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 Writing 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
- Innovation
- Approach
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 Rigorous 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
Significance
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.
Innovation
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).
Approach
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.
- Outline the branching of next steps (omit detail if you don't have the space):
- 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
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
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.
- In the Research Strategy:
- 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.