Health Research Authority
The new GDPR regulations came into effect on 25th May 2018. For a full and comprehensive outline of the changes, please visit the HRA website: https://www.hra.nhs.uk/planning-and-improving-research/policies-standards-legislation/data-protection-and-information-governance/gdpr-guidance/.
HRA Approval was fully implemented on 31 March 2016 and is now the route for applying for approvals for all project-based research in the NHS led from England: portfolio, non-portfolio, commercial and non-commercial, those requiring review by an NHS REC and also those not requiring NHS REC review. HRA Approval does not apply to Research Tissue Banks, Research Databases and studies taking place only in non-NHS sites.
This completes the phased roll out that has been underway since May 2015.
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 SSSFT Research and Innovation department on 01785 783170 or firstname.lastname@example.org.