Guidance for Managing Editors

Guidance for Managing Editors
Guidance for Managing Editors

Implementing Cochrane’s revised CoI Policy within Archie

This guidance was developed by the ME Support and Community Support teams, in collaboration with the MEs’ Executive and Cochrane’s Research Integrity Team.

In this document, Conflict of Interest (CoI) refers to the policy which seeks to minimise the impact of conflicts of interest on published Cochrane Library content. Declarations of Interest (DoI) are the statements made by authors and editors.

If you have queries about any aspect of this guidance, please contact support@cochrane.org.


Background  

Cochrane’s updated Conflict of Interest Policy for Cochrane Library content (2020) was launched on 14 October 2020.

This revised policy applies to:

i. New titles registered on or after 14 October 2020
ii. Review updates where work began on or after 14 October 2020

To ensure new authors are aware of the CoI policy before title submission, please use the latest version of the Review proposal forms available in the EPPR. These forms were amended in October 2020 to include important information about the revised policy. If you choose not to use the updated forms, please ensure you copy and paste section 6 of Review proposal forms (CoI Policy information) into your existing group templates. Please also make new authors aware that their title will not be registered until a DoI form has been received from each author and assessed at the editorial base.

The revised policy runs in parallel with the existing Commercial Sponsorship Policy (2014), applicable to protocols, reviews and updates in progress before 14 October 2020. Note that these reviews are governed by the Commercial Sponsorship Policy (2014) up to the point when work begins on the next update. When these reviews are next updated, the Conflict of Interest Policy for Cochrane Library content (2020) will be applicable.

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Declaration of interest forms in Archie


Editorial staff and group editors

The Conflict of Interest Policy for Cochrane Library content (2020) applies to everyone involved in the editorial process. From January 2021 the role-based DoI forms for editorial staff and group editors will collect information required to assess compliance with the revised policy.

Newly-appointed editors must be free of relevant financial interest from the date of appointment. Editors already in post have 5 years from policy launch to divest themselves of any financial interests relevant to the group’s topic area. If they have relevant financial interests, during the 5 years from policy launch, they should not undertake peer review, be a contact editor or provide sign-off on Cochrane Reviews to which their conflicts relate. Editors should not acquire any new relevant financial interests during the 5-year grace period, so that by October 2025 they will be free of any relevant financial interests.

Review authors

An updated DoI form is available to authors within Archie, providing the information necessary to apply the revised policy.

From 14 October 2020, Archie will generate an updated form for any author who has not previously completed a DoI form for the review in question, regardless of stage. This means that there is not an exact correspondence in Archie between the different forms and policies (see below table). The revised form provides information which can be used to apply either policy.

For new titles registered, and review updates where work began on or after 14 October 2020, the updated form will be generated when you inform authors about DoI forms. For protocols, reviews and updates in progress before 14 October 2020, the 2014 policy applies to the whole author team, regardless of which form is generated.  

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Overview of policies, DoI forms and workflows (A = old form, B = updated form)

 Scenario  Version stage  Form  Policy   applied  EMD DoI   statement   service  Workflows   concerned        New workflow tasks  New task emails  New workflow roles
1. Cochrane titles, protocols, reviews, and updates in progress before 14 October 2020 A Commercial Sponsorship Policy (2014) No

Title Registration
Protocol Development
Review Development
Review Update
In Progress before 14 Oct 2020

     
2. New author(s) added after 14 October 2020 to titles, protocols, reviews and updates in progress before 14 October 2020. Commercial Sponsorship Policy (2014) No Title Registration
Protocol Development
Review Development
Review Update
In Progress before 14 Oct 2020
     
3. Title, protocol, review and updates in progress before 14 October 2020 but DoI forms not previously requested from authors before 14 October 2020. B Commercial Sponsorship Policy (2014) Yes, until end March 2021 Title Registration
Protocol Development
Review Development
Review Update
In Progress before 14 Oct 2020
     
4. New title registered on or after 14 October 2020 CoI Policy for Cochrane Library Content (2020) Yes Title Registration
Started after 14 Oct 2020
Protocol Development
Review Development
Review Update

