NIH utilizes a “just-in-time” (JIT) process to collect time-sensitive information that is not included in the application. Any application with an overall impact score below 30 automatically receives an email from NIH requesting JIT information through eRA Commons. This automated email is based on the score threshold and is not an indicator that the application is likely to be funded.
However, for applications that are likely to be funded, the PI and Sponsored Research will receive an additional email directly from the specific Grants Management Specialist in the NIH Institute or Center requesting the JIT information. This second email is the most important as it indicates that the NIH Institute/Center is considering the application for funding.
What will a JIT request include?
A JIT Request will include the following (as applicable):
- Current Other Support for all Key Personnel (always required)
- Northwestern’s standard reports in Cognos to prepare Other Support: GA401 - Current Awards and GA402 - Pending Proposals - All Roles
- NIH instructions and format requirements for Other Support
- Institutional Animal Care and Use Committee (IACUC) Approval: If the proposed project involves research with live vertebrate animals, select in eIACUC the appropriate InfoEd record corresponding to the grant or contract that is funding the study. In planning protocol submissions, please note the IACUC requires each protocol to be funded by one grant (or grant subproject if there are more than one PI involved). Pending or out-of-date approvals are not acceptable. If your IACUC submission is still under review, inform your Sponsored Research Officer, who can alert the funding agency. Sponsored Research can submit all other JIT materials while the IACUC approval remains pending. Once the department has confirmed approval, contact your Sponsored Research Officer, who will submit the information to the sponsor. [Note: Sponsored Research does not send interim letters with JIT stating that protocol review is underway.]
- Institutional Review Board (IRB) Approval: If the proposed project involves human subjects research, select in eIRB the appropriate InfoEd record corresponding to the grant or contract that is funding the study. You may also provide Sponsored Research a copy of the IRB approval letter with the NIH grant number as the funding source as soon as the IRB approval is available. If your IRB submission is still under review, inform your Sponsored Research Officer, who can alert the funding agency. Sponsored Research can submit all other JIT materials while the IRB approval remains pending. Once the department has confirmed approval, contact your Sponsored Research Officer, who will submit the information to the sponsor. [Note: Sponsored Research does not send interim letters with JIT stating that protocol review is underway.]
- Human Subjects Education: If the proposed project involves human subjects research, you must submit certification to OSR that any person identified as senior/key personnel involved in human subjects research has completed an education program in the protection of human subjects. This is generally the CITI training certificate.
- Human Embryonic Stem Cells (hESCs): If the proposed project involves hESCs and your application did not identify an hESC line from the NIH Human Embryonic Stem Cell Registry in the application, the line(s) should be included.
- Other Information
- Revised budgets, changes to human subjects or vertebrate animal sections, copies of current F&A Rate Agreement(s), and other statements or assurances
When should I start my protocol submission to the IRB or IACUC?
If your application scores within or near the NIH Institute or Center published paylines or near the previous fiscal year published paylines, as soon as you receive the first auto-generated JIT email request you should begin the protocol submission/amendment process.
When is it a new protocol vs. a protocol modification or amendment?
It will depend on the type of protocol and if the proposed research plan has already been approved by the regulatory committee. See below for details for IRB (human subjects) and IACUC (vertebrate animals) submission requirements.
IRB: Submission Requirements
If the change is only to add a funding source and there is no change in the approved protocol(s), see Modifications: Funding Changes
- If the change includes scientific changes or modifications to an already approved protocol(s), see Preparing a Modification in eIRB+
- If the proposed project has not yet been approved by the IRB, a new submission will be required. See New Study Requirements
Questions for IRB? Email: firstname.lastname@example.org
IACUC: Submission Requirements
- If all procedures in the grant application are approved in the protocol and the only change is only to add a funding source, follow the Protocol Form Amendment Instructions
- If the change includes scientific changes or procedural changes to an already existing protocols, follow the Procedural Amendment Instructions
- If the proposed project has not yet been reviewed by the IACUC, a new submission will be required. Reference eACUC: Click Protocol Guide
Questions for IACUC? Email: email@example.com