SAEM Research Learning Series: Exception From Informed Consent

Have you ever wondered how researchers are able to conduct prospective studies on truly emergent conditions, such as cardiac arrest and status epilepticus? How can they obtain informed consent? In this Research Learning Series podcast episode from SAEM, Dr. Jill Baren (University of Pennsylvania) shares stories, pearls, and roadblocks in her career, conducting emergency research under the Exception From Informed Consent (EFIC) regulations. As an established researcher in this area,1–9 Dr. Baren shares advice and stories which include reaching to the community, getting angry hot-line comments, and getting push-back from the U.S. Food and Drug Administration.

A 32 year old woman arrives in your emergency department after being in a motor vehicle collision where she was the seat-belted driver. She undergoes chest CT imaging despite a negative chest x-ray because of her ongoing anterior chest wall diffuse tenderness. You discover a small 10% pneumothorax (PTX), but no other associated thoracic injuries. Should you place a tube thoracostomy (chest tube)? Should this patient be admitted to the hospital? A 2019 Annals of Emergency Medicine paper by the NEXUS Chest research group tackles these questions.
My 