1. B IOMEDICAL E NGINEERING Significance & Innovation Dawn M Elliott, PhD

2. B IOMEDICAL E NGINEERING Research Plan Significance + Innovation + Approach (Study Design)  R01 = 12 Pages  R21 = 6 Pages Review Criteria Overall Impact (overall score) Scored Review Criteria  Significance  Investigator  Innovation  Approach  Environment

3. B IOMEDICAL E NGINEERING Dawn’s advice: In Specific Aims – in the final paragraph  Explicitly address Overall Impact In Aims or Research Plan explicitly state:  “This study is significant because….”  “This study in innovative because….” Why make the reviewer figure it out, when you can just tell them?

4. B IOMEDICAL E NGINEERING Significance

5. B IOMEDICAL E NGINEERING Significance (NIH Directions) Explain the importance of the problem or critical barrier to progress in the field that the proposed project addresses Explain how the proposed project will improve scientific knowledge, technical capability, and/or clinical practice in one or more broad fields Describe how the concepts, methods, technologies, treatments, services or preventative interventions that drive this field will be changed if the proposed aims are achieved 5

6. B IOMEDICAL E NGINEERING Writing the Significance Section Suggested length 1-2 page Identify research problem that you propose to address  Explain importance of resolving problem link to mission of NIH institute & public health aspects  Briefly identify most important, relevant studies of other researchers – and identify important questions that have not yet been addressed  Specify how your study will differ from previous work; how it will contribute to scientific knowledge/clinical practice  Address anticipated impact of your research on your field on public health 6

7. B IOMEDICAL E NGINEERING Writing Significance The Significance section is where you begin to increase the level of detail that will extend and validate what was written in the Specific Aims section Provide a critical analysis of the primary literature that describes the existence of a critical gap in knowledge  Explain why its continued existence represents an important problem that must be resolved

8. B IOMEDICAL E NGINEERING Significance Structure Organization  Short summary of objective of study “This proposal will investigate…”  Multiple sections for key points Clinical significance Basic science significance Each section and background material should directly and explicitly tie into your proposal (final sentence of each section)  “Arguably the costs and lost quality of life due to degeneration is a national epidemic”  “A central unresolved question is whether…”  “Our proposal will quantify….”

9. B IOMEDICAL E NGINEERING Be Straightforward – and Current Does this study address an important problem?  “This research question was identified as a major research focus (cite NIH program announcement or other source)” If the aims of the application are achieved, how will scientific knowledge be advanced?  “Our knowledge of... will be advanced by...” What will be the impact of these studies on the concepts or methods that drive this field? How will your studies speed advances, hasten translation? Keep in mind NIH focus on public health: identify how your research will improve public health 9

10. B IOMEDICAL E NGINEERING Dawn’s advice: Use images to break up the page and make points Make sure they are readable! Don’t use too many abbreviations and include a list Use formatting to your advantage

11. B IOMEDICAL E NGINEERING Significance ≠ Illness Don’t argue that a particular illness is significant Significance: What will you do to help cure the illness/lessen its consequences/prevent sequelae? 11

12. B IOMEDICAL E NGINEERING Writing Significance Describe the positive impact your contribution will have  How will your contribution enable subsequent thinking and research?  Call attention to decreased mortality/morbidity, improvements in the quality of life, medical outcomes, reduction in cost of medical care

13. B IOMEDICAL E NGINEERING Innovation

14. B IOMEDICAL E NGINEERING Innovation (NIH Directions) Explain how the application challenges and seeks to shift current research or clinical practice paradigms Describe any novel theoretical concepts, approaches or methodologies, instrumentation or interventions to be developed or used, and any advantage over existing methodologies, instrumentation or interventions Explain any refinements, improvements, or new applications of theoretical concepts, approaches or methodologies, instrumentation or interventions

15. B IOMEDICAL E NGINEERING Think Broadly about Innovation New mechanistic hypothesis New combination of expertise (unusual multi- disciplinary team) leading to new perspective New combination of 2 previously used methods Refinement of existing model or technology Unique sample or opportunity provide the novelty 15

16. B IOMEDICAL E NGINEERING Writing Innovation Suggested length ½ - 1 page Does your research incorporate a new perspective on your subject? Does the proposed research employ novel concepts, approaches or methods?  “The proposed research employs a novel method that we developed...” Are the aims original and innovative?  “These aims are original in that... While they build on..., they are designed to advance our understanding of...” Does the project challenge existing paradigms or develop new methodologies or technologies? 16

17. B IOMEDICAL E NGINEERING Example from my (funded) grant 1/3 page Bulleted list

18. B IOMEDICAL E NGINEERING Another example from (funded) grant 1 st paragraph of 1 page Innovation section: The studies we propose will capitalize on innovative state-of-the-art technology in high-resolution microMRI, image registration, and computational modeling to quantify and evaluate internal disc stress and strain fields with unmatched capability. …Our proposal, which integrates experiments and modeling, where both approaches inform each other, is a powerful and distinctive approach. Simultaneous development of both experimental and modeling techniques to quantify disc internal stress- strain fields noninvasively, especially at tears, provides capabilities not previously achieved.

19. B IOMEDICAL E NGINEERING Make Sure Your Research Question is Unique Search NIH Research Portfolio Online Reporting Tool Expenditures and Results (RePORTER) database to see if anyone else has been funded to carry out similar research http://report.nih.gov 19

20. B IOMEDICAL E NGINEERING Innovation is Necessary, But Not Justification “This model has been tested in rabbits, mice, rats, drosophila, dogs, cats, chickens, zebrafish and hamsters, but no one has looked at it in a frog yet.” 20

21. B IOMEDICAL E NGINEERING But… “This model has been tested in rabbits, mice, rats, drosophila, dogs, cats, chickens, zebrafish and hamsters, but no one has looked at it in humans or better yet patients with the condition of interest.” …. is a different story 21

22. B IOMEDICAL E NGINEERING Writing Innovation Describe the positive impact that will result from your innovative approach  Positive impact under Significance stems from concrete benefit that is relevant to NIH’s mission  Positive impact under Innovation stems from advancement that would have been unlikely without substantive – not incremental – departure from the status quo

23. B IOMEDICAL E NGINEERING Too Much Innovation Be careful about arguing you’re “outside the mainstream” Need to balance innovation with:  Feasibility (preliminary data, scope of research)  Credibility (training, publications) 23

24. B IOMEDICAL E NGINEERING Final Thoughts Grant writing is different from other technical writing Read by only a few people  Tired and fitting this service into busy schedules  But get excited by good ideas presented well Persuasive writing – tell a story and draw the reviewer in Win their interest in going to bat for your proposal, do not beat them into submission