Trial By Error: Professor Crawley Was Asked to Correct Ethics Statements in 11 Papers; 7 Are Still Uncorrected

By David Tuller, DrPH

A few years ago, a valued source alerted me to a strange quirk in the work of pediatrician Esther Crawley, Bristol University’s methodologically and ethically challenged star researcher and grant magnet. Not all tips are reliable, but this one definitely was. As it turned out, Professor Crawley had–based on a single 2007 letter from a local research ethics committee (REC)– exempted a whole batch of separate studies from ethical review. (I first reported on this peculiar situation in November, 2018.)

In each of these eleven papers, the ethics statement went something like this:

“The North Somerset and South Bristol Research Ethics Committee decided that the collection and analysis of these data was part of service evaluation and as such did not require ethical review by a NHS research ethics committee or approval from the NHS R&D office (REC reference number 07/Q2006/ 48).”

The reference number—which identified the REC letter in question—was the same for each paper. It seemed pretty brazen of Professor Crawley to exempt eleven studies from ethical review by citing a letter issued in connection to a completely unrelated previous data collection effort. The system of academic ethical review, which is supposed to protect human research subjects, does not usually work this way.

At issue was whether the cited studies met criteria to be considered “research” or whether they were instead “service evaluation.” The former requires ethical review, while the latter—which involves the use of anonymized data to track and monitor the provision of specific services—does not. It was astonishing that an experienced investigator like Professor Crawley appeared to believe she possessed an unfettered right to exempt her own work from proper oversight by referencing an REC decision about something else entirely.

In any event, I alerted the Health Research Authority, the agency within the UK’s National Health Service that monitors local RECs. The HRA was sufficiently concerned about these anomalies that it began pressing Bristol for answers. After a period of months during which nothing conclusive happened, the HRA finally confirmed to me in January, 2019, that it had asked Bristol to agree to an official investigation. Presumably, had Bristol provided satisfactory explanations for this breach of standard research practice or take steps to fix the problem, such an investigation would not have been necessary.

The HRA published the results of the investigation—“Report of a publications review jointly commissioned by the Health Research Authority and the University of Bristol”–on October 22, 2019. According to the report, the three-member review panel included “two members of academic staff at the University of Bristol…and an independent Chair nominated by the HRA who was a clinical academic from another Russell Group university.” (The Russell Group is an association of leading UK research universities.)

Here’s a short excerpt:

“This report describes the deliberations and conclusions of a panel of experts commissioned by the Health Research Authority and the University of Bristol to review eleven publications on chronic fatigue syndrome and myalgic encephalomyelitis, all of which cited the same National Health Service Research Ethics Committee reference 07/Q2006/48 in the ethics statement…

“The publications review was commissioned following a number of complaints received by the HRA and by journal editors, questioning the repeated use of the same REC reference in eleven papers published in peer-reviewed journals over a period of several years, for which the main author and Principal Investigator (Pl) was a member of academic staff at the University of Bristol. The REC reference was cited in each case as confirming that the collection and analysis of the data was part of service evaluation and did not require ethical review.”

Here’s the main conclusion: “In all eleven papers, the Research Ethics Committee reference, as cited in the ethics statement, was either inappropriate or inadequate to cover the activity described.” However, the panel bent over backwards to find the principal investigator—i.e. Professor Crawley–blameless, attributing the errors to misunderstandings and miscommunications. At the same time, the report requested corrections to the ethics statements in all eleven papers, providing proposed language for each one.

After this public accounting, I assumed that Professor Crawley would ensure that all these ethics corrections, however humiliating, were made without delay. That was apparently a misjudgment. I learned recently, via a post on the Science for ME forum, that this task appears to have remained unfinished. So I checked myself.

**********
Seven papers remain uncorrected

As it turns out, two of the papers were corrected right after the release of the report, and two more in the first part of 2019. But the ethics statements in the other seven remain uncorrected, for unknown reasons–at least as far as I could determine. I will need to follow up on this with the appropriate people.

Here are the eleven studies, in the order listed in the HRA-Bristol report.

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 Nov 1, 2019: Unidentified CFS/ME is a major cause of school absence: surveillance outcomes from school-based clinics, BMJ Open

6. Corrected 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 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 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