“Can a physician submit a single humanitarian use device (HUD) submission to the IRB; or does a site need to submit an IRB application for each physician at the site authorized to use the device? If a single IRB application can be used, would changes to the list of authorized physicians at the site require review by the convened IRB?”
Independent Research Center


WCG IRB approves HUDs for clinical use for the facility not the individual. A single application may be submitted to the IRB. You will need to designate a principal investigator (PI) who is responsible for use of the HUD at that facility. The PI must be a licensed medical doctor. The submission does not need to include a list of all the investigators authorized by the site to use the HUD.

A change in the PI responsible for use at that facility requires review and approval by the IRB. That change would likely be eligible for expedited review. However, some changes in research may require review by the convened IRB, for example, if the PI had a conflict of interest with the device manufacturer or an administrative action related to medical licensure.


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