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Writing a Data Management & Sharing Plan

Learn what NIH expects Data Management & Sharing Plans to address, as well as how to submit your Plan.

• Applications for Receipt Dates BEFORE Jan 25 2023
• Applications for Receipt Dates ON/AFTER Jan 25 2023

Writing a Data Sharing Plan

Under its 2003 data sharing policy , NIH expects investigators to submit a data sharing plan with requests for funding or grants, cooperative agreements, intramural research, contracts, or other funding agreements of $500,000 or more per year.

Data sharing plans should describe how an applicant will share their final research data. The specifics of the plan will vary on a case-by-case basis, depending on the type of data to be shared and how the investigator plans to share the data.

Examples of information to cover in a data sharing plan include:

• The expected schedule for data sharing
• The format of the dataset
• The documentation to be provided with the dataset
• Whether any analytic tools also will be provided
• A brief description of such an agreement
• Criteria for deciding who can receive the data
• Whether or not any conditions will be placed on their use
• Investigators choosing to handle their own data sharing may wish to enter into a data-sharing agreement.

Generating large-scale genomic data? NIH’s Genomic Data Sharing (GDS) policy may also apply to your research. See our GDS Policy Overview  to learn more.

Examples of Data Sharing Plans

The exact content and level of detail to be included in a data sharing plan depends on the specifics of the project, such as how the investigator is planning to share data, or the size and complexity of the dataset. The examples below give a sense of what a data sharing plan can look like. 

Example 1 This application requests support to collect public-use data from a survey of more than 22,000 Americans over the age of 50 every 2 years. Data products from this study will be made available without cost to researchers and analysts. User registration is required in order to access or download files. As part of the registration process, users must agree to the conditions of use governing access to the public release data, including restrictions against attempting to identify study participants, destruction of the data after analyses are completed, reporting responsibilities, restrictions on redistribution of the data to third parties, and proper acknowledgment of the data resource. Registered users will receive user support, as well as information related to errors in the data, future releases, workshops, and publication lists. The information provided to users will not be used for commercial purposes, and will not be redistributed to third parties.

Example 2 The proposed research will include data from approximately 500 subjects being screened for three bacterial sexually transmitted diseases (STDs) at an inner city STD clinic. The final dataset will include self-reported demographic and behavioral data from interviews with the subjects and laboratory data from urine specimens provided. Because the STDs being studied are reportable diseases, we will be collecting identifying information. Even though the final dataset will be stripped of identifiers prior to release for sharing, we believe that there remains the possibility of deductive disclosure of subjects with unusual characteristics. Thus, we will make the data and associated documentation available to users only under a data-sharing agreement that provides for: (1) a commitment to using the data only for research purposes and not to identify any individual participant; (2) a commitment to securing the data using appropriate computer technology; and (3) a commitment to destroying or returning the data after analyses are completed.

Example 3 The proposed research will involve a small sample (less than 20 participants) recruited from clinical facilities in the New York City area with Williams syndrome. This rare craniofacial disorder is associated with distinguishing facial features. Even with the removal of all identifiers, we believe that it would be difficult if not impossible to protect the identities of subjects given the physical characteristics of subjects, the type of clinical data (including imaging) that we will be collecting, and the relatively restricted area from which we are recruiting subjects. Therefore, we are not planning to share the data.

What data that will be shared:

I will share phenotypic data associated with the collected samples by depositing these data at ________________ which is an NIH-funded repository.  Genotype data will be shared by depositing these data at ________________.  Additional data documentation and de-identified data will be deposited for sharing along with phenotypic data, which includes demographics, family history of XXXXXX disease, and diagnosis, consistent with applicable laws and regulations.  I will comply with the NIH GWAS Policy and the funding IC’s existing policies on sharing data on XXXXXX disease genetics to include secondary analysis of data resulting from a genome wide association study through the repository.  Meta-analysis data and associated phenotypic data, along with data content, format, and organization, will be available at ____________.  Submitted data will confirm with relevant data and terminology standards.

Who will have access to the data:

I agree that data will be deposited and made available through ________________ which is an NIH-funded repository, and that these data will be shared with investigators working under an institution with a Federal Wide Assurance (FWA) and could be used for secondary study purposes such as finding genes that contribute to process of XXXXXX.  I agree that the names and Institutions of persons either given or denied access to the data, and the bases for such decisions, will be summarized in the annual progress report.  Meta-analysis data and associated phenotypic data, along with data content, format, and organization, will be made available to investigators through ____________.

Where will the data be available:

I agree to deposit and maintain the phenotypic data, and secondary analysis of data (if any) at ________________, which is an NIH-funded repository and that the repository has data access policies and procedures consistent with NIH data sharing policies.

When will the data be shared:

I agree to deposit genetic outcome data into ________________ repository as soon as possible but no later than within one year of the completion of the funded project period for the parent award or upon acceptance of the data for publication, or public disclosure of a submitted patent application, whichever is earlier.

How will researchers locate and access the data:

I agree that I will identify where the data will be available and how to access the data in any publications and presentations that I author or co-author about these data, as well as acknowledge the repository and funding source in any publications and presentations.  As I will be using ________________, which is an NIH-funded repository, this repository has policies and procedures in place that will provide data access to qualified researchers, fully consistent with NIH data sharing policies and applicable laws and regulations.

How to Submit Data Sharing Plans

The plan should be included in the Resource Sharing section  of the application. See the  How to Apply – Application Guide  for form instructions.

Writing a Data Management and Sharing Plan

Under the 2023 Data Management and Sharing (DMS) Policy , NIH expects researchers to maximize the appropriate sharing of scientific data, taking into account factors such as legal, ethical, or technical issues that may limit the extent of data sharing and preservation.

NIH requires all applicants planning to generate scientific data to prepare a DMS Plan that describes how the scientific data will be managed and shared. For more on what constitutes scientific data, see Research Covered Under the Data Management & Sharing Policy .

Applications subject to NIH’s Genomic Data Sharing (GDS) Policy should also address GDS-specific considerations within the elements of a DMS Plan (see NOT-OD-22-189 and details below).

Submitting Data Management and Sharing Plans

The DMS Plan should be submitted as follows:

• DMS Plans should be included within the “Other Plan(s)” field on the PHS 398 Research Plan or PHS 398 Career Development Award Supplemental Form as indicated in the Application Instructions . See below for details on developing and formatting Plans.
• A brief summary and associated costs should be submitted as part of the budget and budget justification (see Budgeting for Data Management and Sharing and the Application Instructions for details).
• Extramural (contracts) : as part of the technical evaluation
• Intramural : determined by the Intramural Research Program
• Other funding agreements : prior to the release of funds

Data Management and Sharing Plan Format

DMS Plans are recommended to be two pages or less in length.

NIH has developed an optional DMS Plan format page that aligns with the recommended elements of a DMS Plan.

Important: Do not include hypertext (e.g., hyperlinks and URLs) in the DMS Plan attachment.

Elements to Include in a Data Management and Sharing Plan

As outlined in NIH Guide Notice Supplemental Policy Information: Elements of an NIH Data Management and Sharing Plan , DMS Plans should address the following recommended elements and are recommended to be two pages or less in length. As described in the Application Guide, the DMS Plan should be attached to the application as a PDF file. See NIH’s Format Attachments page.

1. Data Type

Briefly describe the scientific data to be managed and shared:

• Summarize the types (for example, 256-channel EEG data and fMRI images) and amount (for example, from 50 research participants) of scientific data to be generated and/or used in the research. Descriptions may include the data modality (e.g., imaging, genomic, mobile, survey), level of aggregation (e.g., individual, aggregated, summarized), and/or the degree of data processing.
• Describe which scientific data from the project will be preserved and shared. NIH does not anticipate that researchers will preserve and share all scientific data generated in a study. Researchers should decide which scientific data to preserve and share based on ethical, legal, and technical factors. The plan should provide the reasoning for these decisions.

