Having only recently joined the HRA, I was delighted to be offered the opportunity to continue the work of my predecessors on our new 'carrying out research across borders' toolkit.
I previously worked within a sponsor office at an NHS Trust so I recognised immediately the value that this toolkit would have for people like me who didn’t really know or understand the approval processes outside of their own nation, but still needed to be able to support colleagues and researchers with any approval related queries that they had, whether it was nation specific or UK wide.
I was only able to respond to their queries by piecing together various bits of information that were proffered by internet searches, chats with colleagues and managers, and previous experiences that I had, but this wasn't quick, easy or ideal.
Having everything in one place would have made life much easier and saved valuable time searching for information.
We developed the toolkit with this in mind. It provides information on the main differences and similarities in research approval processes in England, Scotland, Northern Ireland and Wales.
An example of this is that the four nations of the UK take a consistent approach to study wide reviews so that you only need to submit one application on IRAS in most circumstances, but there may be some differences in the approval process that you may not necessarily be aware of, such as:
- for any research taking place in the NHS in England and / or Wales, you will receive a Health Research Authority and Health and Care Research Wales Approval letter
- in Northern Ireland each participating Health and Social Care body will confirm their capacity and capability after the relevant study wide reviews and participating site assessments and arrangements are complete
- for any research taking place in the NHS in Scotland, you will receive R&D permission after the relevant study wide reviews and site assessments and arrangements are complete
The toolkit provides more information on the differences in the communication of approvals for research, and other commonplace activities involved in the set up and conduct of research in the UK, as well as more complex areas such as the requirements for using medical devices in different nations and information on sectors whose research could overlap with the NHS, such as research involving prisoners or research taking place in social care.
We hope there is something useful for everyone and that by providing this information, along with where to find more detailed information about the processes across the UK, allows research to be better designed to be run throughout the UK from the very beginning, rather than having to adapt the study design as new information is uncovered over time. Furthermore, it should help people to know what to expect during the design, approval and site setup stages of research to enable them to be better prepared and in doing so, reduce the time taken at each of these stages.
It has been a pleasure to play a role in supporting this work on behalf of the HRA and work with colleagues from across the UK. Our work doesn’t end now though. As is always the case in research, things change so we will keep updating the toolkit to try to keep pace with those changes. With that in mind, if you do plan to use the toolkit, please ensure you visit the NHS Scotland website to get the most recent version.
Finally, I’d like to extend a massive thanks to all the people who worked on this project before me, as well as colleagues from across the nations. I can honestly say that I’ve learnt so much about the processes and legislation in different nations whilst working on this project so I hope that you also find some nugget of information in the toolkit to make setting up your study that bit easier.
A blog by Matthew Sanderson, HRA Research Regulation Specialist
Read the new toolkit
The toolkit can be found on the NHS Research Scotland website.
As guidance changes the toolkit will be updated to reflect requirements in all four nations.