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Ethical review

Ethical approval is essential for NHS research because it helps protect patients and the public by ensuring that research is appropriate, proportionate, transparent, and carried out with suitable safeguards.

The TVS SDE has approval from South Central – Oxford C Research Ethics Committee (REC) for a research database. (REC reference: 22/SC/0330)

If there has been no independent ethical review, the TVS SDE undertakes ethical review in line with the REC Research Database Conditions. These conditions allow projects to be reviewed under the research database approval The assessment draws on information provided across the Data Access Request Form (DARF), including:

  • the aims and purpose of the proposed work;
  • the potential benefits;
  • any patient and public involvement;
  • the data requested and why it is needed;
  • risks and how these will be managed;
  • potential bias, including selection and causal bias;
  • how findings and outcomes will be shared;
  • the proposed legal basis; and
  • any conflicts of interest.

 

Analysis methodology question guidance

The analysis methodology section helps reviewers understand how the proposed work will be carried out and whether the project is scientifically sound.

The TVS SDE undertakes a scientific critique of the proposed information science in the context of the data being requested. This is part of the REC Research Database Conditions, which state that research projects should be subject to scientific critique and be appropriately designed in relation to their objectives.

The TVS SDE team and Services and Data Access Review Committee (SARC) may include members who are not experts in your specific area of work. Please write this section in plain English so that all reviewers can understand the proposed approach.

We recognise that methodology may develop during the project. This section is not intended to duplicate a full peer review of the methods or statistical techniques. It helps the TVS SDE team and SARC understand the proposed work as a whole, including whether the approach is suitable for the data requested and the aims of the project.