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.

 

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.

 

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)

 

Intelligence dosn't come into to it. It seems eminence does

 

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.

 

this

 

So within whose remit is it?

 

I contacted the HRA about the issue in 2017
https://www.s4me.info/threads/david...how-to-avoid-ethical-review.6653/#post-121341

 

This is why we need The Research Police!

 

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.

 

It does seem strange that the Terms of Reference and the draft Report must have been prepared, or at the vey least seen, by the legal department, and yet this was not spotted.

 

there is a feedback or concerns page
https://www.hra.nhs.uk/about-us/governance/feedback-raising-concerns/

eta: not sure if it is useable for a report done by the HRA tho

 

Those in positions of power require not only intelligence but also morality and empathy. Let's face it, plenty of intelligent people behave appallingly!

 

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.

 

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.