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How to Craft the "Significance” & "Innovation" Sections of a Grant Application (2020)

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UCLA CTSI
UCLA CTSI

William Parks, PhD Professor of Medicine at Cedars-Sinai Medical Center and UCLA Associate Dean for Graduate Research Education Scientific Director, Women’s Guild Lung Institute

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Significance and Innovation William Parks, PhD
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
R01 Grant Sections • Face Page • Table of Contents • Performance Site • Project Information • Project Description: Abstract • Project Narrative: 2 sentences • Facilities and Other Resources • Equipment • Key Personnel • Biosketches • Budget (all years) • Budget Justification • Cover Page Supplement • Introduction (resubmission only) • Specific Aims • Research Strategy • Significance • Innovation • Approach • Preliminary Data • Research Plan • Protection of Human Subjects • Women & Minorities • Planned Enrollment Table • Children • Vertebrate Animals • References Cited • Multiple PI Plan • Letters of Support • Resource Sharing • Authentication of Key Biological and/or Chemical Resources • Checklist
Innovation
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
Innovation Applicant’s Assessment of their Innovative Strengths Reviewers’ Assessment of the Innovative Strengths
Innovation • Keep it short • 1 paragraph • Be realistic
Significance
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 • Does the project address an important problem or critical barrier to progress in the field? • 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
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
• 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: must be 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
WhERE IN THE APPLICATION? RESEARCH STRATEGY 1 The research strategy • Describe the strengths and weaknesses in the rigor of . • Describe plans to address weaknesses in the rigor of the prior research. are factored into research designs and analyses. Introduction to Applications Research Strategy Vertebrate Progress Report Publication List REVIEW GUIDELINES 3 also be asked to (see Update 2)! • Is the prior research rigorous? address weaknesses in the rigor of prior strategies to ensure a robust and unbiased approach relevant biological variables, such as sex, ATTACHMENT FOR AUTHENTICATION OF KEY BIOLOGICAL AND/OR CHEMICAL RESOURCES 2 resources used in the proposed studies. CELL LINES SPECIALTY CHEMICALS ANTIBODIES OTHER BIOLOGICS Standard laboratory reagents that are not expected to vary do not need to be included in the plan. Examples are buffers and other common biologicals or chemicals. DO NOT put experimental methods or preliminary data in this section DO focus on authentication and validation of key resources What are the four elements of rigor? RIGOR OF THE PRIOR RESEARCH 2 RIGOR OF THE PROPOSED RESEARCH 3 BIOLOGICAL VARIABLES 4 AUTHENTICATION what you need to know Send inquiries to reproducibility@nih.gov See also NIH Notice NOT-OD-18-228 NIH ENHANCING REPRODUCIBILITY GUIDELINES
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
Impact vs. Significance 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

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How to Craft the "Significance” & "Innovation" Sections of a Grant Application (2020)

  • 2. 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
  • 3. R01 Grant Sections • Face Page • Table of Contents • Performance Site • Project Information • Project Description: Abstract • Project Narrative: 2 sentences • Facilities and Other Resources • Equipment • Key Personnel • Biosketches • Budget (all years) • Budget Justification • Cover Page Supplement • Introduction (resubmission only) • Specific Aims • Research Strategy • Significance • Innovation • Approach • Preliminary Data • Research Plan • Protection of Human Subjects • Women & Minorities • Planned Enrollment Table • Children • Vertebrate Animals • References Cited • Multiple PI Plan • Letters of Support • Resource Sharing • Authentication of Key Biological and/or Chemical Resources • Checklist
  • 5. 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
  • 7. Innovation • Keep it short • 1 paragraph • Be realistic
  • 9. 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 • Does the project address an important problem or critical barrier to progress in the field? • 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
  • 10. 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
  • 11. • 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: must be 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
  • 12. WhERE IN THE APPLICATION? RESEARCH STRATEGY 1 The research strategy • Describe the strengths and weaknesses in the rigor of . • Describe plans to address weaknesses in the rigor of the prior research. are factored into research designs and analyses. Introduction to Applications Research Strategy Vertebrate Progress Report Publication List REVIEW GUIDELINES 3 also be asked to (see Update 2)! • Is the prior research rigorous? address weaknesses in the rigor of prior strategies to ensure a robust and unbiased approach relevant biological variables, such as sex, ATTACHMENT FOR AUTHENTICATION OF KEY BIOLOGICAL AND/OR CHEMICAL RESOURCES 2 resources used in the proposed studies. CELL LINES SPECIALTY CHEMICALS ANTIBODIES OTHER BIOLOGICS Standard laboratory reagents that are not expected to vary do not need to be included in the plan. Examples are buffers and other common biologicals or chemicals. DO NOT put experimental methods or preliminary data in this section DO focus on authentication and validation of key resources What are the four elements of rigor? RIGOR OF THE PRIOR RESEARCH 2 RIGOR OF THE PROPOSED RESEARCH 3 BIOLOGICAL VARIABLES 4 AUTHENTICATION what you need to know Send inquiries to reproducibility@nih.gov See also NIH Notice NOT-OD-18-228 NIH ENHANCING REPRODUCIBILITY GUIDELINES
  • 13. 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
  • 14. Impact vs. Significance 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