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  • So we now see that on a cyclic basis applications are handled by CSR which…
  • 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.
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  • Slide 106 from 1/22 reviewer training
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    • 1. Strategies for NIH Grant Success:Overview of the NIH Peer Review Process Cheryl Kitt, Ph.D. Deputy Director, CSR Womens 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 DevelopmentNational Institute on National Institute National Institute National InstituteDeafness 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 CenterNational Institute of John E. Fogarty National Center National Center on for Complementary National LibraryBiomedical 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 ProcessPrepare 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 SectionResearch Idea Submits Application Reviews for Scientific Merit Institute Evaluates for Relevance Allocates Funds Advisory Councils and BoardsConducts Recommends ActionResearch 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 ApplicationsImpactMake It ExcitingBe Very ClearRealistic Aims & Timelines – Not OverlyAmbitiousBe Brief With Things That Everybody KnowsNote the Study LimitationsProofread the Application
    • 11. ScoringOverall 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. ScoringApplications scored on five review criteria and overallimpact 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 weaknessesModerate 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 ReviewsOverall Impact/Merit. Likelihood fellowship will enhance candidatespotential for, and commitment to, a productive independentscientific 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 thelikelihood for the candidate to maintain a strong research program,taking into consideration the criteria below in determining theoverall impact/priority score.•Candidate•Career Development Plan/Career Goals & Objectives/Plan toProvide 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 onlyOverall 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 Videohttp://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 databaseECRs 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