Significance & Innovation
Dawn M Elliott, PhD
BIOMEDICAL ENGINEERING
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
BIOMEDICAL ENGINEERING
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?
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Significance
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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
B I O M E D I C5A L E N G I N E E R I N G
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
B I O M E D I C6A L E N G I N E E R I N G
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
BIOMEDICAL ENGINEERING
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….”
BIOMEDICAL ENGINEERING
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
B I O M E D I C9A L E N G I N E E R I N G
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
BIOMEDICAL ENGINEERING
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?
B I O M 11
EDICAL ENGINEERING
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
BIOMEDICAL ENGINEERING
Innovation
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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
BIOMEDICAL ENGINEERING
Think Broadly about Innovation
• New mechanistic hypothesis
• New combination of expertise (unusual multidisciplinary 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
B I O M E D I C15
AL ENGINEERING
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?
B I O M E D I C16
AL ENGINEERING
Example from my (funded) grant
• 1/3 page
• Bulleted list
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Another example from (funded) grant
• 1st 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 stressstrain fields noninvasively, especially at tears,
provides capabilities not previously achieved.
BIOMEDICAL ENGINEERING
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
B I O M E D I C19
AL ENGINEERING
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.”
B I O M E D I C20
AL ENGINEERING
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
B I O M 21
EDICAL ENGINEERING
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
BIOMEDICAL ENGINEERING
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)
B I O M E D I C23
AL ENGINEERING
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
BIOMEDICAL ENGINEERING