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

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.

Deferred Consent for Randomized Controlled Trials in Emergency Care Settings

“…However, our results are consistent with other evidence indicating the acceptability of deferred consent to parents and to practitioners with experience of the process. 13,19,20 The higher consent rate for emergency compared with elective admissions may reflect a greater capacity for informed decision-making when parents were approached after the medical emergency had taken place, in a potentially less stressful environment. For elective admissions, parents may have felt responsible for…”

“…11 Legislation introduced in the United Kingdom in 2008 allows the use of deferred consent for studies involving children provided that treatment is urgently needed, urgent action is needed for the purposes of the trial, it is not reasonably practicable to obtain consent prospectively, and an ethics committee has given approval to the procedure under which the action is taken. 12,13 However, there is a lack of evidence for the acceptability, design, and conduct of deferred consent in children, particularly relating to complex situations such as the death of a child.…”

“…There are strong ethical and safety arguments that the advantages of using data without consent in these situations outweighs any harms relating to a lack of consent. 13,24,25 Regulatory and management barriers to comparing standard treatments are well recognized: "The clinician who is convinced that a certain treatment works will almost never find an ethicist in his path, whereas his colleague who wonders and doubts and wants to learn will stumble over piles of them." 26 Informed consent is not required for treatment with nonvalidated therapies that are currently used in practice but for which there is a lack of evidence on benefits and risks.…”

Clinical Trial Decisions in Difficult Circumstances: Parental Consent Under Time Pressure

“…Professionals without previous experience of deferred consent have been found to be apprehensive about the approach or find it inappropriate not to give parents any choice before starting the study. 35,39 On the other hand, approximately two-thirds of parents of critically ill children reported that deferred consent was acceptable to them, 41 or parents suggest that professionals should just get on with treating their child and worry about consent later. 39 These different viewpoints indicate the need for further discussion and reflection on the best practice regarding the informed consent process and to consult with parents (and, if feasible, young people) as partners in the design of consent procedures for trials that will be implemented in emergency settings.…”

Ethics of Drug Research in the Pediatric Intensive Care Unit

“…Research suggests that parents favour deferred consent over waived consent and consider it an acceptable alternative to informed consent for emergency situations [59,60]. In a study by Woolfall et al [60], parents suggested it would be advisable for the researchers to seek advice from the bedside nurse to establish the moment when the child's condition was stable and then ask for consent.…”