Section 20
Exemptions from CORIHS Approval Requirement

The only activity that is exempt from prior review and approval from CORIHS involves the emergency use of an experimental drug (i.e., not approved by the Food and Drug Administration).

Emergency use is defined as the use of an experimental drug on a human subject in a life-threatening situation in which:

  • there is no standard acceptable treatment available;
  • there is insufficient time to obtain CORIHS approval

A. The emergency use must be reported to CORIHS within 5 working days, with chair endorsement, and should include:

  • Patient history
  • Justification for the emergency use
  • Department Chair endorsement
  • Consent form (see subsection B, below), and
  • Investigational Drug Brochure and/or protocol (generally available from the pharmaceutical company)

Any subsequent use of the experimental drug (i.e., use in another patient) must be approved by CORIHS via the standard application process prior to commencement of the activity.

B. The investigator is required to obtain informed consent of the subject or the legally authorized representative unless both the investigator and another 'independent' physician certified in writing all of the following:

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

If time is not sufficient to obtain an independent physician's determination that the above four conditions apply, the investigator shall make the determination and within 5 working days after the use of the drug, have the determination reviewed and evaluated in writing by such a physician. Notification to CORIHS is still required within the 5 working days.

C. The Office of Research Compliance should be contacted for further information concerning the emergency use of investigational drugs as well as the emergency use of investigational devices (IND, IDE requirements etc.).

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Last Updated: 2004-04-28