Introduction
Planning Your Application
Project Summary/Abstract
Research Plan (overview)

1. Specific Aims
   
2. Background and Significance
   
3. Preliminary Results/Progress Report
   
4. Budget and Justification
   
Assurances

• Human Subjects
  
• Vertebrate Animals
Resources and Environment
Overall Considerations

This information is based very closely on NIH Publication No. 93-3606, "Quick Guide for the Preparation of Grant Applications", written and distributed by the Hispanic Cancer Control Research Network (HCCRN), Hispanic Cancer Control Program, Special Populations Studies Branch, National Cancer Institute, NIH. The original publication was the result of a grant-writing workshop sponsored by HCCRN in 1991 and a follow-up activity in 1992. It contains information and suggestions especially pertinent to cancer control research, along with more generic information. This document has been modified to more specifically meet the needs of investigators preparing applications for laboratory-based research projects.

The guide is organized according to the major sections of the PHS-398 (or SF 424) Grant Application Instructions. Each section is described, and a checklist is provided detailing what that section should cover. In addition, suggestions are included to enhance an application’s success. The checklists are not exhaustive, but rather are designed to job their application writer's memory and ensure completeness. This document in no way obviates the need for an inexperienced applicant to seek further advice from experienced colleagues or from appropriate program personnel at NIH.

Several key issues should be considered before, during, and after your application is written.

1. The deadlines for NIH grant applications depend on the grant mechanism. See schedule of standard due dates on: http://grants.nih.gov/grants/funding/submissionschedule.htm. For new R01 applications, February 5, June 5, and October 5 are the due dates. March 5, July 5, and November 5 are the due dates for R01 renewals, resubmissions and revisions. Please note: The deadlines for investigator-initiated applications in response to Request for Applications (RFAs) and some Program Announcements (PAs) may differ.
2. The review and selection process for applications takes 8 to 10 months. Submit your very best application because reviewers expect you to have taken the time needed to think it through before submitting. For new investigators, there is an opportunity for resubmission of your application in the next review round when there are only minor concerns.
3. Before you begin writing your grant application, familiarize yourself with the new NIH SF 424 Application Guide for electronic applications and all the requirements and certifications. See NIH Forms and Applications for other types of required forms and applications, including the PHS 398 application. If you are submitting an unsolicited or investigator initiated application in response to a Parent Announcement, or a specific RFA or PA, read the announcement in detail.
4. The submission of electronic applications to NIH involves the interaction between two systems: Grants.gov (http://grants.gov) and the NIH eRA Commons (https://commons.era.nih.gov/commons/). Individual investigators do not need to register with the Grants.gov system; however, you must be a registered Commons user to submit an application or be included as a Senior/Key Person. Commons registration can take up to five days. For more information, see Electronic Submission.
5. If at all possible, find someone in your institution who can assist you in understanding and completing the application. Ask your colleagues for copies of successful NIH grant applications to get a more concrete idea of what each section should include. Incomplete applications are returned without review.
6. Establish deadlines for the preparation of the grant application, particularly when collaborating investigators are involved. Be aware of institutional deadlines that could delay your application. Allow time for equipment failures, personnel shortages, etc.
7. Reread your application. Have someone else read it. Proofread it again.
8. If several people are contributing to the writing, decide who will do the final editing.
9. If possible, have objective experts (e.g., successful grantees, an institutional panel) review your proposal. Friends or close associates are rarely as critical as the reviewers on an NIH study section.
10. Do not feel inhibited about requesting technical assistance from the funding agency or your, institution. Talk to the program representative who will manage the grant for advice on scientific and technical issues and to the grants management specialist for advice on administrative issues. Your institutional grants office can also be of assistance. Talk to them and find out how they can help you.
11. Investigate any special research priorities of funding agencies, and ascertain from the program representative whether your project falls within the scope of an existing initiative (RFA or PA) or an area of special emphasis.
12. When submitting a revised application (resubmission), answer all reviewer concerns mentioned in the earlier Summary Statement. Changes you make in the revised application must be described and illustrated, e.g., bracketing, underlining, etc. Regardless of how you feel, don't insult the reviewers. If you differ in your opinion try to courteously convince the reviewers of your point -of views. In addition to responding to specific reviewer concerns, review all other aspects of the application to determine whether updating, or improvement is called for or possible. Just because it was not criticized before is no guarantee it will not be criticized in the review of the revised application.

Purpose: The purpose of the Project Summary/Abstract is to describe succinctly every major aspect of the proposed project except the budget. The abstract is an important part of your application. It is used in the grant referral process, along with a few other parts of the application, to determine what study section is appropriate to review the application and to what institute at NIH it is most relevant. Members of the Study Section who are not primary reviewers may rely heavily on the abstract to understand your proposal.

