Business plan 2025-2026

About us

The Health Research Authority (HRA) is an independent arm’s length body of the Department of Health and Social Care (DHSC). We have up to 300 staff in England who work at home and in our four offices. Our staff are supported by a community of almost 1,000 people who volunteer their time generously to help us deliver our services, alongside NHS staff and members of the public who advise us on our work.

The HRA is led by a Board, Chaired by Neelam Patel which includes our Chief Executive, Matt Westmore, two executive directors and up to four non-executive directors. Two further directors also attend. The Board has strategic oversight, agreeing high-level policy and ensuring that the HRA is run effectively and efficiently. Find out more about our leadership.

We are one of many organisations that work together in the UK to regulate different aspects of health and social care research. Most of our services apply to research undertaken in England, but we also work closely with the other countries in the UK to provide a UK-wide system.

The UK government has set out five missions as part of its plan for change. Our work directly supports the missions for health and growth. At the heart of our work are people. People who could benefit from research findings improving their care, helping them to have a better quality of life and play a more active role in society.

The UK’s health mission sets out to address the main underlying drivers of ill-health and tackle persistent inequalities in health to put the NHS on a more sustainable footing for the future. Research will be key to doing this well. Research that has been done with and for everyone so that the whole population can benefit from its findings will do this best. That is why our work to ensure that research is done in a way that people can trust, including everyone, is important to build a health service fit for the future.

The UK is a great place to do high quality health and social care research – with a diverse population, strong science base and national health service. Attracting more research to happen here will benefit both people in the UK and help grow our economy. That is why our work to make it easier to do research is important to the government’s mission to kickstart the UK’s economic growth.

Our role

The HRA is a connecter and enabler in the health and social care research system. To make it easy to do research that people can trust, we:

• work with people to understand what you want research to look like and act on this so that you can trust research
• make sure that people taking part in research are treated ethically and fairly, by reviewing and approving health and social care research studies that involve people, their tissue or their data before they can start as part of a UK-wide regulatory service
• champion research transparency, so that you can always see when research is taking place, or the results of that research if it has finished
• work with other organisations across the UK to reduce the burden, cost and time to set up research, meaning that wherever you are, research studies can be set up smoothly and are always subject to the same scrutiny before they start. This includes running streamlined digital services and a UK-wide partnership to help plan, apply for, approve, set-up, manage and complete research in the UK.
• are one of the gatekeepers of patient data, making sure that your information is used in ways that you can trust

More information on how we work in partnership to make it easy to plan, support, manage and complete health and social care research in the UK is detailed in our strategy 2025-28.

You can find out more about our work and what we do on this website, in our monthly newsletter HRA Latest, and via social media.

How we will make change happen

There are three key aspects to our approach to change. We will be

• user centred – with people at the heart of everything we do
• agile – trying new things and learning from then
• collaborative - working with others to make progress more quickly

Our plans for 2025-26

This business plan sets out how we intend to achieve our strategy, by setting out the steps we will take to make progress on our strategic objectives as well as deliver our core statutory functions. Its focus is on our plans for the first year of our new strategy. Over time we expect to add to it and update it to show our plans over the strategy timeframe. We have set target outcome measures in our strategy in recognition that we work with uncertainty and will need to continually iterate how we respond to external drivers and government priorities to realise these. These include the 10 Year Health Plan and the government’s industrial strategy. This will also enable us to use our own learning about what works and what doesn’t to continually improve.

Our strategy and business plan are central to our planning, performance, innovation and change, people and risk management processes. These processes make sure we successfully deliver on our priorities and that our people understand their role in achieving our strategy.

We are committed to delivering on government priorities as part of our strategy and business plan development. This includes the UK government's Plan for Change, the 10-year health plan for England and the UK's Modern Industrial Strategy.

2024-25 results

Our annual report and accounts looks at our strategic and operational performance during 2024-25 as well as our financial results. The annual report and accounts process as well as our quarterly performance management systems make sure we evaluate our work against our strategy and business plan to achieve our priorities.

A summary of our achievements in delivering our 2022-2025 strategy is published on our website.

Our strategy

Our vision is for high-quality health and social care research today, which improves everyone’s health and wellbeing tomorrow.

