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121. Emergency Use of Investigational Drugs: FDA Exemption from IRB Review

When emergency use of a test article occurs at a University or affiliate site, prospective approval from the IRB must be obtained when possible; however, University policy allows exemption from prior IRB approval in accordance with FDA regulations (§56.104(c)) for emergency use of a test article if

  • the emergency use is reported to the IRB within 5 working days, and
  • any subsequent use of the test article at a University or affiliate site is subject to IRB review.

NOTE: The IRB may determine 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 this use of the test drug.

As noted previously, the University neither has nor expects to have research studies involving planned emergency research.

NOTE: Emergency use of an investigational drug is not considered research under DHHS regulations. The outcome of this care may not be included in any report of a research activity subject to DHHS regulations.

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