The second component of the Project Summary/Abstract is Relevance. In this section, describe the relevance of this research to public health. Be succinct and use plain language that can be understood by a general, lay audience.

Recommended Length: The first component/section must be no longer than 30 lines of text, and follow the required font and margin specifications. The Relevance component should be no more than two to three sentences.

The abstract should include:

• a brief background of the project;
• specific aims, objectives, or hypotheses;
• the significance of the proposed research;
• refer to the health relatedness of the project (i.e., relevance to the mission of the agency);
• the unique features of the project;
• the methodology (action steps) to be used;
• expected results;
• evaluation methods; and
• description of how your results will affect other research areas.

Suggestions

• Be complete, but brief.
• Use all the space allotted.
• Avoid describing past accomplishments and the use of the first person.
• Write the abstract last so that it reflects the entire proposal.
• Remember that the abstract will be used for purposes other than the review, such as to provide a brief description of the grant in annual reports, presentations, and dissemination to the public

Purpose: The purpose of the research plan is to describe the what, why, and how of the proposal. This is the core of the proposal and will be reviewed with particular care. The what will be Part 1: Specific Aims; the why, Part 2: Background and Significance; and the how, Part 3: Preliminary Results contributes to both the why and how. Part 4: Research Design and Methods. The assessment of this research plan will largely determine whether or not the proposal is favorably recommended for funding.

Recommended Length: The maximum length of the research plan is 25 pages.

Content: The research plan should answer the following questions:

• What do you intend to do?
• Why is this worth doing? How is it innovative?
• What has already been done in general, and what have other researchers done in this field? Use appropriate references. What will this new work add to the field of knowledge?
• What have you (and your collaborators) done to establish the feasibility of what you are proposing to do?
• How will the research be accomplished? Who? What? When? Where? Why?

Suggestions

1. Make sure that all sections (2,3,4, and 5--the what, why, and how of the proposal) are internally consistent and that they dovetail with each other. Use a numbering system, and make sections easy to find. Lead the reviewers through your research plan. One person should revise and edit the final draft.
2. Show knowledge of recent literature and explain how the proposed research will further what is already known.
3. Emphasize how some combination of a novel hypothesis, important preliminary data, a new experimental system and/or a new experimental approach will enable important progress to be made.
4. Establish credibility of the proposed principal investigator and the collaborating researchers.

Purpose: The purpose of the specific aims is to describe concisely and realistically what the proposed research is intended to accomplish.

Recommended Length: The recommended length of the specific aims is one page.

Content: The specific aims should cover:

• broad, long-term goals;
• the hypothesis or hypotheses to be tested, and
• specific time-phased research objectives.

1. Generally, the Specific Aims section should begin with a brief narrative describing the long-term goals of the project and the hypothesis guiding the research. This is followed by a numbered list of the Aims.
2. State the hypothesis clearly. Make sure it is understandable, testable and adequately supported by citations in the Background and by data in the Preliminary Results Sections. Be sure to explain how the results to be obtained will be used to test the hypothesis.
3. Show that the objectives are attainable within the stated time frame.
4. Be as brief and specific as possible. For clarity, each aim should consist of only one sentence. Use a brief paragraph under each aim if detail is needed. Most successful applications have 2-4 specific aims.
5. Don't be overly ambitious. A small, focused project is generally better received than a diffuse, multifaceted project.
6. Be certain that all aims are related. Have someone read them for clarity and cohesiveness.
7. Focus on aims where you have good supporting preliminary data and scientific expertise.

Purpose: The purpose of the background and significance section is to state the problem to be investigated, the rationale for the proposed research, the current state of knowledge relevant to the proposal and the potential contribution of this research to the problem(s) addressed.

Recommended Length: Approximately 3 pages

Content: The background and significance section should cover:

• the rationale for the proposed project;
• the state of existing knowledge, including literature citations and highlights of relevant data;
• gaps that the project is intended to fill

1. Make a compelling case for your proposed research project. Why is the topic important? Why are the specific research questions important? How are the researchers qualified to address these?
2. Establish familiarity with recent research findings. Avoid outdated research. Use citations not only as support for specific statements but also to establish familiarity with all of the relevant publications and points of view. Your application may well be reviewed by someone working in your field. If their contributions and their point of view are not mentioned, they are not likely to review your application sympathetically.
3. Make sure the citations are specifically related to the proposed research. Cite and paraphrase correctly and constructively.
4. Highlight why research findings are important beyond the confines of a specific project i.e., how can the results be applied to further research in this field or related areas.
5. Stress any innovations in experimental methods (e.g., new strategies, research methods used, interventions proposed).

