How parents and practitioners experience research without prior consent (deferred consent) for emergency research involving children with life threatening conditions: a mixed method study

摘要: Objective Alternatives to prospective informed consent enable children with life-threatening conditions be entered into trials of emergency treatments are needed. Across Europe, a process called deferred has been developed as an alternative. Little is known about the views and experiences those first-hand experience this controversial process. To inform how sought for future paediatric critical care trials, we explored parents practitioners involved in CATheter infections CHildren (CATCH) trial, which allowed certain circumstances. Design Mixed method survey, interview focus group study. Participants 275 completed questionnaire; 20 families participated (18 mothers, 5 fathers). 17 CATCH one four groups (10 nurses, 3 doctors 4 clinical trial unit staff). Setting 12 UK children9s hospitals. Results Some were momentarily shocked or angered discover that their child had could have without prior consent. Although these feelings resolved after reasons why needed explained interventions already used care. Prior seeking first few times, apprehensive, although abated talking CATCH. Parents reported decisions child9s participation voluntary. However, mistiming discussion caused distress some. Practitioners supported use Conclusions Our study provides evidence support medicine; it also indicates crucial importance practitioner communication appropriate timing discussions.