This year, the Department of Health and Social Care (DHSC) announced that the NHS will offer home testing kits as part of the cervical screening programme for the very first time. This decision was informed by the results of YouScreen, a study reviewed and approved by the Health Research Authority. Findings suggest that an option to take part from home could result in 400,000 more women taking up their invitation for screening every year.
There are over 800 Research Ethics Committee (REC) members at the Health Research Authority (HRA) who volunteer their time to review applications for health and social research before studies like YouScreen can go ahead.
In this blog, REC member and former Chair, Professor Paula McGee, and researcher Dr Anita Lim tell us how the REC review process ensured that the YouScreen study was ethical and fair, and how it feels to have been a part of such groundbreaking research.
Paula is an Emeritus Professor of Nursing who joined South Birmingham REC in 2015.
Nearly all cervical cancers are caused by an infection from certain types of human papillomavirus virus (HPV) which is spread through sexual contact. The infection may be symptomless but can be detected through cervical screening, which is essential to prevent abnormal cells from developing. However in recent years, the number of women who respond to their invitation from the National Cervical Screening Programme in England has declined.
Many women don’t, or are unable to, attend screening for various reasons; with poverty and social inequalities playing a major role. The challenge for service providers is to find different ways to encourage women to be screened, which this study has helped revolutionise.
At the time of the review, the COVID-19 pandemic was affecting almost all aspects of daily life. This created challenges for REC members and applicants, as Zoom meetings replaced in-person meetings and we had to quickly get used to new ways of working.
The pandemic was also a time of considerable innovation. Studies such as YouScreen began to explore new approaches to patient care, as established practices were no longer sufficient. Self-screening in 2020 was a novel intervention. If it took place anywhere, it was not within the NHS and test results were not recorded on the national database.
This study was part of a force for change.
YouScreen research study application
The YouScreen study proposed testing a self-sampling approach to cervical screening to reach women who hadn’t responded to contact by the NHS National Cervical Screening Programme.
The plan was to use the national screening database and GP records to identify women aged between 25 and 64, living in one of the 5 London boroughs with the lowest screening uptakes, and who had been invited for screening more than 15 months ago, but not attended.
Women would be approached when visiting their GP practice and offered a kit, or would receive one via post. No written consent would be taken as returning the completed test was deemed sufficient indication of consent. Each kit contained study information and instructions on how to use the swab and return it for analysis via pre-paid postage. The researchers aimed to recruit 10,000 women.
The research application also included the research protocol, recruitment materials, research information for participants, the communication of each individual’s results, peer reviews, details of the sponsor and the lead researcher’s CV.
The committee had around 2 weeks to read the documents and identify the points that we wished to raise.
The REC review meeting
As members, we’re aware that applying for ethical review and attending part of a REC meeting is stressful. It's very important that researchers are made welcome when they attend and are treated with respect. We aim to be helpful and constructive, even when we must ask researchers to make changes.
Research applications are the product of months or even years of hard work and are reviewed by people who were not involved in it and who may not be experts in that area. It’s our responsibility to approve the ethical rather than the scientific elements of a study, even if these two sometimes seem to collide.
Our REC noted that the YouScreen application was well written and well-prepared and discussed several points, including the involvement of GP practices, how recruitment would be manged, and translation. We also discussed:
- The accuracy of the test and if there was a possibility of a false negative result
- The test kit would be used off-licence
- Whether the kit might have the unintended consequence of discouraging women from attending clinics for cervical screening
- Returning samples by post during the pandemic
- Consideration of pregnant women
- Whether GP practices were “on board” with the study
- Provision for women who were virgins or victims of female genital mutilation (FGM)
- Provision in the event that abuse or safeguarding issues might be highlighted through the testing process
- The proposed retention of samples for future research, and what this might be
The researcher responded well to each point. However, we agreed that the last 3 topics should be addressed more clearly in the participant information.
