What does informed consent mean in the context of GnRH analogues for gender dysphoria?

Dr Isobel Ross

The “gender affirming” model relies on “informed consent” to justify the prescription of GnRH analogues (henceforth “puberty blockers”) to gender-distressed minors or those with gender incongruence. However, I suggest that informed consent is ill-equipped to safeguard patients in this context and that a different model of care is required.

Informed consent is based on the Principle of Respect for Autonomy and an autonomous decision requires a person to have the following attributes:

1) The capacity to understand, weigh-up, and communicate the potential consequences of a decision and

2) Freedom from controlling influences.

From a NZ legal perspective, Right 6 of the Code of Health and Disability Services Consumers’ Rights (1996) requires the provision of:

“An explanation of the options available, including an assessment of the expected risks, side effects, benefits, and costs of each option” to the standard that “a reasonable consumer in the consumer’s position” would expect.”

Gillick competence

The legal concept of “Gillick competence” is important when patients are minors. Adults are considered to have autonomy over their medical decisions unless a clinician has good evidence to the contrary. My understanding of the practical application of this concept is that minors under the age of 10 are considered not to have autonomy. Gillick competence comes into play in the grey area between 10 and 18. Between 16 and 18, minors are considered to have competence to make their own health care decisions in most, but not all, circumstances. The law allows that children between 10 and 16 may have the capacity to make some, but certainly not all, healthcare decisions. The higher the stakes involved, the greater the need to ascertain understanding and decision-making capacity. Usually, parents or guardians will participate in decision making on behalf of children in this age group.

However, based on my clinical experience, a clinician is unlikely to challenge a patient’s autonomy unless that patient’s high-stakes decision deviates from what the clinician deems to be in their best interests. For instance, I have observed instances of patients with full blown dementia signing surgical consent forms for hip-fracture surgery.

Potential pitfalls of the informed consent model for puberty blockade in minors

There are many ways for the informed consent model to fail to uphold autonomy.

Mistaken beliefs and “diagnostic overshadowing”

Gender clinicians may act under mistaken beliefs. For example, they may believe that “gender identity” is something fixed or that gender dysphoria is always the cause rather than a symptom of mental distress. In other words, gender dysphoria might have its origins in trauma, or neurodivergence, or social difficulties, or other psychiatric problems. Gender incongruence might be induced by social contagion. Diagnostic overshadowing occurs when a clinician attributes a patient's symptoms to a pre-existing or prematurely formulated diagnosis, rather than considering other possible causes. It results from a belief in “this and only this". The consequence is that clinicians will fail to offer treatment “options” that a reasonable parent (or patient) might wish to consider. For example, psychological exploration and therapy and/or watchful waiting.

Reliance on poor quality evidence and lack of awareness or denial of potential harms

Gender clinicians may rely on poor quality evidence of the benefits of puberty blocker therapy (as detailed in the Cass Review, 2024, and the recent Ministry of Health Evidence Brief, 2024). If studies that purport to show substantive improvements in mental health, gender dysphoria, and suicide risk are poorly designed and at risk of bias, they cannot be relied upon as a basis for treatment. If gender clinicians themselves are unaware of how unreliable the research evidence is, they will be unable to inform patients and parents about how weak the evidence of benefit is. Furthermore, gender clinicians may ignore or may be unaware of the potential for significant harms. This is because gender researchers, beginning with the Dutch researchers, have failed to investigate for theoretical harms that are suggested by a well-established knowledge of the importance of puberty for many aspects of adolescent development, not just secondary sex characteristics. For example, the effect of puberty on neurocognitive development. But absence of evidence is not evidence of absence. Thus, clinicians may fail to provide complete or adequate information that might allow parents and young people to understand what is potentially at stake and what, I believe, a reasonable parent (or patient) would want to know in this context.

Evaluation of understanding and capacity for understanding

Gender clinicians, like other clinicians, may not adequately evaluate a young person’s capacity to understand what is at stake or their ability to communicate their understanding. Health literacy is important in this context but is rarely addressed by clinicians as a whole. Based on my clinical experience and my PhD research, clinicians rarely attempt to elicit explicit demonstrations of understanding from patients. I would be surprised if the situation were any different in the gender clinic. There is a difference between asking someone, “Do you understand?” and receiving a “Yes” response and asking someone to explain, in their own words, what you have just told them. Unfortunately, this standard, as advocated by health literacy researchers, is rarely achieved in medicine. But when the stakes are as high as they are in puberty blockade, (as I argue below), I suggest that this standard must become the norm, should the Ministry of Health decide to retain puberty blockers as a permitted treatment for gender dysphoria. However, I believe very few parents would consent to puberty blockade for their children if they were fully aware of the current state of the evidence.

