Relevant IRB Policy/Procedure
Investigators should always consult with Clinical Research Support (CRS) at RegulatoryAffairs@fredhutch.org to determine whether a proposed activity may meet criteria for emergency use, compassionate use, or expanded access.
Emergency Use
“Emergency use” addresses use of a test article on a human subject in a life-threatening situation in which no standard acceptable treatment is available, and in which there is not sufficient time to obtain Institutional Review Board (IRB) approval. “Not sufficient time” for IRB review and approval is defined by Fred Hutch as seven (7) business days or less. Such emergency use requires an Emergency Treatment Notification (ETN) with the FDA.
Whenever possible, physicians are to notify the appropriate IRB of a proposed emergency use of a drug, biologic, or device in a life-threatening situation in advance of the use. The appropriate IRB for emergency uses depends on the location of administration of the emergency use:
- The University of Washington Human Subjects Division (HSD) manages the notification of emergency use when the use will or did occur at the Fred Hutchinson Cancer Center in-patient clinic or at the University of Washington (regardless of the primary appointment of the physician). The physician follows UW HSD’s Single Patient Emergency Use SOP. For further information, visit the University of Washington's Human Subjects webpage and click the “Single Patient Emergency Use” red button.
- The Seattle Children’s IRB manages the notification of emergency use when the use will or did occur at Seattle Children’s (regardless of the primary appointment of the physician). The physician follows the Seattle Children’s IRB Policy for Emergency Use. For further information, visit the Seattle Children’s Emergency Use Process webpage.
Note: Whenever emergency care is initiated without prior IRB review and approval, the patient may not be considered to be a research subject. Such emergency care may not be claimed as research, nor may the outcome of such care be included in any report of a research activity.
Compassionate Use or Expanded Access
Compassionate uses (for devices) and expanded access uses (for drugs or biologics) are scenarios in which there remains sufficient time (more than 7 days) to obtain prospective IRB review and approval. Compassionate use and expanded access are reviewed by the Fred Hutch IRB if Fred Hutch is the primary academic appointment of the PI. Such uses, whether for an individual patient or a group of patients, involve submission of a new IRB application for IRB review. Review Selecting the Right IRB and Submissions to the IRB.