As we await detailed information about NHSE’s plans for a puberty blocker trial, there are critical questions to be answered about the ethics of blocking pubertal development as a treatment for gender distress. All of the issues we outline here must be addressed to avoid a repeat of the historic failings that led Dr Cass to conclude that these children and young people “deserve much better”.
The first question to address is what medical condition the puberty blocker trial intends to treat? What are the diagnostic criteria that will be relied on to identify patients eligible for treatment?
Given the acknowledged disconnect between a diagnosis of childhood gender dysphoria (DSM-V) or gender incongruence (ICD-11) and a trans identity in adulthood, can either of these diagnoses be relied on to justify such a consequential medical intervention?
Does the PB trial framework address concerns over the way gender non-conformity is pathologised in diagnostic frameworks through reference to regressive stereotypes (both in DSM-V and ICD-11), particularly for young children who lack the developmental maturity to truly understand what makes them a boy or girl.
Since early childhood gender non-conformity is correlated with same-sex attraction in adulthood, how will the trial safeguard children against covert parental influence rooted in homophobia or a subconscious preference for a non-homosexual outcome for their child?
Similarly, given concerns that childhood social transition may influence the trajectory of a child’s identity development, how will researchers identify cases where family environment may have cultivated the child’s belief that they do not ‘belong’ in their sex category.
If additional criteria are applied to gatekeep participation in the puberty blocker trial (e.g. age of onset of gender distress) how will clinicians verify that patients (or parents) are not ‘gaming’ the eligibility system by adapting their claims to fit the criteria?
What information will be provided to young patients and their parents regarding physical/cognitive consequences to ensure transparency over potential risks & attested benefits, especially where these are unknown/uncertain?
Given high rates of progression (95%+) to cross-sex hormones following puberty blockade, with corresponding likelihood of impaired sexual function & loss of fertility, how is informed consent obtained for a child with no concept of what this means for their future self?
Since the high progression rate to cross sex hormones raises the prospect that puberty blockers themselves “may change the trajectory of psychosexual and gender identity development” (The Cass Review) how does the trial framework address and justify this risk in pursuit of research data?
Have trials for other paediatric medical interventions with analogous diagnostic uncertainty and significant long-term consequences been approved? This is key to reassuring the public that the PB trial is not being given special treatment for ideological/political reasons.
To ensure public confidence, will there be transparent selection criteria for membership of the research ethics committee (REC) tasked with approving the PB trial? What steps have been taken to ensure that (as per the Health Research Authority) “Members of a REC do not represent any interest group”?
Will the minutes of any ethics committee meetings be published to ensure the decision-making process regarding the puberty blocker trial is transparent and comprehensive?
What steps have been taken to avoid a repetition of the historic irregularities in oversight and reporting (including by the HRA and NHSE) that afflicted the GIDS Early Intervention Study?
Since the previous HRA-approved puberty blocker trial found “no statistically significant changes reported in gender dysphoria or mental health outcome measures” (Cass) what grounds are there to believe that this trial will find something different and thus warrants the known risks?
How will the trial avoid the fate of simply adding to what Dr Cass described as the “remarkably weak evidence” in this area? Approval for such an experimental intervention must not be given unless evidence of a sufficient quality is guaranteed.
To answer the previous question, it is necessary to know the precise criteria that will be used to track treatment outcomes (and thus evaluate success or failure), the time period under review, and the likely numbers of children involved (to avoid an underpowered study).
Since patients who embark on the puberty blocker trial (and their parents) will be inclined to believe the treatment is beneficial (or even essential), how will the trial guard against placebo effect?
Of all these issues, perhaps most pivotal is the child’s capacity to consent. Given the likelihood of proceeding to cross-sex hormones and thus impaired sexual function and fertility, puberty blockers cannot be viewed in isolation. This alone poses an unenviable question for the ethics committee.
Deb Cohen outlines some more of the unanswered ethical questions about the proposed NHS puberty blocker trial in her article for BBC In Depth.
Footnote: we have used the term “puberty blocker trial” in this post as in Cass Recommendation 6. Until details about the precise nature of the research protocol are available, this vocabulary choice itself belies an unanswered question.