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

Welch, V., Turner-Halliday, F., Watson, N. , Wilson, P., Fitzpatrick, B., Cotmore, R. and Minnis, H. (2017) Randomisation before consent: avoiding delay to time-critical intervention and ensuring informed consent. International Journal of Social Research Methodology, 20(4), pp. 357-371. (doi: 10.1080/13645579.2016.1176751)

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.

• Item Type: Articles
• Status: Published
• Refereed: Yes
• Glasgow Author(s) Enlighten ID: Minnis, Professor Helen and Watson, Professor Nicholas and Wilson, Prof Philip and Fitzpatrick, Dr Bridie
• Authors: Welch, V., Turner-Halliday, F., Watson, N., Wilson, P., Fitzpatrick, B., Cotmore, R., and Minnis, H.
• College/School: College of Medical Veterinary and Life Sciences > School of Health & Wellbeing > General Practice and Primary Care; College of Medical Veterinary and Life Sciences > School of Health & Wellbeing > Mental Health and Wellbeing; College of Medical Veterinary and Life Sciences > School of Health & Wellbeing > Public Health; College of Medical Veterinary and Life Sciences > School of Health & Wellbeing > Social Scientists working in Health and Wellbeing; College of Social Sciences > School of Social and Political Sciences > Sociology Anthropology and Applied Social Sciences
• Journal Name: International Journal of Social Research Methodology
• Publisher: Taylor & Francis
• ISSN: 1364-5579
• ISSN (Online): 1464-5300
• Published Online: 11 May 2016
• Copyright Holders: Copyright © 2016 Taylor and Francis
• First Published: First published in International Journal of Social Research Methodology 20(4):357-371
• Publisher Policy: Reproduced in accordance with the copyright policy of the publisher