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The retracted study should be listed in the “excluded studies” section, with the reason noted, and including a citation to the published retraction notice. This reason must be noted using neutral language and should not accuse authors of scientific misconduct. If there is any doubt about the phrasing of such a note, the CRG must contact the named Associate Editor and Senior Editor for the CRG Network (who will refer on to the Deputy Editor in ChiefResearch Integrity Team) before publication of the Review.
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If an included study is retracted after the Cochrane Review has been published, the study data must be removed from all analyses and the extent of changes required in response to the retraction should be determined. While this takes place, an Editorial Note should be added to the Cochrane Review to clearly alert the reader that an included study has been retracted. The wording of the Editorial Note should be agreed with the EMD before publication and should cite the retraction notice. The CRG should contact the Network named Associate Editor (who will refer on to the Research Integrity Team as needed). See section 7.4 Template text for Editorial Note on a Cochrane Review for template text.
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Depending on the reason for the published Expression of Concern, it may be appropriate to exclude the study or its data from the Cochrane Review (e.g. if the Expression of Concern is for serious concerns about the validity of the data). Note that Expressions of Concern may be published for reasons that do not affect the validity of the data (e.g. authorship disputes), in which case it may be considered appropriate to include the study in the Cochrane Review. If uncertain, contact the Network named Associate Editor (who will refer on to the Research Integrity Team as needed).
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If the Expression of Concern relates to the validity of the data in the included study, an Editorial Note should be added to the Cochrane Review to acknowledge that concerns have been raised about one or more studies and/or study data included in the Cochrane Review. This should remain in place until either the Expression of Concern on the included study or the included study itself is retracted. The text of the Editorial Note on the review should be agreed with the Network named Associate Editor, who will refer to the Research Integrity Team, and should cite the Expression of Concern that is published on the included study. See section 7.4 Template text for Editorial Note on a Cochrane Review for template text.
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- Check that there are no post publication amendments published about the study. Search for the study in PubMed, Medline (and other bibliographic databases, as appropriate), the Retraction Watch Database, and PubPeer to clarify if there are any Expressions of Concern, comments, or Letters to the Editor regarding the study, and to confirm that the study has not been retracted. See section 1 Searching for post-publication amendments and consult with an Information Specialist if further assistance is needed with how to do this.
- If an Expression of Concern is identified, the actions outlined in section 2.2 What to do when there is a published Expression of Concern should be followed.
- If the study has been retracted, the actions outlined in section 2.1 What to do when a study is retracted should be followed.
- Check the version of the article on the publisher’s website, for any un-indexed notifications, e.g. ‘Editorial Note’ or links to post-publication amendments that do not (yet) appear on mirror sites/bibliographic databases.
- If information is missing from the report of the included study and/or further information is required to determine whether you have concerns, contact the authors of the study to ask for clarification and/or unpublished information in line with MECIR standard C49. All correspondence must be kept neutral. Do not accuse authors of misconduct, or fabrication or falsification of data.
- Describe your concerns in detail, including the exact method(s) used to determine that there may be a problem with the study, in an email to the Journal Editor using neutral language. You may find that the act of drafting this email crystalizes whether you have significant concern about the study if you are unsure. All language used must be kept neutral and follow the templates provided in section 7.1 Templates for corresponding with Journal Editors and authors. No accusations of scientific misconduct must be made. You should inform the Network named Associate Editor, who will refer to the Research Integrity Team, before contacting the journal editor. This allows the Research Integrity team to keep a track of such cases which will inform updates to this guidance. It is the responsibility of the Journal Editor to initiate further investigation (for example contacting the Author’s institution).
- If you are unsure whether you have sufficient concerns about an included study to warrant contacting the Journal Editor, you may wish to consider following some of the steps described in section 7.2 Methods for determining whether you have concerns about a study. Please note however that these methods are all unvalidated, and do not necessarily indicate that a study is untrustworthy. They may, however, help to consolidate, strengthen, or alleviate your concerns about a particular study.
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If concerns remain and you contact the Journal Editor to request an investigation and/or clarification of whether the data can be included in a Cochrane Review (which can take a considerable time where a Journal and potentially also an institution is involved) the publication of a new or updated Cochrane Review should not usually be delayed. If you have sufficient concerns about an included study to warrant contacting the Journal Editor, the study of concern should be categorized as “Awaiting Classification”, with a note added to explain why. The language of the note must be kept neutral, for example “The data could not be verified”. If any other note of explanation is required, you must contact the Network named Associate Editor, who will refer to the Research Integrity Team.
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If concerns remain and you contact the Journal Editor to request an investigation and/or clarification to determine whether the data can be included in a Cochrane Review (which can take a considerable time where a Journal and potentially also an institution is involved), an Editorial Note should be added to the Cochrane Review to state that the journal editor has been contacted with concerns about the included study. The statement should remain as neutral as possible and include links to any published articles that might provide additional information (e.g. Letter to the Editor, etc.) and propose a timeline for any update (if known). The text of any Editorial Note must be agreed with the Research Integrity Team before publication. You should contact the Network named Associate Editor who will refer to the Research Integrity Team.
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If the Journal Editor does not respond when concerns are raised, and no response is received on following up with the Journal Editor, consider contacting the Journal Publisher. If no response is received from the Journal Publisher, contact the Network named Associate Editor who will refer to the Research Integrity Editor for advice.
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If a Correction article is published on the included study, the effect of this on the Cochrane Review should be determined and the Review updated if the correction affects the outcome of the review. If an Editorial Note was added to the Cochrane Review, this will need to be updated as appropriate. The Network named Associate Editor, who will refer on to the Research Integrity Team, should be contacted to agree the wording.
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Support and advice are available to CRGs from the EMD on managing cases where there are concerns about the trustworthiness of an included study, or a study that is eligible for inclusion in a Cochrane Review. You can access this support by contacting the Network named Associate Editor who will refer to the Research Integrity Team as needed. They will advise on the wording of communications to authors, journal editors, institutions and also text within a Cochrane Review (for example, explaining why data from a study were excluded from the analyses, or why a study is “awaiting classification”) to mitigate the risk of defamation/libel. If further legal advice or support is required, it can be arranged by the EMD.
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All correspondence must be kept neutral and the following templates should be followed. If a template is deemed inappropriate for a particular situation or the CRG would like to deviate from the template, the Network named Associate Editor must be contacted, and will refer to the Research Integrity Team, before contacting the study author(s) or Journal Editor. Correspondence must never accuse individuals of misconduct or fraud.
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Example text is provided below for Editorial Notes to alert readers of a Cochrane Review to a post publication amendment on an included study. The text for all Editorial Notes should be agreed with the Research Integrity Team and may need to be modified to reflect the exact circumstances. If you need to add an Editorial Note to a published review, you should contact the Network named Associate Editor who will refer to the Research Integrity Team.
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