Informed Consent or Scare Tactics? A Response to Levine et al.’s “Reconsidering Informed Consent for Trans-Identified Children, Adolescents, and Young Adults”

https://doi.org/10.1080/0092623X.2022.2080780

Excerpt (full article below)

Informed consent parody

As a psychiatrist in private practice, I engage in providing informed consent about medications and psychotherapy with patients all the time. The goal is to use the informed consent process to educate patients about the risks and benefits of accepting a suggested treatment as well as the risks and benefits of not accepting treatment. However, Levine et al.’s caricature of the informed consent process brought to mind the following imaginary scenario between a middle-aged woman and her primary care physician:

Patient: Doctor, I am calling you because I have a headache that won’t go away.

Physician: Did you try taking some aspirin?

Patient: As you know, Doctor, I’ve never taken any medications and don’t like the idea of doing so. Does aspirin have any side effects?

Physician: Yes. Aspirin can cause nausea, vomiting, stomach pain, heartburn, hives, rash, swelling of the eyes, face, lips, tongue or throat. It can cause wheezing or difficulty breathing, hoarseness, fast heartbeat, loss of hearing, ringing in the ears, bloody vomit, or bright red blood in the stools.¹⁰

Patient: That’s horrible. Isn’t there anything else I can take, Doctor?

Physician: Yes, there’s also acetaminophen, which is the generic form of Tylenol. That might relieve your headache.

Patient: What kind of side effects does Tylenol have?

Physician: Tylenol can cause red, peeling or blistering skin; rash, hives, itching; swelling of the face, throat, tongue, lips, eyes, hands, feet, ankles, or lower leg. It can cause hoarseness, difficulty breathing or swallowing.¹¹

Patient: But Doctor, that also sounds terrible. What do you think I should do?

Physician: Oh, that’s not for me to say. According to Levine et al.’s model of “informed consent,” I only have to warn you about the worst case scenarios and risks of treatment. I don’t have to offer my opinions or recommendations about the best course of action for you, my individual patient. Further, following this model of informed consent, perhaps the best thing I can suggest is to just live with your headache and talk about it for some unspecified period of time with a mental health professional. In that way, you don’t have to accept the risk of taking any medications at all.

This physician does not assist his patient, as one routinely does, on deciding what might be the best course of action to take after outlining the risks and benefits of accepting treatment versus the risks and benefits of not getting the treatment. Instead, in the guise of providing “informed consent,” inadvertently or otherwise, this physician, by emphasizing the most serious side effects, frightens the patient from accepting any treatment at all. Levine et al., however, go even a step further and argue that there are no proven benefits to gender affirming treatment at all.

Unfortunately, Levine et al.’s distortion of a more commonplace approach to informed consent is not altogether unsurprising. There is a precedent for distortions of the traditional informed consent concept on the gender-affirming side of clinical debates surrounding provision of transition services for gender dysphoric individuals. As mentioned above, while once an evaluation by mental health professionals was seen as a requirement for access to hormones and surgery, the WPATH SOC (2011) guidelines eschew such “gatekeeping”:

Criteria for Hormone Therapy: Initiation of hormone therapy may be undertaken after a psychosocial assessment has been conducted and informed consent has been obtained by a qualified health professional, as outlined in section VII of the SOC. A referral is required from the mental health professional who performed the assessment, unless the assessment was done by a hormone provider who is also qualified in this area (p. 34).

In other words, and as is frequently the practice in many “gender affirming” settings today, patients are assumed in this version of “informed consent” to be eligible almost immediately for hormone treatment because they provide a history that might be consistent with a GD/GI diagnosis—that is if any DSM or ICD diagnosing is being done at all. In fact, the prescriber (endocrinologist, general practitioner, nurse practitioners, physician’s assistant) does not have to do any kind of psychiatric assessment. This approach has greatly advanced the rights of adult transgender people to obtain needed care without the stigma and obstacle of a mental health evaluation. However, in my opinion, the application of this approach to minors under the age of eighteen may be one of the factors that may have triggered an unintended backlash in an increasing number of bills in US state legislatures not only condemning the practice, but also making it a crime to provide such treatment.¹²

The society for evidence-based gender medicine

Levine et al. declare under “Funding,” that their paper “was supported by the Society for Evidence-based Gender Medicine” [SEGM] and that one of the authors, E. Abbruzzese,¹³ lists their affiliation as the SEGM.¹⁴ Never having heard of SEGM and curious about who they are, I looked them up online (https://segm.org/). There they declare themselves to be an organization whose “aim is to promote safe, compassionate, ethical and evidence-informed healthcare for children, adolescents, and young adults with gender dysphoria [GD].” That sounds like my kind of organization as I entirely concur with the need for such care for people diagnosed with GD/GI.

