Writing the NIH K Award – Research Plan Presented by Sumeet S. Chugh, MD Price Professor and Associate Director, Smidt Heart Institute Director, Division of Artificial Intelligence in Medicine Cedars-Sinai Medical Center

1. cedars-sinai.org
Writing the NIH K Award – Research Plan
NIH K/Career Development Award Workshop
Thursday, June 22, 2023
Sumeet S. Chugh MD
Price Professor & Associate Director, Smidt Heart Institute
Director, Division of Artificial Intelligence in Medicine
Cedars-Sinai Health System, Los Angeles CA
Professor of Medicine, UCLA

2. The Research Plan: No Debate, Make it Good
• Good science = good training → independence
• Well thought-out
• Innovative
• Cohesive
• Doable
• Appropriate controls & safeguards

3. Area of science and scope of project
• Generally related to expertise of mentor
• Should demonstrate transition to independence
• Project should evolve into an independent R01 in near future
• Consider # and scope of aims that fit the study timeline
• Neither too limited nor too ambitious
• Resources should be adequate to support the project (finances,
expertise, populations, animal models, technology…)
Picture: Unsplash+ Adapted from Nemeth E

4. Research Plan (NIAID website https://www.niaid.nih.gov/grants-
contracts/write-research-plan#A8)
• Specific Aims: A capsule of your research plan
• Research Strategy
• A. Significance
• B. Innovation
• C. Approach
◦ Preliminary studies
Picture: iStock 4

5. Proposal: Page Limits
• Candidate Information and Goals for Career Development (6 pages)
• Specific Aims (1)
• Research Strategy (6)
• Training in the responsible conduct of research (1)
• Sponsor and co-sponsor statements (1)
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6. Specific Aims: Craft a Title at the Outset
• Helps you stay focused, avoids meandering
• Keep it succinct, but should distinguish your project within the research area
• Make it reflect the problem you are addressing, the project’s goals, your approach
• Make it specific
• 200 characters or less
Picture: Jooin 6

7. Specific Aims: Broad approach
• Tackle important research that will move you toward independence
• Should build on your strengths, accomplishments and training
• Staying in your niche, propose a project that
• Addresses a highly significant problem.
• Is innovative—can create new knowledge.
• Is unique.
• Start broadly with an emphasis on significance, and then focus on generating
experiments with clear endpoints reviewers can readily assess.
Picture: Harvard business review 7

8. Specific Aims: Pitfalls
• Aims too exploratory or too vague: should be hypothesis-driven, specific and focused
• Proposal solely based on an idea without preliminary data
• 3 aims (magic number); don’t appear overly ambitious, generally better to propose less
• Aims dependent on each other: avoid the “Dead End” hypothesis (X causes Y) in favor
of (Does X cause Y or Z?)
• Presumptions about aim outcomes (“This aim will demonstrate that…”)
• Descriptive aims don’t excite reviewers (measure levels of X in 1,000 samples of Y to
characterize the pattern of expression of X)
Picture: Freepik Adapted from Nemeth E 8

9. Specific Aims: Narrative
• Half-page to provide the rationale and significance of your planned research, use it well
• Get to the point quickly, e.g. start with a sentence that states your project's goals.
• Get specific points across:
• Note specific expertise to do a specific task or that of collaborators
• Describe past accomplishments related to the project
• Describe preliminary studies and new and highly relevant findings in the field
• Show how the aims relate to one another
• Describe expected outcomes for each aim
Picture: Thomas Kienzle 9

10. Specific Aims: The Hypothesis
• You can create one hypothesis for the entire application or one for each Specific Aim
• Reviewers expect hypotheses that anchor your different SAs to a common theme
• Following a central hypothesis keeps you focused with both writing the proposal and
conducting the science if the grant is funded.
• A strong hypothesis should be well-focused and testable by the Specific Aims and
planned experiments.
• Use strong verbs like identify, define, quantify, establish, determine
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Picture: Great Elmwood Science Fair

11. Specific Aims: Chance favors the prepared mind
• Get outside opinions for a fresh perspective. Is my science high priority for you?
• Discuss your draft aims with others outside your field. Do they understand your
project? Are they excited about it? Your reviewers will feel the same
• Have your application reviewed by a colleague who has been successful, or better yet,
has served on an NIH study section
• Circle back, reconsider and hone your Specific Aims continually (50% of the science)
• “Chance favors the prepared mind” (Louis Pasteur)
Picture: Authentic Journeys 11

12. Research Strategy: NIH Guidelines
• Add bold headers or an outlining or numbering system—or both—that you use
consistently throughout.
• Start each of the Research Strategy's sections with a header: Significance, Innovation,
and Approach.
• Organize the Approach section around your Specific Aims
• Your goal: present a well-organized, visually appealing, and readable description of
your proposed project. Writing should be streamlined, organized, easy to grasp
Picture: Zoltan Ducsai 12

13. Research Strategy: Significance
• Scan the review committee roster, don’t assume that all reviewers are
familiar with field
• Highlight basic biology, area importance, research opportunities, and new
findings; OK to point out significance throughout the application
• Put in context of 1) the state of your field, 2) your long-term research
plans, and 3) your preliminary data
• You are aware of opportunities, gaps, roadblocks and research under way
• How your project will fill knowledge gaps and advance the field
Picture: InstaAstro 13

