Declaration of Helsinki embraces health equity, 2024, Nature Medicine editorial

[Hutan]

https://www.nature.com/articles/s41591-024-03433-5

The updated Declaration of Helsinki empowers ethics committees to require community engagement and equitable partnerships

1964 saw the US Surgeon General report that smoking is a health hazard, the UK abolish the death penalty for murder, and Nelson Mandela and seven others sentenced to life imprisonment in South Africa. It was also the year that the World Medical Association met in Helsinki, Finland, to adopt a statement of ethical principles for medical research involving human participants. Much has changed in the intervening 60 years, as shown by nine amendments that reflect the evolving global ethical milieu, but the Declaration of Helsinki remains relevant and continues to powerfully influence health research. The tenth amendment, published in October 2024, elevates inclusive health research to a core pillar of research ethics, a welcome change that will benefit patients and improve research outcomes.

The Declaration alone is necessary, but not sufficient, for ethical research. Unethical research continued long after 1964, from the Tuskegee syphilis study (which ended in 1972 and led to the Belmont Report that enshrined consent into US law), to trials of zidovudine in pregnant woman living with HIV in Zimbabwe in the 1990s (where half received placebo, despite the drug being reasonably likely to work, leading to more than 1,000 newborns contracting the virus)1, and the more recent gene-editing of babies with no clear health benefit. Involving patients, the public and communities at the earliest stage of project design is the true defense against unethical research.

It is therefore welcome that the latest revision for the first time requires “meaningful engagement with potential and enrolled participants and their communities”. Research participants are no longer ‘subjects’ but experts: on their life, their health, their culture and their beliefs. Lived experience forms a vital trove of knowledge that should be respected and embraced. The Declaration now reflects best practice and existing frameworks, such as the San Code of Research Ethics and the TRUST Code for equitable research partnerships, which are bolstered by the Declaration. It is now for institutional review boards and research ethics committees, who are mandated to insist on “meaningful engagement”, to decide what this means in practice. They should require recruitment of a patient, public or community advisory board before the research has started, a commitment to co-design, and a willingness to change tack based on community feedback. Without a willingness to adjust proposed research, engagement is performative and not meaningful.

...

Research should benefit the population studied, especially if they are at risk of exploitation, but caution should not preclude the inclusion of ‘vulnerable groups’ in research (who were first mentioned in the 2020 revision), as this can widen disparities. The Declaration now states that “the harms of exclusion must be considered and weighed against the harms of inclusion”. This requires co-design with these communities, or as argued in a new book (whose authors include Indigenous peoples in South Africa and sex workers in Nairobi) research should be “led by vulnerable groups for vulnerable groups”3 while acknowledging that many groups do not consider themselves vulnerable, perhaps highlighting the need for more inclusive terminology in the next version of the Declaration.

Similarly, the revised Declaration mandates “rigorous design” to avoid “research waste”, which should be interpreted as well-powered studies that can demonstrate safety and efficacy, so as not to repeat the fiasco during the COVID-19 pandemic, when more than 500,000 people took part in underpowered or poorly designed clinical trials, exposing them to potential risks and no potential benefit4.

...

As journal editors, we can and should insist that inclusive health research is a prerequisite for publication. But by the time a paper lands on our desk, the research has already been done — equitably or not. The power of the Declaration lies in its impact far upstream in the research process, at the point of approval by research ethics committees. By incorporating the principles of inclusive health research, community engagement and global justice, the revised Declaration is a powerful tool to enact change.

 

[Hutan]

Thanks to @bicentennial for the heads up about this.

Here's a link to the Declaration of Helsinki, published by the World Medical Association
https://www.wma.net/policies-post/wma-declaration-of-helsinki/

 

[bicentennial]

Nature Medicine

• Volume 30 | December 2024 | 3383
  • Editorial
  • Published: 02 December 2024

pdf version
Declaration of Helsinki Embraces Health Equity
https://www.nature.com/articles/s41591-024-03433-5.pdf

html? version
Declaration of Helsinki Embraces Health Equity
https://www.nature.com/articles/s41591-024-03433-5l

looks like its the inclusion principle that generates co-production

"The updated Declaration of Helsinki
empowers ethics committees
to require community engagement
and equitable partnerships"

So if required of and by the standardising ethic committees it empowers....then ...

