Conflicts of interest and Cochrane Library content


Relevant to the Cochrane Library editorial policy on conflicts of interest, which provides a summary of key points of the Conflict of Interest (CoI) Policy for Cochrane Library Content (2020).





Cochrane's conflict of interest policies

Cochrane has two active conflict of interest policies relating to Cochrane Library content:

Under the 2020 policy, two-thirds of the author team as a whole, including the first and last authors, must have no financial conflicts of interest relevant to the topic of the Cochrane Library content. Additional restrictions apply; a two-page summary is available in the Quick Guide for Authors on the CoI Portal of Cochrane Online Learning.

  


Editor responsibilities

Authors' declarations of interest

Managing Editors are responsible for checking that all authors have submitted declaration of interest forms, and that the author team is in compliance with the applicable conflict of interest policy (see Editorial checks in the Editorial Manager Knowledge Base).

In addition to the key criteria shown in the Quick Guide, editors are encouraged to consult the

  • five flowcharts designed to help determine whether an author team is compliant with, or in breach of, the CoI Policy (2020); and the
  • CoI Scenarios in the form of six interactive quizzes or a single PDF document, designed to support understanding of the 2020 policy and its application.

Cochrane's Research Integrity Editor supports MEs in determining authors' compliance with both CoI policies. Editors can initiate a CoI Referral by delivering questions and key information to the Research Integrity Editor via Editorial Manager: follow the steps at Referrals to the Research Integrity Editor.

Peer reviewers' declarations of interest

Editors are responsible for assessing peer reviewers' declarations of interest. See Section 6.3 Rules for peer reviewers for rules relating to peer reviewers' declared interests and for editors' specific responsibilities in assessing them. 

As with the assessment of authors' declarations of interest, editors can initiate a CoI Referral by delivering questions and key information to the Research Integrity Editor via Editorial Manager: follow the steps at Referrals to the Research Integrity Editor.

Guidance for Managing Editors

Please see additional guidelines in the CoI Portal's Guidance for Managing Editors – Editorial Manager/Convey.

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Steps to take if a published CDSR article is found to be in breach of Cochrane's CoI policy


The following information has applied since February 2020 and is due for review to reflect Cochrane's changed editorial structure.




If the Research Integrity Editors and/or CoI panel identify a published review or protocol as not adhering to the Cochrane conflict of interest policy, the Editorial & Methods Department (EMD) will contact the Managing Editor of the Cochrane Review Group (CRG) editorial team on behalf of the Research Integrity Editors and/or CoI panel. 

  • If an update of an affected review is already planned, or is planned as a result of the Research Integrity Editors and/or CoI panel decision, the Research Integrity Editors and/or CoI panel will ask the CRG editorial team to make a statement within the review to identify it as noncompliant and set out a plan to become compliant.
  • For a protocol, the Research Integrity Editors and/or CoI panel will ask the CRG editorial team to make a statement within the protocol to identify it as noncompliant and set out a plan for it to be compliant when it is published as a review.
  • If the Research Integrity Editors and/or CoI panel ask for the protocol or review to be withdrawn because no update will be made, see the separate guidance.

Table 1 outlines what the statement must include, where it should be located, and which What's New/publishing event to use. Table 2 and Table 3 provide template text that CRGs can use in the affected review(s) or protocol(s) in their immediate response (stating noncompliance) and in their longer-term response (addressing compliance after a full update or amendment).


Table 1. What the statement must include, where it should be located, and which What's New/publishing event to use

The statement must:

Note

1

Include the following information:

  • Clarify that the statement is from the Co-ordinating Editor (person responsible for protocols and reviews published by the CRG).
  • Record the date of the statement.
  • State that the review or protocol is not compliant with the Cochrane conflict of interest policy.
  • Clarify that the next update to the review, or in the case of an affected protocol, the published review to follow, will have a majority of authors and the lead author free of conflicts of interest (in the case of breaches of the 2014 Commercial Sponsorship policy) or that the published review will have 67% of authors and the first and last author free of relevant financial conflicts (in the case of breaches of the 2020 CoI policy).
  • For reviews, set a timeframe for the update, such as in six, nine, or 12 months. For protocols, set an estimated publication date or timeframe for the review to follow.
2

Be added to the 'Declarations of interest' section

The 'Declarations of interest' section is the most prominent location for this information (accessible from the top and side navigation of published Cochrane Reviews).

