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Experts comment on news that the High Court have rejected a challenge to the PATHWAYS clinical trial for puberty suppressing hormones.
Prof Sir Jonathan Montgomery, Professor of Health Care Law, UCL, said:
“The judge has made it clear in today’s ruling that he was satisfied that all the scientific, ethical and legal concerns raised by the claimants about the PATHWAYS trial had been fully considered by the MHRA and HRA. He considered 31 witness statements, over 13,000 pages of documentation, and heard oral submissions over two days. He concluded that ‘the Trial was commissioned by NHS England and designed by its co-sponsors with conspicuous care, in consultation with other expert bodies‘. He described the MHRA process as ‘rigorous’ and noted how ‘careful’ the HRA and the REC had been in their scrutiny. The claimants failed to persuade the judge that any of the legal arguments that they raised had a realistic prospect of succeeding. He found that both regulators had met their legal transparency obligations and that as a result of his judgment a ‘vast amount of material explaining the MHRA’s and HRA’s reasons for the approvals‘ was available to the public.
“The judgment also provides reassurance that the utmost care is being taken to protect the interests of participants in the trial. As the judge pointed out, ‘Each child will have been assessed over many months by specialist doctors. In each case, the treating team will have formed the opinion that the child has a reasonable prospect of receiving a clinical benefit from the treatment. There is a detailed process to ensure that the child assents and a parent consents to the treatment, having been fully informed of what it involves and of its potential outcomes. A second opinion will be obtained from a National Multi-Disciplinary Team (“NMDT”) of paediatric and other specialists to ensure that participation is clinically appropriate in the individual case.’
“The judge was concerned not to undermine the legislation that allocated responsibility for oversight of research approvals to the MHRA and the HRA. He stated that ‘The rule of law is endangered if decisions are taken by persons other than those to whom they have been entrusted.’ Now that we know that the criticisms of the trial design have been fully and diligently considered by the expert regulators to whom Parliament has entrusted scrutiny, it is time to permit the study to commence. This will help to address the past failure to ensure a sound evidential basis for the care of young people with gender incongruence that was identified by the Cass Review, and for which Parliament provided when it prohibited supply of puberty suppressing hormones except within a clinical trial. Those young people and their families are entitled to expect no less.”
Dr Matt Westmore, Chief Executive, Health Research Authority, said:
“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 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.”
https://www.judiciary.uk/wp-content/uploads/2026/07/Bayswater-Approved-Judgment.pdf
https://www.judiciary.uk/wp-content/uploads/2026/07/Bayswater-Press-Summary.pdf
Declared interests
Prof Sir Jonathan Montgomery: “Sir Jonathan Montgomery is Professor of Health Care Law at University College London and a former Chair of the Health Research Authority. He has been providing advice to the study team on how to ensure compliance with legal and ethical requirements on an unremunerated basis and is not one of the investigators in receipt of the grant.”
Dr Matt Westmore: “Dr Matt Westmore is the Chief Executive of the Health Research Authority (HRA). The legal challenge was brought against the decisions made by the HRA and other regulators to give approval to PATHWAYS Trial. The HRA is an arm’s length body of the Department of Health and Social Care. It’s the appointing authority for Research Ethics Committees, responsible for establishing, supporting, and appointing members to committees in England. Committees are made up of volunteers independent of funders, sponsors, and research teams, and review research proposals before they can start. Dr Matt Westmore is Chief Executive of the HRA and has no conflicts of interest with the PATHWAYS Trial.”