EPATH has joined WPATH and USPATH in issuing a joint holding statement outlining significant ethical concerns regarding the UK Government’s proposed PATHWAYS randomized controlled trial on gender‑affirming care for adolescents.
As organizations dedicated to advancing high‑quality, evidence‑based transgender healthcare, we fully support rigorous research. However, the current PATHWAYS study design raises several issues that conflict with internationally recognized ethical standards for clinical research and adolescent care.
Key Concerns Highlighted in the Statement
- Risk of Coercion and Compromised Informed Consent: The proposed model links access to gender‑affirming care with participation in the study. This structure risks undermining voluntary informed consent by placing young people and their families in a position where declining participation may limit access to clinically indicated treatment.
- Delayed Access to Medically Necessary Care: The study design includes delaying or restricting puberty‑blocking treatment for adolescents who meet clinical criteria. Such delays may prioritize research objectives over patient well‑being and contradict established clinical guidelines.
- Ethical and Clinical Issues with Late Initiation of Puberty Blockers: Initiating puberty blockers later in adolescence introduces additional risks and may not align with best‑practice care pathways. The statement emphasizes that research must not compromise the health or safety of participants.
- Need for Meaningful Inclusion of Lived Experience: The statement calls for the integration of transgender adolescents, their families, and community stakeholders in the design and governance of any research that directly affects them. Patient‑reported outcomes and lived experience must be central to ethical and effective study design.
- No Single Study Should Determine Access to Care: The organizations stress that the PATHWAYS trial should not be used as the sole basis for national policy decisions. Adolescents who choose not to participate must retain full access to the complete range of evidence‑based gender‑affirming treatments.
Commitment to Ethical, Patient‑Centred Research
EPATH remains committed to supporting high‑quality research that strengthens transgender healthcare. Ethical research must be voluntary, clinically sound, and designed with the well‑being of participants at its core. We welcome opportunities for collaboration that uphold these principles and advance the health and rights of transgender young people.
The full joint statement is available here.