Written evidence from the Health Research Authority (HRA) (RAG0105)

Executive summary

Making it easier to do high-quality, trusted research in the UK has the potential to benefit UK growth directly – supporting greater efficiency and productivity in the conduct of research and attracting increased foreign direct investment – and indirectly through the use of research findings to improve people’s health.

The Health Research Authority (HRA) was established in 2011 in recognition that benefits in health and wealth were not being realised because the UK’s health research activities were being seriously undermined by an overly complex regulatory and governance environment[1]. We work to make it easier to do research that people can trust, with a statutory function to encourage and facilitate safe and ethical research. To achieve this, as well as coordinating some research approvals directly, we have powers of cooperation UK-wide with other agencies and regulators to coordinate and standardise practise relating to the regulation of health and social care research. Our role in the system is underpinned by a community of almost 1000 people who volunteer their time generously to help us to deliver our services – sitting on research ethics committees and the Confidentiality Advisory Group – and members of the public who advise us on our work.

Our mission aligns with the ambitions of the Action Plan[2] to tackle complexity in the regulatory system, reduce uncertainty, and challenge and shift “excessive risk aversion”. Health research, especially multi-centre clinical research, is a complicated activity involving multiple agencies and partners. Distinct bodies are an important part of a trusted system that ensures research is legal, ethical and deliverable so that people can be confident and able to choose to take part. We are focused on growing operational integration to achieve our mission.

Since we were established we have worked in collaboration across the health and social care research system to improve speed, reduce cost and increase the predictability for researchers to navigate this complexity to earn regulatory approval while maintaining trust in health and social care research. This has included developing shared digital services – since 2017, all researchers have used our digital services to apply for the approvals that they need from multiple bodies for their research to take place anywhere in the UK – and joining up processes so they can operate faster in parallel – our Combined Review approval time with the Medicines and Healthcare products Regulatory Agency (MHRA) is now at 60 days or less for 100% of all initial trial applications, with the latest data showing an average time for Combined Review determination (including questions raised) of 38 days in October 2025.

The UK government has identified life sciences as one of eight priority areas in its industrial strategy. The work of the HRA has the potential to make a considerable contribution to realising the Life Sciences Sector Plan[3] and 10-year health plan for England[4] to support UK growth going forward. Our 2025-28 strategy recognises this, setting out to support “a health and social care system that stays fit for the future and helps our economy grow”. Our strategic objectives set out to support the UK government’s commitments to turbocharge medical research, increase participation in clinical trials and cut administrative costs for business by 25 % by the end of the Parliament.

There is an opportunity to build on the success of the collaborative, cooperative approach that we have taken to date and take a more transformative system-wide approach going forward to realise the scale of the UK government’s ambitions. Our statutory coordination and standardisation role and leadership of UK‑wide digital and operational reform alongside successful cross-sector leadership such as the UK Clinical Research Delivery Programme provide a strong foundation on which to take more transformative, system-wide action to “turbocharge” research delivery and realise benefits for patients, the NHS and the economy.

About the HRA

1. The Health Research Authority is an independent arm’s length body of the Department of Health and Social Care. We were established in 2011 in recognition that benefits in health and wealth were not being realised because the UK’s health research activities were being seriously undermined by an overly complex regulatory and governance environment[5].
2. We have a statutory function to encourage and facilitate safe and ethical research to protect and promote the interests of patients and the public in health and social care research. We do this by:
• coordinating and standardising the practice relating to health and social care research regulation,
• overseeing Research Ethics Committees (RECs),
• managing approvals for the use of confidential patient information,

We work with people to understand what they want research to look like and act on this. Overall, the HRA role is to make it easy to do safe, ethical, and transparent research that people can trust.

