National Institute of Health (NIH)

Writing a Grant Application: A "Technical" Checklist

ESSENTIALS:
 Significance
 Sound hypotheses
 Productivity and demonstration of feasibility -- high quality results and figures
 Logical development of experimental design

Before you start:

 Is it really time to write this grant? Is it premature?

 Should you write that paper first?
 Plan ahead and don't rush -- give yourself 2-3 months to prepare the grant.
 Arrange with colleagues or mentors to review a first draft of your specific aims EARLY (6 weeks or so) just
to make sure you are on the mark.

Specific Aims

 Do the aims address interesting and significant issues?

 Are they hypothesis-based?
 Are they "win-win" - i.e., will an outcome consistent with the null hypothesis still be a contribution to the
field?

Background

 Clear, well organized -- use subheadings where possible. Make sure the significance of the topic is
EXPLICITLY stated.
 State CLEARLY where the gaps in knowledge exist in the field that your results will address.
 Make sure your references reflect an updated knowledge of the field.

Preliminary Results

 Draw as much as possible on your past productivity; emphasize how your previous work leads up to the
present proposal or at least demonstrates feasibility of methods to be used.
 DO NOT show preliminary results that are not of high quality -- this is your chance to represent yourself.
 Show detailed numbers and representative raw data where necessary, especially if this is work that is
unpublished.
 Make sure that the major methods to be used in the proposed work are reflected by preliminary results. (If
you do not have expertise or preliminary results with a technique, make sure you list a solid, experienced
consultant or collaborator and include a letter agreeing to the collaboration.)
 Put time and effort into preparing METICULOUS figures, graphs, or tables; this is your chance to
demonstrate rigor and organization that will increase the reviewer's confidence that you can carry out the
project.

Experimental Design

 This IS one of the most common places where the text is insufficient. This is NOT just a place to tediously
list group sizes, detailed methods, etc. This IS the place to demonstrate your ability to think knowledgeably
and logically.
 DEVELOP your aims; of all the sections this may well be the part of the grant upon which you spend the
most time.
  One method that often works is to divide this section into subheadings after each specific aim is restated, as
follows:

Specific Aim #.

1. Rationale: how does this design relate to your hypotheses? What is your reasoning (IN DETAIL)?
2. Methods: list general approaches first, explaining why the methods you propose are the best
available for your questions. (Caveat: If you realize that you do not have the best, most direct
methods for your questions, you need to rethink your aims or incorporate collaborators or new
preliminary data showing feasibility with the necessary techniques.) **Don't forget to address
statistical analysis.
3. Anticipated results: you need to spend a great deal of thought as to potential outcomes and their
likelihood. Explain how you will interpret the different outcome scenarios and how these results
relate back to your hypotheses. This is an opportunity to demonstrate creativity and enthusiasm for
the data to be obtained, and show that they will be competently addressed.
4. Problems and pitfalls: be honest with yourself. If this section feels horribly uncomfortable, it is
because you are probably trying an experiment that is not feasible. All experiments have pitfalls,
but extraordinarily large pitfalls are likely to be unreasonable; hence, this section should serve as a
reality test. Explain the pitfalls, and how alternate approaches will be used to overcome them if
they occur. Do not think that avoiding mentioning a pitfall is a good strategy - it usually doesn't
work. The reviewer will very likely notice the pitfall and believe that you are not aware of it,
decreasing confidence in your ability to manage the data.

Timetable

Not a futile exercise, although it does not need to take up an inordinate amount of space. The idea is here to take it
seriously and use it as a reality check for yourself.

Writing Your Application

On This Page: Introduction
 Get Prepared
 What to Know Before You Start Writing the Research
Proposal
 Developing Your Research Plan
 Additional Elements Required in a Grant Application
 Important Writing Tips

Introduction

Writing a grant application is a major undertaking. The following guidance

may assist you in developing a strong application that allows reviewers to
better evaluate the science and merit of your application.

 Though the advice provided is relevant for all research grants, it is

general in nature and geared toward the NIH Research Project (R01).
 The tips and guidelines included in this document are not intended to
replace your organization's internal guidance , specific advice provided by
NIH program or grants management staff, or instructions found in the
various application guides.
 This document is written for the Investigator. Therefore, all references to
“you” refer to the Program Director/Principal Investigator (PD/PI).

Get Prepared

To ensure efficient and thorough completion of your application, consider

taking the following preliminary steps:

 Review the grant application instructions for important information on the

application process and guidance on preparing specific sections of the
application.
 Carefully read the funding opportunity announcement (FOA) for any
special instructions.
 Solicit feedback from colleagues and/or mentors on your research idea
while it is still in the concept state.
 Prepare an outline following the application framework and structure
described in the application guide.
 Make sure you have adequate preliminary data.
 Develop a feasible timeline with draft application deadlines. Be realistic
about the time it can take to write and revise the application.
 Ask your colleagues or your Office of Sponsored Research for copies of
successfully completed NIH grant applications. Examine them closely.
 Contact someone in your institution who can assist you in understanding
and completing application materials.
 Make sure that your institution will allow you enough time to accomplish
the research, if funded.
 Become familiar with the NIH peer review criteria; reviewers will use
them to rate your application.
Is Your Idea Original?

