HRA (Health Research Authority) & Bristol University's report on E. Crawley's CFS/ME Studies over registration to the Research Ethics Committee (2019)

Binkie4 said:
Thank you @dave30th for all you are doing.
It isn’t easy to tackle the eminences of the ME world and the Establishment that has consistently supported them. Chipping away at their foundations is a very worthwhile achievement.
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"Chipping away" is exactly it. Chipping away at the structure of a building very badly built in the first place. The have no way to repair the crumbling structure that is being chipped away, so they just keep erecting more facades to make their building superficially look modern and mainstream. But those facades will eventually come down with the rest of the rotten structure, as the self inflicted demolition progresses.
 
chrisb said:
Whilst we are thanking Dave for his efforts, and vindication, we might also remember the efforts of a former member here, Lilpink, who as I recall it, initially drew the attention of a wider audience to this matter.
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As I wrote in my post about the findings, and previously, a "shrewd sleuth" flagged this issue for me. I didn't discover it myself. That might have been "lilpink"--I'm not sure.
 
Barry said:
But those facades will eventually come down with the rest of the rotten structure, as the self inflicted demolition progresses.
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Let's hope. In the US, it would be devastating and a serious career black mark to have to correct the ethics statements in 11 studies after having had to agree to a 3,000-word correction/clarification in another study. Going forward, it would be hard for such an investigator to convince his/her academic institution and journals that his/her research should be taken seriously. Given the circle-jerk nature of this domain of science in the UK, I don't really know what the repercussions here will be, if any.
 
Did someone check whether the ethics statements in all eleven studies actually have been corrected by now?

Stumbled across @dave30th 's piece from 30 October 2019 / Trial By Error -- Review (Reprise)

Last November 12, I published a post called “How Bristol Investigators Avoided Ethical Review.” That post addressed the series of eleven studies conducted by Bristol investigators and exempted from ethical review on questionable grounds. The lead investigator of these studies was Professor Esther Crawley, Bristol’s methodologically challenged pediatrician, whose work was the subject of a report released last week by the National Health Services’s Health Research Authority.

That investigation confirmed my argument that these studies all qualified as “research” and not “service evaluation.” Professor Crawley has now been directed to make corrections to the ethics statements in all eleven studies. While this remedy falls significantly short of what I believe is appropriate, it would nonetheless be a humbling and perhaps humiliating task for any serious investigator to have to correct so many studies at one go. And of course this mandate comes just a few months after Archives of Disease in Childhood appended a 3000-word correction to the dung-heap known as the Lightning Process trial–also from Professor Crawley and her colleagues.
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Edit: At least one of the studies actually was corrected:

John Mac said:
A correction has appeared in BMJ Open for a UK/Dutch study published in 2015.
Esther Crawley was one of the original studies authors.
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Edit 2: Not sure though whether the correction is correct ...

see also the correction on 'Unidentified (CFS/ME) is a major cause of school absence: surveillance outcomes from school-based clinics, 2011, Crawley et al' --

forum thread here.

Apologies not able to read as much as would be necessary to get an idea of the whole issue....
 
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@Esther -- such things sometimes happen when I have a go at tidying up my drafts folder a bit.

I realize I missed most discussions about the school absence study and think I should read through that thread first?
Kalliope said:
New blog post today by David Tuller.

- This post is about a serious issue–ethical approval for research studies involving children. It is also about how powerful institutions, like leading medical journals, respond to concerns. But the story is really too long and complicated. I recommend it only for those following things pretty closely or who for whatever reason like this kind of granular, somewhat obsessive analysis.

The School Absence Study, Revisited
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Will have a look at the summary @Luther Blissett provided:

Luther Blissett said:
I tried to write a summary of the main points of the first part. Hopefully it might be of some use to others who cannot manage the full post. It's just over one page long.
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So my main question now is whether the amendments made in the two 'corrected' papers I found posted on S4ME were actually correct and what has happened since ...
 
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Unfortunately I now forgot almost everything I have been reading in addition.

But I checked the first three papers mentioned in David's review/ reprise from 30 October 2019, and couldn't see a notice of correction on any:

https://www.ncbi.nlm.nih.gov/pubmed/19452195
http://bmchealthservres.biomedcentral.com/articles/10.1186/1472-6963-11-217
http://bmchealthservres.biomedcentral.com/articles/10.1186/1472-6963-11-308

It was a particularly confusing for me to check as the list doesn't comprise title and year of the papers.

Only later I saw that a list with the titles is included in the report by the Health Research Authority's (HRA) and the University of Bristol.

