Performance report

Chief Executive's introduction and performance overview

Every year our annual report is a chance look back with enormous pride at our achievements over the past 12 months. We have now settled into our new post-pandemic world, with that time reminding us all of the vital importance of high quality health and social care research.

As you’ll be aware, in June 2022 we launched a bold new strategy for the HRA, with a vision to make it easy to do research that people can trust. And this report marks almost a whole year of activity guided by our strategic aims.

We now have two key principles. To include, so that health and social care research is done with and for everyone, and to accelerate, so that research findings improve care faster because the UK is the easiest place in the world to do research that people can trust. Our strategy also sets out how we’ll make these happen – using digital technology well and always looking for ways to do things better.

This work supports key government priorities, including the Recovery, Resilience and Growth Programme, the review of clinical trials led by Lord O’Shaughnessy and Sir Patrick Vallance’s work on the life sciences regulatory environment.

My thanks go to our incredible Research Ethics Committee (REC) members, who alongside members of our Confidentiality Advisory Group (CAG) give their time generously to review thousands of applications every year.

With the Medicines and Healthcare products Regulatory Agency (MHRA) we’ve embedded combined review for all new Clinical Trials of Investigational Medicinal Products (CTIMPs) and combined medicine and device trials. It is also great to see the ongoing good performance on Research Ethics Committee and Confidentiality Advisory Group review times despite wider challenges in the sector.

We’re continuing our work to Make it Public, so that trusted information about health and social care research is publicly available for the benefit of all. In March 2023 we held the UK’s first ever week dedicated to research transparency. Our events brought together more than 300 people from across the country. Our transparency annual report highlighted some real successes, and where we need to focus in the next year.

March also marked the first anniversary of our Shared Commitment to Public Involvement. Over the past year we have seen five new organisations join the partnership, including NHS England and Cochrane. The anniversary was an opportunity for all of the partners to come together, share success stories and reaffirm our commitment to ensure that public involvement is at the heart of health and social care research.

More broadly, we’ve continued to provide advice and guidance for researchers to make it easier for them to involve the public in research.

Public involvement and transparency were two of the key areas highlighted in the response to the government consultation on clinical trials regulation. We’re working closely with the MHRA, the research community and members of the public on flexible and proportionate legislation that is supported by clear guidance.

The HRA continues to play a leading role in the field of artificial intelligence and data regulation, a constantly evolving field that is exciting to be part of. We’ve joined the NHS Innovation Service to advise and guide innovators on the research approvals process. We have also joined the Artificial Intelligence and Digital Regulations Service (AIDRS) to support developers and adopters of new technologies through the regulatory pathways.

Whilst there is lots to be proud of over the past year, it hasn’t been without challenges.

It is our duty as a public body to ensure value for money in all we do and realise savings for the public purse where we can. This is true every year, this year, against the backdrop of a cost of living crisis, it has been a particularly difficult environment for public finances. I am pleased to say that we have sought and realised over £700k savings for the public purse mostly through moving our research ethics service on-line.

Despite the best efforts of everyone involved, our work on new IRAS (the Integrated Research Application System) has not progressed as far as we had planned over the past year. Our current system continues to deliver a good service and remains a core strength of UK research. The difficulties in developing the new system means that we carry the risk of failure of the current system longer than we had thought, and it will delay some changes we want to make. My team continue to work hard to mitigate both risks. We know how important a smooth running, easy to use system is to the research community and are working hard to let you know when change is coming, and to make sure our systems make it easy for everyone to do research that people can trust.

Our recently agreed Community Committee, which will formally include members of the public in our governance, will ensure that any decision made at Board level has been given scrutiny by members of the public. I’m pleased to see that this Committee will be established later this year.

I want to end by talking about the incredible efforts of our staff. They have continued to work tirelessly throughout a difficult period of organisational change at the HRA, and I want to acknowledge the impact of that and how tough it has been. We will continue to support staff in every way we can, working alongside our Staff Voices volunteers and staff led interest groups who continue to provide invaluable feedback and challenge to ensure we make the best decisions.

