Foreword by Matt Westmore, Chief Executive
Our vision is for high-quality health and social care research that improves people's health and wellbeing. Our business plan sets out the work we will carry out during the 2021/22 financial year to meet our strategic aims. It describes our plans and how we will use our resources to achieve them.
I joined the HRA at the end of February 2021, at a challenging but exciting time. If 2020 was the year of the emergency response, 2021 will be the year of recovery and building resilience. If 2020 was the year for rapid innovation borne of necessity, 2021 will be the year for embedding that innovation for the long term. And if 2020 was the year to prioritise research to support the immediate public health emergency, 2021 will be the year to build on what we've learned for all research.
In the last year, the HRA has played a critical role in the UK life sciences response to the global challenge of COVID-19. The HRA has approved over 700 studies; we reviewed urgent public health studies in less than 36 hours. The HRA has also supported the ongoing delivery of vaccine trials, the world's first COVID-19 challenge trial and the broader portfolio of non-COVID-research. Like many others, we have done this through extraordinary levels of effort and commitment. However, the HRA has also capitalised on existing commitments to innovation, such as our user-centric approach, enhanced use of digital technology and improved collaboration across the research system, including with the devolved nations.
Therefore, this business plan sets out how the HRA will continue to deliver both our vital contribution to the pandemic and a high-volume 'business-as-usual' service working collaboratively across the sector. We will use the last years’ experience to transform the HRA's contribution to the UK's health and social care research landscape for the better and for good.
I look forward to working with my new HRA colleagues, our volunteers, partners and the broader research landscape to achieve these aims and make a difference to the UK life sciences sector, our health and social care service and all of us that depend on them.
- Wider context
- Strategic objective 1: Enable high-quality research which is in the interests of participants and carried out with patient and public involvement and high standards of transparency
- Strategic objective 2: Provide a user-friendly and efficient service which facilitates a strong research environment
- Strategic objective 3: Be a knowledgeable, well-run organisation that's true to its values
The Health Research Authority (HRA) is an arm's length body of the Department of Health and Social Care. Our vision is for high-quality health and social care research that improves people's health and wellbeing. This plan sets out our strategic objectives and the work we will do during 2021/22 to deliver them
Objective 1: Enable high-quality research which is in the interests of participants and carried out with patient and public involvement and high standards of transparency.
We will provide ethics review or HRA/Health and Care Research Wales approval for new studies and amendments; based on last year's figures we estimate this to be 5000 new studies and 17000 amendments. We will provide legal and governance assessment at a national level for NHS sites on an estimated 4500 studies; and support for the appropriate use of confidential patient information where consent is not possible. We will also manage the technology platforms for more than 8000 users seeking national health and social care research approval on behalf of partners across the UK.
We will facilitate UK-wide collaboration with a strong focus on patient and public involvement and engagement; this will include agreeing on a sector-wide consensus statement reaffirming the importance of public involvement. We will deliver the next phase of our Make It Public transparency strategy. This will include enabling all clinical trials of medicinal products to be registered in a UK registry before a study begins, and publishing a tool to allow the public to see all approved research studies and their findings.
Objective 2: Provide a user-friendly and efficient service which facilitates a strong research environment.
We will implement the findings of a significant review of the research ethics service. This includes a range of changes to streamline research ethics review to increase proportionality, reduce the burden on research ethics committee members and improve the experience for researchers. We will also establish a fast track ethics service for selected study types as business as usual (having successfully delivered a pilot in 2020/21). This will halve the time it takes to provide an opinion. The roll-out of our new streamlined approval process with the Medicines and Healthcare products Regulatory Agency (MHRA) for all applications for clinical trials of medicinal will be completed.
In collaboration with NHSX, a new project will begin to streamline, modernise and simplify the development of high-quality data and AI-driven healthcare technologies and devices.
All activities in this section will be co-developed with our users, volunteers and stakeholders. For example through action plans in response to user, volunteer and stakeholder surveys, a new volunteer advisory group and our Make It public Campaign Group.
