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grant writing

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Scott Paul

on 14 January 2013

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Transcript of grant writing

How to write Successful GRANTS What makes a Introduction
Preliminary Steps
Process
Structure
Rules
Final Issues GRANT Successful? “The time spent to fully conceptualize and synthesize the [grant] proposal will enhance the investigator’s ability to conduct a better study and will provide the framework for future reports of the work.” “The proposal should be innovative and exciting, and its conceptualization stimulates the investigator to develop a logical sequence for future activities.” Inouye & Fiellin. Ann Intern Med 2005; 142:274-282 PRELIMINARY STEPS INTRODUCTION Hard Work Contact this person before starting to write the grant
Prepare a “letter of intent” or “concept paper” (1-page)
Maintain contact with this person while writing the grant (NIH)
Project Officer’s endorsement does not affect your grant score (NIH)
May provide important "inside" information
(where to send, priority of institutes) Seek guidance from Program Officer or Grants Administrator Successful grants typically involve at least 12 months of preparation prior to submission (see timeline p 276 – Annals) PACE YOURSELF STEP 2 Your office of research support can obtain copies of successful grants
Freedom of Information Coordinator (NIH) (http://www.nih.gov/icd/od/foia/coord.htm)
Get copies of grants for a processing & copying fee
You may not have access to entire grant
Computer Retrieval of Information on Scientific Projects (CRISP) database
(http://crisp.cit.nih.gov) (info on PI & abstracts of funded grants) Review successful grant applications Private foundations: contact foundation for a list of recently funded grants and contact PI directly
Purpose: to determine form and structure of grant likely to be funded, avoid duplication, and gauge priorities of funding agency STEP 1 Find out as much as possible about the reviewers
on the Study Section likely to review your grant
Centers for Scientific Review Website has the names and
affiliations of everyone on the study section likely to review
your grant (http://www.csr.nih.gov/committees/rosterindex.asp)
Foundation websites have information such as members of the
board of directors, foundation staff, or advisory board members,
who review grants; for example, the Templeton Foundation (http://www.templeton.org/about_us/who_we_are/)
- Make understandable to lay reader
Review the research literature for reviewers’ areas of expertise Step 3 Homework The Center for Scientific Review has produced
a video of a mock study section meeting to provide an inside look at how NIH grant applications are reviewed for scientific and technical merit.
The video shows how outside experts assess applications and how review meetings are conducted to ensure fairness. The video also includes information on what applicants can do to improve the chances their applications will receive a positive review. http://www.csr.nih.gov/Video/Video.asp A Video on Peer Review at NIH Reviewers will be intelligent, savvy about research, and have a broad fund of scientific knowledge (NIH); but also busy, clinical researchers, reviewing proposals on “borrowed” time

Regarding foundations, well-educated scientists or lay people

Reviewers may have little in-depth knowledge about your area of expertise—especially in the area of religion and health
make significance crystal clear, but don’t overstate
avoid jargon (especially theological jargon); avoid abbrev
reviewers will not search references (don’t expect)
proposal must be completely self-contained
reviewers will spend AT MOST two hours per grant Step 4 Focus Understand the Reviewer's Perspective Communicate importance of your study’s contribution to existing body of knowledge, advancement of the field, alleviation of human disease and suffering

Should be readily apparent to people outside your field

Use quantitative terms to present the problem (90% of…)

Show innovation and creativity

Paint a clear picture of the impact of proposed study –in terms of innovation, increasing knowledge, or creating a paradigm shift Stress the SIGNIFICANCE of your study Step 5 Input from statistician at the start of the project will increase its likelihood of success, rather than bringing statistician in at last moment

study design
data analysis plans
sample size calculations Consult a Statistician Early Step 6 Obtained and follow guidelines exactly

Failure to do so may result in the grant being returned without review or having a reduced priority score

Follow requirements for documentation of IRB approval

Follow instructions regarding font size, margins, format, content

Grammatical and typographical errors bother reviewers Follow the Rules Step 7 Complete application 6-8 weeks before actual deadline

Ask colleagues and experienced investigators to preview your application –and give them at least 2-4 weeks to do so

