Trial By Error: Bristol Investigating Crawley Papers

Andy

Senior Member (Voting rights)
In the last year, I have raised multiple concerns about studies from the University of Bristol with the UK Health Research Authority, among others. The HRA is the National Health Service arm that oversees approvals for research in England; the agency’s role is to ensure that research receives a favorable opinion from an ethics committee before it begins.

Yesterday, the agency confirmed to me that, after reviewing the matter, it has raised questions with University of Bristol officials about a number of these studies and has asked them to investigate the situation. The HRA is now awaiting the outcome of that investigation.
http://www.virology.ws/2019/01/31/trial-by-error-bristol-investigating-crawley-papers/
 
Have just got round to looking at the Health Research Authority's website (see https://www.hra.nhs.uk ). On their section on their governance the say:

We are an arm’s length body of the Department of Health (DH), which operates within a Framework Agreement with DH and the Care Act 2014 which governs its functions.

In making decisions and undertaking actions, we take account of the NHS Constitution, a statute which brings together in one place the rights and responsibilities of staff and patients when using NHS services and the values and principles which underpin the NHS.

We lay our Annual Report and accounts before Parliament, and robust public and parliamentary accountability arrangements are in place between the DH and the HRA to ensure good communication and effective collaborative working between the two organisations. Quarterly accountability meetings are held which provide a mechanism for the DH to assure itself of the HRA’s delivery of its objectives.

We are governed by a Board that functions as a corporate decision-making body. The Board is composed of five non-executive directors (including the Chair) and three executive directors. We are committed to openness and transparency with Board meetings held in public and Board papers and minutes published on our website.

We are responsible for a budget of approximately £13m and we currently have approx.1,000 committee members who voluntarily serve on the our Research Ethics Service Committees (RECs), a National Research Ethics Advisors’ Panel (NREAP) and a Confidentiality Advisory Group (CAG). Staff are based in London, at the HRA head office at Skipton House, and four offices in Bristol, Newcastle, Manchester and Nottingham.

The Board Members are Dr Allison Jeynes-Ellis, Dr Janet Messer, Graham Clarke, Ian Cook, Juliet Tizzard, Karen Williams, Orof Deirdre Kelly, Prof Sir JonThan Montgomery and Teresa Allen (those with science or medical backgrounds seem to come from pharmacology, biochemistry or very much biomedical backgrounds, see https://www.hra.nhs.uk/about-us/who-we-are/our-board-members/ ). They don't seem to list the volunteers that sit on their Research Ethics Committees (see https://www.hra.nhs.uk/about-us/committees-and-services/res-and-recs/ ) So far I have not found anything on their site relating to research malpractice in published studies.
 
It may be a useful exercise to go through the HRA's research summaries relating to ME, ME/CFS, etc by searching on their Research Summaries page (see https://www.hra.nhs.uk/planning-and-improving-research/application-summaries/research-summaries/ ), I found 61 summaries for CFS and 58 for ME/CFS, but will need to return to this when I am more on the ball.

Their procedures for 'feedback or concerns' seems to relate primarily to researchers rather than third parties (see https://www.hra.nhs.uk/about-us/governance/feedback-raising-concerns/ ), which is perhaps not surprising given the status quo in the UK is not set up to take into account third party or patient input, but are there matters we at S4ME, individually or collectively would want to raise with them?

It will be interesting to see how proactive they will be in relation to this Bristol debacle, whether their raising the current issues with Bristol came from a real understanding or some form of 'going through the motions'.
 
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Great to hear but I wish it was a more independent investigation, it's like letting Volkswagen investigate whether they cheated emissions.

It is. I remember when someone complained about the ethical approval given to one of Crawley's trials one of the things she quotes in terms of harm is the cochrane meta analysis for GET. But the quote she gives is misleading because it doesn't contain the caveat around very little data being available and she quotes the number of patients within all the trials they looked at rather than the number in trials with some form of harms reporting. When a researcher gives misleading evidence to the ethics committees we can be sure she will do the same for an internal private inquiry.

The Vice chancellor for Bristol is also implicated in the ethical issues since he has failed to investigate in the past instead preferring to put pressure on Berkeley to try to shut @dave30th up. So the university really needs to be investigated externally and publicly.
 
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Doing a search for 'Crawley' on the the HRA research summaries page (see https://www.hra.nhs.uk/planning-and...search_type=&rec_opinion=&date_from=&date_to= ), though MAGENTA and FITNET-NHS appear, none of the studies raised by @dave30th appear.

This is not surprising in relation to the studies for which she sidestepped ethical aproval on false grounds, but the Lightning Process study also fails to appear.

Did someone check the local planning department at Alpha Centauri?
 
There are matters beyond our immediate control that make this challenging as I am sure you understand

Considering the issues raised all fall within the bounds of BMJ's own rules and guidelines, this is most definitely not something that anyone should understand, or even find reasonable. There are no known extenuating circumstances, in fact it is utterly bizarre to raise this. Coming from a lower-level employee, sure, but coming from the editor this seems to suggest external interference.

Why does everything Crawley publish need so much institutional water-carrying? Why is there any happening at all? Scientific journals are supposed to be arbiters of research, not cheerleaders and enforcers. If this continues it will eventually raise fundamental problems within the whole of UK medical institutions.
 
There are matters beyond our immediate control that make this challenging as I am sure you understand

My impression is that David, and perhaps the rest of us, is supposed to have some insight into these matters outside control. Perhaps there is something unusual going on that is supposed to be discreetly in public circulation (if that makes sense). It is all pretty peculiar, certainly.

But it is hard to see what takes precedence over the interests of the patient community, and scientific probity as a whole.
 
Is it clear what is meant by "our"? If it means the editorial staff, the problem could be the proprietors. If it means the company then it is hard to see. One would have thought any comments could be framed in such a way as to avoid any legal threats. It seems to imply "force majeure".
 
Did someone check the local planning department at Alpha Centauri?
“But the plans were on display…”
“On display? I eventually had to go down to the cellar to find them.”
“That’s the display department.”
“With a flashlight.”
“Ah, well, the lights had probably gone.”
“So had the stairs.”
“But look, you found the notice, didn’t you?”
“Yes,” said Arthur, “yes I did. It was on display in the bottom of a locked filing cabinet stuck in a disused lavatory with a sign on the door saying ‘Beware of the Leopard'. Ever thought of going into advertising?"
 
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