Mayo Clinic serves as the IRB of record.

The Mayo Clinic IRB serves as the central IRB for this study in the United States at the request of the U.S. Government.

As part of the EAP, you and your hospital need to rely on the Mayo Clinic IRB for this Expanded Access Program) protocol. In accordance with 45 CFR 46.103(e), agreeing to participate in the program by registering on serves as documentation of each participating institution’s reliance on Mayo’s IRB.

A separate IRB reliance agreement is not required. The Mayo Clinic IRB is a nationally recognized IRB that is accredited by the Association for the Accreditation of Human Research Protection Programs.


You must complete this form to register as a local physician/PI including the Statement of Investigator FDA 1572.

You will recieve a confirmation email after completing the registration for record keeping to the email provided.

Additional information is available at

If you have any questions please email, which will be monitored from 7am-7pm CST.

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