Retrospective registration, outcome switching and ethical approval
Case text (Anonymised)
Journal A received a number of concerns from a reader regarding a paper published in the journal. These concerns were reviewed and sent to the authors of a paper, along with additional comments from the editorial board. The concern was largely around retrospective registration, and an inconsistency between the trial registry record and the published paper. An editorial board member conducted a full comparison of the trial registry entry with the paper.
The authors have admitted honest error with full explanations. The editor-in-chief has asked for confirmation that all authors and institution are aware and outlined options for next steps. The suggested options for next steps from the editor-in-chief are: (a) retraction of the paper; (b) substantial corrections and explicit declaration of the flaws of the trial procedures and protocol violations and selective and misleading reporting; which may well render the trial invalid or at least biased, and then providing a better and corrected summary table and narrative of what can be legitimately said. This is not ideal and will regrettably give the impression of insufficient rigour in the execution of a trial and the data still being in the public domain, although a more confident statement of a negative trial is better than selective reporting of some positive findings; (c) or we invite retrospective critique and commentary on trial and trials in general when reported to be invalid or flawed; this is an important educative role, but does not remedy that the trial data are in the public domain and are misleading.
Again, the authors offered an apology claiming honest error and preference for the article not to be retracted. They have offered to publish a correspondence letter to explain the registration issues in due course or correct any inconsistent sections according to the review comments and registry information. The journal is now questioning the next course of action: retraction, corrigendum and/or an editorial outlining the issue.
Question(s) for the COPE Forum
• The Editorial Board were initially considering retraction but are now considering publishing a narrative/editorial of the issues for transparency, confirming the journal’s current/new policy of requiring prospective registration and an explanation of any changes in protocol in the methods section. Should this accompany a corrigendum?
• Ethics approval: approved in April 2011, but the protocol states study execution time is August 2010 to July 2013. The authors state that the first patient was referred in May 2011. Does this need further explanation?
• Should the editorial board consider retraction?
• Are there any other actions the board should consider?
The Forum asked if the journal had contacted the institution and if there was an investigation in progress. The editor informed the Forum that the journal has asked for confirmation that all of the authors and the institution are aware of the issues, but no response has been received to date. The authors have stated that the institution was not aware of the need for prospective registration. The editor may like to pursue the institution for more information.
The Forum suggested publishing an editorial note on the paper or, if the institution agrees to undertake an investigation, publishing an expression of concern. As there seems to be no institutional oversight, perhaps the editor should give the authors the benefit of the doubt. This could be an important educational opportunity, to educate the authors regarding trial registration; although now an international standard, many authors do not know about prospective registration. Hence a lengthy corrigendum and an editorial highlighting the issues would be appropriate.
The Council of Science Editors has a lengthy section on their website about correcting the literature with samples of actual corrections (https://www.councilscienceeditors.org/resource-library/editorial-policie...). In general, the correction options are errata, corrigenda, expressions of concern, and retractions, although some of the wording is nuanced in ways that might be helpful in this situation. The editorial note referenced above seems to fall under the category of an Editorial Expression of Concern. The National Library of Medicine has a fact sheet (https://www.nlm.nih.gov/pubs/factsheets/errata.html) detailing the types of corrections that can be linked to an article. This list includes “Comments” which could be used to link commentary from the authors as well as from editors.
Some journals ask for the full protocol to be submitted to the journal along with the article. The journal then checks the protocol against the paper before the paper is peer-reviewed. The authors are asked to explain any deviations from the protocol. The editor may wish to consider this approach to avoid similar situations in the future.