By David Tuller, DrPH
Today I sent the following e-mail to Sue Paterson, director of legal services at Bristol University. I cc-d several other people on the e-mail.
Dear Ms Paterson—
Earlier this month, I sent you an e-mail to ask, among other questions, when Bristol University plans to finish its investigation of studies that exempted themselves from ethical review as “service evaluation”–all based on a single research ethics committee letter. As you know, I have documented that at least 11 studies have cited this letter, which appeared to have nothing to do with any of them.
Perhaps the most problematic example is a study related to school absence, which was published by BMJ Open in 2011. This study included in-person interviews with minors—a data collection method that clearly identifies it as “research” requiring ethical review and not “service evaluation” that is exempt from such oversight. Because it appeared no one involved took the issue seriously, I brought the matter to the attention of the National Health Service’s Health Research Authority, which requested Bristol to conduct an “independent” review of the matter.
I have not yet heard back from you. Since my academic position at UC Berkeley’s Center for Global Public Health involves investigating ME/CFS research and related controversies, it seemed like a good idea to touch base again in my effort to obtain information.
In addition to the many studies exempted from ethical review under questionable circumstances, I have documented as well that the 2017 pediatric Lightning Process study, conducted by Bristol investigators and published in Archives of Disease in Childhood, included serious ethical and methodological violations. Specifically, the investigators enrolled more than half the participants before trial registration and then swapped outcome measures based on these early results. Years ago, the major medical publishers all adopted a policy barring the publication of studies in which participants were recruited before trial registration. In other words, the journal clearly erred in publishing the study in the first place. Moreover, the investigators failed to disclose in the paper itself both the pre-registration recruitment and the outcome-swapping—a perplexing and unacceptable lack of transparency.
Last June, Archives of Disease in Childhood slapped an editor’s note on the study that confirmed my criticisms. However, the journal appears to have abrogated its editorial obligations in its failure to take further action and resolve the matter to date.
Because it is critical for these issues to be addressed publicly and not swept under the rug, as many involved would appear to prefer, I am cc-ing a number of people on this e-mail. First, I am cc-ing three members of the House of Commons, all of whom have all expressed dismay at the poor quality of much of the research into ME/CFS–Carol Monaghan MP, Nicky Morgan MP, and Darren Jones MP, the latter from the Bristol area. I am also cc-ing two parliamentary aides involved in the matter.
I am cc-ing Tom Whipple, science reporter at The Times, for two reasons. Last year, he covered the high-profile scandal involving a Bristol cancer biologist who resigned in disgrace amid accusations of scientific misconduct. Moreover, Mr Whipple has previously demonstrated interest in issues of research integrity related to studies of ME/CFS.
I am also cc-ing Dr Fiona Godlee, editorial director of BMJ, which publishes both BMJ Open and Archives of Disease in Childhood. In an e-mail to me last fall, Dr Godlee professed to be concerned about the issues I have raised involving pediatric studies from Bristol. In fact, with regards to the Bristol research, she asssured me that “we are actively working on the various aspects of this case and will do all we can to reach a timely resolution.” For reasons I find difficult to comprehend, she and her journals have so far failed to achieve this promised “timely resolution.”
Finally, as you likely know, the National Institute for Health and Care Excellence (NICE) is in the process of developing new guidelines for ME/CFS. It is critical that NICE only consider studies that meet accepted thresholds for research integrity. Since some Bristol studies appear to fall short in that regard, I am cc-ing four of those involved in the NICE process–Dr Luis Nacul, Dr William Weir, Dr Charles Shepherd, and Professor Jonathan Edwards.
Here are my questions:
1. What is the composition of the “independent” panel investigating the studies exempted from ethical review under the guise of “service evaluation”? How many on the panel are affiliated with Bristol, and how many do not hold such an affiliation? When do you expect the results of the investigation into these studies, and how will these results be released and disseminated?
2. Does Bristol believe that conducting in-person interviews—with minors, in the case of the school absence study–can be defined as “service evaluation,” despite Health Research Authority guidelines indicating that this form of data collection qualifies as “research” requiring ethical review? If Bristol believes this data collection method can qualify as “service evaluation,” can you explain why?
3. Is Bristol concerned that experienced researchers from the university either did not realize that conducting in-person interviews means a study is by definition “research,” or else realized this but conducted these interviews anyway, despite the lack of ethical review? Does Bristol plan to launch an educational campaign to inform its researchers about the difference between “research” and “service evaluation,” in case they are unfamiliar with these seminal concepts?
4. As you know, I have been seeking the consent forms for the school absence study and have been frustrated that both Bristol and the Bath clinical service involved in the research have declared they don’t hold these critical documents. Presumably the investigators themselves know whether they consented anyone for this study and, if they did, who holds these forms. Have you checked with the investigators and asked whether such consent forms exist, and if so, where they are? If not, can I assume that Bristol is unconcerned that no one seems able to locate consent forms for a study in which more than 100 minors and their families seem to have been interviewed in person? Since the investigators argued that the study was “service evaluation” and therefore exempt from ethical review, would it be fair to assume that perhaps they did not obtain consent from the participants and that no consent forms exist?
5. As you know, a key investigator involved in these studies publicly accused me of writing “libelous blogs” but has failed for two years to provide evidence or documentation that anything I have written is libelous. Despite my efforts to obtain clarity on this matter, Bristol has also declined to provide evidence or documentation that anything I have written is libelous. Since my examination of this body of research has led to Bristol’s current “independent” investigation of some studies as well as an editor’s note on the Lightning Process study, is the university prepared at this point to withdraw and apologize for this unwarranted libel accusation? If not, is Bristol prepared at this point to provide evidence or documentation to support the charge that I have committed libel?
7. Last year, a high-profile Bristol investigator resigned amid charges of flagrant research misconduct. Is Bristol concerned that the current situation, following so closely on last year’s events, could bring additional negative attention to the university, raise questions about its commitment to scientific integrity, and further damage its reputation?
8. Do you believe these multiple concerns about the conduct of Bristol investigators raise questions about the university’s governance and oversight practices? Does Bristol have plans to address these matters on a university-wide basis? If not, why not?
Thank you in advance for any responses you can provide.
David Tuller, DrPH
Senior Fellow in Public Health and Journalism
Center for Global Public Health
School of Public Health
University of California, Berkeley