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

[Amw66]

Parents must, but how to find them? The education department has claimed to know nothing about it. The specific schools were not identified in the study.

would you like a few posts on parents forums?
I take it its Bristol/ Avon area

 

[Amw66]

Bristol uni - research ethics tool down .....
http://www.bris.ac.uk/social-community-medicine/people/simon-m-collin/pub/95047718

 

[dave30th]

would you like a few posts on parents forums?
I take it its Bristol/ Avon area

Sure that would be good. Actually, the schools were said to be in the Bath area.

 

[Amw66]

Sure that would be good. Actually, the schools were said to be in the Bath area.

Will PM any responses

 

[Peter T]

Sure that would be good. Actually, the schools were said to be in the Bath area.

I hesitate to be specific on line, but it may be possible to identify one of the schools from information in the published paper.

[added - Have messaged @dave30th with the name one of the schools I believe to be involved. Am happy to share it privately but don’t feel appropriate to do so in a public forum.]

 

[rvallee]

so many similarities; will they never learn.

What's there to learn? The people most responsible, especially Horton, didn't even get any blame. That's about as clear a green light to do it again as it gets.

Not much surprise that there so many similarities.

 

[rvallee]

I have tried repeatedly to get a copy of the letters. Bristol says they don't have them and the clinic in Bath should have them. The clinic in Bath referred me back to Bristol. No one will acknowledge having them. Since there was no ethical review and no apparent consent, there's no real way to conduct oversight.

What's weird is that for PACE they simply noted their transgressions and had them approved in secret. It worked then and was cleared on the basis that it was all reported and so the transgressions magically become irrelevant, can't see why not do it the same way again.

Hubris, maybe? After all the conflicts of interest were not noted either, even in secret, and those were cleared too, or mostly glossed over anyway. Though both cases have the implausible deniability of promising that the numerous changes were not meant to get a better outcome, that is despite direct admission of having done so. Damn, this is all so ridiculous. Down isn't up, it's both down AND up. Nothing matters.

I'm no expert but that seems like a very lousy way to run ethical review on clinical research, especially with children.

 

[Barry]

Is there not a more fundamental human rights issue that could be escalated, to an authority above and outside of medical trial ethics? I presume Brexit will screw up escalating things to the European court of Human rights (is that the correct name), but it feels like when all the supposed checks and balances are severely compromised by cronyism, it needs escalating outside the influence of the cronies.

 

[Peter T]

Is there not a more fundamental human rights issue that could be escalated, to an authority above and outside of medical trial ethics? I presume Brexit will screw up escalating things to the European court of Human rights (is that the correct name), but it feels like when all the supposed checks and balances are severely compromised by cronyism, it needs escalating outside the influence of the cronies.

The European Court of Human Rights is not directly part of the EU and our membership of it predates the establishment of the EU. I think it was set up just after the Second World War, partly at the instigation of the UK and Churchill.

The official court of the EU is a separate body, called the European Court of Justice. Theresa May did want to take us out to the European Court of Human Rights in addition to the European Court of Justice, but gave up because of the outcry. So unless it is raised again before Brexit, the current withdrawal agreement seeks to just get us out of the latter.

 

[Sly Saint]

Is there not a more fundamental human rights issue that could be escalated, to an authority above and outside of medical trial ethics? I presume Brexit will screw up escalating things to the European court of Human rights (is that the correct name), but it feels like when all the supposed checks and balances are severely compromised by cronyism, it needs escalating outside the influence of the cronies.

taken from a different thread

Human rights (mentioned above) are an integral in every aspect of life. Article 8 of the European Convention on Human Rights would be the most likely vehicle for ME patients (right to private and family life which broadly includes the right to appropriate healthcare). There are other possibilities but Article 8 is the most relevant. However, launching a legal action is an expensive and lengthy business and always needs expert professional advice first. In the context of the NICE review, it would most likely arise as part of a (hypothetical) judicial review. Such an action would also need to avoid the mistakes of the last JR attempt ten years ago.

 

[Kalliope]

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.

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...

 

[chrisb]

The choreography of this makes matters look even worse for Bristol. A letter from the regulator but not from Bristol. Is this position tenable, or is there movement behind the scenes?

 

[Trish]

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

Is this bit supporting patients, or supporting Crawley's research and implying it's valuable and that's why they've treated her softly.

 

[dave30th]

Is this bit supporting patients, or supporting Crawley's research and implying it's valuable and that's why they've treated her softly.

As I have added to the FB post, the letter came from chief executive Teresa Allen. I had sent her a copy of my letter to Bristol. I don't know exactly what prompted the letter, but it is phrased in a way that lends support to my position in relation to Bristol. And yes, I think it puts more pressure on Bristol to respond appropriately, which might have been the intention behind the decision to send it. I can disagree with the purported "independent" nature of the panel and with the recommended remedies while at the same time appreciating that the letter was sent in what I interpret as an effort to weigh in on my side of the dispute and shore up my support at Berkeley. Having said that, I want to stress that my department and the chancellor's office have been completely supportive throughout. No one there has doubted my integrity or the accuracy of my findings.

 

[Trish]

I don't know exactly what prompted the letter, but it is phrased in a way that lends support to my position in relation to Bristol.

It's really good that they have written to your University praising your efforts. I hope they have sent a copy of their letter to the appropriate people at Bristol too. It certainly should prompt Bristol to withdraw their complaints about you.

Your efforts on this have been very worthwhile. Thank you.

 

[Sean]

My eyes are not the best these days, but I am pretty sure that letter says the winner is @dave30th, and Crawley & Bristol are not.



Well played, sir, and totally deserved.

 

[dave30th]

I hope they have sent a copy of their letter to the appropriate people at Bristol too.

Not sure about that, but I intend to make sure Bristol knows about it.

 

[Kalliope]

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.

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...

As blogpost:
Trial By Error: The HRA's Letter to Berkeley's Chancellor

The HRA was aware of the Bristol vice-chancellor’s complaints to Berkeley about my “actions and behaviour.” So I very much appreciate that Teresa Allen, the chief executive, took the initiative to alert Berkeley to the outcome of the investigation. She did not have to do this. She presumably understood that Berkeley would interpret the letter as vindication of my position. I am therefore deeply grateful that she went out of her way to keep the chancellor of my academic institution in the loop. It means a great deal to me.

 

[Binkie4]

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.

 

[chrisb]

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.