Agenda:

1
NIH Grant Writing
WORKSHOP
Agenda Types of Grant Opportunities (10) Tim
Gilbertson, Biology, USU The Application Process
(20) Sponsored Programs Office, USU The Review
Process (10) Ron Gillam, Communicative
Disorders, USU What Reviewers Look For Tips
for Proposals (25) Sue Kinnamon, Colorado State
University Discussion/QA Session (25)
Thursday, Nov. 30, 2006
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Thinking beyond the R01 surviving in todays
funding environment
Grant applications arriving at the Center for
Scientific Review (pre-electronic submission)
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http//grants.nih.gov/grants/oer.htm
4
New Grant Applications and Success Rates
35
60,000
49,656
30
31
50,000
43,069
25
40,000
Projected
22
20
Number of Applications
Success Rate of Grants Funded
30,000
19
24,154
15
20,000
10
10,000
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SOURCE Dr. Elias Zerhouni, NIH
Director http//grants.nih.gov/grants/award/award.
htm
0
0
1998
1999
2000
2001
2002
2003
2004
2005
2006
2007
Success Rates
Applications
5
Research Awards
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NIH Research Project Grant Program (R01)
The Research Project Grant (R01) is the original
and historically oldest grant mechanism used by
NIH. The R01 provides support for health-related
research and development based on the mission of
the NIH. R01s can be investigator initiated or
can be in response to a program announcement or
request for application. This website is devoted
to the investigator initiated R01 application,
which means a good idea and an application, no
specific program requirements. However, the R01
research plan proposed by the applicant must be
related to the stated program interests of one or
more of the NIH Institutes and Centers based on
descriptions of their programs. All Institutes
and most Centers at NIH support the R01 grant
mechanism.

• Applicants for an R01 award are not limited in
  dollars but need to reflect the actual needs of
  the proposed project. Modular applications are
  most prevalent with modules of 25,000, up to the
  modular limit of 250,000.
• Applications are generally awarded for 1 - 5
  budget periods, each normally 12 months in
  duration.
• Applications can be renewed by competing for an
  additional project period.
• Supplements and amendments are allowed.
• Only two revisions of a previously reviewed R01
  grant application may be submitted.

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NIH Small Grant Program (R03)

• The common characteristic of the small grant is
  the provision of limited funding for a short
  period of time. Examples of the types of projects
  that ICs support with the R03 include the
  following
• Pilot or feasibility studies
• Secondary analysis of existing data
• Small, self-contained research projects
• Development of research methodology
• Development of new research technology

Institutes Centers

• Applicants for an R03 award may request a
  project period of up to two years and a budget
  for direct costs of up to two 25,000 modules or
  50,000 per year.
• Small grant support is for new projects only
  competing continuation applications will not be
  accepted.
• A doctoral student can not apply for an R03
  grant to support his/her thesis or dissertation
  research. However, support from an R03 award may
  be used to assist students as co-investigators or
  research assistants who are pursuing dissertation
  studies when the work is within the scope of the
  R03 award.
• All NIH Institutes and Centers will accept two
  revisions of a previously reviewed R03 small
  grant application.
• The Research Plan (Specific Aims, Background and
  Significance, Preliminary Studies, and Research
  Design and Methods) of an application for a small
  grant may not exceed a total of 10 pages.

Before preparing an application for an R03 grant,
all investigators should consult the list of
participating ICs as well as the IC staff listed
as contacts to determine if an R03 application is
appropriate. There is also a list of ICs that do
not accept unsolicited R03 applications.
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NIH Exploratory/Developmental Research Grant
Award (R21)
The R21 is intended to encourage
exploratory/developmental research projects by
providing support for the early and conceptual
stages of development. For example, such
projects could assess the feasibility of a novel
area of investigation or a new experimental
system that has the potential to enhance
health-related research. These studies may
involve considerable risk but may lead to a
breakthrough in a particular area, or to the
development of novel techniques, agents,
methodologies, models or applications that could
have major impact on a field of biomedical,
behavioral, or clinical research.