2021 will see the start of a three-year programme to redesign our digital systems. This will transform the external user and partner experience and support improvements in internal operational quality and efficiency. We will recruit user-research expertise to help ensure all developments are user-led. We will implement joint initiatives with our partners in the National Institute for Health Research (NIHR) and MHRA to share data between our information systems so that researchers don't have to renter it.
Working in partnership with the cross-sector DHSC-led Recovery, Resilience and Growth programme, we will ensure a coordinated system to support the setup and delivery of research. We will continue to support the Four Nations Policy Leads Group. This group sets UK health and social care research policy, agrees UK-wide policy on research governance and ethics review, and acts as the United Kingdom Ethics Committee Authority.
Objective 3: Be a knowledgeable, well-run organisation that's true to its values.
We will enhance the role of our Public Involvement Network in our work in particular, and our engagement and collaboration with HRA volunteers more generally, through establishing a volunteers' group and acting on survey findings.
We will publish and implement our Equality, Diversity and Inclusion strategy and ensure our digital transformation widens access, offering services that are accessible to all. To embed learning from the pandemic and establish our revised hybrid approach to office and remote working after restrictions due to the pandemic have been lifted, we will develop and implement a future ways of working framework for our staff. This, in turn, will feed into a new and wider-reaching people strategy that we will publish later in the year and our estates strategy that will provide flexible workspaces that meet our needs and achieve 6sqm/full-time equivalent space utilisation.
We developed this business plan at a time of significant change for the HRA.
A period that presents opportunities but against a backdrop of uncertainty for the wider sector and society. We appointed a new Chief Executive, Matt Westmore, who started at the end of 2020/21. The pandemic continues, but we are beginning to emerge, and we enter a new post European Union transition landscape. There are many discussions and initiatives ongoing laying the groundwork for an exciting future at the time of writing. This business plan balances our stretching ambitions with the realities of the fast-changing situation we remain in. Accordingly, we will review our strategy during this year.
What are already clear are overarching ambitions that guide how we will approach delivering our strategic and operational objectives:
- to learn from, embed and build on what we achieved in response to the pandemic
- to continue our long-term drive to simplify our approvals processes
- to work with partners to make the end-to-end research system, including study setup, much more streamlined and connected.
With these ambitions guiding our approach to business-as-usual and the extensive programme of change set out below, the HRA will play a positive role in the UK life sciences sector whilst continuing our unswerving focus on promoting and protecting the interests of participants and the general public in research.
HRA 2021/22 business plan
Our mission is to protect and promote the interests of patients and the public in health and social care research. Our work helps researchers carry out high-quality and ethical studies in the interest of research participants, patients and the wider public. We do that by providing expert advice and guidance to researchers and reviewing research studies through 64 Research Ethics Committees in England, the Confidentiality Advisory Group and specialist review and assurance of research on behalf of NHS organisations. We work with the devolved administrations to coordinate and standardise the practice of research regulation across the UK.
We work across the whole health and care system - reviewing around 5,000 new research studies each year, from multi-centre clinical trials of new medicines and advanced therapeutics to observational studies using tissue banks or health data. We also review 17,000 amendments to existing research studies. We provide legal and governance assessment at a national level for NHS sites on an estimated 4500 studies.
We manage the technology platforms for national health and social care research approval on behalf of partners across the UK. This includes supporting around 8000 registered users of the online Integrated Research Application System (IRAS) and the back-office systems that support the review of applications to enable researchers to apply for research approvals from several different regulators, committees and review bodies.
How we work
The HRA has around 220 staff supported by a network of 1,000 experienced volunteers. We could not operate without our network of volunteers. They provide advice and review on Research Ethics Committees, the Confidentiality Advisory Group and as part of our Public Involvement Network. They give their time to support health and social care research and our work. They make an invaluable contribution to our work, to research and research participants.
The Board, led by Professor Sir Terence Stephenson, governs the HRA. The board members are our Chief Executive, Matt Westmore, two executive directors and four non-executive directors, with three further directors attending. The Board gives strategic oversight, agrees on high-level policy and ensures that the HRA is run effectively and efficiently. Find out more about our leadership.
