RESUBMITTING A GRANT

APPLICATION

David Felson, M.D., M.P.H.

Professor of Medicine and Epidemiology
Principal Investigator, B.U. Multidisciplinary
Clinical Research Center Grant
Director of Training, B.U.CTSI
Former Member, NIH SBSR and EDC1 Study
Sections
 Outline of this Talk
• Review of Options in Submitting a Grant
• Rates of Success of Grants at NIH
• Deciding about Resubmission
• Examples of Approaches
• Writing to the Reviewers
Why Would You Want to Write a
Grant?
• To Have the Resources and Time to Pursue a
Question that you believe is important

• To protect your time and give you freedom

• To pay your salary

• As a measure of academic accomplishment

 What Qualities Characterize a
Successful Grant Writer
• Good research skills • Ingenuity and
• Salesmanship flexibility
• Good communication • Administrative skills
skills • Good human relations
• Persistence
 What Kind of Grant Should You
Write?
Career Development Grant to do Research (R,
Grant (K series) P series)
• Funds you, a junior • Provides funds to
investigator carry out a research
• Goal is to protect your project
time/optimize career • Scientific proposal is
development central piece of grant,
• Scientific proposal not includes prelim data,
only part of grant experience of
investigators
 Career Development Grants at NIH
K01 Ph.D. (nonclinical) Biomed/behavioral
research
K02 Ph.D. (nonclinical) Biomed/behavioral
research; must have grant
K08 MD or other Biomed/translational/beh
clinical avioral research
K23 MD or other Patient-oriented research
clinical
K99/R00 PhD or Clinical Any research; 2 yrs of K;
(non U.S. eligible) 3 of R support
 The Travels of an N.I.H. Grant
Application (R series)*
• Based on title and abstract, Center for
Scientific Review (CSR) assigns your grant
to institute and study section, a review
group (SRA heads study section)
• Institute appoints a primary contact person
for your grant

*K grants go to organ-based NIH institute (e.g. NHLBI) but

process is otherwise the same
hart shows the major choices reviewers and program staff make about each application to determine whether it will be funded.
For information about when funds are released, see the Funding Timeline.
 N.I.H. Study Section
• 14-30 N.I.H.-funded scientists representing a wide
range of expertise and geographic & gender
diversity
• Each grant reviewed by  2 members
• Members review 6-10 grants each
• Study section reviews 80-100 grants
• Each study meets three times per year for 2 days
each time
 Once you’ve submitted, you’re
not done
• Check Commons to determine review group
• Examine the names of listed reviewers;
check with your mentors/senior colleagues
• Are those with right expertise reviewing
your grant?
• Act early (with institute assignee) to
challenge reviewers if needed.
Study Section Review: Topics in
Write-up of a Grant Review
• Significance
• Innovation
• Approach (general feasibility, power,
methodologic concerns)
• Other factors (human studies, productivity
or promise of the investigator)
 Priority Scores
• 50% of R applications are unscored and not
further discussed. Since there is no discussion,
there is no summary of concerns.
• Priority scores (1 - 9) are assigned usually by
consensus after airing of reviews.
• Priority scores get assigned a percentile ranking
based on current and previous study section
reviews.
• Summary Statement is prepared by SRA.
 From Study Section to Institute
Council
• Institutes have ‘pay lines’: the percentage
of competitive applications funded. These
serve as general guides.
• Grant and summary statements sent to
Institute Advisory Council. Council can
change ranking of grant based on institute
priorities.
• Institute staff make ultimate funding
decisions.
K23 success by year

• 2002: 46.6% (the high point)

• 2008: 37.6%
• 2009: 43.9%
• 2010: 37.8%
• 2011: 34%
K08 Success by Year

2002 52%
2008 44%
2009 47%
2010 44%
2011 42%
 Research Project Grant investigators
Competing applicants, awardees, and funding rates
Research Project Grants
Success rates, by gender
 R01-Equivalent grants, New (Type 1)
Success rates, by career stage of investigator
 2011 N.I.H. Funding Success Rates
by Submission No. of Type 1 Grants*
Submission No. All Research R01’s only
Project Grants
First (original) 10.1% 9.5%
First Resubmission 37.7% 36.8%
(A1)
Second 27.8% 26.1%
Resubmission
(A2) (if allowed)
Total Funding of 15.2% 15.1%
Type 1’s

