Chmelo, J.
Phillips, A. W.
Greystoke, A.
Charman, S. J.
Avery, L.
Hallsworth, K.
Welford, J.
Sinclair, R. C. F.
Funding for this research was provided by:
The Jon Moulton Charitable Foundation (N/A)
Article History
Received: 5 February 2020
Accepted: 7 April 2020
First Online: 23 April 2020
Ethics approval and consent to participate
: Approval was granted by the Health Research Authority on 16 January 2019 (REC 18/WA/0427). Newcastle upon Tyne Hospitals NHS Foundation Trust (NUTH) acts as a study sponsor. This study is registered on ExternalRef removed (NCT04194463). Written informed consent will be obtained after patients have been provided with a participant information sheet and had sufficient time to consider their participation. We will ensure that patients understand that their participation is voluntary: the decision to participate (or not) will not affect a patients’ treatment in any way and they may withdraw from the study at any time without providing the reason. The consent process will be in accordance with Good Clinical Practice (GCP) guidance and local standard operating procedures. Participants will also be fully informed about requirements regarding data protection and direct access to their individual data.
: The authors declare that they have no competing interests.