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.
**********
For a 2011 study, Professor Esther Crawley of Bristol University hypothesized that many children remained undiagnosed for chronic fatigue syndrome/myalgic encephalomyelitis. So she decided to investigate whether school absence records could yield further cases.
Working with three schools, she designed a pilot program that targeted students with a history of being absent for unexplained reasons 20 percent or more of the time. Students and their families were invited to meet and discuss this pattern of school absence with Professor Crawley, a pediatrician, along with a school staff member. Some of these students were subsequently evaluated and treated at Professor Crawley’s Bath clinical service for young people with CFS/ME. (I am using CFS/ME here because that is the term Professor Crawley uses.)
The study, published in the journal BMJ Open, concluded that a program involving this kind of school outreach based on absence records could identify previously undiagnosed children, who could then benefit from treatment. But there was a troubling twist: Professor Crawley and her co-authors did not seek ethical review from a U.K. National Health Service Research Ethics Committee, as would normally be expected for studies involving human subjects. Instead, the paper included the creative claim that the study was exempt from such ethical review because it qualified as “service evaluation.”
[Key information in this post comes from documentation provided by an independent researcher, who obtained it via a freedom-of-information request to the NHS Health Research Authority and then corresponded with BMJ Open about the issue. To be fully transparent, Professor Crawley is not a fan of my work and has publicly accused me of writing “libelous blogs.” However, she has repeatedly failed to respond to requests that she present documentation or evidence that anything I have written about her work is false or inaccurate.]
According to HRA guidelines, service evaluation studies are “designed and conducted solely to define or judge current care” and “involve minimal additional risk, burden or intrusion for participants.” For these studies, investigators are not required to seek the kind of ethical review from an REC that is mandated for what is deemed “research”—that is, studies that are potentially more risky, burdensome or intrusive for participants and raise more possible ethical concerns.
A pre-publication review of the 2011 paper highlighted the lack of ethical review as a major concern. [BMJ Open has an open review process, so reviews and author responses are posted with the published article.] In his comments, the reviewer questioned how the actions taken to identify new patients, as described in the paper, could be considered service evaluation rather than research. In her response to this pre-publication review, Professor Crawley did not provide direct and satisfactory answers to the reviewer’s concerns, yet BMJ Open editors apparently took no further steps to address the issue.
The independent researcher who obtained the documentation wrote to BMJ Open about the issue earlier this year. After reviewing the matter, the journal’s editor acknowledged the obvious—that Professor Crawley’s 2011 study “is not strictly a service evaluation”–but maintained that it was nonetheless exempt from ethical review for other reasons. This retroactive claim for exemption, however, was itself based on false information.
(I know, I know–it’s confusing. Sorry!)
The central question here is whether the 2011 BMJ Open study should have been defined as “research,” which would have required REC ethical review, or “service evaluation,” which would not. BMJ Open itself appeared to have expressed its view by publishing the study under a prominent heading slugged “Research.” The study included a hypothesis to be tested as well as a specific “research question”–markers of what is typically defined as research and not as service evaluation.
Moreover, the paper clearly presented itself not as investigating “current care,” per the HRA definition of service evaluation, but as piloting a new strategy or intervention to identify previously undiagnosed patients. The main outcome measure was “the number of children newly diagnosed as having CFS/ME.” On the face of it, this does not sound like part of service evaluation involving care for patients already being seen.
To support the claim that the study did not need to undergo ethical review from an REC, the paper provided the following explanation: “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).” [The separate issue of obtaining approval from NHS R&D is not of concern here.]
An REC reference number cited in a paper would often identify an opinion specifically about the particular study and data-collection method at issue. In this case, the REC number involved a 2007 decision about a data collection procedure very different from the activities involved in the 2011 pilot program to conduct outreach through the monitoring of school absence records. [The independent researcher obtained the documentation about this 2007 decision under her freedom-of-information request.]
The 2007 REC decision involved an application seeking permission to expand the schedule of assessments of children referred to and receiving specialist care at Professor Crawley’s CFS/ME clinical service in Bath. The clinical service was at that time conducting assessments with several questionnaires at entry and at twelve months. The REC application proposed adding further assessments at six weeks and six months, arguing that this would be useful for service evaluation as well as improving the delivery of clinical care.
In response to a question about how patients for this expanded questionnaire regimen would be “identified,” “approached, and “recruited,” the REC application declared that “there will be no change in the way potential participants are identified.” In other words, the application was explicitly not describing or seeking permission for identifying new patients or implementing new methods to recruit undiagnosed children. It was simply seeking permission to collect some more data on patients who were being referred to the CFS/ME clinical service through standard channels. The additional burden to patients and their families was considered minimal; the REC application estimated that filling out the two sets of extra questionnaires would take less than twenty minutes each time.
After reviewing the application, the North Somerset & South Bristol REC sent a letter dated May 1, 2007. Here’s the operative phrasing: “Members [of the REC] considered this project to be service evaluation. Therefore it does not require ethical review by a NHS Research Ethics Committee or approval from the NHS R&D office.”
The letter referred to “this project”—-i.e. the activities proposed in the application, specifically the expanded schedule of assessments that would take participants less than forty minutes to complete. The letter did not indicate that the same consideration or determination applied to other, as-yet-unspecified projects with as-yet-unspecified data-collection activities—-such as efforts to monitor school absences and recruit new patients.
Yet Professor Crawley has cited this 2007 REC reference number to support the case that not just the 2011 study but several other studies were exempt from REC review as service evaluation rather than research. Some of the other studies that cite the REC reference number appear to genuinely qualify as service evaluation. But by the BMJ Open editor’s own admission, Professor Crawley’s 2011 study “is not strictly service evaluation,” a determination that contradicts what the paper states about itself.
In the 2011 paper, the authors appear to make excessive claims about the 2007 service evaluation exemption provided by the North Somerset & South Bristol REC. The 2007 REC letter did not make a blanket assertion that any data collection from any young people seen by the clinical service could be considered service evaluation. It made the narrower finding that expanding the current assessment schedule by adding several questionnaires at two points in time, as specifically outlined in the REC application, could be considered service evaluation.
Let’s compare that limited scope of activity approved as service evaluation to the data collection strategy pursued for Professor Crawley’s 2011 study. After school attendance officers identified children who met the study’s designated absence threshold, the families “were sent a letter from the school that invited them to meet with a paediatrician from the Bath specialist CFS/ME team (EMC) and a member of school staff to discuss why their child was missing school.” [EMC is Professor Crawley.] Some of these students were then assessed at the Bath clinical service and offered treatment, if indicated.
It should be noted that the study’s designated thresholds for school absences netted many more students than were ultimately diagnosed as having CFS/ME. Letters were sent to the families of 146 students who met the absence criteria. In the end, 28 of them were identified as having CFS/ME. Let’s put that another way: For this study, the families of 118 students who did not have CFS/ME were sent school letters calling them to a medical meeting about a sensitive issue. The families were sent these letters, which could possibly have caused anxiety and alarm, as part of what was purportedly service evaluation of care for young people already diagnosed with CFS/ME.
It is hard to understand how sending out such letters and recruiting new patients in this potentially intrusive manner could be considered part of service evaluation for “current care,” especially since this was a pilot project. It seems unusual that researchers would bypass ethical review for such an active patient recruitment effort–even more so given that their approach for identifying possible cases of CFS/ME was likely to impact an unknown number of students and families beyond the specific group of interest.
In fact, a reviewer invited by BMJ Open to comment on the draft of the 2011 paper appeared perturbed at the lack of ethical review and approval. In his comments, he expressed surprise that the REC would have considered the outreach aspects of the study to be service evaluation exempt from ethical approval, rather than research requiring it.
Here’s what he wrote: “It is understandable that the REC might see use of routine data from the existing clinical service as not being research…but it is surprising that they did not see the surveillance component as research. Children who are unknown to services were being contacted using information from their schools and it seems to me that there are significant issues of confidentiality and data protection which, in my experience as a researcher and one time REC member, I am surprised the REC did not think amount to research. Assuming the REC was fully aware of these issues, and still made a decision that the work was not research, then it would be unfair to oppose publication on those grounds, but the authors should make a fuller explanation, and in the interest of openness might want to make their application to the REC and subsequent correspondence available with the publication.”
The reviewer’s statement clearly presumed that Professor Crawley and her colleagues had filed an application and corresponded with the appropriate REC about the specific set of activities involved in this school absence study. Given that presumption, he made a reasonable request–that they should publish the REC application and correspondence along with the paper. The reviewer also requested the authors to provide more information about what the families were told and how their consent to participate in the project was obtained.
A pre-publication review like that should raise red flags with editors–at least enough for them to ensure that the authors provide acceptable answers. That apparently did not happen in this case. In response to the reviewer’s comments, Professor Crawley did not cite any correspondence with the REC about the school absence study under discussion, perhaps because no such correspondence existed. Nor did she offer much detail on what information was provided to families and on how consent was obtained. And she did not mention that she was not relying on recent REC correspondence about this specific study, as the reviewer presumed, but on an REC opinion about a much narrower method for additional data collection from four years earlier.
Instead, Professor Crawley explained in her response that “the specialist service has been advised that ethical approval for routine collection and analysis of service data is not required.” She did not provide a legitimate explanation for why this pilot program qualified as “routine collection and analysis of service data” when it involved outreach to families whose children were not already enrolled in the clinical service, including many families whose children did not even have CFS/ME. Instead, she pointed out that she is a community pediatrician and that the children were seen in school clinics, although it is not immediately evident why these facts should have exempted the study from ethical review.
In her response, Professor Crawley also referenced top-level admiration for her work. “The project has been of great interest to the Department of Education who included it last year as an exemplar in their training for attendance officers in the UK,” she wrote. But whether or not education officials were impressed with Professor Crawley and her work was of course irrelevant to the question at hand, which was whether the study should have been considered research or service evaluation. It was not clear why Professor Crawley included this point, except perhaps to suggest that she had well-placed supporters.
According to Professor Crawley’s response, she sought further assurance that the data collection involved was indeed part of service evaluation. Here’s what she wrote: “We checked with the co-ordinator for the local REC that recording outcomes on school based clinics run by school nurses is part of service evaluation (and therefore does not require a submission to Ethics) and they have agreed that it is.”
This statement is confusing. The clinics described in this study cannot reasonably be defined as nurse-run school-based clinics. According to the paper, they were set up specifically so Professor Crawley could meet with the children and families identified through the pilot program she developed. Professor Crawley is not a school nurse. The paper’s description of the meetings with families indicated the presence of “a member of school staff,” not a school nurse. Professor Crawley’s own response to the pre-publication reviewer indicated that this staff member was “usually the attendance officer.”
In fact, the study itself stated that “it would be of interest to evaluate whether school nurses, rather than doctors, can undertake the initial assessments in school clinics.” In other words, the way Professor Crawley personally collected data for this pilot program had little or nothing to do with the provision of routine care in nurse-run school clinics.
In any event, Professor Crawley provided no documentation of this exchange with the unnamed “co-ordinator for the local REC.” Nor did she provide any details of what this unnamed local coordinator was told. Was the coordinator told simply that this was data collection made during routine nurse-run school clinics? Or was the coordinator told that this was a pilot program to identify previously undiagnosed patients using their school absence records?
Furthermore, was the coordinator told that families would be sent letters inviting them to meet with a community pediatrician at the school, in the likely presence of the school attendance officer but not a school nurse? Was the coordinator told that the students might then be recruited as patients into the clinical service run by the community pediatrician? Was the coordinator told that most of the families identified and impacted by this recruitment process turned out not to have children with CFS/ME? Absent further documentation of this apparently critical exchange, Professor Crawley’s second-hand reassurance that the unnamed local coordinator agreed with her interpretation of events is utterly meaningless.
The independent researcher who drew my attention to this case (and provided input for this post) had sought clarification from BMJ Open about the lack of ethical review. In response to her inquiry, she received an e-mail from editor Adrian Aldcroft in June. He wrote this about the study:
“While we appreciate the article published in BMJ Open is not strictly a service evaluation, we agree with the statement provided by The University of Bristol that further ethical approval would not have been required for the analysis due to the following exemption:
‘REC review is not required for the following types of research: Research limited to secondary use of information previously collected in the course of normal care (without an intention to use it for research at the time of collection), provided that the patients or service users are not identifiable to the research team in carrying out the research.’
The data in the BMJ Open article meet these criteria.
As such, we do not think any further action is necessary relating to the article.”
This response did not resolve the matter. First, to state that the 2011 article was “not strictly a service evaluation” was to validate the complaint. It was also a tacit acknowledgement that the paper’s own claim for exemption from ethical review was unjustified. Then, in a sort of sleight-of-exemption, Aldcroft cited a recent statement from Bristol University that studies were exempt if they involved “secondary use of information previously collected in the course of normal care.” And Aldcroft then stated flatly that the data in the article “meet these criteria.”
This last statement is startling because it so obviously untrue. The 2011 paper did not involve “secondary use” of data “previously collected in the course of normal care.” The data were collected through implementation of a pilot program designed by Professor Crawley to answer the specific “research question” posed at the beginning of the article: “Are school-based clinics a feasible way to identify children with CFS/ME and offer treatment?”
Moreover, the Bristol University exemption cited by Aldcroft stated that the patients or service users must be “not identifiable” to the research team. In this case, Professor Crawley was the community pediatrician who met with the families; she was also the head of the research team. Under the circumstances, it is impossible to argue that patients in the study were “not identifiable” to the research team, per the exemption requirements. It is therefore hard to understand Aldcroft’s statement that the data in the 2011 article meet the necessary criteria for exemption from ethical review. It would have been easy for him to determine the correct answer by reviewing the paper itself.
Last Thursday, I wrote to Aldcroft to follow up. I also wrote to both the local REC and the HRA, and to Bristol University. (I did not write directly to Professor Crawley, since I gather she does not want to receive e-mails from me. Instead, I wrote the legal department representative to whom I complained earlier this year about Professor Crawley’s false accusation that I had written “libelous blogs.”)
I did not hear back from Bristol. A spokesperson for the HRA wrote that he could not answer my specific questions about this case, but he sent general information about RECs and service evaluation. I did receive an e-mail from Trish Groves, editor-in-chief at BMJ Open (she also has other titles), who wrote that Aldcroft had forwarded my e-mail to her.
Dr. Groves wrote that the 2011 study authors had addressed the concerns about ethical review raised by the peer reviewer. After citing the “ethical approval” statement included in the 2011 paper itself (and quoted above in this post), Dr. Groves wrote: “Given the guidance provided by the local REC, we consider that the authors were entitled to reach the conclusions that they did concerning the need for ethics approval.”
This reply is disingenuous and troubling–especially given that BMJ Open itself published the study under the heading “Research.” Dr. Groves has now provided a completely different account of the matter than Aldcroft, the journal’s editor, which indicates some incoherence or confusion in the journal’s position. Aldcroft acknowledged that the paper was “not strictly a service evaluation” and then provided a retroactive justification for why it was exempt from ethical review anyway. According to Dr. Groves’ version, all was done properly the first time around. But she did not then explain why Aldcroft, on behalf of BMJ Open, had presented an alternate point of view.
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.
Dr. Groves did leave the door open a tiny crack. She wrote: “BMJ Open is a member of the Committee on Publication Ethics (COPE) and follows its best practice guidance and policies. In light of the matters that have been raised, we will submit this case (anonymised, as always) to the COPE Forum.”
Leading scientific journals are members of COPE. Unfortunately, when it comes to rigorous and honest assessment of research from members of the GET/CBT ideological movement, including Professor Crawley, leading scientific journals have exhibited little in the way of “publication ethics.” So I am not optimistic that an examination by COPE will produce better results.
Comments
46 responses to “No Ethical Review of Crawley School Absence Study”
I will watch with great interest the contortions BMJ-Open will have to perform to get out of this one!
Keep poking away. Crawley and friends seem to be playing fast and loose with the truth. As for the other publications and institutions, they will fall like dominos once you succeed in removing enough of the foundation of lies, misstatements, and half-truths.
What is the point of having Ethics Rules when they are ignored? It’s bad enough if it happens with adults, but with children it’s unforgivable. Even when a level 1 psychology student I had to take Ethics into consideration when doing experimental work. Unbelievable that a so called professional can ignore them the way EC does. Thank you Dr Tuller for your hard work – much appreciated.
It’s quite shocking that a supposedly reputable medical journal, as well as a university, are willing to back up Esther Crawley’s flagrant ethical violation. Patients apparently don’t qualify as people with rights, as far as they’re concerned.
Further evidence that this group of researchers has little respect for rules or patients.
What can be expected ethically from someone like Esther Crawley, who led a trial on the quack “Lightening process”?
“Smart people can convince themselves to believe a lot of stupid things.”
– by dr. David Tuller
#PACEtrial #PACEgate #CBT #GET #FITNET
And the hard work of the ‘researcher’..both should be applauded imo.
Thank you David for a very comprehensive account of what is, as you say, a complicated issue. I wondered recently why I dont get horrified by the number of appalling happenings surrounding this woman and her cohorts and I think its that I have come to believe that they are so cosied to ‘official UK’ that they really dont see the need to abide by the rules of mere mortals. However history always tells us that that is the rock on which they perish. Keep chipping away David. This is another to add to the pile of doggy doo when the proverbial hits the fan
No surprises with EC’s work the MAGENTA trial reviewer “Suzanne Broadbent” slammed the poorly designed GET aspects of the trial and EC’s response was woeful but the trial still went ahead as EC planned….
Do UK Universities have a blind spot in regards to CFS/ME or i s all their research this woeful??
The FITNET ethics board at Bristol Uni when reviewing that study asked bizzare questions that reflected a lack of understanding of the disease..ie they were concerned about the 90 minute long interview, not because it might be to onerous but because the child might leave the room. They had no qualms that EC tells parents their child may worsen from walking to bed ridden. Quite happy that children with CFS which is known to cause heart rate abnormalities don’t wear heart rate monitors pre trial and to establish a health baseline…heart rate monitors are only worn if the child can exercise for 30 minutes 3 times a week.
So Crawley has set up a study to find MORE patients when NHS services are already overstretched and when the critetia for diagnosing MECFS are disputed. So it seems she may identify kids who don’t actually have ME and worry them and their parents. But on the other hand the ones who don’t have ME and are just chronically tired, as many teenagers are, should respond well to CBT and GET and Crawley will come out smelling of roses.
Although the point here is less about that and more about her seemingly passing off ‘research’ as ‘service evaluation’ and in so doing bypassing the need for proper ethical review, and the fact that despite warnings from a peer reviewer BMJ-Open were happy to publish a study with what appear to be very substantial ethical flaws/ questions over ethical consent.
Thank you for exposing this and to the investigator. UK science and journals seem to be completely devoid of any scientific or ethical integrity.
Children with M.E. have been taken from their parents and denied access to food, water or parental contact – or thrown in swimming pools – in an attempt to try to force the child to ‘stop pretending to be ill.’ What is happening to people with M.E. is a gross violation of basic human rights. It amounts to legalised medical torture and abuse of some of our most vulnerable members of society.
The problem is not merely that M.E. patients are inappropriately treated as if they were mentally ill. It is so much more than that. The ‘CFS’ government spiel encourages the idea that patients given this misdiagnosis are lazy, selfish, manipulative, dishonest and deluded people that are ‘enjoying the sick role’ and so deserve to be treated with scorn, contempt and outright ridicule. Patients are persecuted by everyone around them in many different ways, continually.
Human rights groups and the media are fed the “CFS” propaganda to enable companies to get out of paying for any type of proper medical care for all these patients, saving them many millions of dollars. The abuse of M.E. patients is not accidental, it is PLANNED, and these groups are working hard to make sure it continues so that their financial support continues and their Reputation remains unquestioned.
I think it’s time to uncover who pulls Ester Crawley’s strings, who is her puppet master, who has given her carte blanch, to ignore ethics, that all of us who have done research have to adhere to. Ask yourselves this , Simon Wessley was given a knighthood, for services rendered to the state, what services ? There are serious medical abuses going on here folks, there is plenty to see.
At first I thought this was a case of not following appropriate ethical process, which shows a disregard for good research practice but not a lot more – I figured, had they applied for approval they would have got it… But then kept reading and thinking and actually I do not think that is the case and I think this is actually more serious than I first appreciated.
As the journal reviewer pointed out (seemingly without realizing that the claimed REC belonged to a completely different type of study as he asks them to disclose it but they did not so he was unable to check) this study is a breach of patient’s personal data. That alone makes this a very serious breach in my view. Maybe the ICO should be asked to investigate this breach.
It seems to me that a REC could not possibly have authorised this research had they been asked to (which they weren’t). Perhaps that is why they were not asked. How could they have authorised it without breaching data protection laws? The only possible way they could have done so would be to have created a prior mandatory step where ALL parents of pupils were asked if a research team could have permission to look at their child’s attendance record in the first place, to identify a subset of people to then invite for interviews. INSTEAD at the point where parents were contacted a data protection breach appears to have already occurred. I mean, this is the child’s personal data, right. It’s about the child’s health.
It seems to me that had an ethical review panel been asked, they could never have authorised the research to be conducted in this way because children’s personal data protection rights were not met. That seems a serious matter to me.
I think as well as the journal, the school and dept for education have questions to answer here. They have a duty to protect the interests of pupils and failed to ensure that appropriate ethical review had taken place and that pupils’ data protection rights were upheld.
As a broader ethical consideration, I also question whether it is really OK for children to be placed in a medical situation at school, where essentially diagnosis is being conducted in the school building where they are supposed to go to be educated, not to be medically evaluated. It is supposed to be a safe education environemnet not an NHS medical environment. It’s not even their normal medical practitioner, it’s an unknown stranger. I wonder how I would feel if I were placed in similar circumstances at work as an adult – I don’t think that would be right. And we aren’t talking about adults here, we’re talking about children. But this would have been a question for an ethics review panel to answer and they could have gone either way. I don’t think the same can be said for the data protection issues though, those are set in law and cannot be bypassed on a matter of opinion.
David Tuller : I think there is more to consider here than the technicalities of judging what qualifies research for ethical review.
We need to put ourselves back into the absentee child’s position, and imagine what they must feel when they are ‘invited’ to a meeting with the ‘Attendance Officer’, and a paediatrician psychologist. Remember that ‘Attendance Officer’ is PC-jargon for ‘Truant Catcher’: Every child who has seen Chitty Chitty Bang Bang, will fear this particular bogeyman as much as they did the evil ‘Child Catcher’ in that film.
Now look at the scene that Crawley set up, when trawling for new child research subjects: The Truant Catcher and psychologist, have the power to enforce school attendance and to launch prosecutions of parents who do not ensure that their child goes to school. At worst, a child might be removed from the care of its parents and put out to be fostered with strangers. Thus these children and parents are actually being ‘made an offer they cannot refuse’. Under these circumstances, many children are going to be terrified out of their minds!
As she is a psychologist, we ought to expect that Crawley is aware of this power game she set up to entrap more research subjects. Even if this was unintended, she has set up a ‘Good Cop’/’Bad Cop’ dynamic, under which her interviews were conducted. It seems fairly certain that many children and parents would sign themselves up for anything, with every child’s bogeyman waiting in the corner to net any child who does not have a ‘sick pass’ to explain their truant behaviour!
Whether intentional or not: this method of obtaining research subjects to ‘prove a hypothesis of undetected levels of CFS among children’ is effectively a case of entrapment with menaces.
If we go on to consider that the clinics will be commissioned to ‘treat’ all these ‘newly discovered cases of CFS’, then we really do need to look into the commissioning of these clinics, and any ‘headage rates’ they are paid per child put through their magical brainwashing system. It appears that there may be a perverse incentive to trawl for as many subjects as possible, and with Crawley being judge and jury in her own court, to brand children with her own ‘CFS/CBT-ready’ mark, for the sake of gains, both financial and in scholarly acclaim.
This looks to be a whole lot more dodgy than merely forgetting to obtain technical approval for ‘data gathering’. If I had been one of the children ‘invited’ to a meeting at school under these circumstances, I think I would have run away from home. (I wonder if they checked to see if any children did run off rather than accept one of these sinister ‘invitations’.).
Not that it makes any of your points less relevant, but Crawley is not a psychologist, she is a paediatrician.
Personally, I still believe that the term “CFS” with no scientific criteria leaves an open wound that can’t be closed.
“Children with M.E. have been taken from their parents and denied access to food, water or parental contact – or thrown in swimming pools – in an attempt to try to force the child to ‘stop pretending to be ill.’ What is happening to people with M.E. is a gross violation of basic human rights. It amounts to legalised medical torture and abuse of some of our most vulnerable members of society.
The problem is not merely that M.E. patients are inappropriately treated as if they were mentally ill. It is so much more than that.
The ‘CFS’ collaborative spiel encourages the idea that patients given this misdiagnosis are lazy, selfish, manipulative, dishonest and deluded people that are ‘enjoying the sick role’ and so deserve to be treated with scorn, contempt and outright ridicule. Patients are persecuted by everyone around them in many different ways, continually.
Human rights groups and the media are fed the “CFS” propaganda to enable companies to get out of paying for any type of proper medical care for all these patients, saving them many millions of dollars. The abuse of M.E. patients is not accidental, it is PLANNED, and these groups are working hard to make sure it continues so that their financial support continues and their reputations remain unquestioned.” .
I think she specialises in psychological ‘research’ topics enough to profess to being a psychologist even without a specific qualification: but that is indeed, another curious fact to add to her case of meddling in things she does not understand. :/
Tho an impotant point ethically is that she has told parents that their children have MECFS when many would doubt the criteria for diagnosis.
Well said – ‘there is plenty to see’
Quite apart from the obvious ethical issues here, Prof Crawley’s assessment that 28 of the 146 students had ME/CFS seems like over-egging the pudding. That’s a prevalence rate of 20 per cent. Which criteria did she use to assess the students? I’m guessing NICE or Oxford. *Rolls eyes*
David Tuller’s account, based on an impeccable source, shows how the naked ambition of an investigator is permitted to tread roughshod over the rights of patients and accepted ethics procedures, aided and abetted by what one likes to imagine is a reputable medical journal. Everybody covering one another’s backs, never admitting error, anything unseemly brushed under the carpet. Such complacency and arrogance can only lead to the kind of disaster for patients that clinical governance is designed to prevent. Does anybody in authority care? It would appear not.
This is reminiscent of the SMILE trial run Esther Crawley, when the research ethics process was less rigorous because she described it as a feasibility study when, in fact, the children would undergo the ‘treatment’: a non-medical commercially available ‘training programme’ delivered by people with no medical qualifications, which had not first been tested on adults. It seemed like a way to get ethics approval for a treatment trial through the back door. However, the fact that the regional and National Research Ethics Service didn’t care about the multiple breaches of the rights of patients/parents to informed consent to participate in research, suggested to me that these ethics committees are set up to endorse unethical research rather than prevent it occurring. Then what happens is that no-one in the process of approval or publication wants to admit culpability so everyone closes ranks and makes up implausible and often contradictory excuses for their role in the matter. Then you find that nobody else in a postition to stop this rot cares either, not the GMC, or the CMO, or the National Patient Safety Agency, or even the National Society for the Prevention of Cruelty to Children. I really hope that the new broom being crafted by your good self and like-minded professionals new to the scene can finally sweep this mess clean. The unnecessary suffering of these children is intolerable.
I concur with your observations about the source of this material.
Given who is involved here, we can be pretty certain this was not a case of inadvertent oversight, but deliberate exploitation of a loophole in the system. No matter what level of safety measures may be in place, where someone is determined to subvert them they will invariably find a way to do so. But eventually they get found out.
Her preference is to use Oxford and call it NICE. NICE requires PEM (or something like it) but her research omits PEM while still claiming to use NICE diagnostic criteria.
A major Dutch university with a rotten bunch of CFS researchers was also appearing in the papers on a regular basis for research misconduct in other departments as well. Some universities have far too little oversight of their faculty, or think they are immune to criticism.
Do we have access to a copy of the letter that was sent? Do we know if the parents and children were advised, in the letter or later, that they were participating in a clinical study? Did they have any idea of this at all? Should they have?
That’s not 20% of all the students, but 20% of the missing school students selected by the schools.
Thank you once again, David, for scholarly treatment of this issue on the continued infringement of patients’ rights by Professor Crawley. It sadly seems that once you rise to a sufficient level of seniority in health care, you are able to reply on the collusion of journal editors to support your position, no matter how tenuous.
As a former scientist, I would have hoped for better from a leading scientific publication. If scientists and members of the public cannot rely on the scrutiny of submitted papers based on both their ethics and scientific methods (with no benefit of the doubt given to anyone, no matter how senior) how can we even begin to judge the treatments these are based upon?
Andy McLellan PhD
Well sad Jo.
Thanks Jen.
I can imagine conversations taking place at Bristol University along the lines of, “Esther, why can’t you concentrate on your work on bed wetting?”
https://uploads.disquscdn.com/images/42fe13d64d2f9a6708bc7e1f2e7899720d2a19b600b1903336bba222910f4dc5.jpg
We should remember that this is not just Crawley. She is working as an employee of Bristol University and as such they are responsible for carrying out trials without ethical approval. It is their job to provide governance over their staff.
Also there are two other professors who were involved with this paper and therefore I would assume the research. Prof Emond and Prof Sterne. It should be a black mark on their record as well.
Thanks for keeping an eye on her misdeeds. I hope in the future she will think twice about unethical practices.
In an of itself, contacting children and their families would not require approval from n NHS REC. They are not patients. It would, however, require approval from (one of) the University’s own RECs. And those holding the data should have had their own questions s result of data protection rules, they should have asked about ethical review. The subsequent medical evaluation of children, and the inclusion of rates of diagnosis in the study, may well mean it met the criteria for evaluation by an NHS REC.
Ah…what a bliss when the world is your playground, well, in Crawley’s case…the UK. Do whatever you like, no need to play by the rules. Makes research…o, sorry service evaluation so much easier.
It’s just like all the other matters they are involved in, no need to take responsibility, do what you like, play by your own rules and deny if people ask questions.
I would love to see what the bioethics community has to say about this. From my point of view this is a black and white situation. Thank yu for reporting, David.
Well put. Alas.
Who in the school systems would have had to agree to this? Surely the attendance officers could not hand over identities without permission from someone higher.
How would one access the bioethics community to find out? Are they likely to read this? I imagine ‘we’ would have to go to ‘them’? Are you able to facilitate this I wonder? I too would be curious to hear their response.
David Tuller states: “Dr. Groves wrote that (….)” “According to Dr. Groves’ version (…)” “Here’s my question for Dr. Groves: (…)”. Note that Trish Groves does not hold a PhD and/or a MD and/or a comparable degree. Source: http://www.bmj.com/about-bmj/editorial-staff/trish-groves (‘Trish Groves (MBBS, MRCPsych)’).
Note that BMJ Open welcomes comments / responses on articles, see http://bmjopen.bmj.com/content/1/2/e000252.responses for an overview of the responses to this article which have been published until now. There is towards the best of my knowledge no deadline for submitting new responses to this article.
See https://forbetterscience.com/2015/10/31/join-the-committee-ignore-publication-ethics/ and https://pubpeer.com/topics/1/2E91E8916236A6EE03F372E64FBBAF and http://www.mcser.org/journal/index.php/mjss/article/view/9657 for views about COPE.
BMJ Open seems to also use the same title, “Dr Trish Groves”, at http://bmjopen.bmj.com/pages/editorial-board/