• You may request a project period of up to two
  years
• The combined budget for direct costs for the two
  year project period may not exceed 275,000. For
  example, you may request 100,000 in the first
  year and 175,000 in the second year to meet the
  needs of your project. Normally, no more than
  200,000 may be requested in any single year.
• All budgets should be in modular format.
• Exploratory/developmental grant support is for
  new projects only competing renewal applications
  will not be accepted.
• Two resubmissions of a previously reviewed
  exploratory/developmental grant application may
  be submitted as defined in NIH Policy at
  http//grants.nih.gov/grants/policy/amendedapps.ht
  m.
• Introduction (required for a resubmission
  application) is limited to one page.
• Items 2-5 of the Research Plan (Specific Aims,
  Background and Significance, Preliminary Studies,
  and Research Design and Methods) may not exceed a
  total of 15 pages.
• No preliminary data is required but may be
  included if available.

9
NIH Pathway to Independence (PI) Award (K99/R00)
The Pathway to Independence Award will provide up
to five years of support consisting of two
phases.  The initial phase will provide 1-2 years
of mentored support for highly promising,
postdoctoral research scientists.  This phase
will be followed by up to 3 years of independent
support contingent on securing an independent
research position.  Award recipients will be
expected to compete successfully for independent
R01 support from the NIH during the career
transition award period.  The PI Award is limited
to postdoctoral trainees who propose research
relevant to the mission of one or more of the
participating NIH Institutes and Centers
Mentored Phase of the Pathway to Independence
Award Program-K99 The total cost per year for the
initial mentored phase may not exceed 90,000
Independent Investigator Phase of the Pathway
to Independence Award Program-R00 The total cost
for the independent investigator phase may not
exceed 249,000 per year. This amount includes
salary, fringe benefits, research support
allowance and applicable FA costs.
10
Training Awards
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http//grants.nih.gov/training/careerdevelopmentaw
ards.htm
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Foundations can provide an important source of
funds to carry your research program and provide
important seed funds while you try to secure NIH
funding
a few examples
apply, apply, apply
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Grant Review Lifecycle
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USU

• Research Idea
• Preliminary Studies
• Decide on the appropriate grant mechanism
• Institute Program Officer
• Get forms from the Sponsored Projects Office
• http//www.usu.edu/research/programs/forms.cfm
• Prepare forms and submit them to the SPO

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Submission Dateshttp//grants.nih.gov/grants/fund
ing/submissionschedule.htm

• Research Grants (R01, R18)
• February 5, June 5, October 5
• Revised Research Grants
• March 5, July 5, November 5
• Other Research Grants (R03, R21)
• March 16, July 16, November 16

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Center for Scientific Review

• Officer assigns grant to an Integrated Review
  Group (e.g., BBBP) and an Institute or Center
• Assigned to a study section
• http//www.csr.nih.gov/committees/rosterindex.asp
• standing committee of about 20 scientists who
  review grants 3 times each year
• Overlap between study sections
• You may request a study section in your cover
  letter

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Notice of Assignment

• 6 weeks after submission (March 31)
• Information
• Study section
• Scientific Review Administrator (SRA)

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SRA

• Analyzes the content of the application
• Checks for completeness
• Assigns 3 reviewers
• Serves as your primary contact for pre-review
  questions

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Review Process

• Proposal sent to reviewers
• Reviewers follow guidelines
• http//www.nlm.nih.gov/ep/Reviewers.html
• Write a critique
• Assign a preliminary score

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Streamlining

• Bottom half of the scores for a given round
• Proposals are not discussed at the meeting
• Authors receive written critiques

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Review Meeting

• June 15
• Short (15 - 20 minute) discussion
• Give preliminary scores (1 - 5)
• Each reviewer summarizes his/her critique
• Questions
• Final scores
• Each member of the panel writes a score on a
  scoring sheet

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After the Meeting

• Calculate average priority score and percentile
  ranking.
• Available on NIH Commons
• June 22
• Summary statement sent in 30 days
• Written critiques
• Summary of discussion
• Recommendations

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Institute or Center

• Program Officer
• Institute or Center Advisory Committee
• September 10
• Make funding decisions
• Amount of funds available
• Institute priorities
• Inform author of funding decisions - end of
  September
• Notice of Grant Award - November