I gather ethic committees are the upstream node that might act as a failsafe
in default of publications trading peer reviewed accolades

Spoiler: a big picture

edit to put the picture under wraps

 

[rvallee]

Those seem good on paper, but there is a lot in the details. The trash studies used in psychosomatics are almost always praised as "well-designed", even though they have the lowest quality and highest possible level of bias. If minimally enforced, this would effectively stop the endless loop of BS studies that make up the whole field. So it's hard to imagine it would be enforced. But we can dream.

Funny that they tackle two of the major issues that we face, but of course when it comes to patient engagement we find the same problem as with the lowest-quality highest-bias combo problem: they just look for patients who want the same outcome to be true, rather than people who will demand higher standards. Or just do whatever they feel like anyway. PACE had patients involved, and they still maximally cheated and got away with it.

Anyway almost all of the trials that make up the psychobehavioral base run afoul of most clinical research standards and still they keep multiplying, so everything is up to enforcement, the rest is just words to make people feel better about themselves.

 

[bicentennial]

Without a willingness to adjust proposed research, engagement is performative and not meaningful.”

RESEARCH ETHIC > COCHRANE .. COFFI .. OSLO > REHAB PUBLICITY

It is no longer ethical to launch a costly research project without recruiting an advisory board

Can we form a streamlined easygoing advisory board?

good on paper, but there is a lot in the details ...

The trash studies used in psychosomatics are almost always praised as "well-designed", even though they have the lowest quality and highest possible level of bias. If minimally enforced, this would effectively stop the endless loop of BS studies that make up the whole field.... hard to imagine it would be enforced. But we can dream ...

two of the major issues that we face

... lowest-quality highest-bias combo problem
... patients who want the same outcome to be true....

people who will demand higher standards .... almost all of the trials that make up the psychobehavioral base run afoul of most clinical research standards and still they keep multiplying, so everything is up to enforcement...

i suppose an ethics commitee does enforcement by preclusion, but where are they in the array and how can they differ from the degenerated peer review array that lost its tight junctions (at both barriers on its gut-brain axis)?

Susch that psychic, sorry psychosomatic rehab may be informed by approving subjects giving informed consent, hence the handbook needed if I am to be some-one’s subject, oh weary-deary me

Not that all CBT modifiers are unwanted of course, just those that are detrimental therefore not transparent and so weirdly enforcable. The problem may be as in Munchausens by Proxy Syndrome - the job entails such rare cases its not a dedicated service til numbers jack up (in virtual reality)

In undoctored real-time there are not enough psychosomatically crippled people to fill a clinic.

I gather that consulting with an amateur advisory board may be off-putting eg consumes time and money, was maligned as obstructive, off the wall or even requiring electronic surveillance due to death-threat activists (activist equates to football hooligan in the security lexicon), how extreme

But maybe all hurdles fell by the wayside in conversation with real-time researchers, clinics, ethic committees, funders, and publishers now editorially interested to better inform amateur advisories

 

[Hutan]

Anyway almost all of the trials that make up the psychobehavioral base run afoul of most clinical research standards and still they keep multiplying, so everything is up to enforcement, the rest is just words to make people feel better about themselves.

We've been contemplating the possibility of legal action on another thread and feeling rather pessimistic about that for now. I think complaints based on the Helsinki Declaration and national research standards might get us somewhere in the short term though. When there is an egregiously bad BPS study, I think we might be able to complain, to the Ethics committee that approved it, to the hosting institution (e.g. the university) and to national commissions with responsibility for health research quality (in my country the Health and Disability Commission would be a good place to start).

The codes and the standards are there. I think maybe we have to try to see if they are worth anything, to see if the organisations there to ensure compliance are actually doing their job.

 

[bicentennial]

THE INDUSTRY-STANDARD OR THE BOG-STANDARD OF MEDICO-LEGAL CONSENSUS

When there is an egregiously bad BPS study, I think we might be able to complain, to the Ethics committee that approved it, to the hosting institution (e.g. the university) and to national commissions with responsibility for health research quality (in my country the Health and Disability Commission would be a good place to start).

The codes and the standards are there. I think maybe we have to try to see if they are worth anything, to see if the organisations there to ensure compliance are actually doing their job.

