Abstract 12442: Exception to Consent in Pediatric Resuscitation Research: Exploring the Experiences of Substitute Decision Makers

Abstract

Introduction: International research ethics standards endorse an exception to prospective informed consent for research in medical emergencies. While an exception to consent may be ethically justifiable to facilitate rigorous evaluation of time-sensitive interventions in acute life-threatening conditions, little information is available regarding the experiences of participants and substitute decision-makers (SDM). We sought to better understand the experiences of parents/guardians with an exception to consent process as implemented in a pilot RCT involving children with septic shock. Hypothesis: Use of an exception to consent process is acceptable to most SDMs. Methods: Design: qualitative research study. Participants: SDMs for children enrolled into the SQUEEZE pilot trial [NCT01973907]. Sample size: Up to 25 participants. Qualitative Methods: SDMs are invited to participate in the qualitative ethics study. Interviews with consenting SDMs are conducted in person or by telephone, taped and professionally transcribed. Participants are encouraged to elaborate on their experience of being asked to consent after the fact and how this process occurred. Analysis: Data gathering and analysis are undertaken simultaneously with qualitative data coded using NVivo. Outcome: Themes emerging from the data. Results: Interviews with 15 SDMs, including bereaved and non-bereaved parents/guardians, have been conducted to date. Preliminary findings: 1) SDMs recognized the need for use of an exception to consent process for research in individual medical emergencies; 2) Most SDMs viewed their child’s research participation positively, with many making altruistic statements about helping other children in the future; 3) Perceptions regarding the appropriateness of the timing of the consent approach following enrolment were variable, with some SDMs stating that it was the “right amount of information at the right time", while others felt that they had been approached too soon. Conclusions: Substitute decision makers, including bereaved parents/guardians, support use of an exception to consent process in research in individual medical emergencies.