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Strategies for NIH Grant Success:
Overview of the NIH Peer Review Process
                       Cheryl Kitt, Ph.D.
                      Deputy Director, CSR




                                        Women's Health 2012: The 20th Annual Congress



    National Institutes of Health
    U.S. Department of Health and Human Services                       March 15, 2012
National Institutes of Health

                                                                             Office of the Director




                                                                                                 National Institute                                      Eunice Kennedy
                        National Institute                  National Institute
 National Institute                                                                               of Arthritis and               National Cancer     Shriver National Institute
                        on Alcohol Abuse                      of Allergy and
     on Aging                                                                                     Musculoskeletal                   Institute           of Child Health and
                         and Alcoholism                     Infectious Diseases
                                                                                                 and Skin Diseases                                     Human Development




National Institute on   National Institute                  National Institute
                                                                                                                                National Institute
Deafness and Other       of Dental and                       of Diabetes and                     National Institute                                        National Eye
                                                                                                                                of Environmental
  Communication           Craniofacial                        Digestive and                       on Drug Abuse                                             Institute
                                                                                                                                 Health Sciences
     Disorders              Research                         Kidney Diseases




                                                                                                                                National Institute
 National Institute     National Heart,                      National Human
                                                                                                 National Institute              of Neurological        National Institute
    of General          Lung, and Blood                      Genome Research
                                                                                                 of Mental Health                 Disorders and        of Nursing Research
 Medical Sciences          Institute                            Institute
                                                                                                                                     Stroke




                          National Center
National Institute of                                        John E. Fogarty                      National Center                                     National Center on
                        for Complementary                                                                                       National Library
Biomedical Imaging                                            International                        for Research                                       Minority Health and
                          and Alternative                                                                                         of Medicine
 and Bioengineering                                              Center                             Resources                                          Health Disparities
                             Medicine




                                                                                   Center for
                                                                                                                         Center for
                                          Clinical Center                         Information
                                                                                  Technology                          Scientific Review
Preparing an Application
                     Electronic Application Process

Prepare to Apply &     Find Opportunity*        Prepare           Submit, Track &
    Register                                   Application            View

  • Register with         • Submit in            • Follow         • Submit via your
  Grants.gov & eRA         response to           Application        organizational
     Commons                  FOA                  Guide &          representative
                                                 Instructions   • Use error correction
                                                                       window
                                                                • Use eRA Commons
                                                                       to track


           *Funding Opportunity Announcement (FOA)
Review Process for a Research Grant
                                       National Institutes of Health



                                      Center for Scientific Review
                                      Assigns to IC &      IRG/Study Section

   Initiates                                   Study Section
Research Idea   Submits Application
                                        Reviews for      Scientific Merit

                                                    Institute
                                      Evaluates for     Relevance
                Allocates Funds
                                      Advisory Councils and Boards
Conducts
                                      Recommends        Action
Research
                                              Institute Director
                                              Takes Final Action
All Applications Go Through
                     Center for Scientific Review (CSR)

Focal Point for Initial Review at NIH
                                    • Receives all NIH
                                      applications
                                    • Refers them to NIH
                                      Institutes/Centers and to
                                      scientific review groups
                                    • Reviews grant applications
                                      for scientific merit
                                    • ICs review RFAs, P’s, T’s,
                                      K’s
CSR Divisions and Integrated Review Groups
Help Your Application Get to the Right Study Section
Your Career Stage Is Considered




• If you submit an R01 grant application:
     If you are a New Investigator (PD/PI who has not yet competed
     successfully for a substantial NIH research grant; for multiple PD/PI R01s-all
     PD/PIs must meet requirements for NI status
      or Early Stage Investigator (PD/PI who qualifies as a New Investigator
     AND is within 10 years of completing the terminal research degree or is within
     10 years of completing medical residency (or equivalent)
• Clustered for review in the study section
CSR Study Sections
• Each CSR standing study
  section has about 23-40
  members
• CSR standing study
  sections convene face-to-
  face, or virtual (electronic)
  meetings
• As many as 60-100
  applications are reviewed
  by each study section
• Scientific Review Officer-
  Designated Federal
  Official with overall
  responsibility for the
  review process
What Reviewers Look for In Applications

