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On October 3, 2017, the FDA issued new guidance regarding individual patient expanded access INDs. The new pathway still involves a submission to the IRB, but the IRB can now provide concurrence by the Chair, or another IRB member, rather than review and approval by the convened board. To use this pathway, the sponsor-investigator needs to request 'Authorization to Use Alternative IRB Review Procedures' from the FDA. This can be done either on FDA form 3926 (section 10.b.), or, if submitting using a FDA form 1571, by a separate attachment to the FDA. Note: This pathway is only available when a physician sponsor-investigator will hold the IND; it is not available when the pharmaceutical sponsor will hold the IND.

To obtain concurrence, the sponsor-investigator should select "Single Patient Expanded Access Application" in iRIS, complete the submission, and attach initiate a new study in PROTECT, complete the "single patient use expanded access form" that can be found in the IRB Library in PROTECT, and attach that form and the documentation that was submitted to the FDA (e.g. FDA form 3926) prior to submission.

Consent Template for Single Patient Treatment IND or IDE (expanded access)

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