Introduction

Writing a grant application is a major undertaking. The following guidance may assist you in developing a strong application that allows reviewers to better evaluate the science and merit of your application.

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

Get Prepared

To ensure efficient and thorough completion of your application, consider taking the following preliminary steps:

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

Is Your Idea Original?  

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

Refine Your Ideas  

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

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What to Know Before You Start Writing the Research Proposal

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

In addition, tips have been provided for demonstrating to reviewers and NIH staff the high quality of the personnel involved, available research resources, and the applicant institution's support of the project. Special instructions for new investigators and foreign applicants are provided, as well.

NIH Peer Review Criteria

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

1 . Significance . Does this study address an important problem? If the aims of the application are achieved, how will scientific knowledge or clinical practice be advanced? What will be the effect of these studies on the concepts, methods, technologies, treatments, services, or preventive measures that drive this field?

2. Approach. Are the conceptual or clinical framework, design, methods, and analyses adequately developed, well-integrated, well-reasoned, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics? For applications designating multiple PDs/PIs, is the leadership approach, including the designated roles and responsibilities, governance and organizational structure consistent with and justified by the aims of the project and the expertise of each of the PDs/PIs?

3. Innovation. Is the project original and innovative? For example, does the project challenge existing paradigms or clinical practice? Does it address an innovative hypothesis or critical barrier to progress in the field? Does the project develop or employ novel concepts, approaches, methodologies, tools, or technologies for this area?

4. Investigators. Are the PD/PI (s) and other key personnel appropriately trained and well-suited to carry out this work? Is the work proposed appropriate to the experience level of the PD/PI(s) and other researchers? Do the PD/PI (s) and investigative team bring complementary and integrated expertise to the project, if applicable?

5. Environment. Do(es) the scientific environment(s) in which the work will be done contribute to the probability of success? Do the proposed studies benefit from unique features of the scientific environment, or subject populations, or employ useful collaborative arrangements? Is there evidence of institutional support?

NOTE: Certain funding opportunity announcements (FOAs) that are published in the NIH Guide for Grants and Contracts may list additional elements under each of the above criteria related to the specific requirement of the RFA.

Independence , Resources and Institutional Support  

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

Independence :

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

Resources:

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

Institutional Support:

• Letters of reference and institutional commitment are important.
• Mention any start-up funds, support for a technician, etc. This is a positive indicator of institutional commitment to the peer reviewers.

Collaborators

Determine the expertise needed for your research study team (individuals, collaborating organizations, resources, etc.). Most scientific work requires collaboration among researchers, and NIH is dedicated to fostering such relationships.

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

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

Are You a “New” Investigator?  

• Determine whether you qualify as a new investigator based on the NIH definition of new investigator. NIH offers funding opportunities tailored to new investigators, such as the NIH Director's New Innovator Award. More information on NIH programs designed for new investigators can be found on the New Investigators Program Web page.

• NIH staff is on the lookout for new investigators. If you qualify, you should self-identify as a new investigator by checking the box on the PHS 398 Cover Page Supplement form in the electronic SF424 grant application package, or for a paper application, mark the checkbox on the application face page.

• It is to your advantage to identify yourself as a new investigator because reviewers are instructed to give special consideration to new investigators. Reviewers will give greater consideration to the proposed approach, rather than the track record.

• First-time applicants may have less preliminary data and fewer publications than more seasoned investigators, and NIH reviewers understand this. Reviewers instead place more emphasis on how the investigator has demonstrated that he or she is truly independent of any former mentors, whether he or she has some of his or her own resources and institutional support, and whether he or she is able to independently lead the research. 

Foreign Involvement – Institution and/or Investigator

• Foreign PD/PIs and those from foreign institutions are highly encouraged to check the eligibility guidelines provided in every FOA.

• The appropriate checkbox on the PHS 398 Grant Application should be marked if the application is being submitted by a domestic institution with a foreign component or if your institution is overseas.

• There are specific requirements and guidelines for research involving foreign institutions that will need to be considered when planning and writing an NIH application (e.g. categorical budgets only, special select agents requirements, etc.)

• Foreign PD/PI's and those from foreign institutions are highly encouraged to contact an NIH NIH program officer as soon as possible in the planning and writing stages.

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Developing Your Research Plan

The research plan describes the proposed research, stating its significance and how it will be conducted. Remember, your application has two audiences: the majority of reviewers who will probably not be familiar with your techniques or field and a smaller number who will be familiar.

