Drafting an NIH Grant Proposal: Significance and Innovation

1. Drafting an NIH Grant Proposal: Significance and Innovation Kim M. Gans, PhD, MPH, LDN Professor, Dept. of Behavioral & Social Sciences and Director, Institute for Community Health Promotion Brown University School of Public Health

2. Who am I? • 1992-present: Assistant to Associate to Full Professor at Brown University School of Public Health • 2009-present: Director, Institute for Community Health Promotion • Starting in Fall 2014: Professor, Department of Human Development and Family Studies and CHIP, University of Connecticut • Research: Intervention studies in community-based settings to improve eating habits, increase physical activity and prevent/treat obesity • Many grant review committees • Past 4 years - standing member of CLHP study section

3. Who am I? • Funded continuously on federal grants since 1986 • PI grants: • 1 USDA grant • 1 R21 grant • 4 R01 grants (Another R01 pending) • 2 R18 grants (like R01 but translational research) • 1 R13 (pending) • 4 Foundation grants (RWJF and Tufts Health Plan Foundation)

4. Overall Impact Function of Importance and Likelihood 1. Importance—the significance and innovation of the research problem—its ability to move the frontier of knowledge forward 2. Likelihood—the ability that you, the PI, can achieve your ends, as judged by your experimental design, the expertise of your team, and the resources at your disposal to execute the project Impact = function of importance (significance, innovation) and likelihood (approach, investigator, environment)

5. Significance and Innovation • The peer review criteria reviewers use to assess the importance of your application • Must highlight these factors effectively • “Sales job”

7. Good quote • “NIH doesn’t want all the detailed minutiae about what reagent you’re going to use, who the vendor is, and what temperature you’re doing the experiment at. • If you’re conveying those things, without having spent the time (i.e. space) to convince the reader in the first place about the value of the work that you’re doing, then your proposal will be received much like a proposition for a long night of sex after one short speed date.” http://morganonscience.com/grantwriting/nih-grant-writing-tips-the-new-format-significance-innovation-approach/

8. NIH Study Section

9. So if Significance and Innovation both speak to Importance, what’s the difference between them? • Significance • The positive effect that successful completion of your research project is likely to have as the result of solving an important, NIH-relevant problem • Innovation • A new andsubstantially different way of considering/addressing an important, public-health relevant problem that results in substantive departure from the status quo, thereby enabling new horizons that are pertinent to NIH • Both seek to advance the field and speak to the importance of the research Russell, SW and Morrison, DC. The grant application writer’s workbook. National Institutes of Health Version

10. Significance • Will your project advance your field and fit the NIH mission to improve health through science? • Whether the project is worth doing • How important your research would be if everything worked perfectly • It does not take into account your ability to conduct the research • Assumes success - that the “aims of the project are achieved” and/or will be “successfully completed”

11. Significance: NIH Reviewer Criteria • Does the project address an important problem or a critical barrier to progress in the field? • 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 intervention that drive this field?

12. What is told to reviewers about Significance • Score the Significance criterion independently of your evaluation and scoring of the other 4 review criteria • Consider whether this specific project advances the field; not whether the field is important • Does the project address an important problem or a critical barrier to progress in the field, or has the ability to improve knowledge, technical capability or clinical practice in a major (1-3), moderate (4-6) or minor (7-9) way? • Relevance to human disease is not required for significance

13. Significance: One Approach Three parts to significance: • Review literature and write contribution statement • Statement of significance • Discussion of benefits Russell, SW and Morrison, DC. The grant application writer’s workbook. National Institutes of Health Version

14. Significance: One Approach Part 1: Review primary literature that substantiates why its an important problem that needs to be addressed • Explain the importance of the problem (i.e. prevalence data, morbidity, etc.) • Background of the field • Detail existence of research gaps/needs/opportunities • Frame why this is an important problem to solve Conclude with a sentence that explicitly describes the contribution that you expect to make. • Should relate back to your specific aims • The expected contribution of the proposed research is…

15. Significance: One Approach Part 2: Statement of significance • Why the expected contribution is important / significant. • What is the positive impact that your contribution will have? • Most important sentence that you will write in the application • Simple and direct • Specific and substantive • Use Bold or italics The proposed research will have a significant positive impact on the field of public health because ….:

16. Significance: One Approach • Part 3: Discussion of benefits • Advancement of the field • Relevant to NIH’s mission • How will proposed research enable subsequent thinking and research • How will it decrease morbidity/mortality, improvements in QOL and/or medical outcomes, reduction in costs, etc. • Provides support for the significance statement • Include references

17. Another approach • Prepare an outline with Bullets of the points you want to make • Then Expand into sentences - Subheadings are one sentence that highlight a key point • Then evidence given for that point follows • Summarize all points of significance at the end

18. Pointers • If you are using a specific Program Announcement, mention it , use specific language from it and cite it. • Scan review committee roster to see who potential reviewers might be • Determine how well reviewers may know your field and add write accordingly • Cite reviewers on the committee if possible • Preliminary studies?

