What Are the Grant Components Required for an NIH Grant?


    The National Institutes of Health (NIH) invests more than $32 billion per year in biomedical research, making it the largest public funder of such research in the world. 

    The NIH reviews approximately 80,000 applications each year; approximately 20% of those receive funding.

    Medical communicators often write or edit research grant proposals to the NIH and other funders.

    What is the key to writing and submitting a successful NIH grant?

    NIH Grants

    The National Institutes of Health funds different types of grants, which have varying requirements. The NIH Guide to Grants and Contracts publishes opportunities daily.

    In this video, a panel of NIH employees who work with grant proposals provides some basic policy updates and an explanation of budget priorities. “In a typical year, NIH can only fund about 20 percent of the grant applications that we receive,” says moderator Kristin Ta, Senior Advisor in the Office of Policy for Extramural Research Administration. “So it’s really important that applicants and recipients provide us with details on all of their research activities and support, so that we can make the best funding decisions.”

    One of the biggest problems the personnel involved with grant proposals see at NIH, says Ta, is “failure by researchers to include all of their contributions and resources from other organizations.”

    Writing and submitting a grant to the NIH is similar to other grant writing tasks. Grant writers can benefit from reviewing an Introduction to Grant Proposal Writing.

    What does the NIH have to say about writing successful grants?

    Tips from NIH

    In this video,NIH experts give advice on how to make sure that you are submitting an application to the right place and communicating with the people who can help you succeed.

    1. Find a home for your application. You’ll want to find an NIH Institute or Center (IC) that funds the type of research your organization does. NIH provides several tools to help accomplish that.

    2. Email a Program Officer and share a brief project description to get feedback on whether the project fits within the NIH guidelines. It’s a good idea to do this early in the process. You might need to contact more than one program officer before deciding where to submit an application.

    3. Read and understand the Funding Opportunity Announcement (FOA). You’ll need to make sure that your organization is applying to the right Institute, check eligibility and budget restrictions, and contact the right person if you have questions.

    4. Get feedback on your draft application. You can use internal resources, set up a mock review, reach out to your network of colleagues, or engage with professionals for external review. 

    5. Double-check the technical details of your application. Check against the FOA and Notice of Special Interest (NOSI), submit in advance and review for accuracy, and respond to any identified errors before the application deadline.

    NIH Resources

    NIH has developed a series of podcasts called All About Grants designed to demystify different aspects of grant writing. The episodes explore the application and award process by talking to NIH staff members. Recent topics include the following:

    • Phase III Trials
    • Sex as a Biological Variable
    • Animal Welfare Assurances
    • Bridge Awards
    • Inclusion Plans

    In addition, NIH posts many helpful videos on its YouTube Channel.

    Once you have identified the FOA and clarified the Specific Aims of the project, it’s time to gather the information needed to write the Research Strategy section.

    Grant Components: the Research Strategy Section

    The Maine Medical Center Research Institute has published guidelines for submitting an investigator-initiated R01 NIH research grant application. This organization reinforces the importance of a strong Specific Aims section that links the researchers’ hypotheses to the aims. “Many applications are won or lost depending on how precisely stated and how compelling the hypothesis and specific aims are presented!” the authors write.

    Another key element of NIH grants is the Research Strategy section. This section includes the following 3 components:

    1. Significance
    2. Innovation
    3. Approach

    What does the NIH have to say about approaching the drafting of these three critical sections?

    Significance Section

    To help draft this section, the NIH provides the following questions on its Write Your Application page
    • 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?

    The Maine Medical Center Research Institute guidelines reinforce the NIH’s questions, adding that grant writers should include a brief background that includes a critical evaluation of the literature that relates directly to the scientific need for the project. 

    Innovation Section

    The NIH seeks to fund scientific breakthroughs and original approaches. It recommends examining the application to consider the following factors: 

    • Does it 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? 
    • Does the research propose a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions?

    Approach Section

    The Approach section of the Research Strategy section describes how the researchers plan to carry out the research and how it aligns with their aims. It should include information on how the researchers will collect, analyze, and interpret data; a timeline for completing the work; and potential issues and challenges. To prepare this section, the NIH poses the following questions:

    • 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 of minorities and members of both sexes/genders, as well as the inclusion of children, justified in terms of the scientific goals and research strategy proposed?

    Human Subjects Research

    If the proposed research does include Human Research Subjects, there are additional sections that need to be included in an application. Those 4 sections are as follows:

    1. Proposed Use of Human Subjects
    2. Inclusion of Women and Minorities
    3. Targeted Enrollment Table
    4. Inclusion of Children

    The Ethics of NIH Grants

    Medical writers play an important role in ensuring that grants fulfill all the application requirements and that the proposed research adheres to the highest ethical standards. 

    A 2021 article in AMWA Journal clarifies some recent changes made by NIH to improve the integrity of grant applications. The article explores recommendations for assessing the rigor of prior research and the proposed work, the reproducibility of biological factors, data management, and other ethical considerations. 

    When high-quality data and research are funded and disseminated throughout the medical community, we all benefit.



    October 31, 2022 at 9:00 AM

    American Medical Writers Association

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