This notification is used by the IRB to initiate tracking to ensure that the investigator files a report within the five day time-frame. The IRB must receive written notification within five working days of the emergency use. Notifications will be reviewed at the next convened Research Review Subcommittee and subsequent IRB meeting. The physician or investigator is required to obtain informed consent of the subject or the subject's legally authorized representative. Any subsequent use of the investigational product requires prospective IRB review and approval.
Subsequent use includes a second use with the first subject or the use with another subject.
The emergency use of an unapproved investigational drug or biologic requires an IND . In such a case, FDA may authorize shipment of the test article in advance of the IND submission. Requests for such authorization may be made by telephone or other rapid communication means. The only exception is a change necessary to eliminate apparent immediate hazards to the research subjects. In such a case, the IRB must be promptly informed of the change following its implementation and will review the change to determine that it is consistent with ensuring the subjects continued welfare.