March 22, 2022

Informed Consent for Gender-Affirmative Care

Reconsidering informed consent for trans-Identified children, adolescents, and young adults

Trans-identified youth present to clinicians as strongly desiring hormones and surgery. However, this conviction should not be confused with the capacity to carefully consider the consequences of gender transition, argues a recent article about informed consent in gender medicine, published in the peer-reviewed Journal of Sex & Marital Therapy. The authors observe that in recent years, a growing number of adolescents and young adults have declared a transgender identity and sought “gender-affirmative” interventions. The medical and surgical interventions that comprise the “gender-affirmative” care pathway aim to change the body so that it matches the young person’s “gender identity”: a subjectively experienced inner sense of self as a male or female, or increasingly commonly, somewhere in-between.

It is well-established that these interventions are based on very low-quality evidence, are often irreversible, and may increase the risk of medical problems including cardiovascular disease, cancer, and bone health problems. They also carry the risk of permanently medicalizing what may very well be a transient transgender identity in a young person. Because “gender-affirmative” care carries significant risks, providers of these interventions require patients and/or their caregivers to sign informed consent forms, signifying that they are aware of the potential benefits, risks, and alternatives. However, the authors assert that the process of obtaining informed consent in gender medicine is frequently conducted in a superficial way, and that rather than serving the patients’ interests, this type of informed consent primarily serves to protect clinicians and their employers. The authors identify three main areas that compromise the informed consent process: (1) poor quality evaluations of gender-dysphoric youth; (2) erroneous assumptions held by the professionals involved in the provision of “gender-affirmative” care; and (3) delivery of incomplete and inaccurate information to patients and family members.

1. Poor Quality Evaluations

One of the key problems is that physicians involved in the provision of “gender-affirmative” care rely on recommendations from “gender specialists" with the assumption that the patient has received a thorough evaluation involving differential diagnosis and has been provided with a range of potential solutions tailored to the patient’s individual situation. Unfortunately, instead of a thorough evaluation, “gender specialists” frequently fast-track the recommendations to transition because it is their own personal belief that transition is the preferred or even the only approach for managing gender dysphoria in young people.

The problems with poor-quality evaluations have been highlighted by some of the most prominent gender clinicians in the US, who are sounding the alarm that the mental health establishment is failing gender-dysphoric kids and vulnerable young adults over 18. Serious ethical dilemmas emerge when evaluations of gender-dysphoric youth are ideologically driven, fail to explore the factors that contributed to the onset of gender dysphoria, and result in a one-size-fits-all solution of gender transition for all who desire it.

2. Erroneous Assumptions

The authors note that one of the most problematic assumptions held by many gender clinicians working with youth is that their patients simply were “born in the wrong body.” This assumption “frees” clinicians from having to contend with the ethical dilemmas of recommending body-altering interventions that are based on low-quality evidence.  Despite multiple attempts to pinpoint the origin of gender dysphoria using brain studies of increased technical sophistication, researchers have yet to identify a distinct structure that accounts for an atypical gender identity, after controlling for sexual orientation and exposure to hormones. While biology likely plays a role, it’s far from deterministic.

Many clinicians and researchers observe that the dramatic increase in the number of teens declaring a trans identity appears to be, at least in part, a result of peer influence. The authors note that the research into the social influence and social contagion as a contributing factor to trans identification of youth is still in its infancy. Still, it raises a serious ethical dilemma: the very real possibility that clinicians are providing treatments with permanent, lifelong consequences to address what may be transient identities in youth.

