How to Write a Successful

1
Dr. Frank Waxman 655 Research Parkway, Ste.
200 Oklahoma City, OK 73104 405.225.9459 F
405.225.9230 fwaxman_at_osrhe.edu

• How to Write a Successful
• NIH Grant Application
• Oklahoma State University
• March 3, 2004

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• What is NIH?
• Begun as a one-room Laboratory of Hygiene in
  1887.
• NIH is the steward of medical and behavioral
  research for the Nation. Its mission is science
  in pursuit of fundamental knowledge about the
  nature and behavior of living systems and the
  application of that knowledge to extend healthy
  life and reduce the burdens of illness and
  disability.
• FY 2004 Budget of about 28 billion.

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• NIH Organization
• NIH is comprised of 27 Centers and Institutes
  (ICs)
• Institutes and Centers are mission oriented, for
  example
• National Cancer Institute
• National Eye Institute
• National Heart, Lung, and Blood Institute
• National Human Genome Research Institute
• National Institute on Aging
• National Institute of Allergy and Infectious
  Diseases
• National Institute of General Medical Sciences

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• Does NIH Easy Money?
• In FY 2002, NIH received gt 30,000 applications
• 31 were funded

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Mechanisms of Support Grants for health-related
research and research training projects or
activities make up the largest category of
funding provided by the NIH. Research project
grants are awarded for terms ranging from one to
five years to institutions on behalf of a
principal investigator when the idea for the
research is initiated by the investigator and the
funding institute anticipates no substantial
program involvement. Institutional sponsorship
assures that the awardee organization will
provide the facilities and the financial
stability necessary to accomplish the research,
and be accountable for the funds. Support may be
requested for research or training.
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Mechanisms of Support Cooperative Agreements are
similar to grants in that they are awarded to
assist and support research and related
activities. However, they differ from grants in
that the awarding institute or center has
substantial involvement in carrying out the
project's activities. The awarding institute
typically issues a specific request for
applications (RFA) describing the program,
functions, and activities as well as the nature
of the shared responsibilities. Most
applications for support are unsolicited.
Occasionally, to hasten the development of a
program or to stimulate submission of
applications in an area of high priority or
special concern, an institute will issue a
Program Announcement (PA) to describe new,
continuing, or expanded program interests, or
issue an RFA inviting grant applications to
accomplish a scientific purpose.
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Mechanisms of Support Research and development
(RD) contracts are awarded to academic
institutions and other non-profit and commercial
organizations to procure specific activities for
scientific inquiries in particular areas of
research and development needed by the NIH.
Contract performance is monitored closely by the
NIH staff to ensure accomplishment of the
research goals.
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Getting Started Think. What do you want to do?
Do you have an adequate foundation of
preliminary data to launch a grant application?
Outline three or four concise specific aims.
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Getting Started Forget about it. Find
something else to do for awhile.
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Getting Started Planning Now, think about it
again. Assess your field. Do you want to go it
alone or are there opportunities for
collaborating with a known laboratory or more
experienced grantee? Check out the competition
see which other projects in your field are being
funded. Search the NIH CRISP database
(http//crisp.cit.nih.gov). Evaluate yourself
How do your strengths match up with the topics
you uncovered in CRISP? Can you capitalize on
your expertise and fill in any gaps with mentors,
consultants or collaborators? Figure out what
resources and support your organization has and
what other support you'll need.
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More Planning Find two colleagues. One should
be dead-on in the discipline that is the topic of
your nascent grant application. The other
should be generally conversant with the field,
but not an expert in the subject area of your
planned application. Both should be experienced
NIH grantees. At least one should be on your
campus.
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Planning with Colleagues Now, talk with both of
them about your ideas for an NIH grant
application. Ask them if they will share a
successful NIH grant they have written. Show them
your specific aims. Show them your recent peer
reviewed publications that are relevant to the
subject matter of your proposed application (some
reviewers look at your pubs first, if they dont
like the quality and quantity, they wont pay
serious attention to your application). True
colleagues will be critical as well as being
supportive. Dont be thin skinned! Dont be
reluctant to revise your plans as needed.
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Planning with NIH See if your proposal matches
any specific initiatives at an NIH
institute. Call a Program Officer about NIH for
an opinion of your idea. Look at the receipt
dates for new applications. Give yourself plenty
of time to prepare your application, probably
three to six months.
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Preparing Your Application Your application has
two audiences the majority of reviewers who will
probably not be familiar with your techniques or
field and a smaller number who are. To succeed
in peer review, win over the primary reviewers,
who will act as your advocates in guiding the
discussions. Peer reviews work this way because
time is limited and discussions are short.
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Preparing Your Application Your objective is to
write and organize your application so the
primary reviewers can readily grasp and explain
what you are proposing. During the discussion of
your application during peer review, the other
reviewers will ask the primary reviewers
questions about your application, and they'll
also skim it during that time (and possibly
before the meeting as well). Most likely, they
will read only your abstract, significance, and
specific aims. But all reviewers are important
because each reviewer gets one vote.
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Reviewer Psychology To keep reviewers on your
side, make your application super user friendly.
Label all materials clearly. Make it easy for
reviewers to find information. Keep it short and
simple. Start with basic ideas and move
progressively to more complex ones. State the key
points directly, and write basic concepts as
nontechnically as possible. You may want to use
Scientific American as a model for the level of
writing to use for your nontechnical parts. Guide
reviewers with graphics. A picture is worth a
thousand words, probably more. Graphics can help
reviewers grasp a lot of information quickly and
easily, and they break up the monotony of
hundreds of pages of text each reviewer contends
with. Edit and proof. Your presentation can also
make or break your application. Though reviewers
assess science, they are also influenced by the
writing and appearance of your application. If
there are lots of typos and internal
inconsistencies in the document, your score can
suffer.
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Develop a Template a. Specific Aims  Aim 1 Aim
2 et cetera  b. Background and
Significance  c. Preliminary Studies
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Develop a Template d. Research Design and
Methods   Aim 1 Rationale and
Design Pitfalls and alternative
strategies Detailed methods   Aim
2 Rationale and Design Pitfalls and
alternative strategies Detailed methods  et
cetera
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• Develop a Template
•  F. Human Subjects
•  
• G. Vertebrate Animals
•  
• H. Literature Cited
•  
• Appendix
•  

