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

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.

 

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.

 

Can you point me to a specific place where that is clear?

 

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':

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

 

http://www.virology.ws/2019/10/28/t...-about-the-investigation-of-bristol-research/

 

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.

 

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.

 

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.

 

Yes, this would also suggest that these meetings cannot be defined as standard clinical services.

 

TL;DR: violations are A-OK and requirements are optional.

 

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.

Are you minded to write to the ombudsman, @dave30th?

 

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

all this conveniently seems to have been forgotten in recent coverage of anti-vaxxers

so many similarities; will they never learn.

 

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.

 

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.

 

but do any parents have them??
or schools?

 

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.