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• What constitutes informed consent in the treatment of childhood gender dysphoria?: some comments on the Trans20 study
  Roberto D'Angelo, Juan C d'Abrera, George Halasz, Philip Morris, Shirley Prager and Ron Spielman
  Published on: 14 December 2019

• Published on: 14 December 2019

  What constitutes informed consent in the treatment of childhood gender dysphoria?: some comments on the Trans20 study

  • Roberto D'Angelo, Psychiatrist Institute of Contemporary Psychoanalysis, Los Angeles
  • Other Contributors:
    • Juan C d'Abrera, Consultant psychiatrist
    • George Halasz, Adjunct senior lecturer, psychiatrist
    • Philip Morris, Psychiatrist
    • Shirley Prager, Psychiatrist
    • Ron Spielman, Psychiatrist and Psychoanalyst

  We wish to express concerns about the Trans20 longitudinal cohort study of transgender and gender diverse (TGD) youth from Melbourne’s Royal Children’s Hospital Gender Service (RCHGS) presented in the BMJ (Tollit et al BMJ Open 2019:9).

  While we agree with the authors that in regard to the management of TGD youth there is ‘’urgent need for more evidence to ensure optimal medical and psychosocial interventionsi”, we have grave reservations about the ethical underpinnings and methodology of the study as described.

  The Trans20 study aims to “document the natural history of gender diversity presenting in children”. It is not clear to us how the methodological design could allow observation of the ‘natural’ history of TGD youth when it intervenes in the developmental trajectories of all 600 expected participants. Given that a vast majority of young people who commence puberty blockers proceed to cross-sex hormonesii, it may well be the case that early intervention ‘locks’ a child into a persistent gender incongruence, closing them off to future choices in identity. We already do possess good data on the ‘natural history’ of gender confusion which shows that a majority of children desist at puberty and return to a gender identity congruent with their natal sexiii. Is this fact presented to concerned families?

  The RCHGS adopts an exclusively gender-affirming model of care, offering psychosocial and biological interventions to children as young as 3. Although...

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  We wish to express concerns about the Trans20 longitudinal cohort study of transgender and gender diverse (TGD) youth from Melbourne’s Royal Children’s Hospital Gender Service (RCHGS) presented in the BMJ (Tollit et al BMJ Open 2019:9).

  While we agree with the authors that in regard to the management of TGD youth there is ‘’urgent need for more evidence to ensure optimal medical and psychosocial interventionsi”, we have grave reservations about the ethical underpinnings and methodology of the study as described.

  The Trans20 study aims to “document the natural history of gender diversity presenting in children”. It is not clear to us how the methodological design could allow observation of the ‘natural’ history of TGD youth when it intervenes in the developmental trajectories of all 600 expected participants. Given that a vast majority of young people who commence puberty blockers proceed to cross-sex hormonesii, it may well be the case that early intervention ‘locks’ a child into a persistent gender incongruence, closing them off to future choices in identity. We already do possess good data on the ‘natural history’ of gender confusion which shows that a majority of children desist at puberty and return to a gender identity congruent with their natal sexiii. Is this fact presented to concerned families?

  The RCHGS adopts an exclusively gender-affirming model of care, offering psychosocial and biological interventions to children as young as 3. Although the Trans20 subjects are administered ostensibly different types of intervention, the therapeutic pathway in that model is a uniformly stepwise progression through the social and biological stages of transition.

  The authors state that the information will be analysed under a “’clinical audit framework”. To us this study more closely resembles an ‘interventional’ clinical trial (lacking an untreated control group) rather than an observational study. We wonder if this distinction was made explicit to the participants and their families during the recruitment phase and formed part of the ‘informed consent’ process.
  Our specific ethical concerns centre on whether the ‘informed consent’ offered to parents and their children reflect the rapid advances in complexity and uncertainty that have been reported in recent studiesiv,v,vi. It would be reasonable to expect a more detailed discussion of the consent process given the controversial nature of the treatments and the vulnerability of the participants. The report noted that consent was obtained through a ‘multi-step’ procedure. What does this mean? Are parents fully informed about the biological and psychological risks associated with delaying puberty through hormone blockers? Which aspects of gender dysphoria are and are not moderated by medical intervention? Are families dispassionately appraised of the high suicide rates and psychiatric morbidity post-transition? What supports, psychiatric or otherwise, are provided to subjects who, in the course of the study a) wish to revert to their natal gender (given the ostensibly fluid nature of gender) or b) are assessed as being dysphoric for reasons other than gender incongruence?

  We welcome additional clinical and research data from the RCHGS Trans20 cohort study to clarify their ethical guidelines, including a detailed nature of the informed consent protocol so others might learn to maximize the safety/risk ratio for these vulnerable young people and their families.

  Dr Roberto D’Angelo, FRANZCP
  Dr Juan Carlos d’Abrera, FRANZCP
  Dr George Halasz, FRANZCP
  Dr Shirley Prager, FRANZCP
  Dr Philip Morris, FRANZCP
  Dr Ron Spielman, FRANZCP

  Tollit, M.A., Pace, C.C., Telfer, M., Hoq, M., Bryson, J., Fulkoski, N., Cooper, C. and Pang, K.C., 2019. What are the health outcomes of trans and gender diverse young people in Australia? Study protocol for the Trans20 longitudinal cohort study. BMJ open, 9(11).

  Steensma, T.D., Kreukels, B.P., de Vries, A.L. and Cohen-Kettenis, P.T., 2013. Gender identity development in adolescence. Hormones and behavior, 64(2), pp.288-297.

  Singh, D., 2012. A follow-up study of boys with gender identity disorder (Doctoral dissertation, University of Toronto).

  Littman, L., 2018. Rapid-onset gender dysphoria in adolescents and young adults: A study of parental reports. PloS one, 13(8), p.e0202330.
  Chew, D., Anderson, J., Williams, K., May, T. and Pang, K., 2018. Hormonal treatment in young people with gender dysphoria: a systematic review. Pediatrics, 141(4)

  Landen, M., 2019. Dramatic increase in adolescent gender dysphoria requires careful consideration. Lakartidningen, 116.

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  Conflict of Interest:
  None declared.

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