How to Craft the "Significance” & "Innovation" - 2023
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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" - 2023
- 1. Significance and Innovation Bill Parks, PhD Department of Medicine Cedars-Sinai Medical Center
- 2. R01 Grant Sections • Face Page • Table of Contents • Performance Site • Project Description: Abstract • Project Narrative: 2 sentences • References Cited • Facilities and Other Resources • Equipment • Key Personnel • Biosketches • Budget (all years) • Budget Justification • Introduction (resubmission only) • Specific Aims • Research Strategy • Significance • Innovation • Approach • Protection of Human Subjects • Women & Minorities • Planned Enrollment Table • Children • Vertebrate Animals • Select Agents • Multiple PI Plan • Letters of Support • Resource Sharing • Authentication of Key Biological and/or Chemical Resources • PHS Assignment Form
- 3. Scored Review Criteria Investigator Initiated R-series Grants • Significance • Investigator • Approach • Innovation • Environment Overall Impact Overall Impact or Criterion Strength Score Descriptor High 1 Exceptional 2 Outstanding 3 Excellent Moderate 4 Very Good 5 Good 6 Satisfactory Low 7 Fair 8 Marginal 9 Poor • Criterion Score • Whole numbers: 1-9 • 1 (exceptional); 9 (well let’s just hope you never get a 9) • Given by reviewers but not discussed at study section • Provided in Summary Statement of all applications • Overall Impact Score • Not the mean of the criteria scores • Different criteria are weighted by each reviewer • Final Impact Score, Percentile • Mean of all scores x 10 ➤ 10 – 90 • Percentiled against R01s applications across 3 meetings
- 4. New ‘Simplified’ Review Framework • January 2025 • https://grants.nih.gov/policy/peer/simplifying-review.htm • "Should the proposed research project be conducted?” • Significance • Approach
- 5. Innovation
- 6. Innovation • Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? • Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? • Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed? Current Instructions to Reviewers
- 7. Innovation • Two flavors 1. New concepts or challenges to existing paradigms or dogma 2. New reagents, assays, technologies, etc. • However, “proposals do not need to be innovative” • Thus, not a major review criteria – but can be a big plus • Not mentioned in instructions to reviewers for K applications
- 9. Innovation • Keep it short • 1-2 paragraphs • Bulleted list • Be realistic Our data will provide new information on how specific functions of macrophages are regulated. Conceptually, our project will demonstrate that macrophages are not necessarily bad players in fibrosis and furthers the idea, which we were among the first to propose, that MMPs function primarily to affect the behavior of immune cells.
- 10. Significance
- 11. Significance • Does the project address an important problem or a critical barrier to progress in the field? • Is the prior research that serves as the key support for the proposed project rigorous? • If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? • How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field? Instructions to Reviewers
- 12. What is Significance and How is it Evaluated? • Not related to the disease or cellular process you are studying • After all, all diseases are significant • Basic science research can have an impact • Rather, if the aims are achieved, will scientific knowledge, technical capability, and/or clinical practice be improved? • Hence, Research Approach impacts Significance • A wet-lab proposal that is descriptive or derivative or will gather correlative information will not be significant - Epidemiology or clinical studies may seek associative findings • Evaluation of and attention to rigor
- 13. Common Misconception • Significance only means translational science, clinical importance, and/or disease related • Not true: basic research can have a great an impact • “NIH’s mission is to seek fundamental knowledge about the nature and behavior of living systems and the application of that knowledge to enhance health, lengthen life, and reduce illness and disability.” • An application does not need to show the potential for clinical impact • You do not need to develop a new drug!
- 14. • Describe the strengths and weaknesses/gaps in the rigor of the prior research (published and unpublished) that serves as the key support for the proposed project and plans to address weaknesses/gaps. • Rigor: Strict application of the scientific method to ensure robust and unbiased experimental design, methodology, analysis, interpretation, and reporting of results. • Variables: sample size, sex, age, weight, health condition, etc. • Must address sex (approach) • Authentication of key biological and/or chemical resources (1 page) • Rigor is addressed by reviewers under both Significance (previous) and Approach (planned) • https://grants.nih.gov/grants/peer/guidelines_general/Reviewer_Guidance_on_Rigor_and_Transparency.pdf • https://grants.nih.gov/grants/guide/notice-files/NOT-OD-18-228.html Significance – Rigor of Previous Work, Yours and Others
- 16. 1. Discuss the rigor of the research and data – both yours and others – that form the foundation of your project. 2. Discuss how will you address any weaknesses pointed out in #1. 3. Include strategies that assure a lack of bias and an overall robust approach. 4. Address relevant variables, especially sex. How to Address Rigor in the Research Strategy Significance Approach
- 17. Significance (Background) • 1-1.5 pages • Critically review the literature and provide a clear premise • No limit on number of citations • Original, timely papers over reviews • Rigor: Point out gaps and flaws; strengths, too • Do not be afraid to say you disagree with something (but explain why and how you will correct this travesty) • Be diplomatic • Limit discussion to things (pathways, diseases, molecules, etc.) you will study • Show (tempered) enthusiasm • Know your audience • Get the reviewers interested Pet Peeves • Needlessly long • Not focused • Not timely nor scholarly • Reliance on reviews • Uses the word “exciting” more than once • Poorly developed premise • Does not address rigor
- 18. Overall Impact vs. Significance Overall Impact • Likelihood of making a sustained, powerful influence on the field • Integrates the 5 scored criteria • Not the mean of the 5 criteria Significance • Focus on relevance and likelihood of making a meaningful advance if the aims are achieved. • Addresses an important problem or critical barrier to progress • Topic ≠ Significance