How to Write a Research Project Grant Application

Table of Contents (click to jump to sections)

Introduction
Strategy for Getting an NIH Grant
Writing an Application for a Research Project Grant
Before You Begin
Application Contents
Developing Your Research Plan
Application Contents Other Than the Research Plan
Writing and Formatting
Submitting Your Grant Application
Problems and Concerns Commonly Cited by Reviewers
Referral and Assignment of the Application
Review of Research Project Applications
How Funding Is Decided
When You Have Not Obtained Funding
When Your Application Is Approved for Funding

 

Introduction

This document is intended to complement existing documents found on the National Institutes of Health and National Institute of Allergy and Infectious Diseases webpages. This document has been customized and updated for the National Institute of Neurological Disorders and Stroke (NINDS) and other neuroscience granting agencies.

Although the advice provided in this document is relevant to all research grants, it is geared toward the traditional research project grant (R01). Research Project Grants support a focused research program conducted by a principal investigator with or without collaborators, postdoctoral trainees, graduate students and/or technicians. These applications must be submitted electronically via Grants.gov, using the SF 424(R&R) application.  The following web site provides full information on the electronic submission process, including a logically organized and very helpful set of FAQ:

http://era.nih.gov/ElectronicReceipt/index.htm

Find out more about NINDS grant mechanisms.

Note: All electronically submitted applications must be responding to a specific Funding Opportunity Announcement (FOA).  However, it is not necessary to respond to a specific Program Announcement (PA) or Request for Applications (RFA). There are a series of “Parent Announcements”, which are FOA’s for “generic” R01 or other grant mechanisms.  A list of all of the parent announcements can be found at

http://grants1.nih.gov/grants/guide/parent_announcements.htm

If you are applying for a grant in response to a Request for Applications (RFA) or a Program Announcement (PA), carefully read the review criteria and any special instructions before preparing the application.

For additional advice on other granting mechanisms, contact an NIH program administrator or call 301/496-9248.

Prior to the publication of this document, NINDS made several other documents about grant writing and funding available. These documents are less complete but do present a useful introduction to the topic of seeking and writing Federal grant applications.

• Common Mistakes in NIH Applications
• Writing a Grant Application: A "Technical" Checklist
• Frequently Asked Questions about NINDS Research Funding
• Links to More Information on Writing Grants

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Strategy for Getting an NIH Grant

• Assess competition in the field.
• Know the level of resources needed to compete.
• • Do an organizational assessment.
  • Look for opportunities to build research with support from various sources.
  • Get a mentor.
• Know the opportunities in the field for
• • collaboration with a known laboratory or mentor
  • carving out a niche
• Find out which NIH institutes supporting research in your area are seeking applications.
• • See our list of Funding Initiatives
  • discuss your ideas with Institute Extramural program staff.
• Make sure you and your collaborators are properly trained for the research.
• Closely examine grant applications from successful grantees.
• Read the instructions for the correct grant application kit (SF 424(R&R) or PHS 398), then read them again. Follow them to the letter.
• Have several experienced grantees critique your application.
• Consider requesting NIH to refer your application to a study section that has a high level of interest and expertise in your research topic.

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Writing an Application for a Research Project Grant

There are several components to a strong grant application. First, the subject must be creative, exciting, and worthy of funding. Then, the project must be developed through a rigorous, well-defined experimental plan. Finally, you must make sure that the information is presented in clear language and that your application follows the rules and guidelines detailed in the grant application kit, (SF 424(R&R))

This document will help you make sure your application for a research project grant (R01) addresses the key questions reviewers ask.

Eight Basic Questions Reviewers Ask

• How high are the intellectual quality and merit of the study?
• What is its potential impact?
• How novel is the proposal? If not novel, to what extent does potential impact overcome this lack? Is the research likely to produce new data and concepts or confirm existing hypotheses?
• Is the hypothesis valid and have you presented evidence supporting it?
• Are the aims logical?
• Are the procedures appropriate, adequate, and feasible for the research?
• Are the investigators qualified? Have they shown competence, credentials, and experience?
• Are the facilities adequate and the environment conducive to the research?

Writing a grant application is a major undertaking. Below is advice from experienced NIH staff to help you succeed. Please note that this document does not repeat instructions in the SF 424(R&R) application kit.

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Before You Begin

Before you start writing the application, make sure you have done your homework: know the field, choose an excellent idea to pursue, and equally important, read the entire grant application kit (SF 424 or PHS 398) very carefully. This "how to" document does not repeat instructions contained in SF 424 or PHS 398.

Begin by focusing on the big picture. It is critical that you are intimately familiar with the field in which you are considering applying to NIH for funding. You must be aware of the field's directions, knowledge gaps, and research already being done. Your application will be reviewed by your peers, investigators who are knowledgeable about the research area of your proposal.

