Clinical research is for and about people, so it has to be people-centred
Clinical research aims to find out more about an illness, condition, treatment, therapy, or care by directly involving people in a project.
This sort of research may ask people to take part by testing a new treatment, using a device or by being cared for in a certain way. It may also ask them to provide information about the care they usually have.
Lots of people are already included in clinical research, but we know there are lots of people who have not had the opportunity to take part.
We want to improve this.
Contents
On this page you'll find information on:
What is important to people when taking part in research?
The principles and hallmarks of people-centred clinical research
How to use the principles and hallmarks
Why people-centred research is important
What difference being people-centred makes
Who created the hallmarks of good people-centred clinical research?
Being people-centred in research
Being people-centred means focussing research on what matters most to the people it is for and about.
It involves working in partnership with them, and thinking about those who should have the opportunity to take part. It also means doing research in ways which people say are important when they take part.
What's important to people when taking part in research?
In December 2022 we carried out a survey that was completed by more than 400 members of the public, researchers and NHS staff.
We asked what mattered most to them when it came to taking part in research. We combined this feedback with a literature review and one-to-one conversations with a range of groups.
Read more about what we did and how we used the feedback we received.
Our work suggests that given the right opportunities, many people would choose to take part in clinical research, and that there are three things important to them doing so:
Trust – people trust the research and the research team
Purpose – people feel the purpose is worthwhile
Possibility – people find it possible to take part in it
Considering these three things that matter most to people when taking part, we have developed some principles and hallmarks of what good people-centred clinical research looks like.
The principles and hallmarks of people-centred clinical research
Good people-centred clinical research always asks 'what matters most?' and 'how can we work together to achieve it?'.
We've co-created nine hallmarks that research and researchers will show if they are doing good people-centred clinical research.
These hallmarks have been grouped under three guiding principles:
Treating people well and with respect
Reliable, honest and open
Caring and respectful
Appreciative and thankful
Doing research that is meaningful
Making a difference
Working in partnership
Making it possible for people to take part
Representative and fair
As simple as possible
Giving choices
Underpinning each of the guiding principles is using great communication.
When you select each of the above principles and hallmarks you will see two accompanying statements.
One of the statements shares what a research team should do when it comes to that principle or hallmark. The second statement is what a research participant can expect and how they might feel when they take part in a clinical trial.
You can download all of the principles and hallmarks along with instructions for use. We'd love them to be used widely and for people to tell us what they think!
Sharing the principles and hallmarks
We've created an infographic which makes it easy to see the hallmarks and principles in one place!
How should I use the principles and hallmarks?
The principles and hallmarks can be used in different ways depending on who you are.
To help explain how to best use them we have developed some quick guidance for:
Researchers and research teams (including public contributors and sponsors)
People who are invited to take part in research
Organisations who support people to take part in clinical research
Find out more about how to use the principles and hallmarks.
Why is people-centred research important?
Research projects can fail when it is not as easy as possible for people to take part, or if they only provide answers for some people in society.
For clinical research to truly benefit health and care and make a difference in the real world for everyone, we need to make sure the people the research is for and about are the focus, and that they are involved as equal partners.
We already know some ways that help researchers earn trust. Researchers already need to show that their projects are ethical, legally compliant and scientifically robust.
We are getting better at improving value and creating possibilities through making sure that patients and the public are involved in research. We're also trying to make research more visible and more inclusive. But there is more to do.
We think research can be improved further by doing research in more people-centred ways. We think there are ethical and practical reasons for being people-centred.
What difference should being people-centred make?
Doing research in people-centred ways should make a difference by:
creating more opportunities for more people to take part
making it better for people who do take part
enhancing research design and delivery
reducing research waste
supporting better health and care decisions
Find out more about the difference people-centred research can make.
Who created the hallmarks of good people-centred research?
The hallmarks of good people-centred clinical research have been created in partnership with members of the public, the research community, the University of Lincoln and the Health Research Authority.
The People-Centred Clinical Research steering group has led this work.
Read more about the steering group.
Acknowledgements
We would like to say a big thank you to everyone who has been involved in the project and supported us, including:
People-Centred Clinical Research steering group members
University of Lincoln's Lincoln Impact Literacy Institute
Expert Citizens CIC
The Lawnmowers
NeurOx Young People's Advisory Group
CRISP, the expert patient group at group King's College Hospital NHS Foundation Trust
All contributors to our survey, and everyone who has one-to-one conversations with us
The People-Centred Clinical Research Project is part of the UK Recovery Resilience and Growth Programme (RRG).
RRG is a partnership of research organisations led by the Department of Health and Social Care, working together to improve clinical research delivery across the UK. All of our recommendations will be shared with these partners to bring change.
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