3. To achieve our functions, we work in partnership UK wide to make it easy to plan, support, manage and complete health and social care research in the UK. We provide some approvals directly as well as providing digital services that all researchers use to find out what they need to do and apply for the approvals that they need from multiple bodies for their research to take place anywhere in the UK[6].
4. We have approximately 300 staff and a community of almost 1000 people who volunteer their time generously to help us to deliver our services – sitting on research ethics committees and the Confidentiality Advisory Group – and members of the public who advise us on our work. We also work with 277 specialists who provide technical radiation and pharmacy assurances at a national level to reduce duplication and inconsistency at a local level.

Q1. What is the role of regulators in supporting and promoting economic growth? How does this translate into actions?

5. Regulators can play a central role in supporting and promoting economic growth by creating the conditions in which high‑quality activity can take place quickly, safely, and with confidence.
6. The HRA’s mission is aligned with the UK Government’s ambitions to promote economic growth through unlocking the potential of the UK’s life sciences sector[7] and those of the 10 Year Health Plan[8] to transform patient care with groundbreaking treatments, while driving growth.
7. Our 2025-28 strategy, Boosting research that improves health and grows the economy[9], recognises this, setting out to support “a health and social care system that stays fit for the future and helps our economy grow”. Our strategic objectives set out to support the UK government’s commitments to turbocharge medical research, increase participation in clinical trials and cut administrative costs for business by 25 % by the end of the Parliament.
8. This has considerable potential to promote economic growth. Clinical trials contribute £7.4 billion annually to the UK economy, supporting 65,000 jobs and generating £1.2 billion of revenue for the NHS and evidence suggests that increased research activity leads to better outcomes for all patients, irrespective of whether they are directly involved in research or the findings of this[10].

Q2. What barriers, if any, are regulators putting in the way of economic growth? How will Government and the public know if regulators are supporting growth, rather than impeding it

9. Our mission aligns with the ambitions of the UK Government’s Action Plan[11] to tackle complexity in the regulatory system, reduce uncertainty, and challenge and shift “excessive risk aversion” to support growth.
10.                     Health research, especially multi-centre clinical research, is a complicated activity involving multiple agencies and partners. Distinct bodies are an important part of a trusted system that ensures research is legal, ethical and deliverable so that people can be confident and able to choose to take part.
11.                     However consistent feedback from industry and investors, those doing research and people wanting to take part in research in the UK is that in practice the health and social care research system can feel fragmented and difficult to navigate.
12.                     Our work is focused on addressing collaborating across the health and social care research system to improve speed, reduce cost and increase the predictability for researchers to navigate this complexity to earn regulatory approval while maintaining trust in health and social care research.
13.                     The UK Government and the public will know that we have been successful in supporting growth if we are successful in our mission, making it easier to do research that people can trust, and stated ambition to make the UK the easiest place in the UK to do excellent health and social care research. This will be visible in the regular publication of system-wide metrics to monitor and show progress in achieving this – the monthly UK clinical research update by the cross-sector UK Clinical Research Delivery Programme and progress in realising the government’s ambitions to turbocharge medical research, increase participation in clinical trials and cut administrative costs for business by 25 % by the end of the Parliament. Success will also contribute to the UK’s international ranking in measures such as those for global clinical trial activity. In 2024 the UK ranked sixth for phase I, fourth for phase II and sixth for phase III in terms of numbers of clinical trials initiated.

Q3. How are regulators expected to balance the growth duty with their other objectives? Does the Government make clear what should be prioritised, and how can this be achieved?

14.                     Promoting economic growth is not contradictory to our function to encourage and facilitate safe and ethical research to protect and promote the interests of patients and the public in health and social care research. Making it easier and more attractive to do health and social care research in the UK and so supporting economic growth is part of how we protect and promote the interests of patients and the public in health and social care research.
15.                     The UK government has clearly set our priorities for growth in health and social care research with we are well-placed to support - turbocharge medical research, increase participation in clinical trials and cut administrative costs for business by 25 % by the end of the Parliament. We have aligned our 2025-28 strategic objectives to achieve these. 

Q4. Can changing the growth duty alone have a significant impact on regulators’ decision-making, or is there a need for broader changes to regulators’ duties, objectives and strategic guidance?