The REC decision
We were pleased to share our favourable opinion on the study with conditions and 1 recommendation. The conditions were to:
- add information to the website about safeguarding and sources of support
- make clear in the participant information that samples would only be kept for future research that related to additional screening tests
- ensure that the recruitment material makes clear that the study is research
We also recommended that the researcher took advice on the best guidance for women who may have experienced FGM and add this to the study information.
Once the researcher told us that they’d completed these actions, the study had the permissions that it needed to start.
Professor Paula McGeeThis study provided a novel approach to cervical screening, a treatable form of cancer if identified early. Diseases and conditions that affect women are woefully under addressed in medical research, and health services are not always designed to meet their needs in the modern world. This study had the potential to bring about an improvement.
A second factor which made this study memorable was that the outcome was published in eClinical Medicine and in the news, which is unusual. Fellow REC members and I were pleased to hear about the success of this study, as it provided a sense of completion from application and ethical review to the outcome.
Throughout my career I’ve been very aware that ethics are an integral part of clinical practice. Ethics matter because people matter. As my career developed, I started to carry out research with vulnerable people and developed a greater understanding of the many ways that ethical issues are present throughout all stages of a study and the responsibilities of researchers to identify and mitigate harm.
The REC review is only one stage, and researchers must be constantly aware of previous unforeseen ethical problems that may arise as their study progresses. It also provides an opportunity for researchers to step back, take stock and see what may have been overlooked, require further clarification or expansion.
Considering applying to become a REC member?
I saw joining a REC as an opportunity to use and expand my knowledge and skills in a different arena. What I find most exciting and interesting is the opportunity to work as part of a team in reviewing each application and engaging in constructive dialogue with researchers before making our decision.
Each study is unique, and it is a privilege to engage with research team members. It is important to recognise and respect their hard work and commitment to making a positive difference to treatment and care.
This process has exposed me to the wide range of research undertaken at local, national and international levels. From clinical trials of potential new medicines, medical devices, patient experiences, PhD studies and more.
Dr Anita LimWhen we began planning the YouScreen trial, we knew it could be pivotal for cervical cancer prevention in the UK.
Because the trial was embedded in the NHS Cervical Screening Programme, one aspect of the design required permission from Public Health England. Before submitting to the South Birmingham REC, we sought advice from a HRA REC Chair. It was an unusual step, but crucial: their feedback was pivotal in persuading Public Health England to support the study. Without that intervention, YouScreen might never have happened.
We then asked through the HRA for a pre-meet call with Professor McGee who read the application and understood the clinical value and importance straight away. She shared her thoughts on the types of questions the Committee might raise.
That preparation proved invaluable. When the meeting came, the Committee raised thoughtful points that improved our trial. This led us to build stronger mechanisms to support women, ultimately strengthening the study. It was a reminder that REC review is not simply a hurdle to clear, but a chance to enhance research for the people at its heart.
YouScreen went on to deliver the evidence needed for national policy change. What we found is that if self-sampling was rolled out across England, an additional 1 million women could be screened. In June 2025, DHSC announced that self-sampling will be rolled out across England from January 2026.
The significance of this cannot be overstated. Cervical cancer is one of the most preventable cancers, yet women who do not attend regular screening remain at greatest risk. Self-sampling removes many of the barriers to access, making it easier for more women to be screened and protected.
My advice for researchers attending a REC meeting
Working with RECs is not just about getting approval, it’s about dialogue. My advice to researchers would be:
- always attend the meeting so you can hear the questions first hand and respond to them. Anticipate what may be contentious and have your rationale prepared and use examples
- be clear on the scientific evidence and clinical implications
- listen with an open mind; thoughtful questions can make your study stronger
- engage with the Chair if you need to, as their insights can help you prepare and engage more effectively with the committee
You can learn more about the YouScreen study in a webinar that Paula and Anita took part in, as part of our new series of ‘Research Revisited’ events.
In the events, we look back at studies that have been reviewed by REC and Confidentiality Advisory Group (CAG) to see the real world impact of the research and how the questions raised during the review process directly impacted on the research and its outcome.