Purpose: The purpose of the preliminary results section is to describe prior work by the investigators relevant to the proposed project. In a new application, the preliminary results are important to establish the experience and capabilities of the applicant investigators in the area of proposed research and to provide experimental support for the. hypothesis and the research design. This section is not mandatory for new applications, but it is virtually impossible to obtain a favorable review without strong preliminary data. In a renewal application, this section becomes a progress report describing studies performed during the last grant period.

Recommended Length: The recommended length of the preliminary results/progress report section is 6-8 pages.

Content: The preliminary results section should include the following:

• most importantly, a description of recent studies by the applicant investigators that establish the feasibility and importance of the proposed project;
• a brief description of older published studies by the applicant that provide important background information relevant to the proposed project;
• results of previous studies by the applicant not directly relevant to the proposed project if they are needed to establish the applicant's competence and experience with the experimental techniques to be used in the proposed project.

1. All Tables and Figures necessary for the presentation of preliminary results must be included in this section of the application.
2. Figures and Figure legends must be legible. There are specific limits on type size given in the application instructions, but beyond these rules, the critical factor is whether the data are legible and convincing to the reviewers.
3. Do not dwell on results already published. Summarize the critical findings in the text. Provide a PDF of a cited manuscript in the Appendix only if it is not published in a publicly accessible journal, or has been accepted but not yet published.

Purpose: The purpose of the research design and methods section is to describe how the research will be carried out. This section is crucial to how favorably an application is reviewed.

Recommended Length: The maximum recommended length of the research design and methods section is 20 pages.

Content: The research design and methods section should include the following:

• an overview of the experimental design;
• a detailed description of specific methods to be employed to accomplish the specific aims;
• a detailed discussion of the way in which the results will be collected, analyzed, and interpreted;
• a projected sequence or timetable (work plan);
• a description of any new methodology used and why it represents an improvement over the existing ones;
• a discussion of potential difficulties and limitations and how these will be overcome or mitigated;
• expected results, and alternative approaches that will be used if unexpected results are found;
• precautions to be exercised with respect to any procedures, situations, or materials that may be hazardous to personnel or human subjects.

Number the sections in this part of the application to correspond to the numbers of the Specific Aims.

1. Give sufficient detail. Do not assume that the reviewers will know how you intend to proceed.
2. Avoid excessive experimental detail by referring to publications that describe the methods to be employed. Publications cited should be by the applicants, if at all possible. Citing someone else's publication establishes that you know what method to use, but citing your own (or that of a collaborator) establishes that the applicant personnel are experienced with the necessary techniques.
3. If relevant, explain why one approach or method will be used in preference to others. This establishes that the alternatives were not simply overlooked. Give not only the "how" but the "why."
4. If employing a complex technology for the fast time, take extra care to demonstrate familiarity with the experimental details and potential pitfalls. Add a co-investigator or consultant experienced with the technology, if necessary.
5. Document proposed collaborations and offers of materials or reagents of restricted availability with letters from the individuals involved.

Purpose: The purpose of the budget and justification is to present and justify all expenses required to achieve project aims and objectives. For multi-institutional applications, there must be a separate budget for each subcontractor or consortium member.

Recommended Length: Special forms are provided for the budget and justification. Read the instructions carefully. If there is a co-investigator at another institution, for whom funds are requested, be sure to include their budget.

Modular Budget Guidelines. Modular budgets are applicable to certain research grant applications requesting $250,000 or less per year for direct costs. Note, consortium/contractual F&A costs are not factored into the direct cost limit. Consortium F&A costs may be requested in addition to the $250,000 limit. Modular budgets are simplified; therefore, detailed categorical information is not to be submitted with the application.

Content: The budget and justification should cover personnel, consultants, equipment, supplies, travel, and other expenses (e.g., animal maintenance).

Suggestions:

1. Be realistic. Both "padding" and deliberately under budgeting reflect naiveté, which will be recognized by reviewers.
2. Provide brief descriptions of duties for all positions listed in the budget, with the number of person months requested each year and any anticipated fluctuations. Special skills or accomplishments of a designated person may be included if not discussed elsewhere. For guidance on current salary limitations contact your office of sponsored programs.
3. If possible, try to identify specific individuals for each position requested. "To be named" personnel are very often deleted by reviewers.
4. For modular budgets, a detailed budget is not required for supplies, equipment, and travel costs.
5. For non-modular budgets, justify all equipment purchases. The proposed acquisition of major pieces of equipment is likely to be scrutinized very carefully. Details are important, especially for non-project specific equipment e.g., FAX machine and computers.
6. For non-modular budgets, break out supply costs into major categories (reagents, disposables, etc.) and travel. Provide special justification for any unusual expenses requested.
7. Explain any year-to-year fluctuations in the budget, including the level of effort of personnel, especially if they can not be attributed to routine salary increases. Changes should parallel the research plan and project aims.
8. Check indirect costs. Some institutions have on-campus and off-campus rates.
9. Be complete but concise. There are no page limits in this section.
10. Provide adequate justification for the need to use outside consultants, if applicable.
11. The budget must be approved by the grantee institution business office before they can sign the application.
12. If applicable, provide documentation of institutional rates for animal maintenance and acquisition. Exceptionally large numbers of animals will need detailed justification.
13. Prorate service contracts to percentage of time equipment is used for this project.

