Rhodes, Freya
Cococcia, Sara
Panovska-Griffiths, Jasmina
Tanwar, Sudeep
Westbrook, Rachel H.
Rodger, Alison
Rosenberg, William M. http://orcid.org/0000-0002-2732-2304
Article History
Received: 27 October 2020
Accepted: 18 March 2021
First Online: 31 March 2021
Declarations
:
: This study was reviewed by the Royal Free London NHS Foundation Trust Research and Development Office and deemed to be a service evaluation of an established pathway of care, using an established and CE marked diagnostic test. Using the Health Research Authority Tool (ExternalRef removed) the study did not meet the criteria that would require it to undergo external ethical review but rather to be registered as a service evaluation conducted within the NHS Trust. It was registered with the Royal Free London Audit and Service Evaluation Department on the 10<sup>th</sup> October 2018. Based on this review of the study the Royal Free London NHS Foundation Trust Research and Development Office deemed that there was no necessity to obtain informed consent from participants in this service evaluation. Although not deemed to be “research” using the HRA Tool, the study was in compliance with the regulatory requirements for service evaluations and was conducted in accordance with the principles of the WMA Declaration of Helsinki.
: Not applicable.
: WMR is an inventor of the ELF test but receives no related royalties. WMR has received speaker’s fees from Siemens Healthineers. The other authors declare no competing interests.