"HRA Approval" completes implementation on 31 March 2016
Monday, 21 March 2016 10:01
From 31 March 2016, HRA Approval will be the process for applying for approvals for all project-based research in the NHS led from England. HRA Approval is the new system that brings together the assessment of governance and legal compliance for the NHS in England with the independent REC opinion provided through the UK Health Departments’ Research Ethics Service.
For any new studies that are led from outside England but have English sites, the NHS permissions coordinating function of the lead nation will share information with the HRA Assessment team, who can issue HRA Approval for English sites and thereby retain existing compatibility arrangements.
This completes the phased roll out that has been underway since May 2015. NIHR CSP (Coordinated System for gaining NHS Permission) will be closed to new applications before the end of March. The timing of the closure of CSP has been agreed between the NIHR Clinical Research Network, the HRA and the devolved administrations.
Studies led from England that have already applied for REC review but have not applied for R&D review, or that need to add new NHS sites in England, or have new amendments, should be brought under HRA Approval so that NHS sites in England can work with sponsors under the new arrangements.
The HRA has closely monitored studies going through HRA Approval and revised processes as part of learning from and building on experience. Each phased roll out has built on the previous one. The latest phase includes:
- A mechanism for studies processed under pre-HRA Approval systems (eg. NIHR CSP and pre-CSP systems) to be brought under HRA Approval to add new NHS sites in England
- Amendments for all studies where the lead NHS R&D office is based in England being 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.
- HRA Approval being available to student studies led from England that require review by an NHS REC or are taking place across more than one NHS organisation.
Over the coming months, Radiation and Pharmacy Technical Assurances will be incorporated into HRA Approval as they roll out across the NHS.
HRA Approval is now the route for all project based research taking place in the NHS in 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.
Please see the HRA Approval Programme section of the HRA website for details. This information will be incorporated into the applicant guidance pages of the HRA website on 31 March 2016.
If you have any queries or comments please contact us.
UEG Research Prize 2016
Wednesday, 02 March 2016 10:24
The prize will be awarded for excellence in basic science, translational or clinical research. The recipient must be able to demonstrate that the previous work has had an impact in its field and that its quality has been recognised internationally. The recipient will have produced a substantial body of basic science, translational or clinical research in a focused area of gastroenterology, hepatology or related disciplines. Priority will be given to applications where science has had crucial impact on clinical practice and management, or is very likely to have it in the near future. Furthermore, the recipient must have been mentioned at least once as (co-)author of an abstract submitted to UEG Week in the past 3 years.
A detailed prospect of more than 5 years of future research activity is required in the application form and must be guaranteed by the recipient when the prize is awarded. The prize money of €100,000 will be paid to the recipient's department.
Furthermore, UEG expects the UEG Research Prize Winner to
- submit a review article to the UEG Journal by end of October 2016 (https://www.ueg.eu/journal/)
- accept potential UEG Week Faculty invitations in subsequent years.
In order to apply for this prize please visit the UEG Website and complete the online application by May 13, 2016 at the latest. Hard copies will not be accepted. In order to guarantee that your submission process was successful, UEG will acknowledge the receipt of each application via return email.
- Further information [ 152 kb ]
Health Data: Better Care or Privacy Nightmare?
Monday, 29 February 2016 10:51
A panel discussion chaired by Sharmila Nebhrajani OBE, with Professor Liam Smeeth, Sam Smith and Peter Knight will be held on Tuesday 15 March 2016, 18.30 – 20.30
Price: £5 (booking required) and Light refreshments provided
Doors open at 18.00 at the British Library, 96 Euston Road, London NW1 2DB
- How will the NHS and UK Government utilise data generated by initiatives such as care.data and the 100,000 Genomes Project?
- Is it possible to guarantee the secure and ethical use of health data?
- How can we effectively communicate the risks and benefits of personal data usage to the general public?
Research Design Services
Friday, 19 February 2016 13:48
The NIHR Research Design Service (RDS) network helps researchers prepare proposals for submission to NIHR and other national, peer-reviewed funding competitions for applied health or social care research, by providing expert advice on research design and methodology. RDS advisers in bases across England offer a unique breadth of experience and a proven track record in improving research applications. Advice is confidential and free of charge. For more information, visit the Research Design Service website.
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