Making a 'Charter for Ethical ME/CFS Research'

[Hutan]

Copying from a post I made elsewhere, this idea arose in forum committee discussions about researchers' responsibilities to act ethically.

..What if we and/or patient organisations developed a charter for all ME/CFS (and ME/CFS-like LC) researchers or research studies? There could be a commitment to

• a criteria including PEM if the disease is labelled ME/CFS;
• an undertaking to not interpret or report results or make comments about the ME/CFS community through a deficit thinking lens

Deficit thinking [1] holds [people] from historically oppressed populations responsible for the challenges and inequalities that they face

and not to involve researchers with a clear history of applying deficit thinking or disrespecting the patient communities they have worked with;​

• have meaningful patient involvement in the research design, management and write up, proportionate to the size and funding of the study;
• have lines of communication with the ME/CFS community during and immediately after the study;
• no collection of psychological data such as perfectionist scores or childhood trauma unless it is directly and clearly relevant to the question being studied
• declaration of conflicts of interest ....

I don't know, the content would take some thinking about.

But, then, the patient organisations could use that charter with the research they fund, and the research they promote. They could ask NIH to adopt it for the research it funds. They could tell the ME/CFS community - 'don't engage with researchers who don't ascribe to the Charter for Ethical ME/CFS Research', or whatever name is used for it. They could ask good researchers to mention compliance with the charter in their papers, alongside compliance with the Helsinki Declaration rules.

It wouldn't solve all the problems, but it could start to take some control of what research is done about us. We do have power, and that is our funding of research and our participation in research.

 

[Jaybee00]

I’m not crazy about researchers using the SF 36 physical function questions (10 questions). It doesn’t mean much to me personally as I score pretty highly on it so it wouldn’t even detect much or any disability in my own case. (The vitality questions are better IMO). Something like step counts would be better than SF 36 PF.

Also for me PEM is a minor issue relative issue relative to fatigue and brain fog so I personally wouldn’t advocate for strict PEM requirements.

But these methodological issues are different from the ethical issues.

 

[poetinsf]

We are getting into the domain of politics when we talk about power and control. Not sure if that is compatible with science. I would think it's better to battle shoddy science with good science and logics, and let the evidence fall where they may. Unless the science community is conspiring against ME/CFS community, I do think bad science will eventually get culled and snuffed out. We just need to stay vigilant and call out when it happens.

 

[Hutan]

We are getting into the domain of politics when we talk about power and control. Not sure if that is compatible with science.

Of course politics is part of getting science done. If we aren't thinking about politics and managing the issues, if we aren't part of the conversation, funding will go to other diseases, and to researchers who may do more harm than good.

I don't think we need to sit passively accepting whatever dross is served up to us as science - and we have seen a lot of bad research. We've seen too many patient organisations, whose people don't necessarily know a lot about what is good science, promoting a whole range of questionable science to their members. They need some help.

Other communities are getting strong about 'nothing about us without us' when it comes to research. If it's not us controlling, or at least having a say, in what research gets done, then it will be others, and they may know a lot less about our disease. We can be strong too, especially when researchers are being funded with funds donated by the community, and when they want ME/CFS participants to donate their time and bio fluids, and put their health on the line for them.

Of course there is a risk that we might dictate too much and not leave enough space for innovative science, but I think it's a risk that we can manage.

 

[Trish]

We are getting into the domain of politics when we talk about power and control. Not sure if that is compatible with science. I would think it's better to battle shoddy science with good science and logics, and let the evidence fall where they may. Unless the science community is conspiring against ME/CFS community, I do think bad science will eventually get culled and snuffed out. We just need to stay vigilant and call out when it happens.

I guess that depends on how long we're prepared to wait. For over 30 years we've been subjected to bad science, clearly deliberately designed to keep ME/CFS firmly in the category of psychosomatic conditions amenable to CBT and GET. A fiction that means those of us who don't recover can be regarded as catstrophisers, malingerers and unreliable witnesses to our own symptoms and disability.

It's a fiction that suits insurance companies and governments, that enables them to refuse disability payments and medical and care support.

So yes, politics is not compatible with science. That doesn't prevent some so called scientists being paid by those insurance companies and governments to advise them not to recognise people with ME/CFS as genuine claimants for disability payments.

That should be exposed and stopped. As should bad science led by such as Walitt should be called out and protested about, not just sidestepped with the hope it will go away.

 

[Hoopoe]

I believe that it would be useful if the patient community was able to create a document that clearly describes how they wish reseach to be conducted, how they wish to be treated, what they do not want, etc.