 Check the literature to verify that the exact project you are considering
has not been done before. Search the literature and the NIH RePORTER
database to minimize overlap with similar studies.
 Assess the competition. See which other projects in your field are being
funded, and consider turning competitors into collaborators to improve the
strength of your proposal.
 Carve out a niche that will allow you to significantly advance knowledge
in your respective field.

Refine Your Ideas

 Generate a hypothesis.
 Make sure your specific research aims can be accomplished within the
proposed time and resources.
 Discuss your research idea with colleagues, mentors, etc. Request that
they review a first draft of your specific aims early in the process. This step
can save lots of valuable time.
 Confirm your confidence and enthusiasm for the proposed research.
Propose research that you are passionate about and totally committed to
doing.

INSIDER TIP: Secure a mentor(s) who can provide

advice and guidance on developing and writing a
successful grant application. Secure a collaborator(s) on
your project who can provide any scientific expertise you
may lack.

What to Know Before You Start Writing the Research Proposal

Careful preparation saves time, resources and will help you build a solid
application. A panel of experts reviews all grant applications submitted to
the NIH in a process known as peer review. Although several factors
contribute to whether your application will be funded, great emphasis is
placed on this evaluation and how the reviewers rate the scientific merit
of your proposal. The following sections describe the criteria reviewers
employ to evaluate applications. Read them carefully for helpful hints on
the information and content you should include in the application to
garner a favorable evaluation.

In addition, tips have been provided for demonstrating to reviewers and

NIH staff the high quality of the personnel involved, available research
resources, and the applicant institution's support of the project. Special
instructions for new investigators and foreign applicants are provided, as
well.
NIH Peer Review Criteria

The goals of NIH-supported research are to advance our understanding of

biological systems, to improve the control of disease, and to enhance
health. In their written critiques, reviewers will comment on each of the
following criteria to evaluate the likelihood that the proposed research will
have a substantial impact on the pursuit of one or more of these goals.
The overall score is assigned based on the reviews for each of these
criteria. Reviewers are instructed to keep the five review criteria in mind;
however, the final priority score they assign is more likely to reflect a
judgment of overall merit.

NOTE: These are general review criteria for evaluating

unsolicited research project grant applications. NRSA
fellowship award, career development award, and specific
funding opportunity announcements (FOAs) may have
different or additional special review criteria. Applicants
should familiarize themselves with the review criteria by
which their application will be evaluated.

1. Significance. Does the project address an important problem or a

critical barrier to progress in the field? If the aims of the project are
achieved, how will scientific knowledge, technical capability, and/or
clinical practice be improved? How will successful completion of the
aims change the concepts, methods, technologies, treatments, services,
or preventative interventions that drive this field?

2. Investigator(s). Are the PD/PIs, collaborators, and other researchers

well suited to the project? If Early Stage Investigators or New
Investigators, or in the early stages of independent careers, do they
have appropriate experience and training? If established, have they
demonstrated an ongoing record of accomplishments that have
advanced their field(s)? If the project is collaborative or multi-PD/PI, do
the investigators have complementary and integrated expertise; are
their leadership approach, governance and organizational structure
appropriate for the project?

3. Innovation. Does the application challenge and seek to shift current

research or clinical practice paradigms by utilizing novel theoretical
concepts, approaches or methodologies, instrumentation, or
interventions? Are the concepts, approaches or methodologies,
instrumentation, or interventions novel to one field of research or novel
in a broad sense? Is a refinement, improvement, or new application of
theoretical concepts, approaches or methodologies, instrumentation, or
interventions proposed?

4. Approach. Are the overall strategy, methodology, and analyses well-

reasoned and appropriate to accomplish the specific aims of the
 project? Are potential problems, alternative strategies, and benchmarks
for success presented? If the project is in the early stages of
development, will the strategy establish feasibility and will particularly
risky aspects be managed? If the project involves clinical research, are
the plans for 1) protection of human subjects from research risks, and
2) inclusion of minorities and members of both sexes/genders, as well
as the inclusion of children, justified in terms of the scientific goals and
research strategy proposed?

5. Environment. Will the scientific environment in which the work will be

done contribute to the probability of success? Are the institutional
support, equipment and other physical resources available to the
investigators adequate for the project proposed? Will the project benefit
from unique features of the scientific environment, subject populations,
or collaborative arrangements?

Additional Review Criteria. As applicable for the project proposed,

reviewers will consider the following additional items in the determination
of scientific and technical merit, but will not give separate scores for these
items.

Protections for Human Subjects

Inclusion of Women, Minorities, and Children
Vertebrate Animals
Biohazards
Resubmission
Renewal
Revision

Additional Review Considerations. As applicable for the project

proposed, reviewers will address each of the following items, but will not
give scores for these items and should not consider them in providing an
overall impact/priority score.

Applications from Foreign Organizations

Select Agent
Resource Sharing Plans
Budget and Period Support

For more details regarding the scoring system, see the OER Peer Review
Process Web page.

