This guide is organized according to the major sections of the SF 424 (or PHS398) 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 jog the 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.
Planning your application
Several key issues should be considered before, during, and after your application is written.
- Before you begin writing your grant application, familiarize yourself with the 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 for multi-component applications. NIH’s Forms Library.
- The submission of electronic applications to NIH involves the interaction between two systems: Grants.gov and the NIH eRA Commons. Individual investigators do not need to register with the Grants.gov system; however, you must be a registered Commons user to be included as a Senior/Key Person or for SPaR to submit an application on your behalf. For more information, see Electronic Submission.
- All applications must be submitted in response to a Funding Opportunity Announcement (FOA). The NIH has developed Parent FOAs for use by applicants who wish to submit unsolicited investigator initiated R01 applications and other common grant mechanisms. In addition, NIH publishes FOAs for specific Request for Applications (RFA) and Program Announcements (PA) that identify special research opportunities. Responding to such an FOA, and downloading the associated application package, ensures that the correct package is used and enables NIH to receive the application from Grants.gov. FOAs can be found at Grants.gov/FIND for all government agencies and in the NIH Guide for Grants and Contracts. If you are submitting to a specific RFA or PA, read the announcement in detail to be sure your application will be responsive to the announcement.
- The deadlines for NIH grant applications depend on the grant mechanism. See schedule of standard due dates, noting that the deadlines for AIDS-related applications differ from those of other applications.For new R01 applications the due dates are February 5, June 5, and October 5. For R01 renewals, resubmissions and revisions the due dates are March 5, July 5, and November
Please note: The deadlines for investigator-initiated applications in response to specific FOAs, such as RFAs and Program Announcements with special receipt (PAR), may differ. Always check the FOA for the receipt date.
- The review and selection process for applications usually 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. There is an opportunity for resubmission of your application in the next review round. Submitting your grant proposal BEFORE the due date is always an option. Dr. Michael Lauer, NIH’s Deputy Director for Extramural Research, reports that a proposal is significantly more likely to be reviewed if it is submitted prior to the due date.
- If at all possible, find someone that 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.
- 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.
- Publish the papers; you can only cite papers which have already been published or accepted for publication. With the new page limitations, preliminary data should be published.
- Become familiar with the NIH peer review criteria; reviewers will use them to rate your application.
- Reread your application. Have someone else read it. Have another person read it. Ask your readers to be critical. Proofread it again. (See item #12.)
- If several people have major contributions to the research project, consider the option for multiple Principal Investigators (PIs). A Leadership Plan is required and New Investigator policies do not apply unless all PIs are considered New Investigators. Also note that all Key Personnel will need to complete a Conflict of Interest form and send that, along with a copy of their up-to-date CITI Responsible Conduct of Research training certificate, to the SPaR team before the application can be submitted.
- If possible, have objective experts (e.g., successful grantees, an institutional panel) review your application. Friends or close associates are rarely as critical as the reviewers on an NIH study section. (See item #10.) If at all possible, aim to pull together your application a month or more in advance so that you can take advantage of the RF APPS peer review process.
- Do not feel inhibited about requesting technical assistance from the funding agency or the SPaR staff. Talk to the program representative who will manage the grant for advice on scientific and technical issues, grant mechanisms, and information on special initiatives. The SPaR staff can also be of assistance. Talk to them and us to find out how they and we can help you. While not everyone is helpful and friendly, your taxes are paying the NIH staff. It is part of their job to be helpful.
- Investigate any special research priorities of funding agencies. Search the NIH Guide for Grants and Contracts for current FOAs and ascertain from the program representative whether your project falls within the scope of an existing RFA or PA or an area of special emphasis. Unlike unsolicited proposals, those in response to an RFA or PA usually have money set aside to fund them.
- SPaR will complete the correct 424 Application Package, and will upload the necessary attachments as you finalize them. Please send final versions of each attachment to your SPaR contact, and work with them to ensure the package is complete. The full package will be sent to you for review before it is submitted; be sure to use that opportunity to review all information that will be submitted. Once the application package is complete, SPaR will submit it on your behalf.
The purpose of the Project Summary/Abstract is to describe succinctly every major aspect of the proposed project. It should contain a statement of objectives and methods to be employed. Members of the Study Section who are not primary reviewers may rely heavily on the abstract to understand your application. Consider the significance and innovation of the research proposed when preparing the Project Summary.
The Project Summary must be no longer than 30 lines of text, and follow the required font and margin specifications. The second component of the Project Summary is relevance of this research to public health. Use plain language that can be understood by a general, lay audience. The Project Summary should not contain proprietary confidential information. The abstract should include:
- a brief background of the project
- specific aims, objectives, or hypotheses
- the significance of the proposed research and relevance to public health
- the unique features and innovation of the project
- the methodology (action steps) to be used
- expected results
- description of how your results will affect other research areas.
- 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 application.
- 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.
Research Plan (Overview)
NIH has restructured the applications by aligning the structure and content with review criteria. This alignment will help ensure that both reviewer and applicant expectations coincide for a more efficient and transparent application process. The Research Strategy/Plan is now organized into three sections: Significance, Innovation, and Approach. The assessment of this research plan will largely determine whether or not the application is favorably recommended for funding. For an application with multiple Specific Aims, the applicant may address Significance, Innovation and Approach for each Specific Aim individually, or address Significance, Innovation and Approach for all of the Specific Aims collectively.
See Table of Page Limits for the maximum length of the research plan. Each type of application as well as activity code may have its own page limits. Regardless of the mechanism, if the FOA specifies page limits, they are the ones you should follow.
The Research Strategy should answer the following questions:
- What do you intend to do?
- Why is this worth doing or the significance of the research? 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? Include a timeline if necessary to clarify the steps of your research plan.
- Make sure that all sections 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.
- Show knowledge of recent literature and explain how the proposed research will further what is already known.
- 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.
- Establish credibility of the proposed principal investigator and the collaborating researchers.
Research Plan Part 1: Specific Aims
The purpose of the specific aims is to describe concisely and realistically the goals of the proposed research and summarize the expected outcome(s), including the impact of the proposed research will exert on the research fields involved.
The recommended length of the specific aims is one page. [Note that the specific aims page will be uploaded as a standalone attachment in the 424 package. However, many researchers find it helpful to write this section as part of their overall research strategy, i.e. within a single Word Document, so that any edits can be made consistently throughout. Then, either the PI or the SPaR team can separate the one-page specific aims to a separate PDF for upload.]
The specific aims should cover:
- broad, long-term goals;
- the specific objectives and hypotheses to be tested;
- summarize expected outcomes; and
- describe impact on the research field.
- Generally, the Specific Aims section should begin with a brief narrative describing the long-term goals or objectives of the research project and the hypothesis to be tested. This is followed by a numbered list of the Aims.
- List succinctly the specific objectives of the research proposed, e.g., to test a stated hypothesis, create a novel design, solve a specific problem, challenge an existing paradigm or clinical practice, address a critical barrier to progress in the field, or develop new technology.
- Make sure your specific objectives or hypothesis are clearly stated, are testable, and adequately supported by citations and preliminary data. Be sure to explain how the results to be obtained will be used to test the hypothesis.
- 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.
- Don’t be overly ambitious. A small, focused project is generally better received than a diffuse, multifaceted project.
- Be certain that all aims are related. Have someone read them for clarity and cohesiveness.
- Focus on aims where you have good supporting preliminary data and scientific expertise.
- Include a brief statement of the overall impact of the research studies.
- This is the most important page of the entire application since it may be the only section the unassigned reviewers read to understand approach, impact, and innovation.
Research Plan Part 2: Significance
The Significance section should explain the importance of the problem or describe the critical barrier to progress in the field that is being addressed. Explain how the proposed research project will improve scientific knowledge, technical capability, and/or clinical practice in one or more broad fields. Describe how the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field will be changed if the proposed aims are achieved.
