What is the process for single patient emergency use and expanded access protocols?
Last updated: 4.7.2020
Given the current situation, it is anticipated that many single patient expanded access requests will fall under the emergency access criteria. Regulatory requirements for these requests remain the same during the COVID-19 pandemic and specify that in an emergency situation where there is not sufficient time to secure IRB review prior to beginning treatment, the emergency use of the investigational drug may proceed, but must be reported to the IRB within 5 working days, as required under 21 CFR 56.104(c).
Under normal circumstances, posted IRB guidance requires that in emergency situations where there is not time to obtained convened IRB approval, the IRB should be contacted ahead of the use and to obtain a letter of concurrence from the IRB Chair. In light of the current situation, the IRB is not requiring a letter of concurrence for COVID-19-related single patient emergency INDs.
As noted above, however, the use MUST be submitted in ARROW using the treatment use application (which also is used for emergency, one-time uses) within 5 business days of treatment. The Office of Clinical Trials is available to assist clinicians with preparing treatment use applications for the IRB.
For FDA guidance specific to COVID-19 convalescent plasma emergency INDs, see: https://www.fda.gov/vaccines-blood-biologics/investigational-new-drug-ind-or-device-exemption-ide-process-cber/investigational-covid-19-convalescent-plasma-emergency-inds.
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