Planning Your Application - Grants Process Overview
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Planning Your Application

On This Page:
Introduction

It's a major undertaking—preparing and submitting an NIH biomedical research 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. Carefully read the scientific mission, goals and objectives of the NIH and the NIH Institutes and Centers (ICs) that support biomedical research. The most successful applications reflect an understanding of NIH's principles. 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.
  • This document is written for the Investigator.  Therefore, all references to “you” refer to the Program Director/Principal Investigator (PD/PI).

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Search for the Right Funding Opportunities

Search Funding Opportunities for Your Research Idea

NIH announces availability of funds for grant programs by issuing Funding Opportunity Announcements (FOAs) in the NIH Guide for Grants and Contracts and on Grants.gov

Types of Funding Opportunity Announcements (FOA) 

The following chart may help you identify the type of funding opportunity announcement that is right for your research. Scroll down for Tips from the Experts.

The following chart may help you identify the type of funding opportunity announcement that is right for your research. Scroll down for Tips from the Experts
Type of Funding Opportunity Announcement

Receipt Date

Money Set Aside

Peer Review

Specificity of Topic

Advantage to Applicant

Parent Announcements

Standard receipt dates, usually open for three years

None

In Center for Scientific Review (CSR) or in an IC, by one of many review committees

Non-specific, investigator-initiated “unsolicited” research. Not all ICs participate in all parent FOAs.

May submit any topic within the breadth of the NIH mission.  Competition tied mainly to an IC's overall payline

IC-Specific Program Announcements (PA)

Standard receipt dates, usually open for three years

No set asides (unless PAS); high-priority applications may be funded beyond the payline

In CSR or in an IC, by one of many review committees (unless PAR)

Often broadly defined or a reminder of a scientific need; investigator-initiated “unsolicited” research

Competition tied mainly to the IC's overall payline

Request for Applications (RFA)

Single

Specifies funds and targets number of awards

Usually in and IC, but sometimes in CSR. Same review committee for all applications. Usually reviewed by a Scientific Review Group, called a Special Emphasis Panel, that is convened on a one-time basis

NIH-Requested Research; Well-defined scientific area

Competition depends on number of applicants and dollars set aside


Tips from the Experts

As noted in the chart above, NIH provides support for NIH-requested research applications that are submitted through specific FOAs, and “unsolicited” research applications that are submitted through general “Parent” FOAs.   

  • Begin searching active FOAs in your scientific field in the NIH Guide for Grants and Contracts or on the Web sites of specific Institutes/Centers (ICs), which list program announcements and requests for applications with associated FOAs that reflect their respective research priorities and initiatives.  The NIH Guide allows searches by scientific area of research, grant mechanism, or specific IC. 
  • ICs can have overlapping research priorities and multiple ICs may sponsor a particular FOA. It is important to look at the FOA to verify which ICs participate, as not all ICs support the same grant mechanisms and programs.
  • If you do not see an FOA specific to your area of interest in the NIH Guide or on an IC Web site, use one of the “Parent” FOAs to develop an investigator-initiated application. 
  • Read the FOA carefully for any special review criteria or special application instructions before writing your application. Take a second look at the funding opportunity announcement!  Be sure to follow the instructions in the FOA and in the application guide carefully.

NIH Mission

Examine the NIH’s scientific mission and goals at About NIH. Consider carefully whether your proposed project fits within the NIH mission. Explore potential ICs that might support your application. Each has its own mission, scientific goals and objectives. Your application should address the mission and research priorities of the Institute or Center likely to fund your application.

NIH & You:  Making Contact
If you have questions about any part of the grants application process, NIH has answers. Be sure to contact the NIH prior to submitting an application. Here are some suggestions before you contact NIH:

  •  As you identify the NIH IC that supports research in your area, check the IC’s Web site to determine whether your idea matches any of the IC's high-priority research areas and for 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 (PO) 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 Request for Applications (RFA) or Program Announcement (PA). 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. Contacts may be found on the IC Web sites, in FOAs, or on the general list of contacts.
 Once you consider how much time and money your project will require to implement and complete, speak to a PO regarding the most appropriate type of funding mechanism.

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Developing a Strategy

Planning on Your Own
Start by determining what type of application may work best for your research. For example, are you seeking support for research training, or support of your experimental research? What area of research will you be conducting? Remember that you are just starting to plan your application, so you don’t need specific details yet, just a broad scientific concept.

Review what it is you hope to achieve in relationship to your field and your resources.

Be realistic about the time it will take to complete each aspect of the application process and plan accordingly. It can take a significant amount of time to get organized, refine your ideas, collect preliminary data, write the grant application, obtain institutional approval for your budget, and approval for working with human subjects or animal subjects, etc. Develop a realistic timeline that includes draft application deadlines, and give yourself enough time to meet them.

Good organization and planning will help ensure a competitive edge and most likely result in a strong application that has the merit to justify NIH funding.

Planning within Your Organization
Set your own internal deadlines and work together with individuals in your organization.