However, while their “donate” button was immediately accessible, I could not find any recommendations on the SEGM website that explained how people with GD/GI might get the kind of quality, evidence-based care for which they are advocating; or exactly what kind of treatment the SEGM would recommend for them. The website, however, is replete with warnings about the harms of gender affirmation—by which the group seems to refer to any kind of endocrinological or surgical intervention—while entirely lacking in alternative recommendations.

In a further search of the internet, I learned that in 2021, the American Academy of Pediatrics (AAP) first accepted and then rejected the group’s application to have an exhibit booth at their annual meeting. This occurrence was reported on Medscape (Nainggolan, 2021). It was also reported in an opinion piece in The Wall Street Journal with the provocative headline, “A Pediatric Association Stifles Debate on Gender Dysphoria” (Shreir, 2021).¹⁵ That opinion piece echoes many of the talking points made in the Levine et al. paper.

However, using the social conservative editorial page of The Wall Street Journal to address a clinical issue brought to mind the late psychiatrist Charles Socarides, who co-founded a now-defunct organization called the National Association for Research and Therapy of Homosexuality. NARTH operated from 1992-2014 and its professional practitioners were advocates of so-called conversion therapy or sexual orientation change efforts (SOCE) for homosexuality.¹⁶ I have outlined previously some of NARTH’s origins and history (Drescher, 1998) as well as its political role as self-appointed “experts” in the anti-gay culture wars in the United States and abroad (Drescher, 2009). Similar to SEGM’s opposition to gender-affirming policies of mainstream professional groups like the AAP, Socarides and other NARTH members challenged the gay-affirming positions of the mainstream American Psychiatric Association with an editorial in The Wall Street Journal defending sexual orientation conversion efforts (Socarides et al., 1997). Socarides also provided legal testimony in legal cases opposing gay and lesbian civil rights, such as Romer v. Evans in Colorado (Socarides, 1993).

NARTH deliberately took upon itself the role of providing “scientific experts” who would testify in courtrooms and legislatures against gay rights. Is SEGM following a parallel path regarding transgender rights? Perhaps. As noted above, one of the “Clinical and Academic Advisors” listed on their website¹⁷ is Marcus Evans (2021) who has also raised concerns about gender affirmation and who, in his Declaration of Interest states he “provided witness statements for a UK judicial review [of a case against the Tavistock Clinic] examining whether minors are able to provide informed consent for gender-affirming treatments” (p. 289). In addition, a search of the internet found Levine et al., 2022 expert witness testimony in the case of B.P.J. v. West Virginia Board of Education¹⁸ where he makes similar points to Levine et al., 2022 apparently in support of a WV law banning transgender girls from playing on girls’ sports teams.

Here, as in the case of NARTH, a small group of outliers from the mainstream of clinicians who treat children (and perhaps even adults) with GD/GI present themselves as “truth-speaking” experts who will provide parents, caretakers, journalists, educators, legislators and courts with “facts” being ignored, elided over or perhaps even covered up by the mainstream. Again, while I have no reason to doubt the beneficent, authentic wishes of these professionals to protect children from the gender affirmative treatments they oppose, any more than I had reason in the past to doubt the good intentions of conversion therapists who believed that being gay was a tragic and unacceptable way to live one’s life (Nicolosi, 1991), I do question the way they choose to go about expressing their concerns.

Concluding remarks

At the risk of repeating myself, I wish to conclude by restating my final remarks in my recent response to Evans (2021):

Evan writes: “Whatever decisions are made regarding medical treatment, a thorough psychotherapeutic and psychiatric assessment is essential to enable us to help these vulnerable young people, their families and their clinical teams make informed decisions.” I completely agree with this statement. However, what he does not specify is how long such an evaluation should last. A month? Three months? A year? Longer? A longer approach may benefit children who might not grow up to be transgender. However, delaying treatment for all children inevitably comes at the expense of those who will remain gender dysphoric. In my opinion, clinicians delaying treatment to GD/GI adolescents who need it and may benefit from it in order to “protect” those children who “aren’t really” transgender is an ethically troubling issue. In other words, “first, do no harm” is a sword that cuts two ways (Drescher, 2022, pp. 2-3).