Allow ample time to refine budgets and subcontracts

Allow ample time to obtain letters of support

Focus on submitting a high-quality application even if you must wait for a later funding deadline (NIH is 3 times per year) Allow Time for Preview and Revision Step 8 Polish conceptualize the project
contact program officer
application forms and instructions
review funding agency’s priorities
review recently funded grants
determine potential reviewers
outline then draft proposal
work with mentor and collaborators
get input from a statistician early on
review required IRB approvals
finalize budget and budget justification
request and obtain letters of support
complete full draft for review by others
write and revise abstract
revise, revise, and revise final grant Summary Grant Writing Process Grant writing is brutal business,and scary, but crucial
Should be logical, rational, and a tell story
Sections should be clear with distinct headings
Write grant using NIH model (PH 398, now SF424) (http://grants1.nih.gov/grants/funding/424/index.htm)
Templeton submission is likewise electronic
Similar format for most Funding Agencies (FA)
May submit to more than one FA at a time
Don’t fear rejections (NIH rejects 85-90%)
Learn from reviewers’ comments
If FA doesn’t provide, ask for comments
NIH allows 2 submissions (2-strike rule)
Make the first submission your best
Can take at least 12 months to get funded by NIH Miscellaneous Table of contents
Abstract *
Research team
Budget and justification
Resources and environment
Research plan (12 pages)
Specific aims *
Background and significance
Preliminary studies *
Research design and methods *
Statistical plan and power analysis
Timeline
Summary paragraph
Human subjects issues
References
Letters of support
Appendix Grant Structure Reviewers are highly sensitive to format Specific aim/hypotheses
Methods section
Preliminary studies
Abstract Important Sections WHY IMPORTANT:
Will guide the assignment of grant to particular study section (in absence of a letter)
First portion of grant that reviewers read
Must engage reviewers’ interest immediately and sustain their interest throughout HIGHLIGHT THE FOLLOWING:
Nature of the problem
Need for the research
Hypothesis to be tested (specific aims)
Methods to be used (50-70%)
Significance and relevance to public health
Unique features of the study SPECIFICS:
300-350 words (use the space)
Sentences should be short, concise, and clear
Flow of thought should be logical and progressive
Write EARLY and revise throughout the process
Many reviewers will ONLY read abstract RESEARCH Find out maximum $$ allowed
Ask for that amount
No credit for asking for less
If need less, then seek different grant type
Don’t under-fund (or over-fund more than 5%)
Reviewers are asked if budget is appropriate
Do budget with your dept business office
Salary support usually 10-30%, except…
Consultants ($5,000-10,000)
Understand “direct” vs. “indirect costs”
250K/year TC x 5 yrs (or less) for typical R01 BUDGET Justify every $ spent
Provide details (no page limit)
Follow rules
Use your grants’ specialist
Reviewers will focus on this section
Reflects experience of investigator
Process helps to avoid under/over budgeting
Describe exactly what each person will do
Explain why it will require time asked for
Justify equipment, supplies, etc. Budget Justification What kinds of resources does your research team already have to carry out this project?
Access to potential subjects or populations
Space for research personnel, equipment
Computers and other equipment
Biostatistics laboratory
Other matching resources (i.e., grant support)
AIM: Convince reviewers that your research environment is ideal for successfully carrying out the proposed study & that everything is already in place just ready to begin Resources & Environment Research Plan Research Plan Background (most commonly lacking, 41%)

Describes the PI’s (or co-investigator’s, or consultants’) previous work that is directly linked to the proposed study
PI’s, co-investigators’, or consultants’ names should be included in the references that are provided of previous work
The PI must convince the reviewers that:
- he or she has the experience/expertise to do the work
- the work is feasible
- suitable groundwork for proposed study has been done Preliminary studies should demonstrate: experience with the proposed methods, i.e., design, intervention, assessment tools, enrollment strategies, availability of subjects

Here, more is better—but only if can be directly linked to proposed project The preliminary study section shows:

