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What is the informed consent model in gender care? 

Informed consent is the bedrock of medical practice and indicates the explicit permission a patient gives for a specified medical intervention. Consent can only be granted following discussions about the anticipated consequences of the proposed treatment, potential risks and benefits, and the outcomes of alternative treatments including no treatment. The courts regard notions of consent as a right of self-determination. Part of the process of eliciting informed consent is the clinician’s assessment of the patient’s understanding of the proposed treatments and the doctor must be satisfied that the patient is free from coercive influences in the decision making process. 

A commentary  published in the Journal of Sex and Marital Therapy compares two recently published papers which address the challenging issue of informed consent in young people with gender dysphoria. The author, Alison Clayton, is a practising psychiatrist in Australia so clearly has skin in the game. Like most psychiatrists, she will be working with gender variant patients, even if not directly in a gender healthcare setting. Understanding and being skilled at eliciting informed consent is a key part of all doctors’ work and it is especially complex within the field of mental health, as capacity to consent to treatment might be impaired for a number of reasons. 

In the commentary, Clayton compares and contrasts a paper by a group of US doctors (Levine, Abbuzzese & Mason 2022), “Reconsidering Informed Consent for Trans-Identified Children and Young Adults” and the Australian Professional Association for Trans Health’s (AusPATH) “Australian Informed Consent Standards of Care for Gender Affirming Hormone Therapy” released earlier this year (AusPATH 2022). She reviews the two papers and pays special attention to the common sources of evidence that both use to draw their conclusions. 

The “Informed Consent Model of Care” has evolved partly as a response to the unprecedented increase in trans-identified young people, which has created pressure on established gender clinics. Clinicians have responded by developing leaner service models that offer rapid evaluation and make recommendations about medical interventions. The affirmative model rests on the belief that transgender is neither a physical nor psychological disorder, but a normal human variant, and that identity itself is indication enough for intervention.  It is therefore not appropriate to challenge a young person’s subjective belief that they are psychologically, in fact, the opposite sex, but to affirm and validate and offer medical and surgical treatment. Under the Informed Consent Model, mental health assessments are not required, and hormones can be initiated after one or two visits to the clinic. 

Levine’s paper challenges a number of the assumptions held by professionals who advocate for this model, which, it might be argued, undermine the integrity of the informed consent process. Claims made about the success of paediatric transition are controversial at best, the co-existence of high levels of mental illness amongst the adolescent cohort of (mainly) girls has been inadequately explored, and long-term evidence of benefit of medical and surgical transition has not been demonstrated. Even the diagnostic processes that provide a foundation for medical intervention have not been agreed upon. 

For informed consent to be valid, key areas of uncertainty must be shared with the patient and their parents. Research suggests that if left alone, children’s cross sex identification naturally resolves naturally with time and maturity (See here for Zucker’s analysis). In other words, the likely trajectory of a child or adolescent’s gender identity is simply not known – doctors cannot predict which patients might persist their cross-sex identity into adulthood and therefore potentially benefit from medical transition, and those who might reconcile with their birth sex. Furthermore, the long-term physical and psychological health outcomes of gender transition remain uncertain.  Levine also criticises the misuse of suicide statistics which, some believe, are misrepresented to advocate for immediate medical transition. Instead, it might be argued, there should be a more considered, exploratory approach where the origins for gender dysphoria are examined and co-morbid mental health problems treated, prior to considering hormone treatment and surgery. 

Evidence around gender medicine in children and young people is lacking.  There are no randomised controlled trials (generally held to be the ‘gold standard’ when testing new treatments) that demonstrate medical and/or surgical intervention in gender dysphoria to be better than any other approach, including the adoption of a ‘wait and see’ policy.  In 2020, The National Institute for Health and Care Excellence concluded that the evidence for puberty blockers and cross-sex hormones in paediatric gender medicine is of ‘very low certainty’ (Evidence for puberty blockers use very low, says NICE – BBC News)

In contrast to Levine’s thorough review of accepted good practice in informed consent, the AusPATH standards of care emphasise the potential benefits of gender affirming hormones as well as social transition and surgery. There is no expectation of a gender dysphoria diagnosis as the patient is deemed to be the expert in their own gender needs. Psychiatric evaluation is not required for all and the informed consent model is proposed for the under 18 cohort. AusPATH recommends that the process of evaluation, informed consent and the initiation of treatment can take place in one or two appointments. 

Whilst Levine’s paper emphasises the lack of evidence for medical intervention in gender dysphoria, no acknowledgement of this shortcoming is made in AusPATH. Furthermore, no alternative approaches of care are given any consideration: ‘informed consent’ is equated with ‘affirmative care’ which is also described as ‘ethical affirmation’. 

AusPATH fails to acknowledge the widely recognised problem of low-quality evidence, asserting instead that there is a clear body of evidence that gender affirming treatment improves quality of life and leads to better health outcomes. Clayton herself reviews the studies that are cited to buttress these claims. Most of these cited studies are small, at high risk of bias and constitute low quality evidence. Many are the very same studies that were used by NICE to conclude that the evidence is of ‘very low certainty’. 

Thus there remains deep uncertainty about how best to help children and young people with gender dysphoria. Clayton’s timely commentary highlights some of the areas of disagreement and challenges standards of care recommended for use in Australia, which appear badly designed and driven by adherence to ideology, rather than commitment to the scientific process. The commentary supports the recommendation made by Levine et al for a thoughtful, slow and thorough evaluation and informed consent process prior to irreversible medical intervention.