Business plan 2020 - 2021

About us 

Our mission is to protect and promote the interests of patients and the public in health and social care research, working with partners across the UK. We do that by providing expert advice and guidance to researchers and by reviewing research studies through 65 Research Ethics Committees in England, the Confidentiality Advisory Group and specialist review and assurance of research on behalf of NHS organisations.

We work across the whole health and care system - reviewing around 6,000 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 18,000 amendments to research studies.

We manage the technology platforms for national health and social care research approval on behalf of partners across the UK. This includes IRAS and the back-office systems that support review of applications to enable researchers to apply for research approvals from a number of different regulators, committees and review bodies.

How we work 

The HRA has over 200 staff supported by a network of 1,000 experienced volunteers. 

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. Our staff enable collaboration to streamline the set-up and review of research, to provide specialist advice, guidance and learning and to support our committees and advisory groups. 

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 patient and public involvement network. They give their time freely to support health and social care research and our work. They make an invaluable contribution to our work, to research and to research participants.

The HRA is run by a Board led by Professor Sir Terence Stephenson. The members of the Board are our Chief Executive, Teresa Allen, two executive directors and four non-executive directors, with two further directors attending. The Board gives strategic oversight, agrees high-level policy and ensures that the HRA is run effectively and efficiently. Find out more about our leadership.

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).

Our plans for 2020/21

To achieve our vision of high-quality health and social care research that improves people’s health and wellbeing, we have three strategic objectives:

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
2. Provide a user-friendly and efficient service which facilitates a strong research environment
3. Be a knowledgeable, well-run organisation that’s true to its values

With recent months dominated by COVID-19, our plans for 2020/21 will include consideration of how to capture the benefits of our revised ways of working, as well as understanding the impact of these decisions on our staff, our volunteers and the research community. The feedback received to date has been positive, and we will look to build on our successes through the next phase of our transformation programme. This programme will consider what the wider research system and our stakeholders expect of us, what has worked well and could be part of our new operating model, what we need to revise and how we can support the UK to be competitive. 

Increasing simplicity for researchers and enabling accelerated timelines are key to our approach at the HRA. To deliver on this we have been collaborating with the MHRA which reviews applications to authorise clinical trials of medicines. In 2019/20, we further developed our pilot of a combined review of these studies Called Combined Ways of Working (CWoW), the pilot has been a real success, managing the review of 100 studies.

Driving transformation of our research systems portal to simplify our processes and remove duplication is a key ambition. The HRA hosts the UK’s research application portal, IRAS, on behalf of the devolved administrations and research regulators across the UK. During 2019/20, we started work on a new IRAS module for receiving applications for clinical trials of medicines (CTIMPs) through the CWoW pilot and in 2020/21, we will start the next phase of our system transformation. 

Enabling research transparency is important, driving up quality and allowing the public to see the outcomes of research. We will publish our new strategy, ‘Make it Public’ and work with partners to bring the strategy to life through new guidance, systems and processes.

EU and trade 

The UK is a global leader in research and innovation and the HRA has a role to play in enabling high-quality research. The HRA will work with the Department of Health and Social Care (DHSC) and its arm’s-length bodies (ALBs) to support the health and care system during the transition period. 

To achieve this, we will:

• work with the Medicines and Healthcare products Regulatory Agency (MHRA) to ensure the UK offers an even more attractive and competitive environment for clinical trials
• 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 
• update business continuity plans regularly, in line with the UK’s future relationship with the EU.

Senior leaders and teams from the HRA will continue to work closely with DHSC to support the health and care system during the transition period.

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 

We review new and amended research studies, through research ethics review, scrutiny of the use of patient data without consent and specialist review of research governance. Our work helps researchers carry out high quality studies which are in the interest of research participants, patients and the wider public. 

Review of research through our 65 Research Ethics Committees provides reassurance to participants, patients and the wider 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. 

In 2020/21, we will focus on: 

• Setting up a new project within our service transformation programme to understand the impact of our response to the COVID-19 pandemic so that we can revise our operating model, taking into account resources, stakeholder expectations and the needs of our volunteers
• Continuing to embed patient and public involvement in the review of research through providing guidance, asking the right questions of applicants and being clear about what improvements are needed
• Working with partners to consider how we support master’s level student research in future so that students can best gain understanding and experience of health and care research
• Continuing to provide expert online guidance, advice and learning to the research community
• Continuing to provide support and learning to volunteers on research ethics committees and the Confidentiality Advisory Group
• Working with members of research ethics committees and other stakeholders to further embed proportionality of review in line with risks and complexity, reducing the workload for committee members and staff

Transparency and openness in research 

Transparency about what research is going on, and what its findings are, is important 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. 

In 2019, we developed a new strategy, called Make it Public, to improve research transparency. In 2020/21, we will work with partners to implement the strategy through:

• Reviewing our guidance and standard conditions for approval
• Modernising the Research Summaries tool to provide enhanced individual study information
• Establishing ongoing monitoring on study reporting and developing a framework for measuring performance 
• Carrying out an options appraisal on arrangements for UK clinical trials registration

Trustworthy use of patient data in research 

Public trust in the use of their healthcare data is crucial for the development of new treatments and technologies which 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 provide advice to the research community on the appropriate use of data in research and to promote good practice across the research system. 

