IRB “Pre-Approval” (45 CFR 690.118)

If a PI is working on a grant proposal, and their Program Officer (or granting organization) needs the IRB office to recognize that a human subjects research project is pending for that proposal, there is a way to do that without needing to submit an entire fleshed out research design with consent forms, protocols, etc. The IRB office calls this a “118” (45 CFR 690.118)” Acknowledgment.

The IRB office will publish the “45 CFR 690.118 Determination for a Project Lacking Institutional Review Board Approval.” This document is the IRB office’s way of saying, “We have not approved a full IRB yet, but know an IRB application is coming IF the grant is awarded.”

This acknowledgment will assign the IRB protocol a project IRB Number/ID, which is always great to include in an NSF Proposal on research.gov. NSF Program Officers, in particular, like to see this because it shows that the project is ready to go and can submit all the interview/focus group/data collection protocols, consent forms, analysis plans, etc. when the PI’s proposal gets the grant.

All that is needed is Initial Application Part 1 of the application (PI name, co-PIs if known, an abstract) and a statement that reads something like what is shown below- it doesn’t have to be exact!

“IF funded, this proposed project will require an approved human subjects research plan. This application is to notify the IRB office of the plan to conduct human subjects research, but only after funding is secured.”

Please see the template letter that the IRB Office will sign and send back to the PI (via IRBnet), once they “acknowledge” that human subjects research might happen if funded.