A brief listing of the metadata, other relevant data, and any associated documentation (e.g., study protocols and data collection instruments) that will be made accessible to facilitate interpretation of the scientific data

For data subject to the GDS Policy: Data types expected to be shared under the GDS Policy should be described in this element. Note that the GDS Policy expects certain types of data to be shared that may not be covered by the DMS Policy’s definition of “scientific data”. For more information on the data types to be shared under the GDS Policy, consult Data Submission and Release Expectations .

2. Related Tools, Software and/or Code

Indicate whether specialized tools are needed to access or manipulate shared scientific data to support replication or reuse, and name(s) of the needed tool(s) and software. If applicable, specify how needed tools can be accessed.

3. Standards

Describe what standards, if any, will be applied to the scientific data and associated metadata (i.e., data formats, data dictionaries, data identifiers, definitions, unique identifiers, and other data documentation).

4. Data Preservation, Access, and Associated Timelines

Give plans and timelines for data preservation and access, including:

• The name of the repository(ies) where scientific data and metadata arising from the project will be archived. See Selecting a Data Repository for information on selecting an appropriate repository.
• How the scientific data will be findable and identifiable, i.e., via a persistent unique identifier or other standard indexing tools.

When the scientific data will be made available to other users and for how long. Identify any differences in timelines for different subsets of scientific data to be shared.

• Note that NIH encourages scientific data to be shared as soon as possible, and no later than the time of an associated publication or end of the performance period, whichever comes first. NIH also encourages researchers to make scientific data available for as long as they anticipate it being useful for the larger research community, institutions, and/or the broader public.

For data subject to the GDS Policy: For human genomic data: Investigators are expected to submit data to a repository acceptable under the Genomic Data Sharing Policy. See Where to Submit Genomic Data . Human genomic data is expected to be shared according to NIH’s Data Submission and Release Expectations , but no later than the end of the performance period, whichever comes first. For Non-human genomic data: Investigators may submit data to any widely used repository. Non-human genomic data is expected to be shared as soon as possible, but no later than the time of an associated publication, or end of the performance period, whichever is first.

5. Access, Distribution, or Reuse Considerations

Describe any applicable factors affecting subsequent access, distribution, or reuse of scientific data related to:

• Informed consent
• Privacy and confidentiality protections consistent with applicable federal, Tribal, state, and local laws, regulations, and policies
• Whether access to scientific data derived from humans will be controlled
• Any restrictions imposed by federal, Tribal, or state laws, regulations, or policies, or existing or anticipated agreements

Any other considerations that may limit the extent of data sharing. Any potential limitations on subsequent data use should be communicated to the individuals or entities (for example, data repository managers) that will preserve and share the scientific data. The NIH ICO will assess whether an applicant’s DMS plan appropriately considers and describes these factors. For more examples, see Frequently Asked Questions for examples of justifiable reasons for limiting sharing of data.

Expectations for human genomic data subject to the GDS Policy: Informed Consent Expectations: For research involving the generation of large-scale human genomic data from cell lines or clinical specimens that were created or collected AFTER the effective date of the GDS Policy (January 25, 2015): NIH expects that informed consent for future research use and broad data sharing will have been obtained. This expectation applies to de-identified cell lines or clinical specimens regardless of whether the data meet technical and/or legal definitions of de-identified (i.e. the research does not meet the definition of “human subjects research” under the Common Rule). For research involving the generation of large-scale human genomic data from cell lines or clinical specimens that were created or collected BEFORE the effective date of the GDS Policy: There may or may not have been consent for research use and broad data sharing. NIH will accept data derived from de-identified cell lines or clinical specimens lacking consent for research use that were created or collected before the effective date of this Policy. Institutional Certifications and Data Sharing Limitation Expectations: DMS Plans should address limitations on sharing by anticipating sharing according to the criteria of the Institutional Certification . In cases where it is anticipated that Institutional Certification criteria cannot be met (i.e., data cannot be shared as expected by the GDS Policy), investigators should state the institutional Certification criteria in their DMS Plan, explaining why the element cannot be met, and indicating what data, if any, can be shared and how to enable sharing to the maximal extent possible (for example, sharing data in a summary format). In some instances, the funding NIH ICO may need to determine whether to grant an exception to the data submission expectation under the GDS Policy. Genomic Summary Results: Investigators conducting research subject to the GDS Policy should indicate in their DMS Plan if a study should be designated as “sensitive” for the purposes of access to Genomic Summary Results (GSR), as described in NOT-OD-19-023 .

6. Oversight of Data Management and Sharing

Indicate how compliance with the DMS Plan will be monitored and managed, the frequency of oversight, and by whom (e.g., title, roles). This element refers to oversight by the funded institution, rather than by NIH. The DMS Policy does not create any expectations about who will be responsible for Plan oversight at the institution.

Sample Plans

NIH has provided sample DMS Plans as examples of how a DMS Plan could be completed in different contexts, conforming to the elements described above. These sample DMS Plans are provided for educational purposes to assist applicants with developing Plans but are not intended to be used as templates and their use does not guarantee approval by NIH.

Note that the sample DMS Plans provided below may reflect additional expectations established by NIH or specific NIH Institutes, Centers, or Offices that go beyond the DMS Policy. Applicants will need to ensure that their Plan reflects any additional, applicable expectations (including from NIH policies and any ICO- or program-specific expectations as stated in the funding opportunity).

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Sample Plan Description	NIH Institute or Center	Tags

Assessment of Data Management and Sharing Plans

Program staff at the proposed NIH Institute or Center (IC) will assess DMS Plans to ensure the elements of a DMS Plan have been adequately addressed and to assess the reasonableness of those responses. Applications selected for funding will only be funded if the DMS Plan is complete and acceptable.

During peer review, reviewers will not be asked to comment on the DMS Plan nor will they factor the DMS Plan into the Overall Impact score, unless sharing data is integral to the project design and specified in the funding opportunity (see NOT-OD-22-189 ).

If data sharing is integral to the project and tied to a scored review criterion in the funding opportunity, program staff will assess the adequacy of the DMS Plan per standard procedure, but peer reviewers will also be able to view the DMS Plan attachment and may factor that information into scores as outlined in the evaluation criteria.

For information about budget assessment by peer reviewers, see Budgeting for Data Management and Sharing .

Revising Data Management and Sharing Plans

Pre-Award Plan Revisions: If the DMS Plan provided in the application cannot be approved based on the information provided, applicants will be notified that additional information is needed. This will occur through the Just-in-Time (JIT) process. Applicants will be expected to communicate with their Program Officer and/or Grants Management Specialist to resolve any issues that prevent the funding IC from approving the DMS Plan. If needed, applicants should submit a revised DMS Plan. Refer to NIH Grants Policy Statement Section 2.5.1 Just-in-Time Procedures for additional guidance.

Post-Award Plan Revisions: Although investigators submit plans before research begins, plans may need to be updated or revised over the course of a project for a variety of reasons for example, if the type(s) of data generated change(s), a more appropriate data repository becomes available, or if the sharing timeline shifts. If any changes occur during the award or support period that affects how data is managed or shared, investigators should update the Plan to reflect the changes. It may be helpful to discuss potential changes with the Program Officer. In addition, the funding NIH ICO will need to approve the updated Plan. NIH staff will monitor compliance with approved DMS Plans during the annual RPPR process as well. For more details, please refer to NOT-OD-23-185: Prior Approval Requests for Revisions to an Approved Data Management and Sharing (DMS) Plan Must be Submitted Using the Prior Approval Module .

