New guidance on creating accessible patient information leaflets for clinical trials

  • 6 January 2026

New guidance on how to create accessible and inclusive patient information leaflets is available to researchers who want to recruit patients to their clinical trials. The guidance was created by health researchers at the University of Bristol and the NIHR Bristol BRC, together with a wide range of individuals and groups.

Clear, plain language

If we want to recruit a representative sample of the population to clinical trials, information about taking part in trials needs to be accessible to everyone, and everyone needs to feel included in the invitation to take part. This means providing information in clear, plain language. Pictures can also help.

The National Literacy Trust says 1 in 6 adults in England have very poor literacy. People from minoritised ethnic backgrounds, where many people speak, read or write languages other than English, can also access information better when it is written clearly. The same applies to people with learning disabilities and autistic people.

By using the new guidance, researchers can reduce the barrier that providing complex and inaccessible written information creates. This could help run clinical trials which better represent the people who live in the UK.

Diverse views

The new guidance on creating accessible patient information leaflets was produced by a diverse group, including:

  • Health researchers
  • People from different patient charities
  • People in patient advice groups
  • People from minoritised ethnic backgrounds, including Chinese, South Asian, Eastern European, Black, African and Caribbean, and Roma communities
  • People with learning disabilities and autistic people
  • People from the LGBTIQ+ community

Including such a diverse range of people means the patient information leaflets are designed by the people they are aimed at.

The group spent 2 years working with people on a project to find out how to make information about clinical trials as accessible and inclusive as possible. They created the accessible patient information leaflet and guidance together.

A graphic illustration of how the MAPLE project was conducted. Part one: Learning how to make better patient information. We gathered information; we listened to patients, communities and charities; and we published the information for researchers. Part two: Helping researchers to make better patient information. We worked with patients, communities and charities. Together, we made a website to help researchers, which has: a how-to guide for researchers; a patient information leaflet that is easy to understand and inclusive for everyone; and images that help to explain the written information and include a wide range of people.

Freely available

The team wanted to make the information and guidance as user-friendly as possible, so they created a website for researchers to use. The website includes:

  • A template for an accessible patient information leaflet, which researchers can download and edit for their clinical trials
  • Information on how to use and to edit the accessible patient information leaflet
  • Advice on, and examples of, pictures that can be used in each section of the leaflet

Researchers must use the guidance provided to help build their accessible patient information leaflet. They must also involve members of the public, to make sure their leaflet works for their target population.

University, NHS and charity-based researchers can download the patient information leaflet for free – researchers in profit-making companies must pay a small fee.

Information in stages

The accessible patient information leaflet is only the first stage in providing information for patients about taking part in a clinical trial. It provides the information patients need to help them decide whether they are interested in taking part and want to find out more.

It is not designed to be used alone, and researchers need to provide patients with additional information, for example about data protection regulations. This reflects the recommendations from the Health Research Authority, who support the approach of providing information to participants in stages.

The work to produce the leaflet and guidance was funded by NHS England and the Department of Health and Social Care, through the Integrated Care Systems (ICS) Research Engagement Network (REN) Development Programme. The research was also supported by the NIHR Bristol BRC.

Mary, a member of the Patient Experience Partnership in Research (PEP-R) group, said:

“Creating an accessible template for a clinical trial is important. It will standardise the approach for trials and offer the benefit of using a tried and tested formula which will appeal to a wide audience. I believe this will benefit all parties both medical and future trial participants.

“This accessible template will improve the message of why the trial is important, increasing the catchment and attracting more trial participants from a broader sector resulting in improved trial outcomes.”

Claire, a member of The Misfits Theatre Company, a theatre and social group led by people with learning difficulties, said:

“It was important to me to be part of the project and having my voice heard as someone with a learning disability.”

A member of the Chinese Community Wellbeing Society (CCWS) said:

“The Chinese community is often overlooked in clinical trials due to various barriers, such as culture and language — many aren’t even aware these opportunities exist. Through two focus groups, we gathered valuable feedback on patient information leaflets, aiming to make them clearer and more accessible. The conversations were engaging, and the community felt heard and valued.”