Institutional Review Board (IRB) Review of Individual Patient Expanded Access Requests for Investigational Drugs and Biological Products During the COVID-19 Public Health Emergency Guidance for IRBs and Clinical Investigators

During the COVID-19 public health emergency, the Agency has received a substantially increased volume of individual patient expanded access requests for COVID-19 investigational drugs. Although FDA has issued guidance on expanded access requests, including expanded access for individual patients, the Agency is aware that Institutional Review Boards (IRBs) seek clarity regarding the key factors and procedures IRBs should consider when reviewing individual patient expanded access submissions, including for reviews conducted by a single member of the IRB, to fulfill its obligations under 21 CFR Part 56. Therefore, FDA is issuing this guidance to provide recommendations regarding the key factors and procedures IRBs should consider when reviewing expanded access submissions for individual patient access to investigational drugs for treating COVID-19.