---

What Are We Doing to These Children? Response to Drescher, Clayton, and Balon Commentaries on Levine et al., 2022

Stephen B. Levine, E. Abbruzzese & Julia W. Mason

https://doi.org/10.1080/0092623X.2022.2136117

Response to Drescher

Drescher’s commentary (Drescher, 2022Drescher, J. (2022). Informed consent or scare tactics? A response to Levine et al.’s “Reconsidering informed consent for trans-identified children, adolescents, and young adults.” Journal of Sex & Marital Therapy. Advance online publication. doi:10.1080/0092623X.2022.2080780 [Taylor & Francis Online], [Web of Science ®], [Google Scholar]) illuminated the mindset of clinicians who are aware of the limitations of the evidence base of youth gender transition, yet actively promote medicalization while eschewing any noninvasive treatment alternatives. Drescher ridiculed the title of our publication (Levine et al., 2022) by naming his own commentary “Informed Consent or Scare Tactics?” Having carefully examined his objections to our paper, we, in turn, suggest that Drescher’s commentary would have been better titled “Risks, Schmisks”— as it succinctly summarizes his counterarguments.

Drescher mocked our suggestion for a slow and deliberate informed consent process for youth embarking on a medicalized lifetime with a skit in which a patient receives extensive disclosures of the risks of taking aspirin for a headache. While Drescher referred to his writing exercise as a “parody,” it is a generous description, and not just because some might find it lacking in humor; the situations he compares are not even remotely equivalent. Even prolonged aspirin use increases the absolute risk of severe bleeding by just 0.47% (Zheng & Roddick, 2019). In contrast, 100% of children will be rendered sterile if puberty is blocked at Tanner Stage 2 and followed with cross-sex hormones, as currently suggested by the Endocrine Society (Hembree et al., 2017). While the risks of exogenous sex hormones have been well-documented and led to a black box warning from the FDA (Jeffrey, 2003; Togun, Sankar, & Karaca-Mandic, 2022), there is now mounting evidence of the detrimental effects of puberty blockers on a range of physiological parameters (Nokoff et al., 2021) including bone density (Biggs, 2021; Klink, Caris, Heijboer, van Trotsenburg, & Rotteveel, 2015; Nokoff, Ma, Moreau, & Rothman, 2022). We think a better example of using comedy to make a point is a skit by comedian Bill Maher, who recently noted that bone density is “kind of important if you like having a skeleton” (Maher, 2022).

The exuberant irreverence of Drescher’s commentary extended to his discussion of the evidence base for youth gender reassignment, with the suggestion that the GRADE designation of low-quality evidence is merely a “a scary buzzword” (Drescher, 2022, p. 3). To clarify, the Grading of Recommendations Assessment, Development and Evaluation (GRADE) is an international best practice in evidence evaluation, which provides a structured way to assess key factors that increase or decrease confidence of findings in a body of evidence (GRADE Working Group, 2013). The GRADE ratings of “very low” and “low” quality—the only two ratings that the body of evidence for youth gender reassignment has ever received—indicate that the true effect of hormones and surgeries is likely markedly different from the results reported by the studies (Balshem et al., 2011; Reed & Guyatt, n.d.). The problem is not that the field of youth gender reassignment has not yet produced “enough” studies, as Drescher’s own phrasing of “low levels of evidence” suggests; the actual problem is that none of the numerous studies produced to date, individually or collectively as a body of evidence, are reliable or trustworthy. This is because all the available studies are uncontrolled observational studies subject to bias, confounding, or chance (National Institute for Health and Care Excellence [NICE] 2020a, 2020b).

