Just in Time (JIT) Requirements

What is JIT and what is required for a JIT Request?

NIH uses Just-in-Time procedures for certain programs and award mechanisms (each FOA will include specific guidance on the use). These procedures allow certain elements of an application to be submitted later in the application process, after review when the application is under consideration for funding. The standard application elements include other support information (both active and pending) for senior/key personnel; certification of IRB approval of the project’s proposed use of human subjects; verification of IACUC approval of the project’s proposed use of live vertebrate animals; and evidence of compliance with the education in the protection of human research participants requirement. Other program-specific information may also be requested using this procedure.

Applicants will be notified (primarily by e-mail) when JIT information is needed. This notification is not a Notice of Award nor should it be construed to be an indicator of possible funding. Applicants should only submit this information when requested. Information must be submitted electronically using the JIT feature in eRA Commons.

The requirement for applicants to verify the accuracy and validity of all administrative, fiscal, and programmatic information extends to information submitted through the JIT process. Applicants are responsible for promptly notifying NIH of any substantive changes to previously submitted JIT information up to the time of award. This includes items such as Other Support changes that could lead to budgetary overlap, scientific overlap, or commitment of effort greater than 12 person-months for the PD/PI(s) or any Senior/Key Personnel; or any changes in the use or approval of vertebrate animals or human subjects. Failure to address changes to JIT submissions prior to award does not diminish the applicant’s responsibility to address changes post-award by submitting a prior approval request to NIH in accord with Administrative Requirements-Changes in Project and Budget-NIH Standard Terms of Award.

Just In Time is an NIH specific term however Yale uses JIT generically across all sponsors to describe any request for additional information after a proposal is submitted, but before an Award is made. JIT information is always handled by the OSP Proposal Manager.
 

Other Support Information on other active and pending support will be requested as part of the JIT procedures. Other support includes all resources made available to a researcher in support of and/or related to all of their research endeavors, regardless of whether or not they have monetary value and regardless of whether they are based at the institution the researcher identifies for the current grant.

Visit the Other Support page for full requirements and further information.

If your proposed project includes an outgoing subaward/s, you must also provide Other Support documentation for all key personnel identified by the Subrecipient. Other Support from external entities must be electronically signed by the individual, but do not require any audit trail or additional confirmations as to the validity of the signature. That will be managed by the external entity.

Other Support documents that include foreign activities and resources, recipients are required to submit copies of contracts, grants, or any other agreement specific to senior/key personnel foreign appointments and/or employment with a foreign institution as supporting documentation. If they are not in English, recipients must provide translated copies.

If the proposed project involves research with live vertebrate animals, verification of the date of IACUC approval of those sections of the application that involve use of vertebrate animals along with any IACUC-imposed changes must be submitted. Pending or out-of-date approvals are not acceptable.

If your project involves the use of animals, the research must have IACUC congruency approval. In addition to protocol approval, the IACUC is required to confirm that the research described in the proposal for funding is consistent with the research described in the IACUC approved protocol – this is referred to as “protocol-proposal congruency”.

Visit the Request a Congruency Review for JIT page for further information.

If your proposed project includes an outgoing subaward/s and Animal Subject use is identified on the Subrecipient Information and Compliance form, IACUC approval documentation from the external entity must be provided to the Department Business Office.


 

If the proposed project involves human subjects research, a certification to NIH that all non-exempt human subjects research has been reviewed and approved by an appropriate IRB must be submitted. Pending or expired approvals are not acceptable.

If your project involves the use of human subjects, and you do not have an IRB Protocol in place, follow the guidelines.

It is recommended that you include a cover letter with your JIT materials stating that the IRB approval is pending and will be provided as soon as possible.

If your project involves the use of human subjects, and you have an existing IRB Protocol in place, a modification/update needs to be submitted in our IRES-IRB System for a JIT congruency request and to add federal funding to the study.

You will need to submit a Modification/Update in IRES IRB to add the Federal funding. Please specify in the Mod. Summary that it is a JIT/Request for congruency and include the funding source and IRES Number. Please note when it is needed by so it can be triaged appropriately.

Please add the new Funding Source in IRES IRB to the Funding Sources screen under option #1. If the new funding requires changes to your protocol please upload the modified, track changed version to the Basic Information screen in IRES IRB. Please see page 8 of the submission guide for directions on how to add funding.

Please be sure to select the final submit button so that the submission goes into Pre-Review state and into the HRPP Inbox. Once submitted, please email michele.antisdel@yale.edu to notify her of this submission and be sure to include the IRES-IRB action number.

If you have any questions on this, please contact hrpp@yale.edu.

If your proposed project includes an outgoing subaward/s and Human Subject use is identified on the Subrecipient Information and Compliance form, IRB approval documentation from the external entity must be provided to the Department Business Office.

If your proposal indicated a Single IRB (sIRB) will be used, please provide a cover letter to include a statement naming the sIRB of record.

If your proposal is being considered for funding by AHRQ, and you did not submit an sIRB Plan with your application submission, please include a copy of the sIRB Plan with your JIT materials.

Visit the sIRB for Multi-Site Research page for further information regarding sIRB.

If the proposed project involves human subjects research, certification that any person identified as senior/key personnel involved in human subjects research has completed an education program in the protection of human subjects must be submitted.

Human Research Training requirements can be found on the Human Research Training page.

Certificates must be current and within 3 years of completion at time of JIT submission.

If the proposed project involves a genomic data sharing plan for the generation of human genomic data, investigators must submit an Institutional Certification, or, in some cases, a Provisional Institutional Certification. Institutional certification forms and directions for completing them are available on the NIH website.This certification should be submitted as a “Genome Data Sharing Certification” in the eRA Commons Just-in-Time module.

For questions regarding the IRB GDS Assurance request, please email HRPP@yale.edu or call 203-785-4688.

For all applications, the eRA Commons JIT link will appear on the Status screen within 24 hours after the impact score has been released. Additionally, NIH issues Just-in-Time emails for all applications that receive an overall impact score of 30 or less. However, applicants should not submit any JIT information until a specific request for information is received via email from the system and/or grantor agency.

You should work with your PreAward Departmental Business Office (DBO) to compile all requested information. Materials will be uploaded to eRA Commons. Further information on how to upload.

Once uploaded to eRA Commons, the DBO will notify your OSP Proposal Manager to review and submit to NIH.