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  • Effective January 2009, all original new (never submitted) and competing renewal applications will be allowed a single amendment (A1)
  • There will be additional sections in some applications that align with review criteria. For example, in multi PD/PI applications, the Multiple PD/PI Leadership Plan is also aligned with the Investigator(s) review criterion. A second example would be applications in which select agents are used, the Select Agent Research section of the Research Plan aligns with the Environment review criterion.

NIH Faculty Presentation Presentation Transcript

  • 1. Adapting to the new NIH Short Form
    • Office of the Vice President for Research
    • And
    • Division of Sponsored Programs
    • April 12, 2010
  • 2. Faculty Panel
    • Linda Snetselaar, CPH
    • Frederic Wolinsky, CPH
    • Ann M. McCarthy, CON
    • John Freeman, CLAS
  • 3. Enhancing Peer Review for NIH Grants
    • Four Priority Areas:
    • Engage the Best Reviewers
    • Improve the Quality and Transparency of Review
    • Ensure Balanced and Fair Reviews Across Scientific Fields and Career Stages, and Reduce Administrative Burden
    • Continuous Review of Peer Review
  • 4. Enhancing Peer Review: Implementation Timeline
    • January 2009
    • Early stage and New Investigator policy
    • Revised Policy on Resubmissions
    • May 2009
    • 9 point scoring system
    • Enhanced review criteria
    • Formatted reviewer critiques
    • Clustering of New Investigator applications during review
    • January 2010
    • Shorter Applications (research plan) for R01s and other mechanisms
    • Restructured Application to Align with Review Criteria
  • 5. Enhancing Peer Review NIH Policy on Resubmissions
      • Effective January 2009, all original new (never submitted) and competing renewal application are allowed a single amendment (A1)
    • Original new and competing renewal application submitted prior to January 25 will be allowed two amendments (A1 and A2)
    • For grandfathered applications allowed two amendments, the A2 application must be submitted no later than January 7, 2011
  • 6. Enhancing Peer Review: New Investigators and Early Stage Investigators
    • Beginning with applications submitted for February 2009 deadlines:
    • NIH will support applications from New Investigators at success rate comparable to established investigators
    • ESIs expected to comprise a majority of funded NI’s
    • Applications from ESIs will be given special consideration during peer review and at the time of funding.
  • 7. Enhancing Peer Review: Early Stage Investigators (ESIs)
    • ESIs are New Investigators who are within ten years of completing their terminal research degree or medical residency
    • All NIs should update NIH eRA Commons profiles and should see eligibility displayed in Commons
    • NIs who wish to request an extension of ESI eligibility due to Illness, military duty, family responsibility or extended period of research training can submit a web-form found at http://grants.nih.gov/grants/new_investigators/index.htm .
  • 8. Enhancing Peer Review: New Investigators (NIs)
    • PD/PI is identified as a New Investigator (NI) if he/she has not previously competed successfully for an NIH-supported research project other than :
    • Small Grant (R03)
    • Exploratory/Developmental Grant (R21)
    • Fellowships and Career Awards (Fs and Ks)
    • SBIR/STTR (R41/R43)
    • Pathway to Independence (K99/R00)
    • Dissertation Award (R36)
    • Clinical Trial Planning Grant (R34)
    • Other – Shannon, AREA, Loan Repayment Program, etc.
  • 9. Shortened Review Cycle for New Investigator R01 Applications
    • NOT-OD-07-083
    • Applies to New Investigator R01 Applications reviewed with CSR recurring study sections
    • Summary statements issued by the 1 st of the month, resubmissions accepted on the 20th
    • Allows resubmission one cycle early
    • Also offered by some institutes (NIMH, NIDA)
  • 10. Enhancing Peer Review: Core Review Criteria
    • Significance – does project address an important problem or a critical barrier to progress in the field?
    • Investigators – do PIs and collaborators have appropriate experience and training?
    • Innovation – does the application utilize novel concepts, approaches or methodologies, instrumentations or interventions
    • Approach – are the overall strategy, methodology and analysis well reasoned and appropriate?
    • Environment – will environment (institutional support, equipment and physical resources) contribute to probability of success?
  • 11. Enhancing Peer Review: New Scoring Procedures
    • 9 point rating scale (1 = exceptional; 9 = poor)
    • Each assigned reviewer and discussant will give a separate score for each of the core criteria
    • Each assigned reviewer and discussant will assign preliminary impact/priority score
    • Preliminary impact/priority score will determine which applications will be discussed at study section meeting
    • Eligible committee member will assign final impact/priority score
    • Overall impact/priority score will be average of all final I/p scores multiplied by 10 (range 10 – 90 with 10 being the best possible score)
  • 12. Restructured Applications
    • Goal : Align the structure and content of applications with enhanced review criteria; NOT-OD-09-025
    • Three sections of application instructions to be revised:
          • Research Plan
          • Biographical Sketch
          • Resources and Facilities
          • Shorter Page Limits
  • 13. Major Changes to the Research Plan
    • Specific Aims includes new language about the impact of the proposed research
    • Research Strategy will have 3 subsections:
        • Significance
        • Innovation
        • Approach
          • Preliminary studies for new applications
          • Progress report for renewal/revision
  • 14. Shorter Page Limits
    • Introduction – 1 page
    • Specific Aims – 1 page
    • Research Strategy
      • 6 pages for R03, R21
      • 12 pages for R01
      • 12 pages for Ks, including candidate info
  • 15. Biographical Sketch Changes
    • Personal Statement: why experience and qualifications make individual particularly well-suited for role in the project
    • Publications: Include no more than 15, and make selections based on recency, importance to the field, and/or relevance to the application
    • Page limit : remains at 4
  • 16. Facilities and Resource Changes
    • Provide a description of how the scientific environment will contribute to the probability of success of the project
    • For ESIs describe the institutional investment in the success of the investigator
    • In Select Agent Section of Research Plan describe the biocontainment resources available at all performance sites
  • 17. Application Alignment with Review Criteria: Major Examples Criteria Application Significance Research Strategy a. Significance Investigator(s) Biosketch Innovation Research Strategy b. Innovation Approach Research Strategy c. Approach Environment Resources