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

Do this panel of intelligent people not think that using school records to identify kids who miss a lot of school and then writing to their parents out of the blue to invite them to attend a "pilot" school clinic is something that should have ethical oversight? Where is a copy of the letters sent out?? Informed consent? Really?? What is actually going on here? I am sure when the conversation took place and Esther asked the REC if she really needed to bother with ethics, she was didn't make it very clear exactly what she was planning to do. Or maybe she'd already done it. Who knows. Deeply depresssing.
 
Seems like someone should be holding HRA/Bristol to account for their shoddy approach to investigating this. In a normal world the Select Committee on science could do this - call them in for a hearing. Unfortunately in the current political situation we are highly unlikely to see that happening.
 
These last comments are most unfair. In the absence of evidence to the contrary, it is a well established principle that everyone must be believed... even if no evidence is gathered directly from them rather than through a third party.
 
Do this panel of intelligent people not think that using school records to identify kids who miss a lot of school and then writing to their parents out of the blue to invite them to attend a "pilot" school clinic is something that should have ethical oversight? Where is a copy of the letters sent out?? Informed consent? Really?? What is actually going on here? I am sure when the conversation took place and Esther asked the REC if she really needed to bother with ethics, she was didn't make it very clear exactly what she was planning to do. Or maybe she'd already done it. Who knows. Deeply depresssing.

Often there may already be issues between the school and parents over attendance when a child is ill. We had real problems with a school who were not sympathetic. If a parent were to receive such a request with an undiagnosed child they may well feel forced to attend as the school could already be making threats (including threats of fines).

I wonder whether a health trust operating a new service has an ethics review process or what the Bath health trust would think to their name being associated with a service that forces children's participation. If it was a genuine service then the Bath NHS trust should have some serious questions to answer.
 
Perhaps the most concerning aspect of this is how research is translated into practise - if there is the green light to essentially do as you please without due accountability then it is little wonder that we have the responses in the ME Action survey; those related to paediatrics are particularly damning, and this research team has been at the forefront for years. There are consequences for actions , and if there is little ethical oversight at the beginning, then what can there be at delivery?
Bath had the highest response rate ( perhaps as it is seen as a centre of excellence)
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Do this panel of intelligent people not think that using school records to identify kids who miss a lot of school and then writing to their parents out of the blue to invite them to attend a "pilot" school clinic is something that should have ethical oversight? Where is a copy of the letters sent out?? Informed consent? Really?? What is actually going on here? I am sure when the conversation took place and Esther asked the REC if she really needed to bother with ethics, she was didn't make it very clear exactly what she was planning to do. Or maybe she'd already done it. Who knows. Deeply depresssing.
Intelligence dosn't come into to it. It seems eminence does
 
Do this panel of intelligent people not think that using school records to identify kids who miss a lot of school and then writing to their parents out of the blue to invite them to attend a "pilot" school clinic is something that should have ethical oversight? Where is a copy of the letters sent out?? Informed consent? Really?? What is actually going on here? I am sure when the conversation took place and Esther asked the REC if she really needed to bother with ethics, she was didn't make it very clear exactly what she was planning to do. Or maybe she'd already done it. Who knows. Deeply depresssing.

My understanding is that for the eleven published projects involved in this enquiry, Crawley produced a single earlier letter from her ethics committee saying that ethical approval was not required for a specific but unconnected service evaluation involving the blinded analysis of anonymised forms [relating, if I recall correctly, an evaluation of a service for adults].

This suggests that the question of whether ethical approval was or was not required was circumvented in all these studies by the production of this single unconnected letter. The lead researchers created the misleading impression that the exemption of these studies had each been formally agreed, which was not the case. This means there were worrying problems with the approval process, regardless of whether or not they could be regarded as service evaluation and therefor exempt from ethical approval.

The most controversial of the eleven studies is the School Absence study, and it was only because of the wider concerns about this study that this abuse of process became apparent. For reasons discussed in various forums, including here, there are many arguments for this study being research, indeed it was published by the journal as such, but even if these arguments turned out to be incorrect some the ethical consideration of a pilot service screening all school non attenders for ME/CFS regardless whether or not there were any health concerns surely requires some specific consideration. It was never acceptable for it to avoid any ethical scrutiny, not even discussion of whether it was service evaluation or research, on the basis a letter written several years before relating to a completely different project.
 
