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Research Ethics Compliance Policy

1: Purpose

This policy outlines the requirement for all research conducted within the OpenSAFELY Service to comply with the research ethics requirements of NHS England. It contains the following sections for reference:

  • Purpose
  • Scope
  • Policy requirements
  • Determining whether an ethics review is required

2: Scope

The UK Policy Framework for Health and Social Care Research requires that all research project proposals are subject to review for a Research Ethics Committee. Therefore, all research projects applying to use the NHS England OpenSAFELY Service are subject to this policy. 

Service evaluations and audits of practice do not require such a review. See Section 4 of this policy for further guidance.

3: Policy requirements

As a condition of access to the OpenSAFELY Service, all research projects must align with the ethical standards set by NHS England.

Researchers:

  1. Must obtain an ethics review from an institutional or organisational ethics board (for example, a researcher’s university ethics committee) before the project application is submitted to NHS England for approval. It is not the responsibility of NHS England, or the OpenSAFELY Service, to obtain an ethics review on behalf of the Service User. 
  2. Must provide the OpenSAFELY Team with proof of this review, before their application is considered by NHS England.
  3. Must operate only within permissions granted by NHS England and any constraints outlined in the ethical review.
  4. Must cooperate with audits, reviews, or output checks as required.

4: Determining whether an ethics review is required

If a researcher is unsure whether or not their project proposal should be classified as research, and therefore subject to an ethics review, the Health Research Authority (HRA) provides guidance and a decision tool to help researchers assess this.

Alternatively, researchers may choose to consult a Research Ethics Committee (REC) for advice. Some institutions require that researchers consult their local REC when making this determination, and do not rely on the HRA tool – It is the researcher’s responsibility to ensure they comply with any such institutional requirements.

Researchers must specify the classification of their proposed project, together with details of how this was determined, as part of their project application. 

When reviewing a project application, if NHS England disagrees with its proposed classification, this will be communicated to the researcher. If NHS England considers that the project should be classified as research, and it has not been formally reviewed by a REC, the researcher will need to arrange and provide evidence of such a review before the application can be approved.

Last updated: 17 October 2025