Comparison of Consent Models in a Randomized Trial of Corticosteroids in Pediatric Septic Shock

Objectives: To describe the use of deferred and prior informed consent models in the context of a low additional risk to standard of care, placebo-controlled randomized controlled trial of corticosteroids in pediatric septic shock. Design: An observational substudy of consent processes in a randomized controlled trial of hydrocortisone versus placebo. Setting: Seven tertiary level PICUs in Canada. Patients: Children newborn to 17 years inclusive admitted to PICU with suspected septic shock between July 2014 and March 2016. Interventions: None. Measurements and Main Results: Information on the number of families approached, consent rates obtained, and spontaneously volunteered reasons for nonparticipation were collected for both deferred and informed consent. The research ethics board of five of seven centers approved a deferred consent model; however, implementation criteria for use of this model varied across sites. The consent rate using deferred versus prior informed consent was significantly higher (83%; 35/42 vs 58%; 15/26; p = 0.02). The mean times from meeting inclusion criteria to randomization (1.8 +/- 1.8 vs 3.6 +/- 2.1 hr; p = 0.007) and study drug administration (3.4 +/- 2.7 hr vs 4.8 +/- 2.1 hr; p = 0.05) were significantly shorter with the use of deferred consent versus prior informed consent. No family member or research ethics board expressed concern following use of deferred consent. Conclusions: Deferred consent was acceptable in time-sensitive critical care research to most research ethics boards, families, and healthcare providers and resulted in higher consent rates and more efficient recruitment. Larger studies on deferred consent and consistency interpreting jurisdictional guidelines are needed to advance pediatric acute care.