How to Craft the "Significance” & "Innovation" [Filler] - 2023

Nov 6, 20230 likes9 views

CTSI R Workshop: How to Craft the "Significance” & "Innovation" Sections of a Grant Application. Scott G. Filler, MD Professor of Medicine at Lundquist Institute/Harbor-UCLA and UCLA Leader, CTSI Pilot Translational and Clinical Studies Program Co-Leader, CTSI KL2 Institutional Development Core

Significance
and Innovation
Scott G. Filler, M.D.
Lundquist Institute for Biomedical Innovation
at Harbor-UCLA Medical Center
sfiller@ucla.edu

Review Criteria
• Factor 1 : Importance of the Research
• Significance, Innovation
• Scored 1 - 9
• Factor 2 : Rigor and Feasibility
• Approach (also includes Inclusion and Clinical Trial (CT) Study
Timeline )*
• Scored 1 - 9
• Factor 3 : Expertise and Resources
• Investigators, Environment
• Evaluated as appropriate or gaps identified; gaps require explanation
• Considered in overall impact; no individual score
*Usually drives the overall score

Additional Review Criteria
that may affect overall score
• Human Subject Protections (for HS and CT)
• Vertebrate Animal Protections
• Biohazards
• Resubmission/Renewal/Revisions

Additional Review Criteria
that will NOT affect overall score
• Authentication of Key Biological and/or
Chemical Resources
• Budget and Period of Support

Significance
• Why is the research important?
• Is there a strong premise?
o Literature
o Preliminary data
• What are the deliverables?
• What will be the overall impact?

Goals of Significance Section
• Emphasize importance of the research and gaps in
current knowledge
o How your proposed research will fill these gaps
o How knowledge gained can be applied to other systems
• Provide essential background information for an
uninformed reader
o Must support the premise
• Get reviewer interested

Key Points
• Don’t assume the reviewer will read every word
• Reviewer may or may not have expertise in your area of
research
• Make sure that your statements are factually correct
• Try to describe broad overall impact
• This is the sale pitch for your grant

Things to avoid
• Jargon and abbreviations
• Dense, hard to understand writing
• Potential pitfalls of the proposed research
• Criticisms of others’ work

Strategic Points
• Do not directly criticize previous work
• Consider citing the work of potential reviewers and
influential researchers in the field
• Consider a diagram illustrating the system you are
studying and the goals of your research
• Avoid red-green color schemes—use blue and yellow
if possible

Innovation
• Does the application challenge and seek to shift current
research or clinical practice paradigms?
• Are the concepts, approaches or methodologies,
instrumentation, or interventions novel?
• Is a refinement, improvement, or new application of
theoretical concepts, approaches or methodologies,
instrumentation, or interventions proposed?

Innovation
• Two types of innovation:
o Innovative technology—applying new tools to an old question
o Innovative hypothesis—applying standard tools to a new
question
• Optimal to have new tools and an innovative
hypothesis

Caveats
• Avoid using standard tools to answer well-
researched topics:
• Does the research have the potential to have a broad,
sustained impact on the field?

Writing the Innovation Section
• One paragraph
• Some use bullet points
• Avoid prolonged rehash of the proposed
research
• Describe overall impact on the field

This document provides guidance on key sections of an NIH R01 grant application, including Significance, Innovation, and review criteria. It discusses that Significance refers to how the project will advance scientific knowledge or improve clinical practice if successful, not just the importance of the disease topic. Reviewers evaluate the rigor of prior research supporting the project and the applicant's plans to address weaknesses. Innovation can involve novel concepts, approaches, technologies, or new applications of existing methods. The simplified NIH review framework focuses on whether the proposed research should be conducted based on Significance and Approach.

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How to Craft the "Significance” & "Innovation" [Filler] - 2023

1. Significance and Innovation Scott G. Filler, M.D. Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center sfiller@ucla.edu

2. Review Criteria • Factor 1 : Importance of the Research • Significance, Innovation • Scored 1 - 9 • Factor 2 : Rigor and Feasibility • Approach (also includes Inclusion and Clinical Trial (CT) Study Timeline )* • Scored 1 - 9 • Factor 3 : Expertise and Resources • Investigators, Environment • Evaluated as appropriate or gaps identified; gaps require explanation • Considered in overall impact; no individual score *Usually drives the overall score

3. Additional Review Criteria that may affect overall score • Human Subject Protections (for HS and CT) • Vertebrate Animal Protections • Biohazards • Resubmission/Renewal/Revisions

4. Additional Review Criteria that will NOT affect overall score • Authentication of Key Biological and/or Chemical Resources • Budget and Period of Support

5. Significance • Why is the research important? • Is there a strong premise? o Literature o Preliminary data • What are the deliverables? • What will be the overall impact?

6. Goals of Significance Section • Emphasize importance of the research and gaps in current knowledge o How your proposed research will fill these gaps o How knowledge gained can be applied to other systems • Provide essential background information for an uninformed reader o Must support the premise • Get reviewer interested

7. Key Points • Don’t assume the reviewer will read every word • Reviewer may or may not have expertise in your area of research • Make sure that your statements are factually correct • Try to describe broad overall impact • This is the sale pitch for your grant

8. Things to avoid • Jargon and abbreviations • Dense, hard to understand writing • Potential pitfalls of the proposed research • Criticisms of others’ work

9. Strategic Points • Do not directly criticize previous work • Consider citing the work of potential reviewers and influential researchers in the field • Consider a diagram illustrating the system you are studying and the goals of your research • Avoid red-green color schemes—use blue and yellow if possible

10. Innovation • Does the application challenge and seek to shift current research or clinical practice paradigms? • Are the concepts, approaches or methodologies, instrumentation, or interventions novel? • Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?

11. Innovation • Two types of innovation: o Innovative technology—applying new tools to an old question o Innovative hypothesis—applying standard tools to a new question • Optimal to have new tools and an innovative hypothesis

12. Caveats • Avoid using standard tools to answer well- researched topics: • Does the research have the potential to have a broad, sustained impact on the field?

13. Writing the Innovation Section • One paragraph • Some use bullet points • Avoid prolonged rehash of the proposed research • Describe overall impact on the field

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