45 CFR 46.118

Certain types of applications for grants, cooperative agreements, or contracts may be submitted to sponsors 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.

Designation under 45 CFR 46.118 is not to be used to simply delay submitting a human research application 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. Requests for a 45 CFR 46.118 designation are made through the ClickTM Research Compliance System.

How to Submit

  1. Complete the HRP-511-Template-Request a 45 CFR 46.118 Determination.
  2. Create and complete a New Study in Click.
  3. Upload the HRP-511 template (Basic Information SmartForm page).
  4. You do not need to upload instruments, consent forms, etc. at this point
  5. Submit the New Study.

For detailed instructions, see the Quick Guides.

Click Templates

  •  Required: HRP-511-Template-Request a 45 CFR 46.118 Determination

Available at the Click Templates page.

Click Quick Guides

  • How to Create, Save and Edit an Initial Study

  • How to Submit an Initial Study

  • Completing the Initial Study - SmartForm Pages

Available at the Click Quick Guides & Videos page.

More Information

For more information, visit HRPP Manual 8-4, 45 CFR 46.118 Designation.