NIH R01 Grant Application Mentor: An Educational How-to Manual, 4th Edition.

This manual includes 300 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
• A 50-minute recording entitled “Crafting Your R01 Proposal Like the Pros: 10 Insider Tips Revealed,” and much more!

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

Before you can begin your NIH grant application, there are several steps you must take. For instance, you have to define your research project idea. This may seem rather obvious, but the process for doing so is anything but simple.

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 R01 grant mechanism is right for you.
• Picking a research project that you feel passionate about, yet meets NIH funding priorities.
• Choosing people with expertise and experience who can advise you on your application.

Next, you will need to more clearly define your proposed research project. NIH has specific criteria for investigators it will support, and there are explicit concepts every grant application must include to be considered. For instance, how you formulate your project title and hypothesis can significantly influence your research’s fundability.

Finally, you should develop a writing schedule to ensure that your grant application meets NIH’s submission deadlines. There are several possible tactics that you may use to help you.

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

There are specific sections of NIH’s R01 application that allow you to outline your research topic and direction.

As you approach these areas, your goal is to get the reviewers emotionally involved to the point that they champion your proposal.

But NIH has placed limits on your efforts. The Project Summary (or Abstract) and the Project Narrative, for instance, have specific page counts that you cannot bypass. Working within these limitations can be particularly challenging with the Summary because initial NIH reviewers will use it to determine to which Study Section it be assigned.

This chapter also examines the Biographical Sketch or “Biosketch” section. This is more than a simple biography or CV for the Principal Investigator. There are ways you can creatively use this area to increase your chances to successfully obtain your needed 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
• NIH says stick with no more than 15 publications — how to pick the best ones
• The key to a good letter of support may be to write it yourself … 4 tips every applicant should know

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.

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 NIH R01 application are those in which you describe your proposed research. In particular, 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. As a matter of fact, these sections are the ones you will spend most of your writing time on.

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.

Consequently, this section examines 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

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.

Your research plan also must be certified by your institutional review board (IRB) prior to funding, so you should begin the approval process early because revisions and final approval can take time. Plus, before NIH can fund your grant, there must be a Human Subject Assurance on file with the Office of Human Research Protections.

There’s also the IACUC and OLAW to consider specifically if you’re working with animals.

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

The agency’s short-form application uses a series of special forms you will use for this purpose. In addition, there are two types of budget proposals that you can submit: Modular and Detailed.

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

That’s why it’s important to review your proposal for content. Take a good look at the most important sections. Ensure your project summary is complete and your budget is in synch with your research strategy. Make certain you’ve adequately addressed your project’s significance, innovation and approach.

It is just as vital to review your application for writing quality. 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 project. This is part of the NIH application upload process, and the agency encourages you to include one. If you’re submitting a changed or corrected application, the cover letter is mandatory.

In addition, you must ensure that you’ve included all the necessary components. If you leave something off, your application might be returned without review.

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

• Review the R01 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

Once your application has been processed, you will receive a Summary Statement. Then, you must interpret:

• The Overall Impact score
• What the percentiles mean
• Reviewer critiques

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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Please note the following for you 50-minute recording: If you choose the CD format, it will be delivered via mail within 7-10 days. If you chose the MP4 format or PDF Transcript, it will be sent via email within 24-48 hrs.

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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.