Performance report

This section provides an overview of the Health Research Authority and our work. This includes our purpose, the key risks to the achievement of our objectives and a summary of some of the key activities we have undertaken in the past year to meet our five strategic aims.

For more details about how we have delivered against our aims, please review the ‘performance analysis’ section.

Chief Executive's introduction

I am delighted to be introducing this annual report which details the many achievements of the HRA during 2018/19. This year, our staff and volunteers have achieved a step change in our performance, delivering a robust regulatory approval service with shorter, more predictable timelines as well as working collaboratively with the research community to drive improvements throughout the research system. These developments have already started to create a more streamlined service across the UK and further improvements are anticipated during 2019/20 and beyond.
If you were to ask our staff what they will remember most from 2018/19 they are likely to tell you that it has been a year of significant change. Every person working with or for the HRA will have been affected by our service transformation programme and for some this has been a life-changing year. A number of these developments have been about modernisation or using technology as an enabler, but our main driver remains to improve our service, making it easier for research applicants, speeding up the process, so that more time can be spent recruiting patients on to studies.
More than 75 per cent of our staff are now working differently as we have introduced new roles and altered our service delivery model to provide a more integrated, streamlined and efficient experience to researchers. Our Research Systems team who look after IRAS and HARP, the two software packages that underpin the HRA Approval process, have adopted the agile method of software development for the first phase of our new IRAS platform, which supports the Combined Ways of Working (CWoW) programme which we are piloting with the Medicines and Healthcare ProductsRegulatory Agency (MHRA).
This has allowed us to start developing software which is built around the needs of users and to work in partnership with others including the MHRA and NationalInstitute for Health Research (NIHR) so that we can exchange information across new interfaces, improving communication, speeding up processing and delivering a single research approval outcome. We have moved all our staff onto Office 365, introduced digital solutions for managing expenses, pay-slips and booking leave. We have welcomed new colleagues from other public sector organisations to help us make best use of our office space and we now have a new Learning Management System (LMS) which offers an amazing range of courses many of which are freely available to the research community as well as staff and our volunteer community to help everyone to develop their skills and knowledge.
We operate within a dynamic and thriving Life Sciences Sector and are working collaboratively with colleagues across the devolved administrations to drive forward system improvements. This group has supported us to publish the UK Policy Framework and the Governance Arrangements for Research Ethics Committees, supported us to introduce a new verification tool in IRAS and helped us launch the new Pharmacy and Radiation Assurance service. Our communications and guidance teams have been busier than ever as we have all worked our way through the changes brought about by General Data Protection Regulation (GDPR) and the preparations for our exit from the EU in addition to everything outlined above.
Our volunteer committee members have also been sharing their ideas on improvements that we could or should be making to support the ethical review of studies. In particular, making things easier for researchers to do responsible research, to ensure that research participants receive information that is clear and concise and helps them to understand what they are being asked to do when they join a study and encouraging best practice in public involvement in research.
2018 has been a truly remarkable year and our staff and volunteers have worked tirelessly to make improvements which are already delivering the benefits which we set out to achieve.

Teresa Allen, HRA Chief Executive

Who we are and what we do

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 deliver our work from five locations in England: Bristol, Manchester, Newcastle, Nottingham and London and. Through the 65 Research Ethics Committees (RECs) in England and the Confidentiality Advisory Group (CAG), we review around 6,000 new research studies each year. This range of studies includes 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 210 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, develop policy 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 and Ethics Advisory 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 focussing on five key areas:

We published the strategy in 2017 and this Annual Report and Accounts covers the second 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 are being delivered as we approach our 2019/20 business year. Others are longer-term goals which will roll into our next strategic period.

Championing health and social care research

Besides reviewing individual research studies to ensure that they are ethically sound, 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 are now moving to a continuous improvement approach to ensure that our approvals process continues to be as fast and efficient as possible.

Developing a proactive, 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 using technology to help us 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 they 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 achievements for the year

Much has been achieved at the HRA in this second year of our strategic plan. We have made good progress towards our strategic objectives guided through our service improvement and technology transformation programmes. Overall, we have provided approval for 4,656 research studies and of these, 3,960 required ethics review. We have also processed 18,694 amendments to previously approved studies.

It has also been a year of significant change for the HRA. More than 75 per cent of our people have been part of the organisational change processes to create structures that support new ways of working and a better service for researchers. Our refreshed approach will support an integrated research approval process providing a more predictable, streamlined and simpler service for the research community. The change has been wide-ranging and disruptive for our staff but despite this, our dedicated staff have delivered on key performance targets maintaining the good service they provide to researchers.

Notably, the full elapsed time for a valid application to receive HRA Approval once it has met Research Ethics Committee conditions has continued to be less than 10 days in most cases in 2018/19. This means that the introduction of HRA Approval has not only reduced the time taken to set up research studies, it has also created a more predictable service, providing researchers with greater certainty as to when they can recruit to studies and complete their planned research. In 2018/19 we have also been able to improve the timelines for studies that do not need research ethics approval. A more predictable and quicker service means more resources are dedicated to research, benefiting patients and the UK’s health.

