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Plan Your Application
It's a major undertaking—preparing and submitting an NIH biomedical research grant application to support your research training needs or pursue your scientific research. This highly competitive endeavor can be subverted by poor planning, preparation, disorganization and lackluster presentation. The successful grantee allows ample time to plan, organize and write a grant application that competes well in the peer review process and ultimately earns funding.
This section offers tips and strategies for planning and organizing your application. Be sure to work closely with your institution's grants support office, the Office of Sponsored Programs, to determine the internal procedure for submitting an application to the NIH. Though the advice provided is relevant for all research grants, it is general in nature and geared toward the NIH Research Project (R01). The tips and guidelines included in this document are not intended to replace your organization’s internal guidance, specific advice provided by NIH program or grants management staff, or instructions found in the various application guides.
He who is best prepared can best serve his moment of inspiration.
― Samuel Taylor Coleridge
An important first step in planning is to understand how NIH works. Your application should fit within the mission and research priorities of the NIH Institute or Centers likely to fund your application. Check out our page on understanding NIH to learn more.
Use RePORTER to Help Identify Where Your Research Fits Best
Now that you have a better understanding of the organization, use NIH’s RePORTER, a Report Expenditures and Results tool that allows users to search a repository of NIH-funded research projects and access publications, including other valuable information for researchers in the planning process. Use the RePORTER search interface to search by term, or use the Matchmaker interface to input an abstract or other scientific text to find a list of the 100 most similar projects NIH is funding. In this way you can:
- Explore what types of projects NIH is/has funded in your area of science.
- Identify the appropriate IC by searching for the IC that is funding projects similar to yours;
- Identify the Program Officials to contact that are associated with similarly funded projects;
- Find collaborators who are experienced NIH grantees or who have skills that complement your own to improve the strength of your proposal.
Use this information to carve out a niche that will allow you to significantly advance knowledge in your respective field and help you develop a list of who to contact at NIH.
Contact NIH Staff
We strongly recommend that you contact the NIH prior to submitting an application.
- Identify the NIH IC that supports research in your area, then check the IC’s Web site to determine whether your idea matches any of the IC's high-priority research areas and obtain specific information related to the IC’s FOAs and specific research priorities. Note: Some ICs publish cleared concepts well before the FOAs are published. Not all concepts become FOAs, this is one reason NIH encourages you to contact a program official as soon as possible.
- Contact a program official at the appropriate IC by phone or e-mail to clarify any questions you may have, such as whether your proposed research project falls within the scope of an existing funding opportunity announcement. The PO is the NIH official responsible for the programmatic, scientific and/or technical aspects of a grant. NIH grants management staff can provide advice on business and administrative issues.
See Contacting NIH Staff to learn more about how and when to contact staff during the application and award process.
Find a Funding Opportunity Announcement (FOA) that Fits Your Research
All applications must be submitted in response to a FOA, so this is a critical step in the planning process. Read Find and Understand Funding Opportunities for more details.
Determine Application Submission Date
Each FOA will state the submission date(s) (also known as receipt date, due date, or application deadline) for grant applications. This date varies depending on the activity code, specific program, or FOA. If you do not believe that you can meet the application deadline comfortably, strongly consider delaying to the next submission date. Reviewers will point out when they feel an application is premature because of inadequate development and presentation, including a poorly conceived budget.
RFAs (requests for applications) and some PARs (Program Announcements with special receipt, referral and/or review consideration) and PASs (Program Announcements with set-aside funds) have special receipt dates indicated in the FOA.
Plan Within Your Organization
Developing and submitting a grant application is a team effort.
Meet with your Office of Sponsored Research (or central grants support office) early in the process. This office can:
- help ensure you are registered in the eRA Commons;
- guide you through the application process and inform you of any institutional deadlines you must meet;
- provide guidance on NIH policies and processes;
- offer specific advice on developing your application, especially the budget.
- Plan your timeline to ensure you get your application to your Office of Sponsored Research on time, especially when collaborating investigators are involved.
- Find experienced staff at your institution who can assist you in understanding all the steps necessary to complete your application. This person may be in a central grants office, or it may be another investigator, a departmental administrator, etc.
Obtain Any Required Prior Approvals from NIH
Certain situations which require prior approval from NIH to submit your application and therefore, need to be considered in the planning process.
- Is your budget over $500,000 in direct costs for any year of the project? If so, NIH policy requires prior approval from IC programmatic staff at least six weeks prior to the anticipated submission date. Information regarding this approval will need to be submitted in a cover letter with your application.
- Are you submitting a conference grant application? If so, you will need to include a letter from the appropriate NIH staff documenting advance permission. Investigators are urged to initiate contact well in advance of the application receipt date.
Get to Know the NIH Peer Review Process & Criteria
Panels of expert scientists review all grant applications submitted to the NIH in a process known as peer review. Although several factors contribute to whether your application will be funded, great emphasis is placed on how the reviewers rate the scientific merit of your proposal. Section V of every funding opportunity announcement details the review criteria that will be used to assess your application. Take note of these criteria and keep them in mind as you plan your application.
Consider These Additional Application Elements
Think about required documentation. Are you using stem cells or select agents? Are you studying vertebrate animals or identifiable human subjects? Know whether you are required to prepare a modular budget or a detailed budget.
