Child-Ethical Research Design: which information informs consent

[bicentennial]

Child-Ethical Research and Ethical Child-Research

Subjecting children to ethical, co-produced ME / CFS research (or study or review) the designs presented to the ethics committees, in the proposals, surely did stumble, trip and fall upon a particular problem peculiar to the domain of ME / CFS

From now on, to be up to the industry standard (never mind the gold standard and never mind the bog standards of medico-legal consensus) an industry standard does require co-production in the design of ethical research

As children are being researched for evidential rehabilitation, must the ethic also include children in the co-production and thereto inform their consent ?

Since ne’er the twain shall meet, I see no consensus between the researchers of ME / CFS biology and the researchers of any behavioural theory and treatment based on the maverick assumption that ME / CFS and other illnesses are psychosomatic, caused by false illness beliefs and de-conditioning

Labels - however favoured, propagated and applied - don’t do joined up thinking and grown-up conversation

This gives a child a problem.

They can consider consent to the bodily research of their own body or they can consider consent to the modification of their own behaviour (by pure and applied sciences, analysis and assessment).

Must they consider both options at once to give consent ? Does informed consent mean knowledge of all the options ? I guess. Is any theory an optional option ? I guess not. I guess some theories are so unjustified its too whacky for an ethics committee

I think - as part of a trial design - the informed consent to a co-production proposal, like informed consent to a trial proposal: must include information on the other theory if both are optional: and especially as both are mutually exclusive and opposed. So do adults and children alike need to know by full information what each theory says about the other ?

I think the onus may be on the ethics committees to finish standardising their industry and co-produce their ME / CFS Research guideline leaflet with the samples they are given, the samples of each core theory proposed with method, to obtain funds, ethical validation, subjects, co-production, research etc, publication, study, review, and prevalence

Is it the case the leaflet (guiding criteria) for a fully informed consent format needs to portray the 2 types of informed consent, as obtained separately in separated programs in the separated indeed segregated worlds of biology, and of behaviour where bio-monitors are still verboten

What sense can a child make of that ? Even an 8yr old can see it makes no sense once informed on both theories to give the option

How expect them to choose between the theories informing consent when these 2 theories cannot even co-exist out here, let alone in a child’s mind

.
EDIT: was a rewrite since I saw no way to delete a new thread once posted by mistake, half-way through the draft, so no more time to think about it, and cut it down further

 

[Hutan]

I've thought about your options @bicentennial.

I started thinking about BPS trials. So, when a child is in a trial like Magenta, with BPS treatments, should they be informed that the treatment is based on an unproven hypothesis that the illness can be fixed by thinking differently and that there are other hypotheses?
At first I was thinking, 'yes, children should be informed of the two competing paradigms (BPS, medical but currently unknown) before they participate in research and even clinical interventions'.

But then I thought a bit more. First, the BPS people would probably never accept it, because the "success" of their treatment is based on the successful selling of it as a cure. If you don't sell it sufficiently well, people don't tick the right boxes in the end of treatment survey. Second, I think you run the risk of damaging the child even by suggesting that the BPS idea i.e. psychsomaticism, is a possible explanation.

Frankly, I think that applies to adults too. There has been enough experimentation and tweaking of the offering and further experimentation, and there is nothing there to suggest that the BPS treatments work. So, suggesting to someone and their family and their medical team that the person's illness is psychosomatic is all downside. There's no cure, and only the various harms that we have covered well elsewhere
for example

• the person distrusts their ability to perceive the world accurately (am I really sick? am I really feeling pain?)
• the family distrusts the person (are they just making this up? should we provide less support so that they have to get on with life?)
• the medical team distrusts the person (nothing the person says is to be believed or taken notice of, a challenge approach is needed rather than pandering to their needs, treatable medical conditions are missed)
• the person distrusts the medical system, avoiding it (treatable medical conditions are missed)
• the person suffers serious harm to their self-esteem and their faith in the world due to not being believed (withdrawal from social engagement, sadness, hopelessness, suicide)

I think, when the person in question is a child, still developing their sense of self, there is even more reason not to expose them to BPS treatment trials. I don't think it is ethical. And if a child is participating in a trial of a medical treatment, there is no good reason to talk to them about the BPS paradigm.