In retrospect there is an avalanche of unscreened, substandard elitist research to be notified as no longer ethical, so maybe a short list will do, in brief marking each paper that notably overlooked its subjects and how, just to alert each Health and Disability Commission, institutional review board and research ethic committee to the notifiable volume yet to come their way in future, on its way already

In future, alerted to the volume, they can "decide what this means in practice" in advance (rather than ideal along idly then take cover, save us the bother). It is their practice to make standards pre-requisite, specifically preclude and then sieve out substandard proposals

They all know "best practice and existing frameworks" specify:

- prior recruitment of a patient, public or community advisory board
- commitment to co-design
- willingness to change tack based on community feedback

 

[Nightsong]

I have just had a (very quick) look at the 2024 Declaration & compared it to the 2013 version. Things that may be of relevance to us:

The language around vulnerable groups seems strengthened, attempting to ensure greater inclusion (19 and 20). The language around design is strengthened and now "must have a scientifically sound and rigorous design and execution that are likely to produce reliable, valid and valuable knowledge..." (21). The language about the oversight of research ethics committees is also strengthened, essentially boosting their authority, ensuring they have sufficient resources, & must now include a member of the public (23). Also more robust language around free and informed consent: for instance participants must now be informed of "qualifications of the researcher", "sources of funding" and "any potential conflicts of interest" (26).

Then there is this addition (6):

Since medical research takes place in the context of various structural inequities, researchers should carefully consider how the benefits, risks, and burdens are distributed.

Meaningful engagement with potential and enrolled participants and their communities should occur before, during, and following medical research. Researchers should enable potential and enrolled participants and their communities to share their priorities and values; to participate in research design, implementation, and other relevant activities; and to engage in understanding and disseminating results.

 

[Sean]

I wonder how much of this was informed by the disaster that is psychosomatics.

 

[bicentennial]

I wonder how much of this was informed by the disaster that is psychosomatics.

As much as any notorious walking disaster still had the infamy and gall
to misinform and disinform a global evolution of ethics
being otherwise informed by abject subjects galore
and then by N.I.C.E, WMA and WHO and other assorted "bullies"

Here is my reading of the Nature Medicine Editorial informing me
- the Editor is most clear, it is a mutual benefit but it took a global evolution 60 years
So I wonder what got inbetween the beneficiaries

Timeline:

The WMA (World Medical Association) started meeting in 1946
- it was a post-world-war thing - looks like it meets in autumn every year

In 1964 Finland had hosted the World Medical Association,
- meeting to adopt a statement of ethical principles for subjecting people to research
- the Declaration of Helsinki (updated 10x since 1964)

IT TOOK OUR WORLD 60 YEARS TO EVOLVE AN ETHIC FOR INCLUDING PEOPLE

In the nick of time and just in time for your delectable Christmas 2024,
the global ethics of health research (involving people) added an inclusion base to the evidence base

The Declaration now reflects best practice and existing frameworks
... which are bolstered by the Declaration.

It is now for institutional review boards and research ethics committees,
who are mandated to insist on “meaningful engagement”,
to decide what this means in practice.

They should require
... recruitment of a patient, public or community advisory board before the research has started,
... commitment to co-design,
... willingness to change tack based on community feedback.

Without a willingness to adjust proposed research, engagement is performative and not meaningful.

To reach us, the Declaration of Helsinki was globally evolved over 60 years
through 10 amendments
to reach us with a 10th ethical amendment of research ethics

This mutual benefit took 60 years of evolution by our conflicted world, from 1964-2024

Thereto, from 1964-2024, our conflicted world evolved 10 updates to standardise mutual benefit (inclusion):

Spoiler: the interim was grim

Already the USA was agreed to denounce tobacco as a hazard, having given up on Prohibition since it failed to make alcohol safe, but at least lynching was irregular, snuff movies went underground until selfies surfaced, the UK was agreed to ban the death penalty, thalidomide was salutary, South Africa locked Mandela away and France was still arguing on the merits of seduction versus rape.

So there was a 20yr delay, 2004-2024, due to highly organised exclusive behavioural modification

Unethical research had continued regardless of the ethical 1964 Declaration e.g a Tuskegee syphilis study brought the profession into such disrepute it made consent a legal requirement under US law.

I remain unclear if US Law responsibly required its citizens to obtain informed consent elsewhere.

