The IRB office, with the help of the Office of Research Regulatory Affairs, has updated its old “Emergency Use” webpage with new and (vastly) improved “Expanded Access” webpage.
The new webpage addressed both compassionate and emergency uses of investigational products, and includes checklists and a consent template for these uses.
Yes, the checklists are long, but they are intended to walk investigators/treating physicians through the entire expanded access process. We hope you will find these resources helpful.