To succeed, you will have to be at least as knowledgeable as they are. Consider the reviewers to be "informed strangers." You must include enough detail to convince them your hypothesis is sound and important, your aims are logical and feasible, you understand potential problems, and you can properly analyze the data.

Developing the Hypothesis

• Most reviewers feel that a good grant application is driven by a strong hypothesis. The hypothesis is the foundation of your application. Make sure it's solid. It must be important to the field, and you must have a means of testing it.
• Provide a rationale for the hypothesis. Make sure it's based on current scientific literature. Consider alternative hypotheses. Your research plan will explain why you chose the one you selected.
• A good hypothesis should increase understanding of biologic processes, diseases, treatments and/or preventions.
• Your proposal should be driven by one or more hypotheses, not by advances in technology (i.e., it should not be a method in search of a problem). Also, avoid proposing a "fishing expedition" that lacks solid scientific basis.
• State your hypothesis in both the specific aims section of the research plan and the abstract.

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Application Contents

Before you start writing, carefully read SF 424 or PHS 398, Application for a Public Health Service Grant.

Please note changes made as a result of modular grants (sections with asterisks below). Go to the NIH modular grants and applications Web page and the notice in the NIH Guide for Grants and Contracts for more information.

The SF 424 and PHS 398 grant application kit gives you information and guidance on these sections of the application:

• Face page
• Description (abstract)
• Performance sites
• Key personnel
• Table of contents
• * Detailed budget for initial budget period
• * Budget for entire proposed period of support
• **Biographical Sketch
• ** Other support
• Resources
• Research Plan
• Appendix
• Checklist
• Personnel report
• Personal data

* Not needed for modular applications. Modular procedures apply to R01, R03 (not supported by NINDS), R21, R15 and R21 applications requesting direct costs of $250,000 or less in all budget periods.

** Changed as a result of modular grants.

Outlined below are sections of the PHS 398 (5/2001) in the order in which you would likely develop them. As the biggest and most important part of your application upon which the rest hinges, the research plan is a good place to begin.

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Developing Your Research Plan

A top-quality research plan is the most important factor determining your application's success in peer review. As with a scientific publication, developing your ideas is key. Read the PHS 398 grant application kit carefully for specific elements to be included in the research plan.

Before proceeding into specific sections of the plan, here are some general tips:

• Your application should be based on a strong hypothesis.
• Be sure your project has a coherent direction.
• Keep the sections of the plan well coordinated and clearly related to the central focus.
• Emphasize mechanism: A good grant application asks questions about biological mechanisms.
• Don't be overly ambitious - your plan should be based on a feasible timetable.
• Specific aims and experiments should relate directly to the hypothesis to be tested.

A. Specific Aims

• Your specific aims are the objectives of your research project, what you want to accomplish. The project aims should be driven by the hypothesis you set out to test. Make sure they are highly focused.
• Begin this section by stating the general purpose or major objectives of your research. Be sure all objectives relate directly to the hypothesis you are setting out to test. If you have more than one hypothesis, state specific aims for each one. Keep in mind your research methods will relate directly to the aims you have described.
• State alternatives to your hypothesis and explain why you chose the one (or more) you selected.
• Choose objectives that can be easily assessed by the review committee. Do not confuse specific aims with long-term goals.

B. Background and Significance

• Keep the statement of significance brief. State how your research is innovative, how your proposal looks at a topic from a fresh point of view or develops or improves technology.
• Show how the hypothesis and research will increase knowledge in the field. Relate them to the longer-term, big picture scientific objectives and to the betterment of public health.
• Justify your proposal with background information about the research field that led to the research you are proposing. The literature section is very important because it shows reviewers you understand the field and have a balanced and adequate knowledge of it.
• Use this opportunity to reveal that you are aware of gaps or discrepancies in the field. Show familiarity with unpublished work, gained through personal contacts, as well.
• Identify the next logical stage of research beyond your current application.

C. Preliminary Studies/Progress Report

By providing preliminary data, this extremely important section helps build reviewers' confidence that you can handle the technologies, understand the methods, and interpret results.

• Preliminary data should support the hypothesis to be tested and the feasibility of the project.
• Explain how the preliminary results are valid and how early studies will be expanded in scope or size.
• Make sure you interpret results critically. Showing alternative meanings indicates that you've thought the problem through and will be able to meet future challenges.
• Preliminary data may consist of your own publications, publications of others, unpublished data from your own laboratory or from others, or some combination of these.
• Include manuscripts submitted for publication. Make sure it's clear which data are yours and which others reported.

D. Research Design and Methods

Describe the experimental design and procedures in detail and give a rationale for their use. Organize this section so each experiment or set of experiments corresponds to one of your specific aims and is stated in the same order. Even holding to this structure, the experiments still must follow a logical sequence. They must have a clear direction or priority, i.e., the experiments should follow from one another and have a clear starting or finishing point.