How does one fully inform consent to a placebo e.g Zimbabwe (ex-Rhodesia) allowed researchers withholding the more-or-less preventive trial drug zidovudine from placated mothers until 1,000 newborns had contracted an HIV virus for the trial

I also gather, also by skim-read: controlling ideology segregated clinical ethics from research ethics to ensure that the AZT debate protracted an exclusive monopoly of power and resources, yet to be remedied
Research, Therapy, and Bioethical Hegemony:
The Controversy over Perinatal AZT Trials in Africa,
Claire L. Wendland, Cambridge University Press, 18 October 2013

So, as you recall, by 2013 there were 10 years still to go, whooosh, and here we are, or were

Spoiler: large bright image (balanced)

 

[bicentennial]

Things that may be of relevance to us ...

... strengthened ...

... the language around free and informed consent ...

could that include a Denver Principle:

In the vetting fields of clinic, research and ethic, a most pertinent principle may be adapted by an advisory committee of people with M.E / CFS, when invited, as stated in 1983 by the Advisory Committee of People with AIDS in Recommendations for Healthcare Professionals

It could well have evolved into:-

“Always clearly identify and discuss the theory they favour

as to the cause of M.E / C.F.S

because this bias affects the treatments and advice they give”

I suppose it remains a bias until cause is established. I recommend the pertinent Denver principle be incorporated asap to sooner accustom these fields with articulate transparency at the earliest stage, if not a trade secret by then.

To explore and intervene in any biology or behaviour of unknown cause, must there be a bias to steer the way in? Can we tell and be told when a signpost is only a signpost, and the cause is only suspected? Is there margin to include a suspected cause, and say its suspected?

Researchers should enable potential and enrolled participants and their communities

to ... engage in understanding and disseminating results.

well slam-dunk does this apply in retrospect? Will the original vetting committee ask a researcher to engage 5 years after publication to let and enable both enquiry and circulation, even amend an obscured conclusion, do we get to jump the paywall too? I am trying not to be flippant, is this for real what can it "mean in practice", will the committees ask for research proposals to include a protocol that enables better circulation and comprehension by amateurs however rank

 

[bicentennial]

So far I could not proceed with the document but happily i can rely on the pertinent extract provided - here is my working theory so far: at last some more of the profligate waste, rough and tumble was noted and can be stopped because it must be stopped, although best it stops of its own accord, willingly and with deep relief all round, because who can survive in a widening gap between the models professed and the reality

I have just had a (very quick) look at the 2024 Declaration & compared it to the 2013 version

Spoiler: Making ends meet

At first glance and compared with the last version ( 2013 ) it seems this updated ethic for co-productive global inclusion was informed at great length and breadth over 10 years to reinforce the vulnerable positions and scrapheaps, in order that science can be held to its profession because who can survive in a widening gap between the professions professed and reality

As we cannot get a grip we need a pioneering map made to chart the stepping stones across this torrent. We have been given an even better model than we had before, but only as a benchmark to find the self-disciplined scientists who are already told and don't need telling again by us, rather do normal consultation like nobody's business, seems there are routes to open for them too, so:

********

- do expand inclusion of vulnerable groups (19 and 20)

- must have a scientifically sound and rigorous design and execution that are likely to produce reliable, valid and valuable knowledge (21)

- ensure more oversight authority with sufficient resource and a Member of the public on board (23)

- do more robust articulation of free and informed consent: eg subjects need to know a researcher’s qualifications, sources of funding and potential conflict of interests (26)

********

Spoiler: Patient Advisory Handbook.Professional Discipline

That took a while, I don’t understand it - seems this very standard info at ( 26 ) was made available to the audience including all professionals, but was not sufficiently available to the subjects. Maybe I’ll find out what did the WMA expect in 2013, and I must look at the existing theory of good practice and frameworks evolving a participation update and now consolidated by it.

There must be a standardised manual for amateur research subjects, a basic primer to inform consents (in general), or at the very least a dictionary, in there somewhere. Also, the professional research and clinic units must sort themselves out, there is no 2 ways about it, a mutual boycott is - well - safe enough here for now but thats not inclusive

Spoiler: Balance risks in the field. Get to grips

Then there is this addition (6):

Should consider carefully how risks : benefits : burdens are distributed because all medical research has a context of various structural inequities

- I am not sure if this means a distribution is considered as an afterthought, or if such distribution can be designed - and as subject I don't trust anyone else's risk : benefit analysis and take a dim view of old marginal safety standards

Meaningful engagement with potential and enrolled participants and their communities should occur before, during, and following medical research

- So I can't accept that any and all of the organisations and institutions in and peripheral to the medical research fields already have all the patient advisories they need or can only recruit through this or that channel and and cannot engage further with the ME / CFS community at large - especially not if there is anathema on all sides

