria (continued)
• Significance:Significance: Does the study address an important pr...
Additional Review Criteria – AmendedAdditional Review Criteria – Amended
Applications (Most Mechanisms)Applications (Most ...
Scientific Review Group or StudyScientific Review Group or Study
Section ActionsSection Actions
• Scored, Scientific Merit...
Priority Scores/PercentilePriority Scores/Percentile
RankRank
• For each study section,For each study section,
application...
Summary StatementSummary Statement
Once applications are reviewed, the results areOnce applications are reviewed, the resu...
What Determines WhichWhat Determines Which
Awards Are Made?Awards Are Made?
• Scientific meritScientific merit
• Program c...
GrantsmanshipGrantsmanship
Steps in preparing a successful grantSteps in preparing a successful grant
applicationapplicati...
There is no grantsmanship thatThere is no grantsmanship that
will turn a bad idea into a goodwill turn a bad idea into a g...
The NIH Grant CultureThe NIH Grant Culture
• Bio-Medical ModelBio-Medical Model
• Randomized Clinical Trial as goldRandomi...
Step One – ScopingStep One – Scoping
• Identify possible research projectsIdentify possible research projects
• Use web-ba...
Step Two – Make NIH ContactsStep Two – Make NIH Contacts
• Confer with NIH Program DirectorsConfer with NIH Program Direct...
Types of GrantsTypes of Grants
• R01 – Research ProjectsR01 – Research Projects
• R03 – Small Research GrantsR03 – Small R...
NIH Grant MechanismsNIH Grant Mechanisms
• R01R01 Traditional investigator-initiated grantTraditional investigator-initiat...
NIH Opportunities forNIH Opportunities for
Young InvestigatorsYoung Investigators
• National Research Service Individual F...
Step 3 Develop Your IdeaStep 3 Develop Your Idea
• Review literatureReview literature
• Generate preliminary dataGenerate ...
The “Top Ten” ListThe “Top Ten” List
1.1. Read and re-read the program announcementRead and re-read the program announceme...
Step 4 Writing the ApplicationStep 4 Writing the Application
• Clear, concise writing styleClear, concise writing style
• ...
Step 5 Preparing the ApplicationStep 5 Preparing the Application
• Follow instructions – PHS 398Follow instructions – PHS ...
General Design IssuesGeneral Design Issues
• Will it work?Will it work?
• Supporting preliminary dataSupporting preliminar...
Methodological IssuesMethodological Issues
• Sampling MethodsSampling Methods
• Power CalculationsPower Calculations
• The...
Human Subjects IssuesHuman Subjects Issues
Four criteriaFour criteria
• Risks*Risks*
• ProtectionsProtections
• Benefits t...
More Human Subject IssuesMore Human Subject Issues
• Recruitment and informed consentRecruitment and informed consent
• Vu...
Step 6 Submit the applicationStep 6 Submit the application
• Include cover letter
• Request Institute assignment for fundi...
Step 7 Monitor Review ProcessStep 7 Monitor Review Process
• Contact Scientific Review Administrator for informationContac...
Step 8 Post Review FollowupStep 8 Post Review Followup
• Contact Program Director for information andContact Program Direc...
Most Common ProblemsMost Common Problems
• Lack of new or original ideasLack of new or original ideas
• Absence of an acce...
SummarySummary
Keys To SuccessKeys To Success
• Find collaborators and mentors who are experienced inFind collaborators and mentors who a...
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 Administrato...
NIH Information SourcesNIH Information Sources
Information on the World Wide WebInformation on the World Wide Web
Selected Sites of InterestSelected Sites of Interest
• ...
CSR Web Site: http://www.csr.nih.govCSR Web Site: http://www.csr.nih.gov
• News and EventsNews and Events
• Resources for ...
