Skip to ContentDepartment of Health and Human ServicesNational Heart, Lung and Blood InstituteNational Institutes of Health
Banner - Clinical Research Guide
Banner - Clinical Research Guide
search the nhlbi website
ContractsOverviewApplicationReviewFundingManagementStudy ClosureToolkit
How can I find funding opportunities (RFAs, RFPs and PAs)?
What do I need to know before submitting a clinical research application?
Am I a new investigator and what if this is my first NIH application?
Which NHLBI staff can help me?
Is my study considered clinical research?
Is my study observational or interventional?
What is the best award mechanism for my clinical research proposal?
What if my project exceeds $500,000 in direct costs in any given year?
Where can I get help with writing the application?
What must I include in Section E: Human Subjects Research?
How and when do I submit my application?

Glossary Box

 

Where can I get help with writing the application?

After deciding which mechanism is best for you, you will want to begin writing your application.  Review applications of colleagues who have had successful review and funding.  Creating a well-organized and well-designed research plan is critical to successful peer review.  Be specific in describing what you are proposing to do, why this research is important and how you will do it. 

There are a number of resources available to you to help you in this process.  You will want to begin with the PHS 398 or SF424 form and its instructions.  Read the instructions carefully before developing your research plan.  The instructions give details about page limitations, format specifications, human subjects research requirements, and budget.  Some types of mechanisms are now using Electronic Submission of Grant Applications.  

Organize your research plan in a logical fashion.  NIAID has created a detailed tutorial called How to Write a Grant Application that takes you through the process while using the PHS 398 forms.  The PHS 398 form requires that you use the following basic format:

Section A:  Specific Aims
Your specific aims are what you want to accomplish in your project.  Generally, this section should begin with a brief narrative describing the long-term goals of the project and the hypothesis guiding the research.  This is followed by a numbered list of the aims.  Most successful applications have 2-4 specific aims that are attainable in the stated time-frame.  Recommended length of this section is one page.

Section B:  Background and Significance
Remember that this is one of the three sections likely to be read by all the reviewers, so write this section in non-technical terms for the broader audience. It's important that you convey the significance of your research and how it relates to the betterment of public health. Recommended length of this section is two to three pages.

In this section, establish your familiarity with recent research findings, the gaps, and roadblocks in your field. If you leave out an important work, reviewers will assume you're not aware of it.  Highlight why you are uniquely qualified to do the research. Ensure that citations are specifically related to your proposed research and are cited correctly. 

Section C:  Preliminary Studies
The purpose of this section is to describe your prior work that is relevant to the proposed project.  By providing preliminary data, you build reviewer confidence you can handle the technologies, understand the methods, and interpret results. Preliminary data will help show you have the expertise to do the job. This section is not mandatory for new applications, but it is difficult to obtain a favorable review without strong preliminary data.

Include enough information to show you know what you're talking about.  Tell them how your early work prepares you for the new project.

Section D:  Research Design and Methods
When reviewers judge your application, this section has the most weight. Here you will describe how you will perform the research. Think carefully about how to organize it. You may want to number the sections in this part to correspond to the specific aims.  It's helpful to create graphs, timetables, flow charts and decision trees to demonstrate the progression and details of your project. 

Applications for clinical studies must include thorough discussions of sample size and power.  For large studies, it is important to include a statistician as a key person to assist you in writing and clearly explaining these elements in your application. 

There is no recommended page length to this section, but you must stay within the 25-page limit for sections A to D.

Other Resources:

How to Plan a Grant Application from NIAID
Grant Writing Tutorial from the National Library of Medicine
Grant Writing Tips from OER
Writing a Grant Application: A Technical Checklist from NINDS
NIH Regional Seminar Presentations: Grant Writing for Success (.pdf)
CSR Advice to Investigators Submitting Clinical Research Applications

 

 

HOME · SEARCH NHLBI · ACCESSIBILITY · SITE INDEX · OTHER SITES · PRIVACY STATEMENT · FOIA · CONTACT NHLBI


National Heart, Lung, and Blood Institute National Institutes of Health logo National Institutes of Health