NOTE: Certain funding opportunity announcements

(FOAs) that are published in the NIH Guide for Grants
and Contracts may list additional elements under each of
the above criteria related to the specific requirement of
the RFA.
Independence , Resources and Institutional Support

Sufficient information must be included to demonstrate to reviewers and

NIH staff the high quality of the PD/PI, the co-investigators, available
research resources, and the applicant institution and its support of the
project. When possible, include letters of commitment for resources, such
as particular pieces of equipment or lab space, or letters from
collaborators stating their willingness to participate in the research.

Independence :

 It's important to provide the reviewers evidence that you are independent
and are prepared and able to lead. Consider whether your career stage and
expertise are appropriate to the size and scope of the project.
 If you have been published, you will want to reveal your independence as
an investigator through your publications.

Resources:

 Understand the level of resources needed to compete.

 Conduct an organizational assessment. Determine what resources and
support your organization has and what additional support you'll need.
 Consider whether the available equipment and facilities are adequate and
whether the environment is conducive to the research.
 Applicants should clearly state that they have the appropriate resources
to conduct the research, such as adequate equipment and laboratory space.

Institutional Support:

 Letters of reference and institutional commitment are important.

 Mention any start-up funds, support for a technician, etc. This is a
positive indicator of institutional commitment to the peer reviewers.

Collaborators

Determine the expertise needed for your research study team

(individuals, collaborating organizations, resources, etc.). Most scientific
work requires collaboration among researchers, and NIH is dedicated to
fostering such relationships.

 Letters of commitment in your application should clearly spell out the

roles of the collaborators. The grant application should contain a signed letter
from each collaborator to the applicant that lists the contribution he or she
intends to make and his or her commitment to the work. These letters are
often the primary assurance the reviewers have that this work will in fact be
done.
 For consultants, letters should include rate/charge for consulting services.
 If you are planning to use the multiple-PI model, then take the following
into consideration:
o The format, peer review and administration of applications
submitted under the multiple-PI model do have some significant differences
from the traditional single-PI model. Therefore, it is essential to consider all
aspects of the funding mechanism before submitting an application,
regardless of the type of research proposal to be submitted.
o All applicants proposing team science efforts are strongly
encouraged to contact their NIH program officials at the earliest possible
date to discuss the appropriateness of the multiple-PI model for the support
of their research.

INSIDER TIP: Reviewers with expertise in your area will

best recognize the potential for your research to advance
science. Applicants may request particular study sections
(and even a particular IC) in a cover letter submitted
with the application. The letter is stored in a separate
location and not forwarded to reviewers. Review the
rosters of the scientific review groups to get your
application assigned to a study section where some
members have the appropriate expertise to review your
project. This is an opportunity to also provide names of
any reviewers that may have a conflict of interest and
should not be considered as reviewers of your
application. It is important to match your area of
research with the areas reviewed by the study section.

Are You a New or Early Stage Investigator?

 Determine whether you qualify as a new investigator based on the

NIH definition of new investigator. NIH offers funding opportunities
tailored to new investigators, such as the NIH Director's New
Innovator Award. More information on NIH programs designed for new
investigators can be found on the New Investigators Program Web
page.
 NIH staff is on the lookout for new and early stage investigators. Check
your eRA Commons account and ensure your funding history and the date of
your residency or terminal degree are accurate to ensure that you are
identified appropriately as a new or early stage investigator. The eRA system
calculates eligibility based on the information associated with the applicant’s
PD/PI profile and account.

 It is to your advantage to identify yourself as a new investigator because

reviewers are instructed to give special consideration to new investigators.
Reviewers will give greater consideration to the proposed approach, rather
than the track record.
 First-time applicants may have less preliminary data and fewer
publications than more seasoned investigators, and NIH reviewers
understand this. Reviewers instead place more emphasis on how the
investigator has demonstrated that he or she is truly independent of
any former mentors, whether he or she has some of his or her own
resources and institutional support, and whether he or she is able to
independently lead the research.

Foreign Involvement – Institution and/or Investigator

 Foreign PD/PIs and those from foreign institutions are highly

encouraged to check the eligibility guidelines provided in every FOA.
 The appropriate checkbox on the PHS 398 Grant Application should
be marked if the application is being submitted by a domestic
institution with a foreign component or if your institution is overseas.
 There are specific requirements and guidelines for research
involving foreign institutions that will need to be considered when
planning and writing an NIH application (e.g. categorical budgets only,
special select agents requirements, etc.)
 Foreign PD/PI's and those from foreign institutions are highly encouraged
to contact an NIH NIH program officer as soon as possible in the planning and
writing stages.

Developing Your Research Plan

The research plan describes the proposed research, stating its significance
and how it will be conducted. Remember, 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 will be familiar.

 All reviewers are important to you because each reviewer gets one vote.
 To succeed in peer review, you must win over the assigned reviewers .
They act as your advocates in guiding the review panel's discussion of your
application.
 Write and organize your application so the primary reviewer can readily
grasp and explain what you are proposing and advocate for your application.