Our vision

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

Our purpose

Our purpose is to protect and promote the interests of patients and the public in health and social care research.

Our values

In all our work, we are guided by our organisational values:

• inspiring leadership: enabling people and teams to develop and deliver dynamic, innovative and transformative services and systems.
• integrity: being fair, ethical and honest in everything we do.
• trusted: being respected for delivering to consistently high standards.
• transparent: being accountable and open about all aspects of our work.
• collaborative: listening to and working with others to identify and make improvements to the health research environment.
• empowering: supporting independent thinking and decision-making.

About us

The Health Research Authority is a non-departmental public body, set up in 2011 with a mission to protect NHS patients, your tissue and your data when you are involved in research. We have transformed UK research regulation and governance by simplifying processes, removing duplication and reducing timelines. We have better supported the research community by putting people first.

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.
• work with other organisations across the UK to make sure that, wherever you are, research studies can be set up smoothly and are always subject to the same scrutiny before they start.
• work with others to coordinate and standardise the way research is set up and managed.
• encourage and support transparency about research so that you can find out what research is taking place, and what it found.
• are one of the gatekeepers of patient data making sure that your information is protected if it’s used for research.
• put in place and support the digital platforms to help research get set-up and managed in the UK.

How we work

Our 263 staff, who work at home and in our offices in Bristol, London, Manchester, Newcastle and Nottingham provide specialist advice and learning to researchers about research ethics and governance. They also develop policies concerning research ethics and governance as well as support our committees and advisory groups to deliver our services. Our staff work with users of our services to design and put in place the digital systems used by the sector to set up studies and also effectively administer the organisation.

We could not operate without the HRA Community.

The community is made up from our Research Ethics Committees (REC) members, Confidentiality Advisory Group (CAG) members and our Public Involvement Network (PIN) which includes members of the public who have experience of or have been impacted by research.

They all make an invaluable contribution to our work and the experience of people taking part in research. This helps us make sure that people can trust the research that we approve so that the research findings can improve care. They give their time generously enabling the HRA to operate efficiently and respond rapidly when needed.

To deliver our ambition to make it easier to do research that people can trust and ensure that health and social care research is conducted with and for everyone, it is important that we are informed by a range of insights and experiences that reflect the population that we serve.

We can make better decisions by working with a diverse group of people. We are working with our HRA Community to ensure that working with us is a positive experience that is open to everyone.

Our strategy: we make it easy to do research that people can trust

In 2022, we launched our new strategy setting out our strategic direction for the next three years and how we will achieve it.

In setting this new strategy, we met many different people who pushed us to think in different ways. We then worked with people who had experience of research or had been impacted by it to launch our strategy. They helped us to explain what we are doing and why it matters in a way that is accessible and informative to all.

Our strategy is focussed on earning and maintaining people’s trust in research. By working in a balanced way we will make it simple and fast to deliver research that people can trust. It sets out four strategy pillars that guide our work – include, accelerate, digital and improve.

Include – so that health and social care research is done with and for everyone.

Accelerate – so that research findings improve care faster because the UK is the easiest place in the world to do research that people can trust.

Digital - use digital technology well to do our work.

Improve - always looking for ways to do things better.

Performance management

We plan our work to deliver our strategy and statutory functions. We do this by preparing an annual business plan which is focussed on setting out how we will deliver our strategy and our statutory functions. This plan is prepared involving a wide stakeholder group and is embedded throughout the organisation in our performance, people and risk management processes.

These processes help make sure we successfully achieve our strategic priorities and meet our statutory functions. Importantly, it helps our people understand their role in delivering our plans.

We regularly monitor and evaluate our performance against our strategy, business plan and financial plan. We moved to a quarterly strategic performance reporting cycle this year. Every three months we collate a strategic performance report for our Executive Committee and Board to review. This, combined with user satisfaction data and financial reporting, provides assurance on how we are delivering on our strategy and highlights areas for focus and improvement.

Individual staff objectives that complement and support these organisational objectives are developed during the annual appraisal process and monitored throughout the year during regular one-to-ones between staff and their managers.

The way that we manage our performance and its relationship with risk and uncertainty is explained in more detail in our Corporate governance report on page 24.

As a learning organisation, we regularly review and refine our performance management and reporting systems to ensure we continue to deliver on our strategy ambition and statutory functions.

We also set operational performance metrics, which are collated and monitored monthly by delivery teams, focussing on continuous improvement and statutory compliance. Operational metrics are reported every three months to our Executive Committee.

Performance analysis

2022-23 was the first year of our new strategy. In our performance analysis we present our achievements and milestones delivered for each of the four strategy pillars: include, accelerate, digital and improve. This helps show the progress we are making to deliver our strategy.

Looking forward we want to do more to show our progress. Next year we plan to show how our achievements and milestones make sure we are delivering on our strategy by showing these alongside our strategy roadmap. We will also highlight areas where we are falling behind or have experienced issues and what we have done to manage this.

Include: health and social care research is done with and for everyone

Include everyone in research

We:

• held ‘Make it Public Week’ the UK’s first ever dedicated week to research transparency during which we published our annual report on research transparency to demonstrate progress and share best practice
• published a webpage, developed in partnership with the Medicines and Healthcare products Regulatory Agency (MHRA), setting out why it is important to increase diversity of people taking part in research and signposting resources to help researchers to do this
• celebrated the first year of the Shared Commitment to Public Involvement with our partners by sharing information about our progress, reflections on the first year and what we plan to do next
• made sure that 100% of the 100 most visited pages on the HRA

Ask you what you want research to look like and act on this

We:

• set up the people-centred clinical research project (PCCR) to improve the way clinical research happens so that more people can take part in ways that are best for them. The project was developed in partnership with a steering group of 8 public contributors and 8 members of the research community.
• completed a survey asking for people’s views on our proposed hallmarks of people-centred research and received over 400 responses which we are now analysing to inform next steps
• set up conversations with a range of organisations to understand better the implications for people who lose capacity in longitudinal research

Involve you in the HRA

We:

• agreed to set up a Community Committee as part of our governance to make sure that we grow opportunities for The HRA Community to be involved in our internal decision-making
• listened to observers attending our Board meetings and put in place actions to improve their experience including providing clear information about observing our meetings on our website
• involved a wider group of people in setting our 2023/24 business plan, including the public contributors, REC members and staff voices
• launched a campaign to help recruit new Research Ethics Committee members with a particular focus on reaching new people who have not previously been involved in health and social care research
• worked to put in place a more consistent, positive experience for everyone who works with us as a member of a Research Ethics Committee, the Confidentiality Advisory Group or as a public contributor

Accelerate: research findings improve care faster because the UK is the easiest place in the world to do research that people can trust

Save money and time so that you can focus on doing good research

We:

• transitioned our fast-track ethics service from a dedicated REC into a pool of existing RECs to support research to be set up faster without additional cost to the public purse
• put in place a light touch combined review process between the HRA and MHRA to further improve performance and reduce timelines
• reduced the impact of MHRA service delays by communicating our review outcomes earlier in the process which enables applicants to prepare their responses while waiting for the formal information request
• published two new model agreements and kept up to date twelve existing agreements to help speed up and streamline study-set up
• completed our Think Ethics programme and agreed future actions to streamline and simplify research ethics review processes
• launched a draft toolkit to support researchers to set-up studies across more than one UK nation

Create a new online system to help you make research happen

We:

• performed a strategic review of our research systems programme including updating the business case for the Department of Health and Social Care‘s (DHSC) Investment Committee
• began to design the ideal user journey for research set-up in collaboration with researchers who use our services, devolved administrations and other regulators, including drafting new questions sets and workflows
• worked with users and stakeholders to incorporate bioresources research studies into the ideal user journey

Support new ways to do research

We:

