This site uses cookies. By continuing to browse the site you are agreeing to our use of cookies.

Now is your chance to improve public involvement in UK clinical trials

Last updated on 24 Feb 2022

We have been working with the Medicines and Healthcare products Regulatory Agency (MHRA) on a set of proposals we hope will improve and strengthen the UK clinical trials legislation. We believe this will help to make the UK the best place to research and develop safe and innovative medicines. Our Public Involvement Lead Jim Elliott blogs about how the proposals and how you can help.

jim-elliott.png

‘We are really pleased to see proposals to improve and strengthen public involvement in UK clinical trials – now is your chance to tell the MHRA what you think.

The MHRA has published a consultation on proposals to improve and strengthen UK clinical trials legislation. These include introducing a legal requirement for the involvement of people with relevant lived experience in the design, management, conduct and dissemination of a trial. This is something that we have long encouraged through guidance and we’re really pleased to see this proposal to strengthen this to a legal requirement. The MHRA is asking for feedback on these proposals by 14 March. What they hear will inform legislation that will go before the UK Parliament. If you have views on these proposals, now is your chance to tell them what you think.

What is new about these proposals?

Currently we strongly encourage public involvement in research because we know that insights from people with relevant lived experience results in better research. We provide guidance and support to researchers to help them to involve relevant people as they develop their research proposals. And the Research Ethics Committees that we coordinate, which are made up of health professionals, researchers, academics and lay people who consider the ethical issues presented by research proposals, look for evidence of public involvement in the applications that they review. But this isn’t currently a legal requirement.

The MHRA is proposing to make it one, by introducing a legal requirement for researchers to work in partnership with people and communities (including patients and carers who have experience of living with the relevant condition) in the design, management, conduct and dissemination of a trial, or explain to the ethics committee as part of the application, why this is not appropriate.

This would strengthen the ability of Research Ethics Committee’s to ask for evidence of public involvement – moving from encouraging to requiring.

What happens next?

These proposals will not automatically become law.

The MHRA’s consultation is open until 14 March for feedback. The MHRA will be reviewing the consultation responses and using these to inform the preparation of legislation that will then go before the UK Parliament. So now is the time to comment on these proposals and shape the final legislation.

Part of a much bigger puzzle

We’re really pleased to see this proposal and look forward to hearing what people think about it.

However, this is just one of a whole raft of things that we can do to encourage more meaningful public involvement to put participants and their families at the heart of research. Making public involvement a requirement doesn’t mean that brilliant, meaningful public involvement will just happen. It is one of a number of levers that can help move us towards that and it must be supported by clear guidance for applicants, unified messaging across funders and regulators, and consistent review by ethics committees.

Our work in the pandemic showed importance of leadership and collaboration to support effective and meaningful public involvement. That is why we are working with a group of organisations that fund, manage, support and regulate health and social care research to develop a public statement of our collective commitment to public involvement and to encourage ongoing work together throughout the research system to make sure this is recognised as a vital part of how you do good research.

And the MHRA’s consultation itself isn’t just about public involvement but makes lots of other proposals that can benefit patients going forward and are closely intertwined with effective public involvement. These include proposals to introduce legislative requirements for research transparency – such as registering research trials and communicating findings with participants - and asks for views on whether there should be legislative requirements to support diversity in clinical trials populations, among many other issues.

How do I have my say?

The content and volume of responses that they receive will really help the MHRA decide the way forward so if you have views, it is worth taking the time to respond.

If you would like to comment on the proposals, you can see the full consultation and there is an online form to respond . You can respond to as many questions as you like – you don’t have to respond to the whole consultation. The public involvement proposals are at section 3.1 and question 1.’

Jim Elliot, Public Involvement Lead

The public consultation will be open until 14 March 2022, 23:00.

Take part in the consultation.

Martin O’Kane, Head of Clinical Trials at the MHRA, said:

‘Our current clinical trials consultation aims to develop a regulatory framework which promotes patient and public involvement in clinical trials, improves the diversity of participants, streamlines clinical trial approvals, enables innovation and enhances clinical trials transparency.

‘In order to achieve this, we are seeking the views of the wider public, clinical trial participants, researchers, developers, manufacturers, sponsors, investigators, and healthcare professionals. We encourage you to get involved and help shape this important future legislation, for the ultimate benefit of patients.’

Back to news & updates