Additional Considerations

Note that funding opportunities or ICs may have specific expectations (for example: scientific data to share, relevant standards, repository selection). View a list of NIH Institute or Center data sharing policies . Investigators are encouraged to reach out to program officers with questions about specific ICO requirements.

Please note that a Plan is part of an application, and, as such, an institution takes responsibility for the Plan and the rest of the application's contents when submitting an application. Although part of the official submission, when not considered during peer review the attachment is maintained as a separate “Data Management and Sharing (DMS) Plan” document in the grant folder viewable via the Status Information screen in eRA Commons. This document is viewable by authorized users and is not part of the assembled e-Application.

New Data Management & Sharing Policy Effective January 25, 2023!

Related resources.

Selecting a Data Repository

Budgeting for Data Management & Sharing

Data Management

NIH Institute or Center Data Sharing Policies

Writing a Research Strategy

This page is focused on providing practical tips and suggestions for preparing The Research Strategy, the primary component of an application's Research Plan along with the Specific Aims. The guidance on this page is primarily geared towards an R01-style application, however, much of it is useful for other grant types as well.

Developing the Research Strategy

The primary audience for your application is your peer review group. When writing your Research Strategy, your goal is to present a well-organized, visually appealing, and readable description of your proposed project and the rationale for pursuing it. Your writing should be streamlined and organized so your reviewers can readily grasp the information. If it's a key point, repeat it, then repeat it again. Add more emphasis by putting the text in bold , or bold italics . If writing is not your forte, get help. For more information, please visit  W riting For Reviewers .

How to Organize the Research Strategy Section

How to organize a Research Strategy is largely up to the applicant. Start by following the NIH application instructions and guidelines for formatting attachments such as the research plan section.

It is generally structured as follows:

Significance

For Preliminary Studies (for new applications) or a Progress Report (for renewal and revision applications).

• You can either include preliminary studies or progress report information as a subsection of Approach or integrate it into any or all of the three main sections.
• If you do the latter, be sure to mark the information clearly, for example, with a bold subhead.

 Helpful tips to consider when formatting:

• Organize using bold headers or an outline or numbering system—or both—that are used consistently throughout.
• Start each section with the appropriate header: Significance, Innovation, or Approach.
• Organize the Approach section around the Specific Aims.

For most applications, you need to address Rigor ous Study Design  by describing the experimental design and methods you propose and how they will achieve robust and unbiased results. See the NIH guidance for elaboration on the 4 major areas of rigor and transparency emphasized in grant review. These requirements apply to research grant, career development, fellowship, and training applications.

Tips for Drafting Sections of the Research Strategy

Although you will emphasize your project's significance throughout the application, the Significance section should give the most details. The farther removed your reviewers are from your field, the more information you'll need to provide on basic biology, importance of the area, research opportunities, and new findings. Reviewing the potentially relevant study section rosters may give you some ideas as to general reviewer expertise. You will also need to describe the prior and preliminary studies that provide a strong scientific rationale for pursuing the proposed studies, emphasizing the strengths and weaknesses in the rigor and transparency of these key studies.

This section gives you the chance to explain how your application is conceptually and/or technically innovative. Some examples as to how you might do this could include but not limited to:

• Demonstrate the proposed research is new and unique, e.g., explores new scientific avenues, has a novel hypothesis, will create new knowledge.
• Explain how the proposed work can refine, improve, or propose a new application of an existing concept or method.

If your proposal is paradigm-shifting or challenges commonly held beliefs, be sure that you include sufficient evidence in your preliminary data to convince reviewers, including strong rationale, data supporting the approach, and clear feasibility. Your job is to make the reviewers feel confident that the risk is worth taking.

For projects predominantly focused on innovation and outside-the-box research, investigators may wish to consider mechanisms other than R01s for example (e.g., exploratory/developmental research (R21) grants, NIH Director's Pioneer Award Program (DP1), and NIH Director's New Innovator Award Program (DP2).

The Approach section is where the experimental design is described. Expect your assigned reviewers to scrutinize your approach: they will want to know what you plan to do, how you plan to do it, and whether you can do it. NIH data show that of the peer review criteria, approach has the highest correlation with the overall impact score. Importantly, elements of rigorous study design should be addressed in this section, such as plans for minimization of bias (e.g. methods for blinding and treatment randomization) and consideration of relevant biological variables. Likewise, be sure to lay out a plan for alternative experiments and approaches in case you get uninterpretable or surprising results, and also consider limitations of the study and alternative interpretations. Point out any procedures, situations, or materials that may be hazardous to personnel and precautions to be exercised. A full discussion on the use of select agents should appear in the Select Agent Research attachment. Consider including a timeline demonstrating anticipated completion of the Aims. 

Here are some pointers to consider when organizing your Approach section:

• Enter a bold header for each Specific Aim.
• Under each aim, describe the experiments.
• If you get result X, you will follow pathway X; if you get result Y, you will follow pathway Y.
• Consider illustrating this with a flowchart.

Preliminary Studies

If submitting a new application to a NOFO that allows preliminary data, it is strongly encouraged to include preliminary studies. Preliminary studies demonstrate competency in the methods and interpretation. Well-designed and robust preliminary studies also serve to provide a strong scientific rationale for the proposed follow-up experiments. Reviewers also use preliminary studies together with the biosketches to assess the investigator review criterion, which reflects the competence of the research team. Provide alternative interpretations to your data to show reviewers you've thought through problems in-depth and are prepared to meet future challenges. As noted above, preliminary data can be put anywhere in the Research Strategy, but just make sure reviewers will be able to distinguish it from the proposed studies. Alternatively, it can be a separate section with its own header.

Progress Reports

If applying for a renewal or a revision (a competing supplement to an existing grant), include a progress report for reviewers.

Create a header so reviewers can easily find it and include the following information:

• Project period beginning and end dates.
• Summary of the importance and robustness of the completed findings in relation to the Specific Aims.
• Account of published and unpublished results, highlighting progress toward achieving your Specific Aims.

Other Helpful Tips

Referencing publications.

References show breadth of knowledge of the field and provide a scientific foundation for your application. If a critical work is omitted, reviewers may assume the applicant is not aware of it or deliberately ignoring it.

Throughout the application, reference all relevant publications for the concepts underlying your research and your methods. Remember the strengths and weaknesses in the rigor of the key studies you cite for justifying your proposal will need to be discussed in the Significance and/or Approach sections.

Read more about Bibliography and References Cited at Additional Application Elements .

Graphics can illustrate complex information in a small space and add visual interest to your application. Including schematics, tables, illustrations, graphs, and other types of graphics can enhance applications. Consider adding a timetable or flowchart to illustrate your experimental plan, including decision trees with alternative experimental pathways to help your reviewers understand your plans.

Video may enhance your application beyond what graphics alone can achieve. If you plan to send one or more videos, you'll need to meet certain requirements and include key information in your Research Strategy. State in your cover letter that a video will be included in your application (don't attach your files to the application). After you apply and get assignment information from the Commons, ask your assigned Scientific Review Officer (SRO) how your business official should send the files. Your video files are due at least one month before the peer review meeting.

However, you can't count on all reviewers being able to see or hear video, so you'll want to be strategic in how you incorporate it into your application by taking the following steps:

• Caption any narration in the video.
• Include key images from the video
• Write a description of the video, so the text would make sense even without the video.

Tracking for Your Budget

As you design your experiments, keep a running tab of the following essential data:

• Who. A list of people who will help (for the Key Personnel section later).
• What. A list of equipment and supplies for the experiments
• Time. Notes on how long each step takes. Timing directly affects the budget as well as how many Specific Aims can realistically be achieved.

