Chief ExecutiveMatt Westmore
Advent calendars are almost empty. Whamageddon is in full flow. And I’ve pencilled in my annual argument with my family as to whether Die Hard is a Christmas movie (spoiler alert, it is).
So, that can only mean one thing. It’s beginning to look a lot like Christmas, and it’s that time of year again where I take a minute to step back and reflect on everything we’ve achieved this year.
In my blog this time last year I looked ahead to what I promised would be a year of exciting changes for health and social care research in the UK.
I’m proud to say that we have made some great progress in 2025.
I’ll start with something we have been building to for many years. Last week we celebrated a huge milestone in our work to replace and update IRAS.
On 10 December the very first users accessed our new ‘Plan and Manage Health and Care Research’ service to make changes to their active research.
We’ve started small, with just 10 sponsors invited to use the service to start with, but this is a huge step forward for us. It marks the beginning of the transformation of the way that health and social care research is done in the UK. We’ll be scaling up the new services gradually, starting with modifications (the new name for amendments you’ll start to hear more often) and adding more users and new functionality in the new year.
Just as IRAS transformed the way things were done when it launched back in 2008, Plan and Manage Health and Care Research will mark a similar shift in making it easier for everyone to do research in the UK.
Thank you to everyone who has helped us to get to this stage, including our early adopters who have taken this big first step with us, the team behind developing the new service who have worked relentlessly to get us here and to everyone who has given feedback on IRAS over the years. We’re doing our best to incorporate all the feedback you have given so together we can develop a world leading system that we are all proud of.
Throughout 2026 we will slowly be bringing more users on board with the new service. Alongside our work on modifications, we’ll be designing services for non-CTIMPS and then for CTIMPs. We’re really keen to involve the research community in the development of new services, so keep an eye out for opportunities to get involved and test new systems in the new year.
2026 will also see the updated clinical trials regulations roll out across the UK. This is something we have been working on with the Medicines and Healthcare products Regulatory Agency (MHRA) in preparation over the last 3 years and represents the biggest overhaul of clinical trials regulations for 20 years. It will mean clinical trials are approved faster, in risk proportionate ways, whilst improving research transparency and inclusion.
The new regulations will come into force on Tuesday 28 April 2026, and we’re busy supporting researchers and sponsors to understand what is changing and how they can best prepare.
If you haven’t taken a look at the guidance available on the HRA or MHRA websites on the changes, before you put your out-of-office on for Christmas, please do take a look.
This has been a huge undertaking for both organisations, and shows the real power and unique strength of the regulatory system in the UK where we work together to achieve meaningful change.
One of the biggest moments this year was in April when the Prime Minister gave us an ambitious challenge to cut the time it takes to get a clinical trial set-up in the UK to 150 days by March 2026.
Speeding up research means that patients get access to life-changing drugs and treatments faster, and the UK is a more attractive place for global companies to invest in research. We are working with partners as part of the DHSC-led UK Clinical Research Delivery (UKCRD) programme to deliver the changes that are needed to achieve the 150 day target.
I am proud of the work the HRA has done to support fast study and site set-up.
This month marked 2 straight years of the HRA achieving our monthly target of providing a final opinion on 100% of all clinical trials of investigational medicinal products (CTIMPs) in England within 60 days of submission. This is an amazing achievement. I want to say a huge thank you to our amazing Research Ethics Committee (REC) Confidentiality Advisory Group (CAG) volunteers, technical assurance teams and everyone working behind the scenes at the HRA, to ensure approvals are completed not only quickly, but still to the highest level of scrutiny we pride ourselves on.
Over the past 12 months we have updated the suite of model agreements used to agree contracts for commercial research, overhauled our information governance guidance and piloted a new approach to pharmacy assurance.
We know that these changes won’t fix things overnight, but these are small changes that together we hope will help make it easier to set up research in the UK. We know there’s much more to do in 2026.
Of course, whilst the speed and ease of being able to start research is important, it’s equally important to ensure that research is done to a high standard. That means that it is carried out transparently, involves members of the public in the design and delivery of research and includes participants from a range of backgrounds.