ENDEND
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Transcript of "Peer Review of NIH Research Grant Applications"

  1. 1. NIH Peer Review inNIH Peer Review in the Population andthe Population and Social SciencesSocial Sciences Center for Scientific Review National Institutes of Health U.S. Department of Health and Human Services
  2. 2. Scientific Review Administrator and Referral Officer Center for Scientific Review National Institutes of Health Charles N. Rafferty, Ph.D.Charles N. Rafferty, 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
  3. 3. OutlineOutline • Overview of NIH and Peer ReviewOverview of NIH and Peer Review • Application Receipt and ReferralApplication Receipt and Referral • Initial Peer Review Process, TheInitial Peer Review Process, The Study SectionStudy Section • GrantsmanshipGrantsmanship
  4. 4. PremisePremise Understanding the peer review process willUnderstanding the peer review process will help you prepare a successful granthelp you prepare a successful grant application.application. Success = AwardSuccess = Award
  5. 5. Dr. Brent StanfieldDr. Brent Stanfield ““Our work is criticalOur work is critical because we know the resultbecause we know the result of peer review is theof peer review is the primary factor determiningprimary factor determining which research NIH funds."which research NIH funds."
  6. 6. National Institutes ofNational Institutes of HealthHealth Much of theMuch of the biomedical researchbiomedical research in the United Statesin the United States is supported by theis supported by the Federal Government,Federal Government, primarily theprimarily the National Institutes ofNational Institutes of Health (NIH)Health (NIH)
  7. 7. NIH Extramural Awarding ComponentsNIH Extramural Awarding Components • 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 (NIDCD)National Institute of Deafness and Other Communication Disorders (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 (NIAMS)National Institute of Arthritis and Musculoskeletal and Skin Diseases (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)
  8. 8. A Typical Institute/CenterA Typical Institute/Center Office of the ICOffice of the IC DirectorDirector NationalNational AdvisoryAdvisory CouncilCouncil Board ofBoard of ScientificScientific CounselorsCounselors ExtramuralExtramural ScientificScientific ProgramsPrograms GrantsGrants ContractsContracts IntramuralIntramural LaboratoryLaboratory StudiesStudies ClinicalClinical StudiesStudies
  9. 9. NIH Extramural ProgramNIH Extramural Program GrantGrant PatronPatron (assistance, encouragement)(assistance, encouragement) CooperativeCooperative PartnerPartner AgreementAgreement (assistance but substantial(assistance but substantial program involvement)program involvement) ContractContract PurchaserPurchaser (procurement)(procurement)
  10. 10. NIH Funding in FY 2004: By MechanismNIH Funding in FY 2004: By Mechanism Total = $27BTotal = $27B Research Project Grants 54% Research Centers 9% Other Research Grants 6% Research Training 3% R&D Contracts 10% Research Management 4% Nat. Lib. Of Medicine 1% Cancer Prev. & Control 2% Construction & Facilities 1% Intramural Research 10% Over 80% of NIH funds support extramural research.
