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:
People-Centred Clinical Research project
Final project report and resources
The principles and hallmarks of people-centred clinical research
How to use the principles and hallmarks
Recommendations for change
Why people-centred research is important
Changes we have made already
What difference being people-centred makes
Who created the hallmarks of good people-centred clinical research?
The People-Centred Clinical Research project
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.
The People-Centred Clinical Research project was set up in 2022 to identify the barriers and enablers to the changes needed to make people-centred clinical research happen more often in the UK.
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.
Working alongside members of the public, researchers and the University of Lincoln we have used the feedback to make recommendations for system-wide action.
Addressing the barriers to people-centred clinical research with recommendations for system-wide action
In August 2024 we published a report titled 'Addressing the barriers to people-centred clinical research with recommendations for system-wide action'.
The report identified the hallmarks of good people-centred research and the barriers to doing it.
We made 19 recommendations for system-wide action and asked the research community to use the report to help them make improvements to any research they carry out in the future.
In the report you can read quotes from members of the public and researchers who gave feedback as part of our survey.
You can find out more about the hallmarks and our recommendations further down this page.
Read the full report and executive summary.
Resources
We have created a series of resources that you can use to help you ensure your research is people-centred:
- full project report and an executive summary
- an infographic which shows the hallmarks and principles in one place
- graphics for each of the hallmarks
What's important to people when taking part in research?
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!
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.
Recommendations for change
As part of the People-Centred Clinical Research project final report we made 19 recommendations for system-wide change.
Possibility – make it possible for people to take part
Offer choices, ensure fair representation and keep it as simple as possible. Use great communication throughout.
Our recommendations are:
- accessibility - improve accessibility. Make research and the information about it more accessible
- available opportunities - improve the availability of opportunities for people to take part in research. Make it easier to find research, including how and where research is advertised, and people are approached to take part
- cost and inconvenience - reduce the cost and inconvenience to participants taking part in research. This includes the impact on benefits and earnings. Reduce complexity and burden for the participant and improve choice
- exclusion and inequity - improve equity, diversity and inclusion in research and research practice
- information about research - make all information about research and research opportunities more focussed on the people it is for. Make information more human, effective and prevent jargon
Trust – treat people well and with respect
Show care, respect and appreciation. Ensure people feel safe and that their information is secure. Use great communication throughout.
Our recommendations are:
- fears about safety, confidentiality and disrespect - provide information and reassurance about safety and protection of data. Work to change the image of research and researchers. Make it clearer how taking part in research and personal data are safeguarded
- care and recognition - remove tokenism. Improve care, value and recognition. Improve how respect is visibly shown throughout research
- communication - improve two-way communication and feedback throughout research
Purpose – do research that is meaningful
Share a clear purpose and show how taking part will help to make a difference. Work in partnership. Use great communication throughout.
Our recommendations are:
- co-production and collaboration - improve collaboration and co-production in research and make this visible to participants. Work in partnership with members of the public. Remove barriers to public involvement
- research designs - improve research designs to be more people-centred
- impact - improve visibility and likelihood of research impact. Ensure research does not waste people’s time and effort
- engagement - improve methods of engagement for research
Culture and capacity – be people-focused
Make sure people are the focus. Ask what matters most. Work on solutions in partnership. Use great communication throughout.
Our recommendations are:
- mindset and attitude - improve researcher mindset to be more people-centred. Embed understanding of the hallmarks
- advocacy - improve research advocacy beyond the research system. Advocate for people-centred approaches
- system capacity - improve capacity across the clinical research ecosystem
- system support, administration and leadership - make it easier to do people-centred research and provide leadership
- ethics processes - support people-centred approaches through the ethics process
- training development and skills - include people-centredness in training and skills development. Provide training and development
- funding and resources - fund people-centred approaches and infrastructure
You can read more about the recommendations in our final report.
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 changes have we made in response to the report?
The recommendations made in the People-Centred Clinical Research report have already influenced a number of projects being led by the Health Research Authority.
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.
Get in touch
If you have any feedback about the People-Centred Clinical Research project or would like to find out more please email communications@hra.nhs.uk
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