PLOS ONE has republished data that were abruptly removed two weeks ago after the authors expressed concerns they did not have permission to release them.
The dataset — de-identified information from people with chronic fatigue syndrome — was removed May 18, noting it was “published in error.” But this week, the journal republished the dataset, saying the authors’ university had been consulted, and the dataset could be released.
This paper has drawn scrutiny for its similarities to a controversial “PACE” trial of chronic fatigue syndrome.
Here’s the second correction notice for “Therapist Effects and the Impact of Early Therapeutic Alliance on Symptomatic Outcome in Chronic Fatigue Syndrome,” released June 1:
The dataset originally included as S1 Dataset was removed in consideration of possible restrictions for the public availability of the data related to the wording of the original consent form for the trial. Upon consultation with the authors’ university it has been established that the file may be publicly shared as it reports de-identified data. Please view S1 Dataset here.
The Data Availability statement for the article is revised to read: The authors have prepared a dataset that fulfills requirements in terms of anonymity and confidentiality of trial participants, and which contains only those variables which are relevant to the present study. Data are available as Supporting Information.
As of today, the Data Availability statement on the paper had not yet been revised, and contains the message posted after the initial correction notice removing the dataset:
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.
PLOS has a very clear 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.
Data from both this study and PACE — whose consent form is very similar — have been subjected to a number of freedom of information requests. When authors of a PACE trial sub-analysis in PLOS ONE refused to share their data, the journal added an editor’s note — which looked a lot like an Expression of Concern.
Update 6/6/16 7:26 a.m. eastern: We’ve heard from Wearden, who explained why the data were re-added to the paper:
It was not that the University had to give permission for the release of the [data], it was just that when I took advice from the University’s research integrity and governance unit, they said that they thought our ethical permission would allow open access to de-identified data.
Hat tip: Tate Mitchell
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