You can now get all the winning strategies you should apply in your next R15 grant application in one place:
NIH R15 Grant Application Mentor: An Educational How-to Manual, 1st Edition.

This manual includes 313 pages of insider guidance divided into 8 thorough sections. Inside this manual you will find:

• Expert advice for developing your Project Summary/Abstract, Biographical Sketch, Environment section and Research Plan
• Surefire guidance to ensure your Research Strategy addresses your project’s Innovation, Significance, Approach and Overall Impact
• Understanding of why your budget’s numbers are almost as important as the words you use to tell your research’s story
• An insider’s view of special considerations for special agents, human and animal subject
• The do’s and don’t’s of submitting your grant application
• And much more!

Each section includes checks to ensure you’re following NIH guidelines every step along the way.

Before you can begin filling in your National Institutes of Health (NIH) grant application, there are several steps you must take first. For instance, you have to define the research project idea for which you are seeking funding. This may seem rather 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. And you must verify that your institution qualifies for R15 Academic Research Enhancement Award (AREA) grant applications. Then — before you write a single word of your application — you should map out a strategy for it, which can include the following:

• Determining if the R15 grant mechanism is right for you.
• Picking a research project that you feel passionate about, yet which meets NIH funding priorities at the same time.
• Choosing people with expertise and experience who can advise you as you work on your application.

Inside this section, you will find step-by-step guidance to walk you through each of these steps.

There are specific sections of the National Institutes of Health’s (NIH’s) R15 grant application that allow you to outline your research topic and direction.

Your story begins with a Project Summary/Abstract, which is a brief yet detailed account of your proposed research. This section is important because initial NIH staff 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.

This chapter tells you what to include and what to leave out of your Project Summary. It also details NIH guidelines pertaining to Abstracts — such as the maximum number of pages — and gives you examples that illustrate what NIH wants to see in an R15 proposal. 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.

Must-have, step-by-step expert guidance includes:

• When to write your Project Summary — the experts weigh in
• Keep your Narrative simple … the audience for it may not be who you think
• Use the Personal Statement to tell why you’re the best individual for the project: we’ll show you how
• Early-stage investigators should stress one detail in their Biosketch
• The key to a good letter of support may be to write it yourself … 4 tips every applicant should know

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.

Must-have, step-by-step expert guidance includes:

• Environment is key for early-stage investigators: How to show your institution supports you
• Underscore your research’s feasibility by demonstrating 2 critical factors in your Environment section
• Colleagues play an important role … what details you should exploit and what you can leave out
• Defining “major” equipment — know where to draw the line
• Ensure you carefully formulate your sharing plans; or pay the price later

Probably the most important parts of your National Institutes of Health (NIH) R15 application are those in which you describe your proposed research. Specifically, these are 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.

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.

Investigators are sometimes a bit surprised to see that the criteria used to judge R15 applications are essentially the same as those for R01 proposals. Keep in mind, however, that an R15 application is essentially an R01 application, but with specific eligibility rules and added expectations for student research. The R15 is still a research grant, and NIH very clearly emphasizes its interest in meritorious research.

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

• Fulfill the Significance, Innovation and Approach criteria
• Support the Overall Impact of your research
  

Must-have, step-by-step expert guidance includes:

• Avoid the dreaded “overly ambitious” reviewers’ critique with advice from the experts
• Are your Specific Aims “sequential” or “parallel”? 1 Way to know for sure
• One section holds the key to completing the rest of your application. Learn the easiest place to start
• How to make the argument that your research is “translational” — Key language every grant-writer should know
• Effectively craft your Innovation section: Here’s how
• Reviewers focus specifically on your Approach — Make sure yours passes muster
• How much preliminary data is really necessary? Know where to draw the line

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.

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 (OLAW).

It may be that the topics described in this chapter do not apply to your proposal due to your research topic. However, understand that R15 research grants are not exempt from any of the requirements described in this section.

With so much to coordinate, this section will walk you through exactly what you need to make sure you don’t leave anything off your to-do list.

Must-have, step-by-step expert guidance includes:

• What NIH really means by “be succinct” … the answer may surprise you
• Think you can exclude children from your study? Make sure you know the rules first
• Informed consent is more than just a piece of paper — what you must include every time
• Animal testing rules: Make sure they really apply to your research
• Do you know all the “Select Agents”? There may be more than you think

When applying for a National Institutes of Health (NIH) 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.

In fact, your budget’s numbers are almost as important as — if not more so— the words you use to tell your research’s story. This part of your application communicates to reviewers what you plan to do with the money you are asking them to invest in your project. Some reviewers even flip to the budget first to get a snapshot of the proposal and help them understand it. 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 an indicator of feasibility.

Must-have, step-by-step expert guidance includes:

• Does your budget match your Research Plan? If it doesn’t, you could be sending up a red flag
• Underbidding your research could wind up hurting you later … what the experts have to say about “bargain” science
• Avoid the “ambitious” title — how to use your budget to show you’re serious about your proposal
• Modular budgets are very popular, but they have their limitations
• Effort reporting defines your personnel justification; make sure you nail it the first time

Before you submit your R15 application, take time to 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.

That’s why reviewing your proposal for content is important. 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. Your Facilities and Other Resources section should profile your institution and students with regard to student 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.

You must also construct 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.

Must-have, step-by-step expert guidance includes:

• Review the R15 application checklist — Have you got all the elements you should?
• More than one PI on the project means special requirements … make sure you meet all of them
• Submitting for subawardees? Keep these extra rules in mind
• Your cover letter: Key details to include — and what to leave off
• Picking your editors … key people who should review your application for both accuracy and readability
• Your application should read as a whole story, so make sure these sections agree

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 and look at the specific criteria that apply to R15 proposals, which are reviewed in parallel with R01 applications in the same SRGs. 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-in-time information and how to resubmit your application if it is not funded the first time around.

When considering this process, you should understand:

• Step-by-step what happens to your proposal once you hit the “submit” key and who’s involved
• How to make the best use of your cover letter
• When and how much additional information you can send to NIH after the deadline
• What peer review really entails and how to make the most it
• How to read between the lines of your reviewers’ critiques
• Whether to resubmit your unfunded application or start over from scratch

This mentoring curriculum is an independent resource of expert analysis and option, plus color-coded exact copies of NIH words when they are especially helpful. But our authors also restated key points in more clear language where they felt the government writers strayed into “grey areas” or even bureaucratese. Plus, we’ve supplied actual language from funded grants to show how other PIs have handled challenging zones to help jump start your own proposal.

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This manual is brought to you as a training tool by the Principal Investigators Association, which is an independent organization. The presented information is not connected with the National Institutes of Health (NIH) or the National Science Foundation (NSF), nor is it endorsed by these agencies. All views expressed are those personally held by the authors and are not official government policies or opinions.