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)

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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:Fitzpatrick, Dr Bridie and Minnis, Professor Helen and Wilson, Dr Philip and Watson, Professor Nicholas
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 > Institute of Health and Wellbeing > General Practice and Primary Care
College of Medical Veterinary and Life Sciences > Institute of Health and Wellbeing > Mental Health and Wellbeing
College of Medical Veterinary and Life Sciences > Institute of Health and Wellbeing > Public Health
College of Medical Veterinary and Life Sciences > Institute of Health and 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

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