JemPD
Senior Member (Voting Rights)
yes i think thats really important point Kitty
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Making a 'Charter for Ethical ME/CFS Research'
- Thread starter Hutan
- Start date
Yes, I expect good researchers would have some useful ideas of things that they would like to see all ME/CFS researchers doing.
Good point
JemPD
Senior Member (Voting Rights)
wow.... how great would it be if we got thier input at the outset, maybe even a joint venture?!
Kitty
Senior Member (Voting Rights)
They may also want to offer feedback about things it would be useful for pwME to know. We can spot dubious research, but we don't always have a picture of the specific challenges that presumably face researchers working within particular institutions, funding systems, etc.
For instance, there's no point asking researchers never use X or Y as a measure or scale, if some arcane internal rule makes it genuinely difficult not to. The solution might be to ask instead that the data is presented in such a way that X or Y can easily be excluded from the analysis, even if it has to be given lip service in the body of a paper.
Because whatever the shoddy practice that the charter is trying to prevent is not specific to ME/CFS?
In any case, I'm still hearing different voices. Some are saying it is about a guideline of HOW research is conducted, and some others are still speaking of control over WHAT to research. It'll probably help to define the goal and scope first.
If it includes things like "no deficit thinking" or "no psychological data" though, it'll be rather transparent that we are trying to prevent any research that includes BPS aspect and there will be no point pretending that it is about the research process.
I don't think you have heard what people have been saying - there has been plenty of bad non-BPS research done on ME/CFS, and that harms us too.
I don't think that asking that researchers only draw conclusions that are warranted by their data is unreasonable, nor is it only targeting BPS research.
Neither do I think that asking researchers to be clear about the hypothesis they are testing, and to not collect personal/psychological data unless it is directly relevant to the hypothesis they are testing is unreasonable. I have seen that problem, where a paediatric biological study collected a whole range of psychological data that were not relevant to the hypothesis. So, the question is, why were they collecting that data? Even just the process of collecting the data can make the participants wonder if there is something wrong with the way they are thinking. We've seen Spanish studies were they report a whole lot of demographic data completely irrelevant to the question they were exploring - e.g. marital status, years of secondary schooling, the status of the person's job. A study that my son was part of, that I think was about sleep, I can't quite remember, it asked a number of really daft questions such as whether he was afraid of spiders.
If people are not asking questions about why information is being collected, then it becomes too easy for researchers to slip in studies that the participant may not have been willing to be part of.
I can think of quite a lot of studies collecting psychological data that I would be very happy with - for example that recent Konig study on the mental wellbeing of people with ME/CFS. What we need though is researchers being up front about the purpose of the study and only collecting the data they need.
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That wouldn't prevent another Walitt paper though. It wasn't about hypothesis testing; it was about phenotyping. Would you ban the use EEfRT test in ME/CFS? unsupervised exertion test? Outright ban anything psychologizing? Or require patient group's supervision over the studies?
I'm not saying that we shouldn't take political action. But we are taking action to achieve something. If the purpose is to prevent Walitt-like papers, you will need to ban psychologizing outright, or require supervision by the patient group. Will you get anybody onboard with that? My guess: probably no. It's more likely be perceived as an attempt to impose our beliefs on the scientific community.
Sure, I'd agree.
What about collecting psychological data to test the hypothesis that the fatigue is functional, for example. I'd think it'll be fine if the document simply asks to be clear about hypothesis and collect only relevant data.
Oh, that reminds me, a related issue is storage of the data and reuse for other studies. There should not be an assumption that the participant is okay about their samples or their data being used in other studies, without them giving express permission. I've seen researchers wanting to collect samples and make their own little biobank and repository of data so that they can go on and do other studies. And I wonder if that is made clear to the study participants that their samples and data could potentially end up being used by a researcher that they don't trust.
I see the Charter as a bit of a checklist to be used to evaluate a research proposal, highlighting some of the things we see go wrong so often.
Regarding the Walitt paper @poetinsf,
And I do think items on the charter/guidelines should be
'Proven record of communicating well with the ME/CFS and/or other disease communities, or an evident willingness to learn how to do that.'
'Proven record of undertaking high quality research, and/or a support network that is likely to allow them to do so.'