The UK offers a unique destination for research, with our relatively diverse population and a single healthcare provider. To help realise this potential in 2026 we will be leading the development of a UK-wide strategy and roadmap to drive greater diversity and inclusion in clinical trials, which should make it easier to recruit appropriately diverse participants to take part in trials. This is a really exciting opportunity to help make the UK an even more attractive destination to do commercial clinical research – which is something that we can all benefit from.
Underpinning all of our work so far this year has been our new strategy for 2025-28. We took the opportunity to align our strategy with the new government’s priorities, and there’s a golden thread running through our work now that shows how what we are doing helps achieve the government’s priority to develop a health and social care system that stays fit for the future and helps our economy grow.
Our mission remains unchanged – to make it easier to do research that people can trust.
I was delighted to welcome some new faces to our Board to help oversee this new direction. In July Neelam Patel was appointed as our permanent Chair having served as Interim Chair since Professor Sir Terence Stephenson stood down from the role at the start of the year. We also welcomed 3 new Non-Executive Directors, Professor Alastair Denniston, Professor Marian Knight MBE and Mark Buswell. Their expertise has been vital and I am grateful for their input and look forward to working with them in 2026.
One of the things that will be a focus for everyone over the next 12 months is the use of artificial intelligence (AI). There’s a real opportunity for us to unlock the full potential of AI and use it to help in a number of areas. I’m excited to see not only how we can better use AI as an organisation, but how we can support researchers to use it to help them write applications and confidently use it in their research.
We know this is a fast moving environment as the technology evolves almost on a daily basis. Research can only truly move forward at the speed of trust, so we need to make sure that we provide clarity on how artificial intelligence can be used safely and ethically. The National Commission into the Regulation of AI in Healthcare being led by the MHRA will play a huge role in making recommendations for a new regulatory framework for the use of AI in healthcare. The commission is being co-chaired by one of our new Non-Executive Directors, Professor Alastair Denniston, so we're looking forward to hearing his unique insight from the commission as it progresses.
Another area of focus will be continuing to build on our strong relationship with the MHRA. Combined Review is now well established and has been a real success for both organisations. We are now looking at what else we can work more closely on to be better aligned and improve the experience of the regulatory process in the UK.
Next year we will also be celebrating the 15th anniversary of the formation of the Health Research Authority. It’s a real milestone for us, with the HRA now firmly established as an important part of health and social care research landscape in the UK.
Not only is our reputation growing in the UK, but on the global stage too. Earlier this year I was invited by counterparts in Canada to co-chair the selection panel to help establish a new pan-Canadian single ethics review service. They were keen to learn lessons from our work in the UK and we are seen as world leaders in this space. Throughout the year we’ve been invited to talk at events in the USA, Germany and Switzerland, the later of which was to join the World Health Organization’s Global Clinical Trials Forum as a founding member, and have provided our experience and advice to the WHO more generally, as well as to Australia and South Africa. I do this gladly, not just to help improve health for anyone in the world, but it is also a great way of learning from (and keeping an eye on!) them as well.
I want to round off my blog this year by saying a huge thank you to our amazing staff and volunteers at the HRA. Without you none of what I’ve talked about in this blog would be possible. At the end of December I always get a round up of our key numbers for the year and I have to take a minute to let it soak in.
Our RECs provided opinions on 3,126 new research projects in 2026. That’s more than 8 a day! We now have nearly 900 REC members, and ably supported by our staff, they have also ensured that more than 6,000 substantial amendments were reviewed this year too – 92% of which within 35 days which is a phenomenal achievement.
I want to say a special thank you to everyone who volunteered to be part of our Seasonal REC this year. Our volunteers already give so much of their time, but to give more time to ensure study reviews aren’t delayed over Christmas is something I’m very grateful for. The additional four meetings we were able to hold meant 14 more studies were reviewed, and vital research makes its way to patients sooner.
I wish you all a very merry Christmas and hope that you get to spend time with your loved ones as we bring in the new year.
I look forward to working with you all again in 2026 in what promises to be another busy year for everyone at the Health Research Authority.