After PLOS ONE allowed authors to remove a dataset from a paper on chronic fatigue syndrome, the editors are now “discussing the matter” with the researchers, given the journal’s requirements about data availability.
As Leonid Schneider reported earlier today, the 2015 paper was corrected May 18 to remove an entire dataset; the authors note that they were not allowed to publish anonymized patient data, but can release it to researchers upon request. The journal, however, requires that authors make their data fully available.
Here’s the correction notice:
S1 Dataset was published in error. The error was corrected in the XML and PDF versions of this article on May 9, 2016. Please download this article again to view the correct version.
The paper “Therapist Effects and the Impact of Early Therapeutic Alliance on Symptomatic Outcome in Chronic Fatigue Syndrome” also contains the following message:
Data Availability: Our ethical permission did not expressly permit us to share patient data, even anonymised patient data, in a public forum. Data will be made available to bona fide researchers on application to the principal investigator, Alison Wearden or the trial statistician, Graham Dunn.
The author’s institution, Manchester University, sent Tate Mitchell the study’s consent form about a month ago, in response to a request. A records officer at the university sent Mitchell this comment along with the form:
Please note that we have not released our entire dataset. The data which are available in association with the PLOS-One article entitled “Therapist Effects and the Impact of Early Therapeutic Alliance on Symptomatic Outcome in Chronic Fatigue Syndrome” comprise a small anonymised subset of our dataset containing only variables relating to the analysis presented in the paper.
For more on this trial, which is sometimes referred to as a sister trial of the controversial PACE trial of chronic fatigue syndrome, see this post by David Tuller. Data from both this study and PACE — whose consent form is very similar — have been subjected to a number of freedom of information requests. And PLOS ONE added an editor’s note — that looked a lot like an Expression of Concern — to a PACE trial sub-analysis when its authors refused to share the data.
We were curious about whether the correction and removal violates PLOS ONE‘s clearly stated requirement about data availability:
PLOS journals require authors to make all data underlying the findings described in their manuscript fully available without restriction, with rare exception.
A PLOS spokesperson told us:
The authors contacted the editorial office about possible restrictions for the public availability of the data in relation to the information outlined in the consent form for the trial. The data was removed to avoid any possible breach in patient privacy. The PLOS ONE editors are in the process of discussing the matter with the authors, in consideration of the requirements for data availability under the PLOS Data policy (http://journals.plos.org/plosone/s/data-availability).
Update 5/23/16 9:10 a.m. eastern: We’ve heard from author Wearden, who told us more about why they decided to remove the dataset:
We published the PLOS One paper on therapist effects and therapeutic alliance and provided a de-identified dataset containing the variables used in the analysis.
On 10th March, I received a freedom of information request for a copy of the patient consent form for the FINE trial. The request referred to the ongoing case relating to the PACE trial, and raised the issue of whether in fact we had been correct to make the data relating to the therapist paper open to the public. We did not request permission to do so in our trial consent form.
The dataset supplied to support the PLOS-One article was supplied in good faith and in the belief (still held) that no patient or therapist would be identifiable from it. The Freedom of Information request made me wonder if we had acted correctly, given our ethical permissions. In consultation with my co-authors and after discussing with various colleagues, I decided that it would be better to remove the dataset from public access (while still being prepared to supply it to bona-fide researchers). I wrote to PLOS-One on 18th April asking them whether it would be possible to do this.
The contents of the paper have not been retracted. The dataset has not been retracted. There is nothing wrong with either of them. The only issue is whether or not we were right in publishing this dataset given the consent that we had obtained from the trial participants.
…when I contacted PLOS about this originally, they acted quickly and efficiently in changing the status of the data.
Since the change in status of the data I have had a few emails and PLOS have told me that they have also been contacted.
I can confirm that I am in current email contact with PLOS. I have just emailed PLOS to tell them how I have been handling emails sent to me.
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