What Parents of Children Who Have Received Emergency Care Think about Deferring Consent in Randomised Trials of Emergency Treatments: Postal Survey

Carrol Gamble,Simon Nadel,Dee Snape,Andrew Mckay,Claire Snowdon,Paula Williamson,Helen Hickey,Bridget Young,Linda Glennie

doi:10.1371/journal.pone.0035982

Abstract

ObjectiveTo investigate parents’ views about deferred consent to inform management of trial disclosure after a child’s death.MethodsA 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.Results220 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.DiscussionDeferred 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.

Highlights

When a child is admitted to hospital in an emergency situation his/her parents need to be able to draw some reassurance that the child is in the ‘best possible hands’ and receiving the ‘right treatment’
The sample was drawn from a database of members of the Meningitis Research Foundation (MRF), a UK medical research charity which provides support to families affected by meningitis and septicaemia
‘‘I understand that you are only trying to better the elimination of meningitis, and in order to do so you have to carry out these trials’’ [6R]

Summary

Introduction

When a child is admitted to hospital in an emergency situation his/her parents (or care providers) need to be able to draw some reassurance that the child is in the ‘best possible hands’ and receiving the ‘right treatment’. In 2004 the European Clinical Trials Directive [2], incorporating the ICH Harmonised Tripartite Guideline for Good Clinical Practice (ICH GCP) on clinical research was translated in to law across its member states [3]. This set valid informed consent as the cornerstone of experimental research involving human beings. The UK amended its legislation in 2006 to incorporate a deferred consent process in emergency situations for incapacitated adults [5] and in 2008 for minors [6] when the following conditions are met: (i) treatment is required urgently; (ii) urgent action is required for the purposes of the trial; (iii) it is not reasonably practicable to obtain consent prospectively; and (iv) an ethics committee has given approval to the procedure under which the action is taken

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Conclusion