You may have seen or heard about a series of studies called PATHWAYS. The series includes a proposal for a clinical trial.
The research proposals, funded by the National Institute of Health and Care Research (NIHR) aim to test how the NHS can best support people with gender dysphoria. In 2024 a review by Dr Hilary Cass said that this is an area in which more research and evidence is needed.
Healthcare for transgender people has become a politicised issue. Even at this early stage, the series of studies has attracted a significant amount of interest. The Health Research Authority has not received an application for PATHWAYS but has already had feedback from people who would like their views about research in this area to be considered as part of the checks which take place before studies can start.
There has been, and continues to be, media and social media discussion about PATHWAYS. This is an area where mis and disinformation is rife, and where some of the language used when talking about research could be distressing.
It's not always clear where to find trusted information about health and social care research, so we share what happens when the HRA receives an application for a research study.
We are one of a number of organisations that work together in the UK to regulate different aspects of health and social care research. We protect and promote the interests of patients and the public when they, their tissue or their data, are involved in research in the NHS.
We review around 4,000 studies every year. Studies like the clinical trial as part of PATHWAYS also need to be reviewed by other organisations before they can start, like the Medicine and Healthcare products Regulatory Agency (MHRA).
When a study is submitted to us, HRA staff make an assessment of the governance and legal compliance of the research.
All research has ethical issues which need careful consideration. Each proposal is also considered by a Research Ethics Committee (REC) which reviews the research proposal. Committees work within a framework, but make an independent decision based on ethical consideration of each individual study, and assessment of information submitted by the study team.
Research Ethics Committees include a range of people with professional and life experience to be able to make an informed decision on proposed studies. For clinical trials, the number and type of people that make up a REC is a set out in law. The HRA is the appointing authority for RECs in England, but each committee makes an independent decision.
Our RECs are well qualified to review studies like PATHWAYS, giving this research the due care and consideration that it deserves. The framework within which all UK RECs work is published on our website.
All research reviewed by the HRA, whether it is approved or not, is also published in a database on our website.
The HRA has not received an application for any PATHWAYS study, but is preparing for if or when we are asked to review them.