  11. 11. 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
  12. 12. Dual Review System for Grant ApplicationsDual Review System for Grant Applications Second Level of ReviewSecond Level of Review CouncilCouncil • 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 Review Scientific Review Group (SRG)Scientific Review Group (SRG) • Provides Initial Scientific MeritProvides Initial Scientific Merit Review of Grant ApplicationsReview of Grant Applications • Rates Applications and MakesRates Applications and Makes Recommendations for Appropriate LevelRecommendations for Appropriate Level of Support and Duration of Awardof Support and Duration of Award
  13. 13. Review Process for a Research GrantReview Process for a Research 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 Research Grant Application Research Grant 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
  14. 14. GROUPSGROUPS CSR IRGsCSR IRGs Study SectionsStudy Sections Special Emphasis PanelsSpecial Emphasis Panels INSTITUTESINSTITUTES Scientific Review GroupsScientific Review Groups Contract Review CommitteesContract Review Committees APPLICATIONS REVIEWEDAPPLICATIONS REVIEWED Research ProjectsResearch Projects Academic ResearchAcademic Research Enhancement AwardsEnhancement Awards Postdoctoral FellowshipsPostdoctoral Fellowships Small Business InnovationSmall Business Innovation ResearchResearch Shared InstrumentationShared Instrumentation Program ProjectsProgram Projects CentersCenters Institutional Training GrantsInstitutional Training Grants Conference GrantsConference Grants Career AwardsCareer Awards Types of Scientific Review GroupsTypes of Scientific Review Groups Where are Applications Reviewed?Where are Applications Reviewed? Small GrantsSmall Grants RFAsRFAs ContractsContracts
  15. 15. Center for Scientific Review (CSR)Center for Scientific 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
  16. 16. CenterCenter forfor Scientific ReviewScientific Review • 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 anAssignment to Scientific Review Group in CSR or in an InstituteInstitute •Scientific ReviewScientific Review • More than 200 chartered study sections and regularlyMore 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 ApplicationsAcademic Research Enhancement Award Applications Small Business Innovation Research ApplicationsSmall Business Innovation Research Applications
  17. 17. Overall Timeframe fromOverall Timeframe from Submission to AwardSubmission to Award   There are three overlapping cycles per year :There are three overlapping cycles per year : JAN FEB MAR APR MAY JUN JUL AUG SEP OCT NOV DEC JAN FEB MAR APR MAY JUN JUL Review Council Cycle 1 Receipt Referral Award Review Council Cycle 3 Receipt Referral Award Review Council Cycle 2 Receipt AwardReferral
  18. 18. Grant ApplicationGrant Application Receipt and AssignmentReceipt and Assignment
  19. 19. Applications Submitted to NIHApplications Submitted to NIH • Over 60,000 grantOver 60,000 grant applications areapplications are submitted to NIH eachsubmitted to NIH each year, of which 25-30%year, of which 25-30% are fundedare funded • Competing grantCompeting grant applications are receivedapplications are received for three review cyclesfor three review cycles per yearper year
  20. 20. CSR Receipt and Referral:CSR Receipt and Referral: Central Receipt Point for ApplicationsCentral Receipt Point for Applications submitted to the Public Health Servicesubmitted to the Public Health Service National Institutes of Health Substance Abuse and Mental Health Services Administration CSR Receipt & ReferralCenters for Disease Control Food & Drug Agency for Health Care Policy & Research Office of Assistant Secretary for Health
  21. 21. Applications are AssignedApplications are Assigned byby Referral Officers:Referral Officers: Professional scientists, most ofProfessional scientists, most of whom also serve as scientificwhom also serve as scientific review administrators of CSRreview administrators of CSR study sectionsstudy sections
  22. 22. Applications are Assigned to:Applications are Assigned to: • Scientific review groups based on:Scientific review groups based on: –Specific review guidelines for eachSpecific 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 andSpecific programmatic mandates and interests of the Instituteinterests of the Institute