We provide a UK-wide research review system coordinated across the regulators in the four nations, streamlining governance and promoting good practice across health and social care research. How we work is as important as what we do. We:
- work in partnership with people and communities
- are collaborative, working across the system
- are consultative and inclusive
- are transparent about our activities, our finances and our decisions
- are targeted, focussing on where we add value
- are clear about our expectations
- take proportionate action where necessary.
The HRA is an arm's-length body of the Department of Health and Social Care (DHSC).
To achieve our vision of high-quality health and social care research that improves people's health and wellbeing, we have three strategic objectives:
- Enable high-quality research which is in the interests of participants and carried out with patient and public involvement and high standards of transparency
- Provide a user-friendly and efficient service which facilitates a strong research environment
- Be a knowledgeable, well-run organisation that is true to its values.
Our strategy is embedded into our work through our planning, performance, people and risk management processes. These processes help ensure we successfully deliver on our strategic objectives and, importantly, our people understand their role in our plans.
We achieve our mission to protect and promote the interests of patients and the public in health and social care research by
- making sure that research is ethically reviewed and approved
- promoting transparency in research
- overseeing a range of committees and services and
- supporting the provision of independent recommendations on the processing of identifiable patient information where it is not always practical to obtain consent for research and non-research projects.
Our priorities for 2021/22
Building on our COVID-19 response
COVID-19 is one of the biggest public health challenges we have faced, and research plays a pivotal role in the fight against it. We are contributing to this important work by
- ensuring COVID-19 research can start as quickly as possible, offering a fast-track process with the devolved administrations, providing a decision within a few days of application
- supporting researchers undertaking urgent public health research on datasets involving patient information and ensuring that their continued use of these data sets is approved and supported
- improving transparency of studies by publishing information within days of approval
- collaborating with key partners to ensure the UK is well-positioned to recover the UK's clinical research delivery and restore the entire diverse and active research portfolio in 2021/22.
Whilst the pandemic has been incredibly challenging, it has also been a time of significant innovation and change. Where those changes have been positive, we are committed to embedding them for the long term.
Supporting the UK life sciences sector in a global context
The UK is a global leader in research and innovation, with our response to the pandemic reinforcing this more than ever. The HRA plays a critical role in ensuring that the UK remains a global leader. To achieve this, we will
- ensure that the UK offers an even more attractive and competitive environment for clinical trials by working with the MHRA to deliver a streamlined and user-centric regulatory approvals service
- collaborate with partners to provide a national clinical trial registry that delivers our transparency ambitions and is easy to use
- engage with the devolved administrations on health and social care research, including the delivery of UK obligations under the terms of the Northern Ireland Protocol
- ensure the appropriate governance and accountability structures are in place to consider and implement policy and regulatory changes.
Levelling up agenda: places for growth and addressing health inequalities
The levelling up agenda continues to be a core priority for government, proactively strengthening public sector presence in the nations, regions and communities across the UK. The HRA works with all devolved nations and operates across England through five regional offices and 64 Research Ethics Committees. 80% of our staff are based outside of London and we are committed to reducing further our London-based roles.
In addition to the geographical spread of our offices, staff from across the organisation have developed an Equality, Diversity and Inclusion strategy, which we will begin implementing this year.
We work in partnership with the research sector and funders, for example the NIHR, to improve access to information about research and its findings, increasing diversity in clinical trial recruitment and public involvement in study design and delivery. Through this work we help to ensure that getting involved in research and benefiting from its findings are opportunities that are open to all.
