To support the preparations for Coronavirus (COVID-19), we have made changes to the services we provide
HRA Approval includes NHS REC review, where applicable, and an assessment
Applications for HRA Approval are made using the IRAS form – this is a combined REC and R&D form.
SSI forms are not used for English sites while we continue to test an alternative approach to providing local information to sites. SSI forms remain in use for sites in Northern Ireland, Scotland or Wales.
Sponsors are responsible for providing the site (ie. simultaneously to the PI and local study team, the R&D office and, where applicable, the LCRN) with the local information package.
NIHR CSP is now closed to new applications; R&D Form and SSI form applications and amendments which have already been submitted to NIHR CSP will complete the CSP process.
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.
Amendments for all studies where the lead NHS R&D office is based in England will be categorized by the HRA and handled in line with the existing UK Process for Handling UK Study Amendments alongside review by an NHS REC where applicable.
Over the coming months, Radiation and Pharmacy Technical Assurances will be incorporated into HRA Approval as they roll out across the NHS.
Please see the HRA Approval Programme section of the HRA website for details.
The Department of Health Framework for Mental Health Research has been published and can be found here.
If you have any questions, please contact the Research and Innovation department on 01785 783170 or email@example.com