Jotting this information down will help when Creating a Budget  and complete other sections later.

Review and Finalize Your Research Plan

Critically review the research plan through the lens of a reviewer to identify potential questions or weak spots.

Enlist others to review your application with a fresh eye. Include people who aren't familiar with the research to make sure the proposed work is clear to someone outside the field.

When finalizing the details of the Research Strategy, revisit and revise the Specific Aims as needed. Please see Writing Specific Aims . 

Want to contact NINDS staff? Please visit our Find Your NINDS Program Officer page to learn more about contacting Program Officer, Grants Management Specialists, Scientific Review Officers, and Health Program Specialists. Find NINDS Program Officer

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Ancillary documents for NIH grant applications: The pages beyond the science

Monica fahrenholz.

a Office of Surgical Research Administration, Department of Surgery, Texas Children’s Hospital and Baylor College of Medicine, Houston, TX

Lily S. Cheng

b Laboratory for Regenerative Tissue Repair, Division of Pediatric Surgery, Department of Surgery, Texas Children’s Hospital and Baylor College of Medicine, Houston, TX

Oluyinka Olutoye, II

Anjali a. degala, sonya s. keswani, allan m. goldstein.

c Department of Pediatric Surgery, Massachusetts General Hospital, Harvard Medical School, Boston, MA

Sundeep G. Keswani

Preparing a grant proposal is no small feat, especially for research (R-series) grants from the National Institutes of Health. The National Institutes of Health is the largest public funder of biomedical research in the world, and as such, procuring a research grant from the National Institutes of Health is one of the ultimate benchmarks of success for a surgeon–scientist. Most investigators are familiar with the page limits for most R-series grants (12 pages for an R01 and 6 pages for an R21), with the addition of a single page allotted for the specific aims. Interestingly, despite the usual focus on the aforementioned research section, the rest of the application can routinely consist of an additional 100 to 150 pages, which means that pages allotted for the specific aims and research strategy represent only 10% of the complete application package. For busy surgeons, it is this abundance of ancillary documentation that can make preparing a research grant particularly onerous. Fortunately, for some, support exists within the department to help prepare much of this documentation by drawing from previous sources, templates, and boiler-plate language that has been developed. Although these resources can significantly reduce the burden on individual investigators, there is a danger of leaning on generalized templates that can dilute the message of the overall grant proposal and introduce extraneous or incorrect information that can ultimately impact the cohesiveness and ultimately the competitiveness of the grant. The focus of this article is to educate surgeon–scientists regarding the purpose and importance of the ancillary information required for National Institutes of Health research grants and how to make the most of institutional resources while tailoring these materials to create a cohesive, competitive grant application.

Significance of the Ancillary Documents

Although the bulk of the overall impact score on a grant will depend primarily on the quality of the science laid out in the research strategy, there are aspects of the scoring criteria that can only be gleaned from the ancillary documentation. As a reminder, the 5 criteria used to score a National Institutes of Health (NIH) research grant (and which are used by many other funding agencies) are: Significance, Innovation, Investigators, Approach, and Environment. 1 Significance, Innovation, and Approach are clearly addressed in the research strategy; however, the scoring for Investigators and Environment relies heavily on information provided in the biosketches, facilities and equipment, and letters of support. Furthermore, the Approach score can be affected by information provided in the human participants and vertebrate animals sections of the application. Whereas other sections, such as the authentication and resource sharing pages, are not explicitly scored, problems in these sections can result in delays in funding if not appropriately addressed. Creating de novo versions of these resources can feel like an insurmountable task, especially for young surgeon–scientists trying to balance starting a research career with establishing a clinical program. Indeed, even with institutional and mentor resources to draw from, it can take up to 6 months to compile a first NIH research grant application. The good news, though, is that this initial investment of time and effort will pay dividends by simplifying the process for later applications. The discussion below reviews the purpose of each section and provides tips to improve your application and make it cohesive. For experienced surgeon–scientists, these tips can help revive tired, boilerplate language and improve future submissions.

We systematically reviewed each of the required documents in a standard R-series NIH grant proposal ( Table I ), providing information on the purpose of each document and how it may affect the criteria scores and overall impact score. Additionally, we provided tips on how to make the document attractive to reviewers. This discussion did not cover documents specific to other types of applications, such as career development (K-series) or project (P- or U-) grants. Additional information on crafting a career development grant can be found in previous publications. 2 – 6 However, much of the discussion here will cover documents that are applicable to these grants as well as many grants from other agencies that use the NIH format. It is also important to keep apprised of format changes and requirements for NIH submissions that are periodically updated by the NIH.

Summary of ancillary documents

Biosketch	Describes why you are uniquely suited to complete the proposed project
Facilities and Equipment	Lists the resources you have that will allow you to achieve successful completion of the proposed project
Budget and Justification	Request for financial support with rationale for amount requested
Human Participants and Vertebrate Animals	Ensures compliance with regulatory processes for studies involving human participants or vertebrate animals
Letters of Support	Demonstrates important collaborative relationships, general support of your proposal, or availability of specific resources
Authentication and Resource Sharing	Fulfills an NIH requirement to validate biological or chemical resources used in your project and describe how you plan to disseminate new resources to the scientific community
Other Documents (for specific applications)	Includes introduction page (for grant resubmissions), multiple principal investigator plan (for grants involving multiple principal investigators)

NIH, National Institutes of Health.

Among the ancillary documents, the biosketch is perhaps the most well-known and ubiquitous. Used by most foundation- and government-based funding agencies, the NIH biosketch is the standard form to communicate an investigator’s unique and specific expertise relevant to the proposed project. 7 Because of its importance and widespread use, many resources have been created to help investigators craft a clear and competitive biosketch, including SciENcv, 8 which can pull directly from an investigator’s eRA Commons and MyNCBI bibliography. Other biosketch examples have been published by the National Institute of Allergy and Infectious Diseases and others. 9 Ultimately, the purpose of the biosketch is to, within the 5-page limit, support the investigator’s or their collaborator’s ability to do the research proposed through a description of previous education, research efforts, funding, and expertise. Information provided in the biosketch will directly affect the criteria score for investigators by providing reviewers an overview of the research team’s experience, training, and accomplishments in the field up to that point. 9 A sample of the current biosketch format can be found at https://grants.nih.gov/grants/forms/non-fellowship-biosketch-sample-2021.docx . 9

Personal Statement

With the new format for biosketches introduced January 25, 2022, 10 the personal statement has taken on new importance. Previously, information on previous funding was provided in Section D of the biosketch, but now this information must be incorporated into the personal statement section in a more limited form. Given this emphasis on the personal statement, one of the worst things an investigator can do is to use a generic personal statement for a given grant proposal. This applies to both the principal investigator (PI) and their collaborators (Key Personnel) who provide biosketches for the application. To craft a compelling personal statement, the text should first address the investigator’s unique qualifications to perform the project, including training and background that led to the present project, in a logical narrative format. For example, the statement could begin with a description of the investigator’s training at Example University, which included gaining expertise in in vivo animal models, clinical data analysis techniques, and assays for drug screening, but more importantly, led to seminal findings that supported the idea for the current proposal. Next, the personal statement should describe the overarching goal of the present proposal and the resources available to ensure its success, including collaborative relationships with key team members. This is an excellent place to highlight working relationships with collaborators on the project, including past successes and how they will contribute to the present proposal. Information about relationships between investigators should be consistent, and collaborators should be sure to include a statement about their specific contributions to the work proposed (i.e., what work they will perform as part of the project team).