Researchers should enable potential and enrolled participants and their communities to share their priorities and values; to participate in research design, implementation, and other relevant activities; and to engage in understanding and disseminating results

- It will make a big difference when there are accomodating inclusive channels opened up, maybe along familiar lines, maybe as follows:

 

[bicentennial]

QUALITY CONTROL OF MEDICAL RESEARCH

Best practice and existing frameworks specify:

- prior recruitment of a patient, public or community advisory board

- commitment to co-design

- willingness to change tack based on community feedback

- productive rigorous scientific discovery


@Suffolkres @Haveyoutriedyoga (questions if relevant - I am shooting in the dark here - never done it)

Does the co-production procedure for a clinical design translate into procedure for a research design?

Did the Let's Talk SNEE website work to facilitate the Quality Advisory Group?

Does a research committee and its institution have a geographically local community of potential research advisors awaiting recruitment? (or are they kept in a bank and supplied by an agency)

Is the servicing of an advisory board best kept in-house or contracted out commercially? servicing of


Haveyoutriedyoga said: ↑

"one piece of the puzzle could be

- having an ongoing budget for lived experience involvement,

- having a group of properly involved lived experience reps (as opposed to helicoptering people in for one question, where they don’t have enough of the context or the relationships with the staff to actually have any meaningful influence),

- having them on recruitment panels, involved in creating key ways of working (relevant parts of standard operating procedures, specific policies),

- having them involved in periodic contract monitoring meetings and steering groups.

- This requires budget (reps should be paid) and somebody good to support the reps in their role and with any accessibility needs.

- They need to have the chance to build relationships with the service staff."

 

[bicentennial]

What about S4ME adapting one which 'we in Suffolk drafted as a proposal earlier' this year?

At least the earlier Suffolk draft has gone through due coproduction process, passed by Clinical Exec etc, within ICB and it has been notionally costed, so should/could be feasible within NHS budgets?

We created the above over 2 decades.

We were unequivocal and independant.

Had good support from Overview and Scrutiny / MPs / APPG etc

But our preferred pathway and outcomes were not shared by all those within.


Suffolk Commissioning have been fantastic.


If 'they', other Partners don't like the message, they shoot tbe message and organise a new less challenging one!

But on the streets we all confuse our mass deceit with accurate news

“The Declaration now reflects best practice and existing frameworks, such as

- San Code of Research Ethics - !Khwa ttu

you too

- TRUST Code for equitable research partnerships, which are bolstered by the Declaration.

It is now for institutional review board and research ethics committees, who are mandated to insist on “meaningful engagement”, to decide what this means in practice.

They should require recruitment of a patient, public or community advisory board before the research has started, a commitment to co-design, and a willingness to change tack based on community feedback.

Without a willingness to adjust proposed research, engagement is performative and not meaningful.”

Aha, the broken record technique, I was told it always works, told by someone who always applies it, tiresome I suppose, but such is the persistent sympobotttom of their perseverant delusion, shooting a gift horse in the mouth, was that over the top or what ? wos it not and wotnot ?

 

[bicentennial]

San Code of Research Ethics - !Khwa ttu

In the last decade, San leaders have arrived at the conclusion that most academic research on their communities was neither requested, nor useful, nor protected in any meaningful way. In many cases dissatisfaction if not actual harm was the result

In March 2017, the South African San published the San Code of Research Ethics, which requires all researchers intending to engage with San communities to commit to four central values, namely fairness, respect, care and honesty, as well as to comply with a simple process of community approval..

Respect

We require respect, not only for individuals but also for the community. We require respect for our culture, which also includes our history. We have certain sensitivities that are not known by others.

Respect is shown when we can input into all research endeavours at all stages so that we can explain these sensitivities.....(the 4 respects are drawn up here)

We need to remember that research has helped us a lot. Without research, we would be in a far worse place. So we should not put research off, only manage it.

Honesty

We require honesty from all those who come to us with research proposals.

We require an open and clear exchange between the researchers and our leaders. The language must be....

This lack of honesty caused much damage among the public, and harmed the trust between the collaborating organisation and the San.

Another common lack of honesty is exaggerated claims of the researcher’s lack of resources, and thus the researchers’ inability to provide any benefits at all.

The “entry by the front door, or by the window” analogy: the Code of Research Ethics describes how researchers may get access to the community and be welcomed as guests, through the front door, instead of acting like thieves passing through the window.