Strategic objective 1: Enable high-quality research which is in the interests of participants and carried out with patient and public involvement and high standards of transparency
Robust review of research underpinned by good practice in public involvement
Review of research through our 64 Research Ethics Committees and Confidentiality Advisory Group provides reassurance to participants, patients and the broader public that health and social care research is conducted ethically and in the interests of patients. Key to this review is how well researchers have involved patients and the public in the design and ongoing management of the study. Good public involvement makes for more relevant research, better recruitment and retention and better outcomes. We will embed our learning from supporting public involvement during the pandemic and working with partners to make public involvement in study design the norm.
|In 2021/22, we will
|By the end of
|Provide ethics review or HRA/HCRW Approval for an estimated 5000 new studies and 17000 amendments to existing studies, of which 8000 are likely to be substantial amendments; legal and governance assessment at a national level for NHS sites on an estimated 4500 studies.
|Manage the technology platforms for 8000 users seeking national health and social care research approval on behalf of partners across the UK. This includes IRAS and the back-office systems that support the review of applications to enable researchers to apply for research approvals from several different regulators, committees and review bodies.
|Manage the Learning Management System with over 8000 registered users and increase uptake of online learning by 10%. Enhance provision for Research Ethics Committee members and chairs by developing a tailored chairs' programme.
|Agree on a sector-wide consensus statement reaffirming the importance of public involvement in study design with actions to support and monitor this.
Transparency and openness in research
Transparency about what research is going on and its findings are vital for patients, service users and the public. It builds trust and accountability, acknowledges their contribution and encourages participation in research. It's also essential for research and care professionals. It leads to improvements and avoids duplication of effort. Our 2019 Make it Public Strategy guides our plans in this area to improve research transparency. In 2021/22, we will work with partners and stakeholders to implement the strategy.
|In 2021/22, we will
|By the end of
|Establish a campaign group to ensure community-wide efforts to realise the vision set out in our Make it Public strategy.
|Collect information on how researchers and sponsors are meeting their research transparency requirements through the final report.
|Develop our digital systems to enable all clinical trials of medicinal products to be registered in a UK registry before a study begins.
|Publish a summary of all approved studies and their findings on the new IRAS website.
Trustworthy use of patient data in research
Public trust in the use of their healthcare data is crucial for developing new treatments and technologies that support wellbeing and provide better care. We review applications to use patient data where it is not possible to obtain consent from individual patients, with expert advice from the Confidentiality Advisory Group. We also advise the research community on the appropriate use of data in research and promote good practice across the research system.
|In 2021/22, we will
|By the end of
|Provide advice and guidance to the Secretary of State for Health and NHS Digital, and review 200 applications seeking to process identifiable patient data without consent.
|Publish guidance on the use of patient data in the development of data-driven healthcare technologies.
|Work with the National Data Guardian to help researchers comply with the newly introduced 8th Caldicott principle.
Strategic objective 2: Provide a user-friendly and efficient service which facilitates a strong research environment
Streamlining research approval
A crucial part of setting up research as soon as possible is helping researchers and research sponsors make smooth applications for approval. Applications can be reviewed swiftly because we provide a UK-wide application portal, IRAS, backed up by advice, guidance and e-learning. We have streamlined how health and social care research is governed, reviewed and set up in the NHS since the HRA was established, and we will continue to focus on simplifying our process and improving user experience in 2021/22. We will continue to partner with the sector, funders, regulatory bodies and the devolved administrations to improve research approval.
We are also enhancing and upgrading our organisation's digital capabilities to support rapidly evolving needs for health and care research across the UK.
|In 2021/22, we will
|By the end of
Design, with users and volunteers, and implement changes to research ethics review to increase proportionality of review, reduce the burden on Research Ethics Committee (REC) members and improve the experience for researchers:
• improve REC member experience through information rationalisation
• improve patient information and consent materials
• Identify further study types that do not require full REC review
• new REC meeting format and arrangements
• improve the consistency of REC review.
|Integrate with the MHRA to provide fast track approval for defined clinical trials, in the first instance by defining the criteria.
|Complete the roll-out for all applications for clinical trials of medicinal products. This will halve the time it takes to provide an opinion on defined studies.
|Streamline and modernise our processes for review of research involving AI and data-driven technologies to ensure this research is enabled to progress swiftly to develop high-quality data and AI-driven healthcare technologies and devices by conducting user and stakeholder analysis.
