To earn people’s trust, research projects involving people, their tissue or their data need a number of approvals before they can go ahead. These approvals and assurances are important to set up research at the locations where it will take place and to ensure that the people the research is for and about can be confident to choose to take part.
The HRA manages 64 Research Ethics Committees in England and co-ordinates a UK-wide service that reviews more than 4,000 research projects a year. Working with Health and Care Research Wales we combine this ethics review with a governance and legal review to provide one HRA and HCRW Approval for each research project taking place in England and Wales. This stops legal and governance checks needing to be repeated at each location the research takes place, reducing duplication, speeding up study set up and enabling study locations to focus on the research. We also provide technical assurances on radiation and pharmacy for research studies that need them. Alongside this work we run the Confidentiality Advisory Group and service, which provides advice on the use of confidential patient information without consent where this may be needed for research and non-research purposes. We work hard to ensure that these approvals are fast, predictable and consistent, which we know is important for everyone involved.
Clinical trials of new medicines (clinical trials of investigational medicinal products also known as CTIMPs) need approval from the HRA and Medicines and Healthcare products Regulatory Agency (MHRA) before they can go ahead. We work together, in parallel to provide a Combined Review. This helps to reduce the time it takes for a clinical trial to be set up in the UK.
A thorough and robust approvals process is crucial to do research in a way that people can trust, but this needs to be proportionate so that it does not stop valuable research that can improve people’s lives from going ahead. We offer an accelerated Proportionate Review where research raises no material ethical issues. We are always working to better understand how we can make the regulatory process more proportionate and agile, without cutting corners, so that we can make it easier to do research that people can trust.
We are focused on continuously reducing the average and maximum time it takes for researchers to earn the approvals that they need for their research to go ahead.
Once research has been approved, it is set up at the locations where it will take place. This can be at anything from 2 to over 300 locations in NHS and wider care settings such as a care home, community hub, prison or people’s homes, taking research to where people are. This can take time and reducing the time that this takes is a major focus for the next three years. We are standardising processes, using our trusted assurances to reduce duplication and improving digital systems to help researchers find out what they need to do and follow an ideal path to set up their research study. This will reduce the burden, time and cost to do research, making it easier to do research in a way that means the people it is for and about can take part - and help ensure that research findings can improve care faster.
Our work to provide approvals fast and make it simple to set up research well directly supports the government’s ambition to turbocharge medical research.
Over the next three years we will
Make it easier to do research across different settings in the UK, broadening access to research
We will:
- achieve a 10% increase in the percentage of people who tell us that it is easy to set up studies in the UK, including across NHS and non-NHS settings
- ensure that researchers have a positive experience when finding out what they need to do and earning the approvals that they need with at least 75% of applicants rating our overall service highly
Provide approvals in time to support the set up of clinical trials in 150 days
We will:
- provide 100% of approvals of clinical trials within a maximum of 60 days, with a median timeline below 40 days. This will support the ambitious target for clinical trial set up in the UK to be cut to 150 days and further in the longer term. We will continue to deliver faster timelines where appropriate
- ensure that you get a decision on support for the use of confidential patient information without consent in England and Wales from the Confidentiality Advisory Group within 60 days or where a precedent has been supported within 30 days
- ensure that all research applications will receive a HRA and HCRW Approval decision in less than 60 days
Make setting up research more efficient, with simple steps and no duplication
We will:
- reduce the burden, time and cost to do research by standardising processes and reducing duplication in the set up of research studies, with a 20% increase in the percentage of people who tell us that the process of study set up is efficient
Implement new clinical trials legislation and continue to take action to make it more proportionate for researchers to navigate the regulatory process without reducing rigour
Ensure our processes are aligned with wider work to help public health researchers find out what they need to do and earn these approvals
Work with others so that social care researchers can find out what they need to do to and access support available to them to earn approvals
Ensure that our policies and practices support international collaboration with UK researchers, and enable the UK to be a global partner in promoting safe and ethical research
This supports the government's ambitions to
- create a faster, more efficient, more accessible and more innovative clinical research delivery system – making the UK a world leader in clinical trials
- reduce the time it takes to get a clinical trial set up in the UK to 150 days by March 2026
- bring the benefits of clinical trials to everyone