Freedom from controlling influences

Gender clinicians may fail to ensure freedom from controlling influences – a requirement of autonomous decisions. Minors suffering from gender dysphoria may have an overwhelming belief that their lives will be immensely improved by transition. This overwhelming belief acts as a controlling influence. However, questioning such a belief would be incompatible with the “gender affirming” model – indeed it might be construed as “conversion therapy”.

A different form of controlling influence is at play when parents are told that their child is likely to commit suicide if they do not receive puberty blockers. This type of coercion also derails autonomy.

Transferring the burden of responsibility to patients and parents

A reliance on informed consent means that treating clinicians are placing the burden of responsibility for decision making on to patients and parents, thereby abrogating their own responsibility to “first do no harm”.

The influence of trust in the doctor-patient relationship

Treating clinicians may underestimate the influence of trust in the doctor-patient relationship. In other words, a patient (or their parent) is likely to infer that if a doctor offers a particular treatment for a particular condition, the treatment must be safe. Otherwise, the doctor would not be offering it… would they?

This trust may be misplaced as revealed by the following leaked quotes from WPATH (World Professional Association for Transgender Health) clinicians, as reported by Mia Hughes in “The WPATH Files”, 2024).

Daniel Metzger, an endocrinologist, said, “[gender doctors are] often explaining these sorts of things to people who haven’t even had biology in high school yet”. Metzger subsequently indicated that even adult patients often have little medical understanding of the effects of these interventions.

Dianne Berg, a child psychologist, and a co-author of the WPATH Standards of Care 8 (2022) “Children” chapter remarked, “[it’s] out of their developmental range to understand the extent to which some of these medical interventions are impacting them” and “They’ll say they understand, but then they’ll say something else that makes you think, oh, they didn’t really understand that they are going to have facial hair”.

What should reasonable patients and parents be made aware of about puberty blockade?

Firstly, patients and parents need to know that the evidence for benefit from puberty blockers (to mental health, to resolution of gender dysphoria, and to reducing suicides) is weak, because of low quality studies (small numbers, poor design, and risk of bias).

Secondly, they need to know about possible harms, including osteoporosis and restricted height. Gender clinicians may mention these.

Thirdly, they need to know about three significant and, I believe, interconnected issues that are currently unlikely to be addressed by gender clinicians. These are:

· The effects of puberty and maturation on gender dysphoria/incongruence

· The effects of puberty blockade on brain structure and function

· The lack of reversibility of puberty blockers in the context of “gender affirming” medical treatment (GAMT).

Puberty can alleviate gender dysphoria

James Cantor (2016) lists older studies that were conducted prior to the adoption of the “gender affirmation” model, and prior to the huge increase in patients presenting with gender dysphoria, with the flipping of the sex ratio from a preponderance of natal boys to a marked preponderance of natal girls presenting in adolescence. These studies showed that “watchful waiting” resulted in a high rate of post-pubertal desistance, where patients came to terms with their natal sex and a high proportion “came out” as gay, lesbian, or bi-sexual. Do gender clinicians discuss this evidence with patients?

The effects of puberty blockers on the adolescent brain

Professor Sallie Baxendale has published a scoping review (2024) of the literature on puberty blockade and neurocognitive development – she was unable to perform a systematic review of the literature because there are so few studies, especially in the context of GAMT for gender dysphoria. She considered the paucity of studies in this area “surprising,” considering our longstanding awareness of the importance of puberty for neurocognitive development. For instance, puberty is especially important for the development of the pre-frontal cortex, which is the region responsible for the higher-level cognitive skills that control and coordinate lower-level cognitive skills, attention, and behaviour. There are also GnRH receptors in brain areas that control learning, memory, and emotion.

Baxendale examined the evidence from mammal studies, other animal studies, the treatment of precocious puberty in children, and the treatment of gender dysphoria. Her conclusions, based on the extremely limited evidence available, were that puberty blockade can adversely affect IQ, executive functioning, social development, stress response, learning, and memory. Furthermore, there is no evidence that such effects are reversible. Of clinical, although not statistical, significance, one case study of puberty blockade for gender dysphoria revealed a marked decline in the patient’s global IQ over three years. Baxendale’s opinion is that patients and parents cannot be told that puberty blockade is “safe” until much more research, especially longitudinal research, is conducted. I strongly suggest that a reasonable parent of a child with gender dysphoria or incongruence would want to know about these uncertainties.

Puberty blockers are not a “pause button”

Puberty blockers have been characterised as a “pause button” that gives young people who experience gender distress or incongruence “time to think” (about whether they wish to continue with GAMT). This may have seemed reasonable in the early days of GAMT, because puberty blockers had been used for some time to pause precocious puberty. In the latter context, age-appropriate withdrawal of puberty blockers resulted in the progression of normal puberty.

