The IRB for the University of Colorado and its Affiliates

The FDA updated Form 3629 (Individual Patient Expanded Access Investigational New Drug Application) and related guidance documents (e.g., Guidance on Expanded Access to Investigational Drugs for Treatment Use, June 2016) in October, 2017. The updates simplified IRB review requirements for physicians seeking individual patient expanded access to an investigational new drug. Previously, all expanded access protocols required full-board IRB review. The update now allows individual patient expanded access treatment use of an investigational drug to be reviewed by a Chair to obtain Chair’s concurrence before the treatment use begins, in place of obtaining full-board IRB review. The treating physician must request authorization to use this alternative review procedure in Form 3629 (Question 10b). 

COMIRB has developed a new request form and submission process for Individual Patient Expanded Access Investigational New Drug. The new Individual Patient IND Request form and the guidance document can be found in the Forms Library under “Expanded Access/Compassionate Use".