Emergency Use

(Call the OIRB right away-(210)567-2351)

The emergency use provision in the FDA regulations is an exemption from prior review and approval by the IRB of a single patient use of a drug, device, or biologic considered to be investigational. The emergency use exemption of an investigational drug, biologic or device is permitted only if each of the following conditions exist:

• A life-threatening or severely debilitating situation exists necessitating the use of the investigational drug, biologic or device;

• No standard acceptable alternative treatment is available; and

• Because of the immediate need to use the drug, biologic or device, there is not sufficient time to use existing procedures to obtain IRBA approval for the use.

Even for an emergency use, the investigator is required to obtain informed consent of the subject or the subject's legally authorized representative. (Rarely exceptions may be allowed.)

Note:  These forms are best downloaded using Internet Explorer (IE) as your web browser but then click "Save" because they are best opened in Microsoft Word from after being saved to your computer (Click the picture for an example).  If you are experiencing problems downloading a form from our page, and using an alternate browser has not helped (i.e., Netscape Navigator, Internet Explorer), please call the Office of the IRB at 210-567-2351.

Instructions:

Always return to this webpage to create new submissions to ensure you are using the most current forms.

 

Form A	Signature Assurance Sheet	Form A Instructions [HTML]
Emergency Consent	Consent Template for Emergency Treatment Use of Investigational Drugs, Biologics or Devices	Emergency Consent Instructions
Justification	Written memorandum, email, or telephone call summary of explanation which justifies administration of the test article	Instructions
Independent opinion for exception from informed consent	A written statement by the investigator and a physician who is not otherwise participating in the clinical investigation that all of the required conditions are met.	Required only when the physician proposes to administer the test article in emergency use situations without informed consent