HRA Approval completes implementation on 31 March 2016

17 March 2016
On 31 March 2016, the roll out of HRA Approval will be complete and HRA Approval will be the only route for approval of research in the NHS in 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.

The phased roll out of HRA Approval started in May 2015 and 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.

Please see the HRA Approval Programme section of the HRA website for details of these arrangements. This information will also be incorporated into the applicant guidance pages of the HRA website on 31 March 2016. There are also training resources and leaflets.

NIHR CSP will close to new submissions before the end of March. 

  • The last date for submission of R&D applications to the NIHR Coordinated System for gaining NHS Permission (NIHR CSP) is 23 March, and for SSI applications is 29 March 2016. The review of these applications may continue beyond the end of March in CSP.

  • Non-portfolio studies may make applications to sites up until 30 March 2016 and NHS organisations should continue to process them using their pre-HRA Approval system for non-portfolio studies.

Any SSI Forms that have not been submitted to CSP or to an R&D office in England prior to the above dates but contain useful information to support study set-up may be used as a mechanism to share information between the sponsor, the local research team, the relevant R&D office and the LCRN, where applicable. However these should not be handled as applications for NHS permission in England.

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 as described by GAfREC.  HRA Approval does not apply to Research Tissue Banks, Research Databases and studies taking place only in non-NHS sites. 

HRA Approval applies only to the NHS in England. Studies with sites in Northern Ireland, Scotland or Wales will be supported through existing UK-wide compatibility systems. Please note that NHS/ HSC organisations in the devolved administrations will continue to use SSI applications.

Any studies led from Northern Ireland, Scotland or Wales continue to apply using the existing systems in each nation. If there are English sites, the national R&D 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. English NHS sites are asked to note that applicants from the devolved administrations may not be familiar with HRA Approval arrangements for site set-up and may still transfer SSI Forms to sites. These should be regarded as part of the package of local information from the sponsor.

Your local NHS R&D office will be able to provide support but if you have any further queries or comments please contact the HRA at hra.approvalprogramme@nhs.net