If this document is supported by many patient organizations then it would not be easy to ignore, at least in some contexts. It would make it much harder for the BPS ideology to infiltrate certain organizations that have an obligation to listen to patients.

It would make it much easier for certain groups to take patient wishes into account. Convenience wins.

 

[Sean]

Lot to be said for patients openly organising to explicitly refuse to take part in any studies that fail to meet minimum technical and ethical standards.

We are under no obligation whatsoever to accept or submit to low quality studies, or blatantly biased researchers (or clinicians). To the contrary, we have every right to reject them, from the start if they are not up to standard.

Don't know how much, if any, difference making warning noises early on about Walitt made to final recruitment numbers. But if it helped keep the number of participants sufficiently low to make the study statistically invalid, then good, to be blunt. We should do more of it.

Also for me PEM is a minor issue relative issue relative to fatigue and brain fog so I personally wouldn’t advocate for strict PEM requirements.

Difference between making PEM mandatory, and requiring that it be properly controlled for in any studies.

I do think bad science will eventually get culled and snuffed out. We just need to stay vigilant and call out when it happens.

We have been doing that for literally decades. It is taking too long, is still proving too easy for our opponents to circumvent or ignore or hijack, and generally block progress and accountability, and is costing us way too much for far too little return.

I have been sick since I was 20. I am now in my 60s. I am running out of time. I don't think I could be accused of not being patient.

We have to get both the science and the politics right.

 

[Jonathan Edwards]

I am not very keen on the idea, other than simply saying that ethical research is that which has good enough methodology to provide useful answers that help PWME.

There is huge pressure from certain patient and public groups to allow access to unlicensed unproven treatments and to ban vaccines. Who decides who is entitled to put on political pressure? If you are trying to counter irrational or self-interested policies you are unlikely to get far with rational argument so it becomes an issue of 'whose alternative facts?'.

 

[Hutan]

Yes, it has to have good methodology to provide answers, even if the answers are just 'this isn't different' or 'this doesn't work'. Getting the good methodology may need the input of a patient advisory group, to check that a plan is feasible. It might involve being aware of conflicts of interest, and building in safeguards.

It also needs to be safe, for the participants and for the ME/CFS community in general. That includes researchers not making derogatory statements about the ME/CFS community, perpetuating negative stereotypes while they are doing the research and when they are reporting about it. People with ME/CFS involved in the research should come away feeling that they have done something useful and that their contribution was valued.

It needs to be open access, because the research is about us, we should be able to read it.

The research might need to recruit participants through patient organisations. In that case, the researcher should ensure that the patient organisation is well informed about what will be done, and that there is feedback to the community later.

There should not be subterfuge, for example, saying that a study is about proteins, when in fact psychological data is collected and that is a major part of the study.

I think good research is not just about finding useful answers - harm can be done even if there is a useful answer.

 

[poetinsf]

Of course politics is part of getting science done. If we aren't thinking about politics and managing the issues, if we aren't part of the conversation, funding will go to other diseases, and to researchers who may do more harm than good.

I have no problem with advocacy. I don't think anybody does. But it gets problematic if we start to demand/dictate what to research and how, or prescribe certain a priori (of harm and good). That's getting too close to what anti-vaccers do.

That said, I'd fully agree that any assault to pacing without full consideration of danger and damage of PEM needs to be vigorously investigated and defended, for pacing is only effective tool that we have. Other than that, I'm fully open to any possibility.

 

[Jonathan Edwards]

It needs to be open access, because the research is about us, we should be able to read it.

This is one thing that I think could be shouted from the rooftops. It should be a matter of law. Not specific to ME/CFS of course but no harm in saying it in whatever context.

The research might need to recruit participants through patient organisations.

I would strongly advise against that for just about any disease and certainly for ME/CFS. It will not produce a representative sample and, if you like, discriminates against those who prefer not to join patient organisations. Not unreasonably, since some are quite toxic.

 

[poetinsf]

We have been doing that for literally decades. It is taking too long, is still proving too easy for our opponents to circumvent or ignore or hijack, and generally block progress and accountability, and is costing us way too much for far too little return.

Yeah I can see where you guys are coming from. I've been sick only for 15 (and recovered), and I haven't been subjected to abuse by the medical establishment (probably because I haven't seen anybody for mecfs after initial half a dozen to figure out what I had). So my perspective may be a little different.

We have to get both the science and the politics right.