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Be the Master of PHS Form 398 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 application. See
PHS 398 for others. Not only are font size and
spacing requirements strictly enforced, but you
should avoid alienating reviewers with
hard-to-read type. Minimum specifications are
10-point font size is the minimum allowed
however, reviewers may be pleased with 11- or
12-point font. NIH suggests using Helvetica or
Arial 12 point. It can't average more than 15
letters per inch, though fewer may be better.
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Form 398 Trivial Pursuits (continued) Use no
more than 6 lines per vertical inch -- don't
squeeze lines together. Margins must be at
least ½ inch. Font size in figures and tables
may be smaller but must be easily readable.
There are other specifications, for example, the
document must not be permanently bound and,
except the appendix, it must be photocopy-ready
(black and white, no glossy paper).
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• The Research Plan
• Specific Aims. What do you intend to do?
• If you dont get the reviewers attention here,
  all is lost!
• Background and Significance. Why is the work
  important?
• Preliminary Studies/Progress Report. What has
  already been done?
• Research Design and Methods. How are you going to
  do the work?

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Develop Solid Hypotheses Choose an important,
testable, focused hypothesis that increases
understanding of biologic processes, diseases,
treatments, or preventions. It should be based on
previous research. An example of a good research
hypothesis Analogs to chemokine receptors can
inhibit HIV infection. Examples of a poor
research hypothesis Analogs to chemokine
receptors can be biologically useful. A wide
range of molecules can inhibit HIV infection.
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General Goodies Make sure your idea is not too
broad. Your hypothesis must be testable during
your three- to four-year award with the level of
resources you are requesting. Keep in mind that
your topic should fit with the NIH mission. Basic
scientists should remember that NIH is the
National Institutes of Health. NIH's mission is
to improve health through science--just moving
science forward is not enough. Reviewers also
want to see how your project fits into the big
picture in your field. Make this clear and
explicit. Search CRISP to see what other projects
in your field NIH funds, so you can carve out
your niche. Don't confuse your hypothesis with
your methods. Methods are the means for
performing your experiments. Your experimental
results will prove or disprove your hypothesis.
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Focus, Focus Sharpen the focus of your
application. Applicants often overshoot their
mark, proposing too much. Make sure the scale of
your hypothesis and aims fits your request of
time and resources. Reviewers will quickly pick
up on how well matched these elements are. Your
hypothesis should be testable and aims doable
with the resources and time frame you are
requesting.
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OK, Sit Down and Start Writing With all this and
more in firmly in mind, at some point you
actually have to start writing the darned
thing. Write the application in the Research Plan
sequence. But, if you get stuck, move on to
another section. Write the Abstract last, but not
at the last minute. Its the one thing everyone
reads.
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Psychiatric Intervention is a Good Thing You
WILL get frustrated, angry with the world, mad as
hell, short tempered with your wife, kids and
pets and so forth as you write your grant. In
fact, you will become clinically deranged at
times. But, you will recover.
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You Have Finished a Draft Eventually, you will
have a 25 page narrative (unless your computer
crashes and you forgot to back up your
files.) Set it aside for a time. Go back and
rewrite it so that it makes sense. Repeat this
process until you are sick of looking at it.
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In Your Spare Time. Besides the 25 page
narrative, there is a bunch of other stuff (i.e.
crap) that you have to do. This means the
sections on animals, human subjects, etc. This is
good stuff to do when you are brain dead from
writing your science narrative.
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Budgets, Budgets Another good thing to do at some
point during the process is your budget. Prepare
your budget after you have written your research
plan and have a good idea of what the costs of
your project will be. Request only enough money
to do the work. Reviewers will judge whether your
request is realistic and justified by your aims
and methods. Significant over- or
under-estimating suggests you don't understand
the scope of the work. Modular Grant Budget
applies to research grant applications requesting
lt 250,000 direct costs per year. Request total
direct costs in modules of 25,000, reflecting
appropriate support for the project. A typical
modular grant application will request the same
number of modules in each year. Additional
narrative budget justification will be required
in the application only if there is a variation
in the number of modules requested.
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More Budgets, Budgets As a rule of thumb for
calculating your costs, figure salaries will be
60 to 80 percent of the total request, rounded up
to the nearest 25,000. Make sure your PIs
salary takes into account the mandatory cap. As
a new investigator, you should request less than
250,000. With a modular budget, you request
funding in increments of 25,000, provide few
details, and budget for the entire funding
period. One major difference between modular and
traditional grants is modular grant budgets do
not get annual inflation-based budget increases.
This means you'll have to build all funding needs
you foresee into the request and plan for the
cost of the entire project when applying.
Generally people request the same number of
modules each year, except for special needs such
as equipment.
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You Have a Decent Draft Remember those two
colleagues? Now that you have a decent draft,
give it to them. If they are good colleagues,
they will be critical. Dont get upset by
criticism, thank them. Its better that they
point out the flaws than the reviewers. Consider
their comments and revise accordingly. But its
ultimately your grant application and you know
the subject matter better than anyone else. So be
as objective as possible. Consider the comments
of your colleagues but they wont (shouldnt) be
