Our Business Plan 2019 - 2020

About us 

Our role 

The HRA was established in 2011 to streamline the regulation of health and social care research in the UK. With our core purpose of protecting and promoting the interests of patients and the public in health and social care research, we:

• make sure research is ethically reviewed and approved 
• promote transparency in research 
• give expert advice to researchers 
• provide independent recommendations on the processing of identifiable patient information without consent, for research and non-research projects 

We work with other organisations in the UK to regulate different aspects of health and social care research, ensuring research approvals and oversight are streamlined and proportionate. We are England-focussed but, through our joint working with the devolved administrations of Scotland, Wales and Northern Ireland, lead the oversight of health and social care research on behalf of the UK.

We support our activity through five locations in England: Newcastle, Manchester, Nottingham, London and Bristol. Through the 65 Research Ethics Committees in England and the Confidentiality Advisory Group, we review around 6,000 new research studies each year, ranging from observational studies in care settings, tissue banks and research databases, to large, multi-centre clinical trials of new medicines and advanced therapeutics.

Our people

Our 225 staff support our committees and advisory groups, provide specialist advice, guidance and learning to researchers about the ethics and governance of current and emerging areas of research and effectively administer the organisation.

We could not operate without our network of around 1,000 volunteers. They serve on the research ethics committees, the National Research Ethics Advisors’ Panel, the Confidentiality Advisory Group and are part of our patient and public involvement network.

All give their time freely to support health and social care research and the HRA’s work. They make an invaluable contribution to our work, to research and to research participants. 

The HRA is run by a Board made up of our Chair, Professor Sir Jonathan Montgomery, our Chief Executive, Teresa Allen, two executive directors and four non-executive directors. The Board gives strategic oversight, agrees high-level policy and ensures that the HRA is run effectively and efficiently. 

Our strategy

The HRA has a three-year strategy focusing on five key areas: 

1. Championing health and social care research
2. Making it easier to conduct high quality research in the UK
3. Developing a pro-active, strategically focused organisation
4. Capitalising on technological developments
5. Ensuring the HRA is governed effectively and provides value for the tax payer

We published the strategy in 2017 and this business plan covers the final year of the roadmap that we set out to achieve our goals. Some areas of work identified within the strategy have been achieved and others draw to a close in the 2019/20 business year. Others are longer-term goals which will roll into our next strategic period. 

Inevitably, some of our work crosses over more than one strategic area. However, the work we have planned for the 2019/20 business is organised under those key areas.

Championing health and social care research

Besides reviewing individual research studies to ensure that they meet good research practice standards and the relevant legal requirements, we are increasingly focussing on research practice both upstream and downstream of the research approval process. That means making expectations clear to the research community, working across the research landscape to promote good research practice and monitoring performance during and after the life of the study.

Making it easier to conduct high quality research in the UK 

The HRA was established to improve the research regulation environment, creating a streamlined approval process to help researchers develop high quality, well-prepared studies at lower cost. Over the past few years, we have established an integrated service to provide both ethics review of studies and assessment of legal compliance and reorganised our processes and structure to support that. We will complete that process to ensure that our approvals process is as fast and efficient as possible.

Developing a pro-active, strategically focused organisation

Collaboration is at the heart of how we work: we are part of a wider system of organisations within the research ecosystem and work with them to facilitate high quality research in the public interest. We want to make more of our external relationships and take opportunities for raising the visibility of the HRA so that people know what we stand for and how we can help.

Capitalising on technological developments

Our ambition is to be a data-driven, technology-enabled organisation. Digital advances continue to shape how the sector works and offers new opportunities. At the HRA we want to enhance the services we provide to the research community and meet future regulatory requirements. One way we plan to do this is by looking at where technology can improve the service we offer for researchers and the wider research ecosystem.  

Ensuring the HRA is governed effectively and provides value for the tax payer 

Our people are the backbone of the HRA, providing expert advice and supporting an effective approvals service. We want to invest further in our people to ensure that have opportunities for development and feel well supported to provide an excellent service to the research community. We need to do that – and perform our other functions – within strict budgets. We are working to ensure that our resources are carefully used and that we modernise our approaches to free up our staff to focus on the areas where they can add most value.

EU Exit 

The HRA will work with the Department of Health and Social Care (DHSC) and its arm’s-length bodies (ALBs) on the consequences of leaving the EU on the health and care system. We will have an important role to help ensure the UK remains at the forefront for science and innovation after EU Exit.