In my personal view, this Code is the most important thing ever for us. All people wanting to work with the San are now required to knock on our door. We give permission only after getting copies of what is proposed, and only if all are satisfied we then give the go-ahead.

The San Code of Research Ethics is the voice of a community that have been exploited for so many years. This code also manages to bridge the gap between the research community and the San Community through dialogue. By taking ownership of the Code the San Community will ensure that this document will remain relevant for generations to come.

The San Code of Research Ethics is important for us and is a stepping stone to work hand-in-hand with researchers and to help each other to understand the issues of the San, and most importantly to guide people to what kind of research the San need.

.

EDIT : spelling

 

[Suffolkres]

QUALITY CONTROL OF MEDICAL RESEARCH

Best practice and existing frameworks specify:

- prior recruitment of a patient, public or community advisory board

- commitment to co-design

- willingness to change tack based on community feedback

- productive rigorous scientific discovery


@Suffolkres @Haveyoutriedyoga (questions if relevant - I am shooting in the dark here - never done it)

Does the co-production procedure for a clinical design translate into procedure for a research design?

Did the Let's Talk SNEE website work to facilitate the Quality Advisory Group?

Does a research committee and its institution have a geographically local community of potential research advisors awaiting recruitment? (or are they kept in a bank and supplied by an agency)

Is the servicing of an advisory board best kept in-house or contracted out commercially? servicing of


Haveyoutriedyoga said: ↑

"one piece of the puzzle could be

- having an ongoing budget for lived experience involvement,

- having a group of properly involved lived experience reps (as opposed to helicoptering people in for one question, where they don’t have enough of the context or the relationships with the staff to actually have any meaningful influence),

- having them on recruitment panels, involved in creating key ways of working (relevant parts of standard operating procedures, specific policies),

- having them involved in periodic contract monitoring meetings and steering groups.

- This requires budget (reps should be paid) and somebody good to support the reps in their role and with any accessibility needs.

- They need to have the chance to build relationships with the service staff."

QUALITY CONTROL OF MEDICAL RESEARCH

Best practice and existing frameworks specify:

- prior recruitment of a patient, public or community advisory board

- commitment to co-design

- willingness to change tack based on community feedback

- productive rigorous scientific discovery


@Suffolkres @Haveyoutriedyoga (questions if relevant - I am shooting in the dark here - never done it)

Does the co-production procedure for a clinical design translate into procedure for a research design?

Did the Let's Talk SNEE website work to facilitate the Quality Advisory Group?

Does a research committee and its institution have a geographically local community of potential research advisors awaiting recruitment? (or are they kept in a bank and supplied by an agency)

Is the servicing of an advisory board best kept in-house or contracted out commercially? servicing of


Haveyoutriedyoga said: ↑

"one piece of the puzzle could be

- having an ongoing budget for lived experience involvement,

- having a group of properly involved lived experience reps (as opposed to helicoptering people in for one question, where they don’t have enough of the context or the relationships with the staff to actually have any meaningful influence),

- having them on recruitment panels, involved in creating key ways of working (relevant parts of standard operating procedures, specific policies),

- having them involved in periodic contract monitoring meetings and steering groups.

- This requires budget (reps should be paid) and somebody good to support the reps in their role and with any accessibility needs.

- They need to have the chance to build relationships with the service staff."

1.'Did the Let's Talk SNEE website work to facilitate the Quality Advisory Group?'

A. In effect, yes, but without that label, but as part of the Terms of Reference and 'Task Finish Group.' 2022-July 2024.

BUT, they, 'new service Development Team' as of October 2024. ....suggested that was, 'ceased.'.. without sign off, or Finish!!!

Hence now, patient/ carer and me, Voluntary Sector, and reps 3 formal complaints to CEO!

We want conrinued co produced delivery as well as service development up to spec and procurement. We were being written out......
We won't capitulate!

2. In 2022 it was suggested by very good Transformation manager, that governance required TOR etc and she suggested payment, but ICB senior Commissioning would not provide proper budget!

4. We have asked for dedicated research aspect of new ME and CFS & LC service requirement, possibly in part via University of Suffolk who are currently formally?? involved with Long Covid Service. Or elsewhere.

 

[bobbler]

San Code of Research Ethics - !Khwa ttu





Respect

We require respect, not only for individuals but also for the community. We require respect for our culture, which also includes our history. We have certain sensitivities that are not known by others.

