University of Hawai‘i
Research Compliance

Section 118 Designation

  • Undefined Research
  • Institutional (Infrastructure) Type or Training Grants

To Request Approval for 118 Designation (aka Institutional/ Training Grants or Undefined Research):

§46.118 Applications and proposals lacking definite plans for involvement of human subjects.

Certain types of applications for grants, cooperative agreements, or contracts are submitted to 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.

These applications need not be reviewed by an IRB before an award may be made. However, except for research exempted or waived under §46.101(b) or (i), 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 department or agency.

Step One: Apply for 118 Designation

  • If your project meets the description stated above, complete the “Section 118 Designation” Application according to the instructions provided within the form, and submit it with any supporting documents to the Human Studies Program.Section 118 Designation Application Form

Step Two: Keep Track

  • Once you receive an approval letter for 118 Designation of your project from the Human Studies Program, make sure to keep track:
    • For Undefined Research – once the project is ready to involve human participants, you MUST submit a separate application for initial approval (see steps for new protocol or proposal above). You must not start involving human participants in your project until you receive an initial approval for your human subjects research project.
    • For Training / Institutional Type Grants – keep track of all human subjects research sub-studies during its review period (time frame between approval date and expiration date). You will need to provide an annual report of all sub-studies funded by your grant during the review period to Human Studies Program prior to the expiration date in order to renew your 118 Designation.APP 15 – Annual Report for Institutional Type Grants or Training Grants Form