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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 has been updated July 2023.


Standard description

Ethical review facilitates the appropriate use of data for public benefit. It helps applicants safeguard the rights, dignity, and well-being of their participants/data subjects. The type and extent of such a review will be dependent on the nature of the application. Ethical issues are not restricted to applications for identifying data, neither are they restricted to research applications. The applicant must assess their project for potential ethical issues.

In line with data sharing standard 5a (Objective for Processing) any moral or ethical issues raised by the proposed project must be briefly explained in the application, including actions taken to mitigate them. 

An ethical review should complement the applicant’s own consideration of the ethical issues raised by their project and their involvement of patients/service users, care professionals and the public. Even if a project is not classed as research, there are still likely to be ethical considerations. It is helpful to ask questions such as ‘would any of the data subjects have concerns about this work?’, ‘Could this work, or its outcomes, disadvantage a particular section of society?’ The obvious way to explore such questions is to engage with members of the population being studied.

Also, it is well worth considering using tools such as a Data Protection Impact Assessment or an Equality Impact Assessment. Such tools are often used to help meet legal requirements but can also be useful in detecting and resolving ethical issues.


Standard requirements

Step 1

Do you require Ethical approval from The Health Research Authority (HRA)?

Not all applications fall within the remit of the HRA. If there is any doubt, the applicant must consult the HRA to discuss their study. Any correspondence must be provided with the application.

If answer to Step 1 is No, proceed to Step 2

Else if answer is Yes - the evidence provided to NHS England should contain:

  • all relevant positive opinion/approval letters from the relevant HRA REC
  • the study protocol version for which REC approval is in place

The approval letter should refer to the same study as the application to NHS England.

The above documents will be considered to ensure the ethical approval aligns with the data requested and the purpose set out in the application. The organisation named in the positive ethical opinion/approval letter need not be the organisation named in the application if the ethical support and the application align in all other respects.

End of requirement 

Step 2

Even though the application is outside of the HRA’s remit there still may be ethical or moral issues that the applicant will need to address.  It may therefore need institutional or organisational REC review (for example, your university’s ethics committee).

Have you sought approval from a non-HRA REC? 

If answer is No then go to Step 3

Else if answer is Yes – the evidence provided to NHS England should contain:

  • all relevant positive opinion/approval letters from the relevant REC
  • the study protocol for which REC approval is in place.

The approval letter should refer to the same study as the application to NHS England.

The above documents will be considered to ensure the ethical approval aligns with the data requested and the purpose set out in the application. The organisation named in the positive ethical opinion/approval letter need not be the organisation named in the application if the ethical support and the application align in all other respects.

End of requirement

Step 3

  • Applicants should justify why they have not sought institutional support.

For example, if there is an ethical issue and there is no institutional body, the applicant will be required to set out what they done to address the ethical issues raised for example consulted an internal expert, such as a Caldicott Guardian, or an external body such as a patient charity that can help the applicant explore any ethical issues.

Last edited: 18 July 2023 1:10 pm