offended if you dont accept each comment.
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The Deadline is Now! At some point, the deadline
will be approaching fast. You will be clinically
insane and obsessed with polishing each and every
sentence into a gem. But it cant go out the
door until its routed through Research
Administration. Please remember that your
Research Administration staff are human beings.
In fact, they are from the government and are
here to help. In any case, you need that
signature on the face page before it goes out the
door. So dont take it to Research Administration
at 430 p.m. on the deadline day and expect them
to sign off without having a chance to review it.
Plan ahead!
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The Cover Letter You may have some control over
the destiny of your baby in terms of where it
goes after it gets to NIH. When your
application arrives at NIH, it goes into a
warehouse, along with the other 5,000 proposals
that arrived on that deadline. A brave and hearty
gang of NIH staff have the mind-numbing job of
opening the boxes and making two key decisions
IRG and Institute Assignments. With a carefully
crafted cover letter, you may be able to direct
your application to its rightful place. Your
cover letter should be brief (never more than one
page)
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Cover Letter IC Assignment Before applying,
talk to a Program Officer and do some research on
the Web into the scientific areas each
Institute/Center (IC) funds. You can improve your
chances of getting an award by requesting
assignment to an IC interested in your
application, one with a favorable payline, or
both. Funding cutoff points (the payline) vary
among NIH ICs, so a score not fundable in one IC
may be fundable in another. Most ICs set a
conservative payline at the beginning of each
fiscal year. But at end of the fiscal year, they
fund some of the deferred grants, and the payline
goes up. Another way to boost your funding
chances is to get your application assigned to
more than one institute, so you'll have a backup
if the primary institute doesn't fund it, the
secondary might. For example, if you're studying
immune-mediated processes of type I diabetes, you
could be funded by NIAID or NIDDK. A dual
assignment could give you a chance of getting an
award from either institute.
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Cover Letter IRG Assignment Having your
application assigned to the right IRG can help
make sure the right people review your
application and exclude your competitors. Frame
your request in positive terms. Never suggest
particular reviewers. Gathering the information
to make an informed request takes work, but many
investigators feel it's worth it. You can access
the review rosters by accessing the following
link http//www.csr.nih.gov/Committees/rosterinde
x.asp Call the Scientific Review Administrator
(SRA) for help in determining which study section
is appropriate.
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Its Out the Door Now what happens? Your baby
goes to an IRG (Study Section). The members of
the IRG get a big box of grant applications, at
which time they mutter expletives which cannot be
repeated here. The box with the grant
applications sits on the reviewers desk (or the
floor) until the time before the meeting gets
short.
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Review Criteria Eventually, the reviewer must
write the critique. Here is the template they
use Significance ability of the project to
improve health Approach feasibility of your
methods and appropriateness of the
budget Innovation originality of your
approach Investigator training and experience of
investigators Environment suitability of
facilities and adequacy of support from your
institution
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Priority Score Each application is assigned to
at least two primary reviewers who are required
to provide written critiques. NIH employs a
triage system. If a reviewer believes an
application is not competitive, generally meaning
its in the bottom 50 of the applications under
consideration, she/he recommends to the SRA that
it be triaged. If both reviewers agree, the
grant is not scored and not discussed at the
Study Section meeting. In this case, you will
still receive a Summary Statement with both
reviewers written comments but your application
will not receive a priority score. If you
proposal is not triaged, it will be discussed
openly at the Study Section meeting. After
discussion, it will receive a priority score on a
scale of 100 500 (each reviewer scores it from
1.0 to 5.0 and the result is averaged and
multiplied by 100).
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Percentile Score Percentile scores are a means
of normalizing rankings between different
IRGs. The priority scores for each IRG are
combined with the results of the previous two IRG
meetings and then ranked as a percentile. The
percentile score is generally the most important
determinant in the decision of whether or not
your application will be funded. However,
applications reviewed by Special Emphasis Panels
(e.g. RFAs) do not receive percentile scores and
are ranked by priority score.
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Council After the grant applications are scored,
they go to Council. Each IC has a National
Advisory Council or Board, mandated by statute,
that provides the second level of review for
grant applications.  The Councils/Boards are
comprised of both scientific and lay
representatives.  Council/Board recommendations
are based on scientific merit (as judged by the
initial review groups) and the relevance of the
proposed study to an institute's programs and
priorities.  With some exceptions, grants cannot
be awarded without recommendations for approval
by a Council/Board. If your application is
approved for funding by the Council/Board, it
goes back to the IC where it is funded, if funds
are available. If your application is not
approved, you can appeal to Council but its
generally not a good idea.
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How Dare You Call my Baby Ugly Odds are,
especially for your first application, that is
will not be funded on the first try. So, get mad
for awhile. Then, get over it and plan a revised
application (A1). A revised application has one
new section, the Introduction in which you
respond to the previous critique (3 pages). Be
positive in your response, thanking the Study
Section for their insightful advice. But dont
be afraid to point out your disagreement, doing
it respectfully, if appropriate. Involve your two
colleagues in the process. Send it back to
NIH. The most important word in NIH grantsmanship
is persistence.