Still without years of publication, but anyway, here's the list of titles:

'Report of a publications review jointly commissioned by the Health Research Authority and the University of Bristol'

URL: https://www.hra.nhs.uk/about-us/gov...th-research-authority-and-university-bristol/


1 Association between school absence and physical function in paediatric chronic fatigue syndrome/myalgic encephalopathy (CFS/ME)
http://adc.bmj.com/content/94/10/752.long

2 Anxiety in children with CFS/ME
http://link.springer.com/article/10.1007/s00787-009-0029-4

3 The impact of CFS/ME on employment and productivity in the UK: a cross-sectional study based on the CFS/ME national outcomes database
http://bmchealthservires.biomedcentral.com/articles/10.1186/1472-6963-11-217

4 What stops children with a chronic illness accessing health care: a mixed methods study in children with CFS/ME
http://bmchealthservres.biomedcentral.com/articles/10.1186/1472-6963-11-308

5 Unidentified CFS/ME is a major cause of school absence: surveillance outcomes from school-based clinics
(= 'The school absence study')
http://bmjopen.bmj.com/content/1/2/e000252.full

6 Treatment outcome in adults with CFS: a prospective study in England based on the CFS/ME national outcomes database http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3665909/
http://academic.oup.com/qimed/articles/106/6/555/1540077

7 Depression in paediatric CFS
http://adc.bmj.com/content/98/6/425.full
https://www.ncbi.nlm.gov/pubmed/23619200

8 CFS or ME is different in children compared to in adults: a study of UK and Dutch clinical cohorts
http://bmjopen.bmj.com/content/5/10/e008830.full

9 CFS symptom-based phenotypes in two clinical cohorts of adult patients in the UK and the Netherlands http://www.sciencedirect.com/science/article/pii/S0022399915300283?via%Dihub
http://www.ncbi.nlm.nih.gov/pubmed/26800634

10 Obesity in adolescents with CFS: an observational study
http://adc.bmj.com/content/early/2016/09/21/archdischild-2016-311293.full
http://www.ncbi.nlm.nih.gov/pubmed/27655658

11 Defining the minimally clinically important difference of the SF-36 physical function subscale for paediatric CFS/ME: triangulation using three different methods
https://hqlo.biomedcentral.com/articles/10.1186/s12955-018-1028-2#ethics


Edit:
Of those that I checked:

#5, #8 and #10 have notices of correction.

#1-3 and #11: Couldn't find notices of correction.
 
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MSEsperanza said:
Still without years of publication, but anyway, here's the list of titles:
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Thanks for checking into this! I've been meaning for a while to check, and haven't gotten around to it. Someone else had also pointed out to me that some were not corrected. I will take a look and alert Bristol and maybe the journals and the HRA. I can't really contact Esther directly at this point.
 
It's true. I've checked the papers against the recommended corrections, and most of the 11 papers have not been corrected. I don't know if there is a requirement to comply with such recommendations by authors and journals, or if it is advisory or voluntary. The fact is, they are all corrections to ethics statements, not to the main text of studies, and the authors were absolved of any blame. ADDED: Of course, i do not think it was warranted to absolve the authors of blame.
 
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dave30th said:
It's true. I've checked the papers against the recommended corrections, and most of the 11 papers have not been corrected. I don't know if there is a requirement to comply with such recommendations by authors and journals, or if it is advisory or voluntary. The fact is, they are all corrections to ethics statements, not to the main text of studies, and the authors were absolved of any blame.
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Well I'm sure they learned their lesson and won't do it again and again and again and so on and so forth. I mean it is a zero tolerance policy, after all. Which apparently means there are zero consequences.
 
Worth asking of the HRA at this point:

ahfco.jpg


Usually ethics and compliance are rolled into one and it's basically 1% ethics and 99% compliance.
 
dave30th said:
https://www.virology.ws/2022/08/29/...tements-in-11-papers-7-are-still-uncorrected/
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Thank you, David.

And another bump -- the HRA's letter of appreciation from 2019 to the Berkeley chancellor[*] :

Kalliope said:
On Wednesday, a senior official at the National Health Service's Health Research Authority sent a letter to the Berkeley chancellor. I did not ask the HRA to send such a letter, so I was surprised when my department head forwarded it to me earlier today. Berkeley has strongly supported my right to make my case all along, but it certainly doesn't hurt to have official confirmation that I was right to raise concerns.

I continue to have questions about the independence of the supposedly "independent" panel that reviewed Professor Crawley's work. I have also made it clear that I find the mandated remedies inadequate. The letter does not address those issues. Nevertheless, the HRA was aware of Bristol's complaints about my "actions and behaviour," so I very much appreciate that the agency took the initiative to alert Berkeley's chancellor to the outcome of the investigation.
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Kalliope said:
Here's the letter:

Dear Chancellor Christ,

You may be aware that we recently responded to concerns that David Tuller shared with us about several research studies involving patients with CFS/ME. This response, made in line with our processes for complaints and concerns, has taken a significant amount of time as we have had to work across a number of organisations and we are grateful to David for his patience. As the concerns raised with us were wide-reaching, unfortunately we were unable to answer questions which fell outside the remit of the Health Research Authority (HRA). You can read a full statement on our website https://www.hra.nhs.uk/…/outcome-expert-panel-review-eleve…/

We have identified and implemented a number of improvements to procedures as a direct consequence of David’s concerns together with similar questions raised by other individuals. We constantly review, with our Research Ethics Committees, the ways in which we work to ensure that they remain fit for purpose, and we are grateful when potential issues are brought to our attention.

We fully understand and support the need for more comprehensive research into this dreadful condition which affects so many people’s lives.

With Regards...
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[*] Edit: see David's post here.
 
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