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Division of Epidemiology, Services and Prevention Research (DESPR)


Guidance for Applicants

NIH Grant Application Process

All grants should be submitted according to the procedures described in the Federal Funding Opportunity Announcement (FOA) to which you are responding. Normally applications are submitted via electronic submission through Grants.gov using the Federal-wide Standard Form 424 - Research and Research Related (SF424 (R&R)). Applicants should take careful note of the submission schedule in each FOA as these dates are fluid. Paper applications will be accepted only for mechanisms when no electronic submission form or method (other than the SF 398) is specified.

Applicants should always refer to the funding opportunity announcement (e.g., Program Announcement/PA or Request for Applications/RFA) to obtain guidance on applying and the correct forms to use. For research project grants using the R01, R03, and R21 mechanism, "Parent" (i.e., generic) PAs are published to offer guidance for applications not addressing a focused NIH priority.

One-time registrations for both Grants.gov/GetStarted and eRA Commons systems must be completed by the applying organization before application submission. These are two distinct systems with separate registration requirements.

Grant.gov

  • The initial registration process can take several weeks. Start early to avoid delays! NIH recommends that new applicant organizations start the registration process at a minimum four weeks ahead of your target submission date.
  • Applicant organizations must register both in Grants.gov and in NIH's eRA Commons.
  • All Principal Investigators (PIs), including multiple PIs, need to be registered in the role of PI once their organizations are registered with Grants.gov.
  • The PI must hold a PI account and be affiliated with the applicant organization in the eRA Commons. PIs may not access grant information if they are only registered in Commons as reviewers or in some other, non-PI category.
  • Both the Principal Investigator (PI) and the applicant organization's Signing Official (SO) need separate accounts in eRA Commons because both need to verify the application. NIDA does not permit PIs to serve as SOs for the same grant.
  • Organizations must include their DUNS number in their Commons profile that matches the DUNS number to be used on the submitted applications.
  • Grants.gov and eRA Commons registration processes may be done concurrently.

All grants should be submitted according to the procedures described in the Federal Funding Opportunity Announcement (FOA) to which you are responding. Normally applications are submitted via electronic submission through Grants.gov using the Federal-wide Standard Form 424 - Research and Research Related (SF424 (R&R)). Applicants should take careful note of the submission schedule in each FOA as these dates are fluid. Paper applications will be accepted only for mechanisms when no electronic submission form or method (other than the SF 398) is specified.

FOLLOW ALL INSTRUCTIONS CAREFULLY! Each funding opportunity announcement (program announcement/request for application (PA/RFA)) includes an application package with an application guide (sample guide). This document is critical to submitting a complete and accurate application to NIH. There are fields within the SF424 (R&R) components that are not marked as mandatory on the federal-wide form but that are required by NIH. For example, the Credential field of the R&R Senior/Key Person Profile component must contain the PI's assigned eRA Commons User ID. Agency-specific instructions for such fields are clearly identified in the application guide. The FOA to which you are applying also may include guidance on application submission. Taking advantage of these resources will save you time in the long run by avoiding the need to correct errors and resubmit your application.

GET INFORMED! NIH is using the Electronic Submission website, http://era.nih.gov/ElectronicReceipt/, as its primary tool for communications. The site is continually updated to provide you with the latest information and answers to your questions.

  • Look at the timeline to determine when the transition impacts research grant programs of interest to your organization and learn about the new submission process. (Note that only Authorized Organization Representatives (AOR) (i.e., Signing Officials (SO)) can submit applications to Grants.gov.)
  • Take advantage of our training resources

    • Training Session. NIH will host a training session at the Natcher Conference Center in Bethesda, MD, on January 11, 2006. NIH is offering this train-the-trainer opportunity as a way to reach individual institutions in an interactive format. There is space for 1,000 people to attend in person; others can access the conference remotely free of charge through VideoCast, NIH's streaming video service. Registration and information on this training opportunity are available at: http://era.nih.gov/training/ElectronicSubmission/.
    • SF424 (R&R) application guides, sample application packages and related resources at http://grants2.nih.gov/grants/forms.htm.
    • Grants.gov: How to Complete an Application Package Demo.
    • eRA Commons Registration training demo.
    • Video Library. Professionally taped video training library, including: An Overview of the Electronic Application Transition Process and A Walk through the SF424 (R&R).
  • Demo facility. By next spring, we plan to have a demo facility for applicants to "practice" the entire process from finding an opportunity in Grants.gov through verifying a submitted application in the eRA Commons.
  • Check out the Tips and Tools resources to avoid common application submission errors.
  • Get support. NIH has several support teams ready to answer the questions and concerns not covered on the website.
  • Monitor announcements. We encourage you to monitor the NIH Guide for Grants and Contracts. It continues to be NIH's definitive resource for policy and funding opportunity announcements.
  • Early submission is encouraged. The electronic system requires applications to follow NIH business rules. Allow time for potential error corrections and the required application verification step by the AOR/SO and PI.

New Investigators

NIH is very welcoming of new investigators regardless of career stage. Applying to NIDA for an NIH grant can be a daunting and tortuous process even for experienced grant awardees. In 2008, NIH enhanced its commitment to advantage applications from new and early stage investigators (ESI). New PIs are those applicants who have not previously been awarded an R01 grant even though they may have had R03 or R21 awards as PIs. ESIs are defined as new investigators whose terminal research degree or medical residency was completed less than 10 years ago. ESI applications will be reviewed separately with new investigators. ESIs will enjoy an accelerated revision cycle. NIH summarizes its policies to support new and ESI applicants on its website.

There are various special support resources available to ESI status applicants which can be found on a special new investigator website. In addition, The National Institute of Allergy and Infections Diseases provides comprehensive advice for investigators at any level. It is sufficiently generic to be useful in applying for grants in any NIH institute or center.

Human Subjects Protection and Inclusion Policies

NIH grantees must adhere to various policies intended to promote the ethical execution of research that supports the nations public health. Below are links to major information sources on the web that address human subjects and inclusion policies that affect grants typical of those in DESPR's portfolio.

Data and Safety Monitoring Guidance

NIH grantees must establish written guidance on procedures for ensuring the safety of participants in clinical research in order to avoid, detect, intercede, and remedy any harm that might occur incident to a research project.

  • Plans for Phase I and II clinical trials
  • Plans for Phase III clinical trials
  • NIDA guidelines for developing Data Safety Monitoring Plans and Boards

Budget Regulations

NIH grantees must use public funds in an appropriate and ethical manner. There exist limits on principal investigator discretion, caps on amounts that can be spent for various purposes, and rules for the carry over of unspent funds to subsequent periods of research:

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