Convince reviewers that the methods you chose are appropriate to your specific aims, that you are familiar with them, and that, unless innovative, they are well established. If your methods are innovative, show how you have changed existing, proven methods while avoiding technical problems. Also, describe why the new methods are advantageous to the research you propose to do.

More and more applicants are including colored charts, graphs, and photographs in their applications. If you must use color to get your point across, it is wise to also place a copy of the item in an appendix, noting this in the body of the text. (However, do not put important figures only in the appendix, or overly-reduced figures in the body of the application with enlargements in the appendix. The Research Plan must be self-contained. The appendix should not be used to circumvent the Research Plan page limits.) Many applicants are not aware that most of the study section members receive only black and white photocopies of their original application. However, assigned reviewers do receive originals of the appendices (which is why five copies are requested) and usually receive original copies of the application as well.

Approach

• State why you chose your approach(es) as opposed to others.
• If you are choosing a nonstandard approach, explain why it is more advantageous than a conventional one. Ask yourself whether the innovative procedures are feasible and within your competence.
• Call attention to potential difficulties you may encounter with each approach. Reviewers will be aware of possible problems; convince them you can handle such circumstances. Propose alternatives that would circumvent potential limitations.
• Consider the limitations of each approach and how it may affect your results and the data generated.
• Spell it out in detail. While you may assume reviewers are experts in the field and familiar with current methodology, they will not make the same assumption about you. It is not sufficient to state, "We will grow a variety of viruses in cells using standard in vitro tissue culture techniques." Reviewers want to know which viruses, cells, and techniques; the rationale for using the particular system; and exactly how the techniques will be used. Details show you understand and can handle the research.
• Make sure any proposed model systems are appropriate to address the research questions and are highly relevant to the medical problem being modeled.

Results

• Show you are aware of the limits to - and value of - the kinds of results you can expect based on current knowledge of the subject. State the conditions under which the data would support or contradict the hypothesis and the limits you will observe in interpreting the results.
• Show reviewers you will be able to interpret your results by revealing your understanding of the complexities of the subject.
• Many applications benefit from statistical analysis. The early involvement of a statistician to determine the amount of data to collect and the methods for analyses will favorably impress reviewers.
• Describe your proposed statistical methods for analyzing the data you plan to collect. Define the criteria for evaluating the success or failure of a specific test.

Other pointers

• Read the PHS 398 carefully for specific requirements, especially those involving human subjects.
• Estimate how much you expect to accomplish each year of the grant and state any potential delays you can anticipate.
• Describe sources of reagents, animals or equipment not generally available. If collaborators will provide them, include letters from the sources in your application.
• Describe any procedures, situations, or materials that may be hazardous and precautions you will take.
• Include supporting data. Where appropriate, include well-designed tables and figures. Use titles that are accurate and informative. Label the axes and include legends. Reviewers will look for discrepancies between your data and text.
• Include relevant publications. If you (or your collaborators) have publications showing your use of the proposed methods, put them in the appendix.

E. Human Subjects

Assuring NIH human subjects are protected is a key responsibility of the applicant, in concert with the applicant's institution. Awards cannot be made until assurances are on file here.

If your proposed research does not involve human subjects, indicate this by noting "Not applicable in this section of the 398." Anyone reading your application will know immediately you have not just forgotten to complete this section.

If your proposed research involves human subjects or samples from human subjects, read carefully and follow the Human Subjects Research section of the PHS 398 instructions.

Include enough information so reviewers have no questions about what you propose to do. In addition, your research plan must be certified by your institution's institutional review board (IRB) prior to funding (unless exempt). Though IRB approval is not required at the time of application, you should start the process early because revisions and final approval can take time.

Before an application can be funded, a Human Subjects Assurance must be on file with the Office of Human Research Protections. Contact OHRP or your institutions grants and contracts office for details and help.

F. Vertebrate Animals

If applicable, your application should include:

• A detailed description of the proposed use of animals.
• A justification for the choice of species and number of animals to be used (describe any statistical methodology used for this determination).
• Information on the veterinary care of the animals.
• An explanation of procedures to ensure that the animals will not experience unnecessary discomfort, distress, pain, or injury.
• Justification for any euthanasia method to be used.

If the proposed research involves vertebrate animals, your project must be reviewed and approved by an institutional animal care and use committee (IACUC) prior to review, and an Animal Welfare Assurance must be on file with the Office of Laboratory Animal Welfare. See the instructions for item 5 of the face page of PHS 398 for further details. For more information, contact OLAW or your institution's grant or contracts office.

G. Literature Cited

Refer to the literature thoroughly and thoughtfully but not to excess. The publications you cite need not be exhaustive but should include those most relevant to your proposed research.

Research proposals typically do not fare well when applicants fail to reference relevant published research, particularly if it indicates that the proposed approach has already been attempted or the methods found to be inappropriate for answering the questions posed.

Each citation must include the names of all authors (not et al.), name of the book or journal, volume number, page numbers (not first page only), and year of publication.

