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Project Application Format

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					Review of the New NIH Application
             Format
     What Applicants Need to Know Now

            January 13, 2010
              Bruce Elliott
         Director, OSR-Chicago




                                        1
  Goals of this Presentation
 Describe the major application changes for due
  dates on or after January 25, 2010
 Applications for due dates on or after January 25,
  2010 require use of new forms and new
  instructions.
  – the forms have been restructured
  – shorter page limits!
 The changes apply to all competing applications:
  new, renewal, resubmission and revision
 Electronic and paper
                                                   2
Why is NIH Restructuring the Application
Packages?
   The new application forms incorporate the
    enhanced peer review criteria for research
    grants that was announced in NOT-OD-09-
    025.
   NIH is restructuring the applications to align
    application structure and content with new
    review criteria.
   This alignment will help ensure that both
    reviewer and applicant expectations coincide
    for a more transparent application process.      3
Enhancing Peer Review Timeline




   Phase out of A2  Enhanced review        Restructured
    applications        criteria              Applications
                       New scoring
   Identification of                        Shorter Page Limits
                        system
    Early Stage                               and New
    Investigator       Criterion scoring
                                              Instructions
    (ESI) R01          Structured
    applications        critiques
                       Score order
                        review
                       Clustering of New
                        Inv. Applications

                                                                    4
How Did NIH Make the Decision to
Shorten Applications?
 Overwhelming opinion from working groups
  was that significant reduction was necessary
  to achieve enhancement (to 7-15 pages).
 RFI: 70% respondents preferred applications
  shorter than 25 pages
  – Would not compromise ability to present scientific
    ideas and would probably enhance
  – Would take less time to prepare


                                                         5
Why is the Length Changing?
 Focus applicants and reviewers on the
  essentials of the science that are needed for
  a fair and comprehensive review of the
  application.
 To reduce the administrative burden placed
  upon applicants and reviewers.
 Shorter applications may have additional
  benefits for reviewers such as enabling a
  larger number of reviewers to read each
  application and participate in review in a
  more informed manner.
                                                  6
New 1-9 Scoring System
 Reviewers are now using new scoring scale of 1
  to 9 for impact/priority score
   1=exceptional; 9=poor
 New concept: Reviewers will begin scoring the
  applications on five individual core criteria, using
  the same 9-point scale: significance, investigator,
  innovation, approach and environment




                                                     7
“Not Discussed” Label
 Reviewers no longer provide non-
  numerical scores, e.g., Unscored or Not
  Recommended for Further
  Consideration
 All proposals now receive impact
  scores
 New terminology: a „Not Discussed‟
  label will replace the existing term
  „Unscored‟
                                         8
Structured Templates For Critiques
  Reviewers will use templates to list strengths
   and weaknesses
    – For each of the individual core criteria
      (which correspond to the new application)
    – For the overall impact
    – For any other relevant review
      consideration for any particular
      application, e.g., protection of human
      subjects or resource sharing


                                                   9
Effective Date for New Application
Packages
  Major changes to application forms due on
  or after January 25, 2010:
   – Restructured Application Forms
      • Require the downloading of new forms (paper and electronic)

   – Shorter Page Limits
      • for ALL competing applications:
            New, Renewal (type 2) , Resubmission (A1)

    (For AIDS applications submitted by PIs eligible for continuous
                   submission, date is February 7)
                                                                      10
   What are the implications for
   resubmissions?
 Only 1 resubmission A1
 New page limits must be followed for A1
  resubmissions
  – No grandparenting of page limits
  – All activity codes! No exceptions!

 Applicants need to download the new
  forms and follow the new instructions
 Reminder: An A2 application is allowed until January 7, 2011 if the
 A0 was submitted before January 25, 2009                          11
Pop Quiz

 Can you submit a new R01 application on
  January 24 for the February 5 deadline and
  be able to use the old 25-page limit for the
  research plan?




                                                 12
Pop Quiz
Can you submit a new R01 application on
 January 24 for the February 5 deadline and
 be able to use the 25-page limit for the
 research plan?

NO!
  Changes apply to ALL applications intended
  for the January 25, 2010 due date and
  beyond
  – Applications submitted early must use the new
    forms and follow the new instructions including
    shorter page limits
                                                      13
How Are Application Being
Restructured?
   Application are revised in three
   sections:
     Research Plan
     Resources and Facilities
     Biographical Sketch

                                      14
Major Changes to the Research Plan
 Introduction – now 1 page for resubmissions
 Specific Aims is a separate page and will
  include new language about the impact of
  the proposed research on the research field.
 Research Strategy will be created as a new
  section and will include 3 of the current
  sections in a restructured format
  – Background and Significance
  – Preliminary Studies/Progress Report
  – Research Design and Methods
                                                 15
New Research Strategy Section

Current Application   New Application
Background and        Research Strategy
Significance          a. Significance
Research Design and   b. Innovation
Methods               c. Approach
Preliminary             •   Preliminary Studies
Studies/Progress            for New
Report                      Applications
                        •   Progress Report for
                            Renewal/Revision
New Research Strategy Preparation

  A single attachment for the Research
   Strategy (previously 3 files) increases
   your control over the look and feel of
   your application.
   – Simpler preparation
   – Easier reading for reviewers
   – Electronic validation of page limits for
     Research Strategy
Section Page Lengths Are Rigid