To achieve this, we will:

• work with the Medicines and Healthcare products Regulatory Agency (MHRA) to ensure the UK offers an attractive and competitive environment for clinical trials
• update business continuity plans regularly, in line with the UK’s future relationship with the EU
• ensure the appropriate governance and accountability structures are in place to monitor and assess the impacts of EU Exit on the HRA.
• assign senior responsible owners (SROs) for key areas that will be impacted by EU Exit, and ensure sufficient resources are allocated to these areas.

Senior leaders and teams will continue to work closely with DHSC to support the health and care system after EU Exit. 

What we achieved in 2018/2019

To provide context for our 2019/20 business plan, we have summarised our achievements in 2018/19, a year of transformation and the second year of delivering on our refreshed strategic aims.

Championing health and social care research 

In March 2020 we implemented the revised Governance Arrangements for Research Ethics Committees (GAfREC), harmonising the approach across the four countries of the UK and reflecting legal, policy and operational developments since 2011.  This version has since been updated in July 2021.

We launched our transparency project to determine baseline measures for both awareness of the requirement to register clinical trials and the registration rate for clinical trials. We also participated in the Science and Technology Select Committee’s inquiry into research integrity. Our response to the outcome of this inquiry was well received and provides a framework for our transparency work in the coming year. 

As part of our public involvement work, we published guidance, informed by feedback from ethics committees, to help researchers explain the difference public involvement has made to their applications for study approval and established several test beds to support the use and evaluation of this guidance. We have also developed a set of expectations for public involvement to support ethics committees and applicants which will be published early in 2019/20. 

Making it easier to conduct high quality research in the UK 

Throughout the year we have implemented many changes to HRA Approval to improve and simplify the service we provide to researchers. Our aim for 2019/20 is to pull all these improvements into an integrated service, streamlined and focused on the user and supported by a newly-established staff structure. 

While making these changes, we have carefully maintained our turnaround times for HRA Approval and research ethics review as well as sustaining user satisfaction scores of 74 per cent and above throughout the year. Improvements delivered in 2018/19 include: 

• launching a new learning management system for researchers enabling access to a wide variety of eLearning modules and support
• implementing a verification tool to help researchers complete their online research applications and reduce the number of submissions with missing documentation
• publishing guidance for the research community on general data protection regulation (GDPR) and model agreements for research studies
• working in partnership with the Medicines and Healthcare products Regulatory Agency (MHRA) to develop and pilot a single submission for approval and ongoing management of Clinical Trials of Investigational Medicinal Products (CTIMPS) and with the devolved administrations to simplify processes across the UK; and,
• rolling out a UK-wide approach to providing Technical Assurance simplifying the process for researchers.

We have also developed and published our Customer Charter.

Developing a pro-active, strategically focused organisation

Our directors visited all 65 Research Ethics Committees in England and spent more than 20 per cent of their time focusing on external engagement to help inform and take forward our work. This external focus enabled us to develop new relationships across the research ecosystem. New initiatives emerging from this approach include working with NHS England and NHS Improvement and the National Institute for Health Research to develop an improved approach to excess treatment costs for research and commercial contracting and working with the Information Commissioner’s Office to proactively support the research community in implementing the EU General Data Protection Regulation (GDPR) significantly more effectively than other EU countries.  

We also held a successful event for our Research Ethics Committee chairs focusing on key developments in the sector including Artificial Intelligence and Machine Learning. 

Capitalising on technological developments 

We made the strategic decision to improve our research IT systems. We invested in the first phase of transformation by creating a streamlined, user focused system to meet the requirements of the forthcoming EU Clinical Trials Regulation and combined ways of working process with MHRA. This first phase, built on a Pegasystem platform, is nearing completion and will be launched in 2019. 

While developing a new system, we have maintained our current research IT systems, with more than 98 per cent system availability and provided enhancements, such as the verification tool and the new learning management system.  

We have developed an IT strategy and roadmap for our IT infrastructure in line with government technology initiatives and cyber security best practice. To this end we have rolled out Windows 10, Office 365 with enhanced collaboration and cyber security functionality. We have also actively engaged with the Future Services Programme with the Department of Health and Social Care and NHS England. 

Ensuring the HRA is governed effectively and provides value for the tax payer 

During 2018-19, we have undertaken significant organisational change to support a new integrated service model aiming to improve researcher experience of the approvals process including research ethics review. Our new target operating model focuses on a streamlined service to the sector, support for improved policy and sector intelligence and harnesses technology to improve the user journey. The majority of these new staff structures will be implemented by April 2019.  

In addition, more than £700k savings (6 per cent of total expenditure) have been achieved to help meet government spending targets, statutory requirements and inflationary pressures. We have also implemented an employee self-service tool to enable our people to have more control over their personal data and provide a more automated, streamlined process for managing our HR processes. We aim to build on this during the 2019/20 business year. 