INSIDER TIP: Appeal to the reviewers and the funding

ICs by using language that stresses the significance of
your proposed work.
Additional Elements Required in a Grant Application

The following elements need to be included in the grant application as

appropriate. Unless stated, these elements do not influence the rating
(priority score) of the application. However, the reviewers are asked to
comment on the adequacy of the information provided for each element.
Any concerns the reviewers identify may negatively affect and postpone
the granting of an award.

 Appendix Materials
T he Appendix may not be used to circumvent the page limitations of the
Research Plan. Essential information should be included within the body of
the grant application. The appendices should contain supportive or
supplemental information.
 Bibliography & References Cited (formerly “Literature Cited”)
Provide a bibliography of any references cited in the Research Plan. Each
reference must include the names of all authors (in the same sequence in
which they appear in the publication), the article and journal title, book title,
volume number, page numbers, and year of publication. Make sure that only
bibliographic citations are included. Be especially careful to follow scholarly
practices in providing citations for source materials relied upon when
preparing any section of the application. Note the location of this information
is slightly different in the SF424 R&R and the PHS398. Please read the
application instructions carefully for whichever application you are using.
 Care and Use of Vertebrate Animals in Research
If you are planning to use live vertebrate animals in the project, you must
adhere to the requirements in the Public Health Service (PHS) Policy : HTML
Version and PDF Version. The PHS Policy is summarized in the brochure What
Investigators Need to Know About the Use of Animals. Additional information
can be found at:
o Office of Laboratory Animal Welfare Web Site
o NIAID's tutorial: Requirement for Grantees Using Research Animals
 Consortium/Contractual Arrangements
Explain the programmatic, fiscal, and administrative arrangements to be
made between the applicant organization and the consortium organization(s).
 Consultants
Attach appropriate letters from all consultants confirming their roles in the
project. For consultants, letters should include rate/charge for consulting
services.
 Facilities & Other Resources
This information is used to assess the capability of the organizational
resources available to perform the effort proposed. Identify the facilities to be
used (Laboratory, Animal, Computer, Office, Clinical and Other). If
appropriate, indicate their capacities, pertinent capabilities, relative proximity
and extent of availability to the project. Describe only those resources that
are directly applicable to the proposed work.
 Inclusion of Women, Minorities and Children in Research
Peer reviewers will also assess the adequacy of plans to include subjects from
both genders, all racial and ethnic groups (and subgroups), and children, as
appropriate, for the scientific goals of the research will be assessed. Plans for
the recruitment and retention of subjects will also be evaluated.
  Protection of Human Subjects from Research Risk
Applicants must assure NIH that all human subjects are protected. Reviewers
will assess the potential risk to human subjects in proposed research and
evaluate what protections are in place to guard against any research-related
risk. Awards cannot be made until assurances are on file with the Office for
Human Research Protections (OHRP). Decision charts are presented that are
helpful in thinking through relevant human subject protections issues (see
http://www.hhs.gov/ohrp/policy/checklists/decisioncharts.html).
 Resource Sharing Plan(s)
This section includes Data Sharing Plan, when applicable, and Sharing Model
Organisms. For more information on data sharing, please see the NIH website
at http://grants.nih.gov/grants/ policy/data_sharing/.
 Select Agents
Identify any select agents to be used in the proposed research. Select agents
are hazardous biological agents and toxins that HHS or USDA have identified
as having the potential to pose a severe threat to public health and safety, to
animal and plant health, or to animal and plant products. CDC maintains a list
of HHS and USDA Select Agents and Toxins.
 Multiple PD/PI
For applications designating multiple PDs/PIs, you must include a leadership
plan.
 Use of Internet Sites
NIH instituted a policy that prohibits the use of World Wide Web addresses
(URLs) in grant 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 page limit, and thereby giving
an unfair advantage to some applicants and a large additional burden for
reviewers.

Important Writing Tips

NIH encourages applicants to describe their research in terms that are easily
understood by peer reviewers, scientists, Congress, and the public.

Titles, abstracts and statements of public health relevance should:

1. Convey the value of the research in plain language – clear, succinct, and
professional
2. Be comprehensible to both scientists and the public
3. Relay the potential impact of the research on health

For more information and writing examples, see Communicating Research

Intent and Value in NIH Applications.

