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

Outcome of an expert panel review of eleven publications on Chronic Fatigue Syndrome (CFS) and Myalgic Encephalomyelitis (ME)

Key Findings
The panels’ findings were unanimous and the Chief Executive of the HRA has accepted its recommendations in full. These were

(a) Research Ethics Committee (REC) documentation was incomplete and was, in some respects, lacking in clarity and open to interpretation

(b) No favourable ethics opinion was obtained in respect of any of the papers reviewed

(c) In all eleven papers, the REC reference, as cited in the ethics statement, was either inappropriate or inadequate to cover the activity described

However,

(d) No additional ethical review was required. Each study was assessed against a number of reference documents including the relevant editions of GAfREC and the UK Policy Framework for Health and Social Care Research to establish whether the study required an ethics opinion. Certain types of research do not require ethical review. It was recommended that the ethics statement should be reworded and clarified in all eleven cases

(e) In two papers, additional minor textual changes in the main body of the publication would improve clarity.

The panel did not recommend the withdrawal of any publication, but made separate specific recommendations for corrections to the ethics statements of all eleven papers. There were suggested minor amendments to the text of two papers, to be notified to the relevant journal editors for each of the publications reviewed.

The panel recommended that funding bodies be notified, where appropriate.
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MEMarge said:
Have just noticed this on AfME website:
https://www.actionforme.org.uk/news/me-research-hra-reviews-ethical-concerns/
@dave30th @Andy
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Sonya Chowdhury, Chief Executive, Action for M.E., comments: “We expect research to be of high quality, including transparency in terms of ethics, the responsibility for which sits with the research team, led by the principal investigator. It’s essential that, when questions or concerns are raised, researchers have the opportunity to respond, through appropriate channels like the HRA.”
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What a ridiculous statement from Sonya.

Could there have been any way to prevent researchers from responding to concerns? What about the HRA's work makes Sonya think that they are the appropriate channel for concerns like this? Is she really impressed by the quality of their analysis of PACE or Crawley's work?

To think I had been saying that there are some signs of improvement at Action for ME.

Has anyone found any justification for classing the interviewing of participants in a pilot trial as a 'service evaluation'? Are they trying to argue that any research that tries to improve services can be seen as a service evaluation? Even though that would include a huge swathe of research?
 
I think it would have been better for AfME to say nothing at all rather than sound like they are trying to smooth over ruffled waters. The statement: It’s essential that, when questions or concerns are raised, researchers have the opportunity to respond, through appropriate channels like the HRA. seems to make no sense at all. I was not aware that we had heard any meaningful responses from the researchers.
 
I wonder if there is an investigation via an FoI worth doing to see the times that the 'pilot clinical service' was running (i.e. was it only set up from the perceptive of a research project). To see who funded the pilot service (i.e. was it normal clinical funding or was it via a separate route - if it was what was said in the funding bill).

Also a complaint to the Bath hospital trust over using the school absence service to force treatment (i.e. a failure of getting patient consent)

I suspect it may also be a violation of the DPA.
 
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Jonathan Edwards said:
I think it would have been better for AfME to say nothing at all rather than sound like they are trying to smooth over ruffled waters. The statement: It’s essential that, when questions or concerns are raised, researchers have the opportunity to respond, through appropriate channels like the HRA. seems to make no sense at all. I was not aware that we had heard any meaningful responses from the researchers.
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Really they should be raising concerns about ethical permissions to the HRA at the highest level and getting them to clarify points such as is it acceptable to pilot service and do a service evaluation without ethical approval and what guidance would they give to ensure that this isn't a backdoor for unethical research. Also getting them to clarify whether it is acceptable to extend a feasibility study to a full study thereby avoiding scrutiny of a full ethics committee.
 
Amw66 said:
Between this and Sterne(?)' s bias assessment for Cochrane I fear that future research will get even worse.

Who is protecting whom?
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I've quickly skimmed the report and my thought is this is academics protecting academics and institutions but I suspect behind the scenes people know it is wrong and note of this gets taken. The British establishment can end up working this way and it is not a good way to operate.
 
Esther12 said:
Has anyone found any justification for classing the interviewing of participants in a pilot trial as a 'service evaluation'? Are they trying to argue that any research that tries to improve services can be seen as a service evaluation? Even though that would include a huge swathe of research?
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The concern would be that the HRA have effectively authorized people to do dodgy trials as 'service evaluations' particularly for non pharma trials - but trials could be done with existing drugs this way!.
 
I have only skimmed this, but I can't see how they think the school absence study is service evaluation. On that basis anyone wanting to do research and call it service evaluation just has to do whatever the hell they want to and call it service evaluation, so long as they are careful not to reveal any research hypothesis at any stage.
 
It seems to me on first reading that the investigation found against the Bristol researchers on the matters of fact, but then said we are not going to do anything meaningful about it, we are going to make life as easy as possible for these dodgy researchers and not seriously look at how such can be prevented from happening again.
 
Peter Trewhitt said:
It seems to me on first reading that the investigation found against the Bristol researchers on the matters of fact, but then said we are not going to do anything meaningful about it, we are going to make life as easy as possible for these dodgy researchers and not seriously look at how such can be prevented from happening again.
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exactly. It is the same approach taken by Archives of Disease in Childhood with the LP study. All the things were wrong, as I documented, but let's just regard them as technical violations rather than substantive.
 
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