In addition to the Research Strategy and Specific Aims pages that describe your proposed research, standard NIH applications include many other components including but not limited to those listed below. Follow the instructions below to help determine which of these additional components are necessary for your application. Some will be relevant to all or almost all grant mechanisms, while others may apply to only a subset.
The best way to determine what applies to your application is to closely review:
- NIH Application Instructions referenced in the NOFO under the "Required Application Instructions" heading
- The intended NOFO, particularly:
- Section I: Related Notices
- Section IV: Application and Submission Information
Abstract
Write a succinct summary of the project that both a scientist and a lay person can understand.
- Use Specific Aims as a template—shorten and simplify the language.
- In the first sentence, state the significance of your research to the field and relevance to NIND's mission: to better understand, treat, and prevent infectious, immunologic, and allergic diseases.
- Next state the hypothesis and the innovative potential of your research.
- Then list and briefly describe the Specific Aims and long-term objectives.
- Include appropriate keywords, e.g., immunotherapy, genetic risk factors.
- Do not include graphics or citations.
- Define or omit abbreviations.
- Be sure to omit confidential or proprietary information in these sections!
These sections may be small, but they're important.
- When your application is funded, NIH enters your title and Abstract in the public RePORTER database.
- All peer reviewers read the Abstract and Narrative.
- Staff and automated systems in NIH's Center for Scientific Review use the Abstract and Narrative to decide where to assign your application, even if you requested an institute and study section.
- The Abstract and Narrative describe the importance and health relevance of the research to members of the public and Congress who are interested in what NIH is funding with taxpayer dollars.
Appendix
What To Add and Not To Add in an Appendix
NIH limits the information you may put in an Appendix (see list below of allowable materials) and will check that you did not try to bypass page limits by putting materials in the Appendix that belong in the Research Plan.
Guidelines differ by grant type and notice of funding opportunity (NOFO), so check your NOFO carefully.
The list of allowable Appendix materials is limited to the following items:
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Blank data collection forms, blank survey forms and blank questionnaire forms--or screenshots thereof
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Simple lists of interview questions
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Blank informed consent/assent forms
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Other items only if they are specified in the NOFO as allowable Appendix materials
Applications that include unallowable Appendix materials will be withdrawn and not reviewed.
For additional details, see NIH's Frequently Asked Questions: Appendix Policy.
Submitting the Appendix
Use the Appendix attachment of the PHS 398 Research Plan form. If you can't submit the materials electronically, contact the Scientific Review Officer listed in your chosen NOFO.
Assignment Request Form
Use of the PHS Assignment Request form is optional but can be helpful on a number of levels. The PHS Assignment Request Form contains four sections for receiving suggestions from applicants. This information is reviewed by the NIH’s Center for Scientific Review (CSR)’s Division of Receipt and Referral (DRR). Note that DRR staff are not required to grant the suggestions made on this form, but often do when feasible and scientifically appropriate. Only NIH staff involved in the assignment and review process have access to this form.
Suggestion of IC Assignment
For applications to parent funding opportunities or those with multiple participating ICs (see “Components of Participating Organizations” in “Part 1. Overview Information” of the selected NOFO), you may wish to recommend primary assignment to the IC whose mission most closely aligns with your proposed research. NIH’s Matchmaker may be helpful if you're unsure and reaching out to a NINDS Program Officer may also be helpful.Study Section Assignment
Review “Section V,” Subcategory “2. Review and Selection Process” for information as to whether applications submitted to the NOFO you have selected will be reviewed by the Center for Scientific Review (CSR) or by an IC-convened panel. You may also find this information in “Section VII. Agency Contacts,” under “Peer Review Contact(s).” If your application will be reviewed by CSR, it may be helpful to use the CSR Assisted Referral Tool to get an idea for which standing study sections might be the best fit for your application. NINDS program staff can also provide some input on this topic. It can be very helpful to write an application with a specific audience (in this case, study section) in mind when possible, so making suggestions here can be helpful.Individuals Who Should Not Review and Why
NIH review staff automatically review conflicts of interest carefully and note that a scientific competitor does not necessarily constitute a conflict of interest. Be sure to provide specific information as to why you think a person could NOT provide a fair and impartial review if you choose to suggest the exclusion of a reviewer. This should be specific details as to actions or observations that would suggest this person could not provide a fair or impartial review.Areas of expertise needed to review your application
This section provides you the chance to help NIH facilitate the most fair and rigorous review of your application. Completing this section can be worthwhile even if you don’t utilize or complete other sections of the form. Use this section to highlight the disciplines involved in your project, and particularly if multidisciplinary. This will help CSR and the Scientific Review Officer (SRO) identify the types of expertise needed to rigorously evaluate your application and recruit and assign the most appropriate reviewers.
Authentication of Key Biological and Chemical Resources
This section is an important part of NIH’s Rigor and Reproducibility efforts and has been required in all applications since 2016.
Note that reviewers are asked to comment on the suitability of this plan, and if not adequate, you will be asked to revise and submit an amended version addressing reviewer concerns via just-in-time procedures.
In addition to the instructions for this section that can be found in the standard NIH application instructions, the below references may be useful for informing your development of this section:
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What Kind of Information Should I Include in the “Authentication of Key Biological and/or Chemical Resources” Attachment?
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NIH Policy Notices on the Authentication of Key Biological and/or Chemical Resources section.
Biosketches
Along with any principal investigators, include a biographical sketch with research support information for everyone you designate as senior/key personnel or other significant contributors (OSCs). This includes consultants and technical staff with senior/key personnel or OSC designations, even if they are not paid a salary from the grant. OSCs who contribute at least one person month or more effort must be designated as senior/key personnel.
Get the NIH Biosketch Format Pages, Instructions and Samples, and learn more in the Frequently Asked Questions on Biosketches. Use SciENcv to help you develop your biosketch and automatically format it according to NIH requirements.
How Reviewers Use Biographical Sketches
Reviewers check carefully to see whether the PI and others have enough experience with the techniques to execute the Research Plan. The personal statement and contributions to science can be big factors in how you rate on the Investigator review criterion.
Reviewers will check that you have asked for an appropriate number of people, amount of time, and level of expertise to conduct the research.
How To Create a Strong Biographical Sketch
- Make Your Personal Statement specific for this application. Use this section as well to explain any gaps in productivity or other aspects that may impact how a reviewer may score you as an investigator. Your personal statement can be a big factor in how you the PI rate on the Investigator review criterion.
- All key personnel's biosketches have a personal statement too, which must explicitly state how their experience qualifies them for their role on your project, including relevant education, expertise, and accomplishments.
- Carefully choose the publications you decide to highlight in your "Contributions to Science." Highlight your team's expertise by listing publications or manuscripts in press for each member. Reviewers will consider your seniority when they evaluate the scientific contributions in your biosketch.
NIH offers the following advice for new scientists:
- If you have one publication, you could summarize the key finding of the paper and its importance in a short contribution.
- If you have no publications yet, you could provide a contribution that describes your efforts on other peoples’ papers and projects. For example, perhaps you used a certain method, provided the literature review for a paper, or cared for all the research animals.
- If you have no research or thesis experience yet, you may still be able to describe one contribution about your training to date.
Note that you do not have to be an author on the publications you reference. It is up to you how you describe your contributions. As one way to do so, you could choose to list a key publication that builds on your work.
For further advice on biosketches, consult with your colleagues who serve as reviewers in your area of science. Learn more about NIH Biosketch Format Pages, Instructions and Samples.
Cover Letter
Check required and optional reasons to write a cover letter for your application. Note that only the Scientific Review Officer—not peer reviewers or Program Officers—sees your cover letter.
When a Cover Letter Is Required
You must have a cover letter for the following:
- Approvals to submit. For applications requiring our approval to submit, state that you have attached a copy of the NINDS acceptance letter to the PHS 398 Cover Letter attachment for:
- Grants requesting $500,000 or more in direct costs for any year.
- Conference grants (R13 or U13).
- Late applications. Include the reason your application is late. Learn more at Late Applications and Post-Submission Materials.
- Continuous submission. Indicate that you are a member of an NIH study section qualified to submit at a nonstandard time.
- Video. Indicate that you plan to send video files later.
Optional Uses for the Cover Letter
You may choose to use a cover letter for the following purposes:
- Point out RFAs and PAs. State the title if you're responding to an initiative.
- Note special areas. Note the involvement of human subjects, select agents, or other areas with special requirements.
- Note a subaward that will be active for only some of the grant's years.
In the past, applicants also used the cover letter to list expertise needed to review the application and to request assignment. Use the PHS Assignment Request Form described above instead.
Creating Your Cover Letter
Here's how to create and format your cover letter:
- Start with the title and a brief description of your application.
- Use the PHS 398 Cover Letter File in the grant application—don't confuse it with the mandatory PHS 398 Cover Page Supplement form.
Follow the format NIH gives you in the SF 424 Form Instructions.
Data Management and Sharing Plan
See NINDS' dedicated Data Management and Sharing Plan page
Equipment
This section gives you a chance to demonstrate the equipment necessary to successfully complete the work is available to you. Follow the applicable SF424 NIH instructions
Facilities and Other Resources
Use this section to describe any additional facilities and other resources necessary for the successful completion of the work proposed in your application. Follow the applicable SF424 NIH instructions
Introduction to Application/Response to Reviewers
This section is required only if the application type is "resubmission" or "revision" or if the NOFO specifies that one is needed. Follow the applicable SF424 NIH instructions
Genomic Data Sharing
Genomic Data Sharing is now included under the following section, "Data Management and Sharing Plan." See important information on NINDS' interpretation of the NIH Genomic Data Sharing policy.
Letters of Support
Your application should include letters of support from your institution, key personnel, collaborators, and other significant contributors. Relevant letters of support will assure your peer reviewers that your collaborations and institutional commitments are on the right track.
What To Include
The letter text should demonstrate the commitment of your institution and contributors. Summarize the agreements you have in place to support your project.