We have also continued to improve our estates utilisation by sharing space with both NHS Business Services Authority and High Speed 2. 

Looking forward we plan to take advantage of the government hub programme to help further improve utilisation rates as well as benefit from high quality, well-managed buildings. 

This year we have developed an assurance framework and new approach to strategic risk management. Both these developments enable us to focus on strategic risk, benefits and assurance to gain best value for the public purse. 

Our plans for 2019/20

1.  Championing health and social care research 

We are increasingly focussing on research practice both upstream and downstream of the research approval process as well as reviewing individual research studies to ensure that they meet good research practice standards and the relevant legal requirements. That means making expectations clear to the research community, working across the research landscape to promote good research practice and monitoring performance during and after the life of the study.

Our areas of focus in 2019/20 are: 

• pushing for greater research transparency 
• promoting public involvement in research 
• supporting the development of data-driven healthcare technologies. 

Pushing for greater research transparency 

Research transparency is central to ethical research. It means registering research studies, making results public, giving access to data and tissue and feeding back the findings of the study to participants. Openness about individual studies promotes effective use of research funding and ensures that participants’ time and commitment is not wasted.

In 2019/20, we will: 

Promoting public involvement in research 

When researchers involve patients, service users and carers in the design of their research, they benefit from better recruitment and retention in the study – ultimately leading to better outcomes. We have made real improvements in public involvement in some areas of research over the past few years, but we want to make this true of all research.

In 2019/20 we will: 

Supporting the development of data-driven healthcare technologies 

New healthcare technologies and treatments which are driven by data science, artificial intelligence (AI) and deep learning have huge promise for the NHS of tomorrow. However, because they use large sets of patient data, public trust is crucial to their development. We want to encourage research in this area that is ethical and has strong patient support.

In 2019/20 we will: 

How we will measure our performance in this area 

2. Making it easier to conduct high quality research in the UK 

The HRA was established to improve the research regulation environment, creating a streamlined approval process to help researchers develop high quality, well-prepared studies at lower cost. Through HRA Approval, we review around 6,000 research studies each year, working with partners in the devolved administrations to provide a UK-wide approval system. 

Over the past few years, we have established an integrated service to provide both ethics review of studies and assessment of legal compliance and reorganised our processes and structure to support that. We will complete that process to ensure that our approvals process is as fast and efficient as possible.

Our area of focus in 2019/20 are: 

• streamlining processes for researchers
• supporting researchers through HRA Approval
• developing innovative and clear policy to support UK-based research
• working with the Medicines and Healthcare products Regulatory Agency (MHRA), National Institute of Health Research (NIHR) and NHS Digital to agree a set of standards which will ensure interoperability across our research systems. 

Streamlining processes for researchers 

We want the research approvals process to be as smooth and efficient as possible so that new studies can be set up quickly. This will maintain the UK as an attractive place to carry out research, to the benefit of patients and the health and care system. 

In 2019/20, we will:

Supporting researchers through their applications 

We want to enable researchers to do their job well; helping them think through the ethical aspects of their research, preparing a good quality application for approval and being clear about what is expected of them. We also want to ensure that research ethics committees are consistent in their approach and provide good ethics advice to researchers.

In 2019/20, we will: 

Developing innovative and clear policy to support UK-based research

The UK Policy Framework for Health and Social Care Research sets out the principles for lawful and ethical research involving people, their tissue and their data. Our guidance and advice applies those principles to particular aspects of research to promote ethical research which promotes the interests of participants.

In 2019/20, we will: 

How we will measure our performance in this area 

3. Develop a pro-active, strategically focused organisation 

Collaboration is at the heart of how we work: we are part of a wider system of organisations within the research ecosystem and work with them to facilitate research high quality research in the public interest. We want to make more of our external relationships and take opportunities for raising the visibility of the HRA so that people know what we stand for and how we can help.

Our areas of focus in 2019/20 are : 

• enhancing our strategic engagement and intelligence 
• increasing our visibility and external audience's understanding of us

Enhancing our strategic engagement and intelligence 

During 2018/19, we reviewed our structures and ways of working to create a new policy and engagement function at the HRA. Our next step is to embed the new function and start work to strengthen our external relationships and partnership working.

In 2019/20, we will:

Increasing our visibility and external audience's understanding of us 

Our staff, Board members and volunteers are the public face of the HRA. We want to develop our approaches so that we make the most of our engagement and enhance external audience’s understanding of what we do, what we stand for and where we can add value.

In 2019/20, we will:

How we will measure performance in this area

4. Capitalising upon technological and data developments 

Our ambition is to be a data-driven, technology-enabled organisation. 