(Actually, given the lack of any strong evidence to support any sort of treatment for ME/CFS, and so, given the speculative nature of any treatments currently, I don't think children should be part of any trial for ME/CFS treatments. Prove that highly speculative treatment works in adults first. (Maybe later when there is some solid physiological basis for a treatment rather than just taking wild stabs at treatment choices, it might be appropriate to see if young people respond to a treatment differently to adults.)

That Magenta trial was such a debacle. There are some horrifying quotes from young people who participated.

 

[Trish]

A trial of a psychological therapy for children or adults that is based on telling then to ignore their symptoms, or that their wrong thinking is perpetuating their symptoms or other such unevidenced brainwashing is so unethical it should never pass an ethics committee and get approval. If ethics committees were doing their job properly it should never reach the stage of individual patients being asked to give informed consent to participate.

The Lightning Process gets around this by calling it training not therapy or treatment, so presumably there is no requirement for participants to give informed consent to participating in LP as a client In fact the opposite. They are vetted before being accepted for the opposite of informed consent, by having to agree not to ask questions, and it's sold to them by telling them it's a secret training they are not allowed to talk about. I have no idea how Crawley got around that in her infamous trial of LP on children.

Although the CBT used for ME/CFS is not as blatantly brainwashing patients as LP, I'm sure they don't tell patients their therapy is based on lies.

 

[Peter T]

I agree that with our present knowledge any trials of any curative treatment for ME/CFS or Long Covid in children should be on hold until after trials on adults.

 

[rvallee]

(Actually, given the lack of any strong evidence to support any sort of treatment for ME/CFS, and so, given the speculative nature of any treatments currently, I don't think children should be part of any trial for ME/CFS treatments. Prove that highly speculative treatment works in adults first. (Maybe later when there is some solid physiological basis for a treatment rather than just taking wild stabs at treatment choices, it might be appropriate to see if young people respond to a treatment differently to adults.)

I definitely agree to that. There is no reason to "try" treatments on children when there are no effective treatments for adults. Psychobehavioral trials are, IMO, unethical by nature, but when children are subjected to they become abuse of authority and fall into immoral territory real quick. I consider them to be criminally abusive, frankly, but my own personal ethical window is definitely not at the same place as most people.

But of course in a discipline with no real standards to speak of, this won't stop anyone. Hell, the unethical trials are the standard. In a sane world, they would have been banned a long time ago, including for adults. But instead they are basically the future of medicine on all conditions where technology doesn't give answers, which spells out plainly what kind of world we live in.

 

[alktipping]

Where is the option for we are a bunch of fraudsters working for vested financial interests . would you like to help us continue in harming your patient group.

 

[Sean]

Children should not be experimented on until the treatment has been proved both genuinely safe and effective in adults. Especially vague dodgy psycho-behavioural treatments with shitty track records.

So, a flat no from me. (Option 3B)

 

[Hutan]

Thank you @bicentennial
Your question made me think. It was a useful question.

 

[Amw66]

This is more nuanced .

Many children and families are in a double bind with ME/ CFS ( related to UK )
To not consent / participate can be interpreted along the lines of FII and factor into safeguarding , particularly if school attendance is poor.
The pressure can be immense .

@Tilly

 

[Peter T]

This is more nuanced .

Many children and families are in a double bind with ME/ CFS ( related to UK )
To not consent / participate can be interpreted along the lines of FII and factor into safeguarding , particularly if school attendance is poor.
The pressure can be immense .

@Tilly

This brings to mind Prof Crawley’s earlier study specifically looking at identifying non school attenders to identify undiagnosed ME/CFS then feeding them into her own clinic many of whom were then given GET and/or CBT. Given she was visibly working with the education authorities in the study and also by then had been involved in diagnosing issues in parents who not unreasonably rejected GET and/or supporting child protection proceedings in such cases, participation could hardly be seen as voluntary.

However in relation to ethical approval I can’t remember if this was one the various studies that the researchers avoided seeking ethical approval by misusing a previous letter for a totally unconnected study saying that that service evaluation did not require specific ethical approval.

 

[Ash]

This is more nuanced .

