Health Secretary updates MPs on Government and NHS England’s work to improve gender identity services & implement recommendations of Dr Hilary Cass’s independent review. Includes extension of puberty blocker ban to Nov 26th & review of adult svcs

I don't really understand why informed consent would be such a difficult issue for this new piece of research. Puberty blockers are already used safely for precocious puberty, so surely giving them (for an appropriately brief time) to older children is not intrinsically dangerous?

The danger, as I understood it, was not to do with any inherent risk in the medication itself. It was to do with the appallingly lax way in which they were prescribed, without appropriate screening, without exploratory talk therapy, without ongoing intense further exploration so that they could be genuinely a "pause" rather than the first step towards further medicalisation.

If all those failings were corrected, and if other boundaries were in place (say, a maximum of six months on the blockers, or whatever other short period the study protocols deemed safe), why would that create difficulties with informed consent.

I mean, there may be other problems with the study, other reasons not to go ahead with it - I really don't know. But how would informed consent be an issue?

Amazing 😁🤦‍♀️ Yep, that's a beautiful demonstration of irony, lack of critical thinking and lack of self awareness. Although, to give Natacha some credit (albeit for a happy accident), it is helpful to call out that it's surely impossible to have informed consent given what's in the Cass Report.

I don't suppose you have the link on X by any chance please?
I'm not really using it any more except to read comments that are referenced here on MN - and boost the particularly good ones.

Every now and again one is worth commenting back on. This is very much in that category. Plus I'm intrigued about any other responses it might have attracted.

For once Natacha Kennedy seems to agree with us. Probably not what was intended… (Also, if you’re your own co-author, you have less than no standing to discuss ethics [in academia].

All NHS REC approvals are managed through IRAS ( Integrated Research Approval System). I imagine most REC applications and decisions are FOIable.

The application forms detail the proposed research design, the justification for undertaking the research, the risks for participants, to what extent the risks can be mitigated, why these risks are justified etc.

There is a strong case for this information being in the public interest and, having been an assessor, can't think of many cases where applications or decisions would need much information redacted. The nature of research means that required information sheets and consent forms need to be transparent and accessible, and only in very limited circumstances would it be deemed ethical to withhold information from participants. E.g. In the case of RCTs, participants usually know the different conditions, just not the specific condition that they will be assigned to.

Seeing this thread again reminded me that in the Scottish Parliament today, the Health, Social Care & Sport Committee interviewed 3 doctors regarding the Cass Review recommendations. One of the doctors arrived late and didn’t speak for long but she did speak about an upcoming UK-wide clinical trial of puberty blockers very confidently and seemed to think it would be starting soon and that it wouldn’t be difficult to establish a research and ethical protocol and then get it authorised.

I was really surprised by that information. A few of the MSPs were glad to hear this because, I think, they feel that kids who have been taken off waiting lists for blockers can now access them via the clinical trial instead.

All in all, both the doctors and MSPs seemed very pleased that things were moving along quickly because an evidence base needed to be established.

Perhaps, another poster might have more knowledge or experience in this area and could interpret the discussion more expertly with regards to the difficulties in establishing this type of research.

In response to a query on whether Research Ethic Committee reviews are in the public domain - no, not usually. I would be very interested to see the study protocol which given the level of public interest it would be good practice to publish. I do struggle to see how this would get through ethical review - as previously suggested, the first point would be can you answer this question without doing a trial - possibly yes by looking at people who have already had puberty blockers and comparing them to a current matched untreated group. To respond and say that we couldn't do that because the clinics refused to cooperate (as they did with Cass) looks terrible and that's not a reason to do a trial. Plus raises serious concerns about safe trial management if the same clinics are involved in recruitment and study procedures.
Go use the existing data - you can justify it as an anonymised review of NHS patient data pretty easily and way, way cheaper and quicker. Could turn that around in 9 months, a trial would be minimum 3 years likely longer.

You can chat with them directly, they are very helpful and responsive.

Thank you @ArabellaScott

It looks like it could be exempt.

If the FOI was submitted prior to it commencing, they could say that "disclosure of the information would or would be likely to prejudice the research programme", while if it had already started they could say that it's an exemption because they "hold information on an ongoing programme of research".

