If you’re applying for grant funding, you may be asked to provide rapid IRB approval before your study is fully developed. These requests are often called “Concept Only” or “Just-in-Time” approvals, and are typically due in less than thirty (30) days. These are different from a letter of support, which you can request from IRB leadership via a Reliance Consultation Request form.

The IRB has a process in place to support these requests, but timing is critical. Follow these steps:

STEP 1: Start a New Study Application in ERICA. Follow our guidance for Concept Only Approval Applications. 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.

• 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.
• Concept Only Approval does not authorize enrollment of human subjects or the conduct of research activities involving participants.
• 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.

STEP 2: Contact the IRB Staff. Email the IRB to alert the IRB staff that you have submitted an application for Concept Only approval. Include your ERICA IRB number and the date your IRB approval is due to the grant administrator or program officer. The IRB will assign your application to a member of the IRB staff for review. Your reviewer will contact you to confirm they have received the application and confirm your due date. Please watch for communications from your reviewer in case additional information is needed during this process.