In 2020/21, we will focus on:

• Reviewing how we scrutinise research applications to the Confidentiality Advisory Group for support to use patient data without consent and review performance measures
• Working with partners to build an environment in which researchers are clear about how to access and use patient data in research lawfully and transparently

Strategic objective 2: Provide a user-friendly and efficient service which facilitates a strong research environment 

Streamlined research approval 

Since the HRA was established, we have worked to streamline the way that health and social care research is governed, reviewed and set up in the NHS. Over the past year, we have been working in partnership with the Medicines and Healthcare products Regulatory Agency to further streamline how applications for clinical trials of medicines are reviewed and have started to consider streamlining the review of clinical trials of medical devices.

In 2020/21, we will focus on:

• Expanding the Combined Ways of Working pilot to allow more research sponsors to apply for authorisation of clinical trials of medicines through a new module in IRAS 
• Working with the Medicines and Healthcare products Regulatory Agency to streamline the review of clinical trials of medical devices

Intuitive research management systems supported by clear guidance and learning 

A key part of setting up research as soon as possible is helping researchers and research sponsors make smooth applications for approval. We do this by providing a UK-wide application portal, IRAS, backed up by advice, guidance and e-learning, so that applications can be reviewed swiftly. 

In 2020/21, we will focus on:

• Continuing the modernisation of our research application system, IRAS, and our systems for managing the review of research studies, including preparing for the end of the transition period
• Gaining Government approval for the complete replacement of IRAS and our systems for managing the review of research studies over the next five years
• Developing a new online resource for guidance, decision tools and e-learning for health and social care researchers across the UK, integrated into new IRAS modules 
• Continuing to provide expert advice to researchers and research sponsors to help them get the approvals they need and to prepare high-quality study documents

Consistency and collaboration across the UK 

Although our regulatory remit is health and social care research in England, we provide the infrastructure for applications across the UK and coordinate the operational, quality assurance and accreditation for research ethics committees across each of the four nations. We do that through close working with colleagues in the devolved administrations and through collaboration with funders, research sponsors and other regulators.

In 2020/21, we will focus on:

• Working with the devolved administration and other partners to improve research review across the UK
• Working with partners to improve study set-up in the NHS through our systems for technical assurances and model agreements, and support for costing and contracting arrangements with the NHS
• Facilitating UK-wide collaboration through forums, joint ventures and a strong focus on patient and public involvement and engagement

Strategic objective 3: Be a knowledgeable, well-run organisation that's true to it's values

A diverse organisation which includes and respects all 

We strive to be an inclusive organisation, which is transparent and accountable, and which is open to all. Over the past year, membership of our Public Involvement Network has grown, enabling 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 have opportunities to thrive at work and our Equality, Diversity and Inclusion programme will help us to take that further. We also want people using our services to be able to access them easily and in a format that suits their needs. 

In 2020/21, we will focus our activities in this area on:

• Enhancing the role of our Public Involvement Network
• Finalising our Equality, Diversity and Inclusion strategy and focussing on activities which have been identified by our staff-led interest groups
• Making our website and other information services accessible to all users

Skilled, high-performing people 

Our staff provide an expert and professional service and we want to ensure that they are able to learn and develop and enjoy a healthy working life – to the benefit of themselves, the HRA and the wider research community. Our volunteers are equally important to us and in the coming year we plan to invest further in their training, support and engagement. 

In 2020/21, we will focus on:

• Investing in our staff through learning and development
• Supporting a healthy work culture, promoting well-being and addressing feedback from our staff 
• Enhancing our engagement and collaboration with our volunteers to make them feel valued and confident in carrying out their role

An organisation that makes good use of public funds 

The HRA is small organisation with limited resources, which are designed not just to fund our own services, but also to facilitate research across the UK. We aim to focus those limited resources on activity which will provide the best value for money to the taxpayer and to invest in modernisation which will reduce resource pressures in future years.

In 2020/21, we will focus on:

• Continuing to modernise our IT infrastructure to enable smarter working and reduce costs
• Moving our London and Bristol offices to a Government hub, as part of the Government Estates Strategy to rationalise office space and provide modern working environments for our staff
• Focusing our commercial activity to generate greater value as well as enhancing efficiency through financial analysis in process improvement

Financial plan 

Our total revenue anticipated for this year is £19,658k (2019/20: £18,359k). We receive most of this directly from the Department of Health and Social Care. In 2020/21 this funding, known as grant-in-aid (GIA), will be £17,093k (2019/20: £16,993k). 

The rest of our revenue comes from three other sources:

• £917k from NHSX to fund regulatory work supporting data driven technologies
• £240k from the devolved administrations as part of cost sharing arrangements for ethics review and UK wide research governance
• £1,408k non-cash revenue from the Department of Health and Social Care to fund depreciation costs.

The HRA is committed to providing value to the public purse. We achieve this in two 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

We have planned for a balanced income and expenditure position for 2020/21 on our core services and activities. The table sets out our financial plan and sources of funds for 2020/21. It also shows how these compare with our 2019/20 financial plan.

Financial plan 2020/21