 The instructions require that materials be organized in a particular

format. Reviewers are accustomed to finding information in specific sections
of the application. Organize your application to effortlessly guide reviewers
 through it. This creates an efficient evaluation process and saves reviewers
from hunting for required information.
 Think like a reviewer. A reviewer must often read 10 to 15 applications in
great detail and form an opinion about each of them. Your application has a
better chance at being successful, if it is easy to read and follows the usual
format. Make a good impression by submitting a clear, well-written, properly
organized application.
 Start with an outline following the suggested organization of the
application.
 Be complete and include all pertinent information.
 Be organized and logical. The thought process of the application should
be easy to follow. The parts of the application should fit together.
 Write one sentence summarizing the topic sentence of each main
section . Do the same for each main point in the outline.
 Make one point in each paragraph. This is key for readability. Keep
sentences to 20 words or less. Write simple, clear sentences.
 Before you start writing the application, think about the budget and how
it is related to your research plan. Remember that everything in the budget
must be justified by the work you've proposed to do.
 Be realistic. Don't propose more work than can be reasonably done
during the proposed project period. Make sure that the personnel have
appropriate scientific expertise and training. Make sure that the budget is
reasonable and well-justified.
 Capture the reviewers' attention by making the case for why NIH should
fund your research. Tell reviewers why testing your hypothesis is worth NIH's
money, why you are the person to do it, and how your institution can give
you the support you'll need to get it done. Be persuasive.
 Include enough background information to enable an intelligent reader to
understand your proposed work.
 Although though not a requirement for assignment purposes, a cover
letter can help the Division of Receipt and Referral in the Center for Scientific
Review assign your application for initial peer review and to an IC for possible
funding.
 Use the active, rather than passive, voice. For example, write "We will
develop an experiment, "not "An experiment will be developed ."
 Use a clear and concise writing style so that a non-expert may
understand the proposed research. Make your points as directly as possible.
Use basic English, avoiding jargon or excessive language. Be consistent with
terms, references and writing style.
 Spell out all acronyms on first reference.

Remember the Details! Below are tips to assist you in

meeting the requirements on font, font size, margins and
spacing. Be sure to follow the format in the instructions
and label sections as requested.

 Use an Arial, Helvetica, Palatino Linotype, or Georgia

typeface, a black font color, and a font size of 11 points or
larger. (A Symbol font may be used to insert Greek letters
or special characters; the font size requirement still
 applies.)

 Type density, including characters and spaces, must be

no more than 15 characters per inch. Type may be no more
than six lines per inch. Use standard paper size (8 ½" x 11)
. Use at least one-half inch margins (top, bottom, left, and
right) for all pages. No information should appear in the
margins.

 Use sub-headings, short paragraphs, and other techniques to make the

application as easy to navigate as possible. Be specific and informative, and
avoid redundancies.
 Use diagrams, figures and tables, and include appropriate legends, to
assist the reviewers to understand complex information. These should
complement the text and be appropriately inserted. Make sure the figures
and labels are readable in the size they will appear in the application.
 Use bullets and numbered lists for effective organization. Indents and
bold print add readability. Bolding highlights key concepts and allows
reviewers to scan the pages and retrieve information quickly. Do not use
headers or footers.
 Identify weak links in your application so the application you submit is
solid, making a strong case for your project.
 If writing is not your forte, seek help!

Proofreading and Final Edits

 Allow sufficient time to put the completed application aside, and then edit
it from a fresh vantage point. Try proofreading by reading the application
aloud.
 Allow time for an internal review by collaborators, colleagues, mentors
and make revisions/edits from that review. If possible, have both experts in
your field and those who are less familiar with your science provide feedback.
The application should be easy to understand by all.
 It is a good idea to have an independent expert provide an objective
critique of your application. If possible, arrange for neutral third-party
reviewers.
 If more than one investigator is contributing to the writing, it would be
helpful to have one overall editor.
 Have zero tolerance for typographical errors, misspellings, grammatical
mistakes or sloppy formatting. A sloppy or disorganized application may lead
the reviewers to conclude that your research may be conducted in the same
manner.
 Prior to submission, perform a final proofread of the entire grant
application.
Peer Review Process
On This Page: What's New?
 Overview
 First Level of Review - Scientific Review
Groups
o Peer Review Roles and Meeting
Overview
o Peer Review Criteria and
Considerations
o Scoring
o Summary Statement
o Appeals
 Second Level Of Review - Advisory
Council/Board
 Post-Review

What's New?
NIH's Center for Scientific Review (CSR) maintains data on impact scores
for R01 grant applications given by each permanent study section
managed by CSR. These data form the basis for calculating percentile
rankings for certain meetings and application types, and the percentile
bases are recalibrated occasionally. Currently, CSR is adjusting the
percentile bases for a number of permanent study sections and Special
Emphasis Panels (SEPs). On March 8, 2013, for applications that are
reviewed in SEPs this round and should be percentiled:

 a percentile ranking will be assigned, calculated from the new

percentile base,
 revised summary statements will be issued for those applications
missing percentile scores, and
 the percentile ranking will appear in the Principal Investigator's eRA
Commons account.

Overview
NIH policy is intended to ensure that grant applications submitted to the
NIH are evaluated on the basis of a process that is fair, equitable, timely,
and free of bias. The NIH dual peer review system is mandated by
statute in accordance with section 492 of the Public Health Service Act
and federal regulations governing "Scientific Peer Review of Research
Grant Applications and Research and Development Contract Projects" (42
CFR Part 52h).
The first level of review is carried out by a Scientific Review Group (SRG)
composed primarily of non-federal scientists who have expertise in
relevant scientific disciplines and current research areas. The second
level of review is performed by Institute and Center (IC) National
Advisory Councils or Boards. Councils are composed of both scientific and
public representatives chosen for their expertise, interest, or activity in
matters related to health and disease. Only applications that are
favorably recommended by both the SRG and the Advisory Council may
be recommended for funding.

