Advice on Application Sections

While the How to Apply – Application Guide and the funding opportunity are your key references for attachment requirements, you may find the following suggestions helpful.

This page lists the Research Plan or Program Plan attachments first, then others. However, you should draft your application in the order that makes the most sense for your project and organization. 

Research or Program Plan Attachments

Your funding opportunity notice specifies which you must prepare:

• A Research Plan includes Specific Aims and a Research Strategy.
• A Research Training Program Plan includes a Program Plan. (No Specific Aims or Research Strategy.)

Many other attachments described below are common to both the Research Plan and the Program Plan. As always, check your funding opportunity and the How to Apply – Application Guide instructions to confirm which forms and attachments are required for your particular project.

Introduction to Application

Write an Introduction to Application attachment for resubmission applications, revision applications, or if the funding opportunity specifies that you need one. An introduction is not allowed for new or renewal applications.

Find guidance and requirements for Resubmission Applications and Competing Revisions, including what information to include in the introduction.

Specific Aims

Most applications need Specific Aims. (Some training funding opportunities will instruct you to complete a Program Plan instead.)

We encourage you to draft your Specific Aims early in your planning and writing process. Ask your mentors and trusted colleagues to review your draft Aims for clarity. Their feedback now can save you from extensive revisions later.

Craft your Specific Aims to encapsulate your specific hypothesis-based goals and expected outcomes.

• The ideal Aims will collectively answer your overall scientific question and address interesting and significant issues in your field.
• When possible, plan Aims where an outcome consistent with the null hypothesis will still contribute to your field and allow your project to continue.

Because the Specific Aims attachment is limited to one page in length:

• We recommend that your Aims focus on your project goals, anticipated outcomes, and the resulting overall impact on your field.
• You can mention major experiments. However, we advise against merely describing your experiments as Specific Aims. You will detail the experiments and their relation to your Aims in the Research Strategy attachment instead.

The typical research project grant (R01) applicant proposes about three related Specific Aims that can be completed during a four- or five-year grant. To choose the appropriate quantity and scope of Specific Aims for your unique project, ask yourself: How much can you reasonably achieve within the timeframe of your award? Do your Aims seem likely to break significant new ground in your field?

Research Strategy

The Research Strategy is the largest scientific narrative section of most applications. (Some training funding opportunities will instruct you to complete a Program Plan instead.)

Organize Your Research Strategy

To organize your Research Strategy, start with the instructions in the How to Apply – Application Guide and your funding opportunity notice. Typically, your Research Strategy follows this structure:

• Three main sections with headers in this order:
  • 1. Significance
  • 2. Innovation
  • 3. Approach
• Preliminary Studies (for new applications) or a Progress Report (for renewals and competing revisions). You can add this information as a subsection of Approach or integrate it into the three main sections above. Either way, label it with a clear subheader or bolding.

Consider these ideas to plan and present your Research Strategy's structure:

• Create an outline to track your structure, then use it as a checklist when you draft.
• Your Research Strategy could also include an overview outline to help your peer reviewers.
• Use subheaders, bold running heads, and/or a section numbering scheme. These approaches can enhance readability and guide your peer reviewers.

Tips on Research Strategy Content

A strong Research Strategy is the heart of your application. Describe your proposed project, its significance, and how you will conduct your research.

As you draft and finalize your Research Strategy content, we advise:

• Learn what to include in your Significance, Innovation, and Approach sections and how they differ. The How to Apply – Application Guide provides extensive guidance on what to cover in each section.
• Describe how your project reflects principles of scientific rigor, reproducibility, and transparency. Find application resources and guidance on Enhancing Reproducibility through Rigor and Transparency.
• Consider including Tables, Charts, and Figures. They can help you summarize data, clarify key elements of your research, illustrate the flow of your planned experiments, and boost visual interest.
• If your project proposes Human Subjects or Clinical Trial research, do not duplicate information from the PHS Human Subjects and Clinical Trials Information form in your Research Strategy. In your Research Strategy discussions, we encourage you to refer readers to the Human Subjects and Clinical Trials Information form for further details.
• If you plan to provide a video, follow the Video instructions.
  • Include key images and a brief description in your Research Strategy. Do not link to or embed the video itself.
  • You must also provide a Cover Letter attachment that explains your intent to submit a video after you apply.

You should also track related information as you write and revise your Strategy. For example:

• While drafting your experiments, take note of related expenses for your Budget and Budget Justification.
• When you need to cite, add the full reference to your Bibliography & References Cited attachment.

Remember that only some of your peer reviewers will be familiar with your specialized field and techniques. Your Research Strategy must be clear enough to convince all reviewers. Find more advice on this aspect at Your Reviewers Are Your Primary Audience.

For more Research Strategy advice, check the NIH All About Grants Podcast: Considerations for Developing a Research Plan.

Program Plan

Training opportunities often require a research training Program Plan. As you design your training program and draft the Program Plan attachment, consider the following:

• How will your program offer a coherent, cogent learning curriculum and training experiences for people at this level of education?
• Does your program description emphasize the strengths and advantages for trainees?
• How well does your program fit the goals described in the funding opportunity?
• Who are the mentors in your program? Do they have a commitment to mentoring future researchers, plus relevant skills to teach?
• Do you have access to a diverse pool of potential trainees? How will you recruit and match trainees with appropriate mentors?
• Does your organization have a strong commitment to the program?

