If you’re applying for grant funding, you may be asked to provide certification of IRB approval before the Notice of Award (NOA) will be released. This requirement may mean that you need IRB approval before you have your funding and/or before your study is fully developed.
Recently the IRB has heard from multiple researchers across campus who need these rapid certifications as a final requirement for their grant. These requests are often part of the materials you need to provide as part of “Just-in-Time” requirements for grant applications submitted to the NIH or NSF, and are typically due back to the grant administrator in thirty (30) days or less.
The IRB has a process in place to support these rapid approval requests, but timing is critical to allow the IRB as much review and processing time as possible.
STEP 1: Contact the IRB. Email the IRB to alert us that you need IRB assistance to complete your JIT requirements.
Include a copy of your email award notification showing the date your IRB approval is due to the grant administrator or program officer. The IRB will assign your request to a member of the IRB staff for consideration. Please watch for communications from your reviewer in case additional information is needed during this process.
The IRB recommends you promptly contact your grant administrator and request an extension of the deadline to submit JIT materials if the date is in less than thirty (30) days.
If your study is multi-site and will be subject to single IRB (SIRB) requirements, you can request a SIRB fee quote via a Reliance Consultation Request form.
STEP 2: Wait for Instructions from the IRB.
We will work with you to determine the most appropriate way forward to satisfy your grant application requirements. We may be able to give you a letter of support, or provide you with options for submitting your ERICA application.
If your study is in the early stages of conceptualization and you are not quite ready to submit a full application, but need IRB approval, we can help you. We may offer an application pathway “Concept Only”, which should only be submitted after consultation with the IRB staff. After you have contacted us with your JIT information from STEP 1, we will follow up and let you know if your study qualifies for a Concept Only approval for now, or if you need to complete a full IRB application.
If you qualify for Concept Only review, you will need to follow our guidance for Concept Only Approval Applications, which the IRB staff will provide to you via email. Depending on how quickly you need certification of IRB approval, we may recommend you complete a simplified version of a traditional application that focuses on meeting the basic IRB criteria required for grant certification.
Please note the following limitations:
- Concept Only Approval does not authorize enrollment of human subjects or the conduct of research activities involving participants.
- The application will not be sent for ancillary committee reviews, with the exception of Conflict of Interest (COI) review.
- Recruitment materials and consent documents will not be reviewed or approved.
- No waivers or vulnerable population determinations will be granted.
- The application cannot be amended, except to add key personnel if required by the grant administrator.
- Concept Only Approvals cannot be renewed and will be closed once you receive either a Notice of Award or notification that the grant was not funded.
- If you decide to proceed with the study after funding is awarded, you must submit a new New Study Application for IRB approval.
Read more about the NIH’s JIT procedures on their website: