How to Request a 118 Letter (Click Here)

The 118 Letter

The “118 Letter” is a memo from the IRB Office that your protocol is under review, but has not yet been fully developed.  This will allow NSF to release your funds while you finalize your IRB submission materials.

Sometimes investigators require IRB approval in order to submit an NSF proposal. Most researchers will request a 118 letter from the IRB for their proposal. Once they receive the grant funding, they will submit the IRB initial application. For your reference, a description of 118 letters is below and can be found here.

45CFR46.118 – Applications and proposals lacking definite plans for involvement of human subjects

Certain types of applications for grants, cooperative agreements, or contracts are submitted to Federal departments or agencies with the knowledge that subjects may be involved within the period of support, but definite plans would not normally be set forth in the application or proposal. These include activities such as institutional type grants when selection of specific projects is the institution’s responsibility; research training grants in which the activities involving subjects remain to be selected; and projects in which human subjects’ involvement will depend upon completion of instruments, prior animal studies, or purification of compounds. Except for research waived under §46.101(i). or exempted under §46.104 no human subjects may be involved in any project supported by these awards until the project has been reviewed and approved by the IRB, as provided in this policy, and certification submitted, by the institution, to the Federal department or agency component supporting the research.

In short, the regulations allow you to secure your grant funding now, even if your specific plans for human research aren’t finalized yet. This applies to projects where you know you will work with humans eventually, but the specific details (like surveys or recruitment plans) are still being developed.