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Trial By Error: No Ethical Review of Crawley School Absence Study

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Chrisb

Senior Member
Messages
1,051
lilpink said:
The clinical service in this study was provided as an outreach from the Bath specialist CFS/ME service. The North Somerset & South Bristol Research Ethics Committee decided that the collection and analysis of data from children and young people seen by the CFS/ME specialist service were part of service evaluation and as such did not require ethical review by the NHS Research Ethics Committee or approval from the NHS R&D office (REC reference number 07/Q2006/48).”
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I am struggling with these documents. Is does not seem clear what was the date on which REC made this decision and whether it predated the commencement of the "research"? The wording leaves open the possibility, and may even suggest the likelihood, that the decision was retroactive.

Given the obvious potential ethical problems of duress and patient confidentiality which would arise as a result of clinicians seeing children at meetings with a school attendance officer present, it seems strange that the ethics committee would wash its hands of the matter if application to them was made, in normal manner, in advance of the "research" being conducted.

Presumably the REC would have been alert to the possibility of parents facing fines for unauthorised school absences.
 
lilpink

lilpink

Senior Member
Messages
988
Location
UK
Chrisb said:
I am struggling with these documents. Is does not seem clear what was the date on which REC made this decision and whether it predated the commencement of the "research"? The wording leaves open the possibility, and may even suggest the likelihood, that the decision was retroactive.
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It predated it by 4 years and links to an altogether different piece of research. I think this is being lost: the REC number quoted by Crawley for this paper at BMJ Open does not correlate with the research she is presenting anyway.
 
C

Chrisb

Senior Member
Messages
1,051
lilpink said:
It predated it by 4 years and links to an altogether different piece of research. I think this is being lost: the REC number quoted by Crawley for this paper at BMJ Open does not correlate with the research she is presenting anyway.
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Sorry. I misunderstood. It is complicated.You are saying that that is the wording of the earlier REC decision. I took you to mean that there was a discrepancy between the REC reference number and the wording of the approval as quoted in the paper.

I think I see a way in which this could have come about, although this is only a possibility.

Let us assume that some time ago a research proposal with a particular set of facts is put before the REC, which determines that this case is exempt from the need for approval as it is, on its facts, a service evaluation. In publishing correct reference is made to the REC decision.

The researchers later come up with new plans which they wrongly consider to be analogous. Rather than properly assess the facts of the new case against the criteria for REC approval, they take the former decision to be a persuasive authority for their decision not to seek REC approval. Failing to understand that the former decision is only an authority playing a part in their decision not to seek a REC ruling, they cite that decision as approval in their case, rather than stating that the published work is exempt from the need for approval. And so ad infinitum.

It is hard to say what this scenario would, if it were correct, say about the researchers in question. There can be little doubt about what it says about those to whom the error, if such it be, was disclosed and did nothing.
 
Countrygirl

Countrygirl

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Note: as requested by several members this second thread discussing David Tuller's response has been merged with this earlier thread. This is the first post in the thread on David Tuller's response. After this the responses to both threads will appear in time-stamp order.

No Ethical Review of Crawley School Absence Study Dr David Tuller
http://www.virology.ws/2017/08/28/trial-by-error-no-ethical-review-of-crawley-school-absence-study/

By David Tuller, DrPH

This is a complicated post. Here are the key points. The rest is details:

*Professor Esther Crawley and co-authors claimed a 2011 study in BMJ Open was exempt from ethical review because it involved the routine collection of data for “service evaluation.” Yet the 2011 study was not an evaluation of routine clinical service provision–it was designed to road-test a new methodology to identify undiagnosed CFS/ME patients among students with records of chronic absence.

*To support the claim that the study was exempt from ethical review, Professor Crawley and co-authors cited a 2007 research ethics committee opinion that had nothing to do with the data-collection activities described in the 2011 paper.

*For the 2011 study, school letters were sent to families of 146 student, inviting them to meet with Professor Crawley. In the end, only 28 were identified as having CFS/ME–meaning more than 100 families of students without CFS/ME received potentially disconcerting letters inviting them to a medical meeting about a sensitive issue. This type of pilot program is beyond the scope of what many would consider to be service evaluation.

*A pre-publication reviewer, noting the data collection activities described in the paper, raised serious questions about the lack of ethical review. In her response, Professor Crawley did not provide satisfactory answers to the concerns raised by the reviewer, but BMJ Open published the paper anyway, without ethical review.

*BMJ Open’s recent response to the concerns has been confused, contradictory and inadequate. In separate e-mails, the editor and editor-in-chief have provided two distinct and incompatible justifications for the decision to publish without ethical review. Neither explanation is convincing.

**********
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lilpink

lilpink

Senior Member
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"Here’s my question for Dr. Groves: Is she really comfortable that–as part of a study defined as service evaluation–more than one hundred families whose children did not have CFS/ME were nonetheless sent school letters on a sensitive issue and invited to meet with Professor Crawley? Does Dr. Groves really believe that testing out a new strategy to identify patients unknown to the clinical service qualifies as service evaluation for routine care? I doubt she actually does believe that, but who knows? Smart people can convince themselves to believe a lot of stupid things. In any event, in dismissing these concerns, BMJ Open has demonstrated that something is seriously amiss with its ethical compass."
 
lilpink

lilpink

Senior Member
Messages
988
Location
UK
"Here’s my question for Dr. Groves: Is she really comfortable that–as part of a study defined as service evaluation–more than one hundred families whose children did not have CFS/ME were nonetheless sent school letters on a sensitive issue and invited to meet with Professor Crawley? Does Dr. Groves really believe that testing out a new strategy to identify patients unknown to the clinical service qualifies as service evaluation for routine care? I doubt she actually does believe that, but who knows? Smart people can convince themselves to believe a lot of stupid things. In any event, in dismissing these concerns, BMJ Open has demonstrated that something is seriously amiss with its ethical compass."
 
Large Donner

Large Donner

Senior Member
Messages
866
Invisible Woman said:
Nope (at least that's not how I understand it). It's having approval for one thing and getting the REC no for that and then going off on what appears to be a fishing expedition for something completely different and reusing the number.

Like being a schoolkid and getting a note from your mum saying you will be missing maths on Tuesday 'cause you've gotta go to the dentist and then using the same note on Friday when you want to spend the afternoon smoking fags at the back of the bike shed.

Except much, much more serious.
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Hey, I need to try that one with the wife to get a pass on doing less babysitting duties, or perhaps i'll take my oyster card to Heathrow airport and see if they let me board a plane to the Bahamas with it!
 
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