Critical Illness Outside the Intensive Care Unit: Research Challenges in Emergency and Prehospital Settings.

Patients with acute critical illness require prompt interventions, yet high-quality evidence supporting many investigations and treatments is lacking. Clinical research in this setting is challenging due to the need for immediate treatment and the inability of patients to provide informed consent. Attempts to obtain consent from surrogate decision-makers can be intrusive and lead to unacceptable delays to treatment. These problems may be overcome by pragmatic approaches to study design and the use of supervised waivers of consent, which is ethical and appropriate in situations where there is high risk of poor outcome and a paucity of proven effective treatment.