H. Consortium/Contractual Arrangements

This section should briefly describe any consortium and contractual arrangements you have made with regard to the proposed research plan. The roles of individuals or organizations with whom you have made such arrangements should be noted and reference made to any letters from them that are included in the application. Letters should describe the individual's or organization's understanding of the consortium or contractual arrangements.

I. Consultants

Careful selection and addition of consultants can add credibility to your application and greatly improve its quality. A letter describing the willingness of an investigator to participate as a consultant to your project should be included in your application.

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Application Contents Other Than the Research Plan

Congratulations, you have completed the hardest part of your application, the research plan. Now, you're ready to work on the other parts. Keep in mind some required information is always changing. Notices in the NIH Guide, and NINDS Funding Opportunities will have the latest changes, the most recent and important of which is the switch to a modular format for most grants. For additional information on modular grants and applications, visit the NIH web page and the NIH grant guide.

Abstract (Page 2)

• Write this carefully because the NIH referral officer depends heavily on the abstract and title to assign your application to a peer review panel and to an IC (Institute or Center) for award. Clarity will also help direct your application to the most appropriate primary reviewers and may encourage other reviewers in the study section to read it.
• Write your abstract after you have finished your research plan. Make it a clear, succinct summary of your project within the 200-word limit. It should state your hypothesis, objectives, why the objectives are important and innovative, and plans and methods for accomplishing your goals.

Title

• Make your title specific and detailed. If your application is a revision, do NOT change the title.
• Stay within the 56-character limitation (this includes spaces between words).

Biographical Sketches

This section is your chance to showcase the knowledge, skills, and abilities of the key staff and consultants involved in your project. Reviewers are concerned that the investigators and proposed staff have the proper experience with the proposed techniques. They look carefully at the biosketches.

With the advent of the modular grant and application, the information in biosketches has changed. Because other support is postponed until just before an award is made, the biosketch section should include the aims of all past and current related research of key personnel as well as related publications. Follow the PHS 398 instruction for the Biographical Sketch.

Beginning with the principal investigator, include the following for each key professional listed on Form BB of the 398:

• Name and title.
• Education - institutions, location, degree(s), year conferred, and field(s) of study.
• Roles in other relevant current or past research.
• Employment history in reverse chronological order - dates, places, nature of position, professional experience, honors. List only relevant publications in chronological order, titles and complete references (include all authors)
• List all staff, professional and nonprofessional, even when not requesting salary. Reviewers appreciate your giving estimates of the effort (not salary) for each person.

Other Support

This section is only required for certain types of applications. Provide this section only if instructed to do so

Budget

Reviewers evaluate a requested budget for whether it is realistic and justified by the aims and methods of the project. Complete the budget section after you have written your research plan and have a good idea of costs.

Request only enough money to do the work. Significant over or underestimating suggests that you may not understand the scope of the proposed work. Avoid requesting expensive equipment unless you absolutely need it, and justify it well. Don't request funds for equipment already listed in the resources section, unless you can provide an adequate explanation. Reviewers look for any "discrepancies" and will delete funds for equipment that should be available to you. Also, make sure you calculate the salary of the principal investigator (PI), taking into account the NIH extramural salary cap. Specific information on updates to salary caps can be found on the NIH grant guide.

Modular grants

NIH's adoption of the modular approach for most grant types involves changes to the application's budget section. Prepare a modular grant application if you are requesting $250,000 a year or less for direct costs (more expensive applications are non-modular) for R01, R03 (not supported by NINDS), R15 and R21 applications. Request monies in $25,000 modules. Generally, you request the same number of modules each year except for special needs, such as equipment.

Be sure to build any funding increases you foresee into the request. Under the modular system, there is no routine funding escalation for future years. You must plan for the cost of the entire project when applying. This is a major departure from the traditional process, in which grantees received inflation-based annual budget increases.

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Writing and Formatting

Read the PHS 398 carefully and follow its guidelines to the letter. Formatting is strictly enforced. Don't risk having your application returned because you exceeded the page limits or used an improper font or font size

Edit thoroughly. Make sure your work is letter perfect. If you cannot meet the application deadline comfortably, consider delaying to the next receipt date.

Follow the format in the instructions. Reviewers expect the research plan to be organized exactly as described in the instructions - you do not want to upset these expectations! Label sections exactly as in the instructions: A. Specific Aims, B. Background and significance, etc.

Conduct your own peer review - get outside opinions. Find colleagues in your field who are experienced and successful grant writers and preferably reviewers (members or former members of NIH study sections). The more critical they are, the better. It's better to know the problems before you send in your application than learn about them after the review when your grant gets an unfundable score.

Page Limits and Format Specification

• Observe the page limitations for your type of application; further, reviewers appreciate comprehensive but succinct proposals. Type setting (font size and spacing) requirements are strictly enforced. Avoid alienating reviewers with hard-to-read type and formatting.
• Refer to the instructions for the PHS 398 forms for detailed instructions and guidance on formatting and page limits.

