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Data sharing standard 7a - Ethical Approval

This standard is part of a series of guidance documents to support the various stages of a DARS application.

Note to applicants

This standard is currently under review. The special provisions for the National Disease Registration Service data are a consequence of the transition of that service from Public Health England (PHE) to NHS Digital. The provisions reflect the historic approach taken by PHE to ethical review.

Standard description

The applicant must assess their project for potential ethical issues and, as indicated within data sharing standard 5a (Objective for Processing), briefly explain any moral or ethical issues and how they will resolve or mitigate them.

The below requirements must be met (neither, either or both depending upon the data requested).  Applicants should note that NHS Digital will review the concordance of document versions submitted for REC approval, against those submitted to the ODR as part of their data request. Applications will be deferred where version control does not align.

Applications for identifiable data (including identifiable NDRS data)

Where the application involves identifiable data the applicant must provide evidence of ethical approval or the outcome from the HRA tool (which includes the answers to the screening questions) which evidences that the ethical approval is not required. 

Where ethical approval is required, the following documents should be provided and  will be considered to ensure that the ethical approval is aligned to the data requested and the purpose set out in the application:

  • any relevant approval letters from the relevant ethics committee
  • the study protocol referred to in that approval letter
  • the most recent protocol (if different from the above)

The approval letter(s) should refer to the same study as the application, but the organisation named in the ethical approval letter need not be the organisation named in the application.

Applications for non-identifiable National Disease Registration Service (NDRS) data

To respect previously existing Office for Data Release requirements, any research application for NDRS data will need ethical support as set out below.

If the application requests data that relates to NHS patients or their care, the application must demonstrate that the project has NHS Research Ethics Committee (REC) Favourable Opinion from the Health Research Authority.

Applicants must demonstrate this approval by providing: 

  • the name of the research ethics committee
  • reference assigned by the committee
  • copies of the approval letter(s) from the committee and/or acknowledgement of amendments to an existing approval, where either a substantial amendment has been sought or the committee has been informed of a non-substantial amendment

If the application requests only data that does not relate to NHS patients or their care, institutional REC approval is sufficient (ethical oversight and approval from the applicant’s own organisation).

Where applicable, evidence of this approval must also be sent with the details listed above (committee name, project reference, evidence of approval and/or acknowledgement of any amendments).

Last edited: 6 May 2022 8:16 am