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

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

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

 

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.

 

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?

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

 

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

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

 

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):

 

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

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)

 

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:-

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?

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

 

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

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:

 

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."

 

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

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 ?

 

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)

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.

.

EDIT : spelling

 

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.

 

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

 

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.

 

I posted this in another thread but it seems relevant here

 

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


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

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

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

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) :

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 :

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"
.