Abstract Body: Background: Prospective informed consent is required for most research involving human subjects, however many countries permit use of alternative consent models to enable time-sensitive resuscitation research. The Canadian Tri-Council Policy Statement (TCPS 2) endorses use of an exception to consent process under certain conditions to support interventional research in the context of individual medical emergencies. Little information is available regarding experiences of substitute decision makers (SDMs) with such research. The SQUEEZE Trial [NCT03080038, NCT01973907], a large multicentre resuscitation trial, enrolled and randomized 406 children with septic shock at 9 pediatric tertiary centres across Canada exclusively using an exception to consent process. We explored experiences of SDMs with the exception to consent process used in SQUEEZE.
Methods: The Hamilton Integrated Research Ethics Board approved conduct of this study (ID #4074). Design: qualitative bioethics study linked to the parent randomized controlled trial. Qualitative Methods: Semi-structured interviews using grounded-theory methodology. Process: When SDMs were approached for deferred consent for their child to continue trial participation, consent for contact was sought for the qualitative ethics study. SDMs who consented to contact were separately approached by the qualitative study team members not involved with SQUEEZE Trial conduct. Interviews were recorded, transcribed, and entered into Nvivo for analysis and to identify emerging themes.
Results: A total of 56 SDMs from across Canada were included in this study. SDMs were diverse and included biological parents, grandparents, and others. Major emerging themes: 1. Recognition that the nature of the SQUEEZE Trial did not allow opportunity to obtain prospective consent, though some SDMs expressed initial feelings of anxiety or annoyance after learning their child had been enrolled. 2. Growing appreciation and gratitude that their child's trial participation could lead to new knowledge that may help other children. 3. Six respondents expressed the timing of the approach for enrolment into the clinical trial was acceptable despite the acuteness of their children’s condition.
Conclusions: SDMs of children enrolled into the SQUEEZE trial accepted the necessity of use of the exception to consent process and expressed altruistic views regarding the benefits of their child's participation for other children and society.