14. Research Strategy: Significance
• Make the task of the reviewer easy
• Develop a consistent sequence or pattern for the discussion of the various specific
aims or hypotheses
• Carry this sequence on through the Innovation and Approach sections of the Research
Strategy
• Carefully consider the placement of tables and figures
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Picture: Pattern and design Adapted from Salusky IB

15. Research Strategy: Innovation
• Identify key areas where information is missing, and innovation is
needed to fill knowledge gaps
• Caution advisable, don’t overdo it: paradigm shifts are not for K-grants;
OK to learn and deploy new approaches/work in new areas, test
innovative ideas
• Focus the attention of the reviewer
• Make it interesting
• Sell the product
• Together, Specific Aims, Significance, and Innovation should provide
an integrated and compelling justification for the project
Picture: Bio Latin America 15

16. Approach: Key perspectives
• Map that shows your reviewers how you plan to test your hypothesis: well-
organized, visually appealing, and readable
• Lay out your experiments and expected outcomes, convince reviewers of your
likely success by allaying any doubts that you will be able to conduct the research
• 3 BIG QUESTIONS the reviewers are asking
• Can your research move you toward independence?
• Can you carry out the work?
• Is the area important—will progress make a difference to human health?
Picture: Clear path asset management 16

17. Approach
• Preliminary data is important: reviewers look for feasibility, proof of concept
that research plan can succeed
• Describe the work to be done to:
• Address each specific aim
• Test each hypothesis
• Outline how each study or experiment will address the specific aims or
hypotheses described previously
Picture: Clever hiker Adapted from Salusky IB 17

18. Approach
• Organization is important, follow a logical sequence
• Describe methods to be used
• General (overview)
• Study design
• Lab procedures
• Statistical methods
• Justify
• Specific studies or experiments
• Technical / methodological issues
Picture: VisionEdge Marketing Adapted from Salusky IB 18

19. Approach: General Methods
• Clinical project
• Study population and recruitment
• Measurement instruments
• Longitudinal follow-up
• Laboratory project
• Cell or tissue culture methods
• Specific analytical procedures
• Precision and accuracy of methods
• Previous experience
Picture: Art Lab Adapted from Salusky IB 19

20. Approach: Experimental Procedures
• Describe experiments in sufficient detail for each Specific Aim
• How they are performed
• How data to be obtained and analyzed
• Expected results
• Conclusions reached
◦ Expected findings
◦ Unexpected findings
◦ Alternative interpretations and approaches
◦ Additional studies
• Relate results and interpretation to specific aims / hypotheses
Artist: Gioacchino Passini Adapted from Salusky IB 20

21. Approach: Four Areas of Focus for Reviewers
• Premise
• Basis of prior knowledge for the proposed research
• Design
• Rigorous study design for robust and unbiased results
• Variables
• Consideration of relevant biological variables
• Authentication
• of key biological/chemical resources
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Picture: Target, Art Instt. of Chicago Adapted from Salusky IB

22. NIH Description of Premise
• What is the research that forms the basis for the proposed research
question?
• Describe the general strengths and weaknesses of prior research that is
crucial to support the application
• How will the proposed research address weaknesses or gaps in
knowledge?
• Scientific premise will be reviewed as part of Research Plan criteria
(http://grants.nih.gov/grants/peer/guidelines_general/Reviewer_Guidance_on
_Rigor_and_Transparency.pdf)
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Picture: Saatchi Art Adapted from Salusky IB

23. In other words……
• Significance
• Why is this research question important?
• Premise
• What is known from prior scientific research and what still needs to be addressed?
• Innovation
• How will the proposed research add to our scientific knowledge?
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24. Approach: Demonstrate Rigor
• “The strict application of the scientific method to ensure robust
and unbiased experimental design, methodology, analysis,
interpretation and reporting of results.”
• “Full transparency in reporting experimental details”
• Will be assessed as part of the Approach
• Elements: Study design, Appropriate controls, Replication of
experiments, Randomization, Blinding, Sample size/power,
Statistical Methods, Missing data, Confounding variables,
Selection bias
Cartoon: Huff Post Adapted from Salusky IB 24

25. Consideration of relevant biological variables
• Consideration of “critical factors affecting health or disease in
vertebrate animals or human subjects.”
• Consideration of sex as a biological variable must be addressed.
• Other biological variables: age, weight, genetic strain.
• Will be taken into account in scoring the Approach
Picture: Vistage Adapted from Salusky IB 25

26. Approach: Add Emphasis
• Create opportunities to drive your main points home, repeat your key points
• Add emphasis by using bold font/italics (underlining is so 20th century)
• Graphics add visual interest; consider decision trees (alternative plans), flowchart
• Other strategies:
• When describing a method, highlight mentor’s experience or availability of special equipment
• While explaining current status of field weave in your own/mentor’s work and prelim data
• Dive into the biology/details of the research area: helps reviewers grasp importance, understand
the field better and how your work fits into it
Picture: Emojipedia 26

27. Approach: Anticipate reviewer questions
• Is the proposed work feasible for the timeframe or too ambitious?
• Did the PI describe potential pitfalls and possible alternatives?
• Will the experiments generate meaningful data?
• Could the resulting data prove the hypothesis?
• Is the work novel or already completed by others?
Picture: @shipwreckphotography 27

28. Authentication of resources
• (Are not scored for the grant)
• Key biological/chemical resources:
• May differ from lab to lab or over time
• Could influence research data
• Integral to proposed research
• Separate attachment (1 page or less) and should not include authentication data
Picture: New Atlas 28

29. Good Luck!
Sumeet.Chugh@csmc.edu
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