19 Oct

What approvals has this study received?

Everyone who received a flexible sigmoidoscopy as part of the UKFSST gave their consent for this procedure (40,674 people).

Consent was not sought from people who received no further contact other than the initial questionnaire as the group in question was extremely large (335,070 people) and it was not possible to ask for consent from each individual.  We received permission to conduct this research study from the independent ethical review committees and organisations responsible for the data of NHS patients, including:

  • local research ethics committees in each of the 14 centres and the South-East multicentre research ethics committee;
  • Section 251 approval from the Patient Information Advisory Group (PIAG – a predecessor of both the National Information Governance Board/NIGB and the Confidentiality Advisory Group) in England, and an equivalent panel in Scotland, the Privacy Advisory Committee (now the Public Benefit and Privacy Panel for Health and Social Care) of National Services Scotland (NSS);
  • Research and Development approval from the NHS Trusts managing the centres involved in the trial;
  • approval from the Caldicott Guardian of the North West London NHS Trust;
  • approval from the UK Cancer Registries, NHS Digital, NHS Central Register (NHSCR), and the Office for National Statistics (ONS).