Drescher also incorrectly asserted that the reason the evidence base for gender transition has been graded as very low/low quality is due to the “absence of randomized clinical trials (RCTs)” (Drescher, 2022 p. 3). While it is true that data from a body of randomized controlled trials (whether the comparator is placebo or another active intervention) starts with the presumption of high quality, it can be downgraded to low quality if there are serious concerns arising from risk of bias, imprecision, inconsistency, indirectness, and publication bias. Conversely, non-randomized study of an intervention (e.g., an observational study) can be upgraded to moderate or high quality when there is a large magnitude of effect; a demonstrated dose-response relationship; and when the potential confounders are not expected to inflate the outcomes in a positive direction—in other words, when the research signals plausible, sizeable benefits (Reed & Guyatt, n.d.). The problem is not that quality research in the space of gender medicine is not feasible; it is that increasingly, gender clinicians who lead the studies view the matter as settled science, and as a result do not bother to design research capable of producing high or even moderate quality evidence. Even more troubling, when called out, such clinicians insist that using rigorous study designs in pediatric gender medicine is unethical (Turban, Almazan, Reisner, & Keuroghlian, 2022).

Nor is it correct to assume that randomization is unethical. According to the principle of research equipoise, “when there is uncertainty or conflicting expert opinion about the relative merits of diagnostic, prevention, or treatment options, allocating interventions to individuals in a manner that allows the generation of new knowledge (randomization)” is ethically permissible (London, 2017, p. 525). That “gender-affirming” interventions are administered to youth “based on very limited data” and that long-term outcomes are unknown has been acknowledged by even the most ardent proponents of pediatric gender transition (Olson-Kennedy et al., 2019, p. 2). Rigorous research has been conducted in other “high stakes” areas of medicine and has led to the development of highly effective treatments, as evidenced by the advances in pediatric oncology (Berg, 2007). Pediatric gender medicine cannot claim an exceptional status when it comes to the quality of research it must undertake.

Drescher is also incorrect in stating that “none of the surgical procedures … are performed on children with GD/GI [gender dysphoria/gender incongruence]” (Drescher, 2022, p. 4). We have seen the claim that “gender-affirming surgery is not performed on children” repeated with increasing frequency. We are not sure whether this assertion hinges on the definition of a “child” as someone who has not yet had their 13^th birthday; or if it is a case of blissful ignorance by those inexperienced with this patient population. Patients as young as 12-13 have been obtaining “gender-affirming” mastectomies in the United States for several years, as evidenced by the data from the National Institutes of Health (NIH)-funded research (Olson-Kennedy, Warus, Okonta, Belzer, & Clark, 2018, Figure); research from a large U.S. healthcare system (Tang et al., 2022, Figure 2); and a recent publication in JAMA Pediatrics (Ascha et al., 2022). The latter asserted strong benefits of mastectomies for youth based on the finding that the young people were no longer “dysphoric” about their chest appearance a mere 3 months post-surgery. Version 8 of the WPATH “Standards of Care,” published in September 2022, ratified the notion that surgeries should be available to youth when it removed previously stated minimum age limits for “gender-affirming” surgical procedures (Block, 2022; Coleman et al., 2022).

Setting Drescher’s misunderstanding of the evidence aside, his fundamental problem with our paper appears to be that we did not outline treatment alternatives to “gender affirmation” for youth gender dysphoria—beyond psychotherapy. Yet, psychotherapy is exactly what Sweden—the first country in the world to legally recognize transgender people—and Finland recommend as the first (and typically only) line of treatment for gender dysphoric youth (COHERE, 2020; Socialstyrelsen, 2022a, 2022b). The UK is now moving in a similar direction, calling on clinicians to lean on their existing skills in mental health support of gender dysphoric youth, and to not “exceptionalise gender identity issues” (Cass, 2022). With these recent changes, Europe is returning to the proven axiom taught to medical students early in their training: “when you hear hoofbeats, think of horses not zebras.” In this context, the profound gender-related distress that has engulfed Western youth in recent years is much more likely to be a novel manifestation of the identity formation struggles of youth, rather than a rare intractable “mismatch” between the body and the brain that must be medically and surgically corrected.

We are puzzled about why Drescher, a psychoanalyst himself, dismissed the contribution of his own field to the management of gender dysphoria in youth by describing it as “just talk” (Drescher, 2022, p. 4). More disheartening, however, is that he chose to conflate psychotherapy for gender dysphoria with “conversion therapy.” The notion that psychotherapy was a missing element in their care was endorsed by detransitioners, who say that a better understanding of the nature of their gender distress would have helped them avoid irreversible and deeply regrettable medical interventions (Littman, 2021; Vandenbussche, 2022).

