The FDA has several mechanisms in place to allow for the treatment of patients with investigational drugs, devices or biologics, in both emergency and non-emergency settings. In these instances, HRPO has a process to submit a request to treat a patient.  The request will be reviewed by the IRB Executive Chair and, if deemed, appropriate the request will be acknowledged.

Note:  If there is not sufficient time to submit a request to the IRB, treatment may proceed.  The emergency use must be reported to the IRB as soon as possible but no later than five working days.  The FDA provides guidance and definitions of  “emergency use” for both investigational drugs or biologics and investigational devices.

An investigator who is unsure if emergency use of an investigational drug, device, or procedure is warranted may email the IRB Executive Chair .

Request Emergency Patient Treatment

Complete Form 11 and a consent form (template) to request emergency use treatment. Submit the completed forms by email.

Submit a Follow-Up report (Form 13) via email within 5 working days from the date of treatment. This is required even if the treatment occurred without prior IRB acknowledgement.

Obtaining informed consent is deemed feasible unless both the treating physician and a physician that is not affiliated with the patient or the patient’s treatment decisions certify to all the following:

  • The human subject is confronted by a life-threatening situation necessitating the use of the test article.
  • Informed consent cannot be obtained from the subject because of an inability to communicate with, or obtain legally effective consent from, the subject.
  • Time is not sufficient to obtain consent from the subject’s legal representative.
  • There is no available alternative method of approved or generally recognized therapy that provides an equal or greater likelihood of saving the life of the subject.

For more information on consent requirements refer to the information found in Form 11.

Under FDA regulations and Washington University IRB policy, any data collected for this treatment cannot be used for research purposes.

Request Single Patient Treatment (Non-emergency)

The FDA recognizes that there are circumstances in which use of an investigational drug is the appropriate option to diagnose, monitor or treat a patient’s disease condition


use of an investigational device or device is the only option available for a patient faced with a serious, albeit not life-threatening condition.

IRB concurrence and FDA approval is REQUIRED before use.

PRIOR TO USE:  Obtain FDA approval, IRB concurrence, approval from sponsor (if there is already an IND/IDE) and consent from the patient.  See Form 14 for detailed information on the process and what documentation is required.

Complete Form 14 and a consent form (template for drug or device) to request single patient treatment: Submit the completed forms, consent document and supporting documents by email.

Report any problems that occur as a result of the drug or device via Form 15 within the following timeframes:

  • Within 1 working day if the problem results in the death of the patient
  • Otherwise, within 10 working days

Submit Form 15 by email to report any problems that occur as a result of the use of the drug or device within the following timeframes:

  • Within 1 working day if the problem results in the death of the patient
  • Otherwise, within 10 working days

Content current as of 08/23/2023