Case study: Research with brain-dead children

The esophageal obturator airway (EOA) is a device used throughout the United States to facilitate artificial respiration of critically ill patients who are not hospitalized. Its use is restricted to persons who are over 15 years old because obturators for children are not available. A protocol submitted to an institutional review board (IRB) intended to develop EOAs suitable for use in children. The investigators proposed to perform preliminary testing of these devices on children who had sustained irreversible loss of brain function (“brain death”). In its review of this protocol, the IRB had to confront several vexing questions.