NIH Mentored Career Development Awards K Series Part 4

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NIH Mentored Career Development Awards (K Series)
Part 4

• Thomas Mitchell, MPH
• Department of Epidemiology Biostatistics
• University of California San Francisco

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Research Plan

• A. Specific Aims
• B. Background and Significance
• C. Preliminary Studies
• D. Research Design and Methods

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C. Preliminary Studies

• This section may consist of your own
  publications, publications of others (on your
  team), as well as unpublished data of yours or
  others.
• When using results from others, make sure it is
  clear which data are yours and which emanated
  from others.
• Suggested length 2-4 pages.

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Preliminary Studies(contd)

• Style This section can be more detailed and
  technical than the Specific Aims and Background
  Significance sections.
• However, it may be read by all reviewers, so
  technical jargon and acronyms should be avoided.
• Function Demonstrates technical competence of
  research team (i.e., you have the expertise and
  competence to accomplish the specific aims you
  have proposed).

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Preliminary Studies(contd)

• By giving examples of relevant research you have
  conducted, this extremely important section helps
  build confidence that you can
• handle the technologies
• understand the methods
• interpret the results
• and, thus, are able to achieve the aims you
  propose.

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Preliminary Studies(contd)

• Interpret preliminary results critically.
• Give alternative meanings to the data to show
  youve thought the problem through and will be
  able to meet future challenges.
• If you dont do this, the reviewers will!
• Tell them how your early work is relevant to and
  prepares you for the new project.
• See Examples 1, 2, and 3.

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D. Research Design and Methods

• Suggested length 10 pages (or approximately
  one-half the length of the research plan).
• Organization and common subsections
• See Examples 4 and 4a.
• Overview of study design
• Describe the experimental design and procedures
  in detail and give a rationale for their use, if
  needed.

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Research Design and Methods(contd)

• In many instances, you may have struggled with a
  crucial design question and arrived at a
  satisfactory solution.
• Dont just present your solution.
• The reviewers may wonder why you chose a
  particular route.
• Therefore, you should provide a rationale for
  your decision and discuss the rejected
  alternatives.

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Research Design and Methods(contd)

• Study population
• Eligibility criteria
• Provide rationales for inclusion and exclusion
  criteria
• (see Example 5).
• Provide rationales for control groups.
• Subject recruitment, enrollment, and retention.
• Describe sources of eligible subjects.
• Describe methods for identifying contacting and
  enrolling subjects, including obtaining informed
  consent.

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Research Design and Methods(contd)

• Study procedures provide an overview of the
  following
• Number of study visits
• Where study visits will take place
• Type of data that will be collected
• Who will collect data or perform procedures
• Where specimens will be stored/analyzed

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Research Design and Methods(contd)

• Study measurements
• Organize and categorize them by
• Specific Aim, or
• How they will be used analytically
• predictor variables
• outcome variables
• confounding variables
• Provide rationales for your choice if several
  options are available.
• Limit the amount of technical detail.

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Research Design and Methods(contd)

• Data quality and management
• Issues that could be included
• Staff training
• Quality audits
• Missing data
• Data analysis
• Hypothesis testing
• Sample size calculations
• Expected findings
• Data interpretation

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Research Design and Methods(contd)

• Potential problems and alternative approaches
• Openly recognizing any inherent holes or pitfalls
  in your research plan can show maturity.
• It is entirely appropriate to acknowledge
  weaknesses and to present alternative plans.
• It is a common and costly mistake to leave this
  kind of information out of your research plan.
• Timeline Indicate when each specific aim will be
  implemented and completed.
• Emphasize feasibility of accomplishing all
  specific aims within the timeframe and resources
  requested (see Example 6).

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AbstractProject Summary and Relevance

• Provide an abstract of the whole application
• Include description of the candidates immediate
  and long-term career goals, training plan,
  mentoring team, and research project.
• Using no more than 2 or 3 sentences, describe the
  relevance of your research to public health.
• Be succinct and use plain language that can be
  understood by a general, lay audience.
• See Example 7.

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Human Subjects Research

• A part of the peer review process will include
  careful consideration of protections from
  research risks for study participants, as well as
  the appropriate inclusion of women, minorities,
  and children (see Example 8).
• The study section will assess the adequacy of the
  safeguards of the rights and welfare of research
  participants and the appropriate inclusion of
  women, minorities, and children.
• Evaluation of the inclusion plans will be
  factored into the overall score for scientific
  and technical merit.

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Budget Issues

• Mentored K awards provide salary support for the
  candidate (usually 75,000/year) plus 25,000 to
  50,000/year to cover the costs of the proposed
  training and research.
• The amount of salary support and funds for
  research/training differ by institute.
• You may not receive salary support from federally
  funded sources in Years 1 3 of the K award,
  although you may be a principal investigator on
  your own R01, R03, or R21 during the K award.

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Budget Issues (contd)

• A detailed, itemized budget is not required by
  NIH, although you do have to provide a
  justification if you are requesting more than
  25,000/year for research/training expenses.
• See Example 9.
• An itemized, detailed budget, however, is
  required for internal review by UCSF, although it
  is not included in the grant application
  submitted to NIH .

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Biosketches

• This section must include the biographical
  sketches of all Key Personnel and Other
  Significant Contributors.
• For the candidate only, the section on
  Publications must be divided into the following
  categories
• Original research
• Non-experimental articles (e.g., literature
  reviews, book chapters)
• Books, pamphlets, etc.

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Resources

• Describe the facilities used to conduct the
  research (see Examples 10 and 11).
• Indicate performance sites and describe
  capacities, pertinent capabilities, relative
  proximity, and extent of availability to the
  project.
• If research involving Special Agents will
  occur, the biocontainment resources available at
  each site should be described.

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Task List

• Develop a list of all components of your grant
  application package, including those required by
  the UCSF Office of Sponsored Research (OSR).
• See Example 12.
• Indicate who is responsible for completing each
  component.
• Develop this list in collaboration with your RSA
  (research support analyst), who will help you
  compile the grant application for submission to
  the OSR and NIH.