However, we now know that the situation for GAMT is quite different, despite some gender clinicians’ claims that patients can come off puberty blockers at any time and go through normal puberty in accordance with their natal sex. Far from being “fully reversible” as initially claimed, the evidence suggests they are not even “mostly reversible”. Rather, patients almost always go on to receive cross-sex hormones as these studies indicate:

Study

The above table speaks for itself – the vast majority of children who receive puberty blockers will go on to receive cross-sex hormones. Thus, puberty blockers are not reversible in the context of GAMT. The reasons for this are not yet well established but both plausible and less plausible theories have been proposed. A low-plausibility theory is that gender clinicians are very astute diagnosticians who can discriminate between patients who will maintain their gender identity and those who will desist. This seems unlikely, especially as the “gender-affirming” model requires clinicians to accept the patient’s expressed gender identity. One plausible theory is that patients who receive puberty blockers perceive them as the first step towards full transition. Evidence for this theory comes from the reports of gender clinicians (Barnes, 2023). Another plausible theory is that “puberty suppression becomes a self-fulfilling prophecy" because of an, as yet, unspecified effect on brain development (Biggs, 2022). Such an effect would be compatible with the aforementioned evidence for potential adverse effects of puberty blockade on neurocognitive development.

What does PATHA (Professional Association of Transgender Health Aotearoa) have to say about the reversibility of puberty blockers? It has recently changed its position from stating, in its 2018 guidelines, that they are “fully reversible”, to this:

“Gonadotropin Releasing Hormones (GnRH) agonists are reversible and should not affect long term fertility. However, prior to starting gender affirming hormone therapy, adolescents are often reluctant to cease puberty blockers in order to conduct fertility preserving interventions.”

In my view, this statement not only significantly underplays the evidence about irreversibility, but it also manages to push responsibility back on to minor patients for being “reluctant to cease puberty blockers”. The strong implication is that it is the children’s fault if, in 10 or 20 years’ time, they find themselves unable to have a family. I find this position ethically indefensible.

By contrast, my view of the evidence is that puberty blockers, in the context of GAMT, are irreversible for all practical purposes. They appear to function as a funnel towards cross-sex hormones and “gender affirming” surgery. These treatments entail irreversible effects and lifelong medical care, with its associated iatrogenic harms. The upshot is, if the Ministry of Health decides that puberty blockers can continue to be prescribed for gender dysphoria, informed consent must also entail a discussion of the risks of cross-sex hormone therapy. Such risks include sterility, lack of sexual function, pelvic floor dysfunction, an increased risk of breast cancer, weight gain, premature menopause symptoms, cardiovascular complications, Type 2 diabetes, and a possibly shorted lifespan.

Concluding remarks

My position, based on the weak evidence of benefits, the lack of evidence for safety, and the strong evidence for the irreversibility of puberty blockers, is that they should be banned for therapeutic use in minors with gender dysphoria or incongruence. This is in accordance with the principles of beneficence (providing benefit) and non-maleficence (not doing harm). As bioethicist, Moti Gorin, puts it, “In almost any particular medi­cal encounter—at least when things go well—by the time a patient has an opportunity to exercise her au­tonomy rights, nonmaleficence and beneficence have already done their work by constraining the set of per­missible treatment options” (2024).

However, I understand that any regulatory decision around puberty blockers is likely to be a pragmatic one, based on competing priorities, of which harm minimisation is only one. If puberty blockers continue to be permitted in the context of GAMT, their use should be preceded by a holistic biopsychosocial, developmental, and medical assessment that allows for a differential diagnosis of the cause of gender dysphoria – other than “born in the wrong body” – and for the possibility of psychotherapy as a first-line treatment. Unfortunately, I do not believe that clinicians who wholeheartedly endorse the “gender affirming” model are in a position to deliver this type of care.

Informed consent for puberty blockers must attain a higher standard of patient and/or parent autonomy than is generally accepted for therapeutic interventions that have good evidence of a favourable risk-benefit ratio. Puberty blockers should be treated as experimental treatments. Because of their high degree of irreversibility, patients and/or their parents must be required to communicate their understanding of all the implications of puberty blockade as described above.

Isobel Ross, February 2025¹

References

Barnes, H. (2024). Time to think, Swift Press.

Baxendale, S. T. (2024). The impact of suppressing puberty on neuropsychological function: A review. Acta Paediatr,113(6),1156-1167. doi: 10.1111/apa.17150. Epub 2024 Feb 9. PMID: 38334046.