While Drescher appeared comfortable with recommendations to change anatomy, physiology, and create the need for lifelong “gender-affirming” interventions based on low quality evidence, he was quick to disdain the alternative of psychotherapy because it “lack[s]… empirical evidence” (Drescher, 2022, p. 4). It is, of course, untrue that psychotherapy for gender dysphoria in youth lacks “empirical evidence”; what it lacks is high quality evidence. Rigorous comparative trials of psychotherapeutic approaches to gender dysphoria in youth are urgently needed. However, if Drescher undertakes a literature search, he will discover that beyond the article by Schwartz (2021), to which he dedicated a significant part of his response, there is a growing body of (low quality) evidence that psychotherapy can ameliorate gender distress in youth and can reduce or eliminate the need for invasive medical interventions (Bonfatto & Crasnow, 2018; Churcher Clarke & Spiliadis, 2019; Evans, 2022; Hakeem, 2012; Lemma, 2018; Spiliadis, 2019). Psychotherapy to “resolv[e] confusion [about gender feelings] and com[e] to self-acceptance” was also a key part of the Dutch protocol (de Vries et al., 2006, p. 87).

The concern that vulnerable adolescents and young adults do not get appropriate mental health evaluation and treatment and are effectively rushed into transition, has been voiced not only by the “critics,” as Drescher asserts, but also by the supporters of “gender-affirmative” interventions such as Dr. Erika Anderson—a psychotherapist, transgender woman, and recent President of the US branch of WPATH, USPATH (Anderson, 2022). There is a convincing body of evidence that gender dysphoria frequently occurs in lesbian and gay youth (Bryant, 2006; Cantor, 2020, Appendix 1; Korte et al., 2008). It also disproportionately affects autistic youth (Bradley, 2022; Hisle-Gorman et al., 2019; Thrower et al., 2020), as well as vulnerable individuals who have experienced various forms of trauma (D’Angelo et al., 2021; Kozlowska et al., 2021). We would have expected Drescher to support the notion that young gay and autistic people suffering from gender dysphoria deserve access to noninvasive treatment alternatives that avoid life-long health risks and do not render them sterile.

A second reason for Drescher’s objection to our publication is that he viewed our recommendation for delay in irreversible medical interventions as putting the interests of “cisgender” gender dysphoric youth above the interests of “transgender” youth. We remind Drescher that the predictive validity of the youth gender dysphoria (or gender incongruence) diagnoses is unknown (Davy & Toze, 2018; Paris, 2015; Zucker, 2010), and that no criteria exist for how to reliably differentiate youth who will desist from a transgender identity as adults, from those for whom this identity will be life-long. That the majority of trans-identified children will not be trans-identified adults is well established (Hembree et al., 2017; Ristori & Steensma, 2016; Singh et al., 2021). The notion that trans-identified teens or young people do not desist, which seems to have been uncritically adopted by gender clinicians, is patently untrue, as demonstrated by a growing number of studies of detransitioners, the majority of whom do not identify as transgender after they medically detransition (Littman, 2021; Vandenbussche, 2022). Recent data from gender clinics show that the rate of medical detransition is now reaching 10-30% within just a few years after the initiation of transition (Boyd et al., 2021; Hall et al., 2021; Roberts et al., 2022); this percentage will likely grow as the patients reach the 10 + year mark when regret has been noted to typically emerge (Dhejne, Öberg, Arver, & Landén, 2014; Wiepjes et al., 2018).

