Section 118 Determination
Request for HSIRB 118 Designation
[Reference: 45 CFR 46.118]
Use this form when your research project involves applications for grants, cooperative agreements or contracts, with the knowledge that human subjects may be involved within the period of support, but definite plans would not normally be described in the applications or proposal. This form may also be used for a sponsored project when the study will involve research with human subjects for which the protocol is not yet fully developed. This form may serve as a notification of a project that may involve human subjects but the specifics are not yet known. Note that a separate protocol with the specifics must be submitted to the HSIRB for review and approval before work with human subjects may begin.