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Retracted studies should not be included in a Cochrane Review. See section 1 Searching for post-publication amendments for links to resources on how to avoid inclusion of retracted studies (see MECIR C48).
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Following investigation by the Journal or study author’s institution, the study may subsequently be retracted, or the Expression of Concern itself retracted. If this happens after the Cochrane Review has been published, the authors of the Review should follow the actions in section 2.2.3 What to do if the study or Expression of Concern is subsequently retracted.
2.2.2 Resolution for a published Cochrane Review (published Expression of Concern)
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- If the study is deemed eligible for inclusion in the Cochrane Review, the study should be included in the Review, and the Editorial Note on the Cochrane Review should be updated to state that the Expression of Concern on the included study has now been removed. The Editorial Note can be removed from the Cochrane Review at the next update.
- If the study is retracted, the actions outlined in section 2.1 What to do when a study is retracted should be followed.
2.3 What to do if you have concerns about an included study
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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Expressions of Concern, comments, or Letters to the Editor regarding the study, and to confirm that the study has not been retracted.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- If the study has been retracted, the actions outlined in section 2.1 What to do when a study is retracted should be followed.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.
- 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 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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There is no time limit on how long studies can remain in the “Awaiting Classification” category. It may be appropriate during protracted investigations to prompt the Journal Editor, as appropriate, for updates.
See section 2.3.3 What to do when a journal investigates for steps to take once an investigation is completed.
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If after your own assessment (which may include following the steps described in section 7.2 Methods for determining whether you have concerns about a study), or attempting to draft a letter to the Journal Editor, you decide that you do not have sufficient concerns about the study to contact the Journal Editor, the study can remain included in the published Cochrane Review. No further action is needed. If the concern was raised by someone outside of the review author group or Editorial Team, they should be informed of this outcome.
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After contacting the Journal Editor, the steps described in section 2.3.3 What to do when a journal investigates should be followed once the journal agrees to investigate the concern.
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Once you have contacted a Journal Editor, they should follow COPE guidelines to investigate the concerns raised to them. If concerns relate to trustworthiness of the data in a study, the Journal Editor may contact the author’s institution to ask them to conduct a formal investigation into the study data. This may take some time and the Journal may decide to publish an Expression of Concern to alert readers to the concerns while an investigation is underway. If this occurs, the Editorial Note on the Cochrane Review should be updated to cite the Expression of Concern on the article and the steps described in section 2.2.2 Resolution for a published Cochrane Review (published Expression of Concern) should be followed.
If the Journal Editor confirms that an investigation will take some time, it may be appropriate to analyse the effect of removal of the study/studies from the Cochrane Review. Depending on the outcome of this analysis, the following steps should be taken:
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The appendix contains the following sections:
- 1 Templates for corresponding with Journal Editors and authors
- 2 Methods for determining whether you have concerns about a study
- 3 Examples of serious concerns about the trustworthiness of a study
7.1 Templates for corresponding with Journal Editors
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