3. Incomplete and Inaccurate Information Shared with Patients and Families

Limitations of the Dutch Protocol are not disclosed

Few clinicians engaged in the provision of hormonal and surgical interventions for gender-dysphoric youth today realize that the practice of pediatric transition is based on a single-site uncontrolled Dutch experiment (documented in two studies). The authors assert that the results of this experiment have been misinterpreted and the Dutch protocol itself has been mistakenly applied to patients for whom it was never intended and without the significant safeguards employed by the Dutch researchers.  Originally, the Dutch protocol, which entails the use of puberty blockers, cross-sex hormones, and surgery including the removal of breasts, ovaries, uteruses, and testes, excluded youth with mental health problems or a post-pubertal emergence of transgender identity.  Paradoxically, today, the Dutch protocol is presented as the solution for severe mental health problems of youth with post-puberty onset of gender dysphoria—the very population that the Dutch protocol disqualified due to concern that the interventions would result in more harm than good.

However, even for the patients for whom the protocol was intended—those with early childhood onset of gender dysphoria that intensified in adolescence—the results of the Dutch protocol are far less robust than commonly presented. The treatment pathway, culminating in gender-reassignment surgeries when patients reached age 18, was associated with only modest improvement in psychological function. Further, because there was no control group, it was impossible to determine whether the intervention or some other factor, such as receiving mental health support or simply maturing, was responsible for these changes.

Even the hallmark result of the protocol—the marked reduction of the gender dysphoria score—is in question. As the authors explain, the gender dysphoria scale used by the Dutch researchers was not designed to capture treatment-associated changes in gender dysphoria. The Dutch clinicians’ handling of the scale (specifically, “flipping” the scale from female to male and vice-versa in the final measurement) may have at best obscured, and at worst severely compromised the final results. In addition, there is little acknowledgement of the fact that the administration of the Dutch protocol was associated with adverse outcomes, including 1 death from complications following vaginoplasty, 3 subjects developing severe diabetes and obesity during treatment, and at least 1 subject who terminated treatment (several others dropped out of the study for unknown reasons). The only attempt to replicate the first stage of the Dutch protocol failed to show any psychological improvements, and long-term outcome data, beyond  1.5 years post-surgery have not been published.

The uncertain permanence of a transgender identity in a young person is not discussed

Few patients and parents are made aware of the central controversy in gender transition in youth—the uncertainty of the permanence or transience of a young person’s transgender identity. All 11 studies of prepubescent children presenting to gender clinics with varying degrees of gender distress found that the majority of the children naturally realigned with their natal sex sometime during puberty or before reaching mature adulthood.

The rate of desistance from a trans identity in teens whose gender dysphoria only emerged after puberty is not yet known due to the novelty of this clinical presentation, however emerging evidence suggests it is much higher than previously estimated. The increasing visibility of detransitioners underscores that regret and detransition are no longer rare occurrences. Therefore, undergoing "gender-affirmative" interventions before maturity increases the risk of permanently medicalizing a potentially transient identity.

The implications of invasive, often irreversible treatment based on very low quality evidence is not adequately or properly communicated

While clinicians recommending and delivering hormonal and surgical interventions opine that transition is the best treatment for gender dysphoric youth, their beliefs must be distinguished from evidence. Several systematic reviews have found that the entire body of evidence regarding pediatric gender transition is of very low quality. While this fact is often acknowledged, its meaning is rarely explained. The “low quality” designation means that the benefits reported in the study are highly uncertain and unlikely to be experienced by patients in the real world. This disconnect, between the study findings and the real world, occurs when the studies are small, employ weak study designs, and do not use proper analysis techniques—the problems that plague most gender medicine studies.  

In contrast, many of the risks of “gender-affirmative” interventions are far more established, such as the risks of surgery, or the risk of infertility when puberty blockers are followed by cross-sex hormones (progression to cross-sex hormones occurs in over 95% of the cases of youth treated with puberty blockers). Other risks are as yet unknown but include a growing list of problems, from adverse effects on bone health, to cardiovascular complications and cancer.

The question of suicide is inappropriately handled

The authors note that patients and families are often rushed into medical treatment with the  emotionally fraught question, “Do you want a dead son or live daughter?” This framing exaggerates risk and is irresponsible in view of the socially contagious nature of suicide. Recent research estimated the rate of suicide in trans-identifying youth at 0.03% over 10 years. While higher than average, it is comparable to the rate observed in youth with other mental health problems. Further, transition is not an appropriate response to suicidal behavior. The authors emphasize that gender-dysphoric youth who are suicidal deserve access to evidence-based suicide prevention protocols and remind readers that to date, gender transition has not been demonstrated to decrease suicide in the long-term.