16.                     As outlined above, promoting economic growth aligns with our existing function to encourage and facilitate safe and ethical research to protect and promote the interests of patients and the public in health and social care research.
17.                     However, other regulators and agencies that we work closely with in the delivery of our mission were not established so explicitly with this duty and/or may have different ‘trade offs’ to manage. Wider partners, stakeholders and the public may not have a shared view on the importance of supporting growth. Changes or further clarification could therefore be helpful to enable a shared understanding of the role of system partners in supporting growth. A clearly articulated, shared aim can support our work to standardise and coordinate practice relating to the regulation of health and care research, managing the nuance of the perception that supporting economic growth is contrary to regulators ‘other duties’, to investors, researchers and the public.
18.                     On the need for broader changes, whilst we have achieved significant improvements through collaboration, formal and authoritative partnerships maybe required to better coordinate the UK’s health and care research system to achieve better health and stronger growth.
19.                     The existing system-wide cooperation that is enabled by the digital services and partnership that the HRA leads, alongside successful examples of cross-sector leadership such as the UK Clinical Research Delivery Programme, provide a ready foundation that could be used to build this transformative change. There is the opportunity to lean in to proven, successful ways of working to increase the mandate for coordinated, coherent change to continually improve the health and social care research system, develop internationally visible cross-sector leadership and accountability of health and social care research and provide a great user experience for those seeking to do research, underpinned by integrated digital services. 

Q5. Is it possible to make regulatory processes quicker and cheaper while maintaining the same level of protection to the public and the environment? Will there have to be trade-offs between these goals, and if so, how should the Government and Parliament clarify how these trade-offs should be made?

20.                     Our experience shows that yes, it is possible to make regulatory processes quicker and lower the cost to business while maintaining the same level of protection to the public and the environment. Our work to provide approvals fast and make it simple to set up research well directly supports the government’s ambition to turbocharge medical research without compromising participant safety. We are focused on continuously reducing the average and maximum time it takes for researchers to earn the approvals that they need for their research to go ahead by ensuring that we work in a proportionate way and that these processes are as efficient as possible.
21.                     A thorough and robust approvals process is crucial to do research in a way that people can trust, but this needs to be proportionate so that it does not stop valuable research that can improve people’s lives from going ahead. We are always working to better understand how we can make the regulatory process more proportionate and agile, without cutting corners, so that we can make it easier to do research that people can trust.
22.                     Risk based proportionate regulation and once-only checks can reduce burden without lowering standards. For example,

1. the Research Ethics Service offers an accelerated Proportionate Review where research raises no material ethical issues. Rather than trading off speed against maintaining standards, this achieves both and allows limited resource to de deployed where it can deliver the greatest value.
2. during the pandemic we delivered the same standard of review in radically shortened timelines. This was in part possible due to adopting a more resource intensive model while routine activity was reduced.

23.                     We are also working to make regulatory processes quicker and cheaper by standardising processes, using our trusted assurances to reduce duplication and inconsistency. For example, we provide standardised study-wide technical assurances for reuse at the multiple sites where research will take place, eliminating the need for these to be repeated.
24.                     Alongside this we are improving our digital systems to help researchers find out what they need to do and follow an ideal path to set up their research study. This will reduce the burden, time and cost to do research, making it easier to do research in a way that means the people it is for and about can take part - and help ensure that research findings can improve care faster.
25.                     Where compromise may be necessary, then transparent, risk-based rules, published metrics, and public engagement need to be employed so that choices and decisions are explained and public trust and confidence in research is maintained.
26.                     It is helpful where Government and Parliament signal their priorities and appetite for greater proportionality to inform our approach.

Q6. How is a stronger growth duty likely to affect how regulators view risk and where the burden of risk falls? To what extent should consumers, businesses and the public be prepared to accept greater risk as a result of changing regulatory protections, and how should a less risk-averse approach be implemented by regulators?