Writing Tips

• Prefer the active rather to the passive voice. For example, write "We will develop a cell line," not "A cell line will be developed."
• Keep related ideas and information together, e.g., put clauses and phrases as close as possible to - preferably right after the words they modify.
• Simplify and breakup long, involved sentences and paragraphs. In general, use short simple sentences; they are much easier on the reader. Your goal is communication, not literature.
• Edit out redundant words and phrases. Edit and proofread thoroughly. Look carefully for typographical and grammatical mistakes, omitted information, and errors in figures and tables. Sloppy work will definitely suffer in review. Reviewers feel that if the application is sloppy or disorganized, the applicant's research may be as well.

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Submitting Your Grant Application

Receipt Date

NIH policy has been changed so that for standard receipt dates the postmark on the application now counts as the date for meeting the deadline. Standard receipt dates can be found by going to the Review, Receipt, and Award Table for receipt dates for various types of grant applications. For applications in response to a Request for Applications the receipt date in the RFA notice in the NIH Guide is the deadline for receipt of the application at the Center for Scientific Review.

Cover Letter

It's a good idea to include a cover letter with your application. The letter should state the title of the application, very briefly describe the focus of the research proposed and, if applicable, identify the program announcement (PA) or request for applications (RFA) to which you are responding. In addition, you may include the names of people whom you feel should not be allowed to evaluate your application because of conflict of interest.

Requesting an SRG and Institute/Center

Your cover letter can and often should request that your application be reviewed by a specific Scientific Review Group (SRG), administered by a specific Institute or Center, or both. NIH usually accommodates these requests but reserves the right to make the final decision.

You can discuss referral decisions with the CSR Referral Office at (301) 435-0715 as well as with the assigned SRA after referral to an SRG has been made. At least the first time through, you should probably let the NIH referral system decide which SRG will review your application.

Where to Send Your Application

All applications sent via the United States Postal Service for Express or regular mail should use the following address:

Center for Scientific Review
National Institutes of Health Suite 1040
6701 Rockledge Drive
MSC 7710
Bethesda, MD 20892-7710

All applications sent via a courier delivery service should use this address:

Center for Scientific Review
National Institutes of Health Suite 1040
6701 Rockledge Drive Bethesda, MD 20817

Applications may not be delivered by individuals to the Center for Scientific Review but must be sent via a courier delivery service or the USPS.

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Problems and Concerns Commonly Cited by Reviewers

Below is a list of the most common reasons cited by reviewers for an application's lack of success:

• Lack of significance to the scientific issue being addressed.
• Lack of original or new ideas.
• Proposal of an unrealistically large amount of work (i.e., an over ambitious research plan).
• Scientific rationale not valid.
• Project too diffuse or superficial or lacks focus.
• Proposed project a fishing expedition lacking solid scientific basis (i.e., no basic scientific question being addressed).
• Studies based on a shaky hypothesis or on shaky data, or alternative hypotheses not considered.
• Proposed experiments simply descriptive and do not test a specific hypothesis.
• The proposal is technology driven rather than hypothesis driven (i.e., a method in search of a problem).
• Rationale for experiments not provided (why important, or how relevant to the hypothesis).
• Direction or sense of priority not clearly defined, i.e., the experiments do not follow from one another, and lack a clear starting or finishing point.
• Lack of alternative methodological approaches in case the primary approach does not work out.
• Insufficient methodological detail to convince reviewers the investigator knows what he or she is doing (no recognition of potential problems and pitfalls).
• Most experiments depend on success of an initial proposed experiment (so all remaining experiments may be worthless if the first is not successful).
• The proposed model system is not appropriate to address the proposed questions (i.e., proposing to study T-cell gene expression in a B-cell line).
• The proposed experiments do not include all relevant controls.
• Proposal innovative but lacking enough preliminary data.
• Preliminary data do not support the feasibility of the project or the hypothesis.
• Investigator does not have experience (i.e., publications or appropriate preliminary data) with the proposed techniques or has not recruited a collaborator who does.
• The proposal lacks critical literature references causing reviewers to think that the applicant either does not know the literature or has purposely neglected critical published material.
• Not clear which data were obtained by the investigator and which others have reported.

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Referral and Assignment of the Application

When NIH receives an application, two things happen. It is referred to a Scientific Review Group (SRG) for review, and it is assigned to an institute or center for possible funding. These steps are very important to the fate of a grant application.

Please be aware that you have the right to request the referral and assignment of your application to the organizations you feel would serve it best. NIH data show that in many cases applicants can correctly self-assign and self-refer to an SRG and institute.

Much of the information you need to know to do this is available, and the rest you can get by calling Program Directors in NINDS or in other institutes.