  23. 23. Assignment to InstitutesAssignment to Institutes Applications are referred to an Institute orApplications are referred to an Institute or Center as the potential funding component:Center as the potential funding component: • This assignment is based on a match between theThis assignment is based on a match between the research proposed and the overall mission of theresearch proposed and the overall mission of the Institute or CenterInstitute or Center • Where applications are appropriate for more thanWhere applications are appropriate for more than one Institute or Center, multiple assignments areone Institute or Center, multiple assignments are mademade
  24. 24. Sample Application NumberSample Application Number Individual Serial AmendedIndividual Serial Amended Research NumberResearch Number GrantGrant 11 R01R01 CACA 123456123456 0101 A1A1 New National GrantNew National Grant Application Cancer SupportApplication Cancer Support Institute YearInstitute Year
  25. 25. Special Referral IssuesSpecial Referral Issues • Investigators should write a cover letter forInvestigators should write a cover letter for their applications!their applications! • Referral Officers almost always honor investigatorReferral Officers almost always honor investigator requests for Institute assignments (funding) andrequests for Institute assignments (funding) and CSR study section assignments (review)CSR study section assignments (review) • NIMH, NIAA, and NIDA review all healthNIMH, NIAA, and NIDA review all health services and treatment research applicationsservices and treatment research applications assigned to them for fundingassigned to them for funding • All other investigator-initiated health servicesAll other investigator-initiated health services and treatment research applications areand treatment research applications are reviewed by CSRreviewed by CSR
  26. 26. Initial Review in CSRInitial Review in CSR
  27. 27. CSR Study SectionsCSR Study Sections • Each CSR standing studyEach CSR standing study section has 12-24 memberssection has 12-24 members who are primarily fromwho are primarily from academiaacademia • CSR standing studyCSR standing study sections convene face-to-sections convene face-to- face meetingsface meetings • As many as 60-100As many as 60-100 applications are reviewedapplications are reviewed by each study sectionby each study section • Each study section isEach study section is managed by a Scientificmanaged by a Scientific Review AdministratorReview Administrator
  28. 28. CSR Review DivisionsCSR Review Divisions Division of Biologic Basis of Disease Elliot Postow, Ph.D. Immunology IRG (IMM) Calbert Laing, Ph.D. AIDS and Related Research IRG (AARR) Ranga V. Srinivas, Ph.D. Oncological Sciences IRG (ONC) Syed Quadri, Ph.D. Endocrinology, Metabolism, Nutrition and Reproductive Sciences IRG (EMNR) Sooja Kim, Ph.D. Infectious Diseases and Microbiology IRG (IDM) Alex Politis, Ph.D. Division of Physiology and Pathology Michael Martin, Ph.D. Cardiovascular Sciences IRG (CVS) Joyce Gibson, D.Sc. Integrative, Functional and Cognitive Neuroscience IRG (IFCN) Christine Melchior, Ph.D. Renal and Urological Sciences IRG (RUS) Daniel McDonald, Ph.D. Hematology IRG (HEME) Joyce Gibson, D.Sc. Digestive Sciences IRG (DIG) Mushtaq Khan, Ph.D. Division of Clinical and Population-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 Health Behavior IRG (RPHB) Michael Micklin, Ph.D. Brain Disorders and Clinical Neuroscience IRG (BDCN) David Armstrong, Ph.D. Behavioral & Biobehavioral Processes IRG (BBBP) Karen Sirocco, Ph.D Division of Molecular and Cellular Mechanisms Donald Schneider, Ph.D. Biochemical Sciences IRG (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 and Function 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.
  29. 29. Biobehavioral and BehavioralBiobehavioral and Behavioral Processes IRG (BBBP) Study SectionsProcesses IRG (BBBP) Study Sections • BRLE – Biobehavioral Regulation, Learning andBRLE – 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 ofAPDA – Adult Psychopathology and Disorders of AgingAging • CPDD – Child Psychopathology and DevelopmentalCPDD – Child Psychopathology and Developmental DisabilitiesDisabilities • MFSR – Motor Function, Speech, and RehabilitationMFSR – Motor Function, Speech, and Rehabilitation • BBBP Small Business ActivitiesBBBP Small Business Activities
  30. 30. Health of the Population IRG (HOP)Health of the Population IRG (HOP) Study SectionsStudy Sections • CLHP – Community-Level Health PromotionCLHP – 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
