The Health Research Authority was created in 2011 to transform the regulation and governance of health and social care research in the UK.
15 years on that’s just what we’ve done.
We provide fast, trustworthy approvals and assurances, and connect the end-to-end research system in the UK so that studies can be planned, set-up, delivered and completed more efficiently and effectively.
The review and approval of applications for health and social care research in the UK is happening faster than ever.
Below are some of the things we’ve achieved to enable that to happen.
1. Created a single UK research approval system
We established HRA and Health and Care Research Wales (HCRW) Approval, a combined process for applying for approvals for all NHS and social care research in England and Wales.
By simplifying processes and reducing duplication we’ve created an approvals system that provides a fast and reliable service that thousands of researchers use every year.
The number of studies receiving HRA and HCRW Approval rose by 3.1% from 3,408 in 2024, to 3,515 in 2025.
2. Faster review times
We know how important it is for research applications to be reviewed quickly. Not only does this speed up the set-up process, it also means participants and patients can benefit from the findings of research sooner, ultimately enabling the NHS to provide better care.
Providing sponsors with a consistent timeline for the review of research applications means they can chose the UK as a destination to do research as they can confidently plan around our processes.
We’re proud to consistently meet our statutory timelines for approvals.
In 2025, the median number of days taken to review Clinical Trials of Investigational Medicinal Products (CTIMPs) in England by Research Ethics Committees was 29 days, less than half of the 60-day Combined Review target, which we have met for two consecutive years.
3. Combined Review
We work with our partners across the UK to provide a world class joined-up regulatory system that people can trust.
Clinical trials of investigational medicinal products (also known as CTIMPs) need approval from the HRA and Medicines and Healthcare products Regulatory Agency (MHRA) before they can go ahead.
We have created a single application route we both organisations work in parallel to review a study. MHRA focusing on the safety of a trial, and the HRA leading on the legal checks and ethics review. A single outcome is provided to applicants, rather than them having to wait for the outcome of two separate reviews.
This helps to reduce the time it takes for a clinical trial to be set up in the UK.
Since its launch in 2022, more than 3,000 studies have been reviewed under Combined Review, with review times for RECs falling 51% from 60 days in 2021 (pre Combined Review), to 29 days in 2025.
4. Providing expert technical assurance reviews
Some research applications, especially studies involving ionising radiation and pharmacy, require technical expertise pre-application. This technical expertise is needed to provide assurance on the proposed research and to provide the technical information UK sites need to start setting up as early as possible.
The HRA offers a technical assurance service which provides a pre-application review to resolve any technical queries with the sponsor, and to ensure the proposed study has all the technical information sites need to set-up. HRA technical assurances can be accepted and used by every site, reducing queries, saving time and enabling set-up to start in parallel to regulatory review. Our technical assurances ensure there is no duplication or wasted effort.
In 2025, we provided 173 Radiation Assurances and 186 Pharmacy Assurances, making it a total of 1,815 assurances given in total since 2018.
5. Speeding up the study set-up process
Through our partnership work with the UK Clinical Research Delivery (UKCRD) programme we have introduced a range of changes to streamline and reform the set-up and to remove unnecessary duplication.
Alongside UK contracting leads, the HRA has led on developing a more efficient and streamlined single UK standardised commercial contracting process, as well as reducing unnecessary duplication in technical assurances.
The latest data shows the average set-up time for commercial clinical trials in the UK has fallen to 122 days, down from 169 during the same period last year, which represents significant progress against the government's 150 day target.
6. Embedding transparency and openness in research
Being transparent about research builds trust. Through our Make it Public campaign, we're making research transparency the norm rather than the exception.
We've embedded research transparency in the UK’s updated clinical trial regulations, which now makes it a legal requirement. We’re also working with sponsors to ensure they register their research, publish the results and share the results with participants.
Our latest research transparency data from 2023 shows that 94% of studies were registered on a public registry, which is more than ever before, and 76% of clinical trials that were reported to us as completed in 2023 provided a Research Ethics Committee with a final report.
7. Involving patients and the public in research
Public involvement is an essential part of health and social care research. Involving people in the design, delivery and evaluation of research has been shown to improve its quality and impact.
Through our Shared Commitment to Public Involvement campaign, we are working with more than 30 organisations to make public involvement a core expectation of high-quality research.
