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					GRANT WRITING AND
   BUDGETING
     Marc E. Freeman, Ph.D.
 Department of Biological Science
     Florida State University
      Tallahassee, FL 32306
          850 644-3896
    HOW TO WRITE YOUR FIRST GRANT

   Nothing beats a good idea
   Be realistic
   Make the presentation clear and simple
   Make the presentation easy to read
   Present yourself as the greatest expert in
    the field
   Submit a realistic budget
         NOTHING BEATS A GOOD IDEA
   Articulate a worthwhile, single, focused
    objective
   Articulate Specific Aims that are clearly related
    to one another and logically fit under the
    umbrella of the overall objective
   Present gaps in our knowledge
   Plant the seed for achieving each specific aim
    by presenting the questions to be asked which
    will fill the gaps
                  BE REALISTIC
   Ask questions which are answerable
   Provide tantalizing preliminary data as
    evidence that the questions are worth
    asking and answerable
   Propose technical approaches which are
    within the realm of your published
    technical expertise OR provide preliminary
    data
   The volume of work proposed should be
    proportional to the time of support
    requested and your other obligations
MAKE THE PRESENTATION CLEAR AND
            SIMPLE
   Assume total ignorance on the part of the
    reviewer
   Provide all of the simplest conceptual
    background
   No abbreviations or acronyms without
    definition
   Use diagrams and cartoons to illustrate
    concepts
   Use formatting for emphasis
   Be redundant
MAKE THE PRESENTATION EASY TO READ

   Think of the reviewer
   Avoid verbosity
   Adopt a unique style of presentation
   Tell the reviewer what he is supposed to
    think and write
   Do not force the reviewer to hunt through
    the application for information
    PRESENT YOURSELF AS THE GREATEST
           EXPERT IN THE FIELD
   Know the literature in depth and breadth
   Do not make statements without
    attribution or preliminary data
   Do not be reluctant to admit shortcomings
   Seek collaborators or mentors when your
    expertise cannot be documented
      SUBMIT A REALISTIC BUDGET

   Request only what you need and you can
    defend
   Justify every item in the budget
    thoroughly
   Do not request less than you need
   Present evidence that your institution
    supports your research
           THE RESEARCH PLAN
   Specific Aims
   Background and Significance
   Preliminary Studies
   Research Design and Methods
   Human Subjects
   Vertebrate Animals
   Literature Cited
   Consortium/Contractual Arrangements
   Consultants
               SPECIFIC AIMS
   One short paragraph to identify system
   One short paragraph to describe
    regulatory steps of the system
   One short paragraph containing a one
    sentence CENTRAL HYPOTHESIS
   One short sentence stating each aim
    individually
   Follow each with a simple statement
    describing what you will do to satisfy that
    aim
                                       Research Plan
                                       Specific Aims
Prolactin (PRL) is one of the most versatile hormones of mammalian organisms.
   Besides its role in lactation, secretion of PRL contributes to a wide range of
   physiological functions, i.e. adaptation to new environment (22), immune functions
   (23) osmoregulation (24,25), reproduction (26) and behavior (27). PRL of anterior
   pituitary origin is secreted by lactotrophs (28). Lactotrophs have spontaneously high
   secretory activity, which is controlled primarily by tonic inhibitory input of
   hypothalamic origin (29), though they receive stimulatory input, as well (29-31).

