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Mentored Career Development Awards K series (PowerPoint)

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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
            Research Plan
A.   Specific Aims
B.   Background and Significance
C.   Preliminary Studies
D.   Research Design and Methods
            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    your team), as well as unpublished data of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.
               Preliminary Studies
                            (cont’d)

   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).
              Preliminary Studies
                         (cont’d)

   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.
               Preliminary Studies
                          (cont’d)

   Interpret preliminary results critically.
   Give alternative meanings to the data to
    show you’ve thought the problem through
    and will be able to meet future challenges.
       If you don’t 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.
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.
    Research Design and Methods
                         (cont’d)

   In many instances, you may have
    struggled with a crucial design question
    and arrived at a satisfactory solution.
       Don’t 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.
    Research Design and Methods
                                  (cont’d)

   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.
    Research Design and Methods
                         (cont’d)

   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
    Research Design and Methods
                               (cont’d)

   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.
    Research Design and Methods
                              (cont’d)

   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
    Research Design and Methods
                            (cont’d)

   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).
                          Abstract
           Project Summary and Relevance

   Provide an abstract of the whole application
       Include description of the candidate’s 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.
         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.
                      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.
            Budget Issues (cont’d)
   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 .
                       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.
                     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.
                          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.

								
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