HRA Approval - What you need to know

Site confirmation

Each site will confirm in writing that you can start site initiation. The exact form of confirmation will be specified in the HRA Approval letter, e.g. an agreement of the Statement of Activities by email, or another written contract / agreement exchange. Once the site has confirmed in the specified way, you can start any necessary site initiation procedures. Following initiation the site will be ready to start recruitment.

The type of agreement used depends on the nature of the study. For some studies the Statement of Activities agreed between site and sponsor is sufficient and replaces the NHS permission letter in England. For other studies, particularly where a clinical intervention is involved, an agreement is necessary and it too replaces the NHS permission letter.

If you / your sponsor has a green light procedure, this may need to be reviewed in light of changes in process.

Sites in Wales, Scotland or Northern Ireland: Systems vary across the UK and sponsors are expected to have discussed the project with local researchers at the participating sites and the relevant R&D office. The instructions in IRAS for submitting NHS SSI forms should be followed. See Studies involving or led from Scotland, Wales or Northern Ireland.

Non-NHS sites: If your study includes non-NHS research sites, you may need to generate and submit non-NHS Site Specific Information (SSI) forms in IRAS. Please refer to the HRA website Site Specific Assessment section for more information.

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.

Radiation Assurance

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.

There is agreement that radiation and pharmacy assurances will be accepted across the UK. Processes are being put in place to facilitate this.

Please see the HRA Approval Programme section of the HRA website for details.

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