Impact
Make It Exciting
Be Very Clear
Realistic Aims & Timelines – Not Overly
Ambitious
Be Brief With Things That Everybody Knows
Note the Study Limitations
Proofread the Application
Scoring
Overall Impact/Priority Score*:
  • Reflects the reviewers’ assessment of the likelihood
  for the project to exert a sustained, powerful influence on
     the research field(s) involved
        Core Criteria*:
           Significance
           Investigator(s)
           Innovation
           Approach
           Environment
                             *each scored from 1-9
Scoring
Applications scored on five review criteria and overall
impact using a scale of 1-9.
     o Discussed applications receive an overall impact score
       from each eligible (i.e., without conflicts of interest) panel
       member and these scores are averaged to one decimal
       place, and multiplied by 10.
All applications receive scores:
     o Not Discussed applications receive only initial criterion
       scores from the three assigned reviewers
Scoring Descriptions
 Impact    Score
                                       Additional Guidance on Strengths/Weaknesses
                   Descriptor

            1      Exceptional    Exceptionally strong with essentially no weaknesses
  High
            2      Outstanding    Extremely strong with negligible weaknesses
 Impact
            3       Excellent     Very strong with only some minor weaknesses

            4      Very Good      Strong but with numerous minor weaknesses
Moderate
            5         Good        Strong but with at least one moderate weakness
 Impact
            6      Satisfactory   Some strengths but also some moderate weaknesses

            7          Fair       Some strengths but with at least one major weakness
  Low
            8       Marginal      A few strengths and a few major weaknesses
 Impact
            9         Poor        Very few strengths and numerous major weaknesses
Fellowship Reviews


Overall Impact/Merit. Likelihood fellowship will enhance candidate's
potential for, and commitment to, a productive independent
scientific research

•Applicant
•Sponsors, Collaborators, and Consultants
•Research Training Plan
•Training Potential
•Institutional Environment & Commitment to Training
Career Awards (K)

Overall Impact. Reviewers should provide their assessment of the
likelihood for the candidate to maintain a strong research program,
taking into consideration the criteria below in determining the
overall impact/priority score.

•Candidate
•Career Development Plan/Career Goals & Objectives/Plan to
Provide Mentoring
•Research Plan
•Mentor(s), Co-mentor(s), Consultant(s), Collaborator(s)
•Environment and Institutional Commitment to the Candidate
Investigators
• Personal Statement:
    • Why your experience and qualifications makes you particularly
      well-suited for your role(s) in the project
• Publications:
    • Recommended: no more than 15---up to five of the best; up to five
      of the most relevant to the proposed research; up to five of the most
      recent
• If Early Stage Investigators or New Investigators, do you have
                                      Investigators
  appropriate experience and training?
• If Established, have you demonstrated ongoing record of
  accomplishments that have advanced their field(s)?
Innovation
•   Does application challenge/seek to shift current research
    or clinical practice paradigms by utilizing novel theoretical
    concepts, approaches or methodologies, instrumentation,
    or interventions?
•   Concepts, approaches or methodologies,
    instrumentation, or interventions novel to one field of
    research or novel in a broad sense?
•   Refinement, improvement, or new application of
    theoretical concepts, approaches or methodologies,
    instrumentation, or interventions proposed?
Approach

•   Are the overall strategy, methodology, and analyses well-
    reasoned and appropriate to accomplish the specific aims
    of the project?
•   Are potential problems, alternative strategies, and
    benchmarks for success presented?
•   If the project is in the early stages of development, will the
    strategy establish feasibility and will particularly risky
    aspects be managed?
Environment