*Type I grants are new grants, as opposed to renewals

 Your future as Grant Applicant
• You will be faced with an unfunded grant.
• You will have to decide whether to:
– Revise and resubmit
– Dump idea
– Repackage and submit in another form/to
another agency
• New policy restricting to one resubmission
changes strategy.
 How to deal with the Summary
Statement if your score is not
good enough to be funded
• Read summary statement seriously only
after you have put it away for a week.
• Show summary statement to senior
colleague/mentor who has experience with
NIH reviews.
 Deciphering the Summary
Statement if your score is not
good enough to be funded
• If >= 2 reviewers raise the same or similar
issue, you must address it.
• Read the summary of discussion (at
beginning) carefully. Written by SRA, it
contains main discussion points and will
often guide you on whether to resubmit.
Deciding on Revise/Resubmit vs.
Other
• Need to decide soon to revise/resubmit and
begin to work on revision/prelim data
• Lots of work/time went into original
submission. A revision is MUCH less work.
Bias toward resubmission.
• If you decide not to revise/resubmit, the
decision on what to do can wait
 When NOT to resubmit:
If you grant is triaged…
• No discussion took place (other concerns
could have been raised)
• No impact scores provided
• Only one resubmission allowed
• Do not Resubmit
Exception: if all reviewers point to one easily
rectifiable problem and no other major ones.
 When you should resubmit…
• Initial score in 10’s, 20’s (reviewers often
thought you would be funded and did not
have major concerns; they will sometimes
be upset NIH did not fund when they see it
again.)
• When concerns expressed by reviewers are
addressable.
 What types of concerns are
usually addressable?
• Lack of preliminary data (get data)
• Lack of innovation (market this better)
• For K grant, lack of institutional support
• High level of expense (can influence scores)
 What types of concerns are
usually not immediately
addressable?
• Lack of productivity (get more papers)
• Lack of significance (sometimes can market
this but if >1 reviewer, this is problem)
 And if you decide NOT to
resubmit…
• Explore other funding options
– For Career Development: Private foundations
(often specialty based)
– For Research Grants: part of Center grants,
R03, R21, private foundations (e.g. AHA,
Arthritis Foundation); local sources (e.g. pilot
projects)
Much work and thought involved in developing
the idea. Can the idea be modified?
 R03
• Small grant ($50,000 per year X 2 years)
• Ideal for collecting preliminary data
• Also used to carry out secondary data
analyses
• Not available at all NIH Institutes
• Funding success rates similar to R01
• Resets the R01 clock
 R21
• Up to 2 years with total of $275,000 (no
more than 200K in any year)
• Must be novel or high risk/high reward
study. Develop new method/technique
• Not available at all NIH institutes
• Funding success rates similar to R01
• Resets the R01 clock
 Can you make your failed
application into a NEW ONE?
• New Application: objectives, aims,
hypotheses all changed; or a new PI
• The Following would NOT be new
applications:
– Title change
– Change in wording of aims/objectives
– New review panel or institute assignment
Example of R01
APOS Shoe Trial
Popular in Europe
As Treatment for
Knee OA
• Placement of balls on the plantar surface can lead to
unloading of painful medial compartment of knee.
• Unloading medial compartment may be visualized on
MRI as shrinkage of bone marrow lesions.
• Walking on hard rubber balls can retrain lower
extremity muscles, producing
coordination/conditioning.
• One controlled (not randomized) trial with controls
normal shoes showed markedly positive results for
reduction of knee pain. No RCTs. NO sham controls
An R01 NOT Resubmitted: APOS
shoe for knee OA: the Review
• Not discussed (triaged) on 1st submission (2
of 3 reviewers with major scores >=4)
• Exerpts from Reviewers’ comments:
• Although the investigators may be able to demonstrate a change in the adduction
moment at the knee with the use of the novel foot wear will not explain how that
foot wear accomplishes it. Little or no theoretical explaination was offered for
the use of the foot wear nor is there an attempt to explain how it might work. As
such, the significance of the study is severely reduced.
• The use of “sham” footwear is valuable, but additional control conditions should
be included to better indicate the possible effects of footwear on knee OA,
moments, etc. The investigators should seriously consider including some type of
“standard” footwear and barefoot conditions.
 APOS Review
• No information is provided regarding how the technician for the APOS foot
wear will make the needed adjustments. This introduces a possible
confounding variable. The Principal Investigator should at least provide
information regarding what adjustments are made and upon what factors or
findings. Furthermore, what is the reliability of the person who will be making
the adjustments for the footwear? Can they be replicated?

