By David Tuller, DrPH
Last month I wrote to the director of legal services at the University of Bristol seeking information about documents from a study conducted by investigators from the institution. The study, published by BMJ Open in 2011, was called “Unidentified Chronic Fatigue Syndrome/myalgic encephalomyelitis (CFS/ME) is a major cause of school absence: surveillance outcomes from school-based clinics.”
More than a year ago, I had sought consent forms and other documents from Bristol through a freedom of information request. In response, Bristol noted that this was a “pilot clinical service” and “a clinical project” and that the university held none of the study documents. Yet the specialist service for pediatric CFS/ME in Bath, the medical unit that ran the “clinical project,” also informed me that it did not hold the documents and suggested I needed to contact the university.
This run-around triggered my e-mail to the legal services director in early March. My goal in touching base again with Bristol about this matter was to double-check that the university’s first answer was correct—that it did not, in fact, have any documents.
On March 28, I received the following e-mail:
Dear Dr Tuller,
We have been asked to respond to your email of 5th March…
We can confirm our original response that the University does not hold the information requested. If you were to submit another Freedom of Information request, you would receive the same answer.
University of Bristol
Today, I sent the following e-mail to the director of legal services:
As you know, I have been seeking documents about a study conducted by Bristol investigators and published by BMJ Open in 2011. The study was called “Unidentified Chronic Fatigue Syndrome/myalgic encephalomyelitis (CFS/ME) is a major cause of school absence: surveillance outcomes from school-based clinics.”
When I submitted a freedom of information request to Bristol more than a year ago, I was told the study involved a “pilot clinical service” and that the university did not hold the documents. But when I appealed to the Bath clinical service that conducted the pilot program, I was referred back to the university. Now Bristol’s FOI office has re-confirmed that the university does not hold documents related to this study. I find this inability to locate key documents for a study conducted by Bristol investigators to be perplexing.
Also, my e-mail to you last month included these questions: “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?” I did not notice an answer to these questions in the e-mail from Bristol’s FOI team. Presumably the Bristol investigators themselves might know the location of any such documents.
So here’s the situation: To collect data for this study, a Bristol investigator conducted in-person interviews with children. Yet no one seems able to find consent forms for this form of data collection among minors. Given my unsuccessful efforts to access these forms or even find out who holds them, would it be fair to assume the study might have been conducted without obtaining informed consent from participants? Can you suggest other possible explanations?
This assumption might make sense in light of the decision to exempt the study from ethical review by calling it “service evaluation” rather than “research.” The school absence study included a hypothesis and generalizable conclusions as well as in-person data collection. These are all well-known hallmarks of “research.” In contrast, “service evaluation” generally relies on anonymized secondary data sets and is exempt from ethical review. The process of ethical review includes a review of consent forms. So perhaps it should not be surprising that a study conducted without undergoing ethical review might also bypass the process of obtaining informed consent.
In exempting the study from ethical review, the investigators cited a letter from a research ethics committee involving an unrelated pediatric data collection strategy. In my reporting, I have identified ten additional studies from the team of Bristol investigators that similarly exempted themselves from ethical review based on the same research ethics committee letter. Some of these studies involved adults, so it is unclear why experienced investigators would consider them exempt from ethical review based on a research ethics committee letter specifically about pediatric data collection.
When I initially raised concerns about the school absence study, no one appeared to take the matter seriously—certainly not BMJ Open. (I have cc’d BMJ editorial director Fiona Godlee, who is aware of my concern about this paper. I have also cc’d Darren Jones MP, Carol Monaghan MP and Nicky Morgan MP, key members of the cross-party parliamentary coalition that has expressed concerns about the methodological and ethical flaws of research in this field.)
The apparent lack of institutional responsibility is what prompted me to communicate with the Health Research Authority, the arm of the National Health Service that oversees research ethics practices. As I learned from the HRA (and reported on Virology Blog in January), Bristol is now conducting an investigation into multiple studies that exempted themselves from ethical review citing this single REC letter. According to the HRA, this investigation is “independent.”
Can you provide any information about when Bristol plans to finish this investigation? Can you provide any information about the size and composition of the panel assessing these studies? Does the panel include one or more Bristol faculty members or others affiliated with Bristol? If yes, how many?
And a couple of related questions: Is the university concerned that this investigation so closely follows last year’s research misconduct scandal involving Abderrahmane Kaidi, a Bristol cancer biologist who resigned in disgrace in September? Does Bristol believe these twin episodes might suggest a problem with governance and oversight policies?
Thank you very much for any additional information you can provide.
David Tuller, DrPH
Senior Fellow in Journalism and Public Health
Center for Global Public Health
University of California, Berkeley
Post-script: In my e-mail to the legal services director, I mistakenly wrote “Darrell Jones MP” instead of “Darren Jones MP.” I sent the recipients a subsequent e-mail to correct the error.
6 responses to “My Latest Letter to Bristol”
it seems that bristol has a problem with secure storage of data…..
Parents know their children best and decisions about healthcare should be made together with the parents. In this study the researchers justify surveillance with: “Surveillance is particularly important for diseases, such as CFS/ME, where there may be poor parental recognition of symptoms and presentation for assessment.” They go on to admit that there is little awareness of ME and not much training for GPs. Surely the best way forward would be to train GPs, raise awareness of the biomedical nature of ME and see to it that children are given the care they need and that this is decided together with the parents. There is at the moment no cure for ME. In this study the researchers claim: “our finding that more than half (12/23) of children with school-clinic-diagnosed CFS/ME returned to full-time school within 6 months of the start of treatment compares well with results from other follow-up studies” are grossly exaggerated, in fact it is doubtful whether this could honestly be replicated.
Keep holding their feet to the fire.
They are hoping you will just go away and stop bothering them (this would probably happen with a parent seeking the information).
You are asking for information you should be able to obtain.
Sorry you have to put so much work into what should have resulted in the documents, or the information on where they were stored, the FIRST time you requested them politely.
The NHS seemed to think that this study was research too, if their webpage entitled “Chronic fatigue syndrome ’cause of school absence’ ” , and dated Tuesday December 13 2011, is anything to go by. (It was also relayed as research in the Nursing Times and in the Guardian newspaper.) Surely the NHS should have known if this was research or not, given that children involved with the study were seen in a NHS clinic at the Royal National Hospital for Rheumatic Diseases in Bath. If it was research then there should be consent forms, so where the dickens are they?
This isn’t a good look for Bristol University, can’t they see that? All they have to do is ask their employee where the forms and documents are and pass the information on in a spirit of transparency and helpfulness. Is that really too much to ask?
Might ask if there has been a serious fire — the most common cause of losses of records. If not, quote Lady Bracknell on “sheer Carelessness “
Maybe you should contact the Information Commissioner David? If the study legally required documents then it must be a breach of regulations for Bristol/Bath to be unable to produce them.