|Streamline and modernise our processes for review of research involving AI and data-driven technologies to ensure this research is enabled to progress swiftly to develop high-quality data and AI-driven healthcare technologies and devices by redesigning our processes for the review of research involving AI and data-driven technologies to increase efficiency and effectiveness.
|Streamline and modernise our processes for review of research involving AI and data-driven technologies to ensure this research is enabled to progress swiftly to develop high-quality data and AI-driven healthcare technologies and devices by starting the iterative development of a new technology platform to simplify the process for applicants and HRA staff.
|Make digital improvements to our research systems to transform the user experience by publishing our digital strategy and product roadmaps.
|Make digital improvements to our research systems to transform the user experience by adding new single identity gateway release allowing continued interoperability with NIHR.
|Make digital improvements to our research systems to transform the user experience by completing implementation of the combined review with the MHRA systems
|Make digital improvements to our research systems to transform the user experience by incorporating system requirements for streamlining data-driven research and ethics review programmes.
|Make digital improvements to our research systems to transform the user experience by developing HRA Analytics and Customer Relationship Management strategies and implementation plans.
|Make digital improvements to our research systems to transform the user experience by rolling out new IRAS – ongoing development including quarterly releases starting in June 2021 continuing through to March 2023.
|September 2021 to March 2023
Implementing joint initiatives with our partners NIHR and MHRA, to achieve high digital integration and interoperability levels. For example
• work with NIHR and MHRA to implement unique study ID and agree on a cross-system data model
Consistency and collaboration across the UK
Although much of our work relates to health and social care research in England, we also provide coordination, standardisation and infrastructure for applications across the UK. We do that through close working with colleagues in the devolved administrations and through collaboration with funders, research sponsors and other regulators.
|In 2021/22, we will
|By the end of
|Provide support for the Four Nations Policy Leads Group. This group sets UK health and social care research policy, agrees UK-wide policy on research governance and ethics review, and acts as the United Kingdom Ethics Committee Authority (UKECA).
|Work in partnership with the cross-sector DHSC-led Recovery, Resilience and Growth programme to ensure a coordinated system to support the setup and delivery of research in the NHS, including supporting the implementation of a national system for contract value review, developing additional template agreements for innovative approaches to trial delivery, and advising on the development of a digital service to find, recruit and follow up research participants.
Strategic objective 3: Be a knowledgeable, well-run organisation that's true to its values
A diverse organisation which includes and respects all
We are an inclusive organisation, which is transparent, accountable, and open to all. Our growing Public Involvement Network enables us to seek the views of patients and the public about our practices, policies and regulatory decisions. We want our staff to feel included in the organisation and to have opportunities to thrive at work. Our 2021 Equality, Diversity and Inclusion strategy will help us to take that further. We also want people using our services to access them easily and in a format that suits their needs.
|In 2021/22, we will
|By the end of
|Work with our public involvement network to enhance the role of the network.
|Publish our Equality, Diversity and Inclusion strategy.
|Develop and implement initiatives and activities set out in the Equality, Diversity and Inclusion strategy.
|Ensure that our digital transformation widens access, offering services that are accessible to all.
|Define and agree on core system usability principles and ensure that they are adopted in all system development.
|Develop and deliver new cyber-security strategy and subsequent change programme to deliver substantial uplift in the security of HRA information assets and better protection against a range of threats.
Skilled, high-performing people
We provide an expert and professional service. We want to ensure that we can learn and develop and enjoy a healthy working life to benefit themselves, the HRA, and the wider research community. We will continue to support a healthy work culture, promoting physical and psychological wellbeing and addressing feedback from our staff. Our volunteers are equally important to us, and we plan to invest further in their training, support and engagement.
|In 2021/22, we wil
|By the end of
|Develop and implement a new future ways of working framework for staff to embed learning from the pandemic and establish a revised hybrid approach to the office and remote working after restrictions due to the pandemic have been lifted.
|Enhance our engagement and collaboration with HRA volunteers working on Research Ethics Committees, the Confidentiality Advisory Group and through the Public Involvement Network by setting up a volunteers' group.
|Enhance our engagement and collaboration with HRA volunteers working on Research Ethics Committees, the Confidentiality Advisory Group and through the Public Involvement Network by implementing changes that act on findings from the volunteers' survey.
|Develop and publish our People Strategy.