  31. 31. Risk Prevention and Health BehaviorRisk Prevention and Health Behavior IRG (RPHB) Study SectionsIRG (RPHB) Study Sections • PDRP – Psychosocial Development, Risk andPDRP – Psychosocial Development, Risk and PreventionPrevention • PRDP – Psychosocial Risk and DiseasePRDP – Psychosocial Risk and Disease PreventionPrevention • BMIO – Behavioral Medicine InterventionsBMIO – Behavioral Medicine Interventions and Outcomesand Outcomes • SPIP - Social Psychology, Personality andSPIP - Social Psychology, Personality and Interpersonal ProcessesInterpersonal Processes • RPHB Small Business ActivitiesRPHB Small Business Activities
  32. 32. Scientific Review AdministratorScientific Review Administrator • 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
  33. 33. Selection of Peer ReviewersSelection of Peer Reviewers Non-Doctoral Scientific Community Non-Research Research Capability Active and Productive Researchers
  34. 34. Criteria For Selection of Peer ReviewersCriteria For Selection of Peer Reviewers • Demonstrated Scientific ExpertiseDemonstrated Scientific Expertise • Doctoral Degree or EquivalentDoctoral Degree or Equivalent • Mature JudgmentMature 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 andAdequate Representation of Women and Minority ScientistsMinority Scientists
  35. 35. Review of Research GrantsReview of Research Grants REVIEW 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
  36. 36. Review Criteria (continued)Review Criteria (continued) • Significance:Significance: Does the study address an important problem?Does the study address an important problem? How will scientific knowledge be advanced? What are theHow will scientific knowledge be advanced? What are the societal benefits?societal benefits? • Approach:Approach: Are design and methods well-developed andAre design and methods well-developed and appropriate? Are problem areas addressed?appropriate? Are problem areas addressed? • Innovation:Innovation: Are there novel concepts or approaches? Are theAre there novel concepts or approaches? Are the aims original and innovative?aims original and innovative? • Investigator:Investigator: Is the investigator appropriately trained?Is the investigator appropriately trained? • Environment:Environment: Does the scientific environment contribute to theDoes the scientific environment contribute to the probability of success? Are there unique features of theprobability of success? Are there unique features of the scientific environment?scientific environment?
  37. 37. Additional Review Criteria – AmendedAdditional Review Criteria – Amended Applications (Most Mechanisms)Applications (Most Mechanisms) • Adequacy of response to theAdequacy of response to the previous reviewprevious review • Degree of overall improvement ofDegree of overall improvement of the revised applicationthe revised application
  38. 38. Scientific Review Group or StudyScientific Review Group or Study Section ActionsSection Actions • Scored, Scientific Merit RatingScored, Scientific Merit Rating (priority scores and percentiles)(priority scores and percentiles) • Unscored (lower half)Unscored (lower half) • DeferralDeferral • Not recommended for furtherNot recommended for further considerationconsideration
  39. 39. Priority Scores/PercentilePriority Scores/Percentile RankRank • For each study section,For each study section, applications in the upper halfapplications in the upper half are scored from 1.0-3.0, with 1.0are scored from 1.0-3.0, with 1.0 the best scorethe best score • Individual scores are averagedIndividual scores are averaged and multiplied by 100 to giveand multiplied by 100 to give the final priority scorethe final priority score • Percentile ranking is calculated based on results of current plus past two meetings
  40. 40. Summary StatementSummary Statement Once applications are reviewed, the results areOnce applications are reviewed, the results are documented by the SRA in a summary statement anddocumented by the SRA in a summary statement and forwarded to the Institute (and the PI) where aforwarded to the Institute (and the PI) where a funding decision is made: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
  41. 41. What Determines WhichWhat Determines Which Awards Are Made?Awards Are Made? • Scientific meritScientific merit • Program considerationsProgram considerations • Availability of fundsAvailability of funds
  42. 42. GrantsmanshipGrantsmanship Steps in preparing a successful grantSteps in preparing a successful grant applicationapplication
  43. 43. There is no grantsmanship thatThere is no grantsmanship that will turn a bad idea into a goodwill turn a bad idea into a good one, but……..one, but…….. There are many ways to disguiseThere are many ways to disguise a good one.a good one. William Raub, Past Deputy Director, NIH