Human, Clinical, Animal, and Select Agent Research

For certain areas of science, you must include additional related information in your application. Find advice and guidance:

• Human subjects. Go to Human Subjects Research for NIH’s definition of human subjects, how assurances and institutional review boards (IRBs) work, certificates of confidentiality, inclusion, and more.
• Clinical trials. The Clinical Trial Requirements website covers NIH’s definition of clinical trials, review criteria, registration and reporting requirements, good clinical practices, the Human Subjects and Clinical Trial Information Form, informed consent, protocol templates, and other related information.
• Human embryonic stem cells or human fetal tissue. Refer to NIH Stem Cell Information, the Guidelines for Human Stem Cell Research, and NIH Grants Policy Statement 4.1.14 Human Fetal Tissue Research.
• Vertebrate animals. If your research will involve animals, go to the NIH Office of Laboratory Animal Welfare (OLAW) for policy guidance, advice, examples, tutorials, a Worksheet for Applications Involving Animals, and more resources.
• Select agents. A select agent is a biological agent or toxin that has the potential to pose a severe threat to public health and safety, animal or plant health, or animal or plant products. Go to NIH Select Agent Information for guidance and resources.

Team Attachments

If your application includes multiple PD/PIs or any consortium/contractual arrangements, finalize your agreements and plans with those individuals and organizations.

For applications with Multiple Principal Investigators, write and attach a Multiple PD/PI Leadership Plan.

• We encourage you to provide a strong scientific rationale to justify the multiple PD/PI approach.
• Describe your leadership team’s organizational structure and procedures for conflict resolution.
• You could also describe how you will share data among PD/PIs, collaborate on publications, and allocate resources.

If relevant, write an attachment that summarizes your Consortium/Contractual Arrangements. Include associated costs or rates. If another organization will execute a significant proportion of the project activities, we strongly advise you to provide a solid explanation of why your organization should be the grant recipient.

Find more advice in the NIH All About Grants Podcast: Assembling the Right Team. Now that your agreements are final, the PD/PIs and involved organizations can complete their Letters of Support.

Letters of Support, Reference Letters, and Other Letters

Arrange for any letters required for your funding opportunity and as stated in the official instructions.

Letters of Support are typically required:

• Your organization, team, and any consortium/contractual individuals or organizations write these to document their role and commitment to your project. Include the rate or price for any contracted services.
• Include the letters of support in your application.
• Make sure the letter details align with what you state elsewhere, e.g., in your Research Strategy and Budget.

Reference Letters are required for fellowships, mentored career development awards, and a few other programs.

• Do not include these letters in your application. Your referees must provide these reference letters directly to NIH by the due date.
• Follow instructions on the main Reference Letters page and in your funding opportunity notice.
• Learn more in the September 2019 Extramural Nexus article “Reference Letters vs. Letters of Support: What’s the Difference?”

An optional Letter of Intent is requested in some funding opportunity notices.

• This letter is not required, binding, or considered during peer review.
• A letter of intent helps NIH staff estimate the potential review workload and recruit reviewers with the expertise needed to review your application.

A Cover Letter is typically optional. You must include a cover letter in scenarios specified in the application instructions or your funding opportunity notice. Learn more in the Cover Letter and PHS Assignment Request Form section.

You may need to provide additional letters in your application or Just-in-Time before award. Some possible examples:

• A certification letter to state your eligibility or qualifications for the award.
• For institutional training grants, a letter that describes the organization's commitment to ensuring that proper policies, procedures, and oversight are in place to prevent discriminatory harassment and other discriminatory practices.
• For small business, additional certification letter(s).

Resource Sharing and Other Plans

Figure out Which Sharing Policies Apply to My Research, then summarize your sharing plans in the following attachments.

In the Resource Sharing Plans attachment, describe how you plan to share model organisms and/or research tools.

• If you are not providing a plan for an organism that would normally require sharing, include a justification.
• Find guidance and sample plans for sharing Model Organisms and Research Tools.

In the Other Plans attachment, describe your Data Management and Sharing (DMS) Plan for scientific data and/or Genomic Data.

• Find guidance on Writing a DMS Plan, including sample DMS plans, an optional format page, recommended elements to include, and more.
• You may request funds in your budget to prepare, document, and archive data. Learn more in the DMS Frequently Asked Questions.

For full details and additional resources, go to the main Scientific Data Sharing website. You should also follow NIH Institute and Center Data Sharing Policies and any related requirements in your funding opportunity.

Appendix

Very few items are allowed as appendix material. We strongly advise you to check your opportunity and the application instructions to confirm what is—and is not—allowed. If you add disallowed materials to the Appendix, NIH must withdraw your application as non-compliant.

Budget and Budget Justification

Crafting your budget can be time consuming. We advise:

• Check your funding opportunity to confirm what type of budget is required.
• Understand the various components of the budget, working with your organization’s Office of Sponsored Research and department administrator.
• Contact the financial/grants management contacts listed in your funding opportunity if you have questions on allowability and other budget topics.

For some NIH policies (e.g., Data Management and Sharing), you may need to explain associated costs in your Budget Justification.

If you wish to budget $500,000 or more in direct costs for any year of your project:

• You must request prior approval from NIH institute, center, or office (ICO) program staff at least six weeks before your anticipated due date. Provide the ICO’s approval information in the Cover Letter attachment of your application.
• Find details in NIH Grants Policy Statement (GPS) 2.3.7.2 Requirements for Submitting Unsolicited Applications Requesting $500,000 or More in Direct Costs.

Biographical Sketches

You must include eRA Commons credentials and biographical sketches for the project directors/principal investigators (PD/PIs) and all other individuals named on the R&R Senior/Key Person Profile Form.

Refer to the main Biosketch Format Pages, Instructions, and Samples website for guidance.

You should also create a SciENcv: Science Experts Network Curriculum Vitae professional profile to help complete your Biographical Sketch.

Do not include current and pending support (other support) information in your application unless otherwise specified in the funding opportunity. Instead, you will submit this information when NIH staff request it Just-in-Time before award. Refer to Other Support Format Pages, Instructions, and Samples for more detail.