HRA Approval - What you need to know

Do I need HRA approval?

HRA Approval is for research projects that involve the NHS in England.

It combines NHS Research Ethics Committee review with a review against NHS standards that individual NHS R&D offices or NIHR CSP previously performed.

HRA Approval is the route for applying for approvals for all project-based research in the NHS led from England. This includes portfolio and non-portfolio research projects, commercial and non-commercial research projects, those requiring review by an NHS REC and those not requiring NHS REC review.

You do not need HRA Approval if you are seeking NHS REC review only and do not need confirmation of capacity and capability from the participating NHS organisation (what used to be called R&D permission) (e.g. using NHS REC approval as a Human Tissue Legislation Licence exemption). In these cases apply to the HRA for NHS REC review only. If this applies to you then you don't need to go any further in this tool. If you aren't sure if you need review from and NHS REC visit Do I need NHS REC approval?

You do not need HRA Approval if there is no NHS care organisation involvement in the study (i.e. you do not require data or tissue samples from the NHS and/or your study will only take place on non-NHS sites). You do not need HRA Approval for studies that are accessing NHS data from central sources only, e.g. NHS Digital, Public Health England or Clinical Practice Research Datalink.

You do not need HRA Approval for Research Tissue Bank or Research Database ethical approval.

Studies led from England which have already applied for REC review but have not applied for R&D review, or need to add new NHS sites in England, or have new amendments, should follow the specific HRA Approval processes for these situations so that NHS sites in England can work with sponsors under the new arrangements.

See Working with individual NHS sites in any UK nation for site-specific information requirements.

Over the coming months, Radiation and Pharmacy Technical Assurances will be incorporated into HRA Approval as they roll out across the NHS. There is agreement that radiation and pharmacy assurances will be accepted across the UK. Processes are being put in place to facilitate this.

At the moment Radiation Assurance is a separate process. Currently this happens before the submission for HRA Approval and is therefore carried out ahead of submission of the IRAS Form. At the moment it only applies to ECMC (Experimental Cancer Medicine Centre) studies. More information can be found on the HRA Radiation Assurance webpages.

Please see the HRA Approval section of IRAS Help for more details.

If you have any queries or comments please contact the HRA at hra.approvalprogramme@nhs.net