The IRB is pleased to announce a specific application pathway in the ERICA new study application for physicians intending to treat patients using a humanitarian use device (HUD) or expanded access of an investigational drug or device.
A humanitarian use device is intended to benefit patients by treating or diagnosing a disease that affects fewer than 8,000 individuals in the United States per year. To be considered for HUD status, a device sponsor must complete a humanitarian device exemption (HDE) application with the FDA. Before an HUD under an approved HDE can be used at the University of Utah or its affiliates for clinical care, IRB approval is required (with the exception of emergency use).
The FDA’s Expanded Access Program allows for the use of investigational drugs or devices (i.e., not FDA-approved) for treatment outside of a clinical trial. Treatment use is not considered a clinical investigation; however, FDA submission and IRB review are necessary.
Prior to this ERICA update, physicians were asked to submit their requests using a new study application for research, which was not ideal. The updates to ERICA include specific questions for these types of applications and omit unnecessary questions and pages. Although these applications are not clinical investigations or research, they must still comply with the FDA regulations for IRB approval and informed consent.
The IRB has published downloadable HUD and expanded access consent checklists which physicians can use to create a consent document. The checklists include suggested language for HUD and expanded access. The consent checklists also include modified standard language such as authorization language and injury language.
These applications can be created by logging into ERICA and clicking on the “IRB Studies” tab and clicking on the “Create a New Study Application” button. On page 1 (Study Introduction) of the application, question 4 now has both “Application for Humanitarian Use Device (HUD) under a Humanitarian Device Exemption” and “Application for Expanded Access of an Investigational Drug or Device” as types of applications. Complete the application entirely, attaching the required documentation, and submit the application to the IRB for review.
You may visit the IRB’s website for information about these types of applications: