Trial By Error: Who Has the School Study Documents?

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 “Unidentified Chronic Fatigue Syndrome/myalgic encephalomyelitis (CFS/ME) is a major cause of school absence: surveillance outcomes from school-based clinics.”

I have been seeking documents from this study—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 “pilot clinical service” and “a clinical project” 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 “clinical project” piloted in the study. In this request, I explained that Bristol had already informed me it did not have the documents. The specialist service—or rather Royal United Hospitals Bath, on behalf of the specialist service—responded that it held no relevant information and advised me to “redirect your request to the University of Bristol.”

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 Bristol’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.

Best—David

David Tuller, DrPH
Senior Fellow in Public Health and Journalism
Center for Global Public Health
School of Public Health
University of California, Berkeley

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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 “service evaluation.” The study included a hypothesis, generalizable conclusions and in-person interviews with participants. Since these are all features of “research” that requires ethical review, the study did not qualify as “service evaluation” 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 research—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 study’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: “This 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.”

After that, I kept writing about the study’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 a 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 the Bath clinical service. That is why I am now appealing to you.

For this study, three schools were sent letters to the families of children who had experienced prolonged school absences. I would like to be provided with: 

1) A copy of the letter sent to these families. If each of the schools sent a somewhat different letter, I would like to receive all variants used.

2) A copy of the consent forms supplied to parents and 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 it qualified as service evaluation and was therefore exempt from ethical review. In response, the lead investigator noted: “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.” I would like to receive a copy of any such correspondence between the REC coordinator and the investigators relating to the issue of whether this study did or did not qualify as 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 didn’t need to worry about the “vexatious” part. On Friday, I received a response from Royal United Hospitals Bath, which oversees the specialist service. Here is the operative section: “We do not hold information in relation to your request. Please redirect your request to the University of Bristol.”

That’s a convenient arrangement. The university tells me it knows nothing because this was a clinical project. Now the clinical folks tell me it’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 study’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 “severe” cases—that is, those well enough to make it to the doctor’s office.

That is just one of the study’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.

{ 13 comments… add one }
  • Couch Turnip 4 March 2019, 3:54 am

    You could try the schools involved perhaps, or the school attendance service, but I doubt that either approach would be very easy. I’d have thought that Crawley should have a copy of these documents and she was working on this from the University of Bristol at the time. From the paper, her work address was given as – “Centre for Child and Adolescent Health, School of Social and Community Medicine, Bristol” – that’s part of the University of Bristol. Her correspondence address for the study was given as a university email address, so was this information on the published paper false? I understand that she is still employed by them, well, for the moment. It looks to me like the University of Bristol was giving you the run around. You could have appealed to the ICO when they said they didn’t have them, but I’m pretty sure there’s a time limit for appealing. Perhaps someone else might like to try from scratch?

  • Peter Trewhitt 4 March 2019, 5:06 am

    Curiouser and curiouser.

    It may be that the schools sent letters to the parents/guardians themselves, but presumably Prof Crawley provided them with some level of template and somewhere has a record of this.

    Is it known if the schools/local education authority are aware of the controversy around this research? Might a freedom of information request to them access the letter’s/letters’ content.

  • Couch Turnip 4 March 2019, 5:22 am

    Perhaps we should just submit a FOI to Crawley’s kitchen table/sideboard drawer?

  • Daisy 4 March 2019, 5:41 am

    If not already tried a way forward maybe to contact the school attendance service in Bath with a FOI as they seem to have been involved too. And then the schools attendance officers.
    From the NHS news in 2011:
    “A pilot clinical service was set up with the school attendance service in Bath to try to improve school attendance. The service was run in three state secondary schools between 2007 and 2008: a girls-only school and two mixed gender schools. The three schools had 2,855 pupils. The schools’ attendance officers identified children aged 11 to 16 who had been absent for more than 20% of school days during a single six-week term.”

    https://www.nhs.uk/news/pregnancy-and-child/chronic-fatigue-syndrome-cause-of-school-absence/

  • Couch Turnip 4 March 2019, 6:47 am

    A new FOI request to Bristol Uni is the best way forward IMO, followed up by an appeal to them if they refuse and then an appeal to the ICO if necessary. It would only take a few months. But there’s nothing to stop other people having a crack at the other routes for good measure.

  • Barbara R 4 March 2019, 7:09 am

    If any intervention any communications were being sent out to schools, the LEA officers must have copies which they would have screened, Failing that for Academies, the Governing Bodies of the Schools involved would have to have seen and approved it. So, ,
    1. Contact the Local Authority Alternative Provision Service ( (formally called Education Other Than At School), , Pupil Referral Units LEA or Academies now, who have medical cases and possibly the Hospital School staff if they have one( under control of the LEA and Officers.
    Send out a letter to all Governing Bodies of Academies.

