Welcome to HRA Latest, with news and updates for everyone working or involved in health and social care research.
As we approach the final weeks of 2024 this is our last full edition of HRA Latest, so keep reading for everything you need to know.
Today we've launched an informal consultation on proposals to simplify the process of seeking and recording consent in low-risk clinical trials. It's part of our work on the UK's new Clinical Trials regulations which you will hear much more about in 2025.
As part of our preparations for the new regulations we're also testing a new Inclusion and Diversity Plan. The plan and supporting guidance has been produced with the Medicines and Healthcare products Regulatory Agency (MHRA) to help researchers design more inclusive studies. Scroll down to sign up to our pilot.
And finally, I'm proud to share our annual report on Research Ethics Committees in England. The report is an overview of their brilliant work and highlights their huge contribution to UK research. I really recommend reading it.
As always thank you for reading HRA Latest.
We're no longer active on X, but for the latest news from the HRA, you can follow us on LinkedIn or sign up for updates on specific topics you're interested in.
Matt Westmore Chief Executive
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Simplifying the process of seeking and recording consent in low risk clinical trials
The laws which regulate the way clinical trials of medicines are carried out in the UK are changing.
One of the proposed changes to the law is to simplify the way that informed consent is sought and recorded in low risk clinical trials.
It is important that these proposed changes work for everyone, using an approach that people can trust.
We want to hear your feedback on our proposed changes to the current process, and we are asking you to complete a short survey.
All of the feedback you share will help us shape the new Clinical Trials regulations in the UK and the accompanying guidance that the HRA is producing.
The survey closes on Friday 10 January 2025.
Blog: There are no distractions – taking the time to have meaningful conversations
Our Director of Policy and Partnerships, Becky Purvis, has written a blog reflecting on her experience of working with the HRA Community Committee.
The Community Committee first met in October 2023 and advises the HRA Board to ensure the decisions we make are informed a wide range of opinions and view points.
In her blog Becky talks about the process the group has followed to ensure everyone's voice is heard - even if at times things can feel uncomfortable - and how the group has realised it is important to invest time in understanding how to work together well.
Professor Sir Terence Stephenson is stepping down as HRA Chair
Professor Sir Terence Stephenson has announced that he will step down from his role as HRA chair early next year.
Terence, an eminent clinical academic, has served as Chair of the HRA since September 2019. During his time with us he helped steer the organisation through our response to the COVID-19 pandemic. He also played a key role in our 10th anniversary celebrations and supported the development of our strategy, making it easy to do research that people can trust.
We are very thankful to Terence for his service and we wish him all the best for his future endeavours.
Get involved in our pilot
We're inviting researchers and sponsors to take part in a pilot to test our new Inclusion and Diversity Plan.
The plan is a set of questions for researchers and sponsors to consider and answer when they design clinical trials and clinical investigations.
As part of our pilot, they will be invited to submit a completed plan as part of their application to a Research Ethics Committees and we will ask them for feedback on their experience of developing a plan.
If you are planning to submit an application for a clinical trial or clinical investigation in 2025 and would be interested in taking part in the pilot, please get in touch.
This is part of our wider work with the Medicines and Healthcare products Regulatory Agency to update the UK's Clinical Trials regulations and we are currently running an informal consultation on our Inclusion and Diversity Plan and supporting guidance.
There's still time to share your feedback - the deadline to take part in the consultation is Monday 9 December.
Annual report for Research Ethics Committees
We’ve published a new report which highlights the amazing work that volunteers sitting on Research Ethics Committees in England have done between April 2023 and March 2024.
During this period, they reviewed an incredible 2,445 research applications, with 96% of studies being reviewed in less than 60 days.
They also reviewed 692 proportionate review applications, taking on average 18 days to reach a final opinion.
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