Many children and families are in a double bind with ME/ CFS ( related to UK )
To not consent / participate can be interpreted along the lines of FII and factor into safeguarding , particularly if school attendance is poor.
The pressure can be immense .

@Tilly

Yes. Coercion absolutely.
I think that’s a perfect violation of ethics though, so it’d still be a straight no. No to ethical approval at any stage. If there is ethical approval in this present context child and parent will be subject to exploitation. They cannot consent under threat.

 

[Trish]

This is more nuanced .

Many children and families are in a double bind with ME/ CFS ( related to UK )
To not consent / participate can be interpreted along the lines of FII and factor into safeguarding , particularly if school attendance is poor.
The pressure can be immense .

@Tilly

Has this got any better now Esther Crawley seems to have vanished and her last 2 big studies, MAGENTA and FITNET have reported in publications to be ineffective and even harmful?

 

[Amw66]

Has this got any better now Esther Crawley seems to have vanished and her last 2 big studies, MAGENTA and FITNET have reported in publications to be ineffective and even harmful?

I've tagged @Tilly who will have more up to date knowledge.
Given that Crawley has been replaced by a physchiatric/ psychological head I would tend to think that it's a case of " the queen is dead, long live the queen "

 

[Tilly]

I've thought about your options @bicentennial.

I started thinking about BPS trials. So, when a child is in a trial like Magenta, with BPS treatments, should they be informed that the treatment is based on an unproven hypothesis that the illness can be fixed by thinking differently and that there are other hypotheses?
At first I was thinking, 'yes, children should be informed of the two competing paradigms (BPS, medical but currently unknown) before they participate in research and even clinical interventions'.

But then I thought a bit more. First, the BPS people would probably never accept it, because the "success" of their treatment is based on the successful selling of it as a cure. If you don't sell it sufficiently well, people don't tick the right boxes in the end of treatment survey. Second, I think you run the risk of damaging the child even by suggesting that the BPS idea i.e. psychsomaticism, is a possible explanation.

Frankly, I think that applies to adults too. There has been enough experimentation and tweaking of the offering and further experimentation, and there is nothing there to suggest that the BPS treatments work. So, suggesting to someone and their family and their medical team that the person's illness is psychosomatic is all downside. There's no cure, and only the various harms that we have covered well elsewhere
for example

• the person distrusts their ability to perceive the world accurately (am I really sick? am I really feeling pain?)
• the family distrusts the person (are they just making this up? should we provide less support so that they have to get on with life?)
• the medical team distrusts the person (nothing the person says is to be believed or taken notice of, a challenge approach is needed rather than pandering to their needs, treatable medical conditions are missed)
• the person distrusts the medical system, avoiding it (treatable medical conditions are missed)
• the person suffers serious harm to their self-esteem and their faith in the world due to not being believed (withdrawal from social engagement, sadness, hopelessness, suicide)

I think, when the person in question is a child, still developing their sense of self, there is even more reason not to expose them to BPS treatment trials. I don't think it is ethical. And if a child is participating in a trial of a medical treatment, there is no good reason to talk to them about the BPS paradigm.

(Actually, given the lack of any strong evidence to support any sort of treatment for ME/CFS, and so, given the speculative nature of any treatments currently, I don't think children should be part of any trial for ME/CFS treatments. Prove that highly speculative treatment works in adults first. (Maybe later when there is some solid physiological basis for a treatment rather than just taking wild stabs at treatment choices, it might be appropriate to see if young people respond to a treatment differently to adults.)

That Magenta trial was such a debacle. There are some horrifying quotes from young people who participated.

I think we need to keep bring up the MAGENTA trial and those quotes along with the FITNET/NHS trial, they need to be seen for what they were.

If brain training does not support learning, why should it cure/restore health? If it worked we would all be world champions in everything we wanted to do and athletes would never get sick?.

Children and their families are put in impossible situation, how do you make sense of the nonsensical?

When my son was first ill we faced what you and @bicentennial so clearly pointed out. Without the knowledge of ME and PEM it is impossible to give informed consent.

This then became my first step, to introduce PEM into every conversation. With every professional and on every patient group, research group I asked the question "explain to me what PEM is".

