By David Tuller, DrPH
Update (later on March 4): Because Royal United Hospitals Bath suggested that I “redirect” my request for documents back to Bristol University, that’s what I did. Earlier today, I sent an e-mail to Bristol’s director of legal services. Here’s what I wrote:
As you likely remember, I have raised concerns about a number of studies conducted by investigators from Bristol University. One of them is a study published by BMJ Open in 2011 called â€œUnidentified Chronic Fatigue Syndrome/myalgic encephalomyelitis (CFS/ME) is a major cause of school absence: surveillance outcomes from school-based clinics.â€
I have been seeking documents from this studyâ€”in particular, the letters sent to families of children with extended school absences and the consent forms used, if any. In responding to a freedom of information request, Bristol noted that this was a â€œpilot clinical serviceâ€ and â€œa clinical projectâ€ and that the university held no documents related to the study.
I recently filed a similar request with the specialist service for pediatric CFS/ME in Bath, which ran the â€œclinical projectâ€ piloted in the study. In this request, I explained that Bristol had already informed me it did not have the documents. The specialist serviceâ€”or rather Royal United Hospitals Bath, on behalf of the specialist serviceâ€”responded that it held no relevant information and advised me to â€œredirect your request to the University of Bristol.â€
Under normal circumstances, these documents would have been included in an application for approval submitted to the local research ethics committee. In that case, they would have been easily obtainable through a freedom of information request to the REC or its parent agency. As it is, the investigators avoided the REC process when they exempted the study from ethical review.
Given the suggestion from Royal United Hospitals Bath, is it possible the documents are held at the university after all and were overlooked during a first review of the records? Should I have appealed Bristolâ€™s negative response to my initial request? Should I file another formal freedom of information request with Bristol to start the process again?
If these documents are definitely not at Bristol, do you know where they might be? If not, would you be able to find out and let me know? Any insight into how I should proceed in this matter would be much appreciated.
David Tuller, DrPH
Senior Fellow in Public Health and Journalism
Center for Global Public Health
School of Public Health
University of California, Berkeley
I first wrote about BMJ Open’s 2011 school absence study in August, 2017. The investigators, all from Bristol University, exempted the study from ethical review on the grounds that it qualified as â€œservice evaluation.â€ The study included a hypothesis, generalizable conclusions and in-person interviews with participants. Since these are all features of â€œresearchâ€ that requires ethical review, the study did not qualify as â€œservice evaluationâ€ under known definitions. It should not have been conducted or published without ethical review.
Two days after I posted that first of many blogs about the study, Northwestern University law professor Steven Lubet and I sent a freedom of information request to Bristol for some documents related to the researchâ€”specifically, the letters sent by schools to families, and information leaflets and consent forms provided to participants. We were concerned that the school letters could possibly have been coercive, especially given the apparent involvement of school attendance officials in the studyâ€™s outreach effort. Also, since this research was conducted without ethical review, we wanted to know what, if anything, the participants were told about the study and what, if anything, they consented to.
Bristol wrote back that it did not have such documents, noting the following: â€œThis study reports on a pilot clinical service set up with the school attendance service in Bath to try and improve school attendance. This was a clinical project and no documents are held by the University.â€
After that, I kept writing about the studyâ€™s methodological and ethical failings and didn’t think much more about seeking the documents. I assumed the local research ethics committee would have no relevant records, since the investigators bypassed it when they decided to exempt the study from ethical review.
Last month, I finally got around to sending a freedom of information request to the specialist service for pediatric CFS/ME in Bath, which provided the clinical support for the study and has long been run by Professor Esther Crawley, the study’s lead investigator. Apparently the documents are not there either.
Here is the main part of the e-mail I sent on February 2 to the Bath specialist service:
In 2011, BMJ Open published a study called: “Unidentified Chronic Fatigue Syndrome/myalgic encephalomyelitis (CFS/ME) is a major cause of school absence: surveillance outcomes from school-based clinics.” The investigators exempted the study from ethical review on the basis of an opinion from the local research ethics committee. The REC reference for this opinion is 07/Q2006/48.
I have previously sent aÂ Freedom of Information request about this study to Bristol University. I was informed that the university does not hold the documents of interest because the study was conducted out of theÂ BathÂ clinical service. That is why I am now appealing to you.
For this study, three schools were sent letters to the families ofÂ children who had experienced prolonged school absences. I would like to be provided with:Â
1) A copy of the letter sent to these families. If each of the schools sent aÂ somewhat different letter, I would like toÂ receive all variants used.
2) A copy of the consent forms supplied to parents andÂ children who came to meetings at the schools to meet with the study’s lead investigator after receiving the letters mentioned above.
3) A peer-reviewer raised concerns about the study’s claim that itÂ qualified as service evaluation and was therefore exempt from ethical review. In response, the lead investigator noted:Â â€œWe 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.â€Â I would like to receive a copy of any such correspondence between the REC coordinator andÂ the investigators relating to the issue of whether this study did or did not qualify asÂ service evaluation and did or did not warrant exemption from ethical review.
I added this paragraph at the end:
Let me state this clearly: This is not a “vexatious” request. It is a legitimate effort to understand why this study was presented and published as “service evaluation” when it appears to be the epitome of what one would call “research,” given that it included a hypothesis, generalizable conclusions, and in-person interviews with study subjects.
I didnâ€™t need to worry about the â€œvexatiousâ€ part. On Friday, I received a response from Royal United Hospitals Bath, which oversees the specialist service. Here is the operative section: â€œWe do not hold information in relation to your request. Please redirect your request to the University of Bristol.â€
Thatâ€™s a convenient arrangement. The university tells me it knows nothing because this was a clinical project. Now the clinical folks tell me itâ€™s a university matter and they know nothing.
Copies of the school letters must exist somewhere. As for consent forms, who knows? It is not clear from the studyâ€™s description of its methodology how or even whether the families that received the school letters were consented or were made aware that they were being studied. It is impossible to assess the matter without a look at documents. But neither the university nor the specialist service seems to hold them. In that case, who does?
On another note: Professor Crawley has launched a survey of pediatricians to investigate the incidence and clinical characteristics of severe pediatric CFS/ME. (This was obviously planned and funded before the recently launched investigation into some of her work.) The survey will ask pediatricians about severe patients they have seen within the last month. Since many if not most severe pediatric patients have probably not seen the doctor within the last many months or much longer, the cases reviewed in the study will likely be skewed toward the less severe among the â€œsevereâ€ casesâ€”that is, those well enough to make it to the doctorâ€™s office.
That is just one of the studyâ€™s problems. Others are discussed in this thread on the Science for ME forum. So yes, it is troubling that Professor Crawley is heading up another study.