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What Reviewers Look For Tips for Proposals
Information adapted from the National Institute
of Allergy and Infectious Diseases, and the
National Institute of Neurological Disorders and
Stroke
http//www.ninds.nih.gov/funding/write_grant_doc.h
tmstrategy
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Develop a Strategy for Planning aGrant

• To begin planning your grant, start with these
  steps
• Check out the competition see which other
  projects in your field are being funded. Search
  the CRISP database
• Evaluate yourself
• How do your strengths match up with the topics
  you uncovered?
• Can you capitalize on your expertise and fill in
  any gaps with mentors, collaborators, or
  consultants?
• Find a Niche!
• Brainstorm ideas with colleagues and mentors,
  READ THE LITERATURE!!!
• 4. Give yourself plenty of time to write the
  application. Ask colleagues to critique your
  proposal!

http//crisp.cit.nih.gov/crisp/crisp_query.generat
e_screen
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Develop a Solid Hypothesis

• Your hypothesis is the conceptual foundation of
  your application. Your proposed experiments
  should specifically test your hypothesis.
• Make sure your idea is not too broad. Your
  hypothesis must be provable during your three to
  five year award with the level of resources you
  are requesting.
• Provide a rationale for the hypothesis, based on
  current scientific literature. Consider
  alternative hypotheses. Your research plan will
  explain why you chose the one you selected.
• A good hypothesis should increase understanding
  of biologic processes, diseases, treatments
  and/or preventions.
• Your proposal should be driven by scientific
  ideas, not by advances in technology (i.e., it
  should not be a method in search of a problem).
  Avoid proposing a "fishing expedition" that lacks
  solid scientific basis.
• State your hypothesis in the specific aims
  section of the research plan, the abstract, and
  many times throughout the application.

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Plan Your Application
After you've chosen your hypothesis, outline
your specific aims List your aims then list
all the experiments you'll do to support each
aim. Use graphics to plan your experiments.
Chart out the experiments with decision trees
showing alternative pathways should you get
negative results. You must discuss the
possibility of negative results and alternate
approaches in your application! Keep in mind
that your experiments support your aims, and your
aims support your hypothesis.
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Writing the research plan

• You should design your research to answer the
  question(s) posed by your hypothesis. Throughout,
  you should give enough detail to convince the
  reviewers that your application should be funded.
  Each reviewer will review your application
  according to the following criteria
• Significance
• Is your hypothesis sound and important, and will
  the results of the proposed studies have a
  significant impact on the field?
• Approach
• Are your aims are logical and feasible?
• Can you analyze and interpret the data?
• Do you understand potential problems, and offer
  alternative approaches?
• Investigators
• Do you and your collaborators have the expertise
  to carry out the research?
• Environment
• Is the environment appropriate for the proposed
  studies (equipment, facilities, etc)?

Study section video http//cms.csr.nih.gov/Resou
rcesforApplicants/InsidetheNIHGrantReviewProcessVi
deo.htm
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Parts of the NIH proposal.

• Research Plan. The heart of the proposal, which
  will be scrutinized for its scientific merit.
  This section is divided into five parts
• A. Specific Aims
• B. Background Significance
• C. Preliminary Results
• D. Research Design Methods
• E. References
• Appendix. Recent reprints and preprints of
  papers.
• Assurances. For research involving human or
  animal subjects.
• Checklist. Summary page, application type,
  yearly budget breakdown, etc.

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A. Specific Aims
This section should include

• One or two paragraphs that develop the conceptual
  framework for your proposal. These should
  describe previous studies in the area, identify
  the gaps that your research will address, and end
  with a statement of your hypothesis or overall
  objective of the proposal.
• A set of aims designed to answer the questions
  posed by the hypothesis. The important word here
  is SPECIFIC! Each aim should be a specific test
  of the overall hypothesis. Organize and define
  your aims so you can relate them directly to your
  research methods in Section D.

Other tips

• Your aims should not be contingent on each other.
  A common fatal flaw is when
• Aim 2 depends on the completion of Aim 1, etc.
  Each aim should stand alone.
• A common mistake of new investigators is being
  too ambitious-- you should
• probably limit your Aims to two or three.
• Consider re-working the Aims after you have
  written the experimental design and
• methods (Section D). You will know more about
  whether the experiments
• proposed in the aims are feasible after you
  have written Section D.