The physiological PRL inhibiting factor is dopamine (DA) (32,33). DA is released from
   three, anatomically and functionally distinct hypothalamic neuroendocrine cell
   populations: I). periventricular hypothalamic dopaminergic (PHDA) neurons of the
   periventricular nucleus (A14), II) tuberohypophysial (THDA) and III)
   tuberoinfundibular (TIDA) neurons (34) of the arcuate nucleus (A12). PHDA and
   THDA neurons terminate in the intermediate and neural lobes of the pituitary gland,
   respectively (35,36). DA, released from THDA/PHDA terminals may reach the
   anterior lobe through the short portal vessels. On the other hand, TIDA neurons
   terminate in the external zone of the median eminence supplying the anterior
   pituitary gland with DA through the long portal vessels. Although the central role of
   TIDA neurons in hypothalamic control of PRL secretion is acknowledged, the relative
   contribution and importance of the distinct neuroendocrine DAergic neuron
   subpopulations to the regulation of PRL secretion is not understood.
Studies from our (37-39) and other (40-43) laboratories suggest
  that the daily activities of all three DAergic neuroendocrine
  neuron populations exhibit similar rhythmic changes (i.e. high
  in the morning, low in the afternoon). Although, the amplitudes
  of these rhythms of TIDA, THDA and PHDA populations are
  differentially modulated by ovarian steroids, the presence of
  rhythms is independent of the ovarian steroid background in
  female rats in all neuroendocrine DAergic neuron populations.
  Our CENTRAL HYPOTHESIS is that the rhythmic activity
  in all three populations of neuroendocrine DAergic
  neurons are paced by direct circadian input from the
  suprachiasmatic nucleus while its amplitude is
  modulated by interneuron-mediated input, ovarian
  steroid background, and PRL feedback from the
  pituitary gland. In this application, we will focus on the role
  of direct suprachiasmatic input, PRL feedback and signaling
  mechanisms in the generation of rhythmic patterns of DA
  release from the TIDA, THDA and PHDA by pursuing the
  following SPECIFIC AIMS:
To characterize the chronobiological and anatomical basis of regulatory
   mechanisms governing the rhythmic patterns of the DAergic input on
   PRL secretion. By conducting in vivo experiments in constant environments we
   will test whether the daily changes in the activities of neuroendocrine DAergic
   neuron populations are light entrained endogenous circadian rhythms. Tract
   tracing studies will be used to investigate the functional anatomical nature of the
   direct connection(s) between the circadian zeitgeber in the suprachiasmatic
   nucleus and the different neuroendocrine DAergic subpopulations. Antisense
   antagonism will be used to verify the functional significance of suprachiasmatic
   efferent fibers on the neuroendocrine DAergic neuron populations.
To characterize the feedback role of PRL in the daily activity of PHDA,
   THDA and TIDA neurons. The incidence of PRL-Rs in the THDA and TIDA
   neurons is higher than in PHDA neurons, although PHDA neurons also express
   PRL-R in ovarian steroid-replaced rats. We suggest that PRL feedback is
   inherently part of the THDA and TIDA neurons’ circadian regulation and it is
   inducible in PHDA neurons by ovarian steroids. In order to verify this hypothesis,
   we will compare the effects of PRL on the activity of PHDA, THDA and TIDA
   neuron populations in ovariectomized and ovarian steroid-replaced rats.
To identify the signal transduction mechanisms involved in the circadian
   regulation of the secretory activity of hypothalamic neuroendocrine
   DAergic neurons. We will identify the receptors, second messenger and cellular
   effector systems involved in mediating the effects of circadian input and PRL
   feedback on the neurosecretory activity of the PHDA, THDA and TIDA neuron
   subpopulations.
    BACKGROUND AND SIGNIFICANCE
   Provide just enough background
    information so the reviewer appreciates
    what you are proposing
   Extraneous information is distracting
   Compartmentalize information with bold
    headings, key words and sentences
   Make copious use of diagrams and cartoons
   Use a terminal sentence pointing to your
    goal at the end of each compartment
              SIGNIFICANCE
   Be imaginative
   Avoid unrealistic ideas
   Keep it simple
   Be brief
   Present in layman’s terms if possible
       PRELIMINARY EXPERIMENTS
   Present preliminary data which supports
    the feasibility of each specific aim
   Do not present preliminary data which will
    completely accomplish the specific aim
   Present preliminary data which proves you
    can use a new technique
   Present preliminary data to support your
    development and validation of a
    previously undescribed technique
      RESEARCH DESIGN AND METHODS
            GENERAL METHODS
   Present most often used methods first
    each in separate titled paragraphs
   Present in a depth which is inversely
    proportional to your published experience
    with the methods
   Cite publications in which you have used
    the methods
   Refer to the preliminary data when
    describing unpublished methods
      RESEARCH DESIGN AND METHODS
Experimental approaches to each Specific
                  Aim
   Each specific aim is its own section
   State specific aim
   State hypothesis associated with that
    specific aim
   State question(s) associated with that
    hypothesis
   Provide rationale for each question
   Describe experiments
   Expected results, interpretation,
    shortcomings and pitfalls
    OUTLINE OF A TYPICAL SPECIFIC AIM
   Specific Aim I
       Hypothesis A
                Basis of hypothesis A
                Question 1
                       Rationale for question
                       Experiment 1, 2, 3, 4……….
                Question 2
                       Rationale for question
                       Experiment 1, 2, 3, 4……….
                Experimental results, interpretation,
                shortcomings, pitfalls
       Hypothesis B………….
                HYPOTHESIS
   Each Specific Aim should be HYPOTHESIS
    DRIVEN
       May consist of more than one
            hypothesis
   Hypothesis should be defended in terms of
    the overall objectives previously stated
       Do not be afraid of redundancy with
            the Background
        EXPERIMENTAL QUESTIONS
   Each question should logically fit under
    the umbrella of its hypothesis
   The rationale for each question should
    serve to clarify the question, the necessity
    for asking the question and its relationship
    to the hypothesis
          What is to be gained by asking the
                      question?
                EXPERIMENTS
   Describe each experiment in sufficient
    detail so the reviewer can understand it
    and believe you can successfully complete
    it
       Do NOT forget controls
       Do NOT forget statistical analyses
       Explain rationale for doses and times
       Refer to previously described general
             methods
       Describe methods unique to this
             experiment
EXPECTED RESULTS AND INTERPRETATION
   State ALL expected and unexpected
    results
    State the interpretation of each
       What will you do if one of the
             unanticipated results emerge?
       Be very careful that an unanticipated
             result does not doom the
             subsequent specific
             aims/questions
SHORTCOMINGS, PITFALLS, LIMITATIONS
   What are possible alternative approaches?
       Why are you using the approach you
       are?
       Why are you not using one of the
       alternatives?
       What are the strengths and
       weaknesses of the approach you are using?
   Are there any pitfalls you foresee?
       How will you deal with them?
   What are your lab’s strengths and weaknesses?
HUMAN SUBJECTS/VERTEBRATE ANIMALS
   Follow the instructions carefully
   Verbosity with detail is good
   Be realistic about number of
    subjects/animals
   Be aware of rules governing limitations of
    use
           SUMMARY STATEMENT
   I assist the reviewer by writing my own
    summary statement as if I were the
    reviewer
          Significance, Approach, Innovation,
              Investigator, Environment
   Be brutally honest
                Strengths and Weaknesses
                   Shortcomings
   What will the project accomplish?
   What will the project not accomplish?
    CONSULTANTS/COLLABORATORS
   Use consultants for techniques that you
    intend to use for the first time
        Secure letters confirming their role
   Interest collaborators in supplying unique
    reagents that are critical to your work
        Antibodies, nucleotides, peptides
        Obtain letters of collaboration
   Have a senior level colleague with the
    greatest experience obtaining grants and
    serving on Study Sections read and
    critique the application
     YOU CAN CONTROL THE FATE OF THE
       APPLICATION BEFORE MAILING
   Review the charge and membership of the
    possible Study Sections to which it may be
    assigned
      http://www.csr.nih.gov/committees/rosterindex.asp#A