• worked with several government bodies to put in place an information platform to simplify the regulatory process for developers of artificial intelligence (AI) technologies in the health and social care sector. This resulted in an increase in AI applications of 7% on last year which was slightly below our target of 10%
• sponsored a project with the Experimental Cancer Medicines Centres to radically reduce the time it takes to set-up their clinical trials
• collaborated with NHS England and the National Institute for Health and Care Research (NIHR) Clinical Research Network to roll out the National Contract Value Review Service
• worked with NHS England to make sure research is embedded in the new Integrated Care Systems
• supported DHSC and NIHR to understand better the issues associated with study set-up in settings outside the NHS such as care homes and schools

Use digital technology well to do our work

Design our digital systems in a human-centred way

We:

• proposed a new delivery approach for our research systems transformation with human-centred design at its core which we plan to put in place in 2023
• ran a procurement exercise to select a delivery partner to help us build our research systems, replacing our end-of-life existing systems
• undertook a peer led review of our research systems programme to make sure the necessary capacity and controls to deliver the programme well are in place
• reviewed and began to put in place changes to our digital service management to improve service users’ experience and better manage issues as they arise

Automate and join-up processes where this will improve our work

We:

• combined our corporate information into a single platform, improving user experience and significantly reducing duplicate records
• automated core processes using Office365 functionality and managed the transition between IT service providers with no loss of service
• launched modern desktop for our IT services, improving cyber security and user experience, with 75% of staff saying they have the IT support they need to work effectively
• made good progress in 2023 in achieving data security and protection toolkit requirements having met all assertions in 2022
• completed a data analytics review to provide the foundations for our future data warehouse solution

Always look for ways to do things better

Always learn, improve and innovate

We:

• launched and promoted a consistent learning approach that incudes on the job learning, interactions with others and formal learning enabling staff to be responsible self-directed learners
• agreed a new delivery approach for our online learning, sharing NIHR’s digital learning platform to create a better experience for learners and bolster our service resilience
• increased the number of equality impact assessments (51) performed on policies and procedures during 2022-23, with seventy-five percent of these being new assessments
• built our confidence to have inclusive conversations, with nine interactive sessions delivered to staff this year
• designed an innovation and change model for the HRA and trialled interventions to improve how we share and grow our understanding of our work as well as confirming a Non-Executive Director (NED), Richard Cooper, as our innovation champion
• launched a contract management system to improve our commercial processes, ensuring consistency and better record keeping

Be a great place to work

We:

• refreshed our staff forum (now called Staff Voices), grew its membership by 57% to 11 and focused on staff wellbeing and innovation in addition to actions from the staff survey action plan
• appointed Richard Cooper (NED) as our wellbeing champion and grew the number of Mental Health First Aiders at the HRA by 200% to 12.
• published pay transparency guidance and revised our recruitment policy - the launch of the policy was supported with learning resources and training attended by 35 managers
• recently saw a decrease of 6% in our staff engagement score in our 2023 staff survey to 76%, below our target by 2% although higher than the industry benchmark of 67%. This is disappointing and we are putting in place an action plan to reverse this trend.

Commit to environmental sustainability and achieving net zero

In collaboration with our Green Team, a staff-led group set up to help make the HRA a more sustainable organisation, we:

• launched our first environmental sustainability strategy and put in place a new role responsible for delivering on it
• raised awareness of ways staff can be more sustainable including publishing an easy guide to booking environmentally sustainable transport
• advised on new questions to be included in our annual staff survey to help inform our next steps on sustainability
• evaluated how well suppliers would help us achieve social value when choosing the delivery partner for our research systems procurement exercise

Sustainability report

The HRA is committed to environmental sustainability and achieving net zero. To help make this happen, the Green Team, a staff-led group, committed to improving sustainability, developed and launched our first environmental sustainability strategy in 2022. This strategy aims to embed environmental sustainability as part of our culture and ways of working and will be updated for 2023.

It has been a successful year for the group with the introduction of our environmental sustainability strategy, a new role created to support our work and continued monitoring of our environmental performance. We are pleased with our progress and want to do more to make sure the environment is protected for future generations.

