Emergency Patient Treatment

 

For requests being made during normal business hours (M-F 8am – 5pm), please contact the HRPO at 314-747-6800. If the request is made outside of normal business hours and time permits, please complete the following procedure.

Note: If there is not sufficient time to complete the following it is permissible to institute treatment and report the emergency use to HRPO as soon as possible, but no later than five working days.

  1. Complete the following forms:
    1. Single Patient Emergency Treatment Using an Investigational Drug, Device or Procedure Form (Form 11).
    2. Consent Template for Emergency Use
  1. Click here to email the clinical summary that justifies emergency treatment is warranted and attach the completed copy of the Form 11 and Consent.
  1. Complete the form below and someone will be paged.

  1. Single Patient Emergency Treatment Follow-Up Report – Form 13

 


Under (FDA) regulations, “emergency use” is defined as the use of a test article (e.g. investigational drug, biologic, or device) on a human subject in a life-threatening or severely debilitating (meaning the disease or condition can cause major irreversible morbidity, such as blindness, loss of limb, stroke, etc.) situation in which no standard acceptable treatment is available, and in which there is not sufficient time to obtain Institutional Review Board (HRPO) approval.  A DHHS notification (dated May 1989) further clarifies immediate life-threatening disease as a disease state in which there is a reasonable likelihood that death will occur within a matter of months or in which premature death is likely without early treatment.

An investigator who has determined that emergency use of an investigational drug, device, or procedure is warranted should then, IF TIME ALLOWS, contact the HRPO before initiating the emergency treatment.  After consultation with the investigator, the HRPO Executive Chair or designee shall make a determination of the validity of the emergency status.  If the investigator deems immediate treatment imperative, the Executive Chair or designee will “note” the emergency administration.  The investigator must also submit a “Request for Single Patient Emergency Treatment Using an Investigational Drug, Device, or Procedure” (Form 11) accompanied by a copy of the treatment consent form and protocol for the Chairperson’s or designee’s review.  Documentation of HRPO acknowledgement will comprise the investigator’s completed Form 11 bearing the Executive Chair’s signature and the date noted.   It is preferable for these forms to be received and noted by the HRPO before commencing treatment.

As indicated above, WHEN THERE IS NOT SUFFICIENT TIME TO CONTACT THE HRPO an investigator who has determined that emergency use of an investigational drug or device is warranted may proceed with the emergency treatment. The emergency use must then be reported to the HRPO within five (5) working days.