Emergency Uses of Investigational Test Articles

The following links are to information on the requirements for physicians to use a US Food and Drug Administration (FDA) regulated test article (i.e., unapproved drug, biologic, or device) to provide medical treatment to a single patient in a life-threatening situation.

• IRB Information Sheet - Emergency Uses of Investigational Test Articles
• IRB Policy - Research Activities in Emergency Situations
• Suggested Wording for Emergency Use Report