Approximately 1-2 pages
The Significance section replaces the previous Background and Significance section. It should cover:
- the state of existing knowledge, including literature citations and highlights of relevant data;
- rationale of the proposed research;
- explain gaps that the project is intended to fill; and
- potential contribution of this research to the scientific field(s) and public health.
- 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?
- Establish significance through a careful review of published data in the field, including your own. 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 point of view are not mentioned, they are not likely to review your application sympathetically.
- Highlight success of your related grants and awareness of potential barriers and alternative approaches.
- 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.
- Clearly state public health implications.
- Show that the objectives are attainable within the stated time frame. Include a time frame for each specific aim.
- Stress any innovations in experimental methods (e.g., new strategies, research methods used, interventions proposed).
Research Plan Part 3: Innovation
Explain how the application challenges and seeks to shift current research or clinical practice paradigms. Describe any novel theoretical concepts, approaches or methodologies, instrumentation or interventions to be developed or used, and any advantage over existing methodologies, instrumentation, or interventions. Explain any refinements, improvements, or new applications of theoretical concepts, approaches or methodologies, instrumentation, or interventions.
The recommended length of the innovation section is 1/2-1 page. Content: The innovation section should include the following:
- Explain why concepts and methods are novel to the research field;
- Focus on innovation in study design and outcomes;
- Summarize novel findings to be presented as preliminary data in the Approach section.
- Describe how the application differs from current research or clinical practice paradigms.
- Provide a careful review of the current literature to support the innovative methodologies, approaches, or concepts of your research.
- Demonstrate familiarity with novel methodologies by citing your publications or your collaborator’s publications.
- Summarize novel findings to be presented as preliminary data in the Approach section.
Research Plan Part 4: Approach
The purpose of the approach section is to describe how the research will be carried out. This section is crucial to how favorably an application is reviewed.
The maximum recommended length of the approach section is 9-10 pages, or less depending on overall page limit.
The research design and methods section should include the following:
- PI’s preliminary studies, data, and experience relevant to the application and the experimental design;
- The overview of the experimental design;
- A description of methods and analyses to be used to accomplish the specific aims of the project;
- 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;
- A projected sequence or timetable (work plan);
- If the project is in the early stages of development, describe any strategy to establish feasibility, and address the management of any high risk aspects of the proposed work;
- A detailed discussion of the way in which the results will be collected, analyzed, and interpreted;
- A description of any new methodology used and why it represents an improvement over the existing options.
Number the sections in this part of the application to correspond to the numbers of the Specific Aims.
- Preliminary data, or a progress report, may be included before the Specific Aims sections. Alternatively, integrate preliminary data with the methods description for each Specific Aim. Preliminary data can be an essential part of a research grant application and helps establish the likelihood of success of the proposed project.
- 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.
- 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.”
- If employing a complex technology for the first 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.
- Explain how the research data will be collected, analyzed, and interpreted. If a resource sharing plan is appropriate, begin to prepare this in concert with your Research Plan (noting that it will be submitted as a separate attachment to the package).
- Develop alternative strategies for potential problems.
- Document proposed collaborations and offers of materials or reagents of restricted availability with letters from the individuals involved.
- Point out any procedures, situations, or materials that may be hazardous to personnel and precautions to be exercised (i.e., use of Select Agents).
Budget and Justification
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.
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 his/her 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 facilities and administrative (FandA) costs are not factored into the direct cost limit. Consortium FandA 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.
The budget and justification should cover personnel, consultants, equipment, supplies, travel, and other expenses (e.g., animal maintenance).
- Be realistic. Both “padding” and deliberately under budgeting reflect naiveté, which will be recognized by reviewers. (A downside to under budgeting is that, if funded, you will be expected to do the work with a less than adequate budget.) SPaR Research Program Managers will assist you with building your project budget, and can provide a “skeleton” of the budget justification once the budget has been finalized. You will be responsible for providing necessary text to ensure that the budget justification section adequately “justifies” the research purpose of each expense budgeted.
- 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.