   Write a cover letter to be included in your
    application package
    Request assignment to the Study Section
                     you select
   Unfortunately the rules have
changed for grants submitted after
        January 25, 2010
 Overview of the Application
         Changes
Application forms will be revised in
three sections:
   Research Plan
   Biographical Sketch
   Resources and Facilities




                                       30
Major Changes to the Research
            Plan
   Specific Aims will include new language
    about the impact of the proposed research.
   Research Strategy will be created as a new
    section and will include 3 of the current
    sections
       Background and Significance
       Preliminary Studies/Progress Report
       Research Design and Methods




                                                 31
             New Research Plan
               Components
Introduction (1 page)
Specific Aims (1 page)
Background and Significance
                                                       Research
Preliminary Studies/Progress Report
                                                       Strategy (12
Research Design and Methods
                                                       pages)
Inclusion Enrollment Report
Bibliography (4 pages) and References Cited
Human Subjects Sections….
    protections, women/minorities, enrollment,
       children
Other Research Plan Sections….
    animals, select agents, multi PD/PI, consortium,
       support, resource sharing
Appendix

                                                                      32
        Changes to Biographical
               Sketch
   Personal Statement added:
       “Briefly describe why your experience and
        qualifications make you particularly well-
        suited for your role in the project”
   Publications revised:
       Limit the list of publications or manuscripts
        to no more than 15
       Applicant is encouraged to make
        selections based on recency, importance
        to the field, and/or relevance to the
        application
                                                   33
    Changes to Resources and
            Facilities
   Instructions added to Resources:
       Provide a description of how the scientific
        environment will contribute to the
        probability of success of the project

       For Early Stage Investigators (ESIs),
        describe the institutional investment in the
        success of the investigator




                                                  34
        Application Alignment with
              Review Criteria:
                  Major Examples
Criteria               Application
Significance           Research Strategy
                         a. Significance
Investigator(s)        Biosketch


Innovation             Research Strategy
                          b. Innovation
Approach               Research Strategy
                          c. Approach
Environment            Resources
                                           35
         A score is also given for overall
                     “impact”
   • Overall Impact is not a sixth review criterion.

