This is thanks to the UK research approval bodies carrying out a new programme of work to implement;
- a consistent nationwide approach to sharing information between sponsor and sites;
- a single ethics and R&D online submission from the Integrated Research Application System (IRAS); and
- an improved UK-wide approach to amendments.
The aim is to ensure compatible and consistent ways of working across England, Scotland, Wales and Northern Ireland further developing the UK as a cohesive and streamlined place to undertake research within the global economy.
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 four 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 – this roll-out has already begun, with studies being led from Northern Ireland, Scotland and Wales now using, as England-led studies have done for some time, a single form for submission to a Research Ethics Committee (where appropriate) and the national R&D coordinating function for the lead nation.Single IRAS form Q&A A Q&A document explaining this development is available. The next stage builds on this and enable e-submission of IRAS forms for NI, Scotland and Wales. The programme will also address arrangements for single site studies in Northern Ireland and Scotland
Consistent amendments process – A clear UK-wide process for amendments across NHS/HSC will mean applicant guidance and amendment implementation will be clearer across the UK. Some initial guidance clarification has already been published.
- Online amendment submission – Researchers will be able to submit amendments simultaneously to a REC (where appropriate) and the national R&D coordinating function for the lead nation. This work will build on e-submission of the combined IRAS form across the UK and will ease the administrative burden for everyone.
For applicants, the benefits of these changes will be:
- consistent and compatible processes UK-wide;
- reduced number of applications to manage, and reduced confusion; and
- online submission, saving time.
This programme of work will involve information technology developments in IRAS, publication of updated guidance, and change management work across the UK.
Mary Cubitt from the HRA has been appointed part time as Four Nations NHS/HSC Compatibility Programme Manager to kick start the work.
Work has already begun and as different elements are ready they will be implemented in stages. The initial focus is a consistent UK wide local information pack for which an implementation timetable will be released after the information technology developments are more advanced but it is expected to be delivered towards the end of 2017. Keep an eye out for updates.
The organisations involved are Health and Social Care in Northern Ireland, NHS Research Scotland, Department of Health and the Health Research Authority in England, and Health and Care Research Wales.