  Cannot blend sections or continue from
   one section to another
  E.g., Cannot continue writing Specific
   Aims on first page of Research
   Strategy
Revisions to Address Environment
Provide description of how the scientific environment will
  contribute to the probability of success of the project

Special facilities for working with biohazards

For Early Stage Investigators (ESIs), includes institutional
  commitment and support; investment in the success of
  the investigator

For Select Agents Research, in addition to Resources
  and Select Agents sections, in the Approach describe
  materials that may be hazardous to personnel and
  precautions to be exercised

Better reflects new Environmental scoring criterion
                                                          19
Revisions to Biographical Sketch
 Personal Statement added:
  – Briefly describe why your experience and
    qualifications make you particularly well-
    suited for your role in the project
 Publications revised:
  – Limit the list of publications or manuscripts
    to no more than 15 based on recency,
    importance to the field, or relevance to the
    application
  – Do not include submitted or in preparation
                                                    20
21
22
23
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

                                          24
    What are the changes for Ts, Fs,
    and Ks?
 Training (T) applications
   – Now transitioning to G.g electronic applications
   – Page limit remains at 25
   – Biosketch and Resources changes apply
 Career Development (K) applications
   – Page limit decreases to 12 pages
   – Research Strategy changes apply
   – Biosketch and Resources changes apply
 Fellowship (F) applications
    – Page limit decreases to 6 pages
    – Research Strategy changes apply
    – Biosketch and Resources changes apply
                              Check table of page limits for exceptions
                                                                   25
Overview of Shorter Page Limits

    Current Page Limit
                                      New Page Limit
(Section 2-5 of the Research
                                    (Research Strategy)
            Plan)

            <25                                6
             25                               12
            >25                   Follow FOA Instructions


 Note: Follow FOA page limit requirements if
 different from the application instructions.
              Full table of page limits available at:
                                                              26
      http://enhancing-peer-review.nih.gov/page_limits.html
    Table of Page Limits (Part I)
Section of Application with Page Limits                        Page Limits


Introduction to Revision Application
For all Activity Codes                                           1 page


Introduction to Resubmission Application
For all Activity Codes, EXCEPT Training (T, D), K12, and R25     1 page

Introduction to Resubmission Application
For institutional Training (T), International Training (D43,
D71), Institutional Career Awards (K12), and Research            3 pages
Education Applications (R25)


Introduction to Revision or Resubmission Applications
For each project and core of multi-component applications        1 page
     Table of Page Limits (Part II)

Section of Application with Page Limits                              Page Limits

Specific Aims
For all Activity Codes that use an application form with the
                                                                        1 page
Specific Aims section
Research Strategy
For Activity Codes R03, R13/U13, R21, R36, R41, R43,
                                                                       6 pages
Fellowships (F), SC2, SC3
Research Strategy
For Activity Codes R01, single project U01, R10, R15, R18,
                                                                       12 pages
U18, R21/R33, R24, R33, R34, U34, R42, R44, DP3, G08,
G11, G13, UH2, UH3, SC1
Research Strategy
For each project and core of multi-component applications,          Generally 6 or
such as Program Project/Center (P)                                   12 pages**


     **Each project or core will follow the page limit of the equivalent activity code.
     Table of Page Limits (Part III)
Section of Application with Page Limits                      Page Limits

Research Strategy                                            Follow FOA
For all other Activity Codes                                 instructions
Combined: Research Strategy and first four items of
Candidate Information                                         12 pages
For Individual Career Development Award (K) Applications
Items 2-5 of Research Training Program Plan
For Institutional Career Development and Research Training    25 pages
Applications, including K12, T, D43, and D71
Research Education Program Plan
                                                              25 pages
For Research Education Grant Applications (R25)
Biographical Sketch
                                                               4 pages
For all Activity Codes except DP1 and DP2
Biographical Sketch
                                                               2 pages
For DP1 and DP2
What Do You Need to Do Now?
Steps for Success
 Read about the upcoming requirement
  changes now so that you can begin
  writing your Research Strategy
 Information available on the Enhancing
  Peer Review website

     http://enhancing-peer-review.nih.gov/




                                             31
Here are the Most Important
References
   Details of changes: http://enhancing-peer-
    review.nih.gov/docs/application_changes.pdf


   Details of changes for K awards:
    http://enhancing-peer-
    review.nih.gov/docs/Details_of_Career_Develop
    ment_Application_Changes.pdf


   Enlightening FAQs: http://enhancing-peer-
    review.nih.gov/faqs.html
Steps for Success
 Return to updated FOA or new parent
  announcement to download new forms
 Choose the correct forms. Applications intended for
  due dates of January 25 or beyond require new
  forms.
   – For Electronic SF 424
     (R&R): ADOBE_FORMS_B
   – For Paper PHS 398: Revision date “June 2009”
 Read new instructions and FOA carefully because
  applications submitted with incorrect forms will be
  delayed and may not be reviewed!

                                                        33
Grants.gov and NIH Commons
will validate against the new
format




                            34
Once you‟ve submitted…
Applicants, do not just submit and walk
away from your electronic application
submissions. You must:
– Check eRA Commons for errors and
  warnings
– Promptly address any issues identified
– Check your application one more time!


Failure to follow instructions will NOT be an
  acceptable reason for a late application.
                                                35
Let OSR Know if You Wish Us to
Review the Restructured
Application with Your Faculty




                                 36
Questions?
Bruce Elliott
b-elliott@northwestern.edu
3-1780

				
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