An organisation that makes good use of public funds
As a non-department public body, we manage HRA's expenditure to high standards through Managing Public Money.
We also take a whole system view seeking to maximise value for money for the entire exchequer. For example, the HRA has achieved over £5.5M annual savings across the research system through introducing HRA and Health and Care Research Wales Approval and streamlining study set up processes. In addition, internal efficiencies have generated over £0.7M/annum to achieve spending review pressures. We aim to focus on activity that will provide the best value for money to the taxpayer and invest in modernisation, reducing resource pressures in future years.
|In 2021/22, we will
|By the end of
|Provide flexible workspaces that meet our business and people needs and achieving 6sqm/full-time equivalent space utilisation.
|Implement our corporate information management strategy enabling smart working, reducing duplication and providing excellent information governance compliance.
|Develop guidance, and a 'value add' framework to enhance our commercial management and give contract managers the tools and support to gain the best value for the public purse.
|Continuously improve our processes by implementing 80% of government internal audit agency review recommendations within the timelines agreed.
Our total funding anticipated for this year is £27.0M (2020/21: £19.7M). We receive most of this directly from the Department of Health and Social Care. In 2021/22 this funding, known as grant-in-aid (GIA), will be £20.3M (2020/21: £15.4M) to fund revenue activities, £2.8M (2020/21: £2.4M) to fund capital investment and £1.4M (2020/21: £1.4M) to fund non-cash revenue (for example, depreciation).
The rest of our revenue comes from two other sources:
- £2.3M from NHSX to fund regulatory work supporting data driven technologies
- £0.3M from the devolved administrations as part of cost sharing arrangements for ethics review and UK wide research governance.
The HRA is committed to providing value to the public purse. We achieve this in three ways:
- streamlining the research approval process, driving economies and efficiencies to the research sector
- achieving 'more for less' in our services and policy work, by improving processes, reducing duplication and using technology to add value and reduce costs
- working with partners to improve the end-to-end research system, thereby delivering value for money for the whole exchequer, not just in relation to HRA's expenditure.
We have planned for a balanced income and expenditure position for 2021/22 on our core services and activities. The financial plan table sets out our sources of revenue funds for 2021/22. It also shows how these compare with our 2020/21 financial plan.
Our total capital funding is £2.8M (2020/21: £2.4M). This funding supports the HRA core infrastructure (estates and technology) as well as research systems transformation investment classified as capital costs, based on accounting best practice. The following table shows how capital funding will be invested.
|Research systems transformation programme
|HRA infrastructure (estates and technology)
|Total capital expenditure
Research systems transformation
The HRA gained approval for our research systems transformation programme from DHSC Investment Committee in December 2020. Funding and activity related to this programme are included within this business plan for 2021/22. Prior year comparatives include bridging funding to enable continuation of the programme prior to the case being approved.
Financial plan 2021/22
|Method of payment
|Regulatory services: integrated approval service
|Regulatory services: Confidentiality advice service
|Regulatory services: Guidance and learning
|Regulatory services: Quality assurance
|Strategy, governance and policy: Corporate governance and chief executive
|Strategy, governance and policy: Policy and engagement
|Strategy, governance and policy: Communications
|Strategy, governance and policy: Public involvement
|Strategy, governance and policy: Research review and fast-track
|Strategy, governance and policy: Streamlining data driven research
|Strategy, governance and policy: Strategic reserves
|Digital: Research systems
Corporate Services, including portfolio office
|Corporate functions: HR, EDI and training
|Corporate functions - Finance, procurement and estates
|Total before depreciation and efficiency
|NHS pension employer contribution increase
|Efficiency target and inflationary pressures
|Total before depreciation
|Total expenditure after depreciation
|DHSC grant in aid
|NHS AI Lab
|Non-cash revenue (depreciation funding)
|Other income (unconfirmed)