  44. 44. The NIH Grant CultureThe NIH Grant Culture • Bio-Medical ModelBio-Medical Model • Randomized Clinical Trial as goldRandomized Clinical Trial as gold standardstandard • Evidence basedEvidence based • Underlying Conceptual ModelUnderlying Conceptual Model • Emphasis on OutcomesEmphasis on Outcomes • Need for MeasurementNeed for Measurement
  45. 45. Step One – ScopingStep One – Scoping • Identify possible research projectsIdentify possible research projects • Use web-based NIH data-bases and resourcesUse web-based NIH data-bases and resources • 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 – PHSReview NIH grant application procedures – PHS 398 Instructions398 Instructions
  46. 46. Step Two – Make NIH ContactsStep Two – Make NIH Contacts • 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, R21, RO1, R03, R21 • 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
  47. 47. 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 TransferR41/R42 – Small Business Technology Transfer Grants Phase I/IIGrants 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
  48. 48. NIH Grant MechanismsNIH Grant Mechanisms • R01R01 Traditional investigator-initiated grantTraditional investigator-initiated grant < $500K/yr, 3-5 yrs. Need approval if more than $500K for< $500K/yr, 3-5 yrs. Need approval if more than $500K for any year of the grantany year of the grant • R03R03 Small GrantSmall 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 interestamount dependent on score, timeliness, budget, NIH interest
  49. 49. NIH Opportunities forNIH Opportunities for Young InvestigatorsYoung Investigators • National Research Service Individual FellowshipNational Research Service Individual Fellowship (F32)(F32) • Mentored Research Scientist Development AwardMentored Research Scientist Development Award (K01)(K01) • Independent Scientist AwardIndependent Scientist Award (K02)(K02) • Mentored Clinical Scientist Development AwardMentored Clinical Scientist Development Award (K08)(K08) • Small GrantSmall Grant (R03)(R03) • Academic Research Enhancement AwardAcademic Research Enhancement Award (R15)(R15) • Exploratory/Developmental GrantExploratory/Developmental Grant (R21)(R21)
  50. 50. Step 3 Develop Your IdeaStep 3 Develop Your Idea • Review literatureReview literature • Generate preliminary dataGenerate preliminary data • Enlist collaborators, include letters ofEnlist collaborators, include letters of commitmentcommitment • Review successful grant applications ofReview successful grant applications of other colleaguesother colleagues
  51. 51. 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 someone whoIf you have not been on a study section, confer with someone who hashas 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 tight asMake sure the writing, organization, & grammar are as tight as possible (write, re-write…read, re-read)possible (write, re-write…read, re-read) 8.8. Seek reviews from experienced peers before submissionSeek reviews from experienced peers before submission 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)
  52. 52. Step 4 Writing the ApplicationStep 4 Writing the Application • Clear, concise writing styleClear, concise writing style • Be focusedBe focused • Don’t rushDon’t rush • Critique, critique, and critique againCritique, critique, and critique again • Follow up with NIH program directorsFollow up with NIH program directors before and after reviewbefore and after review
  53. 53. Step 5 Preparing the ApplicationStep 5 Preparing the Application • Follow instructions – PHS 398Follow instructions – PHS 398 • Never assume that reviewers “know what youNever assume that reviewers “know what you mean”mean” • Refer to literature thoroughlyRefer to literature thoroughly • Present a clear rationale for the proposed workPresent a clear rationale for the proposed work • Make sure that the experimental approach isMake 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
  54. 54. 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
  55. 55. 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
  56. 56. Human Subjects IssuesHuman Subjects Issues Four 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 clinicalData Safety and Monitoring Plan for clinical trialstrials • Exemptions applicableExemptions applicable • Inclusion plansInclusion plans • Minorities, women, children,Minorities, women, children, *Risks include the possibility of physical, psychological, or social*Risks include the possibility of physical, psychological, or social injury resulting from research.injury resulting from research.
