Ethical approval, registrations, user involvement and data

Tom Burns; Jorun Rugkåsa; Ksenija Yeeles; Jocelyn Catty

Chapter 4Ethical approval, registrations, user involvement and data

The Oxfordshire Research Ethics Committee A gave ethical approval for the ULTIMA Study (22/02/2006, reference no. 05/Q1604/180).

The Staffordshire NHS Research Ethics Committee gave ethical approval for the OCTET Study (30/10/2008, reference no. 08/H1204/131). An amendment to the ethical approval (20/07/2011) covered the additional work required for the OCTET Follow-up Study, which was funded by a supplementary grant held from 2012 to 2014.

The OCTET Trial is registered with the International Standard Randomised Controlled Trial Number Register (reference: ISRCTN73110773). All three studies were part of the UK Clinical Research Network Study Portfolio.

We performed all three studies in accordance with the ethical standards laid down in the 1964 Declaration of Helsinki and its later amendments.¹⁵ Some changes to the original research protocols were agreed with the funder and the relevant ethics committees during the course of the research, as we describe below (see Part 2, Chapter 6, Methods and Part 4, Chapter 19, Methods).

We held a number of meetings with service user and carer representatives during the course of the programme to discuss the procedures for the studies. (We give details about governance for the OCTET Study in more detail below; see Part 2, Chapter 5, Governance.) The service user and carer representatives on the OCTET Steering Group formed part of the OCTET Follow-up Study’s governance structure. We designed the OCTET Follow-up Study partly to meet concerns raised by service users and service user representatives in the consultation phase of the OCTET Trial.

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Copyright © Queen’s Printer and Controller of HMSO 2016. This work was produced by Burns et al. under the terms of a commissioning contract issued by the Secretary of State for Health. This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed, the full report) may be included in professional journals provided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising. Applications for commercial reproduction should be addressed to: NIHR Journals Library, National Institute for Health Research, Evaluation, Trials and Studies Coordinating Centre, Alpha House, University of Southampton Science Park, Southampton SO16 7NS, UK.

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NLM Citation

Burns T, Rugkåsa J, Yeeles K, et al. Coercion in mental health: a trial of the effectiveness of community treatment orders and an investigation of informal coercion in community mental health care. Southampton (UK): NIHR Journals Library; 2016 Dec. (Programme Grants for Applied Research, No. 4.21.) Chapter 4, Ethical approval, registrations, user involvement and data.