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

Vicki Welch, Fiona Turner-Halliday, Nicholas Watson, Phil Wilson, Bridie Fitzpatrick, Richard Cotmore, Helen Minnis

Research output: Contribution to journalArticle

1 Citation (Scopus)
5 Downloads (Pure)

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 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.
Original languageEnglish
Pages (from-to)357-371
Number of pages15
JournalInternational Journal of Social Research Methodology
Volume20
Issue number4
Early online date11 May 2016
DOIs
Publication statusPublished - 2017

Keywords

  • informed consent
  • randomised controlled trials
  • birth parents
  • complex interventions

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