You must apply for an Institutional Review Board’s (IRB) approval for compassionate use prior to initiating treatment. You should specify in the application that the primary intent is treatment, not clinical research, because not all IRBs are familiar with expanded access protocols and how to review them.
If your institution does not have an IRB you can:
• Use a for-profit IRB. This is a private IRB that reviews research proposals at a cost.
• Partner with an IRB from your local hospital/institution. Universities that are affiliated with hospitals will most likely have an IRB.
• Start an IRB at your institution.
Some drug companies may require an IRB approval letter before the drug will be shipped. If treatment cannot be delayed, some IRBs have sent manufacturers a written statement indicating that the IRB is aware of the proposed use and considers it to meet the requirements for emergency compassionate use. Although this is not a formal IRB approval, the acknowledgment letter has been acceptable to drug companies.
In an emergency life-threatening situation in which no standard acceptable treatment is available, and in which there is not sufficient time to obtain IRB approval, by law you may begin treatment and report the emergency use of the investigational drug to an IRB within 5 working days (21 CFR 56.104). Some IRBs have specific procedures for approving emergency requests (see example of emergency use guidance here). However, you should notify the IRB right away and follow your institution’s procedures for such cases.
Requirements of IRBs differ, but as a general rule you should email the following to the IRB:
• description of case and treatment plan, including justification for compassionate use;
• a proposed consent form;
• any available documentation from the FDA regarding the emergency IND.
Obtain informed consent
In general, the consent should satisfy federal requirements under 21 CFR 50.
You can edit this sample informed consent form as needed.
Print all application steps
as one document (PDF)