Strategy for NIH Funding

Put the Finishing Touches on Your Application   ·   Part 4. Submit Your Application

Prepare Your Just-in-Time Information

Do not wait to prepare the information you will need to send us before we can make an award, called just-in-time. Know what we will ask for and when to send it.

While this document is geared toward the basic research project grant, the R01, much of it is useful for other grants.

Table of Contents

• Just the Facts
  • Get Ready for Just-in-Time
  • Prepare Your Just-in-Time Information
  • Prepare Your Other Support Submission
    • Overlap and Bridge Awards
  • If You Have Human Subjects Documentation
    • Human Subjects Assurance
    • IRB Certification
    • Training Certification
  • If You Have Animal Research Documentation
    • Animal Welfare Assurance
    • IACUC Certification
• Our Advice

Just the Facts

(This section has factual information only; for advice on this topic, go to Our Advice below.)

Get Ready for Just-in-Time

For applications that have overall impact scores of 40 or less, NIH sends an email requesting some information just-in-time. That means you send information when we request it, after initial peer review.

Your business official must submit your just-in-time information through the eRA Commons. Within 24 hours after NIH releases the score, the option to send the information appears in the Commons Status section for all applications (all grant types).

If funding is likely, you will get a request from NIAID, which may include additional items. Your business office should respond as soon as possible to maximize your chance of a prompt award.

Just-in-time information is required as follows.

All applications

• Other support information.

Applications in any of the following areas (unless the information was included in the application)

• Human subjects
  • Federalwide Assurance (FWA) number
  • Certification of institutional review board (IRB) approval of the Research Plan
  • Letter to document training in the protection of human subjects
• Animals
  • Animal welfare assurance number
  • Certification of institutional animal care and use committee (IACUC) approval of the Research Plan
• Human embryonic stem cells
  • Identify an approved cell line from the NIH Human Embryonic Stem Cell Registry.
  • If you want to get approval for a new cell line, read NIAID's How to Get a Human Embryonic Stem Cell Line Approved.

In addition, we may request other items just-in-time, for example, a formal agreement of the terms of a collaboration with an investigator from another institution.

Keep in mind that just-in-time doesn't save you much time. Even though you must wait for our request, you should start preparing your submission early so you don't risk a delay for your award (or worse—see the End-of-year warning below).

Talk to your program officer for funding advice, and keep in mind that a just-in-time request is not a guarantee of an award.

In addition to meeting our request, be sure to ask your business office about your institution's own requirements.

Prepare Your Just-in-Time Information

To see how we ask you for your just-in-time information, go to:

• Sample Just-in-Time Email From NIH
• Sample Just-in-Time Email From NIAID
• How and when will I find out if I need to send information just-in-time? in the Just-in-Time questions and answers

End-of-year warning. We may skip over your application if it comes up for funding at the very end of the fiscal year and your just-in-time submission is not ready. While waiting for you, we are likely funding other applications—and you could lose your chance of funding if we run out of money or time.

When it's due. NIH's email doesn't set a due date. Within two weeks of receiving NIAID's just-in-time notification, your institution's business official should submit your other support and human subjects training information. Your grants management specialist may set a different due date.

You don't need to sign because you have a signature assurance on file with your institution.

Since IRB and IACUC approvals may take you more than two weeks to get, your business official may submit these approvals later.

How to submit. Your business official should submit PDFs through the just-in-time feature of the eRA Commons Status module.

As you must ensure that just-in-time information is accurate and current, notify us promptly of any substantive changes to information you submit before the award, including changes of PI, key personnel, and the use or approval of vertebrate animals or human subjects.

Prepare Your Other Support Submission

After NIAID's request or if your application's score was within or near the NIAID Payline, you will send NIAID a list of your other support, which includes any unfunded applications you have submitted to any organization.

Other supports shows us the following—see the linked glossary term for additional information.

• No other organization is supporting the research you outlined in your Research Plan—scientific overlap.
• Your time is not committed more than 100 percent—commitment overlap.
• You have not requested funding for items paid for by another source—budgetary overlap.

If you have nothing to report, we need a letter stating that fact from your institution's business office.

Overlap and Bridge Awards

Report funding from an R56-Bridge award, and take note of these overlap issues.

