The time just after the NIH review councils meet is one of anticipation for NIH applicants. Was my application selected for funding? Investigators eye their emails closely and then – there it is! A request for Just in Time (JIT) information!
While receiving a JIT request is a good omen, by no means should it be taken as a given that an award is forthcoming. What follows is a summary of the award process before the Notice of Award (NOA) is fully released, to hopefully demystify the process somewhat.
The first JIT request is automatically generated by the NIH system for applications that receive scores of 30 or less. For some Institutes and Centers (I&C) that range can be outside of their paylines.1 This is one of the reasons why an initial JIT request should not be construed as an intent to award. The score given to an application during the initial peer review process is important, but it is not the sole factor determining an I&C’s funding decision. Other considerations are portfolio balance, public health needs, programmatic relevance, I&C priorities, requirements specified in congressional appropriations, and availability of funds.
Your specific I&C will also send out a request for JIT. The I&C request will often contain a more detailed request for information than the automatically-generated did. The Program Officer (PO) and Grants Management Specialist (GMS) will review the submitted items and will correspond with the applicant until all items are addressed satisfactorily.
Documents commonly requested as part of JIT
The JIT documents requested from an applicant vary depending on the proposed science and specific conditions stipulated by the I&C.
Other Support documentation is required for each person designated as key personnel. The form captures details about funded and in-kind activities, including the amount of effort dedicated to each. The purpose of Other Support is for NIH to confirm that key personnel have the proposed effort available to dedicate to the proposed project. Additionally, in Other Support key personnel can address how any overlap between the proposed project and other current or pending projects will be managed.2
Studies involving human subjects will be required to provide documentation of IRB approval as well as human subjects education certificates for key personnel. Similarly, studies involving animal, embryonic stem cells, or genomic data will be required to submit specific assurances before NIH will release the Notice of Award.
NIH I&Cs can impose additional restrictions depending on certain circumstances. Below we share an anonymized example of restrictions placed on an investigator’s NOA. Investigators should prioritize addressing any NIH restrictions and requests promptly so that the award is able to carry out all study activities.
Before the start of recruitment, PI will provide to the [I&C] Program Official a timeline of projected participant accrual, randomization, retention, and completion of intervention.
Recruitment for this award is restricted until a PI provides to the [I&C] Program Official a timeline for data analysis and manuscript preparation. Funding for the last nine (9) months of the award should be confined to support data analysis and manuscript preparation activities only. If data analysis and manuscript preparation plan is to be updated during the study, an updated plan must be submitted to and approved by the [I&C] Program Official prior to implementation.
Just in Time information must be sent by the organization’s business official via eRA Commons since this is the official method of communication. After you submit the JIT, the program officer reviews it. If there are any remaining questions, they will reach out to you to discuss them with you and the grants management specialist. If all issues are addressed satisfactorily, the NOA will be released.
As we mentioned previously, an investigator should address all NIH inquiries promptly to avoid delays in receiving the NOA. Additionally, NIH staff are instructed to process all awards prior to the end of the federal fiscal year, September 30th. Delaying responses could potentially jeopardize funding.
Do you have any questions that you would want us to answer in a future post? Let us know!