Since the HRA was established in 2011, the world of health research has change significantly. Digital advances continue to shape how the sector works and offers new opportunities. At the HRA we want to enhance the services we provide to the research community and meet future regulatory requirements. One way we plan to do this is by looking at where technology can improve the service we offer for researchers and the wider research ecosystem.

Our areas of focus 2019/20 are: 

• modernising our research application and monitoring systems 
• working with partners to enhance the interoperability of systems across the research system.

Modernising our research application and monitoring systems 

Following an independent review of our research technology systems in 2017, we agreed a programme of transformation to deliver modern, intuitive systems, driven by user need and able to accommodate anticipated changes in the legislative landscape. In 2018/19 the HRA started this research IT systems transformation programme, engaging Pegasystems to support the replacement of the Integrated Research Application System (IRAS) to meet requirements of EU clinical trials regulation.  

In 2019/20, we will: 

Work with partners to enhance the interoperability of systems across the research system 

There are many players within the research landscape that researchers need to interact with – from funders, regulators to registries and publishers. We have already made great progress in developing an integrated approvals service which operates across the UK. We are now focussed on developing our technology infrastructure to create a seamless journey for researchers throughout the life of their study across a number of organisations. 

In 2019/20, we will:

How we will measure performance in this area 

5. Ensuring the HRA is governed effectively and provides value for the tax payer 

Our people are the backbone of the HRA, providing expert advice and supporting an effective approvals service. We want to invest further in our people to ensure that have opportunities for development and feel well supported to provide an excellent service to the research community. We need to do that – and perform our other functions – within strict budgets. We are working to ensure that our resources are carefully used and that we modernise our approaches to free up our staff to focus on the areas where they can add most value.

Our areas of focus in 2019/20 are:

• developing our organisation 
• using our technology more effectively to manage our workload and measure our performance.

Developing our organisation 

The 2018/19 business year was a period of change for our staff, as we restructured our teams to support a new integrated approvals service and a new policy and engagement function. We want to support staff in their roles, investing in their learning and development and creating equality of opportunity for all.

In 2019/20, we will: 

Using our technology more effectively to manage our workload and measure our performance

Technology offers new opportunities to streamline our day to day processes and understand better our performance. We work nationally and collaboratively across multiple stakeholders. Our technology needs to support this flexible way of working and rolling out Windows 10 and Office 365 aims to do just that. We are also committed to rolling out increased functionality on our electronic staff record (ESR) to help support our people management, reducing manual processes and removing waste in the system.

In 2019/20, we will:

How we will measure our performance in this area

We will monitor our financial progress throughout the year.

Financial plan

The HRA's total revenue funding for 2019/20 is estimated to be £18, 359k (2018/19: £15,990k). We receive most of our revenue funding directly from the Department of Health and Social Care.

This funding, known as grant-in-aid (GIA), is not yet confirmed, but indicative revenue budgets have been notified at £12,784k for 2019/20. This includes funding to support:

• 2018/19 Agenda for Change terms and conditions £120k
• NHS Pensions increased employers’ contribution partly funded £264k. 

The balance comes from four other sources:

• £4,500k for research IT systems transformation to meet EU Exit preparedness requirements;
• £300k from the Devolved Administrations as part of cost sharing arrangements for ethical review and UK wide research governance developments; 
• £66k from NHS Business Services Authority (BSA) and High Speed 2 (HS2) and as part of cost sharing arrangements for estates; and,
• £1,000k 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:

1. Streamlining the research approval process, driving economies and efficiencies to the research sector (worth £4billion* to the UK economy). 
2. 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 2019/20 on our core services and activities. 

Extensive organisational change programmes completed in 2018 and early 2019 have made this possible. Adapting our organisational structures to reflect a more integrated and streamlined process providing an improved service to researchers and reducing costs have released over £700k savings (six per cent of expenditure) to manage a reduced spending review allocation, inflationary pressures and provide much needed investment in core IT infrastructure. 

A further £300k efficiency target has been set for 2019/20 to help fund additional budget pressures from NHS Pension contributions and Agenda for Change terms and conditions. 

In addition, we are planning to continue our research IT systems transformation programme in 2019/20. £4,500k additional funds (2018/19, £2,002k) will be invested in technology to provide a modern, intuitive user experience for researchers, improved data sharing with the research regulators and importantly meet the requirements of EU Exit and the future Clinical Trials regulations. 

The table over the page sets out our prioritised business plan and sources of funds for 2019/20. It also shows how these compare with our 2018/19 financial plan.

*UK Health Research Analysis 2015 – UK Clinical Research Collaboration  

*Collaboration previously included within Integrated Approvals Service.