  • Barbara R 4 March 2019, 7:15 am

    https://www.bristol.gov.uk/schools-learning-early-years/alternative-learning-provision.

    Alternative Learning Provision

    The Alternative Learning Provision (formerly the Pupil Referral Service) is for pupils who can’t attend mainstream educational settings.

    The service is made up of:

    Lansdown Park Secondary Specialist Provision
    St Matthias Park Pupil Referral Unit
    Bristol Hospital Education Service

    The Educated Otherwise/Alternative Learning Provision Hub commissions alternative provision from a range of alternative providers.

    All alternative providers used by the Local Authority have gone through a stringent process of quality assurance and been included onto a framework agreement of alternative provision.

    For further information contact:

    Chris Davies
    Headteacher, Alternative Learning Provision Virtual School Bristol
    Email: chris.davies@bristol.gov.uk

    Julie Ley
    Business and Administration Support
    Email: julie.ley@bristol.gov.uk
    telephone: 0117 903 1294

    Education for ill children

    The Hospital Education Service offers teaching to children who miss school for long periods because they’re in hospital or too ill to attend school.
    Who can use the service

    The Hospital Education Service is for pupils who miss school because of severe or chronic ill health, including serious mental health. The service also helps students who frequently need hospital treatment followed by periods at home or in school.

    Pupils are referred to us by health professionals.
    What the service aims to do

    We help minimise disruption to pupils’ education.

    We teach children in hospital, at our base or where they live, and we aim to teach a broad and relevant curriculum that’s suited to their needs.

    You can find out more at the Hospital Education Service website.
    Contact information

    Hospital teachers are based in the Bristol Royal Hospital For Children and Riverside Adolescent Unit. Teachers working with students where they live are based at our main base at Redhouse Centre.

    For general enquiries or enquiries about home tuition, contact the head of the service, Jim Bowyer, at the Redhouse Centre. If you’re enquiring about pupils in hospital or units, contact the relevant site.
    Contact information
    Bristol Hospital Education Service

    Falkland Road

    Montpelier

    Bristol, BS6 5JT
    Opening Hours

    Tel: 0117 377 2377
    Bristol Royal Hospital For Children

    Paul O’Gorman Building

    Upper Maudlin Street

    Bristol, BS2 8BJ
    Opening Hours

    Tel: 0117 342 8263
    Riverside Adolescent Unit

    Blackberry Hill Hospital

    Manor Road

    Bristol, BS16 2EW
    Opening Hours

    Tel: 0117 340 4878

    https://www.bristol.gov.uk/schools-learning-early-years/hospital-education-service
    Education for ill children
    The Hospital Education Service offers teaching to children who miss school for long periods because they’re in hospital or too ill to attend school.
    Who can use the service
    The Hospital Education Service is for pupils who miss school because of severe or chronic ill health, including serious mental health. The service also helps students who frequently need hospital treatment followed by periods at home or in school.
    Pupils are referred to us by health professionals.
    What the service aims to do
    We help minimise disruption to pupils’ education.
    We teach children in hospital, at our base or where they live, and we aim to teach a broad and relevant curriculum that’s suited to their needs.
    You can find out more at the Hospital Education Service website.
    Contact information
    Hospital teachers are based in the Bristol Royal Hospital For Children and Riverside Adolescent Unit. Teachers working with students where they live are based at our main base at Redhouse Centre.
    For general enquiries or enquiries about home tuition, contact the head of the service, Jim Bowyer, at the Redhouse Centre. If you’re enquiring about pupils in hospital or units, contact the relevant site.
    Contact information
    Bristol Hospital Education Service
    Falkland Road
    Montpelier
    Bristol, BS6 5JT
    Opening Hours

    Tel: 0117 377 2377
    Bristol Royal Hospital For Children
    Paul O’Gorman Building
    Upper Maudlin Street
    Bristol, BS2 8BJ
    Opening Hours
    Tel: 0117 342 8263
    Riverside Adolescent Unit
    Blackberry Hill Hospital
    Manor Road
    Bristol, BS16 2EW
    Opening Hours
    Tel: 0117 340 4878

  • Tina Rodwell 4 March 2019, 8:12 am

    It is truly astounding that this is allowed to continue and so bizarre. It is inconceivable that anyone who knows a little bit about medical conditions, safeguarding children and do not harm would ever let this go.

    If parents behaved with gay abandon over record keeping and lack of accountability; as has happened with the School Absence study (and many more), their child would be taken away. so why are these establishments and researchers allowed to keep going?

    I miss one letter to school that confirms my son’s ill-health for that half term, I get taken to court. What compounds my “down the rabbit hole” experience is that the Paediatrics I see, have little to no understanding of my son’s illness. They seem stressed beyond their capacity to support or help in anyway and I’m never sure who I should feel most dumbfounded for – them or me. They are told through the safeguarding pathway to Fabricating and Inducing Illness (FII) to look out for parents like me, especially when I ask questions, and know too much. It means I’m scuppered whichever way I go. My son then, is left to struggle up stream without a paddle, while lactic acid and exhausted in both cognition and muscles and as he struggles to breath, no one person can tell me why. This is my fault, my doing – the facts don’t count?

