This standard operating procedure (SOP) includes the following sections: Purpose, Procedure, Contacts, and Links.
Purpose
To ensure that applicants send information NIAID needs to issue grant awards.
Procedure
Just-in-time refers to information that NIH requests after an application has been peer reviewed and is within a range of possible funding.
Receiving a just-in-time request does not guarantee or indicate in any way whether an applicant will get an award.
Information required after review includes other support, certification of institutional review board (IRB) approval, certification of institutional animal care and use committee (IACUC) approval, and a letter to document training in the protection of human subjects.
Though required just-in-time, you may include IRB or IACUC review and training documentation with an application. Send them together, not separately.
A different rule applies for other support information. If you send it before we request it, NIH may delay processing your application or return it without initial peer review.
If a human or animal assurance number changes after initial submission, the new number and approval date will be required just-in-time. Also, if you are using human embryonic stem cells (hESC) and did not identify an hESC line from the NIH Human Embryonic Stem Cell Registry in your application, you must do so just-in-time.
Grants management specialists request just-in-time information directly for applications that are likely to be funded. Refer to Sample NIAID Request for Just-in-Time Information.
Get more information and advice at Respond to Pre-Award Requests (“Just-in-Time”).
Investigators
- Give your just-in-time information to your institutional business official, who signs and submits the materials when funding is likely or at NIAID's request.
- For human subjects applications, provide the following information for each person identified under key personnel:
- Federalwide Assurance number. If your institution doesn't have one, it must file an assurance with the Office for Human Research Protections (OHRP).
- IRB approval of all NIH-supported non-exempt human subjects research (i.e., protocols).
- Letter to document training in the protection of human subjects. Check a Sample Letter to Document Training in the Protection of Human Subjects.
- For more information, check the Human Subjects Resource SOPs.
- For vertebrate animal applications, provide the assurance number, IACUC approval with date, and any IACUC-imposed changes.
- If your institution does not have an animal welfare assurance, it must file one with the Office of Laboratory Animal Welfare (OLAW).
- Read more in the Animals in Research SOPs.
- For applications involving human embryonic stem cells, identify the hESC line from the NIH Human Embryonic Stem Cell Registry.
- For all applications, include other support information. Check Respond to Pre-Award Requests (“Just-in-Time”).
- For all applications, provide any other information requested by the NIAID grants management specialist.
- For conference grant applications that are recommended for funding, applicants must provide a Plan to Promote Safe Environments and include how it will be communicated to all conference/meeting attendees. For more information about what to include in the plan, refer to Safety Plan under Developing Your Conference Grants Application on the Conference (R13) page.
- For human subjects applications, provide the following information for each person identified under key personnel:
- Promptly notify NIH of any substantive changes to previously submitted just-in-time information up to the time of award, including changes in principal investigator (PI) or key personnel status or the use or approval of vertebrate animals or human subjects
Institutional Business Officials
- Check the just-in-time notice for deadlines and special instructions.
- Submit just-in-time information after receiving a just-in-time notice. Send files in PDF format through the just-in-time feature of the eRA Commons Status section.
Program Officers
- Review just-in-time information and document your approval on the Program Officer Checklist. For further details, see the Program Officer Checklist SOP.
- Work with the PI and grants management specialist on restrictive award terms. See the Bars to Grant Awards SOP.
Grants Management Specialists
- Review the information in the IMPAC grant folder.
- Consider information to be current up to 120 days after submission.
- After 120 days and for applications that will be funded, check with grant recipients to ensure that just-in-time information is valid.
- If any information is incomplete or out of date, contact the recipient institution.
- If additional information is required, email a just-in-time request to both the PI and the business office. Check Sample NIAID Request for Just-in-Time Information.
- Give a deadline for submission. Refer to the Grants Fiscal Year Timeline for Staff when assigning your deadline.
- Earlier in the fiscal year, give recipients a longer turnaround time.
- As the end of the fiscal year approaches, make sure your deadline allows NIAID at least a few days to process just-in-time information before September 30.
- Copy the program officer when you send the request.
- If an applicant has not submitted information to address summary statement concerns and unacceptable human subject codes (e.g., sex or age), request it with the just-in-time information. Applicants must follow NIH’s Inclusion Policies for Human Subjects.
- Contact the PI and the business office if they miss the submission deadline for their just-in-time information.
- Work with the applicant and program officer to resolve any issues with other support (e.g., scientific or budgetary overlap, time and effort exceeding a total of 100 percent).
- Issue a restricted award at the end of the fiscal year if time doesn't allow an applicant to submit just-in-time information.
Contacts
Use the contacts listed above for questions about your specific situation. If you have a general question or a suggestion to improve this page, email the Office of Knowledge and Educational Resources at deaweb@niaid.nih.gov.
Links
OLAW and Institutional Animal Care and Use Committee tutorial
Respond to Pre-Award Requests ("Just-in-Time")
eRA Commons—Submit Just-in-Time