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

MEMarge said:
Full report:
https://www.hra.nhs.uk/about-us/gov...th-research-authority-and-university-bristol/
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Skimming this and: multiple violations and missed requirements but it's all good because if those are retroactively fixed, did it really happen at all? Also of note: optional requirements. Apparently those are all the rage lately.

Damn. Orwell would be impressed by this one. A panel openly recommending to amend past records in order to retroactively clear misconduct. Impressive. Big Brother did that in private and pretended not to be doing that.
 
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Adrian said:
We should remember that the Bristol Vice Chancellor has already been involved in putting pressure on Berkley to keep David Tuller quite. So they should be passing this issue to their senate as the governing body rather than someone who reports to the vice chancellor.
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I have pointed out to the HRA that I consider the vice chancellor to have already compromised his independence in this regard and should have no place in adjudicating this matter. That argument has not apparently persuaded anyone involved.
 
edit: @Barry already posted these links back in 2017 - https://www.s4me.info/threads/trial...week’s-post-27-december-2017.1677/#post-28696

The HRA has helpful guides on 'is it research' and 'do I need NHS REC approval':

Decision tools
  • Is it research? Use this to check whether your project is categorised as research.
  • Do I need NHS REC approval? This tool will help you work out whether your study needs approval from an NHS REC. You can print the answer as evidence.
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https://www.hra.nhs.uk/planning-and...lanning/access-study-support-advice-services/

Taken from this short paper:

Service evaluation, audit and research: what is the difference?
Alison Twycross1,
  1. Allison Shorten2

https://ebn.bmj.com/content/17/3/65
 
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Last week, the National Health Service’s Health Research Authority published a long-awaited (by me) investigation of 11 studies from Bristol University. All 11 studies were spearheaded by Professor Esther Crawley, the University of Bristol’s high-profile pediatrician. I had flagged these studies as problematic because in every case the Bristol team exempted them from ethical review on the questionable grounds that they constituted “service evaluation” rather than “research.”

This “independent” investigation confirmed the obvious–the ethics statements were inadequate to describe the activities involved, as I had pointed out. To be clear, a shrewd sleuth initially sussed out these irregularities and alerted me to the issues; again, my work has piggy-backed on other people’s discoveries.

I have many thoughts about this investigation and the inadequacy of the recommended remedies. For now, however, I am posting the letter I received from the HRA at the same time the agency sent me the report itself. As the letter requests, I am posting the text in full rather than selected excerpts. (The formatting of the text in WordPress differs somewhat from the formatting of the original letter. Because of my lack of technological prowess, I’m not sure how to reproduce the image of the letter in the blog. The phrases below in bold replicate the use of boldface in the letter itself.)
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http://www.virology.ws/2019/10/28/t...-about-the-investigation-of-bristol-research/
 
Since David Tuller has been told not to quote from the letter, but only to publish it whole, I'm not sure if we are allowed to quote bits, so I'll paraphrase
- they say all 11 papers contain material which classifies them as research.
- they say that research that uses anonymised data doesn't need ethics approval.

From the report about the school absence study (study 5 - paragraph 63:
However, on balance, the panel considered that the project described in Paper 5 constituted service delivery and evaluation, for the purpose of improving paediatric CFS/ME services, rather than research.
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They go on to say it doesn't need ethical approval.

I don't understand.

On the one hand it's research, on the other it's service evaluation.

On the one hand only anonymised data in research is exempt, on the other you can do face to face collection of data from kids who haven't even been diagnosed yet and who haven't sought your services, yet be exempt from ethics approval.

What am I missing here?
 
Am I wrong in imagining that the Panel's report wholly fails to address the important substance, rather than mere form, of a matter? Was it not an issue that meetings were held between the clinicians and children/parents in the presence of School Attendance Officers? This all seems to have been brushed off in the report (paragraphs 62 and 63). There seems to have been clear confusion as to the roles of the parties and ethical guidance should have been required. If the senior administrators think this acceptable one does have to wonder about their judgment.
 
