Parent Attitudes to Research Without Prior Consent in Two Pediatric Emergency Clinical Trials in Australia: A Qualitative Study of Transcripts From 2017.

Abstract

Objectives: Research in critically ill children poses challenges in acquiring prospective informed consent. International ethical guidelines generally have provisions to perform research without prior consent (RWPC) in circumstances where consent is not feasible, but there is a paucity of data regarding the community acceptance of this process. The objectives of the current study were to explore the attitudes and experiences of parents of children enrolled into trials to determine understanding and acceptability of RWPC to parents of children involved.

Design: Qualitative study of semi structured telephone interviews in 2017 exploring themes of medical research, trial participation in RWPC. Interview transcripts underwent inductive thematic analysis with intercoder agreement, using Nvivo 14 software.

Setting: Two clinical interventional trials in Australia conducted in critically ill children without prospective consent.

Subjects: Parents of children enrolled in critical care research.

Interventions: None.

Measurements and main results: A total of 49 interviews were conducted and analyzed. Parents of participants were supportive of processes used in the trials and RWPC. Paperwork was often not thought to contribute to improved understanding, with verbal information more valued. There was no consensus on the optimal approach of RWPC in situations when clinical outcome was poor.

Conclusions: Our study in 2017 shows that parent/carer supported RWPC in two pediatric trials involving critically ill children. Parents were satisfied with existing approval methods and safeguards. Parents valued brief verbal information at the time of randomization. These historical findings support the feasibility of conducting research on time-sensitive interventions in emergency settings with RWPC, aligning with community expectations.