Radiation Assurance update April 2018: read more here
HRA and Health and Care Research Wales Approval is the process for the NHS in England and Wales that brings together the assessment of governance and legal compliance, undertaken by dedicated HRA and Health and Care Research Wales staff, with the independent REC opinion provided through the UK Research Ethics Service.
HRA and Health and Care Research Wales Approval applies only to the NHS in England and Wales. Studies led from England or Wales with sites in Northern Ireland or Scotland will be supported through existing UK-wide compatibility systems, by which each country accepts the centralised assurances, as far as they apply, from national coordinating functions without unnecessary duplication.
Submitting your application where the lead site is in Wales
The process for submitting your IRAS Form where the lead site is in Wales will vary depending on whether your project requires review by an NHS REC.
Studies requiring REC Review
Wales is currently rolling out joint validation which incorporates both assessment and ethical review validation. Currently however you may still receive separate validation letters for the assessment and ethical review aspects of your approval.
To ensure your application is 'valid first time' then you are encouraged to read the information contained on the HRA website research planning section.
During this interim period of rolling out the joint validation process and the implementation e-submission, please ensure Health and Care Research Wales are notified of all studies which are Welsh led via email (Researchemail@example.com). Please ensure to include the following information:
By informing Health and Care Research Wales it will allow us to identify the study on the NHS REC document management system, removing the need for applicants to send a separate email containing the study documents. If you have not heard from Health and Care Research regarding your application after 7 working days please contact us.
Further guidance on submitting an application for projects that require a review by an NHS REC is available on the HRA Website*.
*Please note that the HRA website is currently being updated to reflect HRA Approval extending to Wales (HRA and Health and Care Research Wales Approval).
Non NHS REC studies
For all studies that involve the NHS but do not require review by an NHS REC please submit your application directly to Health and Care Research Wales. To determine whether your study requires and ethical opinion or not please review the guidance on the HRA website.
For non-commercial studies, you must prepare the Statement(s) of Activities and Schedule(s) of Events documents for each type of research site in your study.
For commercial studies, you must prepare the draft template agreement you propose to use with sites, the costing template and a template delegation log. For studies which are part of the National Institute for Health Research (NIHR) Clinical Research Network (CRN) Portfolio (studies with sites in England) you must ask the lead CRN to validate the costing template, at least one week before application for HRA and Health and Care Research Wales Approval.
In flight studies
‘In flight studies’ which have already started an SSI application (Site Specific Information) will continue to use this route. Until 10 June 2018, applications on either documentation will be accepted in Wales, but after this date all applications should be submitted using SoA/SoE for non-commercial studies and provide the above documentation for commercial studies.
Where an SSI has been submitted to an NHS organisation and/ or in the process of exchanging agreements, the NHS organisation will continue to issue NHS Research Permission.
All applications received in Wales after 16 April 2018, regardless of the documentation completed, will follow a process that is aligned across England and Wales, and which maintains compatibility across the UK. The Permissions Service in Wales will undertake “Health and Care Research Wales Assessment/Approval”, and NHS organisations as sites will facilitate conversations to assess, arrange, and “confirm capacity and capability” to deliver the study.
If you have any questions regarding the processing of ‘inflight studies’ please email Health and Care Research Wales permissions team for guidance and support.
Studies involving Northern Ireland and Scotland
For any new studies that are led from outside England or Wales but have English and/or Welsh NHS sites, the national R&D coordinating function of the lead nation will share information with the HRA and Health and Care Research Wales who can issue HRA and Health and Care Research Wales Approval for English and Welsh sites and thereby retain existing compatibility arrangements.
Amendments(s) to all studies involving the NHS/HSC should be notified to NHS/HSC according to the IRAS Help guidance.
Applicants should continue to submit Welsh led amendments to Health and Care Research Wales Permissions team to be categorised in accordance with the UK wide management of amendments process. Applicants should continue to notify their NHS REC of any Substantial Amendments as well as per standard processes.
In addition to categorisation, we are further aligning our processes with England and will be reviewing amendments for welsh led studies to ensure HRA and Health and Care Research Wales Approval is extended to incorporate the approved amendment.
On 31 March 2016, HRA Approval was introduced as the process for applying for approvals for all project-based research in the NHS led from England. As of 16 April 2018 this has been extended to include all project-based research in the NHS led from England or Wales, and is referred to as “HRA and Health and Care Research Wales Approval”. Further information regarding this change is available here.
The new process replaces the need for local checks of legal compliance and related matters by each participating organisation in England and Wales. This allows participating organisations to focus their resources on assessing, arranging and confirming their capacity and capability to deliver the study.
Please continue to review our website for future updates/ information on the above.