More information about the PATHWAYS TRIAL

PATHWAYS  is a programme of research aiming to find out how the NHS can best support children and young people with gender incongruence.

The research was informed by the Independent Review of Gender Identity Services for Children and Young People in the UK, led by Dr Hilary Cass (the Cass Review). There has been significant media and social media interest in PATHWAYS and we've received a number of questions and requests under the Freedom of Information Act about the studies, and about our role as one of the organisations which reviews health and social care research before it can start.

Because of this exceptional level of public interest, we have published a wider range of documents about the study than are usually available on our website, in the format in which they would usually be shared with someone making a request under the Freedom of Information Act.

They are available for anyone to view, though we understand that the format might mean they are not accessible for people who use assistive technology. If you would like to access a document on this page but would require it in another format, please email the communications team.

The documents on this page

When an applicant submits a study to the Health Research Authority for regulatory review, they need to include copies of all of the documentation which will be used in the study if it gets permission to start.

As part of the review process, the Research Ethics Committee (REC) may request changes and updates to these documents, based on their feedback. The REC is independent from the research team, the sponsor and the funder. It is a legally constituted group of volunteers which contains a balance of experts in medicine or research, as well as lay people.

The documents on this page are split into two sections.

The first section includes documents relating to the approval for PATHWAYS Trial approved on 6 November 2025.

The second section includes documents relating to a substantial modification which was submitted by King’s College London following a scientific dialogue with the Medicines and Healthcare products Regulatory Agency (MHRA).

This modification was given a favourable opinion with additional conditions on Thursday 18 June 2026. The additional conditions were addressed in correspondence and a final outcome acknowledging the conditions were met was issued on 24 June 2026.

We have published the final versions of all the approved documents relating to the original application and subsequent modification of PATHWAYS Trial, along with the minutes of the meetings where the study was discussed, and decision correspondence between the HRA and the study team.

Please note that any documents listed in the modification section will supersede any previous versions under the original trial application section.

About these documents

These documents have been redacted in line with our policies and procedures. These are the same if the documents are shared following a request made under the Freedom of Information Act, or if they are published on our website.

Please contact the communications team if you need any of the above documentation in an alternative format.

The research summaries for PATHWAYS HORIZON and PATHWAYS TRIAL have also been published on our website.