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Revised Guidelines for National Institutes of Health (NIH) Grants

 
The National Institutes of Health (NIH) has implemented significant changes in the application instructions and forms for both paper-based PHS 398 applications and electronic SF 424 (R&R) applications. The new application instructions and forms must be used for applications intended for due dates on or after January 25, 2010.
 
In addition, reviewers have been issued revised instructions regarding the assessment of grant applications. The following is a brief summary of these changes with specific emphasis on R01 grants (see NIH excerpt for additional details). Please visit the NIH Office of Extramural Support web site for details about how these new guidelines will affect other grants.
 

Summary of Major Changes
 
New Emphasis on the Significance and Impact of the Research 
  • New Research Strategy section will focus on Significance, Innovation, and Approach (see detailed definition).
    • Knowledge Gap: Specify what scientific information is lacking (basic science, clinical intervention, methodology, etc.)
    • Impact: Emphasize how the accomplishment of your goals will help bridge this knowledge gap.
Page Limitations and Other Format Changes
  • Specific Aims (1 page) + 12 page limit for R01
  • Methods are minimized and should be referenced.
Revised Guidelines and Scoring System for Reviewers Based on Significance and Impact
  • Keep in mind what the reviewers are looking for and how they will be evaluating applications.
  • The Impact score is a new and critical component (i.e., How will your project make a difference? How will the funding agency benefit from its investment?).
  • Submission due dates remain the same.
 One Resubmission for Grants Submitted on or after January 25, 2010
  • Resubmissions are subject to the new page number limits and format changes.
  • Introduction of resubmissions to address reviewers' comments are limited to one page.
  • Grants submitted prior to January 25, 2010 will be allowed two resubmissions. Both resubmissions must be submitted prior to January 7, 2011.
New Personal Statement Requirement Added to Biographical Sketch
  • Focus the Personal Statement on how your skills, training, and environment will enhance the achievement of the goals of this particular grant.
     
  • Look at the sample biosketch (under 'Additional Format Pages,' dated November 13, 2009).
  • Remember to have your Key Personnel update their biosketches as well.
Facilities and Other Resources (Impact on Project and Investigator)
  • Provide a description of the unique features of the scientific environment and how it will contribute to the probability of the success of the project.
  • Early Stage Investigators must describe how the institutional investment will contribute to their success.
 Appendix
  • Do not use the Appendix to circumvent the page limits of the Research Strategy.
  • The Appendix may include the following materials as PDF files:
    • Manuscripts and/or abstracts accepted for publication but not yet published.
    • Manuscripts and/or abstracts published, but a free, online, publicly available journal link is not available (limit 3).
    • Patents directly relevant to the project (limit 3).
    • Surveys, questionnaires, and other data collection instruments; clinical protocols and informed consent documents.
    • For materials that cannot be submitted electronically or materials that cannot be converted to PDF format (e.g., medical devices, prototypes, DVDs, CDs), applicants should contact the Scientific Review Officer for instructions.
  • The Appendix must not include:
    • Unpublished theses or abstracts/manuscripts submitted (but not yet accepted) for publication.
    • Photographs or color images of gels, micrographs, etc. are no longer accepted as Appendix material. These images must be included in the Research Strategy PDF.
    • Publicly accessible publications.

TALK TO YOUR PROGRAM OFFICER!
Before you start your application, discuss your plans in detail with your Program Officer. The Program Officer is responsible for helping you get your grant(s) funded. He or she can direct your efforts toward the mission of a specific institute and will appropriately guide your research development.

STRATEGY GUIDE FOR PREPARING NIH GRANTS
This guide [PDF, 241KB] will be useful throughout the process of preparing and submitting your NIH grant. In the coming months, we will continue to update this guide by incorporating changes in NIH policies and procedures as we receive new information. 

Important NIH Links

Impact vs. Significance (re: NIH NOT-OD-09-025)
Since the release and implementation of NOT-OD-09-025, there has been some confusion regarding the distinction between Significance and Overall Impact. In response, the NIH Office of Extramural Research convened a working group consisting of NIH review and program staff to develop additional guidance on this issue.

Outstanding Titles and Abstracts
Your title and abstract affect how NIH assigns your application. All reviewers read the title. Review some examples of outstanding titles and abstracts.

Not Funded, Reapply
Time to reapply? See the Not Funded, Reapply guide and the Renewal Application guide.

Parent Announcements (For Unsolicited or Investigator-Initiated Applications)

Excerpts from NIH SF424 (R&R) Application Guide

Part I: Instructions for Preparing and Submitting an Application

From SF424 (R&R) Application Guide Nov 13, 2009; page (I-1)

Modifications related to changes in the SF424 (R&R) forms include:
  • A new Agency Routing Identifier field has been added to the Cover Component.
  • A document upload field has been added to the Cover Component for attaching the SFLLL or other explanatory documents.
     
  • A new field has been added to the Project/Performance Site Location(s) from for the Congressional District of the project. The Areas affected by Project and congressional Districts of Project fields on the cover component have been deleted.
  • Fields requesting the type and year of degree have been added to the Senior/Key Personnel forms.
  • Questions on Human Subjects Research on the other Project Information form have been re-ordered and a new question, whether the project is exempt from Federal regulations, has been added.
The PHS 398 application components have been modified by realigning the structure and content of applications with new review criteria. Additionally, page limits for many applications have been shortened to help reduce the administrative burden placed upon applicants, reviewers, and staff. Specific modifications related to changes in the PHS398 components include:
 
  • Three sections of the previous Research Plan (Background, Significance, Preliminary Studies/Progress Report, and Research Design and Methods) have been consolidated into a new single section within the Research Plan entitled Research Strategy. The new Research Strategy section will be sub-divided into three parts: Significance, Innovation, and Approach, although this will now be a single upload.
  •  The Facilities and Other Resources section has been changed to require a description of how the scientific environment will contribute to the probability of success of the project, unique features of the environment, and for Early Stage Investigators, the institutional investment in the success of the investigator (e.g., resources, classes, etc.).
  • A new Personal Statement requirement has been incorporated into the Biographical Sketch.

 

Additional details on all the form changes noted above can be found at: http://era.nih.gov/ElectronicReceipt/files/Adobe_Forms_B_Summary.pdf.

A description of how these application changes relate to the enhancement of peer review can be found at http://enhancing-peer-review.nih.gov/docs/application_changes.pdf. Additional information on NIH’s efforts to enhance peer review can also be found at http://enhancing-peer-review.nih.gov.

Additional details on all the form changes noted above can be found at: http://era.nih.gov/ElectronicReceipt/files/Adobe_Forms_B_Summary.pdf.

A description of how these application changes relate to the enhancement of peer review can be found at http://enhancing-peer-review.nih.gov/docs/application_changes.pdf. Additional information on NIH’s efforts to enhance peer review can also be found at http://enhancing-peer-review.nih.gov.

Additional details on all the form changes noted above can be found at: http://era.nih.gov/ElectronicReceipt/files/Adobe_Forms_B_Summary.pdf.

A description of how these application changes relate to the enhancement of peer review can be found at http://enhancing-peer-review.nih.gov/docs/application_changes.pdf. Additional information on NIH’s efforts to enhance peer review can also be found at http://enhancing-peer-review.nih.gov.