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Shuhan He MD Administrator
Shuhan He MD is an Emergency Medicine Physician at Harvard Emergency Medicine Department at the Massachusetts General Hospital. Dr. He is interested in making better tools to Conduct Science, especially regarding scientific outcomes. He is the founder of MazeEngineers.com, Conductscience.com, Sciencen.com and an array of tools to help scientists get the job done better and with more translation to the patient at the bedside.
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Shuhan He MD Administrator
Shuhan He MD is an Emergency Medicine Physician at Harvard Emergency Medicine Department at the Massachusetts General Hospital. Dr. He is interested in making better tools to Conduct Science, especially regarding scientific outcomes. He is the founder of MazeEngineers.com, Conductscience.com, Sciencen.com and an array of tools to help scientists get the job done better and with more translation to the patient at the bedside.
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Academic, clinical and medical success depends largely on the availability of grant funds which in turn depend upon the quality of research proposal and application. Grant is the lifeline of biomedical research; it brings prestige and honor to the investigator. Most importantly, it ensures financial and technical support without which research cannot be conducted. But grants are hard to come by, and it is not easy to write a successful grant application.

Grant writing is a challenging task and is akin to a nightmare for the inexperienced researcher. Funding agencies, such as the National Institute of Health (NIH) award grants largely on the basis of application quality.

This article will walk you through the grant writing process, its organization, and other key aspects to keep in mind so that you can maximize your chances of obtaining funding.

Getting Started

As haunting as the idea of applying for a grant may be, there is a way around it. For starters, a good application can be written if your proposal is good. Once you have developed the proposal idea, you can pen it down eloquently. Just keep in mind that your proposal, or study idea, should be relevant to the mission of the NIH. It should address an important biomedical problem and provide a plausible solution. Here is what the NIH’s mission is:

NIH’s mission is to seek fundamental knowledge about the nature and behavior of living systems and the application of that knowledge to enhance health, lengthen life, and reduce illness and disability.”

You need to ask yourself some fundamental questions to fall in line with the mission. Is your study:

  • Focused on protecting and improving healthcare?
  • Likely to create and renew scientific database?
  • Capable of curing and treating disease?

If the answer to all of these questions is a ‘yes’ then move forward – look up the literature database to find out whether your idea is novel and unique. Chances are there must already be dozens of research proposal on it, if not hundreds. This is because tremendous research is being done in biomedical and clinical sciences and you do not want to invest energy, time and labor into an already explored subject.

The ideal scenario is that your literature search brings zero results. This means your proposal is unique and is destined to grab the reviewers’ attention. However, an ideal scenario is hardly likely. Suppose your research produces significant relevance to publications, there is still a chance your research proposal and application will be funded because you can add value to the existing evidence with a scientific and technological update or propose a new medical or clinical intervention. Additionally, you can provide a comparative analysis of cohort studies, randomized clinical trial or systematic analyses.

Once you finalize your study proposal, you need to determine:

  • Number of study subjects
  • Immaculate study design with convincing real-time data
  • Study budget
  • Your collaborators

These factors determine your seriousness with the project and serve as proof of your capability to the granting agency.

Let us now dissect the sections of the grant.

Anatomy of a Grant Study Protocol

A grant consists of following key elements:

  1. Abstract
  2. Specific Aims
  3. Background & Significance
  4. Preliminary Results
  5. Research Design and Methods

Let us now see what each section means and what the NIH exactly wants you to include in it.

1.     Abstract

This is the first section of the application the reviewers read. In fact, most of the reviewers pretty much make up their mind based on this section alone – such is the importance and power of this section. For this reason, the ‘Abstract’ of the grant application has to be well-written, top-notch and articulate. There is a lot that depends on this section – it can make or break you.

So what does Abstract contain exactly?

The Abstract, also called Project Summary, defines every critical element of the proposal. It is brief but concise and should consist of:

  • 30 lines or less
  • Background, Objectives and Specific Aims of the proposal
  • Description of the research design and data collection methods
  • Significance and relevance of the proposal to public health

The Abstract has to be in the simplest of the languages so that even a non-medical professional will be able to grasp it. Avoid fancy vocabulary and use of first-person.

2.     Research Proposal – Specific Aims

Here you discuss the problem and solution at length, for instance, the study you plan to conduct if you get the funding. The reviewers are interested to know how you are going to address the clinical challenge and why your research is crucial. Here you ought to describe:

  • Proposal – what you intend to do.
  • Significance – what is the worth of your research? How innovative it is.
  • Comparison & References – with the existing body of evidence.
  • Plan – how you plan to accomplish the study, who the collaborators are, and what the population size and the research center, etc. will be.
  • Study outcome; primary and secondary

Here is what you need to keep in mind:

  • Tell a story – walk the reviewer through your plan in the form of a story. Tell your story nicely and convincingly. Highlight the important points; use numbering and bullet points wherever necessary.
  • Use references – plenty of them. Educate the reviewers about what has already been done in the field of your research, what is missing and how you plan to fill the literature gap.
  • Highlight how your study – with novel ideas, updated experimental and technological system, and approach – will enable biomedical science to progress and benefit healthcare
  • Sell yourself – show your credentials, history of publications, professional career background and the names and achievements of the collaborators
  • Describe goals convincingly and realistically without being over-ambitious.