First Level of Review

Initial peer review meetings are administered by either the Center for
Scientific Review (CSR) or another NIH IC. The focus of review is
specified in the Funding Opportunity Announcement. Peer review
meetings are announced in the Federal Register. The meetings are closed
to the public, although some meetings may have an open session; the
Federal Register provides the details of each meeting.
A. Peer Review Roles and Meeting Overview
Scientific Review Officer:

Each SRG is led by a Scientific Review Officer (SRO). The SRO is an

extramural staff scientist and the Designated Federal Official responsible
for ensuring that each application receives an objective and fair initial
peer review, and that all applicable laws, regulations, and policies are
followed.
SROs:

 Analyze the content of each application, and check for completeness.

 Document and manage conflicts of interest.
 Recruit qualified reviewers based on scientific and technical
qualifications and other considerations, including:
o Authority in their scientific field (42 CFR 52h.4)
o Dedication to high quality, fair, and objective reviews
o Ability to work collegially in a group setting
o Experience in research grant review
o Balanced representation

 Assign applications to reviewers for critique preparation and

assignment of individual criterion scores.
 Attend and oversee administrative and regulatory aspects of peer
review meetings.
 Prepare summary statements for all applications reviewed.

SRG Members
 Chair:

 Serves as moderator of the discussion of scientific and technical

merit of the applications under review.
 Is also a peer reviewer for the meeting.

Reviewers:

 Declare Conflicts of Interest with specific applications following NIH

guidance
 Receive access to the grant applications approximately six weeks
prior to the peer review meeting.
 Prepare a written critique (using Review Critique Fill-able
Templates) for each application assigned, based on review criteria
and judgment of merit.
 Assign a numerical score to each scored review criterion (see
Review Criteria at a Glance).
 Make recommendations concerning the scientific and technical
merit of applications under review, in the form of final written
comments and numerical scores.
 Make recommendations concerning protections for human subjects;
inclusion of women, minorities, and children in clinical research;
welfare of vertebrate animals; and other areas as applicable for the
application (see guidance for reviewers on Human Subjects
Protection and Inclusion, Human Embryonic Stem Cells, and
Vertebrate Animals).
 Make recommendations concerning appropriateness of budget
requests (see Budget Information for Reviewers).

Other NIH Staff

 Federal officials who have need-to-know or pertinent related

responsibilities are permitted to attend closed review meetings.
 NIH IC or other federal staff members wishing to attend an SRG
meeting must have advance approval from the responsible SRO.
These individuals may provide programmatic or grants
management input at the SRO's discretion.

Peer Review Meeting Procedures

 Applications are reviewed based on established review criteria (see

Review Criteria at a Glance).
 Assigned reviewers summarize their prepared critiques for the
group.
 An open discussion follows.
 Final scoring of overall impact scores is conducted by private ballot.

