NIH R21 Grant Application Mentor

Section 1: Beginning the Grant Application Process

Before you can begin writing your National Institutes of Health (NIH) grant application, several important tasks must be accomplished. For instance, you have to define the research project idea for which you are seeking funding. This may seem obvious, but the process for doing so is anything but simple.

You will also have to determine whether your research project will even qualify for an NIH grant, and several factors influence that determination. Then — before you write a single word of your application — you should map out a strategy for the process, which can include the following:

• Knowing what the R21 grant is and is not.
• Determining if the R21 grant mechanism is right for you.
• Picking a research project that you feel passionate about but which also matches NIH funding priorities.
• Choosing people with expertise and experience who can advise you as you work on your application.
• Because not all NIH institutes fund the unsolicited R21, you must first determine whether the institute you have chosen for your research will accept this type of grant.

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Section 2: Outlining Your R21 Grant and Individual Qualifications

There are specific sections of the National Institutes of Health’s (NIH’s) R21 grant applications that allow you to outline your research topic and direction.
As you approach these areas, think of yourself as a storyteller. You are trying to get the reviewers involved to the point that they champion your proposal. All good stories have a resolution. Yours will be your Impact — how does your research advance your field and enable future investigations?

Your story begins with a Project Summary/Abstract, which is a brief yet detailed account of your proposed research. This section is important because NIH
reviewers will use it to determine the study section that reviews your application. In addition, the Project Summary is the only section of your proposal that every reviewer reads. Most of them will scan the rest of your application, but they all read your Abstract in its entirety. The second part of the Project Summary is the Narrative, which tells reviewers the significance of your research.

This chapter discusses what to include and what to leave out of your Project Summary, and details NIH guidelines pertaining to Abstracts (such as the maximum number of pages). Examples from successful grants will illustrate what NIH wants to see.

We also examine the Biographical Sketch section, which is more than a simple biography of the principal investigator (PI). There are ways you can creatively use this area to increase your chances of successfully obtaining funding. The Biographical Sketch section must include a personal statement, which details why you’re the best person to carry out this work. This chapter describes each of these elements and how to effectively include them in your Biographical Sketch.

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Section 3: Showing Your Institution’s Resources and Commitment

One of the core criteria National Institutes of Health (NIH) reviewers use to score your grant application is the Environment in which you perform the research. They want to ensure you will have the resources — meaning the institutional support, equipment and physical items — you need to successfully complete your proposed investigation. Additionally, they want to know of any unique features of your scientific environment, subject populations or collaborative arrangements that will benefit your project. You will detail these elements in the Facilities and Other Resources and Equipment sections of the short-form application.

Where you perform your research has not always been so important. In fact, reviewers note that “environment is one of the review criteria that used to be
virtually meaningless. Almost nobody got a bad score for it.” As one characterized it, “The only place that a reviewer could find information about [it] was the list of centrifuges and computers, which is really not very helpful.”

Obviously, this is no longer the case.

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Section 4: Proving Your Research Topic’s Significance

The most important parts of your National Institutes of Health (NIH) R21 application are those in which you describe your proposed research—the Specific
Aims and Research Strategy sections. They address your project’s Significance, Innovation and Approach, which are three of the five core grant criteria that reviewers use to score your application. (These criteria will be discussed in more detail in Chapter 8.)

At the same time, these sections will heavily influence your application’s Overall Impact score. Unfortunately, there is no template for incorporating overall
impact into your application, and there is no section called “Overall Impact” — or even an incentive to simply add a paragraph labeled as such. Instead, the NIH Office of Extramural Research has stated that you should describe “impact” clearly in the words you feel are relevant to your project.

Consequently, we will examine how you can use the Specific Aims and Research Strategy to perform double duty:

1. Fulfill the Significance, Innovation and Approach criteria
2. Support the Overall Impact of your research

As you address each of these sections, note that NIH limits your Specific Aims to no longer than one page, and the Research Strategy cannot exceed six pages for an R21 application.

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Section 5: Human Subjects and Animals

When outlining your project, if you plan to use human or animal test subjects — or sample or data from them — you must complete the key portions of the
application associated with these groups.

Keep in mind that the R21 is a two-year grant and that using human subjects takes considerable time in terms of recruitment and IRB approval, so it may not be the best type of grant for a human study. However, a limited exploratory study to collect data from a small trial in which you already have the subjects, the consent forms, and IRB approval might be appropriate for an R21. In any case, if you do involve humans, you must include this important section. Both you and your institution must assure NIH that human and animal test subjects will be protected. NIH cannot award any grant until such assurances are on file with the agency.

Include enough information so reviewers will have no questions about what you propose to do. In addition, your research plan must be certified by your
institutional review board (IRB) prior to funding. Although you do not need IRB approval when you submit your application, you should begin the approval process early because revisions and final approval can take time.

And before NIH can fund your grant application, there must be a Human Subject Assurance on file with the Office of Human Research Protections. This is
usually handled at the institutional level. Similarly, for proposed research using vertebrate animals, there is specific information you must include regarding the animals’ treatment and the rationale for including them. Also, an institutional animal care and use committee (IACUC) must review and approve your proposal before you submit it. At NIH, an Animal Welfare Assurance must be on file with the Office of Laboratory Animal Welfare.

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Section 6: Budgeting Your R21 Research

When applying for a National Institutes of Health (NIH) R21 grant, in addition to your proposal’s science, you also have to forecast how much money you will need to complete your research. Therefore, you should use the budget and associated justifications to present and support all the expenses required to achieve your proposal’s objectives.

