Transcript Document

NIH Mentored Career Development
Awards (K Series)
Part 4
Thomas Mitchell, MPH
Department of Epidemiology & Biostatistics
University of California San Francisco
Writing a competitive mentored
K award grant application
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Main sections of the grant application:
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The Candidate
Statements by Mentors, Co-Mentors, and Collaborators
Description of Institutional Environment
Institutional Commitment to Candidate’s Research Career
Development
Research Plan
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Specific Aims
Research Strategy
 Significance
 Innovation
 Approach
Research Strategy
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Significance: The positive effect that successful completion of your
research project is likely to have by solving an important, NIHrelevant problem.
Innovation: A new and substantially different way of addressing an
important, NIH-relevant problem, which enables departure from the
status quo.
The purpose of the Significance and Innovation subsections is to
help justify the need for what is proposed.
In writing these subsections, keep in mind that you are writing for a
general audience that is “uninformed (about your topic) but
intelligent,” so you should write this section in non-technical
language.
Suggested length: Ideally, both subsections combined should not be
longer than 1 page.
Significance
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The Significance subsection 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.
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This is where you include some of the material that used to be in
the “Background” section, which substantiates and validates that
there is an important problem.
Explain why its continued existence represents an
important problem that must be resolved.
Significance
(cont’d)
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Describe the contribution you expect to make.
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Example: “The proposed research will contribute to our
knowledge of the effects of mail order pharmacy by assessing
whether mail order use is associated with improved patient
safety, appropriate services utilization, and clinical outcomes in
diabetes patients.”
Write a simple, direct statement regarding why the
expected contribution is important.
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Example: “This contribution will be significant because
understanding the effects of mail order pharmacy use on patient
safety and clinical outcomes will help health systems design safe
and efficient medication delivery systems with the potential to
improve CVD-related outcomes in diabetes patients.”
Significance
(cont’d)
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Describe the positive impact your contribution will have.
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How will your contribution enable subsequent thinking and
research?
If applicable, call attention to decreased mortality/morbidity,
improvements in the quality of life or medical outcomes,
reduction in cost of medical care, etc.
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Example: “Improved medication adherence through mail order
pharmacy use has the potential to decrease CVD-related
hospitalizations and deaths in diabetes patients. Through a full
assessment of the risks and benefits of mail order pharmacy use,
we can gain important knowledge on how to potentially improve and
expand the use of mail order pharmacy services.”
Innovation
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Innovation: A new and substantially different way of
addressing an important, NIH-relevant problem, which
enables departure from the status quo.
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Examples: Challenging existing paradigms, testing novel
hypotheses, using newly developed state-of-the-art
measurements.
Provide the context (with citations from the literature) so
reviewers will be able to understand how your project is
innovative.
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For example, if you plan to assert that innovation stems from a
new approach that you will take, you need to support that claim
with discussion of previous approaches and why they were
unsatisfactory.
This is another place where you include material that was
previously in the “Background” section.
Innovation (cont’d)
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Write a statement that begins with the phrase,
“The proposed research is innovative
because…..”
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Complete this sentence by stating what objectively
sets your project apart, such as a different approach
you are taking or a different technology you have
created, compared to past investigators.
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Example: “The proposed research is innovative because it
addresses the potential of a healthcare system-level factor –
in this case, the provision of mail order pharmacy service –
rather than patient-level or provider-level factors to improve
patient adherence to medications. “
Innovation (cont’d)
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Describe the positive impact that will result from
your innovative approach.
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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.
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Example: “Many researchers and policy makers have lamented that
the field of medication adherence research is “stuck” with few good
options for moving forward. 3-5 Research that comprehensively
assesses the impact of system-level interventions such as mail
order pharmacies can significantly advance the field of structural
interventions to improve patient health.”
Approach
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NIH guidelines for this section
 Describe the overall strategy, methodology, and
analyses to be used to accomplish the specific aims
of the project.
 Discuss potential problems, alternative approaches,
and benchmarks for success anticipated to achieve
the aims.
 If the project is in the early stages of development,
describe any strategy to establish feasibility and
address the management of any high-risk aspects of
the proposed work.
 For new applications, include information on
Preliminary Studies as part of the Approach section.
Approach (cont’d)
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Organization of this section: 2 approaches
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“Modular” approach
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Each Aim:
 Introduction
 Background
 Preliminary Studies
 Research Design
 Expected Outcomes
 Potential Problems & Alternative Approaches
Timeline
Future Directions
Approach (cont’d)
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“Unitary” approach
 Introduction
 Background
 Preliminary Studies
 Research Design
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Study design
Study population
Study procedures
Study measurements
Data quality and management
Data analysis
Expected Outcomes
Potential Problems & Alternative Approaches
Timeline
Future Directions