Evidence of your past successes
Evidence of your team’s past successes
Evidence that your team can work together
Evidence that necessary resources in place
Evidence of access to populations to study
Evidence of ability to conduct research
Evidence of ability to publish results, and…
Convinces reviewers that this project is the natural next step in your research area Preliminary Studies TRACK RECORD Common complaints:
pilot work is lacking
pilot work is in adequately described
no clear linkage to proposed study Experience Matters Summary
describe in detail and standardize (manualize)
describe well enough so that intervention can be replicated in other settings
describe those doing the intervention, their credentials, and training required
convince reviewers that intervention is sufficiently strong to have an effect
describe plan on how to monitor adherence
describe methods of maintaining quality assurance for interventionists (fidelity)
convince reviewers that randomization or un-blinded administration of intervention will not lead to potential biases
describe how you will address contamination and co-interventions OUTCOMES Intervention Studies described procedures in detail
describe variables and instrument reliability and validity
discuss alternative instruments and why you chose the ones you did
list all variables in a table (see examples p W-32. W-33 of Annals)
outline screening and enrollment procedures
outline assessment and follow-up procedures
described interviewer training and standardization
describe plan to assure the quality of the data
fully describe and define
ensure adequate blinding of assessment (how achieved & maintained)
ensure outcome measures are valid & reliable (especially important) DATA COLLECTION Section includes data management procedures, analytic approach, and sample size calculations
Data management procedures involve double entry of data, error and validity checks, training of staff who handle data
Don’t write this section yourself
Statistical language very important
Describe the analysis for each specific aim (SA)
Provide separate section & heading for each SA
Spend most attention on SA #1
Describe and cite methods of analysis
Don’t become locked into using a single statistical method
Describe alternative methods & why chose the one you did
Describe how confounders will be handled
Provide power analysis for SA #1
Provide table with size of sample, size of effect, and power (called a sensitivity analysis)
Describe how losses to follow-up will be handled
Describe how missing data will be handled Statistical Plan and Power Analysis Most Common Complains
Insufficient description of analytic approach
Lack of intention-to-treat analytic strategy (patients analyzed in the groups to which they were randomized)
Inadequate control for potential con founders
Insufficient description of handling missing data
Failure to consider dropouts Statistical Plan (continued) Time 0 – grant begins
Time for training of personnel
Time for recruitment of subjects
Intervention or observation period
Time for follow-up of all subjects
Time for cleaning of data
Time for statistical analysis
Time for writing up results & submission
Ends your research plan1 TIMELINE Provide a figure (visual) of your timeline Discuss the strengths and weaknesses of the proposal
Discuss how the weaknesses will affect the validity or interpretation of the results
Convince reviewers that the limitations will not invalidate the results
Discuss the implications of the work Ending Summary Paragraph Explain risks and dangers
of intervention (potential side-effects)
of observing & not treating (controls)
of diagnosing & not treating in observational study
Explain benefits of the study
Explain how benefits outweigh risks
Explain precautions taken to minimize risk (e.g., suicide for studies of depression)
Data safety monitoring board (interventions)
IRB focuses on these things
IRB “pending” usually adequate (for NIH), but…
Gender/minority/children issues Human Subjects Considerations References
Should be up to date, including recent ones
Classic references
2000 and more recent
Not included in 12-page limit for research plan
No page limit, but must be relevant & current
Follow reference format Appendices
Avoid use of appendices
The grant should stand alone
Appendices should only provide supporting materials (questionnaires)
Reviewers may not receive and usually don’t read the appendices Make the grant easy to read (have it reviewed by an English teacher if possible)
well-organized
outline, outline, outline
give them what they expect (length, outline, detail)
Make it easy to scan / selectively read
table of contents
easy subject headings
lots of white space
Plain and direct style of writing -- simple sentence construction
Anticipate every question, critique
explain why you chose particular procedure, questionnaire
provide alternative ways of approaching subject and why you chose the one you chose for limitations that cannot be overcome, describe how you will address
Review checklist for grant-writing process
(p 279 Annals article –extremely helpful) RULES of THUMB Annals of Internal Medicine article on grant writing (Ann Intern Med. 2005;142:274-282)
Grant Application Writer’s Handbook
- 4th edition by Liane Reif-Lehrer, 2004
- $35 on Amazon.com (used)
NIH grant writing tutorial http://www.niaid.nih.gov/ncn/grants/default.htm Key Grant Writing Resources You can do it! Be crystal clear about application deadlines
Know where to send application & how
Include letter with instructions on institute at NIH you’d like proposal reviewed by
May assign to more than one institute to fund (for NIH grants)
Don’t be discouraged or overwhelmed; just take one piece at a time and do it well Finally Take your best shot! Questions about Grant writing