The problem is, who gets to decide what is right and how?

 

[poetinsf]

That should be exposed and stopped. As should bad science led by such as Walitt should be called out and protested about, not just sidestepped with the hope it will go away.

I'm with you on that one.

 

[JohnTheJack]

It needs to be open access, because the research is about us, we should be able to read it.

Yes, and open access in the broadest sense: an unequivocal commitment to prompt sharing of anonymized data.

 

[Andy]

I have no problem with advocacy. I don't think anybody does. But it gets problematic if we start to demand/dictate what to research and how, or prescribe certain a priori (of harm and good). That's getting too close to what anti-vaccers do.

The irony being that the GET and CBT researchers are the ones closest to being equivalent to anti-vaxxers. The patient community has been consistent in calling for higher research standards in the ME/CFS field, and the suggestion that we can't demand that harmful, and consistently useless, research not happen is ridiculous.

 

[Hutan]

The research might need to recruit participants through patient organisations. In that case, the researcher should ensure that the patient organisation is well informed about what will be done, and that there is feedback to the community later.

I would strongly advise against that for just about any disease and certainly for ME/CFS. It will not produce a representative sample and, if you like, discriminates against those who prefer not to join patient organisations. Not unreasonably, since some are quite toxic.

Many studies, some good and some bad, have been promoted by patient organisations. DecodeME is a good one. There still has to be screening of participants.

Biobanks and patient registries are a source of research participants. Those two sorts of organisations must surely have some requirements of the researchers that they provide data and samples to? Those requirements might provide a start on a standard set of requirements. Does anyone have copies of existing researcher criteria for biobanks and patient registries?

Yes, I totally agree that some patient organisations are quite toxic. Which is why we need to keep trying to help them to improve, for example, to make better decisions about what research is supported.

 

[FMMM1]

harmful, and consistently useless, research not happen

Yea, seems to go on & on --- self reported outcomes in unblinded studies.

• Researchers should bid for enough money to include objective outcome indicators;
• those responsible or public grant allocations (ultimately elected politicians - MPs in the UK) should require that applications which as per NICE are "low" or " very low" quality are refused.

 

[Hutan]

The problem is, who gets to decide what is right and how?

All sorts of people are currently deciding; I'm suggesting giving those people some sensible guidelines.

For example, Australia's NHMRC was giving out funds for Long Covid - Andrew Lloyd (a prominent BPS researcher) was on the panel to decide what research was funded. If there were some guidelines that LC charities could promote, that they could get the NHMRC for example to agree to, it might make it harder for bad research to be done
e.g. by requiring that

• researchers make their data and methods and reports open access.
• results be made public within a specified generous amount of time, even if they are not published in a journal, so data isn't just put away in a bottom drawer
• for substantial pieces of research, that protocols are published, before work on the study starts
• appropriate involvement of people with LC/ME/CFS in the research team
• the research has the support of a patient organisation - thereby guaranteeing that the researcher had to sit down with a patient organisation and talk about their work, and helping to build the links between people with ME/CFS and researchers

It's sort of a back up to the standard ethics approval process, but taking things a bit further.

 

[Sean]

To be clear, my primary concern is methodology. The state of ethics will largely follow that.

If the failings in this field are characterised by anything it is persistently, sometimes wilfully, poor quality methodology, ludicrous and unsafe claims based on it, and a pathological resistance to changing that situation.

I agree with the freedom for researchers to study what they wish. But that comes with a very serious obligation to use the most robust methodology possible, to not cut corners, to not leave critical but awkward questions unresolved, and to be a lot more restrained and honest in the inferences and conclusions they draw from the results than they have all too often been.

I certainly don't think that patients should have a final say in anything about studies. Except whether we participate in them.

That is the one power we indisputably have over research. We should use it wisely, based on the best understanding and advice available about methodology. But we should use it, including in explicit bargaining.

Major improvements in methodology is the single most important and urgent problem in this field. Until that improves, not much else will.

Open access, including to properly anonymised full data sets, is also a non-negotiable minimum standard.

 

[Trish]

I would like to see openness in ethics applications and in the information given to patients for informed consent that states clearly what hypotheses are being tested by any psychological or behavioral tasks, tests and questionnaires.

For example patients should be told well before being asked to do a task that is testing for catastrophising, or effort preference etc that conclusions will be drawn about psychological factors and asked to sign that they understand what is being tested and why.

And ethics committees should also be told what hypotheses are being tested and with what tests and given clear evidence that the test is validated for that purpose and that patient population.