The original text in the 'Declarations of interest' section must not be changed; only add the new statement or other content as agreed.

3

Have an associated What's New/publishing event of 'Amended’ (no new citation)

  • A ‘What’s New’ event must be added, to make changes transparent to readers and to alert the publisher to a new version of the review.
  • The event must be ‘Amended’ (no new citation) and have an appropriate description highlighting the change and location of the change. 

Table 2. Template text for the noncompliance statement and What's New/publishing event (immediate response)

Section

Time

Purpose

Template text

Notes on text and formatting

Declarations of interest

Following Research Integrity Editors and/or CoI panel requestTo state noncompliance and plan for updating/revising to become compliant

For reviews:

"Clarification statement added from the Co-ordinating Editor on [date]: This review was found by the Cochrane Research Integrity Editors and/or CoI panel, post-publication, to be noncompliant with the Cochrane conflict of interest policy. It will be updated by [date]. The update will have [a majority of authors and lead author free of conflicts/67% of authors and the first and last author free of relevant financial conflicts - delete as appropriate depending on whether the 2014 or 2020 policy applies]."

For protocols:

"Clarification statement added from the Co-ordinating Editor on [date]: This protocol was found by the Cochrane Research Integrity Editors and/or CoI panel, post-publication, to be noncompliant with the Cochrane conflict of interest policy. When it is published as a review it will have [a majority of authors and lead author free of conflicts/67% of authors and the first and last author free of relevant financial conflicts - delete as appropriate depending on whether the 2014 or 2020 policy applies]."

  • Statement should be added below the original declarations of interest text. Do not delete or overwrite the pre-existing declarations of interest text.
  • Include date in statement to make clear to readers the timeline of changes to the declarations of interests.
  • Italicize the statement to give readers a visual indication that something in this section has changed over time.
  • Include "post-publication" to show that the editors thought that what they were publishing was correct at the time.
  • Include "by the Cochrane Research Integrity Editors and/or CoI panel" to show how noncompliance was drawn to our attention.
  • Reviews: "It will be updated by [date]" could instead read ‘It will be updated within [X] months'. In either instance, it remains necessary to date the statement itself, to make clear to readers the intended timeframe of the update.
  • Reviews: "The update" should be singular –not "future updates", for example.
  • Protocols: “The review is expected to be published by [date]” could instead read “The review is expected to be published within [X] months” or “[X] years”. In either instance, it remains necessary to date the statement itself, to make clear to readers the intended timeframe of publishing the compliant review.

What’s New/publishing event

Following Research Integrity Editors and/or CoI panel requestTo alert readers to statement of noncompliance plan for becoming compliant

For reviews:

"Clarification message from the Co-ordinating Editor added to the Declarations of interest statement about the review’s compliance with the Cochrane conflict of interest policy."

For protocols:

"Clarification message from the Co-ordinating Editor added to the Declarations of interest statement about the protocol's compliance with the Cochrane conflict of interest policy."

  • The DOI link will need to be changed to link to each review/protocol's own DOI section.
  • As in requirements listed in Table 1, the event for reviews must be 'Amended' (no new citation) and the event for protocols must be 'Major Change'.

Table 3. Template text to address compliance when completing a full update or revision, and What's New/publishing event (longer-term response)

Section

Time

Purpose

Template text

Notes on text and formatting

Declarations of interest

Publication of update/revision to become compliantTo declare new conflicts of interest and to clarify history of conflicts of interest

For reviews:

"When originally published, the authors declared no conflict of interest [or – the above/below conflicts of interest]. From [date], the following conflicts of interest were declared. These conflicts applied during the period that the review was in preparation."

  • Old declarations of interest statements and new declarations of interest statements should both be visible.
  • Clarify that the newly declared conflicts of interest applied during the period when the review was being prepared. Do not delete or overwrite the pre-existing declarations of interest text.
  • Italicize the statement to give readers a visual indication that something in this section has changed over time.
What's New/publishing eventPublication of update/revision to become compliantTo alert readers to changes in the declarations of interest

For reviews:

"The authors' Declarations of interest have been updated to reflect the review's compliance with the Cochrane conflict of interest policy."

  • The DOI link will need to be changed to link to each review's own DOI section.
  • Include the template text provided here as part of the event description for whichever events are appropriate to the changes being made. (For guidance on choosing appropriate event(s), see Select the correct What's new event.)



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