Our strategic objectives

1. the UK is the easiest place in the world to do excellent health and social care research that people can trust, helping grow the contribution of life sciences to our economy
2. health and social care research is done with and for everyone, meaning that we can all benefit from research findings, helping reduce health inequalities
3. the health and social care research system is streamlined, efficient and encourages and supports success, increasing the impact of investment

We know that we need to be a trusted, effective organisation that makes it simple and fast to do research well. In our strategy, we have set out how you will see us work in this way, with measurable outcomes.

There are four areas where you will see the biggest change. These are where we can make impactful change fastest to support government objectives. These are:

• we are part of modern, digital government. We will build our digital foundations as part of the vision for modern, digital government
• we are efficient and take action to increase productivity. We will embed productivity into everything we do, guiding our decision-making
• we give approvals and assurances, working in partnership UK-wide to provide a world-class regulatory system. We are focused on reducing the burden, time and cost to do research with and for everyone
• anyone can understand what we do and why it matters to them and be confident in our decisions. We will build the profile that we need to achieve our objectives well

More information about our strategy can be found on the HRA website

Strategy key results 2025 - 2028

UK government objectives that we support

The UK is the easiest place in the world to do excellent health and social care research that people can trust, helping grow the contribution of life sciences to our economy

• creating a faster, more efficient, more accessible and more innovative clinical research delivery system – making the UK a world leader in clinical trials (UKCRD mission)
• the time it takes to get a clinical trial set up in the UK will be cut to 150 days by March 2026 (PM commitment)
• 99 percent of UK studies receive a combined review decision within 60-days (UKCRD metric)
• 90 percent of studies open to recruitment within 60 days of HRA approval letter or equivalent process used by the Devolved Administrations (UKCRD metric)

Health and social care research is done with and for everyone, meaning that we can all benefit from research findings, helping reduce health inequalities

• more people are confident to take part in health and social care research and bring the benefits of clinical trials to everyone
• increase in UK adults that say they would take part in research if asked (baseline from HRA public attitude polling in 2023 (68 percent of UK adults would take part in health and social care research if asked)
• increase in UK adults that are confident that they would be treated with dignity and respect if they took part in research (baseline from HRA public attitude polling in 2023- 75 percent of people are confident that they would be treated with dignity and respect if they took part in research)
• increase in public confidence in access to healthcare data for research (supporting the health data research service)​
• increase in people registered with Be Part of Research

The health and social care research system is streamlined, efficient and encourages and supports success, increasing the impact of investment

• cut administrative costs for business by 25 percent by the end of the Parliament New approach to ensure regulators and regulation support growth
• meet commitment for government departments to reduce their administrative budgets by 15 percent by the end of the decade Spring statement 2025
• support a thriving domestic AI ecosystem, with serious players at multiple layers of the “AI stack” and widespread use of AI products and services across the economy AI opportunities plan
• we are a digital service to be proud of A blueprint for modern digital government

Health Research Authority and Health Care Research Wales (HRA and HCRW) Approval service

In 2025-26 we will:

Continue to work with HCRW to bring together research ethics review and governance and legal review for researchers wanting to do research in England and Wales.

Milestone, activities and measures

100 percent of HRA Approval decisions, when all relevant permissions are in place, within 60 days and 100 percent of decisions on any amendment within 35 days.

Research ethics review service by English Research Ethics Committees (RECs)

In 2025-26 we will:

Coordinate ethics reviews of health and social care research studies by English RECs.

Milestone, activities and measures

100 percent of ethical reviews by English RECs of Clinical Trials of Investigational Medicinal Products (CTIMPs) within 60 days.

Confidentiality Advisory Group service

In 2025-26, we will:

Review research and non-research applications to consider whether there is sufficient public interest to temporarily lift the common law duty of confidentiality and enable access to the requested confidential patient information.

Milestone, activities and measures

Time from valid application to the Confidentiality Advisory Group to receiving a final outcome within 60 days - (average of median for research and non-research KPIs) For precedent set time from valid applications to the Confidentiality Advisory Group to receiving a final outcome within 30 days. (average of median for research and non-research).

Technical assurances service

In 2025-26, we will:

Coordinate technical assurances to support the set up and management of clinical studies reducing duplication and streamlining research.

