Randomisation before consent: avoiding delay to time-critical intervention and ensuring informed consent

Abstract

Obtaining informed consent can be challenging in stressful and urgent circumstances. One example is when potential participants have recently had their child removed into care; intervention is urgent and mandatory whereas participation in associated research is voluntary. Using a nested qualitative study, we examined experiences of consent processes in a randomised controlled trial (RCT) of a family assessment and intervention service for maltreated young children. Some potential participants found it difficult to use information; some believed consenting might influence the return of their child. In response to these ethical challenges, we propose reversing the typical process of securing consent, so that randomisation to an intervention occurs before inviting potential participants to consider the trial. This will avoid delays, delineate research from intervention, and make it easier to consider information. We suggest that this innovation could be useful in trials across service areas that incorporate urgent and complex interventions.

‘Informed consent’ in consensual child welfare: some reflections on its controversial nature

“…This statement follows from what has been said about informed consent in other fields of human services: it is messy and blurred (e.g. Barnett, 2007;Welch et al, 2017), but it is even more so in this context due to the nature of child welfare. Based on the interviews with social workers, young people and parents, we have highlighted four particular challenges: the binary nature of informed consent, which may not reflect children's and parents' experiential view of care orders; the relational elements of informed consent in family matters challenging the individualistic approach to informed consent; the multifaceted nature of adequate information, and consent being given in a statutory context in which the public authorities have the power to use coercion.…”

Partnership approaches to the evaluation of complex policy initiatives: Qualitative research as key to building effective relationships

“…In addition, the qualitative consultation has provided opportunities for all those involved in the trial to highlight concerns about the conduct of the trial or how taking part would impact on professional integrity and autonomy. For example, we have used interviews with parents to assess the effectiveness and suitability of our ethics procedures, in particular our consenting process (Welch et al, ).…”

“…The focus groups and interviews followed a semi‐structured approach to gathering data (Willig, ) and used topic guides that have evolved iteratively from the thematic analysis during the process of stakeholder engagement. For example, analysis of the data generated from early consultations with health and social work professionals has led to the development of topic guides that specifically explore issues of consent with birth families (Welch et al, ). A semi‐structured approach allows flexibility in question use, gaining a balance between exploring pre‐defined areas of interest while allowing participants to share experiences and views that are participant‐led (Willig, ).…”

The Best Services Trial (BeST?): a cluster randomised controlled trial comparing the clinical and cost-effectiveness of New Orleans Intervention Model with services as usual (SAU) for infants and young children entering care

“…As we have described previously, this makes informed consent challenging and we aim to learn from good practice in previous trials, e.g. those conducted with patients after head injury [ 60 ], to ensure we adhere to good clinical practice [ 26 ]. Fourth, the monitoring of serious adverse events has never been conducted in this context and we aim to use innovative methods to both detect and evaluate potential SAEs.…”

“…These have included the following: A very high initial response rate during the feasibility trial caused us to carefully examine the ethics of consent in the target population. In order to try to improve the ethical basis for the study, we introduced randomisation before consent (modified Zelen randomisation [ 26 ]). Unanticipated consequences of randomisation before consent included delays in service delivery since the infant mental health teams, which had had their capacity modelled on likely trial recruitment numbers, became overwhelmed with treating non-trial participants who were randomised but did not then consent to the study.…”