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Approach
(Basic Science)
Scott G. Filler, M.D.
Lundquist Institute for Biomedical Innovation
at Harbor-UCLA Medical Center
sfiller@ucla.edu
Approach: Review Criteria
• Are the overall strategy, methodology, and analyses
well-reasoned and appropriate to accomplish the
specific aims of the project?
• Have the investigators included plans to address
weaknesses in the rigor of prior research that serves
as the key support for the proposed project?
• Have the investigators presented strategies to ensure
a robust and unbiased approach, as appropriate for
the work proposed?
Approach: Review Criteria
• Are potential problems, alternative strategies, and
benchmarks for success presented?
• If the project is in the early stages of development,
will the strategy establish feasibility and will
particularly risky aspects be managed?
• Have the investigators presented adequate plans to
address relevant biological variables, such as sex, for
studies in vertebrate animals or human subjects?
Approach--Overall Layout
• Preliminary data
• Aim 1
o Rationale and overall approach
o Experimental methods
o Anticipated results
o Alternative outcomes (potential pitfalls)
o Future directions
• Aim 2
o Rationale and overall approach
o Experimental methods
o Anticipated results
o Alternative outcomes (potential pitfalls)
o Future directions
Approach--Alternate Layout
• Aim 1
o Preliminary data
o Rationale and overall approach
o Experimental methods
o Anticipated results
o Alternative outcomes (potential pitfalls)
o Future directions
• Aim 2
o Preliminary data
o Rationale and overall approach
o Experimental methods
o Anticipated results
o Alternative outcomes (potential pitfalls)
o Future directions
Preliminary Data
• Present compelling preliminary data
o Supports premise of the work
o Demonstrates feasibility
o Sparks interest, but leaves reviewer wanting to learn more
• Potential pitfalls in preliminary data
o Clear weaknesses
o No statistical analysis
o Supports alternative hypothesis
Approach
• Describe overall approach and the controls
• Only mention key details
• Need power calculations for animal studies
o Many details of animal studies can be move to
Vertebrate Animals section
• Address sex as a biological variable
Approach
• Rigor and Transparency
o Strong scientific premise (Significance)
o Scientific rigor (Approach)
• Blinding, sample size, reducing bias
o Consideration of relevant biological variables, such as
sex (Approach)
• Include animals of both sexes if feasible
o Authentication of key biological and/or chemical
resources (separate page)
Approach
• Potential pitfalls
o One aim depend on another *
o Excessive detail
• Detracts from overall message
• Target for criticism
o Densely written prose
“If reading a grant gives the reviewer a headache, that
grant is unlikely to receive a good score”
Anticipated Results and
Potential Pitfalls
• What do you think the results will be?
• Creativity and flexible thinking very important
• Interesting alternative outcomes
• What if hypothesis is not supported?
• Never present a potential pitfall for which you
don’t have a good solution
Future Directions
• Where is your research going?
• What will be its impact?
• How can the specific information learn
be applied to a broader question?

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How to Structure the “Approach” Section of a Grant Application (Filler 2020)

  • 1. Approach (Basic Science) Scott G. Filler, M.D. Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center sfiller@ucla.edu
  • 2. Approach: Review Criteria • Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? • Have the investigators included plans to address weaknesses in the rigor of prior research that serves as the key support for the proposed project? • Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed?
  • 3. Approach: Review Criteria • Are potential problems, alternative strategies, and benchmarks for success presented? • If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? • Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?
  • 4. Approach--Overall Layout • Preliminary data • Aim 1 o Rationale and overall approach o Experimental methods o Anticipated results o Alternative outcomes (potential pitfalls) o Future directions • Aim 2 o Rationale and overall approach o Experimental methods o Anticipated results o Alternative outcomes (potential pitfalls) o Future directions
  • 5. Approach--Alternate Layout • Aim 1 o Preliminary data o Rationale and overall approach o Experimental methods o Anticipated results o Alternative outcomes (potential pitfalls) o Future directions • Aim 2 o Preliminary data o Rationale and overall approach o Experimental methods o Anticipated results o Alternative outcomes (potential pitfalls) o Future directions
  • 6. Preliminary Data • Present compelling preliminary data o Supports premise of the work o Demonstrates feasibility o Sparks interest, but leaves reviewer wanting to learn more • Potential pitfalls in preliminary data o Clear weaknesses o No statistical analysis o Supports alternative hypothesis
  • 7. Approach • Describe overall approach and the controls • Only mention key details • Need power calculations for animal studies o Many details of animal studies can be move to Vertebrate Animals section • Address sex as a biological variable
  • 8. Approach • Rigor and Transparency o Strong scientific premise (Significance) o Scientific rigor (Approach) • Blinding, sample size, reducing bias o Consideration of relevant biological variables, such as sex (Approach) • Include animals of both sexes if feasible o Authentication of key biological and/or chemical resources (separate page)
  • 9. Approach • Potential pitfalls o One aim depend on another * o Excessive detail • Detracts from overall message • Target for criticism o Densely written prose “If reading a grant gives the reviewer a headache, that grant is unlikely to receive a good score”
  • 10. Anticipated Results and Potential Pitfalls • What do you think the results will be? • Creativity and flexible thinking very important • Interesting alternative outcomes • What if hypothesis is not supported? • Never present a potential pitfall for which you don’t have a good solution
  • 11. Future Directions • Where is your research going? • What will be its impact? • How can the specific information learn be applied to a broader question?