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B. Background and Significance

• Convey the significance of your research, and if
  possible, how it relates to the betterment of
  public health
• Give enough background so that your reviewers can
  understand how your proposed research fits into
  gaps in the research area. Identify the gaps and
  explain how each gap will be addressed by the
  specific aims of your proposal. These questions
  will be addressed by the experiments proposed in
  Specific Aim 2.
• A picture is worth a thousand words! Use
  pictures and diagrams to illustrate your
  important points and hypotheses. Use JPEG format
  when possible dont resave figures or you will
  lose resolution.
• Show reviewers your intimate familiarity with the
  field, referring to all relevant scientific
  literature. If you leave out an important
  reference, reviewers will assume you are not
  aware of it. Use complete citations in the text
  (e.g., Kinnamon Cummings, 1993) instead of
  numbers-- it will save your reviewers a lot of
  time looking up the references they might be
  interested in.
• Use white space. Make sure there is at least 1.5
  lines between paragraphs. No one likes to read a
  dense proposal with few pictures and no white
  space.
• Recommended length of this section is 2-3 pages

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C. Preliminary Studies/Progress Report

• By providing preliminary data, you build reviewer
  confidence you can handle the technologies,
  understand the methods, and interpret results.
  Preliminary data will help show you have the
  expertise to do the job. Recommended length of
  this section is 6-8 pages.
• Interpret preliminary results critically. Give
  alternative meanings to the data to show you have
  thought the problem through and will be able to
  meet future challenges.
• Though you may include publications of others,
  focus on your own preliminary or unpublished
  observations.
• Progress report The first part of this section
  should discuss the progress made during the
  previous period of support, if your application
  is a competing renewal. List the aims of the
  previously funded proposal (can be abbreviated)
  and describe all research, published and
  unpublished, that resulted from each aim. If an
  aim was not completed, explain what other studies
  were done in place of the aim. Looking at
  progress reports from your non-competing renewals
  can help you write this section.

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D. Research Design and Methods

• When reviewers judge your application your
  Research Design and Methods section has the most
  weight.
• This section describes the experimental design
  and procedures -- how you will perform the
  research.
• Think carefully about how to organize it. You may
  want to divide your Research Design and Methods
  section into a description of your proposed
  experiments and your methods, placing detailed
  methods in a section at the end. You dont want
  to interrupt the flow of the experimental design
  with technical details. There is no recommended
  page length to this section, though you must stay
  within the 25 page limit of the research plan
  sections A to D.
• Make clear the logical paths of experiments and
  how they progress, how they build upon each
  other, or branch out. Make sure to include paths
  that show alternatives -- what you will do if you
  get negative results. This may be the most
  common mistake that leads to an unfunded
  application.

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D. Research Design and Methods, cont.

• Make sure reviewers can find items easily, so
  organize this section to correspond to your
  specific aims.
• This part should give details (but not too
  much!) specify animals, exposure times, reagents
  and how you will get them, statistical analysis
  methods, etc.
• I usually begin this section with a restatement
  of the overall hypothesis, and a general
  description of the methods to be used, why they
  are appropriate, and the animal model and its
  appropriateness.
• Then describe the specific experiments that you
  will use to address each specific aim. Each aim
  should have the following sections
• 1. Rationale why you are proposing the
  experiments. You may have said this earlier, but
  you should remind the reviewer again here.
• 2. General experimental design for each subaim
  or experiment-- include controls and how you
  will analyze and interpret your results
• 3. Possible outcomes and interpretation--
  really important!! Specify all the possible
  outcomes of the proposed experiments and how you
  will interpret them in light of your hypothesis.
• 4. Pitfalls and alternative approaches. For
  this, mention any limitations of your approach
  and alternative methods for solving problems.
  But, do not identify any fatal flaws that you do
  not have a way to address with alternative
  approaches. Dont give the reviewers things to
  criticize! They will find enough on their own!

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D. Research Design and Methods, cont.

