RecruitingInterventional

Improving diversity in clinical research for patients undergoing surgery (PROTECT-DIVERSITY)

The PROTECT-DIVERSITY study wants to make sure clinical trials are open to everyone, especially patients having planned surgery. Often, not enough people from different backgrounds take part in research, which means the results might not apply to everyone. This study will test if offering consent forms in different languages and using various ways to collect information about people (like their background or ethnicity) can help more patients get involved. We'll be comparing paper and electronic consent forms given by chance. We'll also see if collecting diversity information from medical records or through questionnaires is better. Your answers can help make future research fairer and more inclusive for all. There are no known downsides to taking part.

At a glance

Status

Recruiting

Sponsor

Queen Mary University of London

Enrolment target

532

Start

06 Mar 2026

Estimated completion

01 Jan 2027

Adult patients undergoing elective surgery

What is this study about?

When doctors and researchers carry out studies, it's really important that the people who take part represent all sorts of different backgrounds and experiences. If a study only includes certain types of people, the results might not be useful for everyone else. The PROTECT-DIVERSITY study is focusing on patients who are having planned surgery to see how we can make sure more people get a chance to be involved in research.

One key thing we’re looking at is how we get consent. We want to find out if using consent forms in different languages helps more patients understand what a study is about and decide to take part. We'll also be comparing traditional paper consent forms with electronic versions to see which works best. Another part of our study is to improve how we collect information about the different people taking part, such as their ethnicity, background, or if they have a disability. This helps us ensure we truly understand if our research reflects the whole population.

By testing these different approaches, we hope to learn how to make it easier and more welcoming for people from all walks of life to join important medical research. This could lead to better healthcare solutions that work for a wider range of patients in the future.

Key takeaways

Aims to include more diverse patients in surgical research.
Compares paper and electronic consent forms.
Checks best ways to collect information about patient backgrounds.
No extra appointments or medical procedures.
No known risks or disadvantages to participating.
Your input helps make future research fairer for everyone.

Who may be eligible?

This study is looking for volunteers who are adults aged 18 or older. You must be planning to have surgery that you and your doctor have arranged in advance (this is called 'elective surgery').

You won't be able to join if you're unable to give your agreement to take part, or if you've already been part of certain other related PROTECT studies. If you've previously taken part specifically in the PROTECT-DIVERSITY comparison section, you won't be able to join again.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Are you having surgery that has been planned in advance?
Can you understand and agree to take part in a study?
Have you not already joined the PROTECT-DIVERSITY comparison before?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll be asked to give your agreement (consent) to join the main PROTECT trial. This will happen in one of two ways, chosen at random: either using traditional paper forms or through electronic forms on a device. As part of the PROTECT trial, some information about you will be collected. This includes details like your sex, ethnic background, whether you are married or in a partnership, if you have any disabilities, your pregnancy status, religion, sexual orientation, and how you identify your gender. You don't have to answer any questions you're not comfortable with. There are no extra tests or appointments you need to attend specifically for this PROTECT-DIVERSITY study, as it works alongside the main PROTECT trial.

Potential risks and benefits

There are no known disadvantages or risks to taking part in this study. The main benefit is that the information we collect could help improve how we gather details about different patients in clinical trials in the future. This means research might become more inclusive and relevant for a wider range of people. You are completely free to change your mind and withdraw from the study at any time without giving a reason, and this won't affect your medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Barts Health NHS Trust
City only
London, England

Common questions

What is 'elective surgery'?

Elective surgery is an operation that you and your doctor have planned in advance. It's not an emergency procedure.

Will my personal information be kept private?

Yes, any information collected will be handled carefully and confidentially, following privacy rules. You can also choose not to answer certain questions.

Do I have to answer all the diversity questions?

No, you don't have to answer any questions you don't want to. Your participation is voluntary.

Will taking part affect my medical treatment?

No, taking part in this study will not affect the medical care you receive for your surgery.

How long will the study last and when is it starting?

The study is planned to start in December 2025 and will run for two years.

How to find out more

Tom Abbot

t.abbott@qmul.ac.uk +44 203 594 0348 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.