Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, whether he has made an assessment of the capacity of children under the age of 16 to provide informed assent to participation in the PATHWAYS clinical trial.

The consideration of consent and assent proposals within clinical trials rightly forms part of the independent scientific and regulatory review process. This trial has been designed with the input of expert clinicians, children, and families, and has benefited from independent peer review, and been subject to formal review and approval via both the Medicines and Healthcare products Regulatory Agency and the Health Research Authority.

PATHWAYS is a clinical trial of an investigational medicinal product, so under-16 year olds cannot legally give the trial consent on their own. Informed consent must come from a parent or person with parental responsibility, although the young person’s assent and understanding are essential. This will include the young person needing to be able to explain in their own words to the clinician what the risks are and that they understand those risks. The research protocol also requires a formal review of the young person’s understanding and wish to continue once they reach 16 years old.

Individuals considering entry into the trial will be subject to strict eligibility criteria. These include that children considering assent will have had a gender incongruence diagnosis for a minimum of two years, have been holistically assessed and will have accessed tailored psychosocial support via specialist National Health Service gender services, and will have been deemed clinically appropriate, within the context of the study, by both their NHS clinical team and the National Multi-Disciplinary Team of professional experts.

Maintaining the safety and wellbeing of children and young people has always been the Government’s priority for this trial, and always will be.