Hopefully there would be some space to argue that the request doesn't relate to the research data, therefore the exemption doesn't apply. As you say, the ICO would be able to clarify this.

Or, you could ask the ICO.

https://ico.org.uk/for-organisations/foi/guide-to-managing-an-foi-request/exemptions/list-of-exemptions/

'Section 22A – research information
This exemption applies if, when you receive a request for information,

• you hold information on an ongoing programme of research;
• there is an intention by someone –whether an individual or organisation, private or public sector - to publish a report of the research; and
• disclosure of the information would or would be likely to prejudice the research programme, the interests of participants in the programme, or a public authority holding or intending to publish a report of the research.

[link on page]

FOI exemptions:

https://ico.org.uk/for-organisations/foi/guide-to-managing-an-foi-request/exemptions/

Basically, I think you can ask and the organisation will tell you if they aren't obliged to provide.

Indeed.

Apologies if this was answered further up the thread and I missed it but does anyone know if ethics approval applications and results are exempt from FOI requests?

To Beowulfa's excellent points, the information in this document will be very revealing.

The guy that is now CBE and head of pretty much most of children's services has 35 odd years of working out how a trial can get around ethics, bearing in mind he will likely be on the ethics panel and was the person that initially WENT AGAINST HIS OWN FUCKING AGREED ETHICS RESTRICTIONS IN THE FIRST PLACE.

He is the Sheriff who instigated the Wild West approach. He is not going to put a stop to it now.

Exactly.

And every month that passes while blockers are banned helps to undermine the myth that blockers save lives, and that young people would feel suicidal without them.

I'm also struggling to see how a trial would get through ethics.

It's a good kick the can down the road strategy though. And as time goes on more evidence of harms will emerge making a clinical trial even less likely.

Here’s a bit more about Hilary Cass’ thinking about the review and some of the challenges it faced:

https://www.cambridge.org/core/journals/the-british-journal-of-psychiatry/article/gender-identity-services-for-children-and-young-people-navigating-uncertainty-through-communication-collaboration-and-care/D0F6B23F37C3D82B38C2470DF65854C9

A bit about PBs:

”This leaves many unanswered questions, including whether puberty blockers may be beneficial for a subgroup of young people, and if so which ones, as well as whether there might be negative outcomes for other young people.

A recent study found that gender non-contentedness (i.e. unhappiness with being the gender aligned with one's sex) was highest in early adolescence and continued to drop into the mid-20s.Reference Rawee, Rosmalen, Kalverdijk and Burke7 This is consistent with accounts shared with the Review by people with lived experience whose gender-related distress resolved in late teens or early adulthood. If pubertal changes are essential to both psychosexual development and resolution of gender-related distress in some individuals, does treatment with puberty blockers change the trajectory for that group? Unfortunately, because we have intervened with the later-presenting group by using a treatment that was intended for those presenting in early childhood, and in the absence of an evidence base, we do not know what their natural history would be, nor the appropriate treatment response.

In light of all these uncertainties, the Review recommended that a puberty blocker trial should be established as part of a wider programme of research, and NHS England and the National Institute for Health and Care Research (NIHR) have already initiated this process.”

This ⬆️

Perhaps I am being overly naive with my faith in paperwork (apparently the Domesday Book was uniquely possible in England out of all European countries at the time, due to the admin efficiency of the Anglo-Saxons).

It may seem as stupid as completing a risk assessment form to confirm whether or not a cement mixer is a good place for a baby to sleep, but this is where we are.

No, giving vulnerable autistic teenage girls experimental drugs to cure them of Wrong Body is an unethical nonsense. Let's see this signed off and formalised.

Yes. But the Cass Report covers this already because it comes from a position that gender identity is a real thing. If even the believers in gender identity are urging caution and saying that the evidence for medical interventions is weak, this demonstrates that objectivity can be applied over and above belief.

So the logical consequence is that a) there will always be people who believe that they have an inner gender identity that differs from their body (and that some will find this distressing) b) they deserve access to evidence-based care.

So we've come back round in exactly the same loop as before, where all roads lead to ethics approval.

