Break it Down to Build it Better Part II

1. Break it Down to Build it BetterPart II Tips and techniques not found in grant writing guides R session 2 v6

2. Workshop Agenda R session 2 v6 • Review of timelines and discussion of Item 1 on prework • Specific Aims page • Flow Diagrams • Develop flow diagrams for your proposed study • Variations of flow diagrams • Organizing your Research Strategy • Study timelines • Lunch • Personnel Planning • What it is • Examples • Work on personnel planning/budget (Budget/resources checklist) • Tables and Figures • Writing from the reader’s perspective—Edge review video and discussion • Workshop evaluation (Plus/Delta)

3. Review of timelines and prework R session 2 v6

4. Important versus Urgent Not Urgent Urgent • Important and urgent • Crises • Pressing problems • Deadline-driven projects, • meetings, preparations • Important but not urgent • Preparation and prevention • Values clarification • Planning • Relationship building • Empowerment Important • Not important but urgent • Interruptions, some phone • calls • Some mail, reports • Some meetings • Many proximate, pressing • matters • Not important or urgent • Trivia, busywork • Junk email, surfing the web • Some phone calls • Time wasters • “Escape” activities Not important First Things First by Steven R. Covey, 1994 R session 2 v6

5. Quick NIH update for 2019 K Session 2 v7.2 • New website for Human Subjects includes: • conditions for exemptions • a guide to the new Forms E package • changes to the Certificate of Confidentiality process • explanation of the single IRB Policy • clinical trails requirements • additional resources and links https://grants.nih.gov/policy/humansubjects.htm

6. Specific Aims R session 2 v6

7. Specific Aims R session 2 v6 Vital part of the proposal Reviewers need to like your idea by the time they finish reading your aims Aims page provides an overview of entire project Needs to persuade reviewers that your project is important, that yours is the right team to do it, and that it will advance the state of the science Must be carefully written, clear, and concise http://www.biosciencewriters.com/NIH-Grant-Applications-The-Anatomy-of-a-Specific-Aims-Page.aspx

8. Powerful Aims Grid R session 2 v6

9. R session 2 v6 Flow Diagrams

10. Flow Diagrams R session 2 v6 • Combination of techniques borrowed from process engineering and Information Technology • Uses standard set of 6 symbols to capture the flow of a study (plus 1 optional) • Why do flow diagrams? • Linear, step-by-step logic; helps organize thinking • Identifies areas needing clarification • Serve as framework for budget development • Provide framework for writing narrative (good clue as to how to organize your research strategy section) • May or may not use in the proposal (the thought process is the most important element)

11. Flow Diagram Symbols End point Event, activity, or outcome Decision point Yes or No Connector List or document Indicates direction of flow Outcome Measure (optional) R session 2 v6

12. R session 2 v6 Examples of Flow Diagrams

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18. Hybrids of flow diagrams and other cartoons R session 2 v6

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22. Figure X. Flow of Study____ R session 2 v6

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24. Figure 3. Schematic of XXXXXXX XXX XXXXXX intervention and assessment time points. R session 2 v6

25. Developing your flow diagrams R session 2 v6

26. Peer review of flow diagrams R session 2 v6

27. Organizing your research strategy R session 2 v6

28. Organizing your research strategy R session 2 v6 Look at your flow diagram(s) Did you do a separate flow diagram for each specific aim? If yes, consider organizing your research strategy by specific aim If no, and you did a single flow diagram for the entire study, consider organizing your research strategy by your study design as a whole

29. Organizing by Specific Aims R session 2 v6 • Background and significance • Preliminary research • Innovation • Approach • Specific Aim 1 • Overview • Recruitment • Methods • Analysis plan (include power calculations) • Specific Aim 2 • Overview • Recruitment • Methods • Analysis plan (include power calculation) • Limitations and mitigation strategies • Summary/future directions

30. Organizing by Specific Aims R session 2 v6 • Significance • Innovation • Approach • Specific Aim 1 • Introduction • Justification, feasibility, preliminary data • Research design (include power calculation) • Expected outcomes (or could be statistical analysis) • Potential problems and alternative strategies • Specific Aim 2 • Introduction • Justification, feasibility, preliminary data • Research design (include power calculation) • Expected outcomes (or could be statistical analysis) • Potential problems and alternative strategies • Summary and future directions

31. Organizing by study design as a whole R session 2 v6 • Significance • Innovation • Approach • Preliminary studies • Research design and methods • Overview of study design • Data collection • Quality control procedures • Statistical analysis and power calculations • Aim 1 • Aim 2 • Aim 3 • Study timeline • Study limitations and mitigation strategies • Summary/future directions

32. Checklist for Approach Section of Research Strategy (Handout) R session 2 v6

33. Study timelines R session 2 v6

34. Figure 6: Study Name Study Timeline * Activities to begin as soon as funding decision is announced. † Beta-test scheduled for Summer 2005. R session 2 v6

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38. Tips for timelines R session 2 v6 Simple is better Plan time for study start-up Use a legend; label appropriately Refer to the figure number in the text and give some information about it Use gray scale and patterns; may or may not be printed in color by recipient Ensure your narrative matches the timeline

39. R session 2 v6 Develop your study timeline

40. R session 2 v6 Rigor and Reproducibility

41. Rigor and Reproducibility R session 2 v6 • New reviewer guidelines • The scientific premise of the proposed research • State the strengths and weakness of published research or preliminary data crucial to the support of your application • Rigorous experimental design for robust and unbiased results • Describe how your experimental design and methods will achieve robust and unbiased results • Consideration of relevant biological variables • Explain how biological variables, such as sex, are factored into research design and provide justification if only one sex is used • New form • Authentication of key biological and/or chemical resources http://grants.nih.gov/reproducibility/index.htm

42. R session 2 v6 Budget: Personnel

43. R session 2 v6 Personnel planning

44. How many interviewers will you need over what time period? R session 2 v6

45. Assumptions for example R session 2 v6 Assume you can enroll between 12 to 16 women a week Total of 96 participants, each with 4 interviews Each interview takes 2.25 hours 864 hours total, but how do the interviews and associated times distribute?

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47. How many lab personnel should you plan for? R session 2 v6

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50. Conduct experiments in series or in parallel? R session 2 v6