• Other suggestions
• When you insert figures using Microsoft Word,
  insert them into a text box that contains the
  figure legend. I use a smaller, bold font for
  figure legends.
• Cite references wherever possible. If a technique
  is well known, the citation is enough.
• You should define the criteria for evaluating the
  success or failure of an experiment
• Remember that if your proposal is highly
  innovative, you'll need to make a very strong
  case for why you are challenging the existing
  paradigm and have data to support your innovative
  approach.
• Show a timeline for experiments. And take care
  you are proposing a realistic level of work for
  the allotted time. I usually put the timeline at
  the end of Section D, before the Detailed Methods
  section.

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Literature Cited

• In this section, you'll want to refer to the
  literature thoroughly and thoughtfully but not to
  excess, listing all publications supporting your
  hypothesis and methods.
• The publication list need not be exhaustive,
  probably less than 100 of the most relevant
  citations. There is no page limit to this
  section.
• Each citation must have the names of all authors
  (not et al.), name of the book or journal, volume
  number, inclusive page numbers, and year of
  publication.
• Citations show reviewers your breadth of
  knowledge of your field. Research proposals do
  not fare well when applicants fail to reference
  relevant published research, particularly if it
  indicates that the proposed approach has already
  been attempted or the methods were found to be
  inappropriate for answering the questions you've
  posed.

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Make sure you follow all instructions
Beware NIH strictly enforces formatting
requirements and may return improperly formatted
applications! Don't risk having your application
returned because you exceeded the page limits or
used an improper font, font size, or
margins. Know your page limits -- 25 pages for
an R01, 15 pages for an R21. Only sections A-D
of the research plan count toward the page limit.
Biosketches and information about human
subjects, literature, consortium arrangements,
and consultants do not. Not only are font size
and spacing requirements strictly enforced, but
you should avoid alienating reviewers with
hard-to-read type, hard to read figures, hard to
read legends, dense text with no white space,
misspellings, etc.
Form Pages
http//grants1.nih.gov/grants/funding/phs398/phs39
8.html
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Unfunded.
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If Your Score Was Not Fundable or You Were Not
Scored

• What if you submit a grant application to NIH and
  it does not get funded? You're in good company!
  Competition has become increasingly tough, and it
  is very common not to succeed at the first
  attempt. The good news is that more people
  succeed on their second try than on their first
  and still more on their third. Over half of all
  NIH applicants eventually get funded.
• Be prepared to have to try again -- consider
  resubmission - the next logical step in the
  process. Because success falls off rapidly after
  the third try, NIH limits you to two
  resubmissions.
• When you hear the news, you'll probably feel
  angry at being rejected and may feel that some of
  the criticism from the reviewers is off the mark.
  It very well may be.
• Wait until you can address the matter calmly and
  objectively before deciding what to do next.
  Sending an angry letter to the study section or
  an institute would definitely not be productive.

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Ask Can it be fixed?

• Your unfunded application's review yielded one of
  three potential results
• Fixable problems
• Fatally flawed
• Lack of reviewer enthusiasm (boring!)
• Before you can decide what to do, you need to
  determine whether the faults are fixable and how
  appropriate the reviewers were. Spend some time
  analyzing the results and gathering as much
  feedback as you can from the summary statement.

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Common Fixable Problems
Problem Poor writing. Solution Rewrite, get
help. Problem Insufficient information,
experimental details, or preliminary
data. Solution Assess what's missing add it to
the research plan. Problem Significance not
convincingly stated. Solution Beef up that
section show importance to NIH mission, public
health. Problem Research not shown to be
feasible by the proposed staff. Solution Get
consultants with the required expertise. Problem
Insufficient discussion of obstacles and
alternatives approaches. Solution Write what
you'll do if you get negative results or an
approach doesn't pan out include decision
trees. Problem Reviewers are not interested in
the subject. Solution They are not the proper
peers request a different review.
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Not Fixable or More Difficult Problems

• Philosophical issues, e.g., the reviewers do not
  believe the work is important.
• Hypothesis is not sound or not supported by data
  presented.
• Work has already been done.
• Methods proposed were not suitable for testing
  the hypothesis.

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GOOD LUCK!