B. Peer Review Criteria and Considerations

 Enhanced review criteria were announced in NOT-OD-09-025 for the
evaluation of applications for research grants and cooperative
agreements received for potential FY2010 funding and thereafter.
Enhanced review criteria for other types of applications are available
through the Review Criteria at a Glance document.
Enhanced Review Criteria for Research Grants and Cooperative
Agreements
The mission of the NIH is to support science in pursuit of knowledge
about the biology and behavior of living systems and to apply that
knowledge to extend healthy life and reduce the burdens of illness and
disability. As part of this mission, applications submitted to the NIH for
grants or cooperative agreements to support biomedical and behavioral
research are evaluated for scientific and technical merit through the
NIH peer review system.
Overall Impact. Reviewers will provide an overall impact/priority
score to reflect their assessment of the likelihood for the project to
exert a sustained, powerful influence on the research field(s) involved,
in consideration of the following review criteria, and additional review
criteria (as applicable for the project proposed).
Scored Review Criteria. Reviewers will consider each of the review
criteria below in the determination of scientific and technical merit, and
give a separate score for each. An application does not need to be strong
in all categories to be judged likely to have major scientific impact. For
example, a project that by its nature is not innovative may be essential
to advance a field.
Significance. Does the project address an important problem or a
critical barrier to progress in the field? If the aims of the project are
achieved, how will scientific knowledge, technical capability, and/or
clinical practice be improved? How will successful completion of the
aims change the concepts, methods, technologies, treatments,
services, or preventative interventions that drive this field?
Investigator(s). Are the PD/PIs, collaborators, and other
researchers well suited to the project? If Early Stage Investigators or
New Investigators, or in the early stages of independent careers, do
they have appropriate experience and training? If established, have
they demonstrated an ongoing record of accomplishments that have
advanced their field(s)? If the project is collaborative or multi-PD/PI,
do the investigators have complementary and integrated expertise;
are their leadership approach, governance and organizational
structure appropriate for the project?
Innovation. Does the application challenge and seek to shift current
research or clinical practice paradigms by utilizing novel theoretical
concepts, approaches or methodologies, instrumentation, or
 interventions? Are the concepts, approaches or methodologies,
instrumentation, or interventions novel to one field of research or
novel in a broad sense? Is a refinement, improvement, or new
application of theoretical concepts, approaches or methodologies,
instrumentation, or interventions proposed?
Approach. Are the overall strategy, methodology, and analyses well-
reasoned and appropriate to accomplish the specific aims of the
project? Are potential problems, alternative strategies, and
benchmarks for success presented? If the project is in the early
stages of development, will the strategy establish feasibility and will
particularly risky aspects be managed? If the project involves clinical
research, are the plans for 1) protection of human subjects from
research risks, and 2) inclusion of minorities and members of both
sexes/genders, as well as the inclusion of children, justified in terms
of the scientific goals and research strategy proposed?
Environment. Will the scientific environment in which the work will
be done contribute to the probability of success? Are the institutional
support, equipment and other physical resources available to the
investigators adequate for the project proposed? Will the project
benefit from unique features of the scientific environment, subject
populations, or collaborative arrangements?
Additional Review Criteria. As applicable for the project
proposed, reviewers will evaluate the following additional items
while determining scientific and technical merit and in providing an
overall impact/priority score, but will not give separate scores for
these items.
Protections for Human Subjects
Inclusion of Women, Minorities, and Children
Vertebrate Animals
Biohazards
Resubmission
Renewal
Revision
Additional Review Considerations. As applicable for the project
proposed, reviewers will consider each of the following items, but
will not give scores for these items and should not consider them in
providing an overall impact/priority score.
Applications from Foreign Organizations
Select Agent
Resource Sharing Plans
Budget and Period Support
C. Scoring
The scoring system described below was implemented for
applications submitted for funding consideration for FY2010 and
thereafter (NOT-OD-09-024)
Before the SRG meeting, each reviewer and discussant assigned to
an application gives a separate score for each of (at least) five
review criteria (i.e., Significance, Investigator(s), Innovation,
Approach, and Environment for research grants and cooperative
agreements; see above). For all applications, even those not
discussed by the full committee, the individual scores of the
assigned reviewers and discussant(s) for these criteria are reported
to the applicant.
In addition, each reviewer and discussant assigned to an
application gives a preliminary overall impact score for that
application. The preliminary scores are used to determine which
applications will be discussed in full. For each application that is
discussed at the meeting, a final impact score is given by each
eligible committee member (without conflicts of interest) including
the assigned reviewers. Each member's score reflects his/her
evaluation of the overall impact that the project is likely to have on
the research field(s) involved, rather than being a calculation of the
reviewer's scores for each criterion.
The scoring system utilizes a 9-point rating scale (1 = exceptional;
9 = poor). The final overall impact score for each discussed
application is determined by calculating the mean score from all the
eligible members' impact scores, and multiplying the average by
10; the final overall impact score is reported on the summary
statement. Thus, the final overall impact scores range from 10
(high impact) through 90 (low impact). Numerical impact scores
are not reported for applications that are not discussed (ND), which
may be reported as ++ on the face page of the summary
statement and typically rank in the bottom half of the applications.
Applicants just receiving their scores or summary statements,
should consult our What's Next page for detailed guidance.
Applicants seeking advice beyond that available online may want to
contact the NIH Program Officer listed at the top of the summary
statement.
An application may be designated Not Recommended for Further
Consideration (NRFC) by the Scientific Review Group if it lacks
significant and substantial merit; presents serious ethical problems
in the protection of human subjects from research risks; or
presents serious ethical problems in the use of vertebrate animals,
biohazards, and/or select agents. Applications designated as NRFC
do not proceed to the second level of peer review (National
Advisory Council/Board) because they cannot be funded.
The following guidance has been given to reviewers to determine
individual review criterion and overall impact scores:

High Impact
Table

Score Descriptor Additional Guidance on

Strengths/Weaknesses
1 Exceptional Exceptionally strong with essentially
no weaknesses

2 Outstanding Extremely strong with negligible

weaknesses

3 Excellent Very strong with only some minor

weaknesses

Medium
Impact Table

Score Descriptor Additional Guidance on

Strengths/Weaknesses
4 Very Good Strong but with numerous minor
weaknesses

5 Good Strong but with at least one

moderate weakness

6 Satisfactory Some strengths but also some

moderate weaknesses

Low Impact
Table

Score Descriptor Additional Guidance on

Strengths/Weaknesses
7 Fair Some strengths but with at least one
major weakness

8 Marginal A few strengths and a few major

 weaknesses

9 Poor Very few strengths and numerous

major weaknesses

Non-numeric score options: NR = Not Recommended for Further

Consideration,
DF = Deferred, AB = Abstention, CF = Conflict, NP = Not Present,
ND = Not Discussed

Minor Weakness: An easily addressable weakness that does not

substantially lessen impact
Moderate Weakness: A weakness that lessens impact
Major Weakness: A weakness that severely limits impact
D. Summary Statement
Applications that are not discussed at the meeting will be given the
designation “ND” as an overall impact score, but the applicant, as
well as NIH staff, will see the scores from the assigned reviewers
and discussants for each of the scored review criteria as additional
feedback on their summary statement.
Understanding the Percentile

 A percentile is the approximate percentage of applications that

received a better overall impact/priority score from the study
section during the past year.
 For applications reviewed in ad hoc study sections, a different
base may be used to calculate percentiles.
 All percentiles are reported as whole numbers
 Only a subset of all applications receive percentiles. The types of
applications that are percentiled vary across different NIH
Institutes and Centers.
 The summary statement will identify the base that was used to
determine the percentile.

