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Feature Trans Care

Gender dysphoria in children: puberty blockers study draws further criticism

BMJ 2019; 366 doi: https://doi.org/10.1136/bmj.l5647 (Published 20 September 2019) Cite this as: BMJ 2019;366:l5647

Rapid Response:

"The HRA appears to be reluctant to enforce its rules"

As a former GIDS clinician, I am concerned about the issues that Barnes and Cohen [1] have raised, relating to the conduct of the GIDS puberty blockers blocker study led by current RCPCH President Russell Viner of UCL. I have spoken at length with the anonymous parent whose concerns about the study the Health Research Authority (HRA) investigated. We both believe that the HRA’s findings [3] present an unbalanced account of the study and miss an opportunity to learn from ethics shortcomings.

Last year the Science and Technology Select Committee concluded that ‘the HRA appears to be reluctant to enforce its rules.’ [2] The HRA's report into the puberty blocker study [3] amply justifies that finding. As Jacqui Wise reports, [4] not only did the researchers not follow HRA rules [5] but the HRA appears not to care. The researchers first defaulted on their requirement to submit an annual review in 2012, and the HRA gave up sending them reminders in 2015. In all, they failed to supply eight such updates, in contravention of the HRA’s rules. In its report the HRA is unconcerned as it is normal for researchers to ignore its rules, which the HRA itself considers to be ineffective and onerous. Professors Scott and Ford [6] also defend the failure to submit updates, by noting that it is a common failing in the research community. Is that meant to reassure? The HRA is thinking of changing the rules, but gives no timetable and hasn't changed them on any of the at least eight occasions it has revised its rule book since 2011. If I consider the taxation system onerous and inefficient, is it OK not to pay tax? If HM Treasury shares my view of the system's faults and is considering making improvements, is it OK not to bother paying tax in the meantime? Ultimately, public confidence in research depends on researchers' adherence to ethical rules.

The HRA report also swerves the issue of conflicts of interest reporting. UCL sponsored this research study and hosted the ethics committee meeting that approved the study. It employed three on the committee, plus a fourth co-opted member who was co-authoring papers with Viner, himself a UCL employee though, prudently, he stayed away from the meeting. Although the HRA report calls it ‘a requirement’ to record potential conflicts in the minutes, none were. Yet somehow the HRA is still ‘not clear whether the potential conflict of interest [regarding the co-opted member] was declared.’ [3]

This was the second ethics committee to consider Viner's study, for an earlier REC had already rejected it. The researchers considered that the earlier REC's decision was an error, and they were unwilling to amend their application to take account of the REC's objections. However, in this situation, the HRA's rules at that time unambiguously called for researchers to appeal to a fresh REC that is centrally-appointed, though they were told by the first REC that they could re-submit to them or to another REC 'within this domain'. Accordingly, what the researchers did was go directly to the UCL-based committee, because they felt it 'would better understand the issues’ [7] and ask it to overturn the first REC's decision. The HRA's justification of this is logically inconsistent, and it even suggests that the first REC 'extended beyond its remit in questioning the scientific design’ [3] of the application even though the HRA's own advice for RECs lists 'Social or scientific value; scientific design and conduct of the study’ [8] at the top of the things that RECs must always consider. Ultimately, if the researchers disagreed with the first REC they ought to have followed the HRA's rules and taken their chances with an appeal. But instead they went to another committee where they thought they would get the result they were seeking. The HRA did nothing to enforce its rules either then or since, so it is hardly surprising that the researchers behaved as they did.

The issue of oversight is a difficult one for the medical community, which prizes its freedoms; and the HRA may think it has done its job well, in giving itself and the researchers a clean bill of health. Yet beyond the laboratory and the clinic, society's expectations of accountability are growing. The public sector is strewn with regulators who failed to grasp that they serve the public not the profession. The latest is the Financial Reporting Council, until very recently the regulator of auditors and accountants and setting the UK’s corporate governance standards. ‘Chronically passive’ [9] and compromised by links with those it oversaw, the entire organisation has been scrapped, and in its place is a new body designed to be ‘respected by those who depend on its work, and where necessary feared by those whom it regulates.’ [10] Food for thought, one hopes, for the new HRA chair, past RCPCH President Sir Terence Stephenson of UCL.

The most important issues were not considered in the HRA's report: the safety and efficacy of the puberty blocker, and how this life-changing experimental treatment was adopted generally within NHS England. The researchers sometimes explain that the introduction of the puberty blocker was such a modest development that ethical review was merely their voluntary choice, and at other times they remind us that it was a decision of such extraordinary delicacy that it was preceded by ‘nearly a decade of consultation with international experts.’ [3, 4] Clearly, there is a gap in supervision here, and in fairness the report does conclude with a call for NHS England to ‘provide guidance to NHS organisations on appropriate and transparent oversight and governance of innovative practice undertaken outside research.’ [3] If it does not heed that advice, the NHS may instead be forced to listen to the High Court in London, where the mother of a GIDS patient is currently seeking to prevent her daughter being ‘subjected to an experimental treatment path that is not adequately regulated.’ [11] My own concerns have led me to join her in that action.

[1] https://doi.org/10.1136/bmj.l5647
[2] https://publications.parliament.uk/pa/cm201719/cmselect/cmsctech/1480/14...
[3] https://www.hra.nhs.uk/about-us/governance/feedback-raising-concerns/inv...
[4] https://doi.org/10.1136/bmj.l6034
[5] https://www.hra.nhs.uk/about-us/committees-and-services/res-and-recs/res...
[6] https://www.bmj.com/content/366/bmj.l5647/rapid-responses
[7] Trust FOI 19-20011 at https://tavistockandportman.nhs.uk/about-us/contact-us/freedom-of-inform...
[8] https://www.hra.nhs.uk/documents/273/consistency-rec-review-2-may-2014.pdf
[9] https://publications.parliament.uk/pa/cm201719/cmselect/cmworpen/769/769...
[10] https://assets.publishing.service.gov.uk/government/uploads/system/uploa...
[11] https://www.crowdjustice.com/case/protect-children/
https://assets.publishing.service.gov.uk/government/uploads/system/uploa...

Competing interests: No competing interests

19 November 2019
Susan H Evans
Psychoanalytic psychotherapist, former registered nurse and registered mental health nurse
Beckenham, United Kingdom