What are the IRB Reporting Procedures for Emergency Use Investigational Devices?
Quorum has procedures in place for review of emergency use of test articles. If a subject is in a life-threatening situation where no standard acceptable treatment is available, and there is not sufficient time to obtain Board approval, please contact our Initial Study Support department. They can be reached by phone at (206) 448-4082 or by email at InitialStudySupport@quorumreview.com. We highly recommend reading this article about Emergency Use of Investigational Devices, including FDA Notification and IRB requirements.