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Welcome to HRA Latest, with news and updates for everyone working or involved in health and social care research.
This month, we celebrated International Clinical Trials Day with everyone in attendance at the annual Research and Development Forum Conference. Staff from across the HRA attended and presented on a range of topics, including the updates to the UK's Clinical Trial Regulations which come into law in April 2026.
Our Inclusion and Diversity Plan guidance is moving forward, and we're now looking for sponsors and researchers to be involved in our pilot. Read more on how you can take part below.
We're really excited to share an interview with former Research Ethics Committee (REC) member Dr John Bull, who reflects on almost 40 years of incredible service, and we're also preparing to celebrate members and volunteers like John during Volunteers' Week at the beginning of June - find out how you can get involved.
As always thank you for reading HRA Latest.
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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 Clinical trial regulations update
Last week, we marked International Clinical Trials Day with a video from our Chief Executive, Matt Westmore, who talked about the upcoming changes to the UK’s clinical trial regulations.
Thank you to everyone who has submitted feedback on our draft guidance to accompany the updated regulations. We received over 800 comments which have been used to make changes.
The guidance will explain what will change in terms of processes, legal requirements and expectations to help researchers and sponsors prepare for when the regulations come into force in April 2026.
In the next couple of weeks we will be publishing the latest version of the draft guidance so keep an eye out for updates.
 Reflections on 38 years as a REC member
After almost four decades of volunteering for our research ethics service, Dr John Bull has retired from his role as a Research Ethics Committee (REC) member.
John became involved in an ethics committee in the 1980s before the formal establishment of the research ethics service and the creation of the Health Research Authority.
We spoke to John about his reflections on his time volunteering with us, why he became involved in research ethics and what the future may look like for RECs.
 Updated amendment tool - important update for research sponsors
We have updated the amendment tool on IRAS Help to version 1.8. This tool is used to categorise and submit amendments to project-based research studies.
The updated tool has reinstated the EudraCT field, so a EudraCT number can be entered.
We've noted that some sponsors are still using an older version of the tool, so please visit IRAS Help for the latest version and details on how to use it.
 Developing our digital services
We're that will make it easier for research applications to be submitted, reviewed and approved in the UK.
As we progress this work, we will move users away from the systems currently used to apply for, approve and manage research including:
- Integrated Research Approvals System (IRAS)
- HRA Assessment Review Portal (HARP)
- Over-Volunteering Prevention System (TOPS)
We're looking for volunteers to help us test our new digital services. If you're a current user or work in services that help deliver research, we'd love to hear from you.
To help keep you updated with our work to develop new services we're launching a newsletter. If you are a user of our current systems we also recommend
 Share your thanks during Volunteers' Week
We’re marking Volunteers’ Week (2 to 8 June) by celebrating all of the incredible volunteers who support the HRA.
We have more than 900 volunteers who regularly give up their time to help us make sure research is ethical, safe and in the best interests of research participants, patients and the public. This includes our Research Ethics Committee (REC), Confidentiality Advisory Group (CAG) and Generic Review Committee (GRC) members.
Did you know that in 2024 more than 75,000 hours of time were volunteered by REC members in England? Our volunteers are vital not only in our work, but in enabling research to happen across the UK. We couldn’t do what we do without them. So, we want to let them all know how much we appreciate their work.
If you would like to share a thank you message, from a personal perspective or on behalf of your organisation, please send them to communications@hra.nhs.uk so we can add them to our website.
 New pharmacy set-up pilot
Together with the Experimental Cancer Medicine Centres (ECMC) network, we have launched a pilot to test improving the existing Pharmacy Technical Assurance process with newly developed pharmacy set-up guidance.
We are looking for sponsors to take part in the pilot. If you would like to take part or receive a copy of the draft guidance please email pilot.testing@hra.nhs.uk.
This pilot forms part of our work on the UK Clinical Research Delivery (UKCRD) programme. It is part of a workstream which is committed to removing duplication of activity that can be done once on a per study basis for pharmacy, radiation and information governance, by improving the use and impact of our central technical and study-wide reviews.
Read more about our work to improve study set-up, including recent updates to template commercial agreements, on our website.
 In case you missed it: Get involved in our Inclusion and Diversity guidance pilot
In September 2024 we launched an informal consultation to ask for feedback on the first draft of our newly developed guidance for how to develop an Inclusion and Diversity Plan.
The Inclusion and Diversity Plan is a document to be developed by sponsors and researchers when planning a clinical trial or investigation.
The set of questions in our guidance will help researchers and sponsors to consider and demonstrate how they will include a diverse range of people that is relevant for their trial when developing their study.
We now have a second draft of the guidance, and we're looking for sponsors and researchers to take part in our pilot, which will involve developing a Plan and submitting it as part of an application for review by a Research Ethics Committee.
If you'd like to take part, please email Engagement.Team@hra.nhs.uk
 Share your feedback on HRA Latest
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If there’s anything you would like to hear about in future updates, please let us know by emailing communications@hra.nhs.uk
News from across UK research
Below are some updates you may have missed about health and social care research in the UK:
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