Send CoI Policy information email to authors

Request DoI forms (multiple requests - key timepoints when work begins and before publication)

Information email to authors on new CoI Policy 

Request to EMD to draft DoI statement (optional)

CRG Advisor assigned to CoIarbiter@cochrane.org

5. Update of existing review started on or after 14 October 2020 CoI Policy for Cochrane Library Content (2020) No (to be reassessed in Q1, 2021) Review Update
Started after 14 Oct 2020

Send CoI Policy information email to authors

Request DoI forms (multiple requests - key timepoints when work begins and before publication)

Contact Person to draft DoI statement for all authors based on submitted forms

Information email to authors on revised CoI Policy

Request to Contact Person to draft DoI statement for all authors based on submitted forms, for editorial review

 

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"Authors" Declarations of interest' section in reviews
 

EMD statement-writing service

The Editorial & Methods Department (EMD) has introduced a new service to produce a one-off declaration of interest statement for authors of new titles registered on or after 14 October 2020 (scenario 4 in above table). Guidance on incorporating a statement request into Title Registration workflows is given in section 5.iii below.

Please note that, if the protocol exceeds 12 months to write or publish, the ME must re-send DoI forms to the review authors. The ME is responsible for checking any subsequent changes to the DoI form responses and ensuring the ‘Declarations of interest’ section of the protocol is updated accordingly.

Exceptionally, EMD can also draft statements for titles, protocols, reviews and updates in progress before 14 October 2020 but where DoI forms were not previously requested from authors before 14 October 2020 (scenario 3 in table above). This service is available until end March 2021. Because of the short timeframe, we do not recommend amending workflow templates for this. Please email CoIarbiter@cochrane.org providing details of the review.

Declaration of interest statements

The updated DoI forms do not ask individual authors to write a DoI statement, but to declare all relevant interests. Where the EMD-statement writing service is not available, the review Contact Person may draft a statement for all authors, based on the information in the submitted forms (the Contact Person has permission to view forms for the whole author team in Archie); or you may prefer to draft this statement within the editorial base. When checking authors’ statements, or drafting your own, please follow the below guidelines.

Declarations in reviews governed by the Conflict of Interest Policy for Cochrane Library content (2020) must include all financial and non-financial relationships that are relevant to the topic of the review (see definition of ‘relevant’) that existed 36 months before title registration, or work commencing on a review update, through to publication of the review or review update.

i. All interests declared in the DoI form must be included in authors’ DoI statements.
ii. A DoI statement for each author must be provided even if an author has not declared any interests.
iii. If the information provided by an author in the DoI form is incomplete, unclear, or contradictory the author should be asked to provide/clarify the information and update their DoI form. The DoI statement must be updated when any changes are made to the DoI form.

 Statement template text  Example
No interests declared XX: has declared that they have no conflict of interest. FR: has declared that they have no conflict of interest.
Financial interests declared

Payments to institution: XX: reports "relationship / activity" from "company / organisation name"; paid to institution. 

Personal payments:
XX: reports "relationship / activity" from "company / organisation name"; personal payment.

GM: reports consultancy fees and travel expenses from Pfizer; paid to institution.
SB: reports grant for research from Bayer; paid to Ottawa Hospital.

HY: reports ownership of stocks in AstraZeneca; personal payment.

Non-financial interests declared XX: reports "relationship / activity" that is related to the topic of this review + "company / organisation name".  SG: reports being the PI of a study that is eligible for inclusion in the work; the study was funded by GSK but the researchers retained complete control over the study design, methods, data analysis and reporting.
RK: reports declaring an opinion on the topic of the review in the BMJ.

The following text will also appear in the ‘Authors’ Declarations of Interests’ section of reviews in RevMan Web, to notify authors that they should not provide any information in this section which does not appear in their DoI forms. We will keep MEs’ updated on the implementation timetable for this. In the meantime, please insert this template text into RevMan Web, or RevMan 5 files:

The statement entered here must accurately reflect all interests declared by authors in their individual Declaration of Interest (DoI) forms. Please do not add any new information in this section. If your circumstances have changed, please complete a new DoI form.