Drescher chose to engage in ad hominem attacks on those involved in the publication of our paper. He referenced an anonymous libelous blog in his attempt to discredit the US registered nonprofit organization, the Society for Evidence-Based Gender Medicine (SEGM) and fanned the flames of baseless insinuations by inventing a non-existent association between SEGM and anti-homosexual groups. In questioning SEGM’s goals, Drescher changed SEGM’s name, substituting “evidence-based” with “empirical-based,” and inadvertently revealed a lack of understanding of the difference between these two concepts. “Empirical-based” medicine relies on expert opinion backed by only minimal research. It is also known as “eminence-based.” In contrast, the cornerstone of “evidence-based medicine” is a rigorous, impartial evaluation of the evidence to assess its certainty, which allows for truly informed decision-making (Drisko & Friedman, 2019). SEGM’s stated goal is to help gender medicine move past its current “empirical-based” status and toward the rigorous principles of evidence-based medicine. While Drescher failed to identify any inaccuracies in the information disseminated by SEGM, he did find fault with the authors’ disclosure of an association with SEGM. We remind him and other researchers that such disclosures are an ethical requirement for publications and are not optional. Unfortunately, disclosures of interest, including conflicts of interest, such as when pharmaceutical companies pay authors promoting the benefits of “gender-affirmative hormones,” are often omitted, and only come to light months after the research conclusions have been widely publicized (Erratum for TURBAN 2019-1725., 2021). Another rarely disclosed conflict of interest in pediatric gender medicine is the fact that the investigators of the studies are commonly the same clinicians who are prescribing or administering “gender-affirming” interventions. This is perhaps the single most problematic source of bias in current research, since the investigators have a significant intellectual (and sometimes financial) stake in “demonstrating” that their work produced positive results (Boutron et al., 2022).

We invite Drescher to examine his own potential conflicts of interest and intellectual biases, including the possibility that his decade-long advocacy to de-pathologize gender dysphoria in the diagnostic categories of DSM and ICD (Drescher, Cohen-Kettenis, & Winter, 2012) may have created a confirmation bias. Had Drescher critically engaged with the fact that over 70% of gender dysphoric youth presenting for care had been diagnosed with a mental illness or neurocognitive disorder prior to the onset of gender dysphoria (Becerra-Culqui et al., 2018), perhaps he would see the reason behind the recommendation for psychotherapy as the first and even only line of treatment, pending reaching maturity.

We agree with Drescher’s concerns about the politicization of transgender health care, as some states move to issue harsh penalties for those who provide gender transition services to minors. We agree that regulating treatments for gender dysphoria is best handled by the medical establishment self-correcting, rather than allowing politicians to make medical decisions. Drescher does not seem to realize, however, the extent to which his own attitude, shared by many gender clinicians, that youth gender transitions must continue without restraint before any reliable data are available, has contributed to this polarization. Drescher’s concern for the wellbeing of gender dysphoric youth is palpable, and we share it, even if he finds that hard to believe. What the field needs now is more reliable outcome data, not more passion and political rhetoric.

---

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

The recommendations for informed consent process for children, adolescents, and young adults

Noninvasive medical care or care that carries little risk of harm does not require a signed informed consent document; rather, consent is implied through the act of a patient presenting for care. For example, when a parent brings in a child for a skin laceration or abscess, consent for sutures or simple incision and drainage is implied. Similarly, when a child presents with pneumonia and is hospitalized, consent for chest x-ray, IV fluids, and antibiotics is also implied. It is assumed that patients or their guardians agree to the interventions and understand the benefits and risks. When risks are greater, such as prior to surgery, chemotherapy, or another invasive procedure, an informed consent document is signed. Such situations require an explicit, or express informed consent.

In the context of interventions for gender dysphoria or gender incongruence, the uncertainties associated with puberty blocking, cross-sex hormones, and gender-affirmative surgeries are well-recognized (Manrique et al., 2018; National Institute for Health & Care Excellence, 2020a; 2020b; Wilson et al., 2018). In these cases, consent should be explicit rather than implied because of the complexity, uncertainty, and risks involved.

Informed consent for social transition represents a gray area. Evidence suggests that social transition is associated with the persistence of gender dysphoria (Hembree et al., 2017; Steensma, McGuire, Kreukels, Beekman, & Cohen-Kettenis, 2013). This suggests that social gender transition is a form of a psychological intervention with potential lasting effects (Zucker, 2020). While the causality has not been proven, the possibility of iatrogenesis and the resulting exposure to the risks of future medical and surgical gender dysphoria treatments, qualifies social gender transition for explicit, rather than implied, consent.

Full unbiased disclosure of benefits, risks and alternatives is requisite

When mental health professionals are involved in evaluations and recommendations, the informed consent process begins either as part of an extended evaluation or is integrated in a psychotherapeutic process, separately or together, with the parents and patient. When pediatricians, nurse practitioners, or primary care physicians perform the initial evaluation, the informed consent process is more likely to be labeled as such in a briefer series of meetings.