• Will the scientific environment in which the work will be
  done contribute to the probability of success?
• Are the institutional support, equipment and other
  physical resources available to the investigators
  adequate for the project proposed?
• Will the project benefit from unique features of the
  scientific environment, subject populations, or
  collaborative arrangements?
Other Issues Reviewers Consider Before
                                 Final Scoring
•   Protections of human subjects
•   Inclusions of women, children and minorities
•   Appropriate use of vertebrate animal
•   Management of hazardous conditions
Critiques (Summary Statements)

  Discussed applications receive a resume and summary of
  the panel’s discussion at the meeting.
     •ALL applications are scored and receive critiques

  Not discussed applications receive criterion scores only

Overall Impact Paragraph
     • Each assigned reviewer writes a paragraph summarizing
     the factors that informed his/her Overall Impact score
After the Review


• NIH Program Officer = Point of Contact
• Wait for summary statement
• Read summary statement carefully
 before calling!
http://www.csr.nih.gov/video/video.asp
   What Happens to Your NIH Grant Application Video
http://www.csr.nih.gov/video/2010/FinalCaptioned_Edited_PeerReviewPr




                                                 kittc@csr.nih.gov
                                                   301-435-8403
CSR Early Career Reviewer Program




               National Institutes of Health
      U.S. Department of Health and Human Services
Purpose of the ECR Program


• To train and educate qualified scientists without
  significant prior review experience so that they may
  develop into critical and well trained reviewers

• To benefit faculty scientific careers by exposing them to
  an experience that will make them more competitive
  as applicants

• To enrich the existing pool of NIH reviewers by
  recruiting scientists from less research-intensive
  institutions


                                                    25
Definition of ECR:


• Has not reviewed for CSR beyond 1 mail review and
  has not been to a face-to-face meeting (except ARRA
  face-face-meetings)

• Has a faculty appointment or equivalent

• Has an active research program and is publishing in
  high-impact journals

• Does not necessarily have NIH or equivalent funding


                                                   26
Responsibilities of ECR


• Attends study section meeting (face-to-face meetings
  but no Fellowship panels)

• Is assigned no more than 2 applications as 3rd reviewer

• Writes a full critique of each application

• Participates in no more than one study section per year
  and no more than twice total



                                                    27
Progress of ECR Program
• The administrators of 343 less research-intensive
  institutions (AREA eligible) were emailed a request for
  suggestions of faculty who would be candidates for the
  ECR program
• There are currently over 500 names in the database
• Over 300 additional researchers have applied for the
  program and once vetted they will be added to the
  database

ECRs Included in 2012/01 Council Round:
    127 ECRs participated across over 240 eligible
    study sections
     o ~50% women

