How do I submit a request to use a Humanitarian Use Device (HUD) for clinical use?
This Institution utilizes the IRB to review and approve HUDs before they are used at a facility for clinical care. Refer to WORKSHEET: Criteria for Approval HUD (HRP-323) for additional information regarding the IRB's criteria to review and approve HUD uses. The clinical use of a HUD is not considered Human Research. However, it must still be submitted for review and approval by the IRB before clinical use (except for emergency use, which must be reported to the IRB within five days). The IRB does not require a research informed consent form for HUD use.
Complete the new submission in the eIRB+ system and attach all requested supplements. The PI should click the “Submit” activity. Maintain electronic copies of all information submitted to the IRB.