Waiver of Prospective Consent for Pediatric Resuscitation Research

Abstract

To the Editor .— We read with interest the recent Pediatrics article “Exception From Informed Consent for Pediatric Resuscitation Research: Community Consultation for a Trial of Brain Cooling After In-Hospital Cardiac Arrest.”1 The article described parental and hospital staff opinions of informed consent relevant to study of induced hypothermia after pediatric cardiac arrest. Focus groups identified attempts to obtain informed consent at the time of hospital or intensive care unit (ICU) admission as particularly problematic. Difficulties with this a priori approach included (1) lack of parental receptivity to research/consent conversations during the stress of admission, (2) inattention to the consent document and its contents when parents believe the likelihood of study applicability to their child is low, (3) anxiety generation in a large number of parents forced to contemplate the cardiac arrest of their child, and (4) extraordinary labor demands and logistic difficulties associated with obtaining prospective consent from all patients admitted to either the hospital or ICU.1 We recently began a study of pediatric interposed abdominal compression cardiopulmonary resuscitation (CPR). Based on existing adult and pediatric data, the study poses minimal risk to children and may be beneficial when results of standard …