A challenge to the regulatory approval of the PATHWAYS Trial has been rejected by the High Court this afternoon.
PATHWAYS is a programme of research aiming to help find out how the NHS can better support children and young people with gender incongruence.
As part of the programme an application for PATHWAYS Trial, a Clinical Trial of an Investigational Medicine Product (CTIMP) investigating the effects of puberty-suppressing medication on young people's physical, social and emotional wellbeing, received a favourable opinion in November 2025.
The approval was given via the Combined Review process, where both the HRA and Medicine and Healthcare products Regulatory Agency (MHRA) review applications for CTIMPs in parallel, and provide a single combined outcome of both reviews.
In February 2026 the MHRA raised some concerns about the trial and began a scientific dialogue with the trial sponsor, King’s College London (KCL).
The scientific dialogue between KCL and the MHRA resulted in the sponsor proposing changes to the previously approved study protocol and associated documents for the trial.
A modification to the trial was reviewed in May 2026, with a favourable opinion being provided in June 2026.
During the initial review of the trial application in November 2025, a legal challenge was brought by a campaign group and two people challenging the decision to approve the trial. This legal challenge was updated to reflect the changes made to the trial as part of the approved modification in June 2026. The legal challenge sought permission to stop the trial and apply for a judicial review.
A hearing took place on 27 and 28 July to hear evidence and consider the application from the claimants. On 31 July Mr Justice Chamberlain refused the applications for permission to apply for a judicial review and to stop the trial.
Dr Matt Westmore, Chief Executive, Health Research Authority"Protecting people who take part in research is why the Health Research Authority exists.
"The checks that we carry out, alongside the independent ethics review process, ensure the interests of participants are put first, and that the research is safe and ethical.
"High profile studies like this will always attract extra scrutiny and we welcome the opportunity to assure the public of the safeguards put in place to protect research participants.
"We are grateful to the Court for its careful consideration of this case, and its recognition that Research Ethics Committees (REC) have the right expertise to review complex studies like PATHWAYS Trial.
"We would like to thank the volunteers who sit on RECs for their time, expertise and careful consideration of these important ethical questions.
"PATHWAYS Trial has all the necessary approvals to begin recruiting participants in line with the approved research protocol."
You can find out more about our review of the PATHWAYS Trial application, including access to minutes and documents, on the dedicated page of our website.