Recommendations for Informed Consent

Because every situation is unique, the authors encourage clinicians to take a slow and thorough approach to the informed consent process prior to initiating gender-affirmative social, medical, and surgical interventions.  The authors recommend:

  • Consent for all stages of gender transition should be explicit, not implied. The authors make the argument that not only medical and surgical interventions, but also social transition should be approached with great care.
  • Full, unbiased disclosure of benefits, risks, and alternatives is requisite. The authors note that three central themes must be covered: (1) that the decision to initiate any phase of gender transition may predispose the child to long-term persistence of transgender identity; (2) that many of the physical changes will be irreversible; and (3) long-term studies are lacking to verify whether these interventions will cause more good than harm.
  • Decisional capacity to consent must be assessed and the family should be involved. The authors note that it is questionable whether young people, even if they are very smart and articulate, can meaningfully consent to the loss of functions they have not yet experienced or appreciated, such as the loss of sexual function or fertility. Therefore, even when youth are old enough to consent to irreversible interventions such as cross-sex hormones or surgery (which, in some jurisdictions is as young as age 15), parents should be involved. Transition puts tremendous stress on the entire family, which is often in crisis, and the entire family should consider its consequences.
  • Informed consent should be viewed as a process rather than an event. The authors observe that a rushed process does not allow for a proper discussion of the benefits, risks, and profound uncertainties associated with gender transition, especially when gender transition is undertaken before mature adulthood. They encourage clinicians to slow down and compassionately and patiently explore the pros and cons of various approaches to the amelioration of gender dysphoria, including the alternative to delay medical interventions until the patient reaches the age of maturity.

The authors suggest that following these recommendations increases the chances that patients and families can provide meaningful informed consent prior to undergoing “gender-affirmative” interventions. However, the authors also acknowledge that even when the appropriate steps are taken, clinicians may face ethical dilemmas they cannot easily resolve.

SEGM Perspective

Clinicians involved in facilitating access to "gender-affirmative" interventions for children, adolescents and young adults need to be alert to the likelihood that patients presenting to receive these interventions may not have been properly evaluated. They should also be aware that much of the current literature in gender medicine suffers from serious limitations. Individual studies making headlines are often written, curated, or funded by those with strong convictions of the benefits of early gender transition. Such studies are often quick to conclude that "gender-affirmative" interventions "work" (no matter how unsupported by their own data such claims may be), while downplaying or outright dismissing the established risks and profound uncertainties. We have discussed some of these troubling trends in on recent publication "The Signal—and the Noise—in Gender Medicine Research." 

Clinicians who work with gender-dysphoric youth need to be aware of the significant controversies that exist regarding the safety and efficacy of "gender-affirmative" interventions. They should familiarize themselves with the recent changes in leading pediatric gender clinics in the world, from SwedenFinland, France, to the most recent UK developments. These countries' decisions to reverse course and no longer recommend gender transition as the first line of treatment to most youth who desire it have been made based on recently-conducted systematic reviews of evidence. Clinicians should reflect on the fact that every independent review of evidence commissioned by national health systems found that the benefits of such interventions for youth are highly uncertain, and the risk/benefit ratio is not favorable for most youth. 

Clinicians in the position of delivering "gender-affirmative" interventions may hold a range of personal views, from strong conviction that such interventions are vital, to deep concern that the harm may outweigh the benefits. Regardless of personal views, ethical clinicians should endeavor to ensure that patients and families truly understand the full range of potential benefits, risks, and uncertainties, as well as alternatives to "gender-affirmative" interventions—including the alternative of delaying gender transition until the age of maturity, when obtaining truly informed consent is more likely.


The full text of the article is available here