Familiarize yourself with the recommendations and instructions in the NIH SF424 Letters of Support instructions.
In multi-component applications, you may include letters of support in the overall component, other components, or both unless stated otherwise in the notice of funding opportunity (NOFO). You may also be instructed to begin the Letters of Support attachment with a table of letter authors, their institutions, and the type of each letter (e.g., institutional commitment).
Specifics for Collaborator Letters
When you request a letter of support, consider providing your collaborator a summary of your agreement as a convenient starting point. Discuss with them what information you think needs to be included.
The letters of support should clearly describe what type of support your collaborators will provide (e.g., reagents, animals, human samples, technology). Make sure to indicate whether the support is available to anyone on request or if your collaborator will provide it to only you. Our staff consider the latter point as they determine who may review your application without conflict.
Note that this letter is not the same document as your formal written agreement with the collaborator. Do not include the text of the formal agreement itself with your letters of support or your application. The formal agreement is for your benefit. NIH does not request, use, or need a copy of it.
Don’t Send Too Many Letters of Support
Include the letters as described in the NOFO’s instructions, but don’t assume that even more letters would be better. We strongly advise against collecting letters of support solely as endorsements of your reputation, expertise, or research plans.
In some cases, applicants have provided over a thousand letters of support. Large quantities of letters pose a significant burden on peer reviewers as they try to determine which are truly relevant to the project.
Unnecessary letters can also limit the pool of experts who are allowed to review your application. Due to potential conflicts of interest, anyone who writes a letter may not review your application. You might unintentionally eliminate the scientists who could have been your best supporters on the review panel.
Multi PD/PI Leadership Plan
This section is required for any multi-PD/PI applications. This section allows you to explain how your team is organized and how you will navigate conflicts if and when they emerge, among other topics. Follow the applicable SF424 NIH instructions.
Narrative
In the Project Narrative, the limit is THREE SENTENCES to describe the project's potential to improve public health.
These sections may be small, but they're important.
- When your application is funded, NIH enters your title and Abstract in the public RePORTER database.
- All peer reviewers read the Abstract and Narrative.
- Staff and automated systems in NIH's Center for Scientific Review use the Abstract and Narrative to decide where to assign your application, even if you requested an institute and study section.
- The Abstract and Narrative describe the importance and health relevance of the research to members of the public and Congress who are interested in what NIH is funding with taxpayer dollars.
Plan for Enhancing Diverse Perspectives
Some NOFOs require this plan to describe how diverse perspectives will be included in the proposed work. If this plan is required, it will be indicated in the NOFO along with instructions provided in section IV of the NOFO if applicable.
References Cited
Put your research plans in scientific context for your reviewers and convince them that you know your field by citing wisely in your application, including a Bibliography. References show your breadth of knowledge of the field. If you leave out an important work, reviewers may assume you're not aware of it.
Cite publications that are current and relevant to the project or show that you or your collaborators used your proposed methods. You may also cite interim research products, such as article preprints, to demonstrate transparency as explained in NIH's Frequently Asked Questions on Interim Research Products. Do not include a copy of publications in the application.
If a publication is public, always link to it, or include its NIH PubMed Central identification number in the text. You will list all citations in your Other Project Information Form: Bibliography and References Cited form. Follow the applicable SF424 NIH instructions
Resource Sharing Plans
With the launch of the Data Sharing and Management Policy for applications submitted on or after January 25th, 2023, it is important to note that existing resource sharing requirements REMAIN in effect.
Resource sharing can be thought of broadly as falling into two main categories:
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All NIH applications and proposals that will produce unique model organism research resources are expected to include a sharing plan for distributing these research resources in the application or proposal, or provide a justification for why such sharing is restricted or not possible.
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This policy statement applies to extramural investigators funded by NIH grants, cooperative agreements, and contracts, including Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) mechanisms. All investigators are expected to develop a model organism sharing plan. There is no cost threshold for this policy
To determine whether a resource is a research tool in the context of the NIH Research Tools Policy, funding recipients should consider whether:
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The resource is primarily a tool for discovery rather than an FDA-approved product or an integral component of such a product;
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The resource is a broad, enabling invention that will be useful to many other users, rather than a project or product-specific resource; and
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The resource is readily useable or distributable as a tool, as opposed to an instance where private sector involvement is either a necessary means or the most expedient means for developing or distributing the resource.
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The NIH uses a broad definition of “research tool” which can the encompass full range of tools that scientists use in the laboratory, including: cell lines, monoclonal antibodies, reagents, animal models, growth factors, combinatorial chemistry and DNA libraries, clones and cloning tools (such as PCR), methods, laboratory equipment and machines
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If through the work of a proposed application, a unique resource you are generating could meet at least one of the numbered criteria above, you should include a resource sharing plan in your application for how the unique resource will be shared or why it cannot be.
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For details on what should be considered and included in the resource sharing plan, review the guidance provided in the NIH Research Tools Policy.
Team Management Plan
Some types of applications require Team Management Plans to provide further details on how teams will be managed. Follow instructions provided in section IV of the NOFO if applicable.