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Workflow templates

As titles registered under the revised CoI Policy proceed to publication (scenarios 4 and 5 in above table), you will need to add workflow tasks to ensure authors are aware of the revised policy and are completing DoI forms at regular intervals. The key timepoints for this are before title registration or before work begins on an update, and prior to publication.

You may wish to create a new workflow template for Title Registration, incorporating the below tasks:

i. Send revised CoI Policy information email to authors
ii. Request DoI forms at multiple timepoints
iii. Request EMD statement-writing service (optional)

You may also wish to create new workflow templates for Protocol Development, Review Development and Review Update, incorporating the below tasks:

i. Send revised CoI Policy information email to authors
ii. Request DoI forms at multiple timepoints

You may then choose to update any titles registered on or after 14 October 2020, to the latest templates.

Workflow tasks

i. Send revised CoI Policy information email to authors before work begins on any new title or review update

This email must be sent before any title is registered, or work commences on any new update.

Titles registered on or after 14 October 2020

As mentioned above, please use the latest version of the Review proposal forms available in the EPPR to make authors aware of the CoI Policy before submission of the review proposal form.

These forms were amended in October 2020 to include important information about the revised policy.

 Task  Duration  Role  Default email template(s)
A1a: Authors receive email informing them of the revised CoI Policy 0 Editorial Base NEW 2021 CoI Policy email for Authors new titles

Email template available here (NEW 2021 CoI Policy email for Authors new titles)

Review updates where work began on or after 14 October 2020

 Task  Duration  Role  Default email template
A1a: Contact Authors to discuss update 1 Editorial Base  
A1b: Run restricted searches 3 Information Specialist  
A1c: Agree update needed 3 Editorial Base / Contact Person  
A1d: Authors receive email informing them of the revised CoI Policy 0 Editorial Base NEW 2021 CoI Policy email for Authors updates
A1e: Request DoI forms 1 Editorial Base  
A1f: Confirm receipt of DoI forms Contact Person / Editorial Base  
A1g: Check declared interests comply with policy 1 Editorial Base  
A1h: Create DoI statements  5 Contact Person / Editorial Base  
A2: Update literature searches 7 Information Specialist  

Email template available here (NEW 2021 CoI Policy email for Authors updates)

ii. Request DoI forms at multiple timepoints

The policy currently suggests authors should update their declarations every 12 months. As automated annual reminders are not currently possible to configure within our editorial systems, this is under review. The key timepoints for authors to complete DoI forms are before work begins and before publication. We also recommend adding the following short reminder to all workflow emails sent to authors (e.g. when returning peer reviewer comments):

It is your responsibility as authors to let us know if you have any potential Conflicts of Interest in relation to this review. Please take a moment to review your current Declaration of Interest and let us know if details have changed. The relevant time period for Conflicts of Interest is from 36 months prior to title registration (or when work began in the case of a review update) through to publication of the review. Failure to disclose any relevant information can delay or prevent publication of your Cochrane Review. More information here

iii. Request EMD statement-writing service

An Archie record for ‘CoI Arbiter’ (CoIarbiter@cochrane.org) has been created to permit sending a workflow ticket to the Research Integrity team mailbox (monitored by EMD) to request the statement, which you can copy and paste into the ‘Declarations of interest’ section of a new protocol.

To prepare for this, you can request a DoI statement at the pre-title registration stage by creating a Vacant Title and the Title Registration workflow, and sending out DoI forms via Archie.

On the People tab, assign an additional ‘CRG Advisor’ Workflow Role to ‘CoI Arbiter’ (CoIarbiter@cochrane.org). Add new workflow tasks after B5 to request DoI forms.

 Task  Duration  Role  Default email template
B1 Decision: RPF clear and complete? 7 days Editorial Base  
B2 Resolve issues 1 day Editorial Base  
B3 Identify CRG Advisors 0 Editorial Base  
B4 Make RPF available to CRG Advisor 0 Editorial Base  
B5 Review and comment on RPF 0 Editorial Base  
B6a Request DoI forms 1 Editorial Base  
B6b Confirm receipt of DoI forms 5 days Contact Person / Editorial Base  
B6c: Check declared interests