To support the preparations for Coronavirus (COVID-19), we have made changes to the services we provide
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/
For patient information on the GDPR regulations please visit the HRA website: https://www.hra.nhs.uk/information-about-patients/
Get Involved: If you are happy for the research team to contact you regarding taking part in research, please complete the 'Consent to Contact' form below and return to the team by email; by dropping it into the Trust at your next appointment; or by post to
Midlands Partnership NHS Foundation Trust
Research and Innovation Department
Top Floor, Block 7
St. George’s Hospital
If you return the form by email please complete the form and email to email@example.com
You do not need to attach an electronic signature and if you are unable to print the form and scan it in then your email will be taken as confirmation of your consent.
The Health Research Authority (HRA) is a non-departmental government body of the Department of Health and Social Care. 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.
- 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. This can vary from study to study but usually consists of
- Localised Organisation Information Document
- IRAS Form
- Protocol and any Amendments
- Relevant Model Agreement
- Schedule of events of SoECAT
- Delegation log
- Any other documents the Trust requires to support set up and delivery of the study
- 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 continue to 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 783180 or firstname.lastname@example.org