• Although the WOMAC is the most frequently used functional outcome tool, it
does have some problems particularly in the stiffness and physical function
subscales. These problems could lead to a difficulty in demonstrating a change
as the result of the treatment. In addition, a change of 7.8 seems to be too low
to be clinically relevant although statistically significant.

• The prevalence of Bone Marrow Lesions has been reported to be less than
78% (stehling, et al, 2010 reported less than 50%). BMLs may also be greater
in those who are more physically active and may be progressive over time.
These present moderate concerns regarding sensitivity to change in a sham
controlled trial
A K23 resubmitted successfully
• Initial summary statement concerns in
resume (score 200 (scale 100-500))
However, the Review Committee identified some weaknesses that reduced the
enthusiasm. While the research area is important, there are some issues related
to the research design. For example, there is a concern that the research
proposal is based on a large VA database which has complete focus on men
when glucocorticoids are major drugs used by women with rheumatic diseases.
In addition, there are some concerns about the proposal presentation and
discussion. Furthermore, the reviewers note that a closer mentors’ involvement
in the candidate’s application preparation will be helpful. Overall, the Review
Committee is positive about the candidate’s commitment, mentors’ expertise,
career development plan and institutional environment and support.
 RESPONSE TO REVIEWERS
• “Because there are few women, the study will include only men. This will
certainly limit the generalizability of the conclusions drawn from this
research.”
•
• We have done additional work to verify the number of expected women and
men in this study. In VA fiscal year 2005, we identified 225,841 patients who
received a GC prescription at least once. 14,914 were women. This estimate
is for a single year whereas our study will encompass eight years. Though
women are certainly less prevalent than men, this is an older and relatively
high risk population; therefore, the rate of CV diseases in both sexes is
expected to be high. Thus, there should be enough women to be able to
perform sex-specific analyses.
 An R01 resubmitted: structural
correlates of knee pain with MRI
(from sum statement resume):
• …In slight counterbalance, the review group commented on the lack of details
about magnetic resonance imaging (MRI) data acquisition strategy and
drawbacks in the interpretation of results; need for further validation of the
quantitative assessment of synovial proliferation; hypothesis on pain studies
are not carefully thought out (categorizing quality of pain into three variables
are inappropriate); need to address clinical site requirements and subject issues
(the review group commented on MRI Issues for e.g., the clinical sites
currently use 1.5 Tesla magnets and research studies use 3.0 Tesla instead of
1Tesla and further, the instrument proposed is outdated). Again, the review
group enthusiasm is modestly tempered by the lack of imaging expert and
absence of defined innovation. On balance, these issues do not fatally
overshadow the positive features of the proposal thus consequently, the review
group has expressed a fairly high (outstanding-excellent interface) level of
enthusiasm for its support.
SUCCESSFUL RESPONSE TO
REVIEWERS: R01
• Added two MSK radiologists to study
• Defended the MRI’s to be used and provided
specific acquisition parameters to be used
• Provided preliminary data validating synovitis
• Added additional analyses suggested by
reviewers (nocturnal pain)
• Pointed out conflicting reviewer concerns
• Shortened study to 3 years (from 4).
 Deciding whether to Resubmit:
Know the Odds and Maximize
Them
• Find out success rates for grants like yours.

• Submit to agencies which offer the highest

likelihood of success.

• Search out private charitable organizations

interested in funding your kind of research.
 Who Reviews the Revision?
• Do not ask for different review group. They
will raise yet other concerns.
• Generally, one of the previous reviewers is
assigned the grant. Other reviewers will
change.
• Most rereviewers (but not all) will focus
only on your response to reviewers.
 Writing Response to Reviewers
(1)
• The reviewer is always right (even when
they’re not!). Be respectful.
• You do not have to respond to every issue,
but must articulate why not.
• If at least two reviewers raise an issue or it
is raised in summary, you must address.
• Try to ‘throw them a bone’---don’t argue
with every suggestion. Give in a bit.
 Writing Response to Reviewers
(2)
• Respond to reviewer by reviewer in order.
• Make it easy for reviewers to track changes
in revised grant. (underline or bold new
text).
Be nice to your reviewers in your
revisions
• Large Font if possible
• Clarity (a messy grant means messy
science).
• Tables/Figures—whenever possible
• Consistency in #’s/labels!
• Make revised part look different from
original
 Other tips on Writing Grants

http://grants1.nih.gov/grants/grant_tips.htm