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My understanding is that for the eleven published projects involved in this enquiry, Crawley produced a single earlier letter from her ethics committee saying that ethical approval was not required for a specific but unconnected service evaluation involving the blinded analysis of anonymised forms [relating, if recall correctly, an evaluation of a service for adults].

This suggests that the question of whether ethical approval was or was not required was circumvented in all these studies by the production of this single unconnected letter. The lead researchers created the misleading impression that the exemption of these studies had each been formally agreed, which was not the case. This means there were worrying problems with the approval process, regardless of whether or not they could be regarded as service evaluation and therefor exempt from ethical approval.

The most controversial of the eleven studies is the School Absence study, and it was only because of the wider concerns about this study that this abuse of process became apparent. For reasons discussed in various forums, including here, there are many arguments for this study being research, indeed it was published by the journal as such, but even if these arguments turned out to be incorrect some the ethical consideration of a pilot service screening all school non attenders for ME/CFS regardless whether or not there were any health concerns surely requires some specific consideration. It was never acceptable for it to avoid any ethical scrutiny, not even discussion of whether it was service evaluation or research, on the basis a letter written several years before relating to a completely different project.
this
 
The constraints imposed by the terms of reference may have had an impact.

It is not within the panel's remit to determine whether there has been misconduct by any person.

So within whose remit is it?

The article announcing the review says this:
Conclusions
On the basis of these findings, the Chief Executive and Chair of the HRA have confirmed to the University of Bristol that a number of actions need to be completed by both parties but that there is no requirement for any action under the University of Bristol Disciplinary Procedure or any other University procedure.
That sounds to me as if they have stepped beyond their remit and instructed Bristol Uni not to take any disciplinary action.

But the full report seems to contradict that statement:
Next steps
This report and the panel's findings and recommendations will be considered by the Chief Executive of the Health Research Authority and the Pro Vice-Chancellor for Research at the University of Bristol, who will decide on any further action to be taken.
My bolding.
 
The article announcing the review says this:

That sounds to me as if they have stepped beyond their remit and instructed Bristol Uni not to take any disciplinary action.

But the full report seems to contradict that statement:

My bolding.

The statement effectively recommending that the university take no action would seem to be "ultra vires". The university must consider the matter as though no such recommendation had been given.
 
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Do this panel of intelligent people not think that using school records to identify kids who miss a lot of school and then writing to their parents out of the blue to invite them to attend a "pilot" school clinic is something that should have ethical oversight? Where is a copy of the letters sent out?? Informed consent? Really?? What is actually going on here? I am sure when the conversation took place and Esther asked the REC if she really needed to bother with ethics, she was didn't make it very clear exactly what she was planning to do. Or maybe she'd already done it. Who knows. Deeply depresssing.

Those in positions of power require not only intelligence but also morality and empathy. Let's face it, plenty of intelligent people behave appallingly!
 
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Where is a copy of the letters sent out?? Informed consent? Really?? What is actually going on here? I am sure when the conversation took place and Esther asked the REC if she really needed to bother with ethics, she was didn't make it very clear exactly what she was planning to do.
I filed FOIs for the letter. Bristol said they didn't have it and it was based at the clinic. The clinic told me they didn't have it and it must be at Bristol. Esther obviously has a copy, but that does not appear to fall into the category of Bristol having a copy. Esther claimed she sought further advice, and though no records exist of those conversations, the report takes it at her word that they occurred. Since she presumably did not tell them she was interviewing children and their parents outside of the context of routine clinical services at the school, and advice they gave her under those circumstances would have been meaningless for being based on inaccurate or incomplete information.
 
Do this panel of intelligent people not think that using school records to identify kids who miss a lot of school and then writing to their parents out of the blue to invite them to attend a "pilot" school clinic is something that should have ethical oversight? Where is a copy of the letters sent out?? Informed consent? Really?? What is actually going on here? I am sure when the conversation took place and Esther asked the REC if she really needed to bother with ethics, she was didn't make it very clear exactly what she was planning to do. Or maybe she'd already done it. Who knows. Deeply depresssing.


You can get away with almost anything if you want to. Most people just don't want to, that's the difference!

That's why so many of us have difficulty understanding why so called self correcting systems don't work.

The people that "want to" realise there is no self correcting system.
 
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