Emergency (Compassionate) Use Requirements
Emergency Use Request for Unapproved Devices, Drugs or Biologics
Effective March 2016, the INTEGRIS Health, Inc. IRB has a new Emergency Use policy. This policy outlines the procedures to follow when emergency use of an unapproved device, drug or biologic is necessary. Please use the following link to access the policy: Emergency Use Policy
INTEGRIS Health encourages all physicians to complete paperwork and obtain approval prior to use whenever possible.
- Step One: Download the following form and complete sections A, B and F: Emergency Use Report Form. Then e-mail the form to [email protected] and call the IRB Office at 405.949.4184 to discuss the request.
- Step Two: The IRB Office will immediately forward your form to the IRB Chair for review. The Chair will contact the requesting physician if there are any questions.
- Step Three: Upon approval from the Chair, the IRB Office will prepare and e-mail a confirmation letter.
- Step Four: The Director of Grants and Research will contact the requesting physician or designee to coordinate FDA requests, determine Consent form needs and answer questions.
- Step Five: Within five (5) working days after initiation of the investigational article, complete sections C, D and E of the form and forward to [email protected]
- Step Six: Upon completion of treatment, complete section G of the form and forward to [email protected]
Please note that if there is indefinite use of the investigational article, the requesting physician must submit an update report six (6) months, one (1) year and annually thereafter until either the completion of treatment or approval by the FDA.
The IRB Office is available to answer questions during this process. The IRB Office may be contact at 405-949-4184 or via e-mail at [email protected].
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