Welsh Government

Obtaining approval

You will need to apply for HRA and Health and Care Research Wales Approval, which needs to be in place before you can start your research study. HRA and Health and Care Research Wales Approval is the process for applying for approvals for all project-based research in the NHS led from England or Wales. 

For information on HRA and Health and Care Research Wales Approval please go to 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).

This page includes the following sections:

Submitting Your Application

Studies involving Northern Ireland and Scotland

Planning and Documentation

Setting up NHS Sites in Wales

Amendments

Background Information

Submitting Your Application

All applications are made using the UK’s online Integrated Research Application System (IRAS). For information on how to prepare and submit an application for HRA and Health and Care Research Wales Approval please refer to the IRAS website.

All applications are made by e-submission of the IRAS Form and associated documents and applications are booked in through the Central Booking Service (this includes studies which do not require NHS REC review).

Detailed guidance on e-submission is available here. 

Read more about e-submission at the Four Nations Compatibility webpage.

What happens next?

The application documents will be checked and you may be contacted to request additional documentation or information. Once your study is valid for Research Ethics Committee review (where applicable) and HRA and Health and Care Research Wales assessment, you will be advised of the name of the reviewer who will be assessing your application for HRA and Health and Care Research Wales Approval.

The reviewer undertaking HRA and Health and Care Research Wales assessment and the Research Ethics Committee (where applicable) will contact you as the application goes through the review process. For advice on the application process please contact the Health and Care Research Wales Permissions Service.

Studies involving Northern Ireland and Scotland

For new studies that are led from Northern Ireland or Scotland but have English and/or Welsh NHS sites, the lead nation will share information with the HRA and Health and Care Research Wales to enable the issue of HRA and Health and Care Research Wales Approval for English and Welsh sites.

For new Welsh led studies which have NHS sites in Northern Ireland and / or Scotland, the Permissions Service will share information with participating nations. The relevant R&D coordinating function will provide advice on the setting up of sites in their nation.

Planning and Documentation

You will need to ensure you are conducting research to required standards and are compliant with relevant legislation. See the policies, standards and legislation page for details. Information on planning your study is available in the HRA website research planning section.

Bite-sized learning module for student researchers: Applying for HRA and Health and Care Research Wales approval - getting it right first time

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.

Setting up NHS Sites in Wales

Before applying for HRA and Health and Care Research Wales Approval, a sponsor is expected to have identified potential participating sites that will be listed in the IRAS application and in most cases have discussed the project with local researchers and the research management staff supporting them.   To add new sites that are not listed on Part C of the original IRAS form, please make an amendment to the study, following the guidance available in IRAS.

Once the sponsor receives the HRA and Health and Care Research Wales Approval initial assessment letter (or HRA and Health and Care Research Wales Approval letter in cases where no initial assessment letter is issued) they can contact participating NHS sites in Wales to provide them with local information and finalise discussions around confirming capacity and capability.  Further information on local information documents can be found on the HRA website*.

Bite-sized e-learning module for student researchers: Setting up research sites in participating NHS organisations in England and Wales

*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).

Amendments

Amendments to all studies should be submitted according to the IRAS Help guidance.

Applicants should submit amendments for Welsh led studies by e-mail to the Health and Care Research Wales Permissions Service to be categorised in accordance with the UK wide management of amendments process. Applicants should also notify their Research Ethics Committee of any Substantial Amendments following the standard process for this.

In addition to categorisation, amendments for Welsh led studies are reviewed to ensure HRA and Health and Care Research Wales Approval is extended to incorporate the approved amendment. The amendment categorisation e-mail provides information on this. HRA and Health and Care Research Wales Approval for amendments is confirmed separately by email.

Background Information

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.

HRA and Health and Care Research Wales Approval brings together the assessment of governance and legal compliance, undertaken by dedicated HRA and Health and Care Research Wales staff, with the independent ethics review provided by the Research Ethics Service. 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.

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