A 118 Designation (or “118 Determination”) refers to federal codes 45 CFR 46.118 (NIH) and 45 CFR 690.118 (NSF), 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. Certain types of applications for grants, cooperative agreements, or contracts may be submitted to federal departments or agencies with the knowledge that human 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 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 (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. Designation under 45 CFR 46.118 is not to be used to delay submitting a human research submission until such time funding is likely. It only applies in circumstances where insufficient information is known about the specifics of the research study. Although the designations are called “45 CFR 46.118 designations,” this designation is also applicable to other agencies’ requirements equivalent to 45 CFR 46.118. The 45 CFR 46.118 designation may also be applied to non-federal sponsors (e.g. foundation, industry) when the 45 CFR 46.118 criteria are met. 
 

A designation under the 118 code may be granted if the following criteria are met:

• Human subjects may be involved within the period of support; 
• Definite plans for human subjects research are not described in the grant proposal;
• An application is being submitted to a federal department or agency;
• The request is for one of the following:
  • Institutional type grants where selection of specific subgrants is the institution’s responsibility; 
  • Training grants where research activities involving human subjects remain to be selected; or 
  • Indefinite projects where human subjects’ involvement will depend on:
    • completion of instruments; 
    • prior animal studies; or
    • purification of compounds; 

and

• Assurance from the PI that no human subjects will be involved in any study supported by these awards until the study is reviewed and approved by the IRB.

If your sponsor requires this determination to release funds to UCR 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. Once an activity is provided a designation under 118, the PI must re-submit the initial study submission to the IRB office for review and approval when definitive plans have been developed. No human subjects may be involved in research until an exempt determination or IRB review and approval has taken place. The 118 designation will be given an expiration date with a limit of up to one year after the date of the designation, by which the PI anticipates human research plans will be definitive enough to submit for review.

Follow these steps to request a 118 designation:

1. Start the process for the IRB protocol (https://ucr.kuali.co) to obtain an IRB# and title. Only the first two pages of the online form need to be completed to obtain this. 
2. Complete and submit a 118 Designation Request Form.