27.                     The HRA takes on risk where appropriate, doing so selectively and with care. Our approach is to de-risk process (duplication, inconsistency) rather than de-guardrail ethics, safety, or data protections so that we maintain trust in research. It reflects a flexible stance where the organisation may be cautious in areas like compliance, finance, or operations – prioritising stability and control – while being more open to risk in strategic or innovative areas such as digital transformation or market expansion. This approach allows for calculated risk-taking where appropriate, supported by strong governance and clear decision-making criteria. It also advocates a culture that encourages measured innovation while maintaining accountability and adapting to changing conditions or opportunities. Our current risk appetite statement is available online.
28.                     In the area of health and social care research, a stronger growth duty cannot be used to justify increased, unacceptable risk to participants or the public. Any real or perceived increase in risk will damage public trust in research, and research findings and the NHS, industry and the health and social care services more generally.
29.                     That said, the most fundamental concepts in research ethics are those of autonomy and informed consent. That, if a participant understands the risks their participation poses them, they may choose to accept those risks or not. As with other areas of public policy, there are risks that the state should regulate out of the choice landscape of the public irrespective of whether a member of the public would make that choice (e.g. seat belt wearing, or clinical research that poses the risk of significant harm with no benefit in the HRA’s context). With appropriate political appetite and public consultation, the boundaries of that choice landscape could be explored.

Q7. What impacts will targets for reducing the administrative burden on business and increasing the speed of approvals have on regulators? What pressures or perverse incentives might these targets bring into regulatory systems?

30.                     One of our explicit strategic objectives is that “The health and social care research system is streamlined, efficient and encourages and supports success, increasing the impact of investment”. We are working to better understand how the actions we take can have this impact on the health and social care research system. One of the challenges is better modelling and understanding this to inform our decision making, which we are currently undertaking work to do.
31.                     Achievable targets, used well, can drive predictability and efficiency. However, regulatory services like the Research Ethics Service or the Confidentiality Advisory Group (CAG) rely on volunteers who generously give their time without payment to support these regulatory activities. Any requirement to accelerate approvals would need to consider how to manage impact to this operating model.
32.                     When taking action to support the 25% administrative-cost reduction goal we are focused on the reduction of system waste (duplication, inconsistent standards) and opportunities for automation, rather than compromising essential ethical or safety scrutiny.

Q8. Do regulators have the resources they need to be able to adequately support growth and innovation in general, and through specific measures such as proposed “fast lanes”? If increased resources are needed, should they come from increases in regulatory fees and charges or through additional public funding?

33.                     The HRA is funded through grant in aid from DHSC and via a smaller level of contributions from the devolved administrations. The HRA does not have the statutory powers to charge fees for services. Any increase in resources available currently requires increased public funding. Giving HRA the ability to charge fees could be considered however, the potential to secure additional revenue would need to be balanced against the perception of bias this approach might introduce to the HRA’s role in assuring that research is safe and ethical, and the impact it might have on the current operating model, which includes approximately 1000 volunteer roles.
34.                     As noted in our answer to Q7, we are working to better understand how the actions we take can best increase the impact of investment in health and social care research to continually inform and improve our approach in support of the UK government’s overall target to reduce administrative costs to the exchequer by 15% by the end of this parliament. Alongside this, as noted in our answer to Q5, reducing the administrative burden on business, increasing the speed of approvals, and providing ‘fast-lanes’ requires some increased investment in resourcing and digital transformation. The indirect, long-term economic benefit of reducing the burden on business and increasing the speed of approvals, has the potential to outweigh the additional direct cost to the public purse of supporting increased investment in resourcing and digital transformation, but these policy drivers are in tension.
35.                     We currently offer ‘fast lanes’ where this is possible within current resources and maintains public trust in research. These include an accelerated Proportionate Review where research raises no material ethical issues and a fast-track ethics review service for research applications that need a rapid research ethics review. This is open to global clinical trials and phase I trials, whether the sponsor is commercial or non-commercial.
36.                     However, the research ethics approval process currently relies on volunteers. Any increase in overall workload and speed needs to take into account the appropriate expectations we can place on those in volunteer roles.

