What if I need to use an unapproved drug, biologic, or device and there is no time for IRB review?
See the IRB Office’s Emergency Use Page. Contact the IRB Office or IRB Chair immediately to discuss the situation. If there is no time to make this contact, see “WORKSHEET: Emergency Use (HRP-322)” for the regulatory criteria allowing such a use and make sure these are followed. Use the “TEMPLATE: Emergency Use Consent Document (HRP-506)” to prepare your consent document. The FORM: Emergency Use of Investigational Drug, Device, or Biologic (HRP-1203) should be submitted with all Emergency Use proposals. Follow the SOP: Emergency Use (HRP-023) to submit a report of the use to the IRB within five (5) business days of the use.
Include in the report a description of how the use meets the criteria outlined in WORKSHEET: Emergency Use (HRP-322), a summary of the patient’s diagnosis and treatment history, and the date and time of the use. Attach to the report the consent document templates used (if applicable), approval of the use from the FDA (drugs and biologics), or concurrence letter from an independent physician that the use of the device is warranted, and no other alternative treatments are/were available (devices).
Emergency use of an unapproved drug or biologic in a life-threatening situation without prior IRB review is “research” as defined by USFDA, the individual getting the test article is a “participant” as defined by USFDA, and therefore is governed by USFDA regulations for IRB review and informed consent.
Emergency use of an unapproved device without prior IRB review is not “research” as defined by USFDA and the individual getting the test article is not a “participant” as defined by USFDA. However, USFDA guidance recommends following similar rules as for emergency use of an unapproved drug or biologic.
Individuals getting an unapproved drug, biologic, or device without prior IRB review cannot be considered a “participant” as defined by DHHS, and their results cannot be included in prospective “research” as DHHS defines that term.
FDA regulations require that any subsequent use of a test article at the institution have prospective IRB review and approval. If it is anticipated that this test article may be used again (for the same patient, a different patient, or for any indication), submit a protocol and consent document(s) to the IRB for review so that an approved protocol will be in place when the next need arises.