HRA median approval timelines April 2016 – March 2019

(Time for meeting REC conditions to issuing HRA Approval (or from submission for non-REC studies.)

non-REC studies: studies that do not need research ethics approval
REC-PR studies: studies that require research ethics proportionate review
full-REC, non-commercial studies: non-commercial studies that require full research ethics
full-REC, commercial studies: commercial studies that require full research ethics.

This graph shows the improvements to timelines achieved for HRA Approval. It demonstrates that the median number of calendar days it takes from final REC opinion to HRA approval has been maintained across different study types over the year. It also shows the improvement to timelines for non-REC studies.

We have also worked hard to help researchers ‘get it right first time’ and have seen an improvement in the percentage of incomplete applications received for assessment, reduced from 30 per cent on average in the first six months of the year to 27 per cent in the last, a 10 per cent improvement in year and 15 per cent on last year. The introduction of the verification tool, providing automated validation checks in our research IT system has helped to reduce waste in the system further. Targeted communications across a variety of different methods including face-to-face meetings, regular tweets and updates in HRA Latest, as well as improved learning and development opportunities for the research community have all helped to achieve this improvement. We are pleased to report that our user satisfaction scores remain high at 78 per cent overall.

Service improvement has been delivered in parallel with our technology transformation programme. Early in the year we procured a technology partner for our new research IT systems platform to meet or align with future Clinical Trials Regulations, EU Exit contingencies and interoperability across the research system. At the heart of our programme has been strong user and stakeholder engagement. Our ambition is that the new system will be easier to use, will streamline current work processes, enhance quality and transparency and provide improved business intelligence of the research ecosystem. We are close to completing the first phase of this programme and are looking forward to iteratively expanding this development to support all research types as well as our own internal systems.

Supporting the UK-wide approvals process, we implemented the governance arrangements for Research Ethics Committees (GAfREC) in 2018, the result of many months collaborative work across the UK research ecosystem. We also provided programme leadership to the Four Nations Compatibility Programme for developments to the UK research governance systems with the aim of simplifying and streamlining the research approval journey for studies that run across UK borders. This has resulted in e-submission of the IRAS form for all UK Nations and the development of a UK local information pack to provide consistent research study documentation for all participating NHS organisations across the UK which will be implemented in June 2019.

Research transparency is a priority for the HRA. During the year we launched a survey to better understand awareness of research transparency and inform our work. The results have been published and show 24 per cent awareness of the requirement to register and 80 per cent registration rate for clinical trials. The Science and Technology Select Committee published our response to their report on research transparency, setting out our commitment to drive improvements and we have set up a Research Transparency Strategy Group to take this work forward in 2019.

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.

To help understand our impact and achievements we have developed metrics and benefit profiles which better reflect the end to end user experience of our service and are more closely aligned to our strategic aims. We have also developed our performance management and reporting systems to enhance these and ensure we drive our performance to meet our strategic aims and statutory requirements.

All this would not be possible without the invaluable contribution made by over 1,000 committee members who volunteer approximately 20,000 days each year to help protect and promote the interests of patients and the public in health and social care research. They give their time freely, as members of:

the Research Ethics Committees (RECs)
the National Research and Ethics Advisory Panel (NREAP)the Public and Patient Involvement Panel
the Confidentiality Advisory Group (CAG).

Our key issues and risks

Strategic objective	Key risks and issues
Making it easier to conduct high quality research in the UK	The complexity, scale and speed of our transformation programme, which includes our Service Improvement Programme and Research IT Systems development. Our Board focussed on driving programme delivery and addressing capacity risk to ensure the programme delivered on its objectives as well as ensuring key performance measures of our core services were maintained. The impact associated with the implementation of new Data Protection legislation. Our response was to deliver guidance, training and offer help with queries from the research community as well as ensuring our own corporate functions were prepared for the new requirements. The former has been well received by the research community and the latter received a moderate internal audit rating during the year.
Developing a proactive, strategically focused organisation	Uncertainty regarding any likely changes to the volume and quality of social care research being performed in England. We addressed this risk – how the HRA fulfils its statutory responsibility to protect and promote participants and potential participants in this type of research – by holding a social care research round table in July 2018 and agreeing a number of actions.
Capitalising on technological developments	The challenges and opportunities associated with the procurement, implementation and funding of new technology to replace our research IT system (new IRAS) improving user experience and meeting EU Exit, interoperability and spending review economies. We focused on strong programme governance, adopting an agile approach to development and ensuring extensive collaboration with key stakeholders. Internal audit provided additional assurance through targeted audits in this area.
Ensuring the HRA is governed effectively and provides value for money	Spending review requirements to provide real terms savings to the public purse balanced by the requirement to deliver on our statutory remit. £700k savings have been achieved over the past two year through our service improvement programme and 2018/19 financial performance was within resource limits set by the Department of Health and Social Care.