Q9. Will changes to regulatory processes, such as proposed paid-for “fast lanes”, have the planned effect? Are companies prepared to pay more for expedited services? Is it clear how potential disadvantages, such as for smaller companies who are less able to afford increased fees, could be managed?

37.                     Noting that HRA does not have the statutory powers to charge for services, paid-for “fast lanes” could, in principle, improve speed and predictability. We have received anecdotal feedback that companies would be prepared, to pay for an improved service. This would be consistent with the approach in other countries. Crucially, it would have to be for an improved service otherwise the introduction of fees could be perceived as an additional barrier to economic growth.
38.                     However, it is important to consider that, if the fast-lane only applies to part of the end-to-end process, speeding up one part of the process can just push delays downstream. We see this effect in clinical trial approvals – increased speed in HRA regulatory approvals did not result in increased speed overall. The solution is to not just focus on each stage of regulation, but to take an end-to-end and system wide view.  
39.                     Our current approach is to make the whole system faster for everyone while offering criteria based accelerated routes (e.g. for urgent public health, early phase). We are focused on continuously reducing the average and maximum time it takes for researchers to earn the approvals that they need for their research to go ahead. Once research has been approved, it is set up at the locations where it will take place. This can be at anything from 2 to over 300 locations in NHS and wider care settings such as a care home, community hub, prison or people’s homes, taking research to where people are. This can take time and is limited primarily by the wider pressures the NHS is under, not the action or inaction of regulators. To change this, system wide barriers must also be addressed such as the priority and capacity to set-up and deliver research in the NHS.

Q10. Can regulators work together where needed, and do they act to avoid duplication or inconsistency in how they regulate? Are there barriers which prevent regulators from working together?

40.                     Our experience operating to encourage and facilitate safe and ethical health and social care research UK-wide evidences that regulators can work together effectively. There is a multitude of legal entities across the research delivery landscape, (e.g. >200 trusts, >1200 primary care networks, 147,000 GP practices etc) meaning that liability and accountability concerns result in duplication and complexity. However, against this backdrop we have made significant improvements, and we know we can go further.
41.                     The HRA was established under the Care Act to specifically co‑ordinate and standardise practice relating to the regulation of health and social care research in the UK. The Act creates a legal duty on HRA and other bodies to co‑operate to achieve co‑ordination and standardisation of regulatory practice; and, in doing so, must seek to ensure that such regulation is proportionate. The duty also explicitly includes co‑operation with devolved authorities for ethics regulation across the UK.
42.                     The HRA must publish guidance on principles of good practice in the management and conduct of health and social care research, and the requirements (whether legal or otherwise) applicable to researchers. Local authorities, NHS trusts and NHS foundation trusts must “have regard to” this HRA guidance, creating a practical lever for standardisation.
43.                     The Act clarifies that co‑operation includes sharing information between the HRA and the listed bodies, facilitating joined‑up regulation and “once‑only” approaches.
44.                     The HRA already delivers joint regulation through Combined Review with the Medicines and Healthcare products Regulatory Agency (MHRA); single HRA and Health and Care Research Wales (HCRW) Approval across England and Wales; UK-wide coordination with devolved nations; and collaboration with the Administration of Radioactive Substances Advisory Committee (ARSAC), Human Tissue Authority (HTA), Human Fertilisation and Embryology Authority (HFEA), National Institute for Health and Care Excellence (NICE) and the Ministry of Justice (MOJ)/His Majesty's Prison and Probation Service (HMPPS). Through UK Clinical Research Delivery Programme, we are leading workstreams on single UK commercial contracting and acceptance of centralised technical assurances.
45.                     However, the process of doing research is usually complicated and often complex, with multiple agencies and partners needing to coordinate and taking place across many locations in the NHS and wider care settings. This often results in duplication and inconsistency of checks and, where there is less familiarity with research, can lead to risk-averse behaviours that take time and resource to resolve. Whilst we have achieved significant improvements through collaboration, formal and authoritative partnerships may be required to improve the system further.

