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

You may have an amazing research idea that will shake the very roots of the scientific world, but if it does not meet the requirements set o ut by the NIH and its Institutes, Centers and Offices (ICOs), your application will not get past the initial review.

The more time and effort you put into your planning process, the more effective it will be and the more smoothly your proposal writing will be. Every grant
application requires a great deal of information, work and time, and planning ahead only helps you to stay focus on your goals.

Key Take-Aways:

• Effective strategies for developing an RO1 grant
• Why Impact is everything
• Creating a writing schedule—what to include
• Insider tips to develop a targeted Title for your proposal
• And more!

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In many ways your Abstract is one of the most important parts of your grant application. It reaches a broader audience than just your reviewers. In fact, it becomes a permanent description of your project, accessible to the general public, the press, politicians and taxpayers.

Just like every section of your application, you must have a strategy for the Abstract. And in this case, you have to tell your proposal’s whole story in a very limited space.

Join Dr. Marjorie Piechowski for this information-filled Webinar where she will teach you how to write for every possible reader and draw attention to the importance of your research.

5 Key Take-Aways:

• Understand How Your Abstract and Your Proposal Narrative Are Connected
• Identifying Common Errors in Abstracts and How to Avoid Them
• When to Write the Abstract
• Examples of Successful Abstracts: See What Was Included and Omitted
• Strategies to Help Your Abstract Influence Proposal Succes.

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Your grant application is — in many ways — a story. Each section must grab attention and build your case for funding, within page and character limits. So you must make the most of every word you write — including what you say about yourself in your Biosketch. This section is more than a simple biography of the principal investigator and other team members. You can use this area creatively to increase your chances of obtaining the funding you seek.

During this webinar Dr. Dorothy Lewis will reveal tricks of the trade and recommended tactics for effectively presenting your capabilities. For example, how to highlight what is most pertinent, the importance of uniformity across your team members’ biographies, and key words, phrases, publications and topics that will impress reviewers.

5 Key Take-Aways:

• Personal statement dos and don’ts
• Best published papers to show off your talents for the proposal
• Consistent conformity to the new application format among all collaborators
• Importance of customizing your CV with different emphasis
• Ideal ways to leave a positive impression on the reviewer.

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A research strategy is not just about experiments, but how you think about solving the problems raised. To successfully meet the requirements of the research strategy component of the NIH grant you must provide a clear picture of your research and its impact, how you will overcome challenges and what you hope to accomplish.

Learn how by joining grant writing expert, Dr. Dorothy Lewis, during her Webinar “NIH Research Strategy: Actionable Next Steps to Develop a Winning Proposal.” You’ll walk away from this valuable Webinar with actionable next steps to help you tackle each component of the research strategy and develop a winning proposal.

5 Key Take-Aways:

• Importance of clarity in the specific aims and matching to approach section
• How to impress the reader regarding innovation and your credentials
• Level of detail needed in approach
• Importance of focusing on strategy, not INDIVIDUAL experiments
• Importance of showing the reader that you can interpret your own data

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If your proposal involves human subjects, you must upload several separate documents indicating who will be involved, why and how they will be impacted. Consequently, you’ll need to thoroughly understand the regulatory and ethical issues associated with human subjects, as well as institutional review board (IRB) processes. Additionally, you will have to consider NIH’s position on including of women, minorities and children in your project.

Join Jaime A. Arango Ed.D. during this insightful webinar and walk away with actionable next steps to make sure you will conduct your research according to all the applicable rules. And you will have the tools to ensure your proposal includes the appropriate details so reviewers will have no questions about what you intend to do.

5 Key Take-Aways:

• A thorough understanding of exempt categories
• Recognizing the IRB’s role in reviewing the research protocol and proposal
• The importance of equitable subject selection and its historical underpinnings
• What IRBs may be looking for when examining your project
• Understand NIH’s human subject compliance resources

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If you are using human or animal test subjects and/or select agents, NIH wants to know how and for what. Consequently, you will have to upload specific information as part of your grant application. But be sure you do not use these documents to bypass the Research Strategy page limits.

