Welsh Government

Interim step in Wales to support 4 Nations implementation of the Local Information Pack

13 March 2018

Researchers working across the four United Kingdom countries should find it easier to set up and carry out health research across the NHS and Health and Social Care in Northern Ireland (HSC) as a result of a 4 National Compatibility Programme.

Sponsors of both commercial and non-commercial research will benefit from these changes, particularly when setting up studies with sites in more than one UK country.

The Four Nations Policy Group has agreed priority areas where they can collaborate to make it easier for researchers to undertake cross-border research in the UK.

  • A UK-wide Local Information Pack for the NHS/HSC created from within the IRAS application – which will mean a consistent approach to sharing information between sponsor and sites no matter where the site is in the UK
  • UK-wide use of the combined Research Ethics Committee (REC) and R&D IRAS form (already completed)
  • Consistent amendments process and online submission

To ensure we take advantage of the motivation and momentum to change that has been generated during 2017, an interim step will be taken in Wales as part of an incremental approach, ahead of full implementation of the Local Information Pack later in 2018.

The interim step means that Health and Care Research Wales will align its processes and paperwork so that there is consistency across England and Wales for researchers.

From 16 April 2018 all researchers starting new applications in IRAS with sites in Wales will complete a Statement of Activities/schedule of events (SoA/SoE) rather than Site Specific Information (SSI) applications. ‘In flight studies’ which have already started an SSI application 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.

  1. 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. e. 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.

Implementation of the interim step is being overseen/delivered by Matthew Harris, Research Engagement Lead. For more information, please liaise with your relevant R&D office for this information or contact Matthew Harris directly (matthew.harris@wales.nhs.uk ).


Workshops

Please confirm your place at a workshop by emailing Rachel Nelson: Rachel.nelson@wales.nhs.uk as some of the venues have limited capacity, by 23 March 2018.

27 March 2018 10:00-13:00 
Lecture Theatre 3, Upper Ground Floor, A Block, University Hospital of Wales, Heath Park 

29 March 2018 10:00-13:00 
Health and Care Research Wales Support & Delivery Centre, Cardiff Office: Training Room 1 

10 April 2018 10:00-13:00 
Seminar Room 1, Swansea University Institute of Life Science 1 (ILS1), Swansea University

13 April 2018 11:00-14:00
Lecture Theatre, Postgraduate Centre, Wrexham