Q11. How are changes in regulatory structures likely to affect how regulators deliver their functions and impact on growth? Do regulators and the Government understand both the benefits from and the downsides to reorganisations? Are changes being planned and delivered in a way that minimises instability or unpredictability, and ensures regulation remains effective?

46.                     Targeted structural change can help where mandates overlap; however, wholesale reorganisations risk instability and unpredictability. In our sector, the priority is operational integration rather than institutional upheaval.
47.                     While it may be possible to further simplify the system, trusted, high-quality research, in a global context, is a necessarily complicated and complex process with multiple agencies and partners involved in its funding, governance and delivery. The most challenging structural environment is the very large number of legal entities that constitute our health and care service commissioner and provider landscape, and their role in the set-up and delivery of research.
48.                     There is an opportunity to establish a more formal partnership between regulators and the research delivery landscape, which offers greater potential contribution to UK economic growth, as noted above in our answer to Q10.

Q12. What are regulators doing in practice to encourage innovation and support economic growth? Are regulatory sandboxes working as expected, and if so, should their use be expanded?

49.                     The recent independent investigation into the NHS in England by Professor Lord Darzi to understand the performance of the NHS and issues that exist, found that “research and innovation are seen as important but not a high enough priority in a world where waiting lists are long and finances are tight. But in the medium term, it is innovation that can make the NHS more sustainable.”
50.                     The HRA enables innovation by publishing clear expectations for inclusive, trustworthy research (including AI/data use), operating proportionate pathways, and improving transparency. We also work with partners to make it easier for innovators to access and understand this information.
51.                     The HRA is a partner in the NHS Innovation Service. The NHS Innovation Service is a free, online platform created to solve both problems. It provides a centralised front door for healthcare innovations that have potential use in the NHS, matching them to relevant organisations to provide tailored support. It can provide support for any healthcare innovation that will impact service provision or delivery of care and could be purchased or adopted by the NHS. Innovations which fall outside of this scope may not be able to receive support via this service.
52.                     We are also part of the AI Digital Regulation Service which was established jointly by ourselves, NICE, MHRA and CQC to support developers and adopters of AI and digital technology in health and social care to understand and follow regulation and evaluate effectiveness.
53.                     The HRA supports the use of regulatory sandboxes where appropriate for example, the MHRA’s AI Airlock; the regulatory sandbox for AI as a Medical Device (AIaMD). This is a proactive, collaborative, agile and the first of its kind approach to identifying and addressing the challenges faced by AIaMD.

Q13. Are regulators using data, digital technology and artificial intelligence to improve their efficiency and productivity? What potential benefits and drawbacks would result from their increased use?