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

The research plan component of the application guide includes the following four sections:

• Specific Aims: what you intend to do
• Background and Significance: why the work is important
• Preliminary Studies/Progress Report: what has already been done
• Research Design and Methods: how you are going to do the work

The application guide and the FOA request that specific elements be included in the research plan. There are page limits for the key sections. You may not exceed a total of 25 pages for the four sections of the research plan component listed above for an R01 application.

There is no requirement that all 25 pages allotted be used. All tables, graphs, figures, diagrams, and charts are included within the page limits. Be sure to follow any page limitations specified in the funding opportunity announcement.

Specific Aims

A strong grant application is driven by a strong, solid hypothesis with clear research objectives. The specific aims are a formal statement of the objectives and milestones of the research project towards testing the hypothesis. Consider whether the specific aims are logical and achievable. List your aims and then all the experiments you'll do to support each aim. Keep in mind that your experiments support your aims, and your aims are the test of your hypothesis.

At its core, the typical, successful R01 grant application has a testable hypothesis in an area of high interest. It includes a concise series of specific aims that address the central hypothesis. Consider whether the aims address interesting and significant issues and whether they are hypothesis-based. The purpose of the Specific Aims section is to clearly and concisely describe what the proposed research is intended to accomplish.

Specific aims should:

• Include specific research objectives
• Be hypothesis-based
• Be obtainable within the proposed timeframe
• Fit together in an overall framework
• Be well-focused rather than broad and diffuse
• Limited to one page .

Background and Significance

The Background and Significance section states the research problem, including the proposed rationale, current state of knowledge and potential contributions and significance of your research to the field.

Briefly sketch the background leading to the present application. Critically evaluate existing knowledge, and specifically identify the gaps that the project is intended to fill. Explain why the literature about your research leads you to think this topic needs study. This should not be a thesis, but should provide information that directly pertains to the scientific need for your project.

Make sure the significance of the topic is explicitly stated. Include sufficient justification for the significance of the problem and a rationale for the proposed studies. State how scientific knowledge or clinical practice will be advanced if the aims of the application are achieved. Describe the effect of these studies on the concepts, methods, technologies, treatments, services or preventative interventions that drive this field.

Tips:

• Show that you have critically evaluated existing knowledge, including background literature and relevant data.
• References should reflect up-to-date knowledge of the field.
• Specify existing gaps that the project is intended to fill.
• Identify controversies that the project is designed to resolve.
• Discussion should convey the importance and relevance of the research aims.
• Highlight potential impacts.
• Highlight why research findings are important beyond the confines of the specific research project. For example, to demonstrate significance, address how research results can be applied.
• Two to three pages are recommended for the Background and Significance section.

Preliminary Studies/Progress Report

Use this section to describe your prior work relevant to the proposed project. Preliminary data may consist of your own publications, publications of other researchers, unpublished data from your own laboratory or from others, or some combination of these. Ensure that you have a body of solid preliminary data that demonstrates the likelihood for success of your research. Reviewers must be convinced that the work is feasible in your research setting and under your direction.

The preliminary results are important to establish the experience and competence of the applicant to pursue the proposed research project and to provide support for the study hypotheses and research design. Preliminary data often aids the reviewers in assessing the likelihood of the success of the proposed project.

Tips:

• Discuss how previous work leads to the current proposal.
• Emphasize how the previous work demonstrates feasibility of proposed methods.
• If you do not have the required expertise for a specific methodology, enlist a collaborator or consultant (include a letter of support or agreement)
• Accuracy and overall presentation are important in figures, tables and graphs.

In a competing renewal application, this section becomes a progress report, describing studies performed during the last grant period. The progress report should include a summary of the previous application's specific aims and importance of the finding. Six to eight pages are recommended for the narrative portion of the Preliminary Studies/Progress Report section.

Research Design and Methods

Use this section to describe how you plan to carry out the research. Your research methods should relate directly to the aims you have described. This section is critical for demonstrating that the applicant has developed a clear, organized and thoughtful study design that tests the central hypothesis. It is NOT a list of recipes for methods, experiments and data collection.

Describe any novel concepts, approaches, tools, or technologies for the proposed studies. Discuss the potential difficulties and limitations of the proposed procedures and alternative approaches to achieve the aims. As part of this section, provide a tentative sequence or timetable for the project.

Tips:

• Should provide an overview of the proposed design and conceptual framework.
• Study goals should relate to proposed study hypotheses.
• Include details related to specific methodology; explain why the proposed methods are the best to accomplish study goals.
• Describe any novel concepts, approaches, tools or techniques.
• Include details of how data will be collected and results analyzed.
• Consider required statistical techniques.
• Include proposed work plan and timeline.
• Consider and discuss potential limitations and alternative approaches to achieve study aims.
• Keep in mind that a carefully developed research plan will also be reflected in a realistic and well-justified budget for the project, whether it is a modular or non-modular budget.

