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NIH R01 Research Strategy Guide

A comprehensive guide and template for crafting a successful NIH R01 Research Strategy section, with detailed instructions for each required component.

Last updated: June 2025•12 min read
NIH Application Guide

Important Notes

This guide is for most standard National Institutes of Health R01 proposals and follows the NIH SF424 (R&R) Application Package Forms Version G Series.

Some funding opportunity announcements (FOAs) have specific requirements that may not be included in this guide, or the guide may have more than is required for your application.

This document does NOT replace the detailed information available within the relevant FOA, the funding agency's forms, instructions, and review criteria.

Format Requirements

  • 12-page limit for the Research Strategy section (unless the FOA specifies otherwise)
  • Progress Report for renewal applications falls within the Research Strategy and is included in the page limits
  • Organize the Research Strategy in the specified order with the required headings: Significance, Innovation, Approach
  • Cite published experimental details in the Research Strategy and provide the full reference in the Bibliography section

Guide Sections

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Overview: NIH R01 Research Strategy

The Research Strategy is a critical component of your NIH R01 application, where you detail your research plans, methods, and approach. This section is limited to 12 pages (unless specified otherwise in the FOA) and must include three main components with specific headings: Significance, Innovation, and Approach.

You may address these components either for each Specific Aim individually or for all of the Specific Aims collectively. The choice often depends on the nature of your research and how interrelated your aims are.

Key NIH R01 Forms and Instructions

The following sections provide detailed guidance on each required component of the Research Strategy, along with a practical template to help you structure your document effectively.

1. Significance(required heading)

General Instructions from SF424, section R.400.3.1:

  • Explain the importance of the problem or critical barrier to progress in the field that the proposed project addresses.
  • Describe the strengths and weaknesses in the rigor of the prior research (both published and unpublished) that serves as the key support for the proposed project.
  • Explain how the proposed project will improve scientific knowledge, technical capability, and/or clinical practice in one or more broad fields.
  • Describe how the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field will be changed if the proposed aims are achieved.

General Review Criteria:

  • Does the project address an important problem or a critical barrier to progress in the field?
  • Is the prior research that serves as the key support for the proposed project rigorous?
  • 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?

Template Guidance: Significance (suggested 1-2 pages)

a. Rigor of the Prior Research:

  • Describe the strengths and weaknesses in the rigor of the prior research (both published and unpublished) that serves as the key support for the proposed project.
  • Describe the basis for each aim.
  • Cite literature and provide preliminary data that support the rigor of the prior research.

b. Significance of the Expected Research Contribution:

  • Remind reviewers of the gap in the research that your work will fill, i.e., your expected outcomes. (For Renewal: State significance of previous studies.)
  • Clearly state: "This work is significant because …" Be specific on how it will advance the field vertically and how it fills gaps in the literature that you cited above.

Pro Tip

When addressing the rigor of prior research, be honest about limitations in the field and explain how your approach will overcome these limitations. Reviewers appreciate a balanced assessment that demonstrates your deep understanding of the research area.

2. Innovation(required heading)

General Instructions from SF424, section R.400.3.2:

  • Explain how the application challenges and seeks to shift current research or clinical practice paradigms.
  • Describe any novel theoretical concepts, approaches or methodologies, instrumentation or interventions to be developed or used, and any advantage over existing methodologies, instrumentation, or interventions.
  • Explain any refinements, improvements, or new applications of theoretical concepts, approaches or methodologies, instrumentation, or interventions.

General Review Criteria:

  • 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?

Template Guidance: Innovation (suggested 0.5 page)

  • Tell reviewers how research in this area is normally done; document your statements with citations. (For Renewal: State how previous work changed thinking in field.)
  • Tell them how your research will be different in a way that will move the field forward.
  • Clearly state: "This work is innovative because …"

Pro Tip

Innovation doesn't always mean developing something completely new. It can also mean applying existing approaches in novel ways or to new problems. Make sure to clearly articulate what makes your approach innovative in the context of your research field.

3. Approach(required heading)

General Instructions from SF424, section R.400.3.3:

  • Describe the overall strategy, methodology, and analyses to be used to accomplish the specific aims of the project. Describe plans to address weaknesses in the rigor of the prior research that serves as the key support for the proposed project.
  • For New Applications, include information on preliminary studies. Discuss the PD/PI's preliminary studies, data, and or experience pertinent to this application.
  • For Renewal and Revision Applications, see Additional Information below.
  • Describe the experimental design and methods proposed and how they will achieve robust and unbiased results. Unless addressed separately in Item 15 (Resource Sharing Plan), include how the data will be collected, analyzed, and interpreted as well as any resource sharing plans as appropriate.
  • Discuss potential problems, alternative strategies, and benchmarks for success anticipated to achieve the aims.
  • If the project is in the early stages of development, describe any strategy to establish feasibility, and address the management of any high-risk aspects of the proposed work.
  • Explain how relevant biological variables, such as sex, are factored into research designs and analyses for studies in vertebrate animals and humans.
  • Point out any procedures, situations, or materials that may be hazardous to personnel and precautions to be exercised.