Information about which scientific areas the various SRGs of the Center for Scientific Review (CSR) handle is invaluable. It is readily available either on the Center for Scientific Review web site. The web site also provides lists of regular SRG members for standing SRGs, as well as meeting rosters for the most recent three meetings of each SRG.

After the application has been assigned to an institute and SRG, a mailer with the assignment and grant number will be mailed to you. You should contact the CSR referral office if you do not receive this mailer within 4-6 weeks of submitting your application. Once you have received the mailer you may discuss referral decisions with the CSR referral office (301/435-0715); or you can call the SRA in charge of the review at the number shown on the mailer.

You should also discuss your project with a Program Director of the institute supporting your area of research before requesting assignment to an IC. You can request primary and secondary institute assignments in your cover letter.

If you do not self-assign, a referral officer in the NIH Center for Scientific Review forwards your application to an SRG and NIH institute or center (IC) based on NIH referral guidelines. The referral officer may also make secondary assignments to other ICs that may be interested in funding the application.

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Review of Research Project Application

This section describes what happens to grant applications during initial peer review. Your application can be reviewed in one of two places, either in NIH's Center for Scientific Review (CSR) or in the review branch of an institute.

Scientific Review Groups (SRGs)

Whereas most investigator-initiated applications are reviewed by a scientific review group (SRG, a.k.a. study section) in CSR, institute SRGs review applications and proposals that address institute specific needs. These are typically applications for program project (P), cooperative agreement (U), training (T) and research career (K) grants, applications in response to requests for applications, and contract proposals.

Both in CSR and institutes, chartered SRGs are composed of scientists who have a broad range of scientific expertise in a general area. Most SRGs in CSR meet three times a year for one to three days. All SRGs are managed by an institute or CSR scientific review administrator (SRA).

Review Criteria

In June 1997, NIH established new review rating criteria, the factors reviewers weigh when assessing the merit of an application. All NIH SRGs for the initial peer review of research project grant applications use the following criteria:

• Significance
• Approach
• Innovation
• Investigator
• Environment

Find out more about peer review issues and policies. Your Institute program and review staff are also good sources of information.

Cover Letter

Your application can include a cover letter in which you can identify people who should not review your application because of potential conflict of interest (e.g., someone who is a competitor or with whom you have a long-standing scientific disagreement). State the reasons for your objections to specific reviewers (e.g., the reasons for a conflict of interest). Avoid submitting lengthy lists of people who should not review the application.

At the Peer Review Meeting

Four to six weeks before an SRG meets, the SRA sends each SRG member a copy of the applications to be reviewed. Usually, the SRA assigns at least two members to be primary reviewers and write critiques before the meeting. The SRA will also ask one or more members to serve as readers, who identify strengths and weaknesses of applications. Other SRG members may or may not read the application prior to the review.

How Priority Scores Are Determined

If your application warrants a full discussion at the review meeting (see below for reasons it may not), reviewers present their evaluations and indicate their level of enthusiasm by suggesting a priority score, where 1.0 is the best and 5.0 is the worst.

Your application is then opened for discussion, and differences of opinion are explored. Then, study section members each assign a score. The priority score on your summary statement is the average of the individual scores multiplied by 100. Three categories of applications do not receive a full review, a priority score, and a full summary statement:

1. Unscored - Refers to applications whose merit is judged to be in the bottom half (corresponds to priority scores between 3.0 and 5.0) of all similar applications that have been reviewed by the SRG members. (Under NIH's streamlined review, applications are subjected to a preliminary evaluation to determine their relative scientific merit.) Applications unanimously judged to be in the lower half are not subject to full discussion and are not scored. The applicant receives the assigned reviewers' verbatim critiques and does not receive a summary of discussion unless reviewers first discussed the application before concluding that it fell in the lower half. If reviewers are not unanimous in agreeing that an application falls in the lower half, the application is discussed and scored using the full range of scores from 1.0 to 5.0.
2. Not Recommended For Further Consideration (NRFC) - Used for applications found to have no significant and substantial scientific merit. In addition, applications including clinical research with inadequate protection against risks to human subjects can be classified in this category.
3. Deferred - In some instances, the scientific review group is unable to make an adequate determination of the scientific merit of an application due to lack of adequate information. In such cases, the group can ask that the application be deferred, generally to a later review date, to allow additional time to obtain the information from the applicant, either by telephone or by the submission of additional material (or, in some cases, a site visit or an outside opinion).

Summary Statements

Prepared by the SRA, summary statements include the reviewers' critiques (as feedback applicants may use to revise their applications), a summary of the deliberations, an average priority score, recommended changes in the budget, and administrative comments, if any. The roster included with the summary statement lists all of the reviewers but does not identify which reviewers were assigned to the application (this is done to protect confidentiality).

Institutes mail summary statements to applicants roughly six to eight weeks after the SRG meeting and provide them to the program staff member responsible for the application. It's a good idea to wait until after you receive and review your summary statement before calling your program Director to learn if your application is likely to be funded.