- If possible, try to identify specific individuals for each position requested. “To be named” personnel are very often deleted by reviewers.
- For modular budgets, a detailed budget will not be submitted for supplies, equipment, and travel costs. Nonetheless, SPaR will require a detailed budget before submission as we need to ensure that all necessary costs have been considered and are covered by the amount requested. Although not required in the Personnel Justification for a modular budget, you may choose to provide a high-level summary of the other, non-personnel costs which have been included in your budget.
- 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.
- For non-modular budgets, break out supply costs into major categories (reagents, disposables, etc.) and travel. Provide special justification for any unusual expenses requested.
- Explain any year-to-year fluctuations in the budget, including the level of effort of personnel, especially if they cannot be attributed to routine salary increases. Changes should parallel the research plan and project aims.
- Be sure to check with SPaR to ensure that you are using the current indirect cost rate. Our indirect cost rate is negotiated with the federal government and can change over time While SPH has both an on-campus and an off-campus rate, the off-campus rate is used only in limited, exceptional circumstances.
- Be complete but concise. There are no page limits in this section; however, do not add extraneous components to the budget justification simply to avoid page limits for other sections.
- Provide adequate justification for the need to use outside consultants, if applicable.
- Reach out to all external consortium partners early, and communicate with them often if their scope changes, to ensure that their final budgets are submitted to SPH well before the submission deadline.
- If applicable, provide documentation of institutional rates for animal maintenance and acquisition. Exceptionally large numbers of animals will need detailed justification.
- Pro rate service contracts to percentage of time equipment if used for the project.
- All proposal budgets must be approved by SPaR office to make sure that the details are correct. As above, a detailed budget will be necessary for this approval process, even if the budget to be submitted will be modular.
The purpose of the assurances section is to ensure that the applicant organization will comply with all relevant Federal laws and guidelines.
A special form must be completed for the assurances section. See page B of the PHS 398 application or section18 of the SF424 (RandR) form.
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
- Be familiar with assurances, certifications and requirements for complying with these regulations.
- Begin to obtain assurances early, since they tend to require the cooperation of different institutions.
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.
There is no specified length, but be succinct.
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, provide enough detail to allow the determination of the appropriateness of the exemption. You must provide sufficient information for reviewers to determine that the proposed research meets:
- The requirements of the DHHS regulations to protect human subjects from research risks (45 CFR Part 46);
- NIH and NCI policy requirements for Data and Safety Monitoring for Clinical Trials, if applicable;
- The ClinicalTrials.gov requirements, if applicable;
- The requirements of NIH policies on inclusion of women, minorities, and children.If the application involves the Inclusion of Women and Minorities, SPaR will request your assistance with the completion of the Targeted/Planned Enrollment Table in the 424 application package. A justification is required if there is limited representation of children, women, and minorities. Peer review and NIH program staff will consider this justification in their evaluation of your application. Failure to address this issue will impose a bar on funding until all the concerns raised by the IRG have been resolved.
- The requirements of NIH policy on reporting race and ethnicity data for subjects in clinical research.
- Observe application guidelines strictly.
- Use basic English and avoid jargon.
- Make sure all acronyms are spelled out when used initially.
- Observe the type size and page limitations strictly; do not use a small font. Although the minimum margin size is 0.5”, leaving a 1” margin is more aesthetically pleasing, if possible.
- Include only those graphs, tables, etc., that are unpublished and essential to the narrative. While many researchers choose smaller font size in tables and graphs, please ensure that it is large enough to be easily legible on the printed page to ease review.
- Make sure that 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.
- Include a section on Resource Sharing Plans, including sharing model organisms or genome wide association studies, if appropriate.
- Have an outside reader review the application for clarity and consistency. Consider submitting your proposal components early through the RF APPS Peer Review process, and addressing any issues that are flagged before the submission deadline.
- Proofread carefully by reading aloud. Do not rely on computer “spell check” to point out mistakes.
- Be consistent with terms, references, and form writing style.
Be sure that your application is received by the appropriate deadline.