So, if Walitt rocked up wanting to do a study with a patient charity that I was involved with, I'd google what he and Nath and Koroshetz had said about people with CFS and similar diseases, and I'd see that they valued Shorter's views and I'd think about what that would mean about the chances of the research being good and unbiased and people with ME/CFS being treated well.
I see the Charter as a bit of a checklist to be used to evaluate a research proposal, highlighting some of the things we see go wrong so often.
Regarding the Walitt paper @poetinsf,
Why not? I've just googled the NIH's programme on sickle cell anaemia, and the impression I get is of much greater integration of researchers and the community they are serving (the community that then helps the researchers do their jobs and further their careers by taking part in possibly painful or risky therapies). I'm not suggesting you have a patient sitting at the test with a clipboard, but what exactly is so scary and wrong about having a community advisory board that helps review the planned studies? Perhaps the NIH would have recruited more people if there had been trusted community reps saying, 'I've looked into all the studies they are planning and they look really solid and useful'.
And I do think items on the charter/guidelines should be
'Proven record of communicating well with the ME/CFS and/or other disease communities, or an evident willingness to learn how to do that.'
'Proven record of undertaking high quality research, and/or a support network that is likely to allow them to do so.'
So, if Walitt rocked up wanting to do a study with a patient charity that I was involved with, I'd google what he and Nath and Koroshetz had said about people with CFS and similar diseases, and I'd see that they valued Shorter's views and I'd think about what that would mean about the chances of the research being good and unbiased and people with ME/CFS being treated well.
Not sure about that one. It could be used as an opportunity to screen hypotheses. If they are testing, say, if fatigue is functional, it could well be Walitt or someone who has done FND study before and not likely have "proven record of communicating well with the ME/CFS communities". Besides, I wouldn't know how to prove record of communicating well. He/she could be new to the field. This could be rather subjective, personal and prejudicial, I would think.
Ravn
Senior Member (Voting Rights)
some random top of my head thoughts on charter idea (post & run, still unable to participate properly in debate)
- ethics review boards already have guidelines to consider when making decisions, if these were consistently applied rather than used as a tick box exercise we wouldn't be discussing here, as things stand a charter could be a good supplement
- ME charter could have educational effect, especially for people new to the field. Good to get to aspiring researchers early and support them in improving study design. More difficult after they've put a lot of work into it and become attached to it
- apply in first instance to patient org funded research, if works well there might be naturally taken up by other funders
- job for world me alliance?
- what vs how: patient orgs have the right to fund whatever they like with their donation money (just at the risk of pissing their donors off), interestingly it's mostly the big orgs like NINDS, not the patient orgs, asking patients for what research should be prioritised - all orgs should be thinking primarily about the how and the quality instead (at this stage, nobody can know what area breakthroughs are going to come from)
- focus on Transparency with capital T, don't tell anyone what to do or how to do it but ask for very clear and detailed description of and justification for what they're planning - basically what they're doing for general ethics approval anyway just more detailed and earlier in the planning process, if study is funded this info is to go on to participant info sheets
- include a requirement to run their plan past some expert patients (who exactly?) and respond to any concerns raised, this info is also to go on to participant info sheets
- reasonable charter requirements unless very good reason provided for exemption: preregistration, full and detailed info to participants to allow genuine informed consent, open access publishing, data sharing (with patient permission), publishing of negative results
- maybe consider (potentially tricky): possibility of enforcement? e.g. requirement to correct/retract if they didn't do what they said they would, or a public rating & comment (on suitability of methodology and cohort size, likelihood of meaningful results etc) by the approval board to help potential participants make up their own mind
- charter could be supplemented by list of recommended but not obligatory tools (with explanation why recommended) , update more frequently than charter itself, as better tools become available
Fantastic thoughts @Ravn
I too have been wondering if this might be something World ME Alliance might want to run with.
I too have been wondering if this might be something World ME Alliance might want to run with.
This is a nice idea - it maybe wouldn't need to be part of the first work, but a regularly updated recommended toolkit would be a great way to direct researchers towards useful consistency e.g. diagnostic criteria, objective measures
It was supposed to be about phenotyping. So how did Walitt get away with slipping in his hypothesis testing about effort preference? And further, how did he get away with using a task designed to test depressed people for anhedonia to test his hypotheses? Were the participants aware that's what he was doing? Were they provided with sufficient information to give fully informed consent for Walitt to use them in that way?