                                                   28
CSR Web Site: http://www.csr.nih.gov




    CSREarlyCareerReviewer@mail.nih.gov

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2 kitt

  • 1. Strategies for NIH Grant Success: Overview of the NIH Peer Review Process Cheryl Kitt, Ph.D. Deputy Director, CSR Women's Health 2012: The 20th Annual Congress National Institutes of Health U.S. Department of Health and Human Services March 15, 2012
  • 2. National Institutes of Health Office of the Director National Institute Eunice Kennedy National Institute National Institute National Institute of Arthritis and National Cancer Shriver National Institute on Alcohol Abuse of Allergy and on Aging Musculoskeletal Institute of Child Health and and Alcoholism Infectious Diseases and Skin Diseases Human Development National Institute on National Institute National Institute National Institute Deafness and Other of Dental and of Diabetes and National Institute National Eye of Environmental Communication Craniofacial Digestive and on Drug Abuse Institute Health Sciences Disorders Research Kidney Diseases National Institute National Institute National Heart, National Human National Institute of Neurological National Institute of General Lung, and Blood Genome Research of Mental Health Disorders and of Nursing Research Medical Sciences Institute Institute Stroke National Center National Institute of John E. Fogarty National Center National Center on for Complementary National Library Biomedical Imaging International for Research Minority Health and and Alternative of Medicine and Bioengineering Center Resources Health Disparities Medicine Center for Center for Clinical Center Information Technology Scientific Review
  • 3. Preparing an Application Electronic Application Process Prepare to Apply & Find Opportunity* Prepare Submit, Track & Register Application View • Register with • Submit in • Follow • Submit via your Grants.gov & eRA response to Application organizational Commons FOA Guide & representative Instructions • Use error correction window • Use eRA Commons to track *Funding Opportunity Announcement (FOA)
  • 4. Review Process for a Research Grant National Institutes of Health Center for Scientific Review Assigns to IC & IRG/Study Section Initiates Study Section Research Idea Submits Application Reviews for Scientific Merit Institute Evaluates for Relevance Allocates Funds Advisory Councils and Boards Conducts Recommends Action Research Institute Director Takes Final Action
  • 5. All Applications Go Through Center for Scientific Review (CSR) Focal Point for Initial Review at NIH • Receives all NIH applications • Refers them to NIH Institutes/Centers and to scientific review groups • Reviews grant applications for scientific merit • ICs review RFAs, P’s, T’s, K’s
  • 6. CSR Divisions and Integrated Review Groups
  • 7. Help Your Application Get to the Right Study Section
  • 8. Your Career Stage Is Considered • If you submit an R01 grant application: If you are a New Investigator (PD/PI who has not yet competed successfully for a substantial NIH research grant; for multiple PD/PI R01s-all PD/PIs must meet requirements for NI status or Early Stage Investigator (PD/PI who qualifies as a New Investigator AND is within 10 years of completing the terminal research degree or is within 10 years of completing medical residency (or equivalent) • Clustered for review in the study section
  • 9. CSR Study Sections • Each CSR standing study section has about 23-40 members • CSR standing study sections convene face-to- face, or virtual (electronic) meetings • As many as 60-100 applications are reviewed by each study section • Scientific Review Officer- Designated Federal Official with overall responsibility for the review process
  • 10. What Reviewers Look for In Applications Impact Make It Exciting Be Very Clear Realistic Aims & Timelines – Not Overly Ambitious Be Brief With Things That Everybody Knows Note the Study Limitations Proofread the Application
  • 11. Scoring Overall Impact/Priority Score*: • Reflects the reviewers’ assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved Core Criteria*: Significance Investigator(s) Innovation Approach Environment *each scored from 1-9
  • 12. Scoring Applications scored on five review criteria and overall impact using a scale of 1-9. o Discussed applications receive an overall impact score from each eligible (i.e., without conflicts of interest) panel member and these scores are averaged to one decimal place, and multiplied by 10. All applications receive scores: o Not Discussed applications receive only initial criterion scores from the three assigned reviewers
  • 13. Scoring Descriptions Impact Score Additional Guidance on Strengths/Weaknesses Descriptor 1 Exceptional Exceptionally strong with essentially no weaknesses High 2 Outstanding Extremely strong with negligible weaknesses Impact 3 Excellent Very strong with only some minor weaknesses 4 Very Good Strong but with numerous minor weaknesses Moderate 5 Good Strong but with at least one moderate weakness Impact 6 Satisfactory Some strengths but also some moderate weaknesses 7 Fair Some strengths but with at least one major weakness Low 8 Marginal A few strengths and a few major weaknesses Impact 9 Poor Very few strengths and numerous major weaknesses
  • 14. Fellowship Reviews Overall Impact/Merit. Likelihood fellowship will enhance candidate's potential for, and commitment to, a productive independent scientific research •Applicant •Sponsors, Collaborators, and Consultants •Research Training Plan •Training Potential •Institutional Environment & Commitment to Training
