Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, how the design of the Liverpool Innova later flow test programme was developed; which research protocol was used to conduct the study; how informed consent was secured from participants of the study; and which Research Ethics Committee approved the study.

The Liverpool City testing pilot was developed in collaboration between NHS Test and Trace, Liverpool City Council, NHS Liverpool Clinical Commissioning Group, Cheshire and Merseyside Health and Care Partnership and the 8th Engineer Brigade. This was a service evaluation and not intended as a research study. The Department and NHS Test and Trace liaised with the Medicines and Healthcare products Regulatory Authority over the use of the Innova lateral flow device in this post-validation pilot service.

The secondary analysis of data provided in a health protection activity is not classified as research and so does not require research ethics committee review. Where the gathering of additional information required interactions that were not a routine element of the pilot service, the local research ethics committee approvals were obtained.