19. Pointers (cont.) • No more than 2 pages (shorter for non-R01) • Use bolding, italics, and sectioning to highlight key points and make it easier for reviewers to read • If significance section is somewhat long, summarize it at the end • If you have trouble writing significance, explain the significance to others verbally and tape yourself (or use Dragon software). • Complete Approach section before tackling Significance because you will have a clearer overall perspective of your proposal

20. √ Significance Checkpoint • Point out the project's significance throughout the application (not just in significance section) • Should extend and validate Specific Aims section • Describe importance of your hypothesis to the field and human disease • Shows that you are aware of opportunities, gaps, roadblocks, and research underway in your field • States how your research will advance your field, highlighting knowledge gaps and showing how project fills one or more of them • Don’t forget to discuss sustainability, dissemination capability

21. Innovation • How advancement of the field results from using innovative approaches that deviate from traditional approaches • Not just “novelty” • Implies not only newness, but a sense of unique utility • An innovative grant proposal will propose to solve a problem in new ways • Show how your proposed research is new and unique, e.g., explores new scientific avenues, has a novel hypothesis, will create new knowledge.

22. Innovation: NIH Reviewer Criteria • 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 or theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?

23. Innovation: One Approach Part 1: Document ( with citations) what the norm has been to this point • Create a literature-based foundation that will allow reviewers to appreciate what the status quo is Part 2: Statement of innovation: The proposed research is innovative, in our opinion, because [what sets your research apart from existing research] Part 3: Discuss positive impact – advancement that would have been unlikely without the departure from the status quo Russell, SW and Morrison, DC. The grant application writer’s workbook. National Institutes of Health Version

24. Innovation Tips • NIH’s three bullet points for Innovation are good guidelines, but don’t make each a subhead and address them individually • Provide a narrative that demonstrates you have thought about the pioneering nature of what you are proposing and that you have considered how your approach is different from others • Highlight significance and innovation in other parts of the application, such as the Abstract, Aims, Summary of Strengths http://www.i2at.msstate.edu/pdf/NIH_R01_Series_Part4_Research_Plan.pdf

25. Innovation Tips • Length: No longer than a paragraph or two. ½ to ¾ page max • Don’t try to pretend that your science is innovative when it isn’t. • Describe how your project is new and unique, but not too far out of the box • Usually do not see grant applications that are shifting paradigms • They are using new approaches or models, working in new areas, or testing innovative ideas

26. Example We believe that the proposed research is very innovative because: 1) It is focused on FCCHs – a novel setting for obesity prevention research; 2) It will include Spanish-speaking FCCPs, which no prior studies in any child care setting have done; 3) It will utilize peer counselors to support and empower FCCPs to change FCCH environments, a novel approach for obesity prevention interventions in childcare settings. Moreover, while peer counselors have previously been shown to be effective in changing individual health behaviors in certain populations outside of childcare, studies have not adequately evaluated their ability to foster environmental change, which will be our focus.; 4) It will integrate peer counseling with tailored written materials and videos, which is a novel intervention strategy never before studied. Dr. Gans has piloted this approach with families; but only using tailored print materials, not tailored videos, and not in childcare settings. The proposed research will expand our knowledge about the efficacy of this innovative approach. Overall, the intervention setting, target population and intervention approaches are all novel. The proposed research will move the frontier of obesity prevention research in childcare forward.

27. Difference between impact of significance and innovation • Positive impact of significance stems from the concrete benefit that is relevant to NIH’s mission. • Positive impact of innovation stems from advancement because of the departure from the status quo.

28. Formatting and Writing Tips • Writing style • Clear, Direct, Succinct writing • Simple declarative sentences • NIH suggests no more than 20 words per sentence • If the writing is unclear, often the thinking is unclear. • Write so that reviewer can summarize in 2 to 3 sentences • If you want to make a number look large, precede it with the word “fully,” (fully 30%). If you want to make a number look small, precede it with “only,” (only 70%).

29. S and I Checkpoint √ • Application makes a solid case for the reason your research is important • Focus on how your project addresses critical research opportunities that can move the frontier of knowledge in your field forward • Highlight significance and innovation in other parts of the application, such as the Abstract, Aims, Summary of Strengths at end of grant http://www.niaid.nih.gov/researchfunding/grant/strategy/pages/3significance.aspx

30. References and Additional Reading • Russell, SW and Morrison, DC. The grant application writer’s workbook. National Institutes of Health Version • Pequegnat, W; Stover, E and Boyce, CA. How to write a successful research grant application. A guide for social and behavioral scientists 2ndedition • Morgan Giddings: http://morganonscience.com/

31. Sample grants from NIAID • http://www.niaid.nih.gov/researchfunding/grant/Documents/Ratnerfull.pdf • http://www.niaid.nih.gov/researchfunding/grant/Documents/Parrishfull.pdf

32. How are grants scored? • http://public.csr.nih.gov/ReviewerResources/MeetingOverview/Documents/OrientationtoPeerReviewFinaltoPostCAK.pdf

33. Questions