By David Tuller, DrPH
*October is crowdfunding month at UC Berkeley. If you like my work, consider making a tax-deductible donation to Berkeley’s School of Public Health to support the Trial By Error: project: https://crowdfund.berkeley.edu/project/33528
In August, I alerted both the University of Bristol and the UK’s Health Research Authority about a problem. In a joint report published in 2019, Bristol and the HRA requested that the university’s methodologically and ethically challenged pediatrician and grant magnet, Professor Esther Crawley, correct 11 papers on ME/CFS. (The studies generally referred to the illness as CFS/ME). Specifically, Professor Crawley was supposed to correct each paper’s ethics statements, and the report itself provided proposed language in each case.
Easy, right? But three years later, it seems only four of these eleven corrections have been made. That the other seven papers remain uncorrected is hard to explain and impossible to excuse or defend. The HRA responded to my concerns quickly, letting me know that it would look into the matter and get back to me by October 4th—this past Tuesday. In contrast, Bristol’s legal department responded with dismissal, informing me curtly that the university would only answer questions from the HRA.
(Bristol doesn’t like me. In the past, the vice-chancellor had complained multiple times to Berkeley’s chancellor about my “behaviour.” Presumably, the university was unhappy about my critiques of Professor Crawley’s ethics and methods. Berkeley determined that the complaints were completely without merit, and advised me to continue with my work.)
On Tuesday, I didn’t hear back from the HRA. Yesterday, October 5th, I did receive a follow-up e-mail from the agency, letting me know that it still had no answers. Why? Because Bristol hadn’t yet provided an explanation and had requested an extension till the end of this week. Hm. Bristol has had more than a month to get its story straight. What’s the hold-up? Does the university thinks this mess will be easier to clear up after a short delay?
In any event, I look forward to Bristol’s rationalizations for why seven of Professor Crawley’s articles remain uncorrected three years after the joint Bristol-HRA report. The forms were misplaced? The administrative assistants are incompetent? The dog ate the corrections? Whatever. I assume the university will find some way to absolve her of any blame or responsibility; after all, she pulls in a lot of research funding.
Below are the two letters I’ve received from the HRA. (I’ve already posted my exchange of letters with Bristol in a previous post.)
Dear David Tuller,
Re: Concerns regarding non-compliance with recommendations from the 2019 review jointly commissioned by the HRA and the University of Bristol
Thank you for your letter dated 30 August 2022, where you outlined your concerns regarding compliance with recommendations which emerged from the 2019 review.
The issues that you have raised are within the remit of the HRA to investigate and will be handled under the HRA’s “Policy and procedure for managing complaints relating to third parties”. We note that your concerns specifically relate to the following:
• The 2019 review jointly commissioned by the HRA and the University of Bristol recommended that corrections were made to the ethics statements of eleven research papers. Despite this, only four of the eleven papers appear to have been corrected.
A Complaints Lead will be allocated to investigate your complaint and they may contact you to request any additional information that we require.
During the investigation we will also liaise with other responsible bodies and experts as appropriate. This may include contacting the sponsor of the trial or study to request further information. We may also wish to establish whether they are aware of the complaint that we have received and if so, the action that they are taking to resolve it. If we do contact others, then we will keep your details confidential unless you have provided us with explicit consent to reveal your identity.
Please be aware that in the course of investigating your complaint, information of a confidential or personal nature may need to be collected. If this is the case, this information will be managed in strict confidence and in accordance with HRA Information Governance policies, the Data Protection Act 2018 and the General Data Protection Regulation.
We will provide you with a response or, if the matter is going to take a little longer to investigate, an update as soon as possible, but no later than 4 October 2022. Where the investigation cannot be completed within 25 working days we will keep you informed about the reasons for the delay and the expected timescale for completion.
After we have completed the investigation a summary of your complaint and the outcome of our investigation will be published on the HRA’s website. Before we publish this information, we will share a copy of the summary with both you and any relevant third parties. You will have an opportunity to advise us of any concerns you may have about the accuracy of the summary. In line with the principles of the General Data Protection Regulation/Data Protection Act we will not publish your name or other information that is personal to you.
Information Governance and Complaints Manager
In our letter dated 7 September 2022, we advised you that we would provide you with an update by 4 October 2022. Unfortunately, our timeline has been slightly delayed as the university has requested an extension until the end of this week to give us a response. We have agreed to the extension in line with our usual practice.
We will be in touch with you again once we receive their response.
Information Governance Support Assistant
Health Research Authority