Respect is shown when we can input into all research endeavours at all stages so that we can explain these sensitivities.....(the 4 respects are drawn up here)


View attachment 24768


Honesty

We require honesty from all those who come to us with research proposals.

We require an open and clear exchange between the researchers and our leaders. The language must be....

This lack of honesty caused much damage among the public, and harmed the trust between the collaborating organisation and the San.

Another common lack of honesty is exaggerated claims of the researcher’s lack of resources, and thus the researchers’ inability to provide any benefits at all.

View attachment 24769


View attachment 24767


View attachment 24766



View attachment 24765

I’m starting to think this might be a place for s4me to take the lead on a charter that is linked directly from this new update and is effectively the community taking control of what translation of that into the m/cfs research is/comes out at

different conditions will have different areas where things can be misapplied or undermined because: it is only in relation to CONTEXT that you can assess whether something is OUTPUTTING something that actually meets such spirit of a requirement and then develop letters/guidance that flag the issues where ‘letters [of the law]’ can be used to skirt that ‘spirit’ and give the appearance of compliance whilst doing the opposite

and me/cfs is indeed a specific context where very few organisations are positioned , or could be (lots bundled in there including will due to conflicts or other missions/obligations that would pull against this naturally and segment it) , to look at this with such eyes and understand/see the full landscape of factors

 

[bobbler]

It needs for once to be something that isn’t compiled on the basis of ‘compromise of different interested parties’ (and then the bunfight of claims of entitlement to seats round table thru nonsense calls for ‘balance’ rather than science) as it is a methodology issue at heart which goes straight to whether something is science or not. Ie there’s a ‘being qualified’ (research term meaning eg if you ask someone to answer an engineering question they need to be an engineer, questions on feeding need to involve those who’ve been there or been near there depending on the question not just any pwme) issue at different levels - and all those little factors and nuances we know of are things most of us wouldn’t be aware of the significance of if it weren’t for experience an individual who has no depth on me/cfs background would be able to see in good time. Certainly not without be very open to a heck of a boot camp and proper open mind without presumptions most of us don’t know we bring until we’ve all been forced to face them.

if it becomes’compromise based’ then it is instead a political (not science) exercise in something appearing to be ‘democratic’ (except we know the make-up and power of and often lead/main voice of players isn’t the same as the constituency underneath claimed) rather than in research terms ‘for each question that needs to be addressed who / what criteria makes someone qualified to answer/speak on that’

now calling out the misuse of the term compromise in terms of research and implementation isn’t the same as throwing out the need for pragmatism and the increased level of working together which is ‘collaboration’ - but for this the clear limit is that those who get a ‘seat at the table’ do so for a remit limited to what they are genuinely both qualified in and disinterested (conflicts of interest) in to work on.

With that latter part that means yes case studies but, as should always have been the case, with those describing them only being included where they exhibit the ability to provide brutal honest disclosure of the complete range of influences and concerns that we’re having to feed into (be born in mind) such processes.

 

[Ravn]

I posted this in another thread but it seems relevant here

[...]I think right now a more effective strategy might be to try and make the updated Declaration of Helsinki work for us

Some possible avenues:

Publish papers investigating how well research in the ME field complies with Helsinki (keeping it neutral, the facts speak for themselves), e.g.

• qualitative analysis of examples of good practice (like DecodeME), partially compliant examples (many in the biomedical line probably fit here) and examples of poor practice (most in the behavioural line)
• quantitative analysis, would show how flooded the field is with poor practice, to a degree that impedes the usual progress of science where the influence of poor papers is expected to fade as better evidence becomes available
• if none exists yet, develop & publish a tool to screen for Helsinki compliance (a screen to quickly identify where deeper questions need to be asked, not a simplistic add-up-a-score type tool)

Monitor for non-compliant papers being published and respond by highlighting the non-compliance, e.g.