54.                     Improving our digital services will maintain and enhance the UK’s competitiveness in the global life sciences market. Working with health and care research partners UK-wide, we are leading the development of new integrated digital services to ‘Plan and Manage Health and Care Research’. These build on the existing Integrated Research Application Service that all researchers have used since 2017 to apply for the approvals that they need from multiple bodies for their research to take place anywhere in the UK. The new services will digitise the end-to-end research journey, allowing users to plan and prepare new research, make changes to existing research and review and approve research applications in a seamless way. We'll also improve the support offered to users. The first component went live in December 2025.
55.                     The new system will contribute to decreasing study set up times from 250 to 150 days and consistently meet statutory 60 day approval limits. This investment is projected to return £1.40 to the economy for every £1 spent, contributing to an additional £3 billion, creating 26,000 new jobs (including 5,000 in the NHS), and reducing sick days by 1.1 million annually through improved patient outcomes.
56.                     Plan and Manage Health and Care Research will deliver an improved user centric experience, offering more integrated and seamless services for the whole research community, making it faster and easier to start research by streamlining research approvals, reducing inconsistencies and duplication in study set up and delivery, and lowering the burden on NHS research and development departments. Meeting user needs is at the heart of the improved service we are developing and we are involving users at every stage. As well as significant user research, our designs respond to the key issues users have told us they experience with the current systems.
57.                     We will also grow our digital maturity so that we can build our new digital services and operate effectively as a secure digital organisation, forming part of the UK government’s vision for modern, digital government. This will include changing our ways of working so that we can use new technology, including artificial intelligence (AI), well. This new service will lay the foundations for adopting AI safely and securely, keeping the UK at the forefront of research approvals and maintaining the UK’s reputation as an excellent place to conduct research.
58.                     Alongside utilising data, digital technology and artificial intelligence to improve our own efficiency and productivity, we are also focused on supporting the use of data and AI technologies in research. We know that the regulatory pathway for artificial intelligence (AI) and digital technologies in health and social care can be slow, complex and difficult to navigate. For researchers this means wasted time and effort, and delays to research projects. To address this we have helped to launch the Artificial Intelligence and Digital Regulations Service which has been designed to give free advice and information on regulations to help developers and adopters navigate this developing area of research. Our 2025-28 strategy commits to make it clear how we support researchers to use new technologies and data to plan and do research, and to research the use of new approaches and technologies in care, in line with the AI opportunities plan.

Q14. Is the new Regulatory Innovation Office working as planned to improve regulation and taking the necessary whole of Government view?

59.                     We welcome that the Regulatory Innovation Office has identified life sciences as key area of focus. We recently took part in a meeting that the Office ran jointly with the Academy of Medical Sciences (AMS) focused on regulating AI and computational models in clinical trials (https://acmedsci.ac.uk/file-download/academy-regulating-ai-forum-report-2025) and look forward to continuing to work with them on this.
60.                     Their system-wide approach resonates with the way that the HRA was established and operates so we look forward to opportunities to mutually support, share and learn from their approach.

Q15. How do UK regulatory systems compare to others internationally? Who should the UK look to for good practice in regulatory design and operation? Are there any advantages to UK regulatory systems?

61.                     When it comes to health and social care, the United Kingdom is seen as a world-leading destination for the research and development of new medicines and vaccines. The World Health Organization ‘Guidance for best practices for clinical trials’ (2024) recognised the UK as a country with a strong clinical trial infrastructure. The Health Research Authority was specifically named in the report as an example of an organisation providing effective “interagency coordination and harmonization” of regulatory and ethics approval for research on health and social care with the Integrated Research Application System (IRAS) highlighted as an example of this in practice:

“…the Health Research Authority in England is a national strategic research oversight body that promotes coordinated approaches to research review across the United Kingdom of Great Britain and Northern Ireland through its Integrated Research Application System. This is a single system for applying for the regulatory and ethics permissions and approvals for research on health and social care/ community care in the United Kingdom of Great Britain and Northern Ireland.”

Our work alongside the Medicines and Healthcare products Regulatory Agency (MHRA) demonstrates the strength of this approach in the UK, with initiatives like Combined Review showing how a joined up approvals service can accelerate the set up of research. The ‘rapid review’ of research during public health emergencies was also highlighted by the WHO as an important part of the ethical review process. This is something that we saw clearly demonstrated during the COVID-19 pandemic, with the Fast-Track process seeing studies approved in as little as 48 hours. 

