How experience makes a difference: practitioners’ views on the use of deferred consent in paediatric and neonatal emergency care trials

Abstract

BackgroundIn 2008 UK legislation was amended to enable the use of deferred consent for paediatric emergency care (EC) trials in recognition of the practical and ethical difficulties of obtaining prospective consent in an emergency situation. However, ambiguity about how to make deferred consent acceptable to parents, children and practitioners remains. In particular, little is known about practitioners’ views and experiences of seeking deferred consent in this setting.MethodsAs part of a wider study investigating consent methods in paediatric emergency care trials (called CONNECT), a 20 item online questionnaire was sent by email inviting practitioners (doctors and nurses) who were involved in talking with families about children’s and young people’s (aged 0–16 years) participation in UK EC trials. To ensure those with and without experience of deferred consent were included, practitioners were sampled using a combination of purposive and snowball sampling methods. Simple descriptive statistics were used to analyse the quantitative data, whilst the constant comparative method was used to analyse qualitative data. Elements of a symbiotic empirical ethics approach was used to integrate empirical evidence and bioethical literature to explore the data and draw practice orientated conclusions.ResultsViews on deferred consent differed depending upon whether or not practitioners were experienced in this consent method. Practitioners who had no experience of deferred consent reported negative perceptions of this consent method; these practitioners were concerned about the impact that deferred consent would have upon the parent-practitioner relationship. In contrast, practitioners experienced in deferred consent described how families had been receptive to the consent method, if conducted sensitively and in a time appropriate manner. Experienced practitioners also described how deferred consent had improved recruitment, parental decision-making capacity and parent-practitioner relationships in the emergency care setting.ConclusionsThe views of practitioners with first-hand experience of deferred consent should be considered in the design and ethical review of future paediatric EC trials; the design and ethical review of such trials should not solely be informed by the beliefs of those without experience of using deferred consent. Further research involving parents and children is required to inform practitioner training and normative guidance on the use and appropriateness of deferred consent in emergency settings.

Deferred Consent for Randomized Controlled Trials in Emergency Care Settings

“…CATCH was one of the first UK studies to use deferred consent in children, and ethics committee decisions (Box 1) were based on opinion because there was a lack of evidence about potential biases caused by exclusion of nonconsenting participants. [15][16][17][18] We aimed to inform future decisions on the use of deferred consent in children by evaluating rates of deferred and prospective consent and reasons for nonconsent for emergency and elective admissions in the CATCH trial.…”

“…Ongoing research (the CONNECT study) is investigating more closely the experiences of parents recruited to CATCH and may help explain why deferred consent rates were not even higher. 15 A major concern relating to deferred consent in CATCH is that inclusion of children in analysis was related to the child's outcome. In CATCH, 13% of patients admitted on an emergency basis were not approached for deferred consent, mainly because many were discharged or transferred before the approach could be made.…”

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.…”

“…38 Although deferred consent helps to avoid this difficulty, clinicians might feel uncomfortable approaching bereaved parents for consent or about conducting study activities such as blood sampling before consent has been sought. 35 …”

“…This is consistent with the experiences of practitioners in another study. 35 Improvement of the logistical processes, such as ensuring that all professionals who might discuss trials with families during night shifts have relevant training and ensuring that there are good channels of communication between different departments involved in a child's care, such as obstetrics and neonatology, could facilitate this process of preemptive explanation and consent seeking in the urgent situation as well (neonatologists' opinion; see Box 2). 36 An additional option is to define different levels of information about relevant research options, to allow the incremental scaling up of information based on a risk assessment or deterioration of a child's clinical status.…”