Trial By Error: Bristol Investigating Crawley Papers

Trial By Error: A Bit More About Bristol’s Investigation
Yesterday I reported that Bristol University, at the request of the UK Health Research Authority, is investigating a number of studies conducted by Professor Esther Crawley. The results of this investigation are expected in two months or so.

Today I can disclose that the scrutiny involves papers linked to a specific research ethics committee (REC) reference: 07/Q2006/48. That is the number of a 2007 REC opinion issued for a study titled “What happens to children with CFS/ME? The study of a longitudinal cohort of children who access a paediatric CFS/ME service. Version 2.” The investigators were seeking permission to add some more questionnaires to those already being filled out by (or about) pediatric patients at the specialized Bath clinic run by Professor Crawley.
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http://www.virology.ws/2019/02/01/trial-by-error-a-bit-more-about-bristols-investigation/
 
Moderator note: Merged threads.


Trial By Error: A Bit More About Bristol’s Investigation

1 February 2019

By David Tuller, DrPH

http://www.virology.ws/2019/02/01/trial-by-error-a-bit-more-about-bristols-investigation/

Yesterday I reported that Bristol University, at the request of the UK Health Research Authority, is investigating a number of studies conducted by Professor Esther Crawley. The results of this investigation are expected in two months or so.

Today I can disclose that the scrutiny involves papers linked to a specific research ethics committee (REC) reference: 07/Q2006/48. That is the number of a 2007 REC opinion issued for a study titled “What happens to children with CFS/ME? The study of a longitudinal cohort of children who access a paediatric CFS/ME service. Version 2.” The investigators were seeking permission to add some more questionnaires to those already being filled out by (or about) pediatric patients at the specialized Bath clinic run by Professor Crawley…
 
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strategist said:
How unusual is it to re-use the same ethics approval for many projects?
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It is not allowed. So it inevitably involves a misrepresentation when signing that approval has been obtained.

How often this happens I have no idea. My past experience makes me think it would be quite hard to do a study without the right ethics approval because there is regular monitoring of studies by R&D departments in most hospitals and they would need to see the specific letter. I wonder whether in fact it was just the ethics application numbers sent to the journals were wrong. But if that was the case it could have been sorted out months ago.
 
Jonathan Edwards said:
It is not allowed. So it inevitably involves a misrepresentation when signing that approval has been obtained.

How often this happens I have no idea. My past experience makes me think it would be quite hard to do a study without the right ethics approval because there is regular monitoring of studies by R&D departments in most hospitals and they would need to see the specific letter. I wonder whether in fact it was just the ethics application numbers sent to the journals were wrong. But if that was the case it could have been sorted out months ago.
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Here it seems Prof Crawley used a letter saying the use of a set of questionnaires relating to an ongoing service evaluation did not require ethical approval in relation to other subsequent projects. She used this single letter repeatedly with different studies and projects as a justification for not applying for ethical aproval in radically different circumstances.
 
Peter Trewhitt said:
Here it seems Prof Crawley used a letter saying the use of a set of questionnaires relating to an ongoing service evaluation did not require ethical approval in relation to other subsequent projects. She used this single letter repeatedly with different studies and projects as a justification for not applying for ethical aproval in radically different circumstances.
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Exactly. The use of the letter seems to be wrong in any event. It's possible some of the studies do qualify as service evaluation. Some of them absolutely do not. I do not actually expect this investigation to be a white-wash. There is no way a panel whose work is being watched could maintain that the school absence study is service evaluation. So I assume there will have to be some repercussions. Whether they are serious or amount to a slap on the wrist remains to be seen.
 
Not sure if this is relevant but there has been an updated protocol document added to the NIHR FITNET page. It is dated 22 Jan and is version 6 when you open the document. At the end of the document there is a table summarising the changes with each version. The changes made for V6 were done back in June but seems they have only now been put on the site. V5 seems to be missing. link to the page is
https://www.journalslibrary.nihr.ac.uk/programmes/hta/14192109/#/
 
Jonathan Edwards said:
Yes, it seems this is a rather anomalous situation that might perhaps be more open to misrepresentation than the usual one.
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To me it seems particularly worrying the School Absence study completely bypassed any ethical aproval process.

This was research with a pre specified hypothesis that a significant percentage of school non-attenders had undiagnosed 'CFS'. This was tested by the schools involved inviting all non attending children and their parents/guardians to a meeting/assesment with Prof Crawley and the relevant school officer. At this point no formal health concerns had necessarily been raised, meaning those without CFS were subjected to an unnecessary medical assesment. Any children identified by Crawley as having CFS were then refered to Prof Crawley's CFS Service, where in turn they were likely to be offered the controversial treatments of GET and/or CBT. It is hard to see how anything up to the refferal to the CFS service was service evaluation, involving blind analysis of anonymised questionnaires, as covered by the supposed letter of exemption.

Given that parents/guardians in this situation are likely to be concerned about potential legal repercussions around school non attendance, it needs to be clear that any consents to participate in the study or to receive subsequent treatment were freely given. It was important that there was clear consideration of the ethical issues involved. I am not saying this research was unethical, but that it should have been essential that there was documented consideration of the ethical issues.

[added - This may be a slight digression, but it does illustrate why it is important that such research goes through an ethical aproval process. ]
 
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dave30th said:
So I assume there will have to be some repercussions. Whether they are serious or amount to a slap on the wrist remains to be seen.
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Two aspects really:
  1. Recognition and identification of wrongdoings.
  2. Remedial actions, assuming '1' carried out properly.
In a way the severity of '2' is less important than is the importance of due diligence being applied to '1'. Even if '2' is a bit lightweight, providing the wrongdoings are properly recognised and their significance, then the knock-on implications will be very significant - BMJ's failures for instance. And would the SMC accurately report such an outcome?
 
New blog post from David Tuller:

A Recap of the School Absence Study

Last week I broke the news that Bristol University is conducting an independent investigation of a number of studies that were exempted from ethical review on the grounds that they qualified as “service evaluation.” Because the issues involved are confusing and complex, I thought it would be helpful to repost here part of my initial investigation of one of those exempted studies–the 2011 school absence paper published in BMJ Open.
 
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