• Other support. If you have received an R56-Bridge award from us, include it in your other support information.
• Overlap. Beware of overlap issues that require us to reduce your award, for example:
  • If you list Howard Hughes Medical Institute as other support, we will adjust your funding since HHMI pays 100 percent of salary and fringe benefits.
  • If you are submitting multiple applications to different organizations, read Broaden Your Horizons in Part 7.

Find more information online:

• Sample Format for Other Support in the SF 424 Application Guide
• Your funding opportunity announcement and the accompanying NIH Guide announcement
• Just-in-Time SOP

If You Have Human Subjects Documentation

If you are conducting human subjects research, you or your institution must send us the FWA number, certification of IRB approval of the Research Plan, and letter to document training in human subjects protection.

Send all human subjects just-in-time documentation together.

Human Subjects Assurance

Your institution needs to have an FWA for human subjects on file with the Office for Human Research Protections (OHRP). Typically, it takes OHRP two weeks or less to approve your application, but if OHRP spots a problem, it could take longer.

You can Search the OHRP Database, or ask your institution to see if it already has an approved FWA. Make sure a new assurance number is on file if it has changed since you submitted your application.

If you have a subaward agreement, check that the subaward organization has an FWA and IRB approval as well.

IRB Certification

You must send us a certification of your IRB's approval of your Research Plan, usually by signing a form your institution provides. Unlike the assurance, we need this every year of your project.

Training Certification

If you didn't submit it with your application, send us a letter certifying that each person identified under key personnel has completed training in the protection of human subjects.

Once your grant is underway, you'll need to send the training letter only for new key personnel. Use our Sample Letter to Document Training in the Protection of Human Subjects, and get detailed information on NIH's FAQ.

Find more information on conducting human subjects research at NIAID Human Subjects Application and Grant Handbook and other NIAID Human Subjects Resources.

If You Have Animal Research Documentation

If you're working with research animals, your institution's business official needs to submit an animal welfare assurance number and a certification of your IACUCs' approval of your Research Plan just-in-time.

Animal Welfare Assurance

Your institution must file an animal welfare assurance with the Office of Laboratory Animal Welfare (OLAW).

If you have a subaward agreement, make sure that the subaward organization has an animal welfare assurance and IACUC approval. If the subaward organization has an assurance but your institution doesn't, get an inter-institutional assurance. See Is Your Institution Assured by OLAW? in our How to Write an Application Involving Research Animals tutorial for details.

Your institution can submit the documentation through the Commons or email the signed assurance to olawdoa@mail.nih.gov as a PDF.

IACUC Certification

You will provide a certification of your IACUC's approval of your Research Plan initially and at least every three years, usually by signing a form your institution provides. For more information about getting IACUC approval, go to OLAW's Institutional Animal Care and Use Committee.

Find more information online:

• OLAW
• How to Write an Application Involving Research Animals
• Animals in Research SOPs

Our Advice

(This section has advice only; you should also read the factual information above at Just the Facts.)

When to prepare. A good time to prepare your just-in-time submission is during or right after you finish writing the application.

Putting this off is a mistake. If we need to get your award out quickly (for example, at the end of the fiscal year), we may skip over your application if you cannot get us your just-in-time information fast enough. At any time of year, not being ready can mean a delay.

When to send. Even though NIH's automatic email instructs your business office to start uploading information to the Commons, you shouldn't necessarily start yet. It depends on the situation:

• If there are no published paylines yet or your application scores well outside of the NIAID Payline, wait.
  • Don't upload anything unless NIAID's grants management contacts you.
  • If we do ask for information later, it will be as current as possible.
• If your application scores inside or near the payline, proceed.
  • We encourage your business office to upload the information in NIH's Request for Just-in-Time Information right away.
  • You don't need to wait for notification from NIH or NIAID.
  • NIAID's grants management will contact you later if we need any additional information.

Strategy for NIH Funding

Put the Finishing Touches on Your Application   ·   Part 4. Submit Your Application

See the other sections of
Part 3. Write Your Application

Table of Contents for the Strategy

We welcome your comments, questions, or suggestions. Email deaweb@niaid.nih.gov.