In all settings, the informed consent discussions for gender-affirmative care should include three central ideas:

1. The decision to initiate gender transition may predispose the child to persist in their transgender identity long-term.
2. Many of the physical changes contemplated and undertaken are irreversible.
3. Careful long-term studies have not been done to verify that these interventions enable better physical and mental health or improved social functioning, or that they do not cause harm.

The informed consent process, culminating with a signed document, signifies that parents and patient have been educated about the short- and long-term risks, benefits and uncertainties associated with all relevant stages of the gender-affirmative interventions. The process must also inform the patients and families about the full range of alternative treatments, including the choice of not socially or medically treating the child’s or adolescent’s current state of gender/body incongruence.

Decisional capacity to consent needs to be assessed and family should be involved

Trans-identified youth typically present themselves as strongly desiring hormones and ultimately, surgery. It should not be assumed that their eagerness is matched with the capacity to carefully consider the consequences of their realized desires. Trans-identified youth younger than the age of consent should be part of the informed consent process, but they may not be mature enough to recognize or admit their concerns about the proposed intervention. For this reason, it is the parents who, after careful consideration, are responsible for signing an informed consent document.

The issue of the exact age at which adolescents are mature enough to consent to gender transition has proven contentious: courts have been asked to decide about competence to consent to gender-affirmative hormones for youth in the United Kingdom and Australia (Ouliaris, 2021). In the United States, the legal age for medical consent for gender-affirmative interventions varies by state.

When patients are age 18 and older, and in some jurisdictions as young as age 15 (Right to medical or dental treatment without parental consent, 2010), they do not legally require parental approval for medical procedures. But because an individual’s change of gender has profound implications for parents, siblings, and other family members, it is usually prudent for clinicians to seek their input directly or indirectly during the informed consent process. This is done by requesting a meeting with the parents.

A recent study by a Dutch research team attempted to evaluate the decisional capacity of adolescents embarking on gender transition (Vrouenraets, de Vries, de Vries, van der Miesen, & Hein, 2021). The researchers administered the MacCAT-T tool, comprised of the understanding, appreciating, reasoning, and expressing a choice domains, to 74 adolescents who were 14.7 years old on average (with the minimum age of 10). They concluded that the adolescents were competent to consent to starting pubertal suppression, calling for similar research for the <12 group, particularly because “birth-assigned girls … may benefit from puberty suppression as early as 9 years of age” (Vrouenraets et al., 2021 p.7).

This study suffers from two significant limitations involving the MacCAT-T tool. It was never designed for children. Rather, it was designed to assess medical consent capacities of adults suffering from conditions such as dementia, schizophrenia, and other psychiatric disorders. There is a fundamental lack of equivalency between consenting to treatment by adults with cognitive impairments and obtaining consent from healthy children whose age-appropriate cognitive capacities are intact, but who lack the requisite life experiences to consent to profound life-changing medical interventions. We doubt, for example, whether even highly intelligent children who have not had sexual experiences can meaningfully comprehend the loss of future sexual function and reproductive abilities.

In addition, even for adults, the MacCAT-T tool has been criticized for its exclusive focus on cognitive aspects of capacity, failing to account for the non-cognitive aspects such as values, emotions and other biographic and context specific aspects inherent in the complexity of the decision process in real life (Breden & Vollmann, 2004). Children’s values and emotions undergo tremendous change during the process of maturation.

The authors’ conclusion about their young patients’ competence to consent should be compared with what a panel of judges wrote in the challenge to the Tavistock treatment protocol (Bell v Tavistock, 2020):

…the clinical intervention we are concerned with here is different in kind to other treatments or clinical interventions. In other cases, medical treatment is used to remedy, or alleviate the symptoms of, a diagnosed physical or mental condition, and the effects of that treatment are direct and usually apparent. The position in relation to puberty blockers would not seem to reflect that description. [para 135]

…we consider the treatment in this case to be in entirely different territory from the type of medical treatment which is normally being considered. [para 140]

… the combination here of lifelong and life changing treatment being given to children, with very limited knowledge of the degree to which it will or will not benefit them, is one that gives significant grounds for concern. [para 143]

It seems clear that perceptions of children as young as 10 years of age as medically competent vary by country, state, and the institution where the doctor works, and, by clinicians’ beliefs about the long-term benefits of these interventions. We maintain that the claim that children can consent to extremely life-altering intervention is fundamentally a philosophical claim (Clark & Virani, 2021). Our view in this matter is that consent is primarily a parental function.

