IRB Application Instructions - 45 CFR 46.118 Designation

Help Information

  • A 45 CFR 46.118 designation is a determination that is used for certain types of applications for grants, cooperative agreements, or contracts that may be submitted to federal 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.

  • If a 45 CFR 46.118 designation has been made by the MSU IRB for this study, answer "yes" and provide the MSU IRB# assigned to the project. If not, answer "no."

  • See HRPP Manual Section 8-4, 45 CFR 46.118 Designation for requirements

Helpful HRPP Manual Sections

Question Number

  • Initial Application (Exempt) - Question 4

  • Initial Application (Expedited and Full Board) - Question 4