IRB review and approval is required before a HUD can be used for clinical care. You can refer to HRP-323 – WORKSHEET – Criteria for Approval HUD for additional information regarding the criteria that the IRB uses to review and approve HUD uses. This worksheet also includes criteria for informed consent. The clinical use of a HUD is not considered Human Research but must still be submitted for review and approval by the IRB prior to clinical use (with the exception of emergency use, which should follow the emergency use process).