Overview
- On Friday the MHRA and King's College London agreed a modified Pathways protocol that introduces minimum entry ages of 11 for birth‑registered females and 12 for birth‑registered males and adds strengthened safety checks.
- The trial was originally paused in February after the MHRA warned of potentially significant long‑term biological harms including likely effects on fertility and bone density and urged a higher lower‑age limit.
- Researchers say no child can take part without parental consent and that participants must meet eligibility checks, show understanding of risks, and receive expanded patient information about fertility preservation and bone monitoring.
- Recruitment will not start before August 1 while a judicial review and planned parliamentary amendments seek to block or delay the study, and a High Court hearing is scheduled to consider emergency injunctions.
- Pathways was set up after the 2024 Cass Review found weak evidence for puberty blockers; the trial aims to study timing effects on mental health, physical development and cognition and could shape future NHS policy and care for gender‑questioning young people.