  • 15. Career Awards (K) Overall Impact. Reviewers should provide their assessment of the likelihood for the candidate to maintain a strong research program, taking into consideration the criteria below in determining the overall impact/priority score. •Candidate •Career Development Plan/Career Goals & Objectives/Plan to Provide Mentoring •Research Plan •Mentor(s), Co-mentor(s), Consultant(s), Collaborator(s) •Environment and Institutional Commitment to the Candidate
  • 16. Investigators • Personal Statement: • Why your experience and qualifications makes you particularly well-suited for your role(s) in the project • Publications: • Recommended: no more than 15---up to five of the best; up to five of the most relevant to the proposed research; up to five of the most recent • If Early Stage Investigators or New Investigators, do you have Investigators appropriate experience and training? • If Established, have you demonstrated ongoing record of accomplishments that have advanced their field(s)?
  • 17. Innovation • Does application challenge/seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? • Concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? • Refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?
  • 18. Approach • Are the overall strategy, methodology, and analyses well- reasoned and appropriate to accomplish the specific aims of the project? • Are potential problems, alternative strategies, and benchmarks for success presented? • If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed?
  • 19. Environment • Will the scientific environment in which the work will be done contribute to the probability of success? • Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? • Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?
  • 20. Other Issues Reviewers Consider Before Final Scoring • Protections of human subjects • Inclusions of women, children and minorities • Appropriate use of vertebrate animal • Management of hazardous conditions
  • 21. Critiques (Summary Statements) Discussed applications receive a resume and summary of the panel’s discussion at the meeting. •ALL applications are scored and receive critiques Not discussed applications receive criterion scores only Overall Impact Paragraph • Each assigned reviewer writes a paragraph summarizing the factors that informed his/her Overall Impact score
  • 22. After the Review • NIH Program Officer = Point of Contact • Wait for summary statement • Read summary statement carefully before calling!
  • 23. http://www.csr.nih.gov/video/video.asp What Happens to Your NIH Grant Application Video http://www.csr.nih.gov/video/2010/FinalCaptioned_Edited_PeerReviewPr kittc@csr.nih.gov 301-435-8403
  • 24. CSR Early Career Reviewer Program National Institutes of Health U.S. Department of Health and Human Services
  • 25. Purpose of the ECR Program • To train and educate qualified scientists without significant prior review experience so that they may develop into critical and well trained reviewers • To benefit faculty scientific careers by exposing them to an experience that will make them more competitive as applicants • To enrich the existing pool of NIH reviewers by recruiting scientists from less research-intensive institutions 25
  • 26. Definition of ECR: • Has not reviewed for CSR beyond 1 mail review and has not been to a face-to-face meeting (except ARRA face-face-meetings) • Has a faculty appointment or equivalent • Has an active research program and is publishing in high-impact journals • Does not necessarily have NIH or equivalent funding 26
  • 27. Responsibilities of ECR • Attends study section meeting (face-to-face meetings but no Fellowship panels) • Is assigned no more than 2 applications as 3rd reviewer • Writes a full critique of each application • Participates in no more than one study section per year and no more than twice total 27
  • 28. Progress of ECR Program • The administrators of 343 less research-intensive institutions (AREA eligible) were emailed a request for suggestions of faculty who would be candidates for the ECR program • There are currently over 500 names in the database • Over 300 additional researchers have applied for the program and once vetted they will be added to the database ECRs Included in 2012/01 Council Round: 127 ECRs participated across over 240 eligible study sections o ~50% women 28
  • 29. CSR Web Site: http://www.csr.nih.gov CSREarlyCareerReviewer@mail.nih.gov

Editor's Notes

  1. So we now see that on a cyclic basis applications are handled by CSR which…
  2. Let ’s examine more closely how CSR actually executes its roles. Nearly all of the study sections and recurring special review panels that you are familiar with come under the aegis of CSR – not one of the 24 funding ICs. Altogether, CSR has about 240 study sections and recurring special emphasis panels. These are organized into ‘Integrated Review Groups’ (IRGs) or departments where there are closely allied scientific disciplines and expertises brought to bear to evaluate science with related broad themes – e. g. the Biological Chemistry & Macromolecular Biophysics IRG or the Biology of Development and Aging IRG. These IRGS are in turn organized into 5 major scientific Divisions according to broad biomedical themes.
  3. 508 text is behind picture
  4. Slide 106 from 1/22 reviewer training
  5. Okay. I changed the title
  6. omit