‘The Words Will Pass with the Blowing Wind’: Staff and Parent Views of the Deferred Consent Process, with Prior Assent, Used in an Emergency Fluids Trial in Two African Hospitals

Abstract

ObjectiveTo document and explore the views and experiences of key stakeholders regarding the consent procedures of an emergency research clinical trial examining immediate fluid resuscitation strategies, and to discuss the implications for similar trials in future.MethodsA social science sub-study of the FEAST (Fluid Expansion As Supportive Therapy) trial. Interviews were held with trial team members (n = 30), health workers (n = 15) and parents (n = 51) from two purposively selected hospitals in Soroti, Uganda, and Kilifi, Kenya.FindingsOverall, deferred consent with prior assent was seen by staff and parents as having the potential to protect the interests of both patients and researchers, and to avoid delays in starting treatment. An important challenge is that the validity of verbal assent is undermined when inadequate initial information is poorly understood. This concern needs to be balanced against the possibility that full prior consent on admission potentially causes harm through introducing delays. Full prior consent also potentially imposes worries on parents that clinicians are uncertain about how to proceed and that clinicians want to absolve themselves of any responsibility for the child’s outcome (some parents’ interpretation of the need for signed consent). Voluntariness is clearly compromised for both verbal assent and full prior consent in a context of such vulnerability and stress. Further challenges in obtaining verbal assent were: what to do in the absence of the household decision-maker (often the father); and how medical staff handle parents not giving a clear agreement or refusal.ConclusionWhile the challenges identified are faced in all research in low-income settings, they are magnified for emergency trials by the urgency of decision making and treatment needs. Consent options will need to be tailored to particular studies and settings, and might best be informed by consultation with staff members and community representatives using a deliberative approach.

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…”

“…Previous evidence from parents indicates that being asked to make choices and to listen to information adds to the stressful environment of the pediatric setting. 20,21 This difference was reflected in the large proportion of parents of children admitted on an elective basis feeling too distressed and overwhelmed to engage with CATCH while having to focus on the impending surgical intervention. On the other hand, consent for emergency admissions was sought for use of data already collected and follow-up data collection only, because the intervention had already taken place.…”

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

“…38 However, it is questionable whether this approach is feasible and desirable because parents are still asked to consider information at a time when it is expected that they are unable to listen to, ask about, and understand the information. 39 Furthermore, even slight delays due to the prior permission-seeking process in emergency situations could lead to avoidable mortality and morbidity in trial participants and underestimate the beneficial effect of treatment. 40 When designing a study that will be implemented in an emergency setting, challenges with the consent process can reduce the number of recruited patients or lead to sampling bias, both of which may limit the study's value.…”

“…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.…”

“…Molyneux et al concluded that deferred consent should not be sought in this situation. 39 The issue of withdrawal of data does not arise in the United States, where the regulations allow investigators access to data that have already been collected, providing the use of the exception from informed consent has been justified. 45 A recent survey investigated parents' views (including bereaved parents) on deferred consent for a hypothetical trial comparing 2 resuscitation treatments in standard use.…”