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.