  57. 57. 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
  58. 58. Step 6 Submit the applicationStep 6 Submit the application • 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
  59. 59. Step 7 Monitor Review ProcessStep 7 Monitor Review Process • Contact Scientific Review Administrator for informationContact Scientific Review Administrator for information and to express any concernsand to express any concerns • TimingTiming • Institute assignmentsInstitute assignments • Study section assignmentStudy section assignment • Provide input about needed expertise - Do Not SuggestProvide input about needed expertise - Do Not Suggest Reviewers by Name!Reviewers by Name! • Identify possible conflicts of study section reviewers –Identify possible conflicts of study section reviewers – e.g.e.g.,, professional, personal, financial, institutionalprofessional, personal, financial, institutional • Be mindful that NIH review administrators are typicallyBe mindful that NIH review administrators are typically managing multiple meetings involving about 100managing multiple meetings involving about 100 applications per roundapplications per round
  60. 60. Step 8 Post Review FollowupStep 8 Post Review Followup • Contact Program Director for information andContact Program Director for information and guidanceguidance • 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
  61. 61. 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
  62. 62. SummarySummary
  63. 63. Keys To SuccessKeys To Success • Find collaborators and mentors who are experienced inFind collaborators and mentors who are experienced in writing and winning NIH grantswriting and winning NIH grants • Make contact with NIH scientific staff at appropriateMake contact with NIH scientific staff at appropriate stages of the review/award cyclestages 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 cultureRecognize that NIH peer review has a special culture based on standing study sections composed of seniorbased on standing study sections composed of senior academic researchers with long histories of service andacademic researchers with long histories of service and expectations of style, academic rigor, and hypothesis-expectations of style, academic rigor, and hypothesis- based researchbased research
  64. 64. Good Luck!Good Luck! If at first you don’t succeed –If at first you don’t succeed – Revise and resubmitRevise and resubmit
  65. 65. Contact InformationContact Information Charles N. Rafferty, Ph.D.Charles N. Rafferty, Ph.D. Scientific Review AdministratorScientific Review Administrator Health of the Population IRGHealth of the Population IRG Center for Scientific ReviewCenter for Scientific Review National Institutes of HealthNational Institutes of Health 6701 Rockledge Drive, MSC 7770, Room 31726701 Rockledge Drive, MSC 7770, Room 3172 Bethesda, MD 20892 (20817 for overnight mail)Bethesda, MD 20892 (20817 for overnight mail) 301-435-3562301-435-3562 301-480-3962 fax301-480-3962 fax raffertc@csr.nih.govraffertc@csr.nih.gov http://www.csr.nih.govhttp://www.csr.nih.gov
  66. 66. NIH Information SourcesNIH Information Sources
  67. 67. Information on the World Wide WebInformation on the World Wide Web Selected 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 ResearchOffice of Extramural Research (http://www.nih.gov/grants/oer.htm)(http://www.nih.gov/grants/oer.htm) • Grants Policy (http://www.nih.gov/grants/policy/policy.htm)Grants Policy (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 RostersCSR Study Section Rosters (http://www.csr.nih.gov/committees/rosterindex.asp)(http://www.csr.nih.gov/committees/rosterindex.asp) • Review Group Meeting DatesReview Group Meeting Dates (http://www. csr.nih.gov/committees/meetings/ssmeet1.asp)(http://www. csr.nih.gov/committees/meetings/ssmeet1.asp) • CSR Reorganization NewsCSR Reorganization News (http://www.csr.nih.gov/review/reorgact.asp)(http://www.csr.nih.gov/review/reorgact.asp)
  68. 68. CSR Web Site: http://www.csr.nih.govCSR Web Site: http://www.csr.nih.gov • News and EventsNews and Events • Resources for ApplicantsResources for Applicants • Study Section InformationStudy Section Information • Employment OpportunitiesEmployment Opportunities • Contact InformationContact Information
  69. 69. ENDEND
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