Informed consent should be viewed as a process rather than an event

Most institutions that care for transgender-identified individuals have devised obligatory consent forms that outline the risks and uncertainties of hormonal and surgical gender-affirmative interventions. However, the requisite signatures are frequently collected in a perfunctory manner (Schulz, 2018), akin to signatures collected ahead of a common surgical procedure. The purpose of such informed consent documents appears to be to protect practitioners from lawsuits, rather than attend to the primary ethical foundation of the process.

Although obtaining the signatures is important, the signed document should signify that the process of informed consent has been undertaken over an extended time period and is not simply quickly completed (Vrouenraets et al., 2021). We believe the latter approach poses an ethical concern (Levine, 2019).

The internal dynamics of the trans-identified young person and their families vary considerably. Parental capacities, their private marital and intrafamilial relationships, their cultural awareness, religious and political sensibilities all influence the amount of time necessary to undertake a thorough informed consent process. It is not prudent to suggest a specific duration for the process of informed consent, other than to emphasize that it requires a slow, patient, thoughtful question and answer period as the parents and patient contemplate the meaning of what is known and unknown and whether to embark on alternative approaches to the management of gender dysphoria before the age of full neurological maturity has been reached, mental health comorbidities have been addressed, and a true informed consent by the patient is more likely.

Final thoughts

Sixty years of experience providing medical and surgical assistance to transgender-identified persons have seen many changes in who is treated, when they are treated, and how they are treated. Today, the emphasis has shifted to the treatment of the unprecedented numbers of youth declaring a trans identity. As adolescents pursue social, medical, and surgical interventions, health care providers may experience unease about patients’ cognitive and emotional capacities to make decisions with life-changing and enduring consequences. An unrushed informed consent process helps the provider, the parents, and the patient.

Three issues tend to obscure the salience of informed consent: conspicuous mental health problems, uncertainty about the minor’s personal capacity to understand the irreversible nature of the interventions, and parental disagreement. Physical and psychiatric comorbidities can contribute to the formation of a new identity, develop as its consequence, or bear no connection to it. Assessing mental health and the minor’s functionality is one of the reasons why rapid affirmative care may be dangerous for patients and their families. For example, when situations involve autism, learning disorders, sexual abuse, attachment problems, trauma, separation anxiety, previous depressed or anxious states, neglect, low IQ, past psychotic illness, eating disorders or parental mental illness, clinicians must choose between ignoring these potentially causative conditions and comorbidities and providing appropriate treatment before affirmative care (D’Angelo et al., 2020).

For youth less than the age of majority, informed consent via parents provides a legal route for treatment but it does not make the decision to socially transition, provide hormones, or surgically remove breasts or testes less fraught with uncertainty. The best that health professionals can do is to ensure that the consent process informs the patient and parents of the current state of science, which is sorely lacking in quality research. It is the professionals’ responsibility to ensure that the benefits patients and parents seek, and the risks they are assuming, are clearly appreciated as they prepare to make this often-excruciating decision.

Young people who have reached the age of majority, but who have not reached full maturation of the brain represent a unique challenge. It is well-recognized that brain remodeling proceeds through the third decade of life, with the prefrontal cortex responsible for executive function and impulse control the last to mature (Katz et al., 2016). The growing number of detransitioners who had been old enough to legally consent to transition, but who no longer felt they were transgender upon reaching their mid-20’s, raises additional concerns about this vulnerable age group (Littman, 2021; Vandenbussche, 2021).

When the clinician is uncertain whether a young person is competent to comprehend the implications of the desired treatment—that is, when informed consent cannot inform the patient—the clinician may need more time with the patient. When parents or guardians do not agree about whether to use puberty blockers or cross-sex hormones, clinicians are in an uneasy spot (Levine, 2021). This occurs in both intact and divorced families. Australia has given legal instructions to clinicians facing these uncertainties: the court is to be asked to decide (Ouliaris, 2021). The court system in the UK has been grappling with similar issues in recent years. While it is a rare case that ends up in a courtroom, clinicians devoted to a deliberate informed consent process are still likely to encounter ethical dilemmas that they cannot resolve.

---