There are several names for research activities where an individual or small number of patients with serious or life-threatening disease can receive an investigational product when they cannot participate in a clinical trial. This research is typically initiated by the clinician and is referred to as:

• Expanded Access
• Emergency Use
• Compassionate Use
• Single Patient IND (Investigational New Drug)

This presentation will cover the variations in these approaches, the Food and Drug Administration (FDA) regulations, and the institutional policies and procedures for preparing a HawkIRB application and obtaining IRB approval.

Pre-registration is recommended.