Deferred Consent in Pediatric Drug Trials: Moving from Why to How

Deferred Consent in Pediatric Drug Trials: Moving from Why to How
Commentary
Martin Offringa, Terry P. Klassen
Pediatric Drugs, 28 October 2021; 23 pp 533–535
Excerpt
Medical care of critically ill and injured infants and children globally should be based on best research evidence to ensure safe and effective treatment. There is an ongoing need for clinical trials investigating emergency drug treatments of children with life-threatening conditions as there are still relatively few clinical trials in this setting and severely ill children are under-represented in research. A main challenge of such trials is seeking parents’ consent for including their critically ill child in a research study. The reasons are obvious: there is not always someone with parental responsibility present when a child enters a hospital’s emergency department, newly delivered mothers may be unable to give consent to emergency investigations or treatment of their baby because of general anesthetic or post-delivery sedation, or parents may be highly stressed in an emergency and struggle to make an informed decision about research in the limited time available…