And just to add, the concern about this medicalisation of children has always been about the massive sudden increase in the numbers of people presenting with "gender dysphoria". Prior to that, there was a steady, very small, number of children who presented at clinics not because of a huge and contagious social phenomenon , but for reasons that - in principle - may possibly need us at least to consider the appropriateness of a medical response.

That is fair comment, Beowulfa.

If we have to go all the way back to basics then that is perhaps the only way to do it.

I think part of the problem is that we have had years of people claiming that 2+2=5 being embedded into the processes and procedures. So subsequent policies have been built on all that bullshit. In the way of a frog being slowly boiled, we've not really woken up to it until it's got so far down the road that people are suggesting that we really ought to consider if putting a frog in boiling water is definitely bad for the frog's health.

The temptation to say 'experimenting on healthy children with dangerous drugs is wrong full stop' is strong, but there will need to be a process of unwinding, over and over again, until we get back to the basics of questioning and defining the words that we have had 'repurposed' by activists over the course of years.

I suppose rewinding that, and looking again at first principles, incredibly painstakingly, is the way this will have to go.

I looked at the NHS information on medical trials for children:

https://www.hra.nhs.uk/planning-and-improving-research/policies-standards-legislation/research-involving-children/

I find the assumption that informed consent is seen (legally) the same as consent for treatment concerning - see first highlight in screenshot. Obviously any prospective trial patient should be able to trust that that a) an ethics committee approval for the trail to go ahead is actually ethical in itself and b) the trial will be managed responsibly. However, it's all prone to human influence and error. On point b, I'm sure many people remember the medical trial that went wrong because of a flawed protocol: https://www.bbc.co.uk/news/magazine-35766627.amp

The second highlight below is equally as important. The WPATH files and the Cass Report both demonstrate that informed consent is meaningless where there is no viable evidence base. Obviously it's a circular argument: you can't build an evidence base without trials. So again, all roads lead to ethics approval.

You can't assume anything

Absolutely @AlisonDonut
Does anyone know if ethics approval information would be exempt from FOI requests? I would hope not, given it's in every child's (and their parents') interest to have a full understanding about any potential involvement in this trial. Without full transparency it's a massive future legal risk for the NHS. The NHS' quiet removal of their previous words about puberty blockers and the unknown risk to the development of the teenage brain, plus the quiet back-pedalling from WPATH SOC 8, doesn't mitigate this risk. Medical lawyers will have a field day on this in the future if it can be easily proven that informed consent to the trial was not sought. Obviously the human cost of this would be heartbreaking - no amount of compensation would undo permanent brain damage (or loss of fertility, sexual function or bone density) or fix the guilt of parents who thought that they were getting good advice from the NHS.

Yes, Beowulfa, that is similar to how I feel. We need the trial because we need to get to the point where we are seeking clear definitions and gathering high-quality evidence in a meaningful way.
The very process of creating appropriate protocols would formalise the presumably highly exceptional nature of any child even beginning to qualify for PBs. This in itself would clarify the extent of their casual over-prescription in the past.
And if the trial itself (or even its preliminary stages when the protocols were being established and scrutinised) revealed that no child would, in fact, meet the criteria for prescription of PBs, then that would be a formalisation and proof of their inappropriateness.

I personally do think we should go through the motions of initiating a clinical trial, possibly because I'm an administrator and like paperwork and attention to detail. And I mean "initiating", because I'm confident once it's written down in black and white it would fail the ethical parameters, and act as a clear dividing line between the previous Wild West approach and scientific standards going forwards.

As has been discussed above, what condition is the trial treating? Wearing the wrong clothes? Not being enthusiastic about puberty? Being gay? What is classed as a "successful" treatment outcome? How can it be quantified?

Seeing the long list of co-morbidities most patients present with would also highlight how much help is needed in other areas eg eating disorders and autism.

Clinical trials involve serious paperwork and the highest standards of data management. None of this has been applied to children so far, and I would like to see this further exposed for the medical scandal it is.

You can't assume anything. The people wedded to this will try any and every means possible to get these, as still yet unlicenced for this use drugs, into kids.

Sloth did you read the reach of the guy that started all this back in the 1990s? Russell Viner? https://en.m.wikipedia.org/wiki/Russell_Viner

He is the person most likely to be on any ethics committees. He is the one that first gave blockers to kids 35 odd years ago.