Milestone, activities and measures

For 100 percent of studies in the HRA managed service:

• Radiation assurance: 40 days
• Pharmacy assurance: 30 days

The Over-Volunteering Prevention System (TOPS)

In 2025-26, we will:

Provide the TOPS database, free to all UK organisations undertaking Phase 1 trials in health volunteers, to prevent participants from taking part too frequently in trials of new medicines.

Milestone, activities and measures

Service is available 100 percent.

All services

In 2025-26, we will:

Sustain user satisfaction with our services.

Milestone, activities and measures

75 percent of applicants rate our overall service highly.

New Clinical Trials Regulations (CT Regs)

In 2025-26, we will:

Develop and publish new guidance to support the implementation of the updated clinical trials regulations well as these come into force in April 2026.

Create updated policy document for RECs and put in place business changes to enable the new CT Regs.

Milestone, activities and measures

March 2026.

UK Clinical Research Delivery

In 2025-26, we will:

Engage with the research community to enable the ideal pathway and make sure this is built into our transformed digital services - all year.

Introduce a single national coordinated contracting process including:

• Commercial Chief Investigator Agreement and Confidential Disclosure Agreements – April 2025
• Commercial Site Agreements – May 2025
• Site selection letter of intent for consultation in use – June 2025
• Commercial Agreement for provision of public involvement services – June 2025

We will make it easier for sites to understand and accept assurance from Pharmacy and Radiation Technical Assurances and Information Governance study-wide reviews. Including:

• Pilot of new guidance with ECMCs – June 2025
• Updates to Study Wide Review – August 2025
• Action plan addressing barriers to study set-up across wider care settings – August 2025

Emerging technology and data

In 2025-26, we will:

Support researchers in the use of emerging technology and data in the planning and management of research or as the subject of research.

Confirm how HRA will support and resource the Artificial Intelligence and Digital Regulations Service (AIDRS) – March 2026.

Milestone, activities and measures

Publish annually how we have enabled innovation and growth driven by AI in health and social care research.

Collaboration and alignment between MHRA and HRA

The HRA and MHRA have been asked by Minister Merron to work together to produce a joint delivery plan for further collaboration and alignment between the two organisations. This will build on past success such as combined review and look for new opportunities to speed and streamline clinical trials approvals.

Milestone, activities and measures

Initial set of options will be submitted to the Minister by October 2025.

Transform our research digital services

In 2025-26, we will:

• gain digital spend controls approval for our transformation programme - May 2025
• implement the first phase of our new digital service management tool and process - June 2025
• agree our target operating model for our digital services - March 2026
• develop a proof of concept for the foundation layer of our research application data set - March 2026
• started the Private Beta of our new streamlined service, making changes to research, to a representative user base - March 2026
• begin to develop our new service, plan and prepare research - March 2026

Data security, quality and information governance

In 2025-26, we will:

• complete the annual Data Security and Protection Toolkit and take actions to make sure we remain compliant - June 2025, actions by December 2025
• put in place a ‘Secure by Design’ (SbD) process for ensuring all our digital systems comply with SbD principles - December 2025

Test AI in our infrastructure and regulatory processes

In 2025-26, we will:

• undertake a stakeholder exercise with REC members to inform how we prioritise test protocols - December 2025
• develop protocols and feasibility reports on test and evaluation of use of AI in specified regulatory processes - March 2026
• run test and evaluation protocols on specified regulatory processes - March 2026
• explore how M365 Copilot can improve how we perform basic workflows and automation using standard functionality including AI and put in place improvements - March 2026

Who we are and what we do

In 2025-26, we will:

Establish sentiment analysis of our stakeholders.

Milestone, activities and measures

March 2026.

In 2025-26, we will:

Undertake discovery work to better understand who needs us and what they need from us to support delivery of our mission and objectives.

Milestone, activities and measures

Approach in place by March 26.

In 2025-26, we will:

Act on the findings of the review of our social media strategy.

Milestone, activities and measures

Planned approach in place by January 2026.

In 2025-26, we will:

Act on the findings of the engaged audiences project.

Milestone, activities and measures

Increase overall engagement levels with email communications by 10 percent.

