Research in Pediatric Anesthesia

In the United States and globally, governmental organizations have initiated programs to stimulate clinical research in the pediatric population. The most important reason for these programs is a lack of high-quality evidence to guide effective and safe treatment in children. In pediatric anesthesiology, physicians and scientists need to evaluate anesthetic drugs, medical equipment, and devices. Under improved global regulations, current and new anesthetic strategies will undergo a scientific evaluation of safety and effectiveness. Along these lines, the number of pediatric patients participating in anesthesiology research is expected to increase. Federal regulations deem minors to lack the required decision-making capacity to consent to participate in studies. In line with the Declaration of Helsinki, enrolling children in research should encompass legal guardian permission and assent of the child. Proxy consent and assent procedures should enable the legal representative to safeguard the child's interest while allowing the child to give meaningful agreement. Assent has been defined in detail by ethical scholars but is generally poorly defined legally. A specific challenge to appropriate proxy consent and a child's assent in pediatric anesthesiology research is the brief treatment interaction the pediatric anesthesiologist can have with patients. This challenge may require contacting potential research subjects well before admission to the hospital, depending on the risk and complexity associated with the study at hand. 

Keywords: Assent, Consent, Ethical review, Institutional review board, Pediatric anesthesia, Quality improvement, Research, Risk.