At the end of the personal statement, investigators can highlight up to 4 publications, as well as current and past funding sources. Note that these should not necessarily be limited to only the highest impact articles, nor should it include a laundry list of every funded project. Selection of publications should consider the following criteria: (1) are the publications relevant to the project, (2) do the publications highlight seminal contributions to the field, and (3) do the publications highlight past work with key collaborators? Selecting relevant, high-impact sources that highlight both the qualifications of the investigator and the effectiveness of the scientific team will give a very positive impression to reviewers. Similarly, when selecting which funded projects to highlight, precedence should be given to current and past projects with relevance to the current proposal or that highlight past collaborations with current team members. Note that there is no limit on the number of funded projects that can be highlighted; however, careful selection can ease the burden on reviewers and ensure that they see key projects that support the investigator’s qualifications for the present work.

Contributions to Science

The second key component of the biosketch is the Contributions to Science section. This section is meant to highlight 3 to 5 key areas of the investigator’s research and their impact that supports the investigator’s dedication and eminence within the field of study. A short introductory paragraph for each area should highlight the investigator’s major findings and their impact on the field, followed by up to 4 relevant publications. For early-stage investigators, this may include work done during training and fellowship, which may or may not have direct relevance to the project at hand. In this case, the paragraph introducing the contribution may highlight key skills or laboratory techniques relevant to the project. In any case, the key message should communicate the specific contribution of the investigator. Even if the contribution was as part of a training program, the text should specify what knowledge, technical ability, or scientific ideas the investigator individually contributed and the result of the overall effort. Experienced investigators may have more contributions to science than the 5 allowed. In this case, the investigator has the luxury of choosing to highlight the contributions that are most directly relevant to the current application. In both cases, contributions should be listed in order of relevance to the project proposed, with the 4 relevant publications for each listed in chronological order.

Common Pitfalls

The first common pitfall in a biosketch is not using the biosketch to support the application. This is a frequent mistake in which investigators use a template or boilerplate format instead of taking advantage of the opportunity to highlight the specific merits of the application and describe how you as an investigator are uniquely suited to accomplish the goals set forth in the application. Another common mistake is to include old or irrelevant biosketches from collaborators. A collaborator’s biosketch should support the feasibility of the application, and a lack of attention to detail will negatively impact the investigator score. Finally, the biosketch can be used to highlight relationships within the investigative team, bring attention to special attributes of the team, and demonstrate the robustness of the collaboration. This is a very effective method to demonstrate a functional and cohesive team, which is especially important if the team does not have a long track record of grant funding or publishing together.

In summary, the biosketch is a key component of the score for Investigators as part of an NIH grant review. Information should always be tailored to the present application, whether the investigator is the PI or other key personnel. Highlighting relevant publications, past collaborations, and contributions to science is key to letting reviewers know why you and your team are the right group to accomplish the goals of the project.

Facilities and Equipment

Facilities and equipment pages are the most likely of all the ancillary documents to be an afterthought, often using material copy-pasted from other sources into an amalgam of information with no flow or connection to the application. Although there is no need to reinvent the wheel for each new application, it is worth an investment of time to create a cohesive initial version and regularly keep the information up to date. The purpose of the Facilities and Equipment attachments is to assure the reviewers that you have the resources necessary to complete the research plan. These resources include everything from key pieces of equipment to institutional infrastructure. This is one of the few places available to communicate relevant information about the research environment, and therefore it is a key part of the Environment scoring criteria. Reviewers will use the information in these pages to assess whether there is sufficient institutional support, access to key equipment, availability of safety training and equipment, and other physical resources (eg, core facilities, animal facilities, bench space, etc) to complete the research. Importantly, for surgeon–scientists, this is also a place to highlight the clinical resources available within the institution. Is the institution a major referral center for your study population of interest? Is it located in an area of high diversity? Do you have access to shared resources like data analysts or research coordinators? Are there active collaborations with other institutions that also provide resources for the work? All of these aspects of the environment are critical to include in your Facilities description, not only to prove that the research can be done but also to show that the institution is uniquely equipped to support it.

To add emphasis to what can otherwise be a wall of text, the Facilities and Equipment pages can incorporate visual elements. Pictures of key pieces of equipment or space diagrams showing proximity of resources can draw attention to important resources or aspects of the environment that support the research and make the information more palatable for the reviewers. A concern that is sometimes raised about early-stage investigators is whether there is dedicated lab space to accomplish the work. As such, a diagram of the lab highlighting the investigator’s allocated space can effectively demonstrate that resource. It is also important to keep general information about your institutional resources and equipment up to date. Did your institution move up in U.S. News and World Report rankings? Did you purchase new pieces of equipment? Are there new core facilities available to help with the project? Taking an hour just once a year to ensure that all this information is up to date is a small cost to add relevance to these documents. It does the application no favors to have outdated or irrelevant information that a reviewer must trawl through to form their opinion on the research environment.

Budget and Budget Justification

There are many aspects to consider when putting together the budget for a project, and specific considerations for the best way to accomplish this have been described elsewhere. 6 Overall, the budget is simply the formal request for the funds required to complete the project and the justification as to why they are needed. Although the budget and justification are not scoreable parts of the application, it is important to remember that the reviewers can provide recommendations to the funding agency about the level of funding. For example, if a reviewer felt that there were too many people being funded on the grant for the work proposed, they could recommend that the funding agency cut the salaries in the final award. Therefore, it is important to properly estimate and justify all costs associated with a proposal.

The best thing an applicant can do to make the budget compelling is to thoroughly justify all costs. This is especially important in the personnel section. Each person supported by the grant should have a well-defined role and specific tasks they will have responsibility for. An effective way to communicate this is to highlight in which part of the aims each person will make their contribution. Vague, overlapping, or ill-defined roles can lead reviewers to think that the personnel budget is inflated. The NIH study section discussion on budget occurs after the grant is discussed and, if the reviewer believes the budget is not justified, they will then recommend reducing the budget and will be specific in what cuts they recommend. A highly detailed and convincing budget section will dissuade reviewers from suggesting a budget reduction because they won’t be able to articulate what exactly to cut. This is true as well for other costs associated with the research. For clinical projects, costs can often be broken down into discrete, billable actions that inform the per-patient cost of the research. Many institutions have research administrators or accounting specialists that can assist surgeon–scientists with defining each cost and whether it should be covered by the award or by the participant as part of their standard care. Basic and translational science projects can be a bit more nebulous because costs for general laboratory supplies, animal care and use, and biological assays can vary depending on challenges encountered during the project performance. Still, it is important to be as detailed as possible, providing cost estimates for each category and a description of how the estimate was calculated. Remember, there is no page limit on the budget justification, so it costs nothing to add detail that may prevent cuts to the budget. It is impossible to accomplish the science without the necessary financial support, so spend time making the budget realistic and appropriate.

Human Participants and Vertebrate Animals

For many surgeon–scientists, the involvement of human participants or vertebrate animals in research is a matter of course. The purpose of these sections is to ensure that humans and animals are properly protected and that their involvement is well-justified. These sections can influence the score for the Approach criteria, which is often a major driver of the overall impact score for a project. Reviewers will be evaluating the procedures being used, whether the approach will answer the scientific question posed, and whether protections are in place to address the risks of the study. Involvement of either human participants or animals must be carefully justified, given the potential risks of the study. Alternative models and rigorous methods must be proposed that will ensure that the data obtained from the research will be relevant and reproducible.

An excellent starting point for these sections is an approved Institutional Review Board (IRB) or Institutional Animal Care and Use Committee (IACUC) protocol. Although IRB or IACUC approval is not required before an NIH application, submitting these protocols ahead of time can provide critical feedback to refine the research methods before an application. These documents will have much of the required information in an easily accessible format; however, it is important to note that some information may need to be tailored to the specific project being proposed. It is common for surgeon–scientists to have so-called “umbrella protocols” that cover animal use for multiple projects or human biological sample collection for retrospective studies. In this case, information gleaned from the IRB or IACUC protocol must be tailored specifically to the proposal. For example, consider a protocol to collect cancer biopsies and outcomes data that includes using a subset of samples either already collected or prospectively collected during the performance period in their proposed research project. In addition to information about the human participant involvement and procedures likely already listed in the IRB, the investigator needs to describe and justify how the retrospective sample subset will be chosen. They will also need to provide an expected breakdown of race, ethnicity, and sex, as well as plans to include patients of all (or specific) ages, for the prospective population and justify any exclusions. For animal protocols, only those procedures proposed in the research should be included, and an accurate estimate of the number of animals along with the species, strain, ages, and sex distribution should be given.

The key point for both sections is to read the section descriptions carefully. Make sure that the information requested is covered, which may be different from that required by the IRB or IACUC. Another critical component is the description of the statistical analysis to be used in studies involving humans or animals. Power calculations are an absolute necessity to justify the group sizes, and this can be described both in these sections and in the research strategy. Similarly, the plan for performing statistical analysis (eg, tests to be used, group comparisons, thresholds for significance, etc.) can be included in both locations. Furthermore, when possible, plans to include an equal distribution of male/female participants (for both humans and animals) and an appropriately diverse population (humans) should be described. Exceptions to this exist, particularly for conditions that disproportionately affect a certain sex or racial/ethnic group, but these should be stated and justified. Finally, make sure the procedures, group sizes, and other critical pieces of information in these sections are consistent with the research strategy. The worst thing an investigator can do is to confuse the reviewer by listing different group sizes or procedures, which can impact the Approach score. More detail as to the components of the vertebrate animal section and human participants section can be found on the NIH website. 11

Letters of Support

Letters of support are meant to demonstrate a collaborator’s commitment of time, expertise, or resources to the project. The applicant should review the funding opportunity announcement from the granting agency to determine whether any letters are required, which can vary depending on the type of award submission. Frequently, letters of support are optional, but they can provide documentation of the commitment from the institution or department chair that promises protected time from clinical duties, dedicated lab space, or additional research resources, which can be particularly important for early career investigators. There are multiple schools of thought regarding letters of support; some investigators request letters of support from each person listed as key personnel on the grant, whereas some only request letters from a select group of critical contributors or from other collaborators who can provide technical assistance on certain techniques but are not supported by the grant. Regardless of the approach to letter requests, reviewers will use these letters as a supplement to judge whether there is sufficient support for the project, particularly for techniques that may not be directly within the PI’s area of expertise, which can affect the Investigators criteria score.

The approach to making letters of support effective is similar to the biosketch, in that the letter of support should detail the nature of the collaborators’ and PI’s scientific relationship, any previous work together, and the specific expertise or resources that the collaborator will provide to support the completion of the research project. As with the biosketch personal statement, a generic letter is not effective. Rather, the letter should reference specific techniques or parts of the aims for which the collaborator is uniquely qualified to assist, or access to equipment, animal models, or patient populations that are critical to the project. Although there is no limit to the number of support letters that can be included, investigators should prioritize letters that support key aspects of the research, particularly those for which outside expertise is necessary.

Authentication of Key Biological and/or Chemical Resources and Resource Sharing Plans

Authentication and Resource Sharing pages describe how the researchers will abide by NIH requirements to ensure the validity of key biological or chemical resources used in the research 12 and to affirm that any research resources developed with NIH support will be shared with the research community. These sections are not explicitly evaluated as part of the criteria scores but instead are graded on a pass/fail basis (i.e., the plan is deemed either acceptable or unacceptable). The key to both sections is relevance and brevity. The NIH guidelines state that the Authentication of Key Biological and/or Chemical Resources attachment should not exceed 1 page. 12 Investigators should be careful not to include any research methods in this section, instead focusing on how they will validate resources that “differ from laboratory to laboratory, or over time” or for which variance in quality could influence the data produced. Examples of this include plans for how the investigators will periodically confirm the identity and purity of cell lines or genomic identity of transgenic animals. These methods are not part of the research plan but are instead meant to ensure that the cells, animals, and other materials used in the research are what the researchers think they are. Similarly, the Resource Sharing Plan should include 3 straightforward sections, as applicable. First, a simple list of any new model organisms being developed (eg, breeding a novel transgenic animal or creation of a new knockout cell line) and the plan for making these organisms available to the research community. Second, a plan for sharing large-scale genomic data (eg, from genome-wide association studies or -omics analysis), and finally, a plan to share research data generated if the budget is >$500,000 in direct costs per year. If your study does not meet any of the criteria above, this section may not be required. 1

Other Documents

The section descriptions above are relevant to any research or career development application submitted to the NIH, but the following documents are only needed in certain situations.

Introduction to Application

One of the most common extra documents researchers will encounter is the introduction to application attachment that is required for resubmission applications. The purpose of this document is to address the previous reviewers’ criticisms of the application and to show how the current application has been improved to minimize those concerns. Although the application may not go back to the same reviewers, new reviewers can use this information to assess how well the applicant responded to previous critiques, which can color their perception of the new application. Remember that reviewers will not have access to the previous application; they can only view the current application and the previous summary statement, so clearly addressing previous critiques in this section is paramount.

Concise language and strategic combination of critiques into themes are keys to make this page impactful. Instead of a laundry list of critiques and responses, it can be helpful to organize individual critiques into overall themes. For example, perhaps multiple reviewers had issues with the previous research and preliminary data supporting one of the aim hypotheses. Instead of addressing each critique individually, the applicant could state that reviewers did not think that the rigor of previous research supported their hypothesis and then proceed to describe new publications and preliminary data they have added to address this issue. Similarly, various individual critiques about the research approach can be addressed with similar language by highlighting key changes to the strategy that broadly address these issues. Because space is limited to 1 page, hitting multiple points at once by organizing critiques into themes can consolidate the text and make it easier for reviewers to quickly grasp the key changes to the application. Finally, it can be helpful to begin and end this attachment with an acknowledgement of the positive comments provided by the previous reviewers. Although most of the focus will be on how you addressed critiques, bookending the discussion with a few quotes highlighting what the past reviewers found most compelling about the proposal can prime the new reviewers to also see the strengths of the revised application.

The Multiple PI Plan

In 2007, the NIH allowed multiple PIs (MPIs) to be included in one proposal as an effort to support team science. 13 This is an important and encouraging trend for surgeon–scientists, 14 because the combination of limited protected research time and other factors can make it challenging to compete for research grants. 15 Partnering with other surgeon–scientists or PhD researchers can give a much-needed boost to the feasibility of the project by distributing the responsibility for overseeing project performance. Furthermore, MPI applications tend to receive larger amounts of funding. 16 If applicants decide to pursue this route, an additional attachment is required: the MPI Project Leadership Plan. The purpose of this plan is to delineate the roles of each PI within the project and how they will handle project oversight and any conflicts that arise. Reviewers will take this document into account when determining the criteria score for Investigators.

There are a few ways to add emphasis to the MPI Plan. First is to provide narrative around the partnership between the PIs. Have the groups been working together for some time? Is this a new collaboration? How did the present project evolve? Some of this information may be repeated in some form in the biosketch and letters of support, but this attachment is an opportunity to reiterate key points and provide additional context for the decision to pursue the MPI mechanism. Second, the MPI plan should provide a clear delineation of leadership and contributions for each PI. It can be helpful to do this visually by providing a schematic that color codes each PI’s contribution within each of the aims and sub-aims. Finally, the MPI plan should outline meeting schedules and methods for addressing conflicts.

