What parents of children who have received emergency care think about deferring consent in randomised trials of emergency treatments: postal survey

PLoS One. 2012;7(5):e35982. doi: 10.1371/journal.pone.0035982. Epub 2012 May 7.

Abstract

Objective: To investigate parents' views about deferred consent to inform management of trial disclosure after a child's death.

Methods: A postal questionnaire survey was sent to members of the Meningitis Research Foundation UK charity, whose child had suffered from bacterial meningitis or meningococcal septicaemia within the previous 5 years. Main outcome measures were acceptability of deferred consent; timing of requesting consent; and the management of disclosure of the trial after a child's death.

Results: 220 families were sent questionnaires of whom 63 (29%) were bereaved. 68 families responded (31%), of whom 19 (28%) were bereaved. The majority (67%) was willing for their child to be involved in the trial without the trial being explained to them beforehand; 70% wanted to be informed about the trial as soon as their child's condition had stabilised. In the event of a child's death before the trial could be discussed the majority of bereaved parents (66% 12/18) anticipated wanting to be told about the trial at some time. This compared with 37% (18/49) of non-bereaved families (p = 0.06). Parents' free text responses indicated that the word 'trial' held strongly negative connotations. A few parents regarded gaps in the evidence base about emergency treatments as indicating staff lacked expertise to care for a critically ill child. Bereaved parents' free text responses indicated the importance of individualised management of disclosure about a trial following a child's death.

Discussion: Deferred consent is acceptable to the majority of respondents. Parents whose children had recovered differed in their views compared to bereaved parents. Most bereaved parents would want to be informed about the trial in the aftermath of a child's death, although a minority strongly opposed such disclosure. Distinction should be drawn between the views of bereaved and non-bereaved parents when considering the acceptability of different consent processes.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Child
  • Data Collection*
  • Emergency Medical Services
  • Humans
  • Parents* / psychology
  • Randomized Controlled Trials as Topic* / psychology
  • Surveys and Questionnaires