In 2025, for the third year running, the number of health and social care studies involving patients and the public in research has remained high at 84%.
This is a remarkable recovery from during the pandemic where the percentage dropped to 22% before HRA and our partners intervened.
8. Developing the next generation of research systems in the UK
In 2008 the Integrated Research Application System (IRAS), the UK’s system for submitting health and social care research applications, was launched.
More than 100,000 studies have been submitted on IRAS since it was launched. IRAS is managed by the HRA and we’re now in the process of developing a new digital service, plan and manage health and care research, that will allow users to plan, approve, manage and complete health and care research in one place.
Over time, it will replace older systems, including IRAS and HARP. We are supporting and involving users throughout the development of our new service which we’re building in phases over the next two years, gradually opening up to more users and study types.
When complete, Plan and Manage Health and Care research will provide the most joined-up and streamlined single application system in the world.
9. Our volunteers
The HRA simply could not function without the efforts of our amazing volunteers who sit on our Research Ethics Committees and Confidentiality Advisory Group.
We have more than 900 volunteers who work with us at the HRA. They bring their huge range of skills and life experiences when reviewing research applications.
In 2025 our volunteers spent more than 75,000 hours volunteering.
10. Research Ethics Committees
Research Ethics Committees (REC) are volunteer led committees who review research applications and give an opinion on whether the proposed research is ethical or not.
They consist of up to 15 members, who are classed as either ‘expert’ or ‘lay’ members and represent people from all walks of life across the UK. Using their expertise, they protect the rights, safety, dignity and wellbeing of research participants by carefully reviewing research applications.
There are 64 RECs in England, with more than 800 expert and lay members. Unlike other countries their decisions apply across all research sites and across the UK nations, which reduces duplication and supports consistency across the research process.
In 2025, RECs met over 1,300 times, reviewing nearly 4,000 research applications and more than 21,000 modifications to approve studies.
11. Confidentiality Advisory Group (CAG)
Under common law it is illegal for people outside the care team to access identifiable patient information without consent. Most researchers will seek consent from patients to use their identifiable information, but sometimes this is not practical.
That’s where the Confidentiality Advisory Group (CAG) comes in. They are an independent body which provides expert advice on the use of identifiable patient information without consent to provide Section 251 approval, the legal basis to use identifiable patient information.
By carefully balancing individual privacy rights against the enormous benefits of research, the CAG ensure that identifiable patient information is protected and that researcher can be undertaken in a safe and transparent way, that otherwise may not have been able to take place.
In 2025, the CAG met 40 times, giving a final outcome on 130 applications.
12. Proportionate regulation
One of the key ways to ensure that research is carried out quickly is to offer a proportionate review process for studies that raise no material ethical issues.
Under our proportionate review process applications are reviewed via email or online by a sub-committee of a Research Ethics Committee (REC), rather than at a full REC meeting.
Since 2018, the time taken for a Research Ethics Committee to complete a Proportionate Review (UK wide) has consistently been within or under our target of just 21 days for approval.
13. Making changes to research
Modifications (previously known as amendments) are proposed changes made to a research project after approval from a review body has been given.
Modifications are classed as either substantial or non-substantial. If a substantial modification needs to be made to a study, it needs to be reviewed by a REC who offer an opinion on whether the changes are in line with the original approval for the study.
In 2025, RECs reviewed nearly 8,000 substantial modifications, which were completed on average within 19 days – well below our target of 35 days.
14. Satisfaction with the HRA
Every month we ask people who use our approval services to rate their experience with us. We want to make sure that everyone we work with has a great experience and receives the right support to help them with their research application.
In 2025, 84% of people who gave feedback rated their experience with us at least a 7 out of 10 or higher.
Our average annual satisfaction score since 2018 is 81%, well above out 75% target.
15. Transforming the UK's clinical trial landscape
April 2026 marked the UK’s biggest overhaul of clinical trial regulations in over 20 years.
We worked in partnership with the Medicines and Healthcare products Regulatory Agency, to update the regulations to further protect trial participants, strengthen patient safety and accelerate approvals by reducing unnecessary burdens on researchers.
For the first time it is now a legal requirement to register clinical trials involving medicines on a public registry, and publish a summary of trial results within 12 months of completion.