Appeal

You can appeal a review if you have reason to believe that the review process was seriously flawed. Flawed means errors due to reasons such as reviewer conflict of interest or personal bias. Differences in scientific opinion cannot be appealed.

If you believe appealable errors occurred, talk with your Program Director, whose name and contact information will appear on the face page of the summary statement, to discuss your best course of action. Find out more about the NIH appeals process.

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How Funding Is Decided

Several factors come into play when NIH institutes and centers (IC) decide which applications to fund. Paramount among them is an application's percentile ranking derived from its priority score, the outcome of peer review. In addition, an IC considers the relevance of the proposed project to its mission and the availability of funds. You can improve your likelihood of gaining funding by requesting that your application receive primary or secondary assignment to an IC seeking applications in your research area. NINDS funding priorities are described on the NINDS web site.

How Paylines Work

Some ICs, such as NINDS, set a payline, which is a funding cutoff point. This means NINDS funds all applications with percentiles better than the payline (barring unusual issues such as overlapping other support), whereas those worse than the payline (with the exception of some high-priority applications at the payline margin) are not funded. Unfunded applications remain in consideration for funding until the September 30 following the Council at which they were eligible for funding, and then are administratively inactivated.

Three things are important to know about paylines:

• The payline is a budget management tool. It may change as the fiscal year progresses and the precise amount of funds available to the institute becomes better known
• Many more grants get funded than those within the payline. What is often referred to as the "payline" is actually the payline for research project grants only. Other types of awards, including training and career awards are not affected by the RPG payline and do not affect it.
• Paylines vary among ICs, and some ICs have no fixed payline. So a percentile that is not fundable in one institute may be fundable in another. If an institute declines to pay an application assigned to it and is willing to relinquish primary assignment, another institute (usually an institute with a secondary assignment) may agree to take on primary assignment and commit to funding the application.

Second Level Peer Review

In the NIH peer review process, applications undergo a second level of peer review. At NINDS, this is carried out by the Institute's Advisory Council. Council members look at summary statements of grants within the payline, especially for applications with special concerns, such as human subject issues.

They also consider a small number of high-priority grants at the payline margin that will be paid selectively. Council may also consider appeal of the review or other information from applicants.

Possible Outcomes of Secondary Review

Following Council review, NINDS takes one of four actions for an application:

• Approved for funding.
• Primary responsibility transferred to another IC that agrees to fund it.
• Kept active for later decision, usually at the end of the fiscal year.
• Not funded; file is closed.

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When You Have Not Obtained Funding

What if you submit a grant application and it does not get funded? One option is to revise the application and resubmit. Revising the application is your opportunity to address reviewers' concerns. Many applications succeed on the second or even third submission (the limit is three).

Most Common Reasons for a Low Score (in priority order)*

1. Lack of new or original ideas.
2. Hypothesis ill-defined, superficial, lacking, unfocused, or unsupported by preliminary data.
3. Methods unsuitable or defective and not likely to yield results.
4. Data collection confused in design, inappropriate instrumentation, poor timing or conditions.
5. Data management and analysis vague, unsophisticated.
6. Inadequate expertise or knowledge of field for PI, or too little time to devote to the work
7. Poor resources or facilities; limited access to appropriate patient population.

*From "Why clinical research grant applications fare poorly in review and how to recover." Cuca JM; McLoughlin WJ, Cancer Invest 1987;5(1):55-8.

When to Revise

How do you know when to revise your application and resubmit or when to begin over with a new idea? If reviewers thought your basic idea was interesting and important, the application may be worth revising. If the problems are repairable, revise the application and resubmit it, requesting that it be reviewed by the same study section.

Common fixable problems

• Poor writing.
• Insufficient information, experimental details, or preliminary data.
• Significance not convincingly stated.
• Approach not shown to be feasible, but applicant can demonstrate feasibility.
• Insufficient discussion of obstacles and alternatives approaches.

Not fixable or more difficult problems

• Philosophical issues, e.g., the reviewers believe the work is not significant.
• Hypothesis is not sound or not supported by data presented.
• Work has already been done.
• Methods proposed were not suitable for testing the hypothesis.

When to Revise and Request a Change of SRG

Sometimes the problem lies with the SRG assignment. For example, suitable expertise may not have been available on the SRG or the reviewers may have an unshakable and unreasonable belief that the applicant's hypothesis is wrong. While these circumstances exist much less often than applicants believe, they do occasionally occur. If, after discussion with knowledgeable colleagues, including NIH program staff, you decide that a different study section would be more appropriate, revise the application and request review by a different SRG. Give reasons for the request (lack of reviewer expertise, lack of interest in the subject, differing philosophies, e.g., a molecularly oriented review group reviewing a clinical application). Try to suggest an alternative SRG.

