Section 118 Determinations

A “Section 118 Determination” (or “118 Determination”) refers to 45 CFR 46.118, a provision of the Common Rule which permits the IRB to certify that certain grants, agreements, or contracts have been awarded with a human subjects research component, but plans for the involvement of human subjects (participants) are not yet definite. These include activities such as training awards where the specific training project has not yet been identified; research training grants in which the activities involving human participants remain yet to be selected, and/or projects in which human participants’ involvement will depend on the completion of instruments/animal studies/additional analyses of food products.

This certification is only appropriate where there is an aspect of the human subjects research that is well into the future planned work for the award, or where there is an indefinite component that is not yet developed, but critical to the IRB review process. A project which contemplates human subjects research from its very beginning is not eligible for a 118 Determination.

If your sponsor requires this determination to release funds to USU or Sponsored Programs requires this determination to set up your index, please fill out the form below. The IRB will review the submitted information and, if appropriate, issue a 118 Determination that contains a due date for IRB approval based on the proposed timeline for the project. You will receive an emailed copy of your submission.