Timeline of Developing Ancillary Documents

For experienced investigators, the discussion thus far has hopefully provided tips to improve existing versions of these documents for future applications. However, for early career surgeon–scientists looking to submit their first NIH application, the amount of documentation to be generated can feel daunting. Herein, we put forth a suggested timeline for developing these documents, breaking down the dependencies between parts of the application and providing tips for how to approach the process ( Figure 1 ).

Timeline of developing ancillary documents.

Before Starting Your Application

Some documents can be generated even before starting on the research strategy. In addition, some documents may be reused from other grant applications. These include the biosketch, facilities, and equipment pages. Although these documents will need to be revisited later in the process to add details about the proposal, a basic draft can be generated at any time. Many examples of biosketches are available online and through individual institutions. We recommend the use of SciENcv 9 to produce tailored biosketches quickly and easily for each new project. Departmental or institutional administrators often have access to boilerplate information about the clinical and research resources at the institution that can serve as the basis for the Facilities description. New investigators can also request examples from mentors or other funded investigators at their institution to serve as a template. This can also be a good opportunity for the PIs of multiple PI applications to begin drafting and discussing the MPI plan.

After Drafting the Research Strategy

For most other documents, it is critical to have a draft of the research strategy available for reference. Even if it is not completely finalized, a rough draft will allow the investigator to assess what resources will be developed (Resource Sharing) or need to be validated on a regular basis (Authentication). Once most of the research strategy has been finalized, then the budget, justification, human participant, and vertebrate animal sections can be drafted. Most institutions require the budget and justification to be completed early in the process, which emphasizes the importance of starting work on the research strategy early.

Before Submitting

Before submitting the final application, investigators should read through all documents in the application package to check for consistency. Enlisting collaborators and other helpers in the process can also help catch mistakes. Common problem areas are changes to patient or animal numbers or references to specific parts of aims resulting from last minute changes to the approach. To make the application consistent, there should be uniformity in numbers, references, and key concepts across all documents in the application, not just the research strategy.

In conclusion, the ancillary documentation for an NIH application can seem like a daunting task. It is the majority of the approximately 100- to 150-page application compared with the 13 pages of science. Ironically, we spend more time as investigators perfecting our science and frequently leave these other parts of the application until the last minute. It is strongly recommended for investigators to develop their own cadre of ancillary document materials that should be periodically updated and should be personalized for each individual application. Identify resources within your institution from which you can obtain boilerplate template forms, then tailor them to your own needs and use them for subsequent grant applications. Although the ancillary documentation cannot make up for a lackluster scientific application, it is nevertheless important to recognize the significance of these documents because they can drive the criteria scores and impact the fundability of an otherwise strong application.

Funding/Support

The authors would like to acknowledge their funding sources from the NIH, including R01GM111808 (to S.G.K.), K08DK133673 (to L.S.C.), and R01DK119210 (to A.M.G.).

Conflict of interest/Disclosure

The authors have no conflicts of interests or disclosures to report.

1 For applications after January 25, 2023, a new policy for data management and sharing (NOT-OD-21-013) will be in effect. Guidance documents for these new changes continue to be updated. See https://grants.nih.gov/policy/sharing.htm for the latest information.

• About Grants
• How to Apply - Application Guide
• Write Application

Write Your Application

The following guidance may assist you in developing a strong application that allows reviewers to better evaluate the science and merit of your proposal. This page provides tips for  demonstrating to reviewers and NIH staff the high quality of the personnel involved in your project and documenting resources and institutional support of the project. We provide information for new investigators and foreign applicants, as well.

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 should not replace your organization's internal guidance, specific advice provided by NIH program or grants management staff, or instructions found in the funding opportunity or application guide .

• Where to Find Instructions for Writing Your Application

What Peer Reviewers Look For

• Research Resources, Institutional Support and Available Expertise  
• Cover Letter & Assignment Request Form
• Are You a New or Early Stage Investigator

Foreign Involvement: Institution and/or Investigator

Develop your budget, your research plan, additional elements required in a grant application, important writing tips, what to know before you start writing, where to find application instructions.

• In addition to form-by-form, field-by-field instructions you'll find guidance on formatting attachments (fonts, margins, etc., developing a budget, and more.
• Section IV. Application and Submission Information of each funding opportunity includes opportunity-specific instructions.
• Notices posted in the NIH Guide for Grants & Contracts may contain corrections, clarifications, or announcement of new policies.

If instructions in the application guide and funding opportunity conflict, the opportunity wins. If instructions in either the application guide or funding opportunity conflict with an NIH Guide notice (including a Notice of Special Interest), the notice wins.   

Careful preparation and an understanding of how your application will be reviewed can help you build a solid application. During NIH’s peer review process , we convene a panel of non-Federal scientists to review your application. Although a number of factors contribute to whether your application will be funded, we place great emphasis on the review of scientific merit. 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.

Overall Impact

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria, and additional review criteria (as applicable for the project proposed). 

Scored Review Criteria

Reviewers will consider each of the review criteria below in the determination of scientific and technical merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field. 

Significance. Does the project address an important problem or a critical barrier to progress in the field? Is there a strong scientific premise for the project? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field? 

Investigator(s). Are the PD/PIs, collaborators, and other researchers well suited to the project? If Early Stage Investigators or New Investigators, or in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?

Innovation. Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?

Approach. Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects? If the project involves clinical research, are the plans for 1) protection of human subjects from research risks, and 2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of individuals of all ages (including children and older adults), justified in terms of the scientific goals and research strategy proposed? Environment. Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements? 

Note that an application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.

Learn more about how applications are scored.

Additional Review Criteria

As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit and in providing an overall impact score, but will not give separate scores for these items. 

• Protections for Human Subjects
• Inclusion of Women, Minorities, and Individuals Across the Lifespan
• Vertebrate Animals
• Resubmission

Be sure to address any of these additional review criteria that apply to your application, as reviewers will consider them when assigning overall impact/priority scores. 

Additional Review Considerations

As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items and should not consider them in providing an overall impact score. 

• Applications from Foreign Organizations
• Select Agent
• Resource Sharing Plans
• Authentication of Key Biological and/or Chemical Resources
• Budget and Period Support

Learn more about how applications are reviewed and scored on our peer review process page.

Research Resources, Institutional Support and Available Expertise

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.

Applicants should clearly state that they have the appropriate resources to conduct the research, such as adequate equipment and laboratory space. When possible, include letters of commitment for these 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.

Independence and Institutional Support

This is important for all investigators, but particularly for new and early stage investigators or those who are early in their independent careers:

• Provide reviewers evidence that you have the appropriate experience and training to lead and manage the research project.
• 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 and Consultants

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.

• Include letters of commitment in your application that 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.
• The format, peer review and administration of applications submitted with multiple PIs do have some significant differences from the traditional single-PI application. Therefore, it is essential to consider all aspects of the funding mechanism before applying, 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 submitting with multiple-PIs for the support of their research.  

Cover Letter & PHS Assignment Request Form

Although optional in most cases, the Cover Letter attachment on the SF424 (R&R) form and the PHS Assignment Request Form can be used to convey information to the Division of Receipt and Referral (DRR) in the Center for Scientific Review. 