• write to the publishing editor (in whatever format the journal allows)
• write to the funders (an accepted compliance screening tool could lend useful credibility here)
• write to the ethics board (ditto for screening tool)

Identify other groups interested in monitoring Helsinki compliance and work with them, make it broader than about ME because the problem is much more widespread

 

[bicentennial]

.
matters of quality control by subjects being the last resort of Science


@Ravn, yes, exactly, given your exact strategic formula, I too think :

right now a more effective strategy might be to try and make the updated Declaration of Helsinki work for us

Some possible avenues :

I think this can and may be done, in these very possible avenues, exactly as outlined here and there by @Ravn - and done in stream-lined ways to be easy for everyone inclusively

*
Publish papers investigating the facts of ME Research compliance e.g :


- qualitative analysis of good practice / partial compliance / poor practice

- quantitative analysis of prolific poor practice impeding an evolution of evidence

- find, apply, evolve & publish a screening tool for validations (NOT a tick-box tool)

- use this untickable validation tool to fast-track into the deeper questions



*
Monitor publications for non-compliant papers then highlight the non-compliance, e.g :


- inform publishing editors (in formats allowed, offering validation)

- inform funders (funders also validated with accepted compliance-screening tool)

- inform the ethics board / their institutions / the national councils and commissions (ditto)



*
Identify all the other groups also keen to duly monitor Helsinki compliance.


*
Colleague with them on all the far-flung problems of clinical research across the manifold fields beyond ours

So, maybe each arm of these avenues could do with its own venue-thread (maybe in this same "Research Methodology news and research" Forum :

Home Forums > Other news and research > Other news and research > Research methodology news and research

Declaration of Helsinki embraces health equity,
2024, Nature Medicine
editorial

Discussion
in 'Research methodology news and research'
started
by Hutan,
Dec 22, 2024

and in this here Forum on "Research Methodology news and research" there are many more matters of quality control by subjects being the last resort of Science

or - if not in this here Forum on "Research Methodology news and research" - then these other Forums already intersperse such matters across these other highly particular threads trailing to this here thread ( given pointers I could add to these indexing lists, by edit) :

* Research Methodology news and research

* Trial design including bias, placebo effect

* General ME/CFS Discussion

* 'News in Brief' for the week beginning 23rd December 2024 is here

* Forums > ...> ME/CFS and Long Covid news > Weekly ME news in brief

Ideas for a Declaration to raise standards in evidence-based medicine

Discussion
in Trial design including bias, placebo effect'
started
by rvallee,
Thursday at 3:05 PM

Have there been any high-profile critiques of

open-label, subjective-measures BPS randomised trials ?

If not, why not ?

Discussion
in 'Trial design including bias, placebo effect'
started
by Sasha,
Thursday at 11:24 AM

What high-quality resources

should S4ME produce

for PwME, clinicians, researchers etc ?

Discussion
in 'General ME/CFS discussion'
started
by Sasha,
Saturday at 1:16 PM

How can we improve the quality of ME/CFS research and clinical care ?

Discussion
in 'General ME/CFS discussion'
started
by Jonathan Edwards,
Friday at 1:32 PM

Home Forums > Advocacy and Fundraising > Advocacy > Advocacy Projects and Campaigns

Making a 'Charter for Ethical ME/CFS Research'
"....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..They could ask good researchers to mention compliance with the charter in their papers, alongside compliance with the Helsinki Declaration rules.

...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" ..... [MEMO 7 MORE PAGES TO SUMMARISE]

Discussion
in 'Advocacy Projects and Campaigns'
started
by Hutan,
Mar 10, 2024

Also there are more interspersed threads on the S4ME Xmas delivery list here - where I found more links to more S4ME Threads reporting more people who - if asked - might or might not have something to say about ethically methodical ME/CFS Research Compliance. And it could be good to ask such people how they define and screen research-method compliance, for the time being eg :

- Carmen Scheibenbogen
(lovely German word to say out loud, has a glockenspiel sound, i say it: shkeebenbogen)

"Despite having met scepticism from colleagues, she says she has a responsibility to her patients. She has initiated several treatment studies in search of a breakthrough treatment"

and / or

- Solve ME (with Dr Brayden Yellman of the Bateman Horne Centre)

"presented diagnostic and management guidance"

and / or

- ABC News

"the overall lack of data means there are no evidence-based guidelines, leaving patients, their partners and healthcare providers unable to make informed decisions"

All this and more to be found in this thread:

'News in Brief' for the week beginning 23rd December 2024 is here
- that was a good week that was

Many such threads can link to this here thread, ethical Declaration of Helsinki (update) for a node (2025) to pass through; or anyone can put this node into a separate indexing thread for keeping track
.
EDITS:
1. some quote boxes keep splintering so I am still trying to put one back together
2. Added link to "Making a Charter for ME / CFS Research"
.