Introduction
Economic growth is a top priority for the UK government. Improving the UK’s regulatory environment so that it actively supports investment, innovation and productivity is central to that vision.
The HRA’s work directly supports the UK government’s missions for health and growth. Our strategy 2025-28 sets our strategic aim to support these two missions, working towards a health and social care system that stays fit for the future and helps our economy grow.
We also set out in our strategy our intent to align with and support the UK Government’s ambitions to realise the opportunities presented by artificial intelligence by taking action to support a thriving domestic AI ecosystem, in line with the AI opportunities plan.
To help achieve this, the HRA strategy 2025-28 commits the HRA to ensure that: Researchers can do research in new ways and using new technologies such as AI to improve care in a way that people can trust.
By the end of the strategy in 2028, we have committed to ensure that we are 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.
Informed by wide engagement with our stakeholders and analysis to identify the most productive and effective interventions, this plan sets out three areas of work that we will focus on over the final two years of our strategy to achieve this. We will seek to align with the outputs of the National Commission into the Regulation of AI in Healthcare as more detail becomes available. We will review and refresh this plan as part of the development of our next strategy to ensure that we can continue to effectively support the UK to realise the cross-cutting opportunity to raise productivity and deliver growth offered by artificial intelligence in a way that people can trust.
This complements our existing work both directly with researchers who are familiar with our services and as part of the AI Digital and Regulation Service and NHS Innovation service to support developers and adopters of AI and digital technology in health and social care research to understand the regulation relevant to them and gain the approvals that they need. The HRA is also engaged with CERSI-AI, the national Centre of Excellence for Regulatory Science and Innovation in AI and Digital Healthcare, where it sits on the National Council alongside health regulators, DHSC and NIHR. This information sharing, horizon scanning and coherent strategy across health and social care research enables us to keep a watching brief on the changing landscape.
The UK has a coordinated approach to health and social care research approval and delivery. The proposals set out in this plan apply and will be coordinated UK-wide as we work closely with our partners in Northern Ireland, Scotland and Wales to make it easy to do health and social care research that people can trust in the UK.
The changes that you will see
It will be simpler and faster to do health and social care research enabled by safe, AI-powered innovation. These activities will ensure that regulation is proportionate to the activity, meaning that activities that are not research are not subject to unnecessary reviews. In 2025, 3,990 studies received a final opinion from a Research Ethics Committee in the UK, enabling them to go ahead in a way that people can trust. By making it easier to understand what they need to do, we can ensure that developers and researchers know when these approvals are relevant to them and are supported to gain them.
It will be easier to invite people to take part in research relevant to them. These activities will support AI-enabled and data driven approaches to be used in a way that people can trust to identify and invite them to take part in research relevant to them. This is crucial to truly realise the benefits of the UK government’s ambitions for the Health Data Research Service and enable its commitment to increase the number of people taking part in clinical trials. This will help reduce health inequalities by supporting activity to identify and invite the people research is for and about to take part, improving the utility of research findings.
We will maintain trust that regulation is keeping pace with developments in research. Public trust in research is high with 68% of UK adults saying that they would take part in research if asked. These activities will ensure that people can continue to trust that the system of safeguards, checks and balances that are already in place to protect them when they take part in research will keep pace with developments in AI enabled and data driven technologies in research. They will also support our work to continue to earn trust to grow more people’s confidence to take part in health and social care research. This work will also ensure that the wider health and social care research system can continue to trust the assurances that the HRA coordinates and provides, reducing duplication of checks and supporting streamlined delivery of research.
Three priorities to enable the use of artificial intelligence to support and do health and social care research in way that people can trust that the HRA will focus on over the next two years – 2026-28:
Be clear where AI development, evaluation and implementation activities are research.
Purpose: Ensure that regulatory processes are proportionate and fit for purpose, being clear where activities are not research and therefore do not require review. Help developers find out what they need to do in order to gain appropriate regulatory approvals where they are doing research.