Acting on issues that matter to people in research

In 2025-26 we will:

Ask the HRA Community Committee to provide advice on how to develop simplified arrangements for obtaining and evidencing consent that people can trust by establishing a sub-group that can co-opt members and undertake work to ensure it is informed by diverse perspectives.

Milestone, activities and measures

Agree approach with Community Committee in July 2025.

In 2025-26 we will:

Continue to engage with partners to identify a deliverable approach to better understand public perspectives relating to the treatment of people who lose capacity while taking part in a longitudinal research project.

Milestone, activities and measures

Throughout the year – dependent on securing funding.

HRA Community

In 2025-26 we will:

We continue to involve people in how we make decisions at the HRA.

Milestone, activities and measures

More than 80 percent of people involved in our work agree that they have shaped and informed the work that they have been involved in.

In 2025-26 we will:

Develop a consistent approach to behaviour of Community members in line with the expectations set out in the HRA Community’s ways of working resource.

Milestone, activities and measures

Update our ways of working to be clear how we will act when people do not respect our ways of working by March 2026.

An increasing diversity of perspectives that inform our work

In 2025-26 we will:

Expand demographic monitoring to everyone we work with so that we can use this information to inform objectives for where we want to increase representation in our work.

Milestone, activities and measures

Develop approach to expand demographic monitoring by March 2026.

Conduct demographic monitoring of HRA Community as part of survey of experiences with us – March 2026.

Conduct demographic monitoring of HRA staff - annual.

Complaints, freedom of information act (FOIA) and data subject rights requests

In 2025-26 we will:

Provide a complaints service including third party complaints.

Milestone, activities and measures

HRA complaints, 100 percent completed in 25 days and no more than 5 percent of complaints resulting in a subsequent appeal to the Chief Executive.

Third-party complaints, no more than 5 percent of third-party complaints resulting in an HRA complaint regarding the process followed.

Transparency – information from health and social care research studies is publicly available for the benefit of all

In 2025-26 we will:

Continue to monitor if sponsors are registering their clinical trial [2 percent increase in the proportion of sponsors registering their clinical trials].

Milestone, activities and measures

Publish compliance monitoring of registration of clinical trials that received a favourable opinion from a REC in 2024. March 2026.

In 2025-26 we will:

Increase sponsor awareness of the need to upload summary of results on a registry within an agreed timeline.

Increase sponsor awareness of the need to let people know about the findings of studies they took part in.

Milestone, activities and measures

Establish compliance monitoring of uploading summary results on a registry within an agreed timeline and feeding back to participants.

Widen participation in research so that findings can help address health inequalities

In 2025-26 we will:

Work together with MHRA in piloting the Diversity and Inclusion Plan including publishing guidance and making sure processes are in place to support the pilot.

Milestone, activities and measures

Target of 20 diversity and inclusion plans submitted during the six-month pilot.

Increase rates of public involvement in applications for review by a research ethics committee

In 2025-26 we will:

Work together with MHRA to develop guidance for public involvement in clinical trials, supporting the update to clinical trials regulation - March 2026.

In 2025-26 we will:

Conduct an exercise to better understand how confident our review committees feel to use insights from good involvement and respond to poor involvement when reviewing research applications. We will use these findings to inform work to support them - March 2026.

In 2025-26 we will:

Conduct our annual review of rates of public involvement in applications for review by research ethics committees.

Milestone, activities and measures

Work with the signatories of the Shared Commitment to Public involvement to develop and disseminate this information.

In 2025-26 we will:

Curate and develop evidence that demonstrates the benefits of public involvement in research.

Milestone, activities and measures

Work with the signatories of the Shared Commitment to Public Involvement to encourage sharing of learning and best practice.

Functional standards and continuous improvement

In 2025-26 we will:

Put in place continuous improvement plans for all applicable functional standards and internal audit review recommendations - April 2025.

Actively monitor our achievement against functional standards mandated assertions and internal audit recommendations - throughout the year.

Improve how we plan to achieve our strategy with our limited people and financial resources

In 2025-26 we will:

Drive greater interoperability in our internal planning by setting a cohesive, end-to-end framework that connects our strategy with capacity and capability planning, business planning, investment decisions and performance monitoring - March 2026.

In 2025-26 we will:

Improve our strategic and operational performance reporting to deliver our 2025 strategy - Sept 2025.

