Sinclair, Lesley
,
McFadden, Margaret
Tilbrook, Helen
Mitchell, Alex
Keding, Ada
Watson, Judith
Bauld, Linda
Kee, Frank
Torgerson, David
Hewitt, Catherine
McKell, Jennifer
Hoddinott, Pat
Harris, Fiona M.
Uny, Isabelle
Boyd, Kathleen
McMeekin, Nicola
Ussher, Michael
Tappin, David M.
Funding for this research was provided by:
Chief Scientist Office, Scottish Government Health and Social Care Directorate (HIPS/16/1)
Cancer Research UK (C48006/A20863)
Chest Heart and Stroke Northern Ireland (2017_09)
Public Health Agency NI (1)
Scottish Cot Death Trust (1)
HSC Research and Development Division (COM/5352/17)
Lullaby Trust (272)
Article History
Received: 30 September 2019
Accepted: 30 December 2019
First Online: 14 February 2020
Ethics approval and consent to participate
: Ethics approval was received from West of Scotland REC2 on 15 August 2017.R&D approval was given to allow SSS staff to pass information to the TCC if the client gives verbal permission. Those who consent to take part in the trial will be sent a written copy of their consent form. In addition, potential participants receive an information sheet which communicates data confidentiality procedures, the fact that participation is entirely voluntary, and the possibility of leaving the study at any time and without justification.Substantial amendments:• AM02, 8 November 2017: changes to main consent form, main PIS and protocol. REC approved 20 November 2017• AM06, 10 July 2018: new procedures to improve recruitment: introduction of trial posters and summary PIS for use in antenatal clinics; permission for local trial staff to contact potential participants to further explain the trial prior to consent. Process evaluation: implementation of £25 voucher for women taking part in interviews to compensate for their time; other minor changes to interview processes. REC approved 4 September 2018The annual report dated 8 August 2018 informed the ethics committee that new sites were to be involved and that one new site had agreed to take part. ‘On the 26th of July 2018 one new site confirmed that they would like to be a site and could use their own research network staff for local research nurse input required by the trial.’ Four other sites in the same area have also agreed to take part. The sponsor designated addition of these sites as minor amendments AM08 and AM09. The ethics committee has been informed regarding these new sites in the annual report dated 13 September 2019.
: Not applicable.
: The authors declare that they have no competing interests.