(till 12:00) Get to Know Your Audience Research Plan - preliminary studies Also called “key personnel”
Principle investigator (PI)*
Co-investigators (2-4)
Statistician (1)
Consultants (1-4) (support letter from each)
Need 2 page biosketch & other support pages for each member of research team
Research personnel (staff) not included here *For NIH grants, may have more than one PI, especially if at a different institution RESEARCH TEAM Concise, accurate summary
study design
sample size
study groups (or sample)
primary outcomes Research Plan First Paragraph Comes right after first paragraph summary
Maximum 3-4 aims (3 ideal)
Get input from mentors, colleagues, collaborators
1st one must sell grant
2ndary aims must naturally flow from 1st
Include 2-3 sentence description for each
State a hypothesis for each aim
Make simple, clear, short (see examp p W31, Annals)
Most common complaints by reviewers:
-poorly focused
-underdeveloped
-overly ambitious Specific Aims Provide current state of knowledge, show how your project builds on previous work, identify gaps in knowledge (but be careful with criticism)
Focus on specific aims and need for proposed study
Provide theoretical framework (describe model w figures) – do for all grants but especially for HSR and nursing
Tell a story, with the conclusion that your study is the next logical, most important step necessary to advance the field
Must be convincing that your study is innovative and represents a substantial contribution
Reviewers pay less attention to this section
No more than about 25% of research plan
COMMON COMPLAINS: did not justify need for study, too much extraneous background information, overstated significance For each area covered in background section explicitly state its relationship to your study
Have a “significance” paragraph at the end of the background section to (1) summarize the current status of the work in the field and (2) explain how your project will make the next key contribution that is needed
In strong but realistic terms, specify how proposed project will contribute to field-- but do not overstate significance
Note: Depending on funding agency, may require that background section be integrated throughout the proposal Background (continued) Preliminary studies should demonstrate: experience with the proposed methods, i.e., design, intervention, assessment tools, enrollment strategies, availability of subjects

Here, more is better—but only if can be directly linked to proposed project Common complaints:
pilot work is lacking
pilot work is in adequately described
no clear linkage to proposed study Experience Matters
DESIGN AND SETTING
observational study, clinical trial, qualitative
what kind of setting (community, outpatient, inpatient)

SAMPLE
how select – describe method (random, advertise, etc.)
outline inclusion criteria, and justify them
NIH requires inclusion of women, minorities, & children
outline exclusion criteria, and justify them (since may introduce important biases)
explain potential biases that may invalidate study results or affect applicability to more general samples
explain how you will handle biases
assure availability of adequate numbers of subjects (with letters of support); best evidence is from previous pilot work 2nd most important part of grant, after Specific Aims
The “heart” of the grant
Should make up at least 50% of 25 pages
After inadequate preliminary studies, most common
criticism was that methods were underdeveloped
Describe procedures from A-Z in detail
Explain every aspect of logic (don’t assume) METHODS and PROCEDURES Preliminary studies (continued) The preliminary studies section shows:

Evidence of your past successes
Evidence of your team’s past successes
Evidence that your team can work together
Evidence that necessary resources in place
Evidence of access to populations to study
Evidence of ability to conduct research
Evidence of ability to publish results, and…
Convinces reviewers that this project is the natural next step in your research area WHY IMPORTANT:
Will guide the assignment of grant to particular study section (in absence of a letter)
First portion of grant that reviewers read
Must engage reviewers’ interest immediately and sustain their interest throughout ABSTRACT HIGHLIGHT THE FOLLOWING:
Nature of the problem
Need for the research
Hypothesis to be tested (specific aims)
Methods to be used (50-70%)
Significance and relevance to public health
Unique features of the study SPECIFICS:
300-350 words (use the space)
Sentences should be short, concise, and clear
Flow of thought should be logical and progressive
Write EARLY and revise throughout the process
Many reviewers will ONLY read abstract Background Focus - Concise - Conceptually clear
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