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Additional Elements Required in a Grant Application

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

• Appendix Materials
  T he Appendix may not be used to circumvent the page limitations of the Research Plan. Essential information should be included within the body of the grant application. The appendices should contain supportive or supplemental information. Please review the NIH Guide Notice, NOT-OD-07-018, announcing a change in policy limiting Appendix materials that may be submitted with grant applications to NIH .
• Bibliography & References Cited (formerly “Literature Cited”)
  Provide a bibliography of any references cited in the Research Plan. Each reference must include the names of all authors (in the same sequence in which they appear in the publication), the article and journal title, book title, volume number, page numbers, and year of publication. Make sure that only bibliographic citations are included. Be especially careful to follow scholarly practices in providing citations for source materials relied upon when preparing any section of the application. Note the location of this information is slightly different in the SF424 R&R and the PHS398. Please read the application instructions carefully for whichever application you are using.
• Care and Use of Vertebrate Animals in Research
  If you are planning to use live vertebrate animals in the project, you must adhere to the requirements in the Public Health Service (PHS) Policy : HTML Version and PDF Version. The PHS Policy is summarized in the brochure What Investigators Need to Know About the Use of Animals. Additional information can be found at:
  • Office of Laboratory Animal Welfare Web Site
• NIAID's tutorial: Requirement for Grantees Using Research Animals
• Consortium/Contractual Arrangements
  Explain the programmatic, fiscal, and administrative arrangements to be made between the applicant organization and the consortium organization(s).
• Consultants
  Attach appropriate letters from all consultants confirming their roles in the project. For consultants, letters should include rate/charge for consulting services.
• Facilities & Other Resources
  This information is used to assess the capability of the organizational resources available to perform the effort proposed. Identify the facilities to be used (Laboratory, Animal, Computer, Office, Clinical and Other). If appropriate, indicate their capacities, pertinent capabilities, relative proximity and extent of availability to the project. Describe only those resources that are directly applicable to the proposed work.
• Inclusion of Women, Minorities and Children in Research
  Peer reviewers will also assess the adequacy of plans to include subjects from both genders, all racial and ethnic groups (and subgroups), and children, as appropriate, for the scientific goals of the research will be assessed. Plans for the recruitment and retention of subjects will also be evaluated.
• Protection of Human Subjects from Research Risk
  Applicants must assure NIH that all human subjects are protected. Reviewers will assess the potential risk to human subjects in proposed research and evaluate what protections are in place to guard against any research-related risk. Awards cannot be made until assurances are on file with the Office for Human Research Protections (OHRP). Decision charts are presented that are helpful in thinking through relevant human subject protections issues (see http://www.hhs.gov/ohrp/humansubjects/guidance/decisioncharts.htm).
• Resource Sharing Plan(s)
  This section includes Data Sharing Plan, when applicable, and Sharing Model Organisms. For more information on data sharing, please see the NIH website at http://grants.nih.gov/grants/ policy/data_sharing/.
• Select Agents
  Identify any select agents to be used in the proposed research. Select agents are hazardous biological agents and toxins that HHS or USDA have identified as having the potential to pose a severe threat to public health and safety, to animal and plant health, or to animal and plant products. CDC maintains a list of HHS and USDA Select Agents and Toxins.
• Multiple PD/PI
  For applications designating multiple PDs/PIs, you must include a leadership plan.
• Use of Internet Sites
  NIH instituted a policy that prohibits the use of World Wide Web addresses (URLs) in grant applications in the place of text describing the same material. This is because of the potential for providing a large amount of extra material from a web site beyond what would fit in the page limit, and thereby giving an unfair advantage to some applicants and a large additional burden for reviewers.
   

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Important Writing Tips

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

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

Proofreading and Final Edits

• Allow sufficient time to put the completed application aside, and then edit it from a fresh vantage point. Try proofreading by reading the application aloud.
• Allow time for an internal review by collaborators, colleagues, mentors and make revisions/edits from that review. If possible, have both experts in your field and those who are less familiar with your science provide feedback. The application should be easy to understand by all.
• It is a good idea to have an independent expert provide an objective critique of your application. If possible, arrange for neutral third-party reviewers.
• If more than one investigator is contributing to the writing, it would be helpful to have one overall editor.
• Have zero tolerance for typographical errors, misspellings, grammatical mistakes or sloppy formatting. A sloppy or disorganized application may lead the reviewers to conclude that your research may be conducted in the same manner.
• Prior to submission, perform a final proofread of the entire grant application.