Regulatory Challenges for the Resuscitation Outcomes Consortium

Resuscitation research is challenging but vital because few effective therapies exist for a number of life-threatening conditions. Cardiovascular disease has been a leading cause of death and morbidity in the United States. Although estimates vary, the American Heart Association estimates >150 000 out-of-hospital cardiac arrests each year in the United States,1 with little improvement in survival (≈5%) despite medical advances.2 Traumatic injury, resulting in severe hemorrhagic shock or traumatic brain injury, is the leading cause of death in persons 1 to 44 years of age and is a leading cause of morbidity.3 For treatments to be effective in these life-threatening situations, they must be administered immediately, usually at the site of the event.4 Consequently, researchers and regulatory agencies find that typical standards for informed consent cannot be applied in the emergency setting.In 2004, the National Heart, Lung and Blood Institute organized the Resuscitation Outcomes Consortium (ROC) to conduct simultaneous prehospital studies of novel therapies for trauma and cardiac arrest. The consortium consists of 11 regional centers in the United States and Canada and a data coordinating center.It was anticipated that these trials would require extra effort from a regulatory perspective because of the need to administer treatments during a relatively brief therapeutic window, making the standard practice of obtaining informed consent from the subjects before enrollment impossible. Because of the nature of the medical conditions being studied, the potential subjects would not be competent to consent. In addition, surrogate decision makers are not commonly available at the scene, and when they are, the emotional nature of the situation makes obtaining consent infeasible.5,6 These challenges are compounded in a trial involving multiple emergency medical services (EMS) systems and hospitals within each regional center. Finally, such trials may be logistically challenging because of the need …