Although they should not take your budget into consideration as part of the assessment process, the information is available to them. And reviewers are told to evaluate the application and assign a priority score based upon the science and feasibility, and some believe the budget is an indicator of feasibility.
For an R21, you must prepare a modular budget, as opposed to a detailed budget.

Remember, the budget for the two years is no more than $275,000, and no more than $200,000 may be requested for any single year. You may request direct costs in $25,000 modules, up to the total direct cost limitation of $275,000 for the two years. Therefore, budgeting is one of the big differences between an R21 and an R01. R01 applicants can seek much more money, and may use the detailed budget mechanism.

Direct from the NIH:

The combined budget for direct costs for the two-year project period may not exceed $275,000. No more than $200,000 may be requested in any single year. Applicants may request direct costs in $25,000 modules, up to the total direct costs limitation of $275,000 for the combined two-year award period.

When establishing your budget, you should count 60 to 80 percent of your total request toward salaries. A typical R21 budgets $150,000 in the first year and $125,000 in the second year, and that’s not much money. As we have repeatedly emphasized, your project must aim for a reasonable scope given limited resources.

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Section 7: Submitting Your Application

Before you submit your R21 application, take time to carefully review the finished product. Make sure your proposal works as a whole rather than a group of
parts. Remember your ultimate goal is to communicate that your research deserves funding, you’re the right person to conduct it, and your institution is the right place to do it.

Ensure all of the sections communicate your message adequately. Your research strategy must include strong specific aims and address your project’s significance, innovation and approach. Your project summary should be a compelling synopsis of your proposed research. And your budget should be in synch with your research strategy.

Reviewing your proposal for writing quality is just as important. You may want to ask colleagues or non-experts to read your proposal and provide feedback. Or you may need to hire a professional editor. Just remember that many errors in English usage, punctuation, and misspellings will negatively impact the reviewers and reflect poorly on you and your institution.

You must also write a cover letter to introduce your proposal. This is part of the National Institutes of Health’s (NIH’s) application upload process, and the agency encourages you to include one. If you are submitting a changed or corrected application, the cover letter is mandatory.

In addition, make sure you have included all of your application’s necessary components. Don’t forget any attachments, and confirm that all attachments adhere to NIH requirements. The agency used to provide a two-day window during which applicants could fix errors, but that is no longer available. Therefore, it is extremely important to ensure all of your documents are uploaded.

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Section 8: The NIH Application Review Process

This chapter outlines the National Institutes of Health’s (NIH) review process. It describes how the Center for Scientific Review assesses applications and assigns them to review groups. It also explains how your application moves from an integrated review group (IRG) to a scientific review group (SRG) to an institute or center’s advisory board or council.

You’ll learn the four steps of the initial peer review process and how an SRG (otherwise known as a study section) rates your application. We describe how five criteria — Significance, Innovation, Approach, Investigators and Environment — are used to score your proposal. We explain the importance of Overall Impact, what percentiles mean, and how to interpret summary statements.

Also included in this chapter is information on tracking your application and steps to take once you’ve received a response from NIH. You’ll learn about just-intime information and how to resubmit your application if it is not funded the first time around.

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About the Co-Author —
Christopher Dant, PhD

Christopher Dant is a faculty instructor at Dartmouth Medical School and the Norris Cotton Cancer Center. His PhD was concentrated in cellular and molecular biology. Early in his postgraduate career, he apprenticed with a Senior Editor at Journal of the American Medical Association (JAMA), and went on to work as a biomedical writer for life sciences investigators in academia, private industry, and government agencies. Before coming to Dartmouth, Dant was a Projects Manager at the Stanford Medical School for grants and manuscripts and served as the Director of Medical Publications at Genentech in San Francisco, where he worked with many thought leaders in medicine. He regularly presents at national and international medical meetings on writing. At Dartmouth, he works with investigators in developing grant proposals and programmatic initiatives, and educates faculty in grant and manuscript writing skills. He is owner of Medcom Consulting (http://medcomconsulting.org/MedCom.html), a medical and scientific communications company for academic investigators writing grants and manuscripts. Christopher is also a published author of fiction and lives in Vermont with his wife Maureen and dog Chauncey.

About the Co-Author and Consulting Editor —
Stephen Matheson, PhD

Dr. Stephen Matheson has a master’s degree in toxicology from Rutgers University and UMDNJ, and a PhD in neuroscience from the University of Arizona. He completed a postdoctoral research fellowship at Massachusetts General Hospital (MGH) and Harvard Medical School, working in developmental neuroscience in the MGH Cancer Center. Dr. Matheson taught at Calvin College in Grand Rapids, Michigan for 10 years, and collaborated with researchers at the Van Andel Research Institute while teaching in the graduate school of the Van Andel Institute. While in academia, Dr. Matheson gained vast experience in writing grant applications that included successful NIH proposals. He also served as a PI or co-PI on several NSF grants, including three successful MRI proposals, and has reviewed NSF grant proposals. He also has experience in reviewing scientific manuscripts for several journals.

Dr. Matheson currently works as a scientific editor at a major multidisciplinary journal of the life sciences, while writing and consulting. He lives in the Boston area and enjoys music, cycling, coffee, and scientific ideas.

• Principal Investigators
• Research Professors and Research Managers
• Other Key Proposal Team Members

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