E. Appeals
NIH established a peer review appeal system (see NOT-OD-11-064)
to provide investigators and applicant organizations the opportunity
to seek reconsideration of the initial review results if, after
consideration of the summary statement, they believe the review
process was flawed as outlined below. This policy does not apply to
appeals of the technical evaluation of R&D contract projects
through the NIH peer review process, appeals of NIH funding
decisions, or appeals of decisions concerning extensions of MERIT
award.
 An appeal is a written communication from a Project
Director/Principal Investigator (PD/PI) and/or official of the
applicant institution that is received after issuance of the summary
statement and up to 30 calendar days after the second level of
peer review, and describes a flaw in the review process for a
particular application. It must display concurrence of the Authorized
Organization Representative (AOR). An appeal letter will be
accepted only if the letter 1) describes a flaw(s) or perceived
flaw(s) in the review process for the application in question, 2)
explains the reasons for the appeal, and 3) is based on one or more
of the following issues related to the process of the initial peer
review:

 Evidence of bias on the part of one or more peer reviewers

 Conflict of interest, as specified in regulation at 42 CFR 52h
“Scientific Peer Review of Research Grant Applications and
Research and Development Contract Projects”, on the part of one
or more non-federal peer reviewers
 Lack of appropriate expertise within the SRG
 Factual error(s) made by one or more reviewers that could have
altered the outcome of review substantially.

Appeal letters based solely on differences of scientific opinion will

not be accepted. A letter that does not meet these criteria and/or
does not include the concurrence of the AOR will not be considered
an appeal, but rather a grievance. The IC will handle grievances
according to IC-specific procedures.
The IC cannot deny the PD/PI and/or the applicant institution the
opportunity to have an appeal letter made available to Council, but
the IC may determine which appeal letters warrant discussion by
the Council members, and Council members may raise certain ones
for discussion if they so choose. The Council may concur:

 with the appeal, and recommend that the application be re-

reviewed.
 with the SRG’s recommendation and deny the appeal.

The recommendation of Council concerning resolution of an appeal

is final and will not be considered again by the NIH through this or
another process.

Second Level of Review - Advisory Council or Board

Who Reviews the Application?
The Advisory Council/Board of the potential awarding IC performs the
second level of review. Advisory Councils/Boards are composed of
scientists from the extramural research community and public
representatives ( NIH Federal Advisory Committee Information ).
Members are chosen by the respective IC and are approved by the
Department of Health and Human Services. For certain committees,
members are appointed by the President of the United States.
Recommendation Process

 NIH program staff members examine applications, their overall

impact scores, percentile rankings (if applicable) and their summary
statements and consider these against the IC's needs.
 Program staff provide a grant-funding plan to the Advisory
Board/Council.
 Beginning in September 2012, Council members will receive a list
of competing applications that will be considered for funding from
PD/PIs that meet the threshold for Special Council Review. These are
investigators who currently receive $1 million or more in direct costs of
NIH funding to support Research Project Grants (see NOT-OD-12-140).
Council members will be asked to recommend consideration of funding
for applications that afford a unique opportunity to advance research
which is both highly promising and distinct from the other funded
projects from the PD/PI. This does not represent a cap to NIH funding.
 The Advisory Board/Council also considers the IC’s goals and needs
and advises the IC director.
 The IC director makes final funding decisions based on staff and
Advisory Council/Board advice.

Post-Review
Not Funded - Next Steps?
The NIH receives thousands of applications for each application receipt
round. Funding on the first attempt is difficult, but not impossible. If an
application does not result in funding, there may be an opportunity to
respond to the reviewers’ comments and resubmit the application.
Applicants just receiving their summary statements, should consult our
Next Steps page for detailed guidance. Applicants seeking advice beyond
that available online may want to contact the NIH Program Officer listed
at the top of the summary statement.
Fundable Score - Next Steps?
Some of the ICs publish paylines as part of their funding strategies to
guide applicants on their likelihood of receiving funding. Application
scores can only be compared against the payline for the fiscal year when
the application will be considered for funding, which is not necessarily the
year when it was submitted. There may be a delay of several months to
determine paylines at the beginning of fiscal years. If the application is
assigned to an IC that does not announce a payline, the Program Officer
listed at the top of the summary statement may be able to provide
guidance on the likelihood of funding. After the Advisory Council meeting,
if an application results in an award, the applicant will be working closely
with the program officer of the funding Institute or Center on scientific
and programmatic matters and a Grants Management Officer on
budgetary or administrative issues. The Grants Management Specialist
will contact the applicant to collect information needed to prepare the
award.