Procedure to request Emergency Use of an investigational drug or medical device for a patient

Although the FDA may excuse the requirement for prior review and approval by the IRB in emergency use cases, if time is sufficient, the UK IRB requests notification of a Medical IRB Chair or designee, who will provide a signed Emergency Use Checklist confirming the use of the article meets FDA single-patient emergency use criteria. 

However, if the immediate use of the test article is, in the healthcare provider’s opinion, required to preserve the life of the patient and time is not sufficient to obtain an assessment by the IRB chair or designee, include the justification in the emergency use report submitted to the IRB within five (5) working days following the emergency use.  See the remaining requirements detailed in the Emergency Use SOP.

Email addresses for IRB Chairs are provided to the right.  Contact the UK Office of Research Integrity (ORI) at (859) 257-9428 for assistance in facilitating communication.

• UK ORI/IRB Emergency Use SOP [PDF]
• UK ORI Emergency Use Checklist [PDF]
• FDA Emergency Use of an Investigational Drug or Biologic (IND) [HTML]
• FDA Emergency Use of an Investigational Device (IDE) [HTML]

ORI Guidance on Emergency Use and Expanded Access for Non-Emergent Compassionate Use

Guidance on Emergency Use of FDA Regulated Test Articles (Drug/Device/Biologic) as well as Expanded Access for emergent or non-emergent compassionate use of drug/biologic or medical devices. [PDF]