I have now started using ME and PEM, connecting the two together. When asked what ME is I simply say "an inability to produce energy on demand or sustain energy for any length of time". Those two understandings form the issues that children and young people have and need to be considered in any trial. The use of the Visable app needs to be promoted and be made to be part of any trial.

However the problem we have is BACME, how the words they use and now the ME Association. That needs to be called out as they sneak in amongst the real science the - what I can only state is stupid opinion stuff (sorry but honestly can't find any other words to describe this - milieu and epiphenomena)

The above was taken from the Isle of Mann information from BACME, which enables doctors to do what they like as before and treat ME as a disorder not a disease.

If any understanding is to be formed for children and young people, we have to look at why they are allowed to call ME a disorder and not find the different types, diagnose and treat the symptoms as per Nancy Kilmas does and which we should be using. They seem to be able to turn any physical medical problem into where emotions possibly have an impact so it must be a mental or behavioural disorder! That is beyond wrong, it is unethical. Their inability to accept that physical illness, also needs to be brought to the attention of all, as they only accept the treatment of CBT or the alike for basically any issue and no one is getting better, so it has to stop? I would go so far to say people on every level are harmed because it leaves them confused and with a large amount of self blame.

To tell a child they are mentally ill or have a behaviour problem and go about teaching them how to dismiss their own self, is beyond appalling and more than harmful. With regards to ME it literally destroys lives not as we would accept from the hurt but also physical harm, as they push through their energy envelope and into a deep PEM state. Case studies would confirm this and this needs to be done.

We should also look at and bring into the conversation the impact on those that have gone through CBT who are neurodivergent, as this also shows harm that has been done over decades.

In conclusion PACE, MAGENTA and FITNET/NHS trials are coercive and abusive by nature and should all be taken down and those that designed them held to account, due to the misinformation and disinformation they have caused. MPs and government should take control of this as there are safeguarding and trust issues that the public need to be aware of, that have been funded by their monies.

 

[Tilly]

This is more nuanced .

Many children and families are in a double bind with ME/ CFS ( related to UK )
To not consent / participate can be interpreted along the lines of FII and factor into safeguarding , particularly if school attendance is poor.
The pressure can be immense .

@Tilly

It is how MAGENTA and FITNET were used to coerce children to participate. At the time it took many of us to gently handle the situation to enable families to understanding ME and PEM and to sidestep the FII. I think I wrote a lot about this and kept most of the information which I can go through if need be.

 

[Tilly]

Just looked at the voting and I would like to see - Just veto CBT or any form of cognitive therapy in ME/cfs due to the behaviour of the research already done.

Pending risk assessment gives them a toe in the door?

 

[bicentennial]

@Tilly ?? 5B. Research misbehaved so ban research/clinic/practice plans to modify ME/"CFS" thought & behaviour

Just looked at the voting and I would like to see - Just veto CBT or any form of cognitive therapy in ME/cfs due to the behaviour of the research already done.

Pending risk assessment gives them a toe in the door?

Hallo Tilly, sorry I was delayed, exactly that, still with the foot in the door in case of the flat no ( @Sean ), so I tried some ways to fit in your vote design, and came up with:

< 5B Research misbehaved. Veto research/clinic/practice plans to modify ME / "CFS" thought & behaviour >

That re-draft fitted into the survey question box, exactly that many letters and spaces. it came after the experiments with ... as you said:

< Just veto CBT or any form of cognitive therapy in ME/cfs due to the behaviour of the research already done >

But the box chops off the "y done" at the end end of your poll answer. We can save a letter by substItUting ban for veto BUT then ban is not the professional term

< Ban cognitive & behavioural modification in ME / CFS research & practice >

< 5B Ban cognitive & behavioural modification practices in ME/"CFS" research & practice as incorrigibl >

That saved a letter but lost the "e" at the end which makes no differnce, but we lost "veto". Maybe veto is the proper term

< Never allow a research/clinic/practice to modify cognition & behaviour in ME/CFS. Past research misbehaved >

That needs a 4-letter word to relace "misbehaved". Who does crosswords ? Or put the ME/CFS in front of cognition. But I think maybe that still lost the inverted commas on "CFS". Or replace cognition with thought which it always was. I think therefore I ignite but I don't cognite. Or do I ?

< xxx will not allow. My health will not allow... >

Any drafts from anyone are as welcome