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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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