Even though there may have been some problems with the original study section assignment, it is usually better to revise and request a change of study section than to appeal and ask for a deferral for re-review. Often the appeal will be unsuccessful, if it appears to be based on a difference of scientific opinion. Moreover, even if deferral for re-review is granted the applicant will not be allowed to make any changes to the application, even responses to any legitimate reviewer concerns in the original critique, and these concerns may still prevent the application from receiving a fundable score. Furthermore, while the original application is undergoing re-consideration, a revised application cannot be submitted. Therefore, the opportunity to revise and resubmit will have been delayed by 4 months while the original application is still pending.

Revising Your Application

Read and reread the summary statement. Identify the concerns. Before you start revising, ask your Program Director to review your summary statement and give you advice. Also, ask someone in your institution who is experienced in grantsmanship and not involved in your proposed research to review your application, summary statement, and revision plans.

Respond to reviewers' comments

Revised applications must include an Introduction limited to three pages and not counted in the 25 page limit. In the Introduction you should respond to the comments and suggestions of the reviewers. Address reviewers' comments point by point - you need not agree with all points, but you must address them. Use page numbers and other identifiers so reviewers can easily find where you have added new data or revised experimental approaches. A bar in the margin is a good way to show where revisions are.  Highlight new sections with indenting, bracketing, underlining, or change of type. If you disagree with the reviewers, explain why and provide additional information if needed. However, an Introduction that is nothing but an angry rebuttal of the previous summary statement is unlikely to be well-received, even by a new SRG. Maintain as positive a tone as possible in the Introduction.

Even if you respond adequately to the criticisms in the summary statement, you are not guaranteed an award. This may happen because a summary statement is not meant to be an exhaustive critique; some problems discussed by the reviewers may not appear in it. Also, when you make changes, you risk introducing new problems. Finally, membership in scientific review groups changes. Your application may be seen by some new reviewers who may have different views of your project.

If you still don't get funded after the second try, try again! Data show that persistence pays off. NIH allows you one more opportunity to revise and resubmit the application.

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When Your Application Is Approved for Funding

If an institute or center (IC) approves your application for funding, NIH staff will contact you or your institution to discuss when the award is to start and the funding level of project. You may also be asked to submit additional information, e.g., updated information on budget costs and other support or information, and certification of institutional approval of human subjects research. It is important to send theses items to us as soon as possible since issuing the award will be contingent on receipt of this information from you.

Upon satisfactory completion of all requirements, the IC sends your institution a Notice of Grant Award, which states the amount of funding for the current year, funding committed for future years, start and end dates, and the terms and conditions of the award.

If it is your institution's first NIH award, you should review the NIH "Welcome Wagon" letter that provides lots of important information on what to do.

There are many policies and reporting requirements pertaining to grants. In addition to the sources listed below, you can read more about rules and regulations in the NIH Grants Policy Statement.

For updates on changes in policies and procedures, read the notices published weekly in the NIH Guide for Grants and Contracts.

What You Can and Cannot Pay for on a Grant

In most cases, your grant will provide for direct (project-specific) costs plus the facilities and administrative costs (F & A costs, also known as indirect costs) negotiated for your institution. Information on direct and F &A costs that may be charged to a grant are outlined in the cost principles. The applicable cost principles are determined by the type of grantee institution.

References:

1. OMB Circular A-21 Institutions of Higher Learning
2. OMB Circular A-87 State and Local Governments
3. OMB Circular A-122 Nonprofit Organizations
4. 45 CFR Part 74, App. E. Hospitals
5. FAR 48 Subpart 31.2 For-Profit Organizations

For more information, see also the NIH Grants Policy Statement. Check to see what costs are allowable.

Reporting Requirements

1. Financial Status Report
   
   When required, Financial Status Reports are due 90 days after the close of a budget period, on Standard Form (SF) 269 or 269A. For NIH awards, send the Financial Status Report to the NIH Office of Financial Management for review and acceptance. The address and phone number is:
   
   NIH
   OFM/Government Accounting
   31 Center Drive, Building 31, B1B05
   Bethesda, MD 20892-2050
   (301) 496-5287
   
   For grants under the Streamlined Noncompeting Application Process (SNAP), a Financial Status Report is required only at the end of a competitive segment rather than annually. Find out more about modified reporting requirements or contact your grants management specialist listed on your notice of grant award.
2. Progress Report
   
   NIH grants require a minimum of an annual report, due to the Institute as part of the noncompeting application (PHS Form 2590) 2 months before the start of each budget period. A final progress report is due 90 days after the expiration or termination of the grant.
3. Invention Report
   
   NIH grants must comply with government-wide patent regulations as stated in Title 37 CFR part 401. Inventions must be reported in any noncompeting or competing continuation application and included on the Final Invention Statement and Certification required within 90 days after the expiration or termination of support.
   
   NIH now enables you to fulfill your invention reporting requirements online using a system called Edison.

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