On October 3, 2017, Dr. Scott Gottlieb, FDA Commissioner, testified before the US House of Representatives Subcommittee on Health, Committee on Energy and Commerce. He announced a significant change to the way that IRB may review single patient expanded access request involving investigational drugs or biologics.
This change, which permits an IRB chair or designee to review and concur with the request is an adjustment from the previous requirement that a convened IRB review and approve the request.
Specifically, the modification includes a revision of Form 3926 which now allows for a physician to select a box on the form that requests a waiver of the full IRB review.
This change will significantly reduce the time delay that occurs when IRBs do not meet on a frequent basis. Further, this change in IRB review of a single patient expanded access request is now consistent with FDA guidance for reviews involving investigational medical devices.
To learn more about expanded access, the streamlined IRB review, the role of the physician and important forms, go to http://clinicalresearchpathways.org/irbs/