Making the UK the easiest place in the world to do research that people can trust

The role of the Health Research Authority

One of the things that makes the UK stand out is a strong joined-up regulation system that is built on decades of experience and designed to support fast, high-quality research.

The Health Research Authority (HRA) is one of a number of organisations working together in the UK to regulate different aspects of health and social care research.

Our aim is for research findings to improve care faster because the UK is the easiest place in the world to do research that people can trust.

Accelerating research

We know how important it is for research studies to be reviewed and approved as quickly and efficiently as possible.

We co-ordinate 64 research ethics committees in England who are part of a UK-wide service that reviews more than 4,000 research projects. It is one of the largest co-ordinated research ethics service in the world. They provide a consistent, reliable service, with the median time to issue an ethical opinion in 2023-2024 being 28 days, way below our 60 day target.

We also set policy for how RECs operate UK-wide, creating a consistent co-ordinated UK-wide research ethics service that can provide a single UK-wide ethics opinion on a research project.

The speed of the review process is a factor in attracting clinical trials from across the globe to the UK. In 2022 the UK ranked fourth for phase I, sixth for phase II and 10th for phase III in terms of numbers of clinical trials initiated.

Working closely alongside the Medicines and Healthcare products Regulatory Agency (MHRA) the introduction of combined review has substantially shortened the length of time it takes for clinical trials to be approved, with the time from application to recruiting a first patient already shortened by 40 days.

Our research ethics review process is also flexible to meet urgent public health needs. In February 2021, we approved the world’s first COVID-19 human infection challenge study to take place here in the UK. We assembled a specialist Research Ethics Committee to review the research proposal to ensure that the interests of the people taking part were considered throughout. Our fast-track service enabled more than 700 studies to be fast-tracked in the first 12 months of the COVID-19 pandemic, with the most urgent reviewed in just 24 hours.

The reliability and consistency of the UK approvals service is something that researchers have told us they value, with 91% of users of our approvals service rating their experience at least 7/10 (March 2024).

Take a look at the HRA's latest performance data.

Making it easy to do research that people can trust

One of the HRA’s most important roles is to identify areas where we can speed up the approvals process and remove barriers the research community face.

Our work to develop the new clinical trials regulations alongside the MHRA gives us a real opportunity to create a regulatory framework that makes it easy to do high-quality, safe research.

Ahead of the new clinical trials regulations we have already made a number of updates to make it easier to understand our expectations when designing clinical trials:

• public involvement – public involvement in the design and delivery of research has been shown to improve the quality of health and social care research and our Shared Commitment to Public Involvement offers organisations a chance to share experience and best practice in this area
• information for participants – we have recently launched quality standards and design principles so that researchers know how to provide simple, clear information for people deciding whether to take part
• people-centred – the People-Centred Clinical Research project outlines nine hallmarks of how you can ensure people are put at the centre of clinical research
• diversity – we are working alongside the MHRA to help researchers improve the diversity of participants in their research through a new Inclusion and Diversity Plan
• transparency – our Make it Public campaign is dedicated to ensuring research carried out in the UK is transparent and has successfully implemented automatic registration of clinical trials on the ISRCTN database

Whilst this work continues we have made other improvements that have made a real difference to the set up of clinical trials.

Reworking processes that slow down how studies get up and running is a large part of this, which is why we have been working with partner organisations across the UK to establish the National Contract Value Review (NCVR) process for commercial contract research.

The NIHR recently analysed data from 63 studies that took place in the past 12 months and found that study set-up times are now over 100 days quicker when compared to pre-pandemic levels.

In practice, this means that study set-up time is being shortened by around four months through the changes introduced by NCVR.

The HRA is also looking towards the future and how we can support innovative ways of doing clinical research.

We know that the regulatory pathway for artificial intelligence (AI) and digital technologies in health and social care can be slow, complex and difficult to navigate.

For researchers this means wasted time and effort, and delays to research projects. To address this we have helped to launch the Artificial Intelligence and Digital Regulations Service which has been designed to give free advice and information on regulations to help developers and adopters navigate this developing area of research.

Experience during COVID-19 pandemic

Our experience gained from thousands of reviews conducted by our committees has enabled the development of robust research policy and regulatory practices.

During the COVID-19 pandemic the HRA played a vital role in enabling the world’s first COVID-19 human infection challenge study to take place in the UK.

Our role at the HRA was crucial. We assembled a specialist Research Ethics Committee (REC) and fast-tracked the review, without lowering our high standards.

We reviewed and approved studies in hours that would normally take weeks, and what resulted was a vaccine that changed the course of this disease across the world.

Sharing our experience internationally

The Health Research Authority is held in high regards internationally, as is the UK-wide research ethics service.

We are proud to work in collaboration with health and social care research communities across the world to share our experience and learn more about the different ways research is carried out in different countries.

Over the last few years we have presented at conferences in a range of countries, including:

• Australia – we shared best practice on ethics at the National HREC Conference in Queensland, Australia
• Canada - shared our experience of managing The Over-Volunteering Prevention System as part of a documentary released in Canada
• USA – the HRA was invited to an even for pharmaceutical companies in Cambridge, Massachusetts to talk about talk about patient centricity and the UK’s vital experience in human clinical research
• Sweden – we presented at the AI and Data in Medicine and Healthcare Conference in Stockholm, talking about the work we have done to streamline the regulation of artificial intelligence in the UK
• Greece – Neelam Patel, Non-Executive Director at the HRA, spoke at the European Knowledge Forum to discuss the importance of diversity in health and social care research and the progress we have made in the UK
• Denmark – our Chief Executive, Matt Westmore, presented at the Enabling Regulatory Science for Clinical Trials symposium at the Danish Embassy in London to talk about clinical trials in the UK and what the enablers and barriers are for public involvement
• Belgium – we were invited to join the Belgian-UK Economic Mission where we shared our experience of digital health solutions in the life sciences industry
• Norway – as part of Cochrane’s new Thematic Group for People, Health Systems and Public Health we presented to a seminar in Trondheim to share our experience of inclusion and diversity in research
• Netherlands – our Deputy Director of Policy and Partnerships, Naho Yamazaki attended the Clinical Data Disclosure Europe conference in Amsterdam to talk about the HRA’s work on transparency, trust in research and regulatory requirements in the UK
• South Korea – Standard Operating Procedures for RECs in the UK were translated into Korean to support Research Ethics Committees in South Korea to align their processes with the UK