Purpose: The purpose of the assurances section is to ensure that the applicant organization will comply with all relevant Federal laws and guidelines.

Recommended Length: A special form must be completed for the assurances section. See page B of the PHS 398 application or section18 of the SF424 (R&R) form.

Content: The assurances cover:

Human Subjects Research; Research on Transplantation of Human Fetal Tissue; Research Using Human Embryonic Stem Cells; Women and Minority Inclusion Policy; Inclusion of Children Policy; Vertebrate Animals; Debarments and Suspension; Drug Free Workplace; Lobbying; Non-Delinquency of Federal Debt; Research Misconduct; Civil Rights; Handicapped Individuals; Sex Discrimination; Age Discrimination; Recombinant DNA, including Human Gene Transfer Research; Financial Conflict of Interest; Smoke-Free Workplace; Prohibited Research; Select Agent Research; Principal Investigator Assurance

Suggestions

1. Be familiar with assurances, certifications and requirements for complying with these regulations.
2. Begin to obtain assurances early, since they tend to require the cooperation of different institutions.
3. Check your institution's grants management office for additional requirements. Different institutions follow different procedures and timelines.

Purpose: The purpose of this section describing the involvement of human subjects is to ensure the protection of the rights and welfare of people who participate in research projects.

Recommended Length: There is no specified length, but be succinct.

Content: See Supplemental Instructions for Preparing the Human Subjects Section of the Research Plan in the SF 424 or PHS 398 application to determine whether this section is required or your human subjects research is exempt.

Provide a complete description of the proposed involvement of human subjects as it relates to the work outlined in the Research Plan section. If an exemption has been designated on the face page, enough detail still must be provided to allow the determination of the appropriateness of the exemption. You must provide sufficient information for reviewers to determine that the proposed research meets:

1. the requirements of the DHHS regulations to protect human subjects from research risks (45 CFR Part 46);
2. NIH and NCI policy requirements for Data and Safety Monitoring for Clinical Trials, if applicable;
3. the ClinicalTrials.gov requirements, if applicable;
4. the requirements of NIH policies on inclusion of women, minorities, and children; and
5. the requirements of NIH policy on reporting race and ethnicity data for subjects in clinical research.

Purpose: The purpose of this section describing the use of vertebrate animals is to ensure the humane treatment of live animals involved in the proposed research.

Recommended Length: There is no specified length, but be succinct.

Content: Provide a complete description of the proposed use of vertebrate animals as it relates to the work outlined in the Research Plan section. There are five points which must be addressed in this section. A full description of these points can be found in the PHS 398 or SF 424 application package. Be thorough in addressing these five areas. Failure to address any of these areas will delay any award until these issues have been resolved.

Purpose: The purpose of the resources and environment section is to describe the resources, facilities, and support available to the researcher.

Recommended Length: There is no specified length, but be succinct.

Suggestions

1. Make sure the resources and environment section addresses all requirements of the proposed research plan.
2. Justify any reliance on resources external to the research.
3. Make sure all subcontractors and consortium members have the capability to perform the tasks assigned to them.
4. Make certain your resources and budget requests are consistent.

1. Observe application guidelines strictly.
2. Use basic English and avoid jargon.
3. Make sure all acronyms are spelled out when used initially.
4. Observe the type size and page limitations strictly; do not use a small font.
5. Include only those graphs, tables, etc., that are essential to the narrative; these should complement the text and be appropriately inserted.
6. Make sure all citations are complete: title, authors, book or journal, volume number, inclusive pages, year of publication. When citing articles that fall under the Public Access Policy, provide the NIH Manuscript Submission reference number (e.g., NIHMS97531) or the Pubmed Central (PMC) reference number (e.g., PMCID234567) for each article. Citations that are not covered by the Public Access Policy, but are publicly available in a free, online format may include URLs or PMCID numbers along with the full reference.
7. Include a section on Resource Sharing Plans, including sharing model organisms or genome wide association studies, if appropriate.
8. Have an outside reader review the proposal for clarity and consistency.
9. Proofread carefully by reading aloud. Do not rely on computer "spell check" to point out mistakes.
10. Be consistent with terms, references, and form writing style.