A report by the ADI-SOGIESC, a committee of experts on Sexual Orientation, Gender Identity, Expression and Sex Characteristics convened by the Council of Europe (of which the United Kingdom is still a member) has published a thematic review on the subject: “Right to the highest attainable standard of health and access to healthcare for LGBTI people in Europe”.
In this report the ADI-SOGIESC note that gender affirming hormone therapy for trans minors in the UK has become almost impossible to access, with puberty blockers being restricted to availability through a proposed trial. The CoE report says that the the total withdrawal of access to healthcare outside of this research trial may breach “the fundamental ethical principles governing research”:
e.g. Council of Europe Additional Protocol to the Oviedo Convention on Human Rights and Biomedicine, concerning Biomedical Research (2005) Article 13 e: “the persons being asked to participate in a research project shall be informed [...] of their right to refuse consent or to withdraw consent at any time without being subject to any form of discrimination, in particular regarding the right to medical care”, 114 and Regulation (EU) No 536/2014 of the European Parliament and of the Council Chapter v: “no undue influence…is exerted on subjects to participate in the clinical trial”,115) as for many young people the only way to receive treatment is to participate in the trial, therefore calling into question whether consent can be constituted as free and informed in these situations.
According to the CoE report, the Oviedo Convention is “the only international legally binding instrument on the protection of human rights in the biomedical field”.
This echoes a statement made by the British Medical Association in December 2022, which raised concerns that proposed trials as the NHS had indicated at the time, without access to healthcare via other routes, could be in violation of the Helsinki Declaration set out by the World Medical Association, as well as paragraph 17 of the General Medical Council’s Good Practice In Research, both of which require full informed consent for research participants.
Trans Safety Network have received suggestions from some healthcare insiders that this proposed trial may start in April 2025, with a plan to randomise treatment on a 50/50 basis between a cohort on puberty blocker medications (which were part of a standard range of treatments for young people who had been positively diagnosed with gender dysphoria up until 2020 when they were stopped in response to the Bell v Tavistock case), and a cohort receiving no medical treatment at all, with both groups likely to be accessing psychotherapeutic support of some kind.
It is not currently clear whether trial researchers intend to subject trans children to unnecessary placebo injections for the sake of “blinding” these research results. Puberty blockers are generally administered via intramuscular injection. Bioethicists have previously raised concerns that any attempt at randomised testing of puberty blockers would be quickly unblinded (owing to the fact that the impacts of puberty are highly visible).
A full protocol for this trial has not yet been published, although some figures involved in it have identified themselves. Dr Michael Absoud, appearing as a speaker at a conference held by noted anti-trans hate group SEGM in Greece earlier this year, described in his biography that he is registered as Deputy Chief Investigator for the trial. Trans Safety Network reached out to Dr Absoud for comment regarding his role in the trial, with questions about the trial protocol, ethical concerns regarding the trial and his relationship with SEGM. No reply to request for comment was forthcoming despite efforts to contact Dr Absoud.
NHS England have been contacted requesting details of the research protocol and documentation of ethical oversight for the trial.