It's the parents who give 'consent', the children are asked for 'assent'.
Relevant section:
3.5.1 Informed Consent for TRIAL
3.5.1.1 The process of determining clinical eligibility
The process of determining clinical eligibility is set out in the clinical service document titled “PATHWAYS TRIAL for Gonadotropin Releasing Hormone Analogues (GnRHa) – Guidance for CYPGS clinicians” A schematic of the interplay between providing research information, determining clinical eligibility and then research eligibility is shown in Figure 3. This will involve a series of clinical meetings with the CYP both on their own and with their parents/caregivers/legal guardians focussing on known and unknown possible benefits and risks of GnRHa including possible longer-term risks, alternative interventions that may alleviate their symptom/distress. Information will be provided in written formats, supplemented with visual material and audio-recordings (e.g., of clinical discussions) adapted to meet the cognitive style of the CYP and their parents/caregivers/legal guardians. NHS interpreter services will be used for those who are not confident in their use of English. CYP and their parent/caregivers/legal guardians will be asked to demonstrate their understanding of GnRHa and alternative treatment approaches by answering questions from clinicians using their own words or alternative preferred communication (e.g., typing, audio recording). As part of the submission documents to the national MDT, CYP and at least one parent/legal guardian will be asked to provide their reasons for requesting GnRHa.
Specific attempts will be made to meet with both parents/legal guardians to elicit their independent views. Where there is a disagreement between parents/legal guardians about GnRHa, this will be flagged to the national MDT to consider in their decision.
While caregivers with parental responsibility will be encouraged to attend sessions to give their perspective and to support the CYP, it will be ultimately the views of parents and legal guardians whose views are formally considered in the clinical eligibility decision.
Fertility: The risks to long-term fertility will be discussed with each CYP considering GnRHa by a clinician in or attached to their Gender Service who has specific training and knowledge about fertility risks and options available to them as well as training in working with CYP experiencing gender incongruence. The information will include options around sperm donation and egg retrieval. CYP will be encouraged to ask questions and explore fertility preservation options prior to commencing on GnRHa (if found clinically and research eligible). For those wishing to pursue fertility options at this time, a referral to specialist fertility preservation services will be facilitated by the Gender Service, noting that referrals are made either directly by paediatric endocrinologists or by the CYP’s GP. There will be no upper limit imposed by research consent on how long young people have to consider and then explore fertility preservation options, and potential participants will be reminded of other constraints, e.g., around the upper age limit of the study.
Where there is clinical uncertainty about a CYP’s suitability for GnRHa based on their physical health, e.g., low bone density, the relevant physical investigations will be undertaken prior to presentation at the NMDT, considered as screening investigations.
3.5.1.2 The process of informed consent to participate in TRIAL
CYP deemed clinically eligible for GnRHa and providing verbal consent to be contacted, will be contacted by the research team. The research team will confirm that the national MDT checklist was fully completed prior to the national MDT decision.
CYP and their parents/legal guardians will initially receive the standard paper PIS in clinic, but this may be supplemented by information in bespoke formats, to support the individual cognitive and learning styles of CYP and parents/legal guardians. CYP will be encouraged to read this information together with their parents/caregivers/legal guardians, prior to discussing it with a clinician in clinic. Specifically, researchers will check whether any bespoke sources of information were used to support the CYP’s discussions with their clinical team in preparation for the clinical eligibility review by the national MDT. These information supports can be re-used and extended as needed by the CYP and their parents/legal guardians.
Following receipt of the information sheets, CYP and their parents/ legal guardians will discuss their participation with the Principal Investigator (PI) or delegated sub investigator (SI) with GCP training. The PI/SI will further explain the purpose of the trial, the research procedures, and the potential benefits and harms associated with GnRHa, including possible long-term risks, and will establish the CYP and their parent/ legal guardian’s comprehension of the information. The uncertainty about impact on long-term health and the importance of signing up to the NHS Registry to provide health information into adult life will be explained. This will usually involve seeing the CYP on their own in part, i.e., without a parent/legal guardian present. The CYP may have their clinical keyworker from the CYPGS present for additional support if they wish. Both parents/legal guardians are encouraged to be involved in the consenting process, where appropriate, and with at least one parent/legal guardian accompanying the CYP to ensure a supportive environment. While caregivers without parental responsibility may attend the meetings with the medical investigator, it will be made clear that it is only parents/legal guardians with parental responsibility who are involved in the decision, alongside the CYP. When caregivers attend the consenting process, parents/legal guardians will also be seen on their own. Where only one parent/legal guardian attends, the reasons for this will be recorded.
The PI/SI will check again that the possibility of fertility preservation was discussed with each CYP and their wishes to access this prior to GnRHa treatment will be recorded. Fertility preservation options should be discussed at each appointment considering endocrine and other medical options.
Informed consent will be obtained in person on paper from parents/legal guardians and assent from CYP by a PI/SI, following Good Clinical Practice (GCP) guidelines. The CYP and their parents/legal guardians will be specifically encouraged to take as much time as they need to make a decision.
For children, informed assent will include demonstrating understanding, retention, and the ability to weigh up the potential benefits and risks of participation, and to communicate their decision freely and without coercion. Clinicians must document the young person’s and parent(s)’ understanding of the trial, including direct quotes where possible, and ensure that both individual and joint discussions have taken place.
A standardised checklist—modelled on that used in the national MDT process—will be employed to ensure that all key aspects of the trial, including the nature of the intervention, potential risks (including those not yet known), implications for fertility, and the right to withdraw, have been thoroughly discussed and understood. Any safeguarding concerns, communication barriers, or co-occurring difficulties that may affect the young person’s ability to assent or comply with trial procedures will be addressed and documented. Reasonable adjustments should be made where necessary. However, consent from a parent or legal guardian is required for the young person to participate in the research.'