Determine the expertise needed to strengthen your research study team (individuals, collaborating organizations, resources, etc.). Most scientific work requires collaboration among researchers, and NIH is dedicated to fostering such relationships.
- Begin to assemble the research study team early.
- Investigate opportunities for collaborating with more experienced, well-known grantees, or a known laboratory. Collaborators can fill gaps in your own expertise and resources and can assure reviewers of the competence of your proposed team.
- Plan on obtaining letters of commitment from your collaborators, which will need to go in your application and provide crucial information for reviewers.
- Include letters in your application that reflect the rate/charge for consulting services.
- Consider a multiple project director/principal investigator model if your work includes multidisciplinary efforts and collaboration where a team science approach could be more effective (multiple-PI model).
- The format, peer review and administration of applications submitted under the multiple-PI model do have some significant differences from the traditional single-PI model which will need to be taken into consideration as you plan
- All applicants proposing team science efforts are strongly encouraged to contact their NIH program officials at the earliest possible date to discuss the appropriateness of the multiple-PI model for the support of their research.
Are you a New Investigator?
NIH offers funding opportunities tailored to new investigators. Take the time to research whether you and your project qualify using the New Investigators Program Web page. What are some of the other advantages?
- Reviewers are instructed to give special consideration to new investigators. They will give greater consideration to the proposed approach, rather than the track record.
- New investigator applicants may have less preliminary data and fewer publications than more seasoned investigators, and NIH reviewers understand this. As an Early Stage or New Investigator, reviewers will be looking for the appropriate experience and training for the project.
Foreign Involvement – Institution and/or Investigator
- The NIH does make awards to Foreign Institutions, international organizations, and domestic institutions with foreign components. However, there are specific programs that are not available to foreign entities, such as program projects, center grants, Institutional National Research Service Awards, SBIR, STTR, or construction grants. There are some exceptions by Institute or Center, but rare.
- To serve as a PI on an NIH award, U.S. affiliation or citizenship is not required on Research Project Grants, but is required on small business, fellowship and training grants.
- Applicants are highly encouraged to check the eligibility guidelines provided in every FOA.
- Foreign institutions must be able to provide research that does not have comparable work being conducted in the U.S. If it is, the grant will likely not be funded.
- If you are a highly qualified foreign investigator with unique expertise or resources not available in the U.S., the likelihood of obtaining an NIH award increases.
- Foreign applicants must submit categorical budgets for any application to the NIH.
- There are specific requirements and guidelines for research involving foreign institutions that will need to be considered when planning and writing an NIH application (e.g. categorical budgets only, special select agent’s requirement, etc.)
- Foreign PD/PI’s and/or research involving a foreign institution are highly encouraged to contact an NIH program officer as soon as possible in the planning and writing stages.
Evaluate Your Resources
- Conduct an organizational assessment. Figure out what resources and support your organization has and what additional support you'll need for your project.
- Consider whether the available equipment and facilities are adequate and the environment conducive to the research.
Consider Human Subjects and Vertebrate Animal Requirements
If your project includes either human subjects and/or live, vertebrate animals, then assurances must be provided.
- Institutional Approval for Research Using Human Subjects:
HHS regulations for Protection of Human Subjects in 45 CFR Part 46 define a human subject as a living person about whom an investigator conducting research obtains either data through intervention or interaction with the person, or identifiable private information.
- Institutional Approval for Research Using Vertebrate Animal:
Office of Laboratory Animal Welfare (OLAW) Web Site
The Public Health Service (PHS) requires institutions to establish and maintain proper procedures to ensure the appropriate care and use of all animals involved in research, research training, and biological testing activities conducted or supported by the PHS. Investigators seeking PHS funds to support animal activities in their research must comply with the Public Health Service (PHS) Policy on Humane Care and Use of Laboratory Animals.
As with human subjects, investigators must provide assurances that live, vertebrate research animals are treated properly as well as state the benefits of the research to humanity. When preparing your application, read the vertebrate animals section of the Grant Application Guide. They list the elements your application must describe.
Prepare for Rigor and Transparency Requirements in Your Application
In the planning process, investigators will need to consider how to address the basic principles of rigor and transparency and include how the following four areas of focus apply to their proposed research (some exceptions apply, see NOT-OD-16-011):
1) the scientific premise forming the basis of the proposed research,
2) rigorous experimental design for robust and unbiased results,
3) consideration of relevant biological variables, and
4) authentication of key biological and/or chemical resources.
As with any step in the planning stages, investigators are encouraged to work with their institution and contact a NIH program official with specific scientific questions.
Organize Your Time to Complete the Application
At this point, you should have a very good idea of what needs to be done and who will be helping along the way. It’s time to make a more detailed plan of how and when everything should be accomplished, given your time and resources.
- Make sure your specific research aims can be accomplished within the proposed time and resources.
- Make sure you have adequate preliminary data.
- Consider identifying experienced investigators in your organization, or in other organizations, who might be able to review a draft of your application and provide you feedback.
- Develop a feasible timeline with draft application deadlines. Be realistic about the time it can take to write and revise the application, incorporate feedback, and get the application to your Office of Sponsored Research on time.
- Build in extra time for unforeseen circumstances (e.g. equipment issues, personnel issues, etc.)
- We strongly recommend you plan submit your application to NIH well ahead of the deadline (days, not hours).