• Late applications
• Required agency approvals, if needed (e.g., approval to submit application with budget period(s) of $500k or more)
• Explanation of subaward budgets not active in all budget periods
• Intent to submit a video
• Anticipation of large-scale genomic data
• Proposed use of human fetal tissue from elective abortions
• A potentially appropriate institute or center assignment
• NIH Scientific Review Group (SRG) Roster Index
• Take advantage of the Assisted Referral Tool (ART)
• Reviewers that may have a conflict of interest and why they should not be considered to review your application
• Only NIH staff with a need to know are provided access to your assignment request and cover letter. Reviewers to not access to them.

Are You a New or Early Stage 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.
• 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 PD/PIs and those from foreign institutions should ensure their eligibility by checking the eligibility guidelines provided in every funding opportunity.
• Foreign PD/PI's and those from foreign institutions are highly encouraged to contact a NIH program officer as soon as possible in the planning and writing stages.
• Foreign applicants can learn more at our Information for Foreign Applicants and Grantees page.

This step will be one of your most time-consuming in the writing process. 

• Know what type of budget will be required to submit with your application (found in your funding opportunity).
• Understand the various components of the budget, working with your institution’s central grants office and department administrator.
• Contact NIH program officials regarding allowability and other budgetary questions.
• For more information, see Develop Your Budget .

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.

• 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.
• Appeal to the reviewers and the funding ICs by using language that stresses the significance of your proposed work.

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.  

• Bibliography & References 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; you can use “et al.” convention in place of listing all authors in a citation), 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.  
• Office of Laboratory Animal Welfare
• PHS Policy Tutorial
• What Investigators Need to Know About the Use of Animals (PDF)
• Interactive training module: Vertebrate Animals Section (VAS) in Grant Applications
• 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 and Collaborators Attach appropriate letters from all consultants and collaborators 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 Individuals Across the Lifespan 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 individuals across the lifespan, as appropriate, for the scientific goals of the research will be assessed. Plans for the recruitment and retention of subjects will also be evaluated. Check out the Inclusion Policies for Research Involving Human Subjects , which includes resources for Inclusion of Women and Minorities and Inclusion Across the Lifespan .  
• Multiple PD/PI  For applications designating multiple PDs/PIs , you must include a leadership plan.  
• Other Plans(s) Applicants proposing to conduct research that will generate scientific data are subject to the NIH Data Management and Sharing (DMS) Policy and must attach a DMS Plan in this section. Note that applicants whose project also falls under NIH’s Genomic Data Sharing (GDS) Policy are expected to provide a single plan that covers the sharing of both scientific data and genomic data. See NIH’s DMS and GDS policies on the NIH Sharing website .  
• Page Limits Follow the page limits specified for the attachments in your grant application, unless otherwise specified in the funding opportunity.  
• Plan for Enhancing Diverse Perspectives When applicable, t he Plan for Enhancing Diverse Perspectives (PEDP) in NIH grant applications is a summary of actionable strategies to advance the scientific merit of the proposed project through diverse perspectives. Learn more about example strategies and how the plans will be reviewed on the PEDP page .   
• 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/policy/checklists/decisioncharts.html ).  
• Resource Sharing Plan(s)  This section includes the Model Organisms Sharing plan when applicable. See NIH’s Model Organisms Sharing Policy .  
• 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.  
• 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.

You’ve planned, you’ve researched, you understand the application…now it’s time to write.  A well-written, well formatted application is an important key to success.  Remember the details when formatting attachments ! 

• 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.  

Start with an outline, following the suggested organization of the application. The thought process of the application should be easy to follow. 

Note:  Upon submission, NIH Systems will automatically add: headers, footers (time stamping, tracking number, funding opportunity number, and page numbers). Therefore, do not include headers or footers.

• Write clear headings.
• 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.
• Bookmark major sections.
• 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.
• Utilize white space effectively.
• Write a clear topic sentence for each paragraph with one main point or idea.  This is key for readability.
• Make your points as direct as possible. Avoid jargon or excessive language.
• Write simple and clear sentences, keeping to about 20 words or less in each.
• Be consistent with terms, references and writing style.
• Use the active, rather than passive, voice. For example, write "We will develop an experiment, "not "An experiment will be developed."
• Spell out all acronyms on first reference.
• If writing is not your forte, seek help!
• Include enough background information to enable an intelligent reader to understand your proposed work.
• Support your idea with collaborators who have expertise that benefits the project.
• 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.
• Remember the Details!    There are format requirements , such as font size, margins, and spacing.  Make sure you are familiar with them before submitting your application and label sections as directed.  You don’t want your application delayed because any of these details are not incorporated.
• If more than one investigator is contributing to the writing, it would be helpful to have one editor not only review for punctuation errors, but ensure that the application has a consistent writing style.
• Request your colleagues or mentors review a first draft of your specific aims early in the process. This step can save lots of valuable time.
• 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.
• Ask those who are providing a review to use a critical eye and evaluate the application using the peer review criteria
• Allow sufficient time to put the completed application aside, and then read it from a fresh vantage point yourself. Also, try proofreading by reading the application aloud.
• Conduct your own review based on the NIH's five peer review criteria.  How would you rate your own application?
• Prior to submission, look over the entire grant application one final time. Remember, you want a convincing proposal that is also formatted according to the application guidelines, punctuation error-free, clear to read, and is to the point!

This page last updated on: June 18, 2024

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Clinical Research Records Storage Frequently Asked Questions

How long must the clinical research site maintain clinical research records.

Clinical research record retention requirements are to be determined on a trial-by-trial basis, taking into consideration:  local, national regulations; NIH, NIAID, and DAIDS policies; and all applicable guidelines.  When more than one requirement applies, the most stringent retention requirement must be followed.

The clinical research records are the property of the research institution. Below please find a link to the DAIDS policy on clinical research record retention.

• Storage and Retention of Clinical Research Records Policy

How do I confirm if clinical research records can be destroyed?

The clinical research site must confirm with their institution and their local IRB/EC whether the clinical research records from the trials listed on the DAIDS Record Storage Assessment page called "List of trials for which clinical research records will NOT be stored by DAIDS" may be destroyed. DAIDS and the DAIDS RSC will not give permission to destroy clinical research records.

Add a Bibliography & Appendix

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, and including appropriate Appendix materials.

Connect to Science with Citations

Your Bibliography and References Cited Attachment should reflect all the source materials you relied on when preparing any section of the application.

List all the publications you have cited. Read more on citing publications as you write at Referencing Publications .

We suggest that you limit your citations to fewer than 100, but don't omit essentials or items that highlight the breadth of your knowledge.

If a publication is public, always link to it, or include its NIH PubMed Central identification number in the text.

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.  

You will list all citations in your Other Project Information Form: Bibliography and References Cited form.

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:

• Blank data collection forms, blank survey forms and blank questionnaire forms--or screenshots thereof
• Simple lists of interview questions
• Blank informed consent/assent forms
• Other items only if they are specified in the NOFO as allowable Appendix materials

For more information and clarification on the types of allowable appendix materials, refer to the Updated Appendix Policy . 

Applications that include unallowable Appendix materials will be withdrawn and not reviewed.

How to Deal with Images

• Put images in the Research Strategy where they count toward the page limit.
• Follow the SF 424 Application Guide for size and resolution information.

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.

For Bibliography

• I highlight my knowledge of the field, ideally using no more than 100 citations.
• I follow NIH public access policy, putting the PubMed Central ID or NIH manuscript number in the citation when citing a paper that results from NIH funding.
• For each citation, I use "et al." in place of listing all authors of a publication and include article and journal title, book title, volume number, page numbers, and year of publication.

Previous Step

Have questions.

A program officer in your area of science can give you application advice, NIAID's perspective on your research, and confirmation that your proposed research fits within NIAID’s mission.

Find contacts and instructions at When to Contact an NIAID Program Officer .

Related Rules & Policies:

• Public Access of Publications SOP