   • Overall Impact is not necessarily the arithmetic mean of the scores for
    the scored review criteria.

   • Overall Impact takes into consideration, but is distinct from, the scored
    review criteria.

   • Overall Impact is the synthesis/integration of the five core review
    criteria that are scored individual and the additional review criteria which
    are not scored individually.

   • To evaluate, the reviewer(s) make an assessment of the likelihood for
    the project to exert a sustained, powerful influence on the research
    field(s) involved, in consideration of the scored review criteria, and
    additional review criteria (as applicable for the project proposed).

        o Likelihood (i.e., probability) is primarily derived from the investigator(s), approach and
         environment criteria.

        o Sustained powerful influence is primarily derived from the significance and innovation
         criteria

        o Research field(s) may vary widely, so it would be helpful if reviewers identify in their reviews
         the research field(s) they believe will be influenced by each project
                    “SIGNIFICANCE”
   • Significance is evaluated and scored independently of the
    evaluation and scoring of Investigator(s), Innovation, Approach and
    Environment.

   • The evaluation of significance assumes that the “aims of the
    project are achieved” and/or will be “successfully completed.”

        o Moreover, reviewers should evaluate the significance of the
         project within the context of a (research) field(s). For example,
         autism is a significant field of study but not all studies (projects)
         of autism are significant.

        o Research field(s) may vary widely, so it would be helpful if
         reviewers identify in their reviews the research field(s) within
         which the project addresses an important problem or critical
         barrier to progress.

        o The research field may be focused on a specific basic research
         area (enzymology) or a specific disease (e.g., autism), or may
         be more broadly defined to cut across many health issues (e.g.,
         language training, psychology).
    Overview of Shorter Page
             Limits
    Current Page Limit
                                     New Page Limit
(Section 2-5 of the Research
                                   (Research Strategy)
           Plan)

            <25                               6
             25                              12
            >25                  Follow FOA Instructions

        Note: Follow FOA page limit
     requirements if different from the
          application instructions.
            Full table of page limits available at:
                                                             38
     http://enhancing-peer-review.nih.gov/page_limits.html
        COMMON REASONS GRANT
    APPLICATIONS RECEIVE UNFUNDABLE
                SCORES
   Poor organization
    Not an integrated body of work
   Exercise in data collection
“Fishing expedition”
 Work too descriptive and not experimental

    “OK, so you showed that there is message
     for the insulin receptor on the pancreas,
                     now what?”
        COMMON REASONS GRANT
    APPLICATIONS RECEIVE UNFUNDABLE
                SCORES
   Lack of sufficient detail
   Insufficient convincing preliminary data
   Applicant not capable of performing the
    work
   Inadequate institutional support
   Objective not very important to health and
    disease
   Overly ambitious
    WHAT DO I DO IF APPLICATION IS NOT
     APPROVED FOR GRANT FUNDING?
   Find out why
    Ask SRA and Institute official
    Obtain Summary Statement
    Read Summary Statement thoroughly and
    often
    Ask a mentor to read Summary Statement
    Mentor and yourself should highlight
    issues for attention
    WHAT DO I DO IF APPLICATION IS NOT
     APPROVED FOR GRANT FUNDING?
   Re-write application
   Respond to Summary Statement by:
    Enumerating each criticism and the
    actions you propose to take
     WHAT ACTIONS SHOULD I TAKE?
   Take the criticism constructively
    No finger pointing or accusations
    Admit the reviewers were right
   Articulate your response to each
    Reorganize and simplify presentation
    Provide more detail
    Provide preliminary data in response
    Get a consultant
    Add experiments
    Eliminate experiments
    DIPLOMATICALLY point out reviewer error
         AND NOW………….
 You   can do nothing more…….

               SO……

  AWAIT THE AWARD
  NOTICE!!!!!!!

				
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