Trial By Error: The School Absence Study, Revisited (Crawley/SMILE)

Kalliope

Kalliope

Senior Member (Voting Rights)
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
 
I’m glad that BMJ Open considers me “high profile” and thinks my critical post was “shared widely.” Moreover, it is possible that what I wrote was “damaging to the publisher’s reputation.” When editors and journals twist themselves upside down to avoid admitting mistakes, they should not be surprised if they suffer reputational damage.
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Love it.
 
There's so much good stuff in this new post. It is quite long, but I also thought it was quite a simple and clear read (although I had re-read his earlier blog on this recently).

If it really is that it is the 2007 letter that is being referred to in this COPE account, that is appalling:

https://publicationethics.org/case/service-evaluation-research-controversial-area-medicine

Besides citing unverifiable exchanges, BMJ Open’s account includes as back-up evidence a snippet of a letter from the research ethics committee itself. This snippet is presented as if it were possibly from a post-2007 or updated ethics committee letter based on new information arising from “regular contact” with Professor Crawley. Instead, it actually appears to have been taken from the 2007 letter already cited in the paper as the source of the ethical review exemption.

That 2007 letter ended with this paragraph, from which the snippet could have been extracted: “This letter should not be interpreted as giving a form of ethical approval to the project, but it may be provided to a journal or other body as evidence that ethical approval is not required under NHS research governance arrangements.” In the context of the 2007 letter, “the project” is solely referring to the collection from current patients of additional data at six weeks and six months. Since this does not describe the data collection involved in the pilot intervention, it is unclear why BMJ Open is citing the letter as evidence to support the case for service evaluation.
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The text is the same as that used on page 5 of the document I posted above.

To me, this really looks like a deliberate attempt to mislead. We're probably not meant to say that... but!!!

It seems like the problems around PACE/Crawley/etc have now become a smaller part of a more important story of the corruption of the systems of oversight for medical research.

Huge thanks to Tuller for going through all this and writing it up. Also, thanks once again to the person who first drew his attention to this problem. These sorts of things should not have to fall to sharp-eyed advocates and trouble-making journalists! Where are the people whose job it is to keep an eye on stuff like this.
 
Esther12 said:
Huge thanks to Tuller for going through all this and writing it up. Also, thanks once again to the person who first drew his attention to this problem. These sorts of things should not have to fall to sharp-eyed advocates and trouble-making journalists! Where are the people whose job it is to keep an eye on stuff like this.
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Seconded. I think it's interesting to note that in this blog we have two non patients working incredibly hard on our behalves. The iniquities that have been brought to bear on our Community are being exposed and uncovered by people outside the Community now...and this reflects a marked sea change seen in ME advocacy /politics over the last 2 years. That's significant imo.
 
I have commented on the Virology Blog directly, but as it seems to be eating up my comments again I have included them as a single quote below:

There can be little doubt that setting up a new screening process to identify what proportion of children with low attendance records may display the symptom of chronic fatigue was a new venture for Prof Crawley's CFS/ME service. There also is no doubt that the consultations about the need for ethical approval for service evaluation undertaken by Prof Crawley did not relate to this research.

It is possible that Prof Crawley's failure to follow due procedures resulted from woolly thinking and was a genuine mistake. However it is concerning that she did not consider several ethical issues involved in inviting children with low school attendance records to what amounts to a medical assessment:

firstly there is the matter of undertaking a preliminary medical assessment of children for a condition you expect a significant proportion not to have,

secondly it is not clear what constitutes free and informed consent in a situation where parents/guardians may fear legal repercussions

and thirdly all the paper work refers only to the symptom of chronic fatigue and provides no information on how and when any subsequent differential diagnosis of CFS/ME might take place.

However there can be no doubt that Prof Crawley, the University of Bristol and the BMJ failed to respond appropriately when the lack of any real evidence that Prof Crawley followed due process in considering ethical issues was raised.



The research then involved looking at how the children identified as having chronic fatigue responded to the service provided by Prof Crawley's clinic in comparison to children referred by the existing processes. Again this would seem to be research rather than evaluation of current provision as it is comparing the existing service to a new source of referrals.

Again there does not seem to be any mention of differential diagnosis as to what was the cause of the symptom of chronic fatigue identified in the previous screening. Again there is the issue of free and informed consent to any intervention in a situation where low school attendance places parents/guardians at risk of legal action. This is particularly relevant as included in the interventions offered by the Clinic are GET and CBT which are particularly controversial for people who might actually have CFS/ME. If no differential diagnosis was undertaken can anyone be considered as giving informed consent.

Although many people might consider this as nitpicking it does raise very important issues of genuine ethical aproval and informed consent, but also the apparent lack of openness and honesty in the British research establishment. So thank you to the person that raised these issues and to David, both of whom have put a lot of work into clarifying the obfuscation of Prof Crawley, Bristol University and the BMJ.
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Esther12 said:
To me, this really looks like a deliberate attempt to mislead. We're probably not meant to say that... but!!!
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It sounds an awful lot like Esther Crawley falsified ethical approval (or an exemption of it) for the school recruitment trial by reusing an exemption which was given for a completely different project. And the BMJ is now lying to avoid looking like crooked idiots for allowing the piece to be published regardless.

It's scientific misconduct and a coverup. The University of Bristol and the BMJ are making themselves complicit by promoting unethical research based on such misconduct, and by supporting the researcher whose conduct violated very basic standards.
 
Valentijn said:
It sounds an awful lot like Esther Crawley falsified ethical approval (or an exemption of it) for the school recruitment trial by reusing an exemption which was given for a completely different project. And the BMJ is now lying to avoid looking like crooked idiots for allowing the piece to be published regardless.

It's scientific misconduct and a coverup. The University of Bristol and the BMJ are making themselves complicit by promoting unethical research based on such misconduct, and by supporting the researcher whose conduct violated very basic standards.
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Absolutely. How can any rational person interpret it in any other way?
 
Peter Trewhitt said:
...secondly it is not clear what constitutes free and informed consent in a situation where parents/guardians may fear legal repercussions
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Feels like this could itself be a (much?) bigger ethical issue in its own right. Parents of high-absence children are almost always in fear of some form of official retribution. Being 'invited' to one of these meetings would have been intimidating for many parents, both in terms of feeling obligated to attend, and the notion of a very unusual school absence meeting itself. We know what a manipulative person EC is at the best of times, so I wonder what actually transpired in those meetings?

Merging two completely separate meeting 'roles' into one is potentially highly unethical in itself: 1) A school attendance meeting (it inevitably was, in this context), and 2) A scientific trial enrolment interview. However it may have been presented, parents would have perceived these meetings so. The potential for conflicts of interests here are considerable, as is the potential for parents to feel coerced or even extorted to play along, and toe the line.

Although this issue is now being examined retrospectively, we must be clear the ethical approval issue in question here is not about whether such things did or did not happen; it is about whether at the time the possibility could reasonably exist of such things. A 'yes' answer would have had to mean, surely, that this one issue alone necessitated ethical approval; how could anyone have sanely answered 'no'.
 
Barry said:
Feels like this could itself be a (much?) bigger ethical issue in its own right. Parents of high-absence children are almost always in fear of some form of official retribution. Being 'invited' to one of these meetings would have been intimidating for many parents, both in terms of feeling obligated to attend, and the notion of a very unusual school absence meeting itself
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In a similar situation, Psychologists were up in arms about Psychometric testing of people at Jobcenters. Large numbers were against any therapeutic interventions taking place at Jobcenters as consent could not be freely given.

DWP work 'coaches' at GP surgeries are similarly controversial.



Let's be honest. Those Parents or carers were forced into a meeting under the threat of legal action and/or fines. Any consequent decisions they made to go along with the study are null and void.
 
I'm also not certain it is ethical to have a medical professional not of the parents' choice at the meeting that was already likely
high-tension for the parents; not to mention the medical professional doing this "evaluation" also happens to head up a clinic that also happens to be recruiting children for a treatment study???

I'd like to know how many parents felt comfortable under those circumtances to have told them no thank you.

If that's not coercion I dunno what is, and I can't believe nobody involved told the rest of them so.
 
Luther Blissett said:
Those Parents or carers were forced into a meeting under the threat of legal action and/or fines.
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I imagine that this might only be 'implicit' by virtue of the route of contact (ie we have to be careful not to make unsubstantiated statements) , but I do quite see that in the minds of any parent or guardian it would be interpreted as that, which of course raises all sorts of ethical questions.
 
Lilpink said:
I imagine that this might only be 'implicit' by virtue of the route of contact (ie we have to be careful not to make unsubstantiated statements) , but I do quite see that in the minds of any parent or guardian it would be interpreted as that, which of course raises all sorts of ethical questions.
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And of course in a face-to-face meeting it is very easy to say things ambiguously, combined with relevant intonations and body language, that can convey messages the words alone do not. Now I wonder, is there anyone we know who would have been in those meetings, who has a track record of excelling at such behaviour? Some parents could have been terrified of not doing as expected, let alone the children.
 
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