Exploring the experiences of substitute decision-makers with an exception to consent in a paediatric resuscitation randomised controlled trial: study protocol for a qualitative research study.
Melissa J ParkerSonya de LaatLisa SchwartzPublished in: BMJ open (2016)
This research represents a rare opportunity to interview parents/guardians of critically ill children enrolled into a resuscitation trial without their knowledge or prior consent. Findings will inform implementation of the exception to consent process in the planned definitive SQUEEZE trial and support development of evidence-based ethics guidelines.
Keyphrases
- study protocol
- cardiac arrest
- phase iii
- healthcare
- clinical trial
- phase ii
- cardiopulmonary resuscitation
- randomized controlled trial
- intensive care unit
- public health
- primary care
- young adults
- emergency department
- septic shock
- mental health
- open label
- clinical practice
- quality improvement
- machine learning
- locally advanced