    Most of the time when I read such research papers, that have gone through ethical approval and reasons as to why there needs to be information gathered or research done on young children, I stare at their lack of understanding and logic in dumbfounded amazement. A review of ethical committees is long overdue.
    For over a decade they have been trying to put the blame on young patients or their parents. It is like watching an ugly sister trying to fit her large and deformed foot in a glass slipper. Post Exertional Malaise (PEM) is never looked at as to how and why it effects the body. Good biomedical science is starting to, and the results are proving how detrimental the lack of understanding of PEM is.

    It is not as though Post Exertional Malaise is not known about, in the Chief Medical Officers report in 2002 and on the NICE guidelines 2007, it is one of the known diagnostic criteria. As far back as 1986 Dr Ramsay had a good understanding of PEM and why it was so important. Now in these papers they mention PEM and don’t explain it. They keep trying to measure activity with is a oxymoron as regards to PEM and ME.

    When they talk about severity and about severe children, they point you to others definition which is concerning. In one paper the case definition for severe children, seems to be defined as fatigue that is so severe that children are unable to attend school for more than one hour a week.
    Now, I have had a couple of buckets of coffee while trying to get my head around what that case definition could possibly mean. I fear it would take a better person than me.

    What I can say, is that with every ME child it is always the same – PEM is the central issue and not waiting for the PEM to subside, causes a deeper PEM state, that takes longer to subside. There is always a possibility that it may never subside, that is why many children that are now adults are left housebound for decades. Severe ME is: near death, in incredible and unbelievable pain and tube fed. For a researcher or doctor who has been working with ME children for any length of time, not understand this is unforgivable.

    When reading a book or watching a film causes PEM, school attendance is not an appropriate measure, now is it? Adding in time to travel, sitting at a desk and meeting and talking to friends, means that will make the PEM so deep the child may take a very long time to stabilise again. Therefore, going into PEM and then back to a more stable state is the measure and the time it takes for the child to regain a pre-PEM state is where restorative rest comes in. Measure and follow this and the child’s health would be protected. PEM is the harm done to a child when they have ME and should be reported as such in all trials.

  • jimells 4 March 2019, 9:24 am

    The maze of bureaucracies in the UK is truly awe-inspiring. Or maybe vomit-inducing. I wonder, is there a Department of Departments to keep track of it all?

  • Richard Vallee 4 March 2019, 10:34 am

    “That’s a convenient arrangement. The university tells me it knows nothing because this was a clinical project. Now the clinical folks tell me it’s a university matter and they know nothing.”

    This is quite similar to “fatigue clinics” not monitoring outcomes. NHS was asked about data on those services and replied that local clinics are responsible for that (an absurd fact that suggests indifference to outcome of nationally delivered services). When asked, clinics reply they do no such monitoring and to ask the NHS (or whatever actual agency is normally tasked with this).

    Also quite similar to the convenient circumstances of there not existing any process by which harms from CBT and GET can be reported, a fact that is then spun to show that no harm has been recorded… because it is literally impossible to do so.

    Then of course pediatricians are not qualified without specialist training in identifying ME patients (let alone the distinction of severe patients) and neither is Crawley or her staff, who work under a wholly fictitious misrepresentation model of the disease, so it’s a wonder how properly the participants were identified.

    This is a completely unaccountable system, which in the delivery of services to a very sick patient population amounts to reckless endangerment. No one knows what others are doing, data are not recorded, services are not monitored, informed consent is not required, reviews seem to be done strictly within a mutual admiration society where no one criticizes each other and everyone’s work deserves a shiny star sticker.

    Very reminiscent of the old asylum systems where the sick were disappeared. Except here the walls are virtual, made up of a byzantine bureaucracy that shields normal accountability by creating special exemptions like allowing weak, subjective psychological research to have medical significance without any of the accountability that medical services are expected to enforce, up to and including making implied assumptions of mental ineptitude without anyone actually being held responsible for such a determination.

    That those documents may not exist is not at all an adequate response. If anything, it makes things even worse, showing that there is an explicit choice made not to write things down (or to purposefully hide them) as much as possible so as not to leave a trace of obviously flawed decisions being made. Reckless and unethical.

  • Alicia Butcher Ehrhardt 4 March 2019, 7:43 pm

    Just out of curiosity: is there a list of child participants, and thus access to their parents? I saved a lot of stuff from the school days in those years my kids were in school.

    Or were they told in person in a meeting, with no paperwork provided?

    Did they sign something – to give consent – which the authorities would have to retain to prove they had the consent?

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