General Review Criteria:

  • Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project?
  • Have the investigators included plans to address weaknesses in the rigor of prior research that serves as the key support for the proposed 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?

Template Guidance: Approach (suggested 9.5-10.5 pages)

For each Specific Aim:

Specific Aim 1: [Title of aim as shown on Specific Aims page]
  • Introduction. Give the working hypothesis. Briefly state the strategy and approach that will be used to test the hypothesis. Give the rationale for this aim.
  • Research Design
    • [Study 1 Title]. Describe the methods and analyses for this study. Use citations to demonstrate the scientific rigor and justification of the approach, and how the methods will achieve robust and unbiased results that will be reproducible. Provide preliminary data from your research team to establish feasibility of the methods in your hands. Point out any procedures, situations, or materials that may be hazardous to personnel and precautions to be exercised. For studies in vertebrate animals and humans, explain how relevant biological variables, such as sex, are factored into research design and analyses.
    • [Study 2 Title]. See above. Continue with each study for this aim.
  • Expected Outcomes. Show reviewers that you have attained the objective of the aim through the collective study outcomes. Unless addressed separately in the Resource Sharing Plan, include how the data will be collected, analyzed, and interpreted as well as any resource sharing plans as appropriate. Your expected outcomes should not rely on acceptance of your hypothesis – what will you learn regardless of the outcome of the research?
  • Potential Problems and Alternative Strategies.
Specific Aim 2: [Title of aim as shown on Specific Aims page]

[See outline for Aim 1. Continue with any other aims.]

Timeline and Benchmarks for Success (suggested 0.5-1 page)

  • State or diagram when studies/benchmarks will be done during funding period.

Future Directions

  • Summarize project outcomes and why they're important.
  • State next steps and why they're important.

Pro Tip

The Approach section is typically the longest part of your Research Strategy. Be detailed but concise, focusing on the experimental details that are most critical for reviewers to understand. Use flowcharts or diagrams to illustrate complex protocols or study designs.

Preliminary Studies for New Applications

For new applications, include information on Preliminary Studies within the Research Strategy. This information is typically incorporated into the Approach section but can also be referenced in the Significance section when discussing the rigor of prior research.

  • Discuss the PD/PI's preliminary studies, data, and or experience pertinent to this application.
  • Except for Exploratory/Developmental Grants (R21/R33), Small Research Grants (R03), and Academic Research Enhancement Award (AREA) Grants (R15), preliminary data can be an essential part of a research grant application and help to establish the likelihood of success of the proposed project.
  • Early Stage Investigators should include preliminary data.

Pro Tip

When presenting preliminary data, focus on quality over quantity. Select the most compelling data that directly supports the feasibility of your proposed aims and methods. Use clear, well-labeled figures with concise legends.

Progress Report for Renewal and Revision Applications

Note that the Progress Report falls within the Research Strategy and is therefore included in the 12-page limit for the Research Strategy.

For renewal/revision applications, provide a Progress Report. Provide the beginning and ending dates for the period covered since the last competitive review. In the Progress Report, you should:

  • Summarize the specific aims of the previous project period and the importance of the findings, and emphasize the progress made toward their achievement.
  • Explain any significant changes to the specific aims and any new directions, including changes resulting from significant budget reductions.
  • Discuss previous participant enrollment (e.g., recruitment, retention, inclusion of women, minorities, children, etc.) for any studies meeting the NIH definition for clinical research. Use the Progress Report section to discuss, but not duplicate information collected elsewhere in the application.

Important: Do not include a list of publications, patents, or other printed materials in the Progress Report. That information will be included in the "Progress Report Publication List" attachment.

Template Guidance: Progress Report Format

Consider using a chart format to clearly present accomplishments from the previous grant period:

Proposal #FindingsSignificance/InnovationNumber of Publications
Aim 1[Summary of key findings][Impact on field][Number]
Aim 2[Summary of key findings][Impact on field][Number]
Aim 3[Summary of key findings][Impact on field][Number]

Pro Tip

For renewal applications, clearly demonstrate how your previous work has laid the foundation for the proposed new research. Highlight significant accomplishments and explain how unfinished aims will be addressed in the current proposal.

Complete R01 Research Strategy Template

Below is the complete template structure for organizing your NIH R01 Research Strategy:

RESEARCH STRATEGY (12-page limit unless FOA specifies otherwise)

1. Significance (required heading; suggested 1-2 pages)

a. Rigor of the Prior Research

b. Significance of the Expected Research Contribution

2. Innovation (required heading; suggested 0.5 page)

3. Approach (required heading; suggested 9.5-10.5 pages)

[For Renewal Applications Only: Progress Report]

Specific Aim 1: [Title]

  • Introduction
  • Research Design
    • Study 1
    • Study 2
  • Expected Outcomes
  • Potential Problems and Alternative Strategies

Specific Aim 2: [Title]

[Same structure as Aim 1]

Specific Aim 3: [Title]

[Same structure as Aim 1]

Timeline and Benchmarks for Success

Future Directions

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Last updated: June 2025
Source: Adapted from university research development offices

This guide is for informational purposes only and does not replace the official NIH guidelines.