Outcome:
- increase developer and researcher understanding and confidence to follow appropriate processes and access support to do so when using AI in their research
- ensure clear, proportionate and fit for purpose regulatory processes, reducing potential duplication, increasing speed and efficiency of gaining approvals
- ensure public confidence that research involving AI development in health and social care is appropriately regulated and that developers have access to relevant information and resources on regulation for non research activities such as evaluation and deployment
Clarify the circumstances in which health information can be accessed using AI-enabled and data driven approaches to identify and contact people about research options relevant to them
Purpose: make it easier to use AI-enabled and data driven approaches in a way that people can trust to support research recruitment and increase inclusive participation in research
Outcome:
- facilitate data-enabled cohort discovery and research recruitment, including supporting the development of Secure Data Environments and the Health Data Research Service
- increase inclusive participation in research so that health and social care research can be done with and for everyone, helping reduce health inequalities
Take action to ensure that review of AI-enabled and data driven research is appropriately informed, rigorous and consistent
Purpose: Ensure that you can trust approvals of AI-enabled and data driven research
Outcome:
- members of Research Ethics Committees, the Confidentiality Advisory Group and others involved in HRA reviews of research proposals such as governance review are confident to review AI enabled and data driven research and are up to date with developing innovations
- researchers and the public can have confidence that decisions about AI-enabled and data-driven research are well-informed, rigorous and consistent, and take account of ongoing innovation
Workstreams to be delivered over the two-years of this plan
Be clear where AI development, evaluation and implementation activities are research
Key deliverables
1. Update the ‘is my study research’ decision tool and supporting guidance that defines when AI activity is research
This will include:
- engagement and involvement to inform the update
- user testing
- pilot and iteration before full launch
- ongoing assessment of effectiveness
- promotion of this decision tool and the assurance that can be taken from this
2. Clarify expectations associated with the use of AI to support research activities relevant to the HRA’s role and remit, working with partners across the system to ensure these are consistent. This may include use of AI tools in:
- writing research protocols
- translation or other manipulation of participant materials
- participation information and consent processes (including supporting consideration of the use of ambient technologies to evidence informed consent under the new simplified arrangements for consent for low intervention CTIMPs)
- producing lay summaries of results for sharing with participants
3. Define data-sharing expectations and governance arrangements for use of synthetic data in research, working collaboratively with other partner organisations including MHRA.
Impact
- updated decision tool in operation. Supports HRA strategy 2025-28 outcome measure: Our assurances are understood, valued and trusted, not unnecessarily repeated to set up research with a 20% reduction in the percentage of people who tell us that there is duplication in study set up
Clarify the circumstances in which health information can be accessed using AI-enabled and data driven approaches to identify and contact people about research options relevant to them
Key deliverables
- Support consistent governance expectations across emerging research data infrastructure:
- support the development of consistent governance expectations for how data are accessed and linked across emerging research data infrastructure including through the use of AI-enabled technologies, so that this can be used to contact potential research participants in a way that people can trust. Emerging research data infrastructure includes Secure Data Environments and the Health Data Research Service
2. Enable responsible research participant identification and contact using health data:
- ensure that research data infrastructure is used to let people know about research relevant to them in way that they can trust by clarifying governance expectations for responsible participant identification and contact using health data, including through the use of AI-enabled technologies
Impact
- supports HRA strategy 2025-28 outcome measure: Work in partnership to support new ways to do research such as working alongside the Health Data Research Service and make sure that regulation keeps up with research so you can trust our decisions
- supports HRA strategy 2025-28 outcome measure: There is greater representation in, and access to, research so that people from all backgrounds across the UK can take part in research relevant to them. This is shown by an increase in the proportion of researchers who use an Inclusion and Diversity Plan and are more confident to include a diverse group of people in their research
Take action to ensure that review of AI-enabled and data driven research is appropriately informed, rigorous and consistent
Key deliverables
- Collate feedback from staff, REC and CAG members, alongside our monitoring of the AI landscape, focused on the use of artificial intelligence in health and social care research applications to:
- inform further work to support researchers in submitting research applications for review with the right information required to aid review
- develop capability and knowledge base for REC and CAG members and others involved in HRA reviews of research proposals, which keeps pace with developments in this area, such as governance review to confidently develop, review and assess these applications
- demonstrate consistency of review and assurances provided for AI-enabled and data-driven research in the UK
2. Conduct further assessment and review as appropriate to inform ongoing iteration of training and support to underpin informed, rigorous, proportionate and consistent review of AI-enabled and data-driven research
Impact
- supports HRA strategy 2025-28 outcome measure: Our assurances are understood, valued and trusted, not unnecessarily repeated to set up research with a 20% reduction in the percentage of people who tell us that there is duplication in study set up
- supports HRA strategy 2025-28 outcome measure: Our community of volunteers and public contributors have a good experience with us and can see the difference they make, maintaining satisfaction at or above 80%