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Article History

Received: 23 April 2019

Accepted: 12 December 2019

First Online: 26 December 2019

Ethics approval and consent to participate

: The University of Bristol Faculty of Medicine and Dentistry Ethics Committee gave full approval in 2007 for the AHEAD feasibility study and pilot trial (reference number 060702) and in 2011 for the cohort study (reference number 101119).Consent procedures were the same in the original feasibility study and pilot trial and in the subsequent cohort study. Firstly, written consent to participation was sought from each schools’ headteacher. Secondly, letters were posted by school staff to the parents/carers of all eligible school pupils explaining the study and enclosing a reply slip to be returned if parents/carers did not want their child to participate. This ‘opt-out’ method of consent has been found to be an ethical and appropriate procedure in low-risk prevention research and avoids the low response rates and potential sampling bias when opt-in parental consent procedures are used [,]. At all data collections, the young people were provided with information about the study and informed that they could ‘opt-out’ of some or all the study activities at any point and were asked to sign individual assent forms.

: Not applicable.

: The authors declare that they have no competing interests. RC is an NIHR Senior Investigator and member of the NIHR-PHR research funding committee. SA is a member of the NIHR-PHR research finding committee.