We work in partnership with our colleagues at the Department of Health and Social Care (DHSC) and our own Green Team, to improve our environmental performance across the organisation. Our approach continues to focus on staff-led initiatives alongside strategic commitments set out in our environmental sustainability strategy to deliver significant, lasting change. Our vision, to make this change happen, is to embed environmentally sustainable practices into our daily business, making environmental sustainability the norm.

Our work is aligned with the five government environment principles which encourage not only our teams but also our partners and suppliers to consider the environment in all activities.

Our estates strategy works to support our sustainability strategy. This includes ensuring that sustainability and environmental performance is prioritised in decision making. We also make sure lease events are managed meeting government policy and supporting our strategy.

Four out of five of our office locations are in spaces shared with other government bodies to improve office utilization and energy efficiency. Where we share offices, energy reporting is provided by our public landlord and is not included in our Greening Government reporting. As a result, our reporting on energy consumption is solely related to one office location, our Manchester office. In 2023, we plan to move to a shared government office in Manchester, further consolidating our estates and improving energy efficiency. We have reduced our estates footprint and our workstations by 50% since 2020 and will go further in 2023.

New initiatives introduced this year to support our strategy include looking at how we buy goods and services to make sure sustainability considerations are included in decision-making and assessing all domestic flight requests against several factors including cost, time, energy consumption and staff wellbeing before booking travel.

The following tables show our key performance indicators that help us measure our ambition to achieving net zero.

Carbon Dioxide (CO2) emitted by rail travel – staff

CO2 emitted by rail travel – Committee Members and public involvement

Staff and HRA Community domestic flights – cumulative CO2

There were no domestic flights during the period of 2022-2023

CO2 emissions from international flights

Paper purchases

Single-use plastics

Financial review

Our accounts consist of primary statements providing summary information about our income and expenditure in the year, our assets and liabilities at the end of the year, and how we have managed our cashflows. They also include detailed notes to these statements that provide more information about the accounts.

Our accounts have been prepared based on the standards set out in the Government Financial Reporting Manual (FReM) to give a true and fair view.

We remained within our agreed revenue and capital funding allocations from the Department and Health and Social Care (DHSC) for the year-ended 31 March 2023. Our total funding from the Department for the year was £23,552,000 (2021-22: £24,719,000) of which:

• £22,793,000 (2021-22: £21,954,000) was revenue funding from DHSC
• £759,000 (2021-22: £2,765,000) was capital funding from DHSC

We also received income from cost-sharing arrangements with other publicly funded organisations, this included:

• £396,000 (2021-22: £349,000) from the devolved administrations for providing support and digital systems to deliver the UK research ethics service
• £44,000 (2021-22: £37,000) towards the costs of our Manchester office from High Speed Two who share our office space in the city

Our total net expenditure for the year was £21,789,000 (2021-22: £19,290,000), resulting in an underspend on our committed revenue funding of £1,004,000, (-4%).

Details of our expenditure are:

• £6,573,000 (30%) funded our core services including the research Ethics Service, HRA Approval, Confidentiality Advice Service and Technical Assurances
• £2,050,000 (9%) funded our Chief Executive’s Office, Policy and Engagement activities and Corporate Governance
• £3,041,000 (14%) related to depreciation of our core infrastructure costs such as computer hardware and our digital research systems
• £640,000 (3%) funded our premises, facilities and estates development activities

In addition to our core statutory functions, we invested in strategic and government priorities including:

• £3,399,000 revenue and £54,000 capital costs on digital research systems transformation.
• £486,000 on building capacity to support the UK research ecosystem making sure that clinical research delivery recovers, is made resilient and grows following the pandemic.
• £148,000 on our Think Ethics programme, putting people and ethics at the heart of health and social care research.

We take great care to plan our activities well to deliver our strategy. Our business planning process appraises how best to invest our limited resources against our strategic objectives so that we spend our funds wisely and maximise our impact.

The move to a virtual operating model for the research ethics service during the pandemic has widened access and released 5% year-on-year savings back to the public purse. At the same time, we have maintained service quality, keeping high levels of user experience and achieving over 94% of our statutory timelines.