62.                     Our National Health Service (NHS) not only provides the infrastructure to carry out research at scale, it provides access to a large, diverse pool of participants who value the importance of research. 14 of the top 100 universities in the world for life sciences are found in the UK, with the academic community working hand-in-hand with industry to pioneer innovative research. The Health Research Authority is held in high regard internationally, as is the UK-wide Research Ethics Service.
63.                     We know how important it is for research studies to be reviewed and approved as quickly and efficiently as possible. The speed of the review process is a factor in attracting clinical trials from across the globe to the UK. In 2024 the UK ranked sixth for phase I, fourth for phase II and sixth for phase III in terms of numbers of clinical trials initiated.
64.                     One of the strengths that makes the UK stand out is a strong joined-up regulation system that is built on decades of experience and designed to support fast, high-quality research. For example, we are recognised around the world in offering a single application process, supported by a single digital platform, to earn approvals from multiple agencies, across the UK. In the last year alone, HRA has advised Canada, South Africa, Australia and The World Health Organisation on how to establish similar approaches to the UK in other nations.
65.                     There are also opportunities to learn from approaches taken by other countries. For example, over the past decade Spain has focused on reducing regulatory approval and set up times, which has yielded an average annual 5.7 per cent increase in industry investment in clinical trials in Spain[12].

Additional questions from the letter of 19 December 2025 from Baroness Taylor of Bolton, Chair of the Industry and Regulators Committee

AQ1. How do you feel you are able to support growth, particularly if you do not have a formal growth duty already?

66.                     As outlined in our response to question 1, the HRA’s mission is aligned with the UK Government’s ambitions to promote economic growth through unlocking the potential of the UK’s life sciences sector[13] and those of the 10 Year Health Plan[14] to transform patient care with groundbreaking treatments, while driving growth.
67.                     Our 2025–28 Strategy explicitly builds support for growth, and the Government objective to “turbocharge medical research” into our work as one of our strategic objectives.

AQ2. What does growth mean for you and your sector?

68.                     As outlined in our response to Question 2, our mission aligns with the ambitions of the UK Government’s Action Plan[15] to tackle complexity in the regulatory system, reduce uncertainty, and challenge and shift “excessive risk aversion” to support growth.
69.                     Therefore, supporting growth is an outcome of success in our mission to make it easier to do research that people can trust. This would be associated with more high-quality health and social care research taking place in the UK more predictably with broader more inclusive participation so that the findings can improve care sooner.
70.                     The HRA understands the importance of its role in contributing to economic growth and the indirect societal and health benefits of a stronger economy, but also through the direct impact that increased research activity has on the health and care system, patients, and the public. For example,

3. Better outcomes for patients: There is strong evidence that NHS organisations involved in research deliver better clinical outcomes for all their patients, regardless of whether an individual patient takes part in a study;
4. Economic value to the NHS: Research brings significant financial benefit to NHS organisations—around £1.2bn a year—and supports tens of thousands of jobs. This income helps sustain services and builds capability within the system;
5. A strong R&D ecosystem: Investment from commercial sponsors, alongside substantial public and charitable funding, supports a world‑leading research and development environment across the NHS, universities, and industry. This ecosystem supports innovation and ensures UK patients benefit from cutting‑edge treatments and technologies, and further supports the wider economy.

AQ3. What changes are you making or planning to your strategic direction to meet the Government’s ambitions to tackle complexity, reduce uncertainty and shift risk aversion?

71.                     We are at a pivotal moment for health and social care research in the UK. The government has made clear its ambition to make the UK the best place in the world for medical research. Our 2025–28 Strategy sets out how the HRA, working with our partners, will contribute to this national mission. It is a call to action - to researchers, to the public, and to our partners across the system. Together, we can create a research environment that is faster, fairer and more impactful. Most importantly, we can change and improve lives through a vibrant UK health and social care research sector.
72.                     Over the next three years, we will turbocharge this work. We will modernise our digital services to support a world-leading research environment, aligned with the government’s vision for smarter, more productive public services, as we make it easier for researchers and the NHS to do research. We will continue to set and uphold high standards for research, working with our partners to ensure that research is done well - with and for everyone.
73.                     Our strategy commits to making the UK the easiest place to do excellent health and social care research that people can trust, explicitly aligning with Government missions to turbocharge medical research and cut administrative costs and sets out the changes that we plan to make to achieve this.
74.                     We are not limited by our strategy and are part of active, ongoing discussions to identify and take further action to achieve the scale of change that is needed to realise the Government’s health and growth missions.

23 January 2026