NIH Faculty Presentation

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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

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

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