Abstract
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.