Our cash balance at 31st March 2023 is £530,000 higher than the year before. This increase is due to the re-negotiated 2023-23 pay award agreed later in the year and due for payment in June 2023.

Key issues and risks

Along with all organisations, we face risks in the delivery of our strategy and statutory functions. We actively and effectively manage these to minimise the impact on the users of our services as well as other stakeholders and our people. Notable risks this year include:

Delivery of transformed and improved research systems strategic pillar: Accelerate

We identified a risk that we may not be able to deliver a new and improved research system that meets the needs of the health research community and makes the UK an attractive place to conduct research. The research system has multiple connections and dependencies across several organisations and is a complex programme to deliver.

We have faced challenges in delivering the programme and paused the programme in January 2022 to review the programme design. In May 2022, we decided to change our approach to the programme delivery.

There have also been changes in key leadership personnel in the year and an extended procurement process to secure a new delivery partner. Revised business case approval is required from the DHSC Investment Committee to move forward with the programme and this was received in May 2023.

In March 2023, an independent Gate Review 0 made recommendations to improve our delivery success which we are putting in place.

Delivery of regulatory activity alongside ambitious strategic programmes strategic pillar: Accelerate

We identified a risk that the HRA would not be able to secure and put in place skills and capabilities to deliver our strategic programmes at the same time as delivering our statutory functions. The risk was specifically related to our capacity to move at pace to deliver our business plan objectives.

Our business and financial planning process identified areas where additional skills and capacity were required to support the delivery of our business plan objectives.

We set aside funding to invest in this additional capacity and have streamlined our recruitment approval process to reduce timelines and improve efficiencies. This risk was closed in July 2022.

Decision making by the organisation and diversity of views strategic pillar: Include

We identified a risk that our decision-making is not informed by a sufficiently diverse range of views and experiences. This could undermine our effectiveness in meeting our public sector equality duty.

We have low representation from individuals with protected characteristics at our Board and Executive Committee. We are committed to providing services which promote human rights, equality and diversity and do not discriminate.

The HRA is not directly responsible for the recruitment and appointment of our Chair and Non-Executive Directors (NED); this decision remains with the Secretary of State. This means we have limited ability to change the diversity of the Non-Executive Director membership of our Board. We are working with DHSC to address this for the next round of NED recruitment.

This year, the HRA Board approved setting up a Community Committee, as a formal advisory sub-committee of the HRA Board, to increase diversity in our decision-making. Previously, a Community Insight Group gave advice to the HRA, including our Board.

The Community Committee will be a formal advisory sub-committee of the HRA Board with representation from a diverse range of individuals including members of RECs, members of CAG and Public Involvement Network (PIN) members alongside HRA Board members. This followed a consultation with the HRA’s community which gave strong support for this formal group.

The Committee will review key plans and strategies prior to their review by the Board. This will allow advice to be provided to the Board and help support the HRA’s strategy of making it easy to do research that people can trust.

Trust of research participants and the public lost in the HRA strategic pillar: Include

We identified a risk that our reputation is adversely affected resulting in research participants and the public losing trust in the HRA. This could lead to fewer people choosing to take part in research. This risk could arise if:

• we fail to perform our statutory functions
• there was an adverse event resulting from a Research Ethics Committee decision
• poor research practice took place
• an issue arose from a third party complaint
• there was a lack of public involvement within the HRA

Our transparency strategy continues to be promoted across the research landscape supporting our role to facilitate safe and ethical research and build public confidence in research. Alongside this, by exploring and developing innovative approaches to how we work, we will make ethics review even more innovative and efficient, whilst retaining public trust and putting people and ethics at the heart of health and social care research.

The new Community Committee, will have representation from a diverse range of individuals, including research participants and members of the public, who will review key plans and strategies, and provide an important public voice in our decision-making.

We also strengthened our complaints team to better support individuals who have raised an issue with a particular research study or sponsor. This, combined with robust procedures such as ensuring RECs are constituted in accordance with governance arrangements for RECs, has helped maintain public confidence in research.

Dr Matthew Westmore

Chief Executive
Health Research Authority
4 July 2023