Writing a Grant
Also see: An Application's Journey Through NIH
Introduction
The typical successful R01 (regular research) grant application
has as its basis a testable hypothesis in a biological area of high
current interest. It includes a short, concise series of specific
aims that address the central hypothesis. A well written background
section is used to indicate the significance of the proposed work
and review important information gleaned from the literature and
the investigator's previous work that would allow reviewers to easily
understand the hypothesis. Proposed experiments are clearly described
in detail, with suggestions for proceeding with the work should
they fail to produce the expected outcome. There is a body of solid
preliminary data that demonstrates the likelihood for success of
these experiments. Finally, sufficient information must be included
to convince reviewers and NIH staff of the high quality of the applicant,
the coinvestigators (including letters stating their willingness
to participate in the research), available research resources, the
applicant institution and demonstration of its support of the applicant.
The application is written on application form PHS 398. Follow
instructions to the letter, including margin and typeface size,
page length, and the table of contents. Applications can be rejected
without review if they violate these guidelines. The application
must be reviewed and signed by the appropriate university or other
institutional administrative staff, and must contain documentation
of approval of animal or human subjects protocols by the appropriate
institutional committees.
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For the First-Time Applicant
- Ask for advice. Start on the application well in advance of the
submission deadline and ask more experienced colleagues to read
it over and offer suggestions. Check the NIH web site and identify
those Program Directors who might be interested, then give them
a call to discuss the proposed research.
- Submission deadlines are true deadlines. Unsolicited applications
must be postmarked on the deadline, applications submitted in response
to an RFA or RFP must be received at NIH on the deadline.
- Do your homework to help steer your application through NIH. You
are allowed to suggest a study section and/or an Institute in the
cover letter submitted with your application. Talk to Institute
staff to ensure it will have a home if it gets a good score in review.
Consider asking for a "secondary" assignment to a second Institute
if at all appropriate. This will allow both Institutes to consider
funding the application if it gets a good score in review. Search
through the research
interests of the different IRGs and their componant study sections,
and look at the rosters of
reviewers. Once a likely study section has been identified,
talk to the SRA (the NIH official that runs the study section) to
make sure that he/she will accept the application for review.
- Don't give up if an application isn't funded the first time. The
summary statement critiques can be used to improve the grant so
that it does better the second time it is reviewed. NIH allows a
grant to be revised and resubmitted twice.
- First-time applicants may have less preliminary data and fewer publications than more seasoned investigators would. Reviewers and NIH staff understand this. More emphasis is placed
on the applicant's demonstration that he or she is truly independent
of any former mentors, has some of his or her own resources and institutional
support, and is able to independently lead a laboratory. Other important
points are a demonstrated clear understanding of the literature,
understanding of the strengths and weaknesses of proposed techniques,
clear and precise language, ability to present and discuss significance
of data, a clear experimental plan, etc.
- New applicants make two common mistakes. One is including
too little detail about proposed studies and insufficient justification
for the significance of the problem. Another is proposing far
more work than can be reasonably done during the grant period.
- Be realistic about the time things take. In general it takes about a year to collect preliminary data, 1
to 2 months for IRB or IACUC approval for human or animal protocols
at the parent institution, 1 to 2 months to write the grant,
5 to 6 months from submission to review, 1 to 2 months
to receive the summary statement following review, and 9 months
from submission to funding. There are 3 submission deadlines
each year, and revised applications are due 1 month later than
new applications. Therefore, the earliest a revised grant can be
submitted is 9 months after the original submission. Plan accordingly.
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Think Like a Reviewer
The typical peer reviewer:
- has a breadth and depth of knowledge, experience, and wisdom and
is capable of understanding and judging a large range of work. He or she has a vested interest in ranking the applications in an unbiased,
fair, scientifically rigorous way, knowing that the interests of
the scientific community are served by giving the best scores to
those grants that are most likely to contribute to our body of
knowledge.
- may not be extremely familiar with all techniques used in a grant,
or may have used the techniques, but does not have experience with
the specific biomedical pursuit found in the grants under review.
All parts of the grant must therefore be clear and written in such
a way that a non-expert can understand them.
- may not know the applicant personally, or feel comfortable with
his or her level of independence, knowledge of the field, ability to
design experiments with appropriate controls, ability to decide
what to do if proposed experiments don't work out, etc. It is the
job of the applicant to convince the reviewer.
- may not fully understand the significance of the research area
without a clear, compelling argument presented in the application.
- is capable of understanding and interpreting preliminary data if
well-presented. These data must therefore be appropriate for
support of the proposed science.
- must read 10 to 15 applications in great detail and form an opinion
about all of them. The successful application is clear and precise,
is easy to read, has a detailed experimental design section, and
is free of typographical and other errors.
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Budget
The requested funds are "direct costs," funds that go directly
for the research project and investigator salaries. The applicant
institution is also awarded "indirect costs," or overhead. This
is a percentage of the direct costs, and the rate is negotiated
between the institution and the NIH. If requested direct costs are
below $250,000 per year, the modular
budget format must be used, where the budget is some number
of $25,000 modules. Detailed budgets are required for requests of
greater than $250,000/year. Permission from NIDDK must be
obtained prior to submission if the requested budget is higher than
$500,000 direct costs per year. (see notice).
Justify your budget request in an accompanying narrative. Whether
modular or detailed, the requested dollar amount should be based
on a realistic, thorough understanding of the real costs of the
proposed work.
When part of the project is done at a second institution, this
is usually funded via a "subcontract" from the parent grant. The
second institution will also get indirect costs with this money,
which also comes from the direct costs of the parent grant. These
subcontract indirect costs must be included in the requested budget
of direct costs.
NIH sets the allowed ceilings for stipend
levels paid by NRSA grants and salary
caps for personnel on regular research grants.
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Institutional Approval for Protocols Using
Animal Subjects (IACUC) and Human Subjects (IRB)
A grant application cannot be funded without documentation of approval by
the appropriate university (or other research institution) committees of all
research protocols involving animals or people as subjects. Institutional
Review Boards (IRB, human subjects) and Institution Animal Care and Use
Committees (IACUC) need ample time, often 2 months or more, to approve new
protocols. In addition, an Assurance of Compliance identification number
for studies involving human subjects, or an Animal Welfare Assurance
identification number for studies on animals (available from the institution
Grants and Contracts Office) must be included on the application face page.
NIH policy was recently changed to allow applications that use human
subjects to be submitted without prior IRB approval (see notice). If a
grant receives a good score upon review, the principal investigator should
begin the process to obtain approval of his IRB. No application can be
funded without this approval. In addition, the principal investigator and
all key personnel must submit a description of education they have completed
in the protection of human subjects (see notice). Applications with animal
research subjects must still arrive at NIH with documentation of IACUC
approval included.
For human subjects, a grant application must provide information pertaining
to six items described in Section C of the instructions for the application.
These are the characteristics of the subjects; the sources of research
materials; recruitment plans and consent procedures; potential risks;
procedures for protecting against or minimizing potential risks; and
potential benefits to the subjects and to mankind. In addition, new policies
at NIH require that clinical research subjects include minorities and women
(Inclusion of Women and Minorities in Clinical Research), and that wherever
possible, children are also to be included (Inclusion of Children in
Research Involving Human Subjects). (The Office for Human Research
Protections (OHRP)) sets these policies.
For animal subjects, a grant application must provide information on the
following five items: a detailed description of the proposed use of the
animals; a justification for the choice of species and number of animals to
be used; information on the veterinary care of the animals; an explanation
of procedures to ensure the animals will not experience unnecessary
discomfort, distress, pain, or injury; and a description of and
justification for any euthanasia method to be used.
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Prohibition of URLs in Grant Applications
NIH has recently instituted a policy
that prohibits the use of World Wide Web addresses (URLs) in
grant and contract applications, in the place of text describing
the same material. This is because of the potential for providing
a large amount of extra material from a web site beyond what would
fit in the 25-page limit, and thereby giving an unfair advantage
to some applicants and a large additional burden for reviewers.
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Co-investigator/Consultant Letters
Most scientific work requires collaberation between researchers,
and NIH is dedicated to fostering such relationships. The grant
application should contain a signed letter from each collaberator
to the applicant that lists the contribution he or she intends to make
and his or her enthusiasm for the work. These letters are often the primary
assurance the reviewers have that this work will in fact be done.
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Special Instructions for New Investigators
NIH has recently discontinued its FIRST award (R29), a 5-year,
$350,000 grant given only to new investigators.
All applicants for NIH support should be certain to now use the
June 2002 version of the Public Health Service
PHS 398 application kit. It is particularly important that new
investigators (as defined below) check the "new investigator"
box on line 3 of the face page in order to be certain they are identified
correctly. NIDDK will use this information as part of the criteria
for funding applications.
A "New Investigator" is a principal investigator on an application or
grant assigned to NIDDK who has not previously served as such on
any PHS-supported research project other than a small grant (R03),
an Academic Research Enhancement Award (R15), an
exploratory/developmental grant (R21), or a mentored research career
development award (e.g., K01, K08, K22, K23). Current or past recipients
of Independent Scientist and other non-mentored career awards are not
considered new investigators. Scientists who have served as principal
investigators of independent laboratories and received support comparable to
that provided by a
regular research grant (R01) from other sources (such as intramural NIH,
other governmental agencies, private foundations or industry)
will not be considered as new investigators.
For the first-time applicant, it is understood by reviewers and
NIH staff that there may be less preliminary data and fewer publications
than a more seasoned investigator would have. Instead, more
emphasis is placed on the applicant's demonstration that he or she
is truly independent of any former mentors, has some of his or her
own resources and institutional support, and is able to independently
lead a laboratory.
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