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Several of us, including me have expained several times that it's nothing to do with us imposing our beliefs on the scientific community. It's about asking people doing what is supposed to be scientific research to do it properly according to well recognised scientific principles.
Things like not relying on subjective outcomes in unblinded trials. The fact that both BPS and medication trials have been done relying on this flawed methodology to support everything from GET, CBT, LP, aripiprazole, vitamins, etc means pwME are subjected to many useless and potentially very harmful treatments.
And ME/CFS is unlike a lot of other conditions in this because there is no biomarker or proven treatment, so we are vulnerable to individual doctors or groups of doctors who often have a vested interest and in some cases significant financial and reputational conflicts of interest in claiming their treatments work.
That makes ME/CFS different from a lot of other chronic disabling conditions where the aetiology is known and well recognised, and in many cases such as diabetes, asthma, MS, Parkinsons' disease etc, there are some biomedical treatments that can be used to improve quality and length of life.
ME/CFS along with a few other chronic conditions such as FM, GWS and now the subset of Long Covid that is most like ME/CFS, are particularly subject to bad science and vulnerable to the BPS idealogues taking over, as they have been in the UK and some other countries for decades. That's why we have a different fight for better science than many other diseases.
Edit to add: Just read this article and the attached references to see what we mean:https://www.s4me.info/threads/opini...s-is-a-national-scandal-george-monbiot.37620/
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The purpose isn't to ban anything, the purpose is to discover the truth and help improve the lives of patients. If psychological research were likely to lead to answers or provide treatments, I would be all onboard. However, it is demonstrably the case that psychological research has had the opposite effect. Wasting money on useless studies that will not provide answers or treatments is something we have every right to prevent. ME/CFS funding is already scarce, the last thing we need is more wasted time and money...
As I said above I think there's a cultural issue here and I find it difficult to understand your perspective, to me your questions are somewhat of a non sequiter. I certainly wouldn't start writing a Charter with the confrontational outlook you propose, and I don't share what I see as an overly narrow definition of politics as 'action to achieve something'. Of course there has to be an objective but politics often proceeds with less definite progression, to invoke a bit of jargon, a Charter might be concerned with "changing the narrative" rather than list of definitevely banned things.
I agree that the confrontational approach you outline would be unsuccessful, and maybe within the cultural context you are referencing (USA ?) that is the only valid approach - but I would argue other cultures are likely to respond to less aggressive approaches which a Charter might be able to encompass. And as I said above I don't accept that there is any longer a definitive monolithic 'scientific community' that is in any way meaningful. To the extent that there is a remnant body of authority to appeal to, it looks to be predominantly white, western, male and patriarchal; for a disease that is global and predominatly affects women I'm not sure it is a body that can usefully be appeased.
I don't know whether a Charter will work, nor whether the effort to produce and promote it will be a sound investment - however I don't see any reason beyond the investment/return question as to why it's not worth investigating further.
There's a question as to why researchers pursuing psychological appraoches have been so poor at engaging with patients and patient advocacy - it is not simply that the investment in psychological approches to ME/CFS have yielded no benefit despite $millions spent - there is also the question of why the relationship between psychiatry/psychology and ME/CFS advocacy has been so confrontational.
The narrative from psychiatry/psychology has been almost entirely that patients are devient, without any meaningful efforts from psychiatry/psychology to engage with mainstream patient orgs to improve realtionships between the professions and the people they are purporting to help. This in contrast to multiple other medical disciplines - is it even conceivable that any one of the psychiatry/psychology researchers who've been involved in ME/CFS would look to the patient engagement exemplified by Decode ME ?
Bad research such as the Smile trial will always find funding from some opaque trust or other.
I think @Ravn point 5 is a good one. Patients who fund charities should have clarity over what the hypothesis is behind any research their money is going to so they can exercise their choice whether to donate or not.
I think @Ravn point 5 is a good one. Patients who fund charities should have clarity over what the hypothesis is behind any research their money is going to so they can exercise their choice whether to donate or not.
Certainly that, but there is a moral imperitive for the same to apply to the use of Public funds supporting research and to Public Institutions hosting research.