.118 Determination

Summary

46.118 Determinations can be granted to satisfy federal sponsor requirements (e.g., Just-In-Time) to allow investigators to have access to funding to begin aspects of the project that do not involve human subjects.

Full Description

What is the .118 Determination Form?

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.

Human subject research activities cannot begin until a full application and all applicable material (e.g., consents, surveys, tools) have been developed, submitted, and IRB approval (§46.111) has been obtained.

Under the federal regulations (§46.118) certain types of applications for grants are submitted with the knowledge that subjects may be involved, but definite plans would not normally be set forth in the application or proposal. These can fall under three categories:

• 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.

When can this be requested?

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 (more than 90 days from the date of award setup), 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 within 90 days of award setup is not eligible for a 118 Determination. A protocol, Reliance Agreement, or NHSR Determination review must simply proceed.

How to request the .118 Determination Letter? 

Please select the "118 Determination" option on the SPARCS protocol form.