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/ME, European 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 database, BMC Health Services Research
4. Uncorrected: What stops children with a chronic illness accessing health care: a mixed methods study in children with CFS/ME, BMC Health Services Research
5. Corrected on Nov 1, 2019: Unidentified CFS/ME is a major cause of school absence: surveillance outcomes from school-based clinics, BMJ 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 CFS, Archives 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 cohorts, BMJ Open
9. Uncorrected: CFS symptom-based phenotypes in two clinical cohorts of adult patients in the UK and the Netherlands, Journal of Psychosomatic Research
10. Corrected on Jan 22, 2020: Obesity in adolescents with CFS: an observational study, Archives 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 methods, Health 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.
David Tuller, DrPH
Senior Fellow in Public Health and Journalism
Center for Global Public Health
School of Public Health
University of California, Berkeley