  • Meet with your Office of Sponsored Research (or central grants support office) early in the process. Give them an idea of the type of grant mechanism you are considering and budget.  This office can help guide you through the application process and can inform you of any institutional deadlines you must meet.  They can also provide specific advice on developing your application, especially the budget.
  • Plan your own timeline to ensure you get your application to your Office of Sponsored Research on time, especially when collaborating investigators are involved.
  • Become familiar with all of your institution’s players, procedures, processes and requirements.  For example, whether you are planning for an electronic submission or a paper application, you must know your organization's key contacts and internal procedures for submitting an application.
  • Experienced staff at your institution can be very helpful.  If at all possible, find someone 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.
  • Allow time for equipment failures and any unforeseen circumstances that may arise.

Select the Right Type of Grant Program
Applying to the right type of grant program will help improve your chances of getting funded.  Use the information on NIH grant programs to help identify the most appropriate funding opportunity announcement (FOA) for your project. 

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Determining 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 and some PARs (Program Announcements with special receipt, referral and/or review consideration) have special receipt dates indicated in the FOA.

Some applications must be postmarked by a specific date, while other applications must be received by the specified date.  The Standard Due Dates for Competing Applications should be referenced for the latest requirements.

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Registering and Obtaining Approvals from NIH

Required Registrations
In order to apply to NIH for funding, both you and your organization will need to be registered with the electronic systems that are involved in receiving and processing your grant applications, Grants.gov and the eRA Commons. Regardless of whether your application is submitted electronically or by mail, as PD/PI, you will need an eRA Commons Account to monitor its status in the application process.

Organizational Registration Requirements

Organizations should allow at least four to six weeks to complete all registrations. 

  • DUNS Number: Your organization will need a Data Universal Numbering System (DUNS) number, an identifier government vendors need to register their organization in the System for Award Management (SAM) so they can apply for a federal grant.
  • SAM is a free website which consolidates Federal procurement systems and the Catalog of Federal Domestic Assistance. Currently CCR, FedReg, ORCA and EPLS have been migrated into SAM.gov.  SAM registration is necessary to submit applications to Grants.gov.
  • Grants.gov: Registration Required.
  • eRA Commons: Registration Required.

Principal Investigator Registration Requirements

eRA Commons: PI/PDs should ensure that the applicant organization creates an eRA Commons account for you at least one month before the application is to be submitted.  Ask your eRA Commons signing official (SO) to register you and associate your profile with your organization in the system. (This individual is typically someone in your central grants office.)

  • Designating an Assistant in the Commons: Once your own Commons account is set up, you have the option to delegate a Commons account holder to an assistant role (ASST) so he or she can view the status of your electronic applications. The person in the assistant role sees the same information as the signing official -- he or she can review errors and warnings and can see the application image, but cannot view the summary statement. For more on how to assign the assistant role, read the May 1, 2007 NIH Guide Notice.
  • Identify your organization's authorized organizational representative (AOR). Your AOR might be the same person as your signing official.  Only the AOR can submit your application to Grants.gov. Keep in mind that Grants.gov’s use of the term “applicant” refers to your organization.

Obtain Required Prior Approvals from the NIH

  • If your budget is going to exceed $500,000 in direct costs for any year of the project, 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.
  • Prior approval is required for conference grant applications. The support of scientific meetings is highly contingent on the scientific interests and priorities of the individual ICs, as well as on the level of investment that each determines is appropriate. Therefore, a conference grant application is required to contain a letter from the appropriate NIH staff documenting advance permission. Investigators are urged to initiate contact well in advance of the application receipt date. Note:  An agreement to accept an application does not guarantee funding.

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Additional Planning Considerations

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. A detailed budget is most useful for planning purposes and reference. It will assist you in managing your project.

Collaborators
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.
  • If you have identified collaborators, you will need to include letters of commitment in your application that clearly state their roles. The grant application should contain a signed letter from each collaborator to the applicant that lists the contribution he or she intends to make and his or her enthusiasm for the work. These letters are often crucial information for the reviewers.
  • 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.
  • For consultants, you will need to include letters that reflect the rate/charge for consulting services.
  • Consider a Multiple PD/PI Model:  If your work includes multidisciplinary efforts and collaboration where a team science approach could be more effective, then you should consider the 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. Therefore, as with the preparation of any research proposal, it is essential that you consider all aspects of the funding mechanism before submitting an application. 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?

  • Determine whether you qualify as a new investigator based on the NIH definition of new investigator. NIH offers funding opportunities tailored to new investigators, such as the NIH Director's New Innovator Award. More information on NIH programs designed for new investigators can be found on the New Investigators Program Web page.
  • It is to your advantage to identify yourself as a new investigator because reviewers are instructed to give special consideration to new investigators. Reviewers will give greater consideration to the proposed approach, rather than the track record.
  • First-time applicants may have less preliminary data and fewer publications than more seasoned investigators, and NIH reviewers understand this. Reviewers instead place more emphasis on how the investigator has demonstrated that he or she is truly independent of any former mentors, whether he or she has some of his or her own resources and institutional support, and whether he or she is able to independently lead the research. 

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, centers, 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 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.

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

  • Institutional Approval for Research Using Human Subjects:

    Does your proposed research involve human subjects? The 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

    Does your proposed research use live vertebrate animals? 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.
Once you’ve completed the planning phase, you’re ready for your next step: writing your application


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