3.     Background

In the Background and Significance section, you provide the rationale of your study as well as highlight its relevance with the existing body of literature. In case if the relevant study, particularly meta-analysis or systematic review, is not available, grab the chance to produce one. A meta-analysis is the grand analysis of multiple – over hundreds and thousands – studies and is considered the strongest evidence. A meta-analysis is likely to win favor with the reviewers. Consider producing one.

The purpose of the Background & Significance section is to justify your proposal. There ought to be a strong clinical ground for your study. You need to convince the reviewers that your study will indeed benefit the healthcare and it is you they want to invest in.

To sound convincing, add the following information in the Background section:

  • The magnitude of the problem you are addressing and how clinically challenging/common it is.
  • That the problem is progressive and is likely to inflict health economics tremendously.
  • Shortcomings and uncertainties of the available treatment
  • The patient population your study is targeting
  • Provide convincing management and solution to the problem.
  • If possible, add a survey from the doctors, clinicians, and surgeons about the preferable treatment method. Try including patient opinion about treatment satisfaction as well. Sometimes there may be a discrepancy or a disagreement between the patient and physician. (Derry, McQuay, Moore, & Paling, 2008)

4.     Research Design & Methods

Here you explain the study design of your proposal. Majority of the study designs are:

  • Diagnostic studies, e.g.,
    • Development of new diagnostic approach and criteria
    • Analysis of the existing diagnostic approach
  • Observational studies, e.g.,
    • Prospective study
    • Retrospective study
  • Interventional or Therapeutic studies, e.g.,
    • Case study
    • Case-control study
    • Cohort study
  • A combination or overlap of the abovementioned study designs

You need to decide which of these designs best fits your research questions and produces the highest quality results. Give considerate thought to the study design because the choice of the design carries weight in the award funding.

Besides you need to take into account basic ethical considerations while designing a study. These include:

  • Appropriate description of the inclusion/exclusion criteria (eligibility criteria)
  • Frequency, duration, and methods of the follow-ups

Another crucial part of the study design is “Sample Size Calculation,” for it too has an impact on the likelihood and magnitude of the funding. Sample size depends upon the primary outcome of society. Try choosing a reliable, realistic and verifiable outcome, and based on that, calculate the sample size.

  • A continuous primary outcome, such as pain score etc., requires a small sample size.
  • A dichotomous outcome, such as infection rate etc., requires a large sample size.

The sample size calculations are based on assumptions of the outcome and can be calculated with the help of study tools. Present the estimated size on a separate section in the application. The reviewers judge the depth of the study by looking at this section.

5.     Study Results

Study results are prone to be affected by a horde of factors termed “biases,” such as measurement or selection bias. A study can be prevented from the biases with the help of statistical tools such as:

  • Randomization – it comes in handy when you want to balance the known and unknown factors.
  • Random Treatment Allocation – most useful for interventional studies where you are comparing more than one intervention for a specific outcome.
  • Blinding – to blind one group of the study, i.e., patients, physicians or the data analysists.
  • Blocking and stratification – to avoid random imbalances in RCTs.

Conclusion

To conclude the article, grants are absolutely crucial for academic or biomedical success. Key to successfully obtaining the grant, in return, depends upon how unique your research idea is and how craftily you are able to sell it. A good idea stems from good background research, study design and a practical methodology. Additionally, you need to realize that writing a grant application and applying for the grant is a team effort. Choosing the right and experienced team is absolutely imperative to convince the reviewer that you actually deserve the funding. Chunks and sections of the application serve their own characteristic function to win favor from the reviewer.

Your application should contain reliable preliminary data, convincing research plan, a suitable budget, and a realistic timeline. The application should be tailored as per the granting agency, i.e., institutes and centers (ICs) of the NIH, such as the National Cancer Institute (NCI), National Eye Institute (NEI), and National Heart, Lung, and Blood Institute (NHLBI) etc., because each agency has its own specific aims and goals. The application format for each IC can differ slightly as well. It’s best to acquire information from the grant officer of the respective IC.

Lastly, it is advisable to simultaneously apply for multiple awards – from both government and private funding agencies – to increase chances of success.

References

  1. Derry, S., McQuay, H.J., Moore, R.A., & Paling, J. (2008, February 7). What do we know about communicating risk? A brief review and suggestion for contextualizing serious, but rare, risk, and the example of cox-2 selective and non-selective NSAIDs. Arthritis Res Ther, 10(1), R20. http://dx.doi.org/10.1186/ar2373
  2. Chung, K.C., & Shauver, M.J. (2015, April 29). Fundamental Principles of Writing a Successful Grant Proposal. J Hand Surg Am, 33(4), 566–572. http://dx.doi.org/10.1016/j.jhsa.2007.11.028