Trial By Error: My Letter to Bristol and the Health Research Authority About Uncorrected Crawley Papers

By David Tuller, DrPH

In 2019, a report from the University of Bristol and the UK’s Health Research Authority recommended corrections to the ethics statements of eleven studies. Professor Esther Crawley, Bristol’s ethically and methodologically challenged star researcher and grant magnet, was the main author and/or principal investigator of all eleven papers. In a post yesterday, I disclosed that only four of the eleven appear to have been corrected.

When I tweeted out the post, the HRA’s twitter account quickly responded with the following: “Thanks for bringing this to our attention David. This case predates our current complaints handling process, but we’re reviewing our records and will confirm what we intend to do next.”

I responded in kind: “Wow, thank you for the quick response! I am also sending a letter directly to HRA and to Bristol asking that you both: 1) Find out why these corrections have not been made, and 2) Ensure they are made without further delay.”

HRA’s twitter response: “Thanks David, we’ll look out for it.”

That seems like a promising development, but I’ll reserve further judgement until I see whether it produces results. In the meantime, below is the letter I wrote to the University of Bristol and the HRA about the situation. At both institutions, the individuals with whom I previously corresponded are no longer in their posts, so I addressed the e-mail to what seemed like the appropriate departments and/or recipients at each.


My letter to the University of Bristol and the Health Research Authority

Subject line: Non-compliance with recommendations from 2019 joint report from Bristol and HRA

To: Relevant Officials at Bristol and the Health Research Authority 

In October, 2019, the University of Bristol and the Health Research Authority (HRA) issued a joint review of eleven papers whose main author and principal investigator was a member of Bristol’s academic staff. The review, available here, recommended that the ethics statements in all eleven papers be corrected, and even suggested specific language for each case. That was almost three years ago–yet only four of the eleven papers appear to have been corrected.

The review of these papers was undertaken after I had alerted the HRA about a perplexing anomaly. All eleven papers cited the same unrelated letter from a local research ethics committee to exempt themselves from ethical review as “service evaluation.” It is troubling to find that the recommendations of the Bristol-HRA review appear to have been overlooked or ignored in the majority of instances.

I assumed it was the role of the main author and/or principal investigator to submit corrections to the relevant journals. Given the delay, I urge both Bristol and the HRA to take immediate action to: 1) determine why the majority of the corrections do not appear to have been made, and 2) ensure that the ethics statements in the uncorrected papers are corrected promptly.

I have written about the current situation on Virology Blog, a well-read science site, and will post this letter there as well. Below are the eleven studies, in the order listed in the HRA-Bristol review, with their current correction status:

1. Uncorrected: Association between school absence and physical function in paediatric chronic fatigue syndrome/myalgic encephalopathy (CFS/ME)Archives of Disease in Childhood

2. Uncorrected: Anxiety in children with CFS/MEEuropean Child & Adolescent Psychiatry

3. Uncorrected: The impact of CFS/ME on employment and productivity in the UK: a cross-sectional study based on the CFS/ME national outcomes databaseBMC Health Services Research

4. Uncorrected: What stops children with a chronic illness accessing health care: a mixed methods study in children with CFS/MEBMC Health Services Research

5. Corrected on Nov 1, 2019: Unidentified CFS/ME is a major cause of school absence: surveillance outcomes from school-based clinicsBMJ Open

6. Corrected on May 3, 2020: Treatment outcome in adults with CFS: a prospective study in England based on the CFS/ME national outcomes, QJM: An International Journal of Medicine

7. Uncorrected: Depression in paediatric CFSArchives of Disease in Childhood

8. Corrected on Nov 1, 2019: CFS or ME is different in children compared to in adults: a study of UK and Dutch clinical cohortsBMJ Open

9. Uncorrected: CFS symptom-based phenotypes in two clinical cohorts of adult patients in the UK and the NetherlandsJournal of Psychosomatic Research

10. Corrected on Jan 22, 2020: Obesity in adolescents with CFS: an observational studyArchives of Disease in Childhood

11. Uncorrected: Defining the minimally clinically important difference of the SF-36 physical function subscale for paediatric CFS/ME: triangulation using three different methodsHealth and Quality of Life Outcomes

Readers of the articles with uncorrected ethics statements are still being offered information that the Bristol-HRA review found to be “either inappropriate or inadequate to cover the activity described.” This is an unsatisfactory state of affairs. Please advise on how you plan to address the issue.

Best–David Tuller

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

4 thoughts on “Trial By Error: My Letter to Bristol and the Health Research Authority About Uncorrected Crawley Papers”

  1. Thank you David for following this up. The children at the Bristol clinic deserve our care. It’s a pity that the hospital has allowed this to happen.

  2. AB commented:

    “The children at the Bristol clinic deserve our care. It’s a pity that the hospital has allowed this to happen.”

    This wasn’t just about the Bristol/Bath clinics though, was it, (although I’m pretty sure they were involved)? I seem to remember that this affected thousands of adult and paediatric ME patients from across the UK who were asked to provide lots of data that was used for research studies without them having any idea that it would be. And didn’t the HRA decide that that was ok, that it was routine clinic data that was collected from them so it could indeed be regarded as ‘service evaluation’? Well, I’ve seen some of what patients had to complete and I can’t remember ever being been asked for so much information up front before a first clinic appointment for other medical problems, or being confronted by forms/questionnaires that looked like they were for some kind of research project. There was nothing about that data collection that looked ‘routine’ to me – abnormal, intrusive and burdensome, but not routine. The people who took part in the PACE trial consented for their information to be used for that research, and yet ME patients from across the UK were being asked for similar information without any notion that it would be used for research papers. Does the HRA really think that, because patients gave this information when asked or told to, that constitutes informed consent? To my mind, it wasn’t acceptable then and it isn’t acceptable now, even though the HRA seemingly tried to draw a line under it back in 2019. The fact that only 4 out of the 11 papers have been corrected to date to what the investigation report recommended comes as no great surprise to me. It should certainly give the HRA pause for thought.

  3. Pingback: Trial By Error: My Exchange of Letters With Bristol About Professor Crawley’s Uncorrected Ethical Statements

Comments are closed.

Scroll to Top