HRA Approval currently applies to project-based research taking place in NHS organisations and independent contractor primary care services. HRA Approval does not yet cover non-NHS organisations commissioned to provide NHS services. For CTIMPs and Clinical Investigations of Medical Devices, the non-NHS/HSC Site Assessment Form (available in IRAS) should be provided with the application and the suitability of the site will be included as part of the ethical review. The non-NHS/HSC Site Assessment Form does not need to be provided for other study types.
Many studies taking place in non-NHS organisations commissioned to deliver NHS services will have HRA Approval because of the NHS sites involved. In those circumstances, non-NHS organisations can take into account the assurances provided by the HRA Approval letter.
As HRA Approval continues to refine and develop, we will undertake further work to ensure that HRA Assessment includes the needs of the wide variety of non-NHS providers.
Studies which are taking place entirely outside of the NHS may still need to apply for an ethical opinion from an NHS REC. Examples of these include Phase 1 studies in healthy volunteers, any study involving adults unable to consent for themselves requiring approval under the Mental Capacity Act (in England and Wales) or the Adults with Incapacity Act (Scotland) and studies involving human tissue where REC review is required as set out in Governance Arrangements for Research Ethics Committees (GAfREC).
If you are still unsure about whether your research project is classed as non-NHS research, please contact the HRA queries Line.