Single Patient Expanded Access

In an emergency, you might need to use an investigational drug, biologic or device to treat a patient and not have time to submit an Investigational New Drug (IND) or Investigational Device Exemption (IDE) application to the Food & Drug Administration (FDA). In such cases, the FDA can allow you to use the product (drug, biologic, or device) before you submit the IND/IDE.

The FDA has different requirements and regulations for using an investigational drug or biologic in an emergency compared to using a device. In both cases, the FDA must determine that the test article is needed for a "serious or life-threatening disease or condition" and that there is no other comparable or satisfactory option to diagnose, monitor, or treat the disease or condition.

Emergency Use falls under the category of Expanded Access to Investigational Drugs for Treatment Use. Usually, the Institutional Review Board (IRB) has enough time to review your request for expanded access to an investigational drug or device. Even if only one person will receive the investigational product, it is still considered research (a clinical investigation) under FDA regulations because the product is not yet approved by the FDA.

In 2017 the FDA released new guidelines for individual patient expanded access INDs. With this new pathway, you still need to submit to the IRB, but now the IRB Chair can give concurrence instead of requiring approval from the full board.

To use this pathway, you, as the sponsor-investigator, must ask the FDA for 'Authorization to Use Alternative IRB Review Procedures.' You can do this by filling out section 10.b. on FDA form 3926, or if you’re using FDA form 1571, you can include a separate attachment with your request.

Please note, this pathway is only available when you, the physician sponsor-investigator, will hold the IND. It is not available if a pharmaceutical sponsor will hold the IND.

To get the IRB Chair's concurrence, you need to start a new study in PROTECT. Make sure to attach the following documents to your submission:

• A completed "single patient use expanded access form," which you can find in the IRB Library in PROTECT under the “templates” tab.
• The documentation you submitted to the FDA, such as FDA form 3926.
• The FDA communication that includes the assigned IND/IDE number and approval to proceed with the treatment.
• Any other supplemental documents.
• A consent document specifically written for the one patient you are enrolling and the treatment you are providing.

By following these steps, you can ensure you have all the necessary paperwork for the IRB Chair's concurrence.

The consent form template below is an example created specifically for Expanded Access use, including for single patient emergency or non-emergency situations. You should use this template as a starting point and make any necessary modifications to fit the needs of the specific patient you are treating.

This example assumes the use of a drug or device. The actual content will vary depending on the nature of the investigational agent or device and whether the procedures are done as part of the clinical investigation or for clinical care.

Please note that our consent template refers to the use of the product as treatment, not as research. When writing this, make sure it is specific to the one person you are treating, including details about the treatment and follow-up plan, pregnancy prevention, and any other relevant information.