Beauchamp, T. L., & Childress, J. F. (2013). Principles of biomedical ethics (7th ed.). Oxford University Press.

Biggs, M. (2022). The Dutch Protocol for Juvenile Transsexuals: Origins and Evidence. Journal of Sex & Marital Therapy, 49(4), 348–368. https://doi.org/10.1080/0092623X.2022.2121238

Brik, T., Vrouenraets, L. J. J. J., de Vries, M. C., & Hannema, S. E. (2020). Trajectories of adolescents treated with gonadotropin-releasing hormone analogues for gender dysphoria. Archives of Sexual Behavior, 49, 2611–2618. 10.1007/s10508-020-01660-8

Cantor, J. (2016). Do trans- kids stay trans- when they grow up? Sexology Today. http://www.sexologytoday.org/2016/01/do-trans-kids-stay-trans-when-they-grow_99.html

Carmichael, P., Butler, G., Masic, U., Cole, T. J., De Stavola, B. L., Davidson, S., Skageberg, E. M., Khadr, S., & Viner, R. (2021). Short-term outcomes of pubertal suppression in a selected cohort of 12 to 15 year old young people with persistent gender dysphoria in the UK. PLoS One, 16, e0243894. 10.1371/journal.pone.0243894

Cass Review. (2024). Independent Review of Gender Identity Services for Children and Young People. https://cass.independent-review.uk/home/publications/final-report/

Chadwick. L. (2022). Does the Affirmative Care Model Protect Kids and Families? A Comprehensive Review. Genspect. https://genspect.org/does-the-affirmative-care-model-protect-kids-and-families-a-comprehensive-review/

de Vries, A. L. C., Steensma, T. D., Doreleijers, T. A. H., & Cohen‐Kettenis, P. T. (2011). Puberty suppression in adolescents with gender identity disorder: A prospective follow‐up study. Journal of Sexual Medicine, 8, 2276–2283. doi:10.1111/j.1743-6109.2010.01943.x

Gorin, M. (2024). What Is the Aim of Pediatric ‘Gender-Affirming’ Care? Hastings Center Report, 54(3), 35–50. DOI: 10.1002/hast.1583

Health and Disability Commissioner. (1996). Code of Health and Disability Services Consumers' Rights Regulations 1996. https://www.hdc.org.nz/your-rights/about-the-code/code-of-health-and-disability-services-consumers-rights/

Hughes, M. (2024). The WPATH Files. https://environmentalprogress.org/big-news/wpath-files

Levine, S. B., Abbruzzese, E., & Mason, J. W. (2022). Reconsidering Informed Consent for Trans-Identified Children, Adolescents, and Young Adults. Journal of Sex & Marital Therapy, 48(7), 706–727. https://doi.org/10.1080/0092623X.2022.2046221

Ministry of Health. (2024). Impact of puberty blockers in gender-dysphoric adolescents: An evidence brief. https://www.health.govt.nz/publications/impact-of-puberty-blockers-in-gender-dysphoric-adolescents-an-evidence-brief

Murley, C. (2014). Does the Gillick Competency Test Apply in New Zealand given the Special Nature of Sexual Health Care Services? Pub Int LJNZ, 1,130.

Nyquist, C.B., Torgersen, L., David, L.W., Diseth, T.H., Gulbrandsen, K., & Waehre, A. (2024). Treatment trajectories among children and adolescents referred to the Norwegian National Center for Gender Incongruence. Acta Paediatr,00,1–9. https://doi.org/10.1111/apa.17530

Professional Association for Transgender Health Aotearoa. (2018). Guidelines for Gender Affirming Healthcare. PATHA. https://patha.nz/Guidelines

World Professional Association for Transgender Health (WPATH). (2022). Standards of Care for the Health of Transgender and Gender Diverse People, Version 8. https://wpath.org/publications/soc8/chapters/

Biography; Dr Isobel Ross

1. I am a retired anaesthetist with over 30 years clinical experience. My medical degree is from the University of Glasgow, and I began my specialty training in anaesthesia in Scotland. On completion of my specialty training in Aotearoa, New Zealand, I worked as a consultant anaesthetist at Capital and Coast District Health Board for over 25 years.

I have a longstanding interest in bioethics, especially in informed consent and its limits and have taught bioethics to both anaesthesia trainees and medical students.

My Masters in Bioethics (Otago) examined the ethical responsibilities of operating theatre team members in the context of potential harms to patients from innovative treatment. Research for my PhD (Otago) involved examining informed consent discussions “in the wild.” Using the methodology of Conversation Analysis, I analysed video-recorded interactions between surgeons and patients. I focused on patients’ displays of understanding in response to surgeons’ information delivery.

I also have expertise in the field of health literacy.