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. 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).

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The revised NIH grant application form now demands specific information regarding how your environment uniquely contributes to your research’s success. This new requirement — one of the five key criteria the agency scrutinizes as part of the review process — is both an opportunity and a challenge.

During this uniquely focused webinar, Dr. Karin Rodland will review the specific information NIH expects and how reviewers process it. She will also give you hints and strategies for using this section to further set your application apart and enhance your chances of success.

Key Webinar Take-Aways:

• Highlight what is important and unique about your research
• Succinctly differentiate your environment from your competitors’
• Demonstrate institutional commitment, particularly if you’re an Early Stage Investigator
• Describe your environment and equipment in an engaging way to keep the reader’s interest
• Express independence, if an Early Stage or New Investigator
• Avoiding pitfalls: What to include and what to omit

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One of the most challenging questions posed by the NIH short form is, “How much money do you think you need to do the proposed work?” This open-ended inquiry can be a minefield for PIs who’ve struggled with the budget section before. If you indicate a number on the lower end, the reviewers may think you can’t plan adequately or accommodate unforeseen setbacks. If you’re number seems too high, the panel may think you’re trying to “game the system.” So exactly, how do you determine your budget, and what do you say about it?.

During this number-crunching webinar Dr. Dorothy Lewis will highlight the differences between modular and detailed budgets and reveal how to balance NIH wants and needs with your institution’s requirements. You’ll learn how to write budget justifications and estimate expenses. And find out the NIH rules on allowed amounts.

5 Key Take-Aways:

• A realistic perspective on costs
• Proper budget justification for the monies proposed
• Your institution’s likely needs for local-level approvals
• Money pits in modular grants
• How to know what research ideas will cost more than others

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You’ve spent weeks, perhaps months, completing your grant application, and you think it’s perfect. No misspellings or bad grammar. No math errors in the budget. But before you submit it, you need to give it a final look—like an airline pilot doing a flight check before takeoff. Why? You may have made a mistake you’re not even aware of. A 2010 NIH review of 45,000 applications identified the most common blunders and troublesome areas in its applications.

During this pragmatic webinar, Dr. Marjorie Piechowski will present strategies for breaking your final grant application review into four specific areas. These tactics will improve your chances of funding by submitting the best possible application, especially if you presented it a few days before the deadline. And although the focus will be on NIH, these approaches apply to other agencies’ applications as well.

5 Key Take-Aways:

• Top 10 most common errors on NIH applications
• Awareness of your application’s most error-prone sections
• Four-part strategy for reviewing your proposal before final submission
• Prioritized checklist of what is most important/necessary to review
• Window for corrections on applications submitted days before the deadline

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Once you have submitted your application to NIH, it goes through a few levels of review. First, the Center for Scientific Review performs a cursory assessment, checking for errors that automatically disqualify an application.

If there are no errors, the center sends your proposal to the group of reviewers known as the IRG. From there, your application goes to a study section (SRG).

The SRG is composed of roughly 20 scientists, mostly non-federal, who have expertise in relevant disciplines and current research areas. The scientific review officer (SRO), who is an NIH staff member, leads this group and appoints a few key reviewers to analyze your proposal in detail. The remaining members scan your application, reading only certain sections in depth.

The study section votes and scores your application on the five review criteria: Significance, Innovation, Approach, Investigator(s) and Environment. The group also evaluates your project’s Overall Impact. The SRO compiles a summary statement that includes your application’s scores as well as a more detailed critique.

After the SRG’s assessment, your application goes to institute/center national advisory councils for review. Councils are composed of both scientists and lay members chosen for their expertise and activity relating to health and disease. Your
application is only eligible for funding if both the study section and the institute/center advisory council recommend it.

During this insightful webinar, your expert presenter shares:

• Ask yourself these top questions before submitting
• How to avoid the most common mistakes (serious and minor)
• Expert tips to make your grant flow without too many words
• Find out which section low scores are mostly associated with
• And more!
  

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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.