People Strategy

In 2025-26 we will:

Take action following our annual staff survey to respond to feedback.

Milestone, activities and measures

2 percent improvement in our staff engagement score which measures how our staff feel working in the HRA, how proud they are to do so, whether they would recommend working here and their motivation in their role.

In 2025-26 we will:

Develop an updated people strategy - March 2026.

In 2025-26 we will:

Update key policies to meet the requirements of the forthcoming Employment Rights Bill - March 2026.

Equality, Diversity and Inclusion (EDI) Strategy

In 2025-26 we will:

Redesign our EDI strategy to align with our updated people strategy and meet our public sector equality obligations - March 2026.

In 2025-26 we will:

Build on our respect commitment so that everyone is treated with dignity, fairness and respect in their role.

Milestone, activities and measures

Increase by at least 2 percent the number of people who tell us they are treated this way (baseline: 72 percent).

In 2025-26 we will:

Demonstrate we value our staff by actively listening to their voices, recognising their contributions and investing in their development

Milestone, activities and measures

Increase by at least 2 percent the number of staff who tell us they feel valued and recognised for the work they do (baseline: 63 percent).

HRA Community

In 2025-26 we will:

Survey the experiences of our HRA Community and act on it.

Milestone, activities and measures

Maintaining satisfaction at or above 80 percent.

Financial strategy

In 2025-26 we will:

Develop and agree our three-year financial strategy - July 2025.

In 2025-26 we will:

Respond to the 2025 Spending Review and make sure we take steps to deliver our strategy whilst managing our resources in line with our future funding - December 2025.

Portfolio Management

In 2025-26 we will:

Produce our Portfolio Delivery Plan for 2025-2026 and develop a Portfolio Strategy - June 2025 and December 2025.

Reduce the cost of doing health and social care research

In 2025-26 we will:

Explore, develop and agree a methodology to monitor and focus our improvement activities including productivity and efficiency targets - March 2026.

In 2025-26 we will:

Define efficiency and productivity processes within our business planning and investment appraisal processes to make sure we remain effective and deliver value to the public purse - November 2025.

Infrastructure digital systems

In 2025-26 we will:

Prepare for the end of the commercial agreement for our corporate website - throughout the year.

Sustainability

In 2025-26 we will:

Monitor CO2 emissions against the HRA’s 2022 target and report quarterly via the Greening Government Commitment (GGC) return - March 2026.

Financial plan

Our total funding anticipated for this year is £33.3M (2024-25: £28.8M). We receive most of this directly from the Department of Health and Social Care. In 2025-26 this funding, known as grant-in-aid (GIA), will be £20.8M (2024-256: £21.8M) to fund revenue activities, £11.0M (2024-25: £5.5M) to fund capital investment and £1.1M (2024-25: £1.0M) to fund non-cash revenue (for example, depreciation).

The rest of our revenue comes from the devolved administrations (£0.5M) as part of cost sharing arrangements for ethics review and UK wide research governance (2024-25: £0.4M). The HRA is committed to providing value to the public purse. We achieve this in two ways:

• streamlining the research set-up process, driving economies and efficiencies to the research sector
• achieving ‘more for less’ in our services and policy work, by continuously improving our processes, reducing duplication and using technology to add value and reduce costs.

We have planned for a balanced income and expenditure position for 2025-26 on our core services and change activities. This is enabled by £1.5M recurrent efficiencies and savings achieved during 2024-25, to manage inflationary pressures and increased investment in transforming our digital services. The financial plan table sets out our sources of revenue funds for 2025-26. It also shows how these compare with our 2024-25 financial plan.

Capital funding

Capital funding of £11.0M (2024-25: £5.5M). This funding supports our essential digital services transformation as well as core infrastructure (estates and technology). Capital funding has been confirmed by DHSC. The following table shows how capital funding will be invested.

Research digital services transformation

Our research digital services transformation programme gained approval from DHSC Investment Committee in 2023. A change request for this programme was considered and approved by the Committee in February 2025. Funding and activity related to this programme are included within this business plan for 2025-26 based on our most up to date programme roadmap. Future funding for the programme is dependent on Spending Review 2025.

Financial plan 2025-26