Emergency Use of a Test Article
Click Here for Instructions for Completing Emergency Use Forms
The emergency use of an investigational drug, device or biologic under FDA regulations at 21 CFR 56.104(c) is described in the Texas Health Resources Corporate Policy for the Protection of Research Subjects (Ch. 8: sections j & k and Ch. 12: sections k & l).
The regulation permits the emergency use of an investigational drug, device or biologic on a one-time basis per Institution without IRB review and approval prior to its use (but the emergency use must be reported to the IRB within 5 working days from the date of use). Any subsequent use of the test article at Texas Health Resources entities requires IRB review and approval prior to use. However, despite this exemption, Texas Health Resources policy recommends informed consent and IRB review, even in emergency situations. Also, the Texas Health Research Compliance Office recommends that physicians/investigators obtain Institutional approval and consult with the IRB Chairperson for guidance when considering the emergency use of drugs or medical devices. Click here to find out which test articles have already been used at which Texas Health Entity.
Note: Each of the Texas Health Resources entities and affiliated facilities are considered to be an Institution.
The FDA acknowledges that it would be inappropriate to deny emergency treatment to a second individual if the only obstacle is that the IRB has not had sufficient time to convene a meeting to review the issue ["Emergency Use of an Investigational Drug or Biologic," FDA Information Sheet, 1998 Update: Click here ].
Data collected from the patient who received emergency treatment cannot be considered research, as defined by the Department of Health and Human Services (DHHS) regulations. Therefore it cannot be used with data for a research study.
Data collected from the patient is considered research under FDA regulations and can be aggregated with other research data, provided that research is not subject to DHHS regulations.
The FDA may require data from an emergency use of a test article in a life-threatening situation to be reported in a marketing application. Therefore, a HIPAA/Privacy authorization should be signed as well.
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