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Overview of the NIH grant application process
Important note: Applications hand-delivered
by individuals are no longer accepted by the NIH Center for
Scientific Review. You must have your application delivered to the
NIH by either courier or postal service.
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Introduction
Preliminary
preparations
The
PHS 398
Delivery
of your application
Review
of your application
Time
allocation
Successfully competing for grants is difficult. If you are a new
investigator, you should find a mentor to help you identify
potential sources of support and help you draft your grant
application. Additionally, if you apply for a NIH grant, NIH staff
can review and comment on your application before you formally
submit it for peer review.
Should your application be rejected at the outset, do not become
discouraged. You are allowed to revise your application and reapply.
Your reapplication has a much higher chance of succeeding than your
initial application.
Preliminary preparations
Before you actually start typing your application, you must
go through several preliminary preparations. First, you must choose
a specific
research problem to focus your study. This task involves
developing a hypothesis or hypotheses.
Once you have defined your research problem, you should discuss the grant
development process with applicants who have had a history of
securing funding. Ask them for their suggestions on
potential funding mechanisms they believe would fit your project. If
possible, obtain copies of applications that have been approved so
that you can emulate some of their strengths - e.g., highly
specific, relevant hypotheses; or perhaps a study question that
contributes something new to the literature published on your
subject.
The next important step is finding
funding for your project. This task involves identifying
potential grant programs. To increase your chances of success, you
should consider submitting your application to more than one
potential funding source (e.g., R01, K23, R21, a
foundation, DOD, ACS). Although you are only permitted to accept
funds from one source for each element of your research program (no
"double dipping"), you can accept funds from multiple sources if
each source funds a different part of your research. If you are
submitting to NIH, consider applying to more than one of NIH's many
funding mechanisms.
Once you have chosen the funding sources to which you will apply,
line up mentors and collaborators to assist you
with your proposed research. This team may include
clinicians for accessing patients and specimens, laboratory
scientists, epidemiologists, social scientists, and a
biostatistician. Ask them for their suggestions on additional
funding sources and publications supporting your proposed research.
Gather from them their two-page biographical sketches for inclusion
in your grant application, as well as previous, successful grant
applications on which they were involved.
Next, line up your proposed research team, which
may include nurses, lab technicians, data managers,
biostatisticians, and administrative support.
The PHS 398
If you are applying for a NIH grant, the form you will most
likely use is the PHS
398 form. Make sure the PHS 398 form you are using is the most
current version, which was revised in May 2001 and updated in May
2002. This version can be completed electronically using the RTF or
PDF fillable
forms. To use the PDF format, you will need to download a (free)
copy of Adobe
Reader if you do not already have it.
Once you have assembled your research team and lined up
collaborators and mentors for your proposed project, you are ready
to start building your PHS 398 application.
The main sections of the PHS 398 are listed below:
Description
Budget
Resources
Research Plan (25 total pages)
Introduction (1-3 pages)
Specific
Aims (1 page)
Background and Significance
(3 pages)
Preliminary Studies (6-8
pages)
Research Design and Methods (13-15
pages)
Biographical sketches (2 pages/person)
Appendix (limit
of l0 publications)
Literature cited
Critical elements of the application include the Description,
Budget, Resources, and Research Plan sections:
Your Description should present the big
picture, and provide a context for your proposed research project.
Why is this issue important? What do you propose to do? What are
your endpoints?
Your Budget should provide such items as
proposed salaries, including those of consultants, and costs of
equipment, supplies, travel, and patient care. You should review
these with your department and/or cancer center administrator
before submitting your application.
Your Resources section should make clear what
resources you already have in place to help you carry out your
project.
In developing your Research Plan, consult your
mentors and collaborators early on to develop hypothesis-driven
specific aims, and to make sure the plan is complete. Get
preliminary reviews from people both in and outside your field of
research. An outsider's perspective will help ensure the plan
flows logically.
Lastly, do not forget important inclusions in
your grant application, particularly those regarding gender and
minority provisions, human subjects, and vertebrate animals. Other
important inclusions include statements of support and commitment
for your division director and department director, and
documentation of approvals from the IRB and grants administration
office.
Make sure you can show evidence of human subjects
protection training for all key personnel you propose. An
October
2000 NIH announcement made this training mandatory for a project
to be awarded.
Delivery of your application
The central receiver of PHS 398 applications is the NIH Center for Scientific Review
(CSR). Again, applications hand-delivered by individuals
are no longer accepted by the NIH CSR. You must have your
application delivered to the NIH by either courier or postal
service. (Please see the November 13, 2001
notice announcing this restriction.)
When you have completed your application, you should send copies of it
to all your project collaborators and mentors.
Review of your application
Following receipt of your application at the CSR, CSR staff
will assign your application in two ways:
- To a "Study Section" of experts in your area of proposed
research. Headed by Scientific Review Administrators (SRAs), this
peer review panel will assess your application for
scientific merit.
- To the Institute best suited to provide
funding for your project.
If you would like your application to be assigned to a specific Study
Section and Institute, affix a letter indicating your preference to
your completed PHS 398 application. NIH will seriously consider your
request.
The Study Section peer reviewers will critique your application,
writing up their summary and comments on what are known as "pink
sheets". Based on the merit of your application, they will assign it
a score within a 100-500 point range. The lower the score, the
better.
At this point, the Institute to which your application was
assigned can decide whether or not to fund your application. This
decision is based on many factors, including the priority score and
special features of your proposed study. In general, NCI will fund
applications scoring below a certain number, called the
"payline".
CSR provides a concise overview
of what happens to applications once they reach the NIH, in this case how R01/R21 grants are processed.
Time allocation
It is very important for you to develop a timeline for
assembling all required documentation for your PHS 398 application.
Letters of support and required special approvals, such as approvals
from the grants administration office and the various IRBs involved,
will take a while to obtain. Administrative approvals may take up to
two weeks to obtain; IRB approvals can take up to six months.
You should reserve a minimum of 50 hours for assembling your PHS
398 form, clearing your schedule the week before the due date to
accommodate last-minute requests. If possible, cancel or reduce
clinical responsibilities while developing your grant application.
Check the submission deadline several times throughout grant
development, to make sure that dates have not changed. Check the deadlines
for the individual grant announcement as well as the NIH Receipt Dates. If delays are unavoidable, and they are serious
(fire, flood, death in the family), call the grant's program officer
and ask for an extension. Most deadlines, however, are
non-negotiable.
The time period from application to award can take up to 18
months. You can expect nine months to pass from application to
scoring of your application by its review committee. In general,
grant applications to the NIH are accepted three times a year, every
four months. (See the NIH Receipt Dates.)
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