Trish said:
Since David Tuller has been told not to quote from the letter, but only to publish it whole, I'm not sure if we are allowed to quote bits, so I'll paraphrase
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I was asked to publish it whole. Since I've done that, the request does not bind anyone else, as far as I'm concerned and I'm sure as far as they're concerned. I mean, no one else has agreed to that condition so the HRA certainly couldn't have any expectation that it applies to anything but the first posting.
 
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Trish said:
From the report about the school absence study (study 5 - paragraph 63:
They go on to say it doesn't need ethical approval.
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It is rather confusing. As I documented at length, this "pilot program" really should not be defined as service evaluation. The point seems to be that they believe it was done in the course of the provision of normal school clinical services, but since it's a pilot program it wouldn't seem to qualify as standard clinical services.
 
In light of the controversy surrounding this area of research, we agreed at the outset that the anonymity of the panel members would be preserved and that the actions arising from this investigation would form the basis for publication.
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It would be interesting to know how often panel members have been given anonymity in previous investigations. It would also be interesting to know what specific evidence was presented to the HRA which resulted in anonymity being deemed necessary in this case. I wonder if this could be obtained via a FOI request. It would be unfortunate if the decision was based on the type of spurious claims that were rejected by the court in Alem’s successful FOI appeal.

We trust this addresses all of the concerns you have raised however if you remain dissatisfied you may wish to write to the Health Service Ombudsman.
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Are you minded to write to the ombudsman, @dave30th?
 
Caroline Struthers said:
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.
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Unfortunately it needs both intelligence plus integrity, 1 out of 2 doesn't cut it. So many examples in public life at the moment.
 
Although one can just about understand the wish for anonymity of the panel members this does introduce problems in an Inquisitorial rather than Adversarial system. No doubt the panel members are highly able in general matters of research and the procedures involved. They may even be knowledgeable about specific issues of research ethics as they apply to cases involving children, but we have no way of knowing whether this is in fact the case.

There is no one here to put the case for the complainant and point out the particular issues in need of consideration. The enquiry secretariat cannot be considered independent. Do the papers presented to the panel for consideration adequately represent the full extent of the case. It would not be unusual for panel members to be discouraged from pursuing their own independent reading to obtain a broad view of the issues.

Purpose
  1. To read and review eleven publications on chronic fatigue syndrome/myalgic encephalomyelitis (CFS/ME) citing Research Ethics Committee reference 07/Q2006/48, as listed below.

  2. To determine in each case:
    (a) Whether the collection and analysis of the data referred to in each publication was covered by an NHS Research Ethics Committee ethical review ('ethical review') and favourable opinion, including whether there was any departure from a reviewed project that was not covered by additional ethical review

    (b) Whether the collection and analysis of the data referred to in each publication was part of service evaluation (either under HRA guidance or in line with National Outcomes Database practice), and therefore did not require ethical review

    (c) If not, whether ethical review for the collection and analysis of the data (i) was required at the time of publication and (ii) would be required under current Governance Arrangements for Research Ethics Committees (GAfREC) if published today

    (d) Whether further action should be considered in relation to any publication based on the outcome of this review
This would seem to exclude whether further action should be considered in relation to consent for, and conduct of, interviews conducted in pursuance of the collection of data, and which might fall within normal requirements for ethical consideration, whether of duties of research or normal medical requirements.

The report states:

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.

Presumably this is the meeting alluded to in the letter in which the HRA confirms that it agrees with the report and its recommendations.

Did that meeting cover all the possible ground? Surely there is a duty to consider whether there are any matters outwith the narrow terms of reference and whether the panel had the necessary skills to enable it to determine substantive, rather than procedural, ethical issues.

There seems to be a possibility that the terms of reference were too narrowly drawn, the panel reported in line with its remit, and that is deemed an end of the matter.

I may have missed something. My reading is not currently entirely reliable.
 
have been taking another look at the Wakefield MMR debacle and found this statement by the Lancet:
https://www.thelancet.com/pb-assets/Lancet/extras/statement20Feb2004web.pdf

A STATEMENT BY THE EDITORS OF THE LANCET
On February 18, 2004, serious allegations of research misconduct concerning an
article by Dr Andrew Wakefield and colleagues published in The Lancet in February,
1998,1 were brought to the attention of senior editorial staff of the journal.
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The editors of The Lancet have seen and reviewed the documentary evidence
available in support of these allegations.
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Allegation 1
The evidence we have seen indicates that ethics committee approval was given for
data collection from clinically indicated investigations in the children with an initially
undiagnosed illness and who were described in the 1998 Lancet paper. This illness
was at first believed to be enteritis combined with a disintegrative disorder.
Subsequent detailed clinical investigations eventually showed this condition to be the
syndrome finally reported in The Lancet. This course of events was not described in
full in the Lancet paper, although the similarity of the behavioural changes with those
of a disintegrative psychosis (Heller’s disease) were commented on in the discussion
section of the 1998 Lancet paper. In summary, the evidence does not support this
allegation.
Allegation 2
As described under Allegation 1, detailed clinically appropriate investigations led to a
re-evaluation of the initial diagnosis of these children, as set out in protocol 172-96.
The evidence we have seen indicates that there was no attempt by investigators to
conduct the study of children reported in The Lancet in 1998 under cover of an
entirely different investigation. In sum, the evidence does not support this allegation.
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Allegation 3
Professor Walker-Smith notes that although the referral pattern was unusual-direct
contact by patients with Dr Wakefield leading to referral to the Royal Free-the
children were indeed consecutively referred. He reports that to the best of his
recollection he did not invite any children to participate in the study. Thus, as far as
the facts can be ascertained by a review of the case notes and from memory, children
reported in the 1998 Lancet paper were consecutively referred to the Royal Free and
were not deliberately sought by the authors for inclusion in their study based on
parents’ beliefs about an association between their child’s illness and the MMR
vaccine.
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Summary
The first three allegations of alleged research misconduct have been answered by
clarifications provided by the senior authors of this work. The wording in the
published paper regarding Ethical Practice Committee approval and patient referral
was accurate, yet at the same time summarised obviously lengthy and complex
institutional and clinical review and referral procedures. In the light of the public
controversy surrounding this work and the allegations made to us, one could argue
that more explanation could and should have been provided in the original paper.
Although, with hindsight, this seems a reasonable criticism, all research papers
published by all journals are inevitably concise accounts of often complicated
research protocols.
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We do not judge that there was any intention to conceal
information or deceive editors, reviewers, or readers about the ethical justification for
this work and the nature of patient referral. We are pleased to have had the
opportunity to clarify the scientific record over the matters raised by these serious
allegations.
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all this conveniently seems to have been forgotten in recent coverage of anti-vaxxers

so many similarities; will they never learn.
 
Caroline Struthers said:
Where is a copy of the letters sent out??
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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.
 
dave30th said:
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.
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Are there violations of data retention polices if they have failed to keep copies of data in an accessible place. I assume records should be kept for each individual patient as well? Don't doctors have a duty to keep adequate medical records?

I guess one of the issues is that there is a doctor who works for two institutions and each is saying look at the other. My assumption is that neither knew about what was going on and there are no records.

But by calling it a pilot study I assume that Crawley has put the ball firmly in the Bath Hospital trust's court and so I wonder if it would be worth questioning them about what approvals they gave, who funded the pilot and what data retention policies they have that would have applied in this case and why they failed.
 
Adrian, my sense is that no one gave approvals for anything, no one consented anyone, and Professor Crawley did more or less what she wanted, with the assistance of three schools in the area. She called it a "pilot study" but then claimed it was part of regular school clinical services. Bristol and HRA have apparently swallowed that line of reasoning. Whether anyone really believes that is hard to know. However, given that the investigation has decided that it was all just a misunderstanding and has basically blamed everything on what they claim is an ambiguous REC letter, that will likely be the fall-back defense to any efforts to inquire further. I am still waiting to hear from HRA if there is a deadline for filing the appeal, since it's not like I don't have other things to do as well.
 
dave30th said:
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.
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but do any parents have them??
or schools?
 
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