Hester, Katy L. M.
Ryan, Vicky
Newton, Julia
Rapley, Tim
De Soyza, Anthony
Funding for this research was provided by:
National Institute for Health Research (DRF-2012-05-149)
Article History
Received: 5 August 2018
Accepted: 3 February 2020
First Online: 15 April 2020
Ethics approval and consent to participate
: The conduct of this study was in accordance with the recommendations for physicians involved in research on human subjects adopted by the 18th World Medical Assembly, Helsinki, in 1964 and later revisions. Favourable ethical opinion from NRES Committee North East – Sunderland (reference 14/NE/0119) was granted, and R&D approval (reference 7005) from the Newcastle upon Tyne Hospitals NHS Foundation Trust was granted prior to commencement of the study. Any protocol amendments were approved by R&D and the Sunderland Research Ethics Committee and were communicated to all relevant parties: investigators, registries and participants. The study was registered with the ISCTRN Registry (ISRCTN84229105) on 25 July 2014. The study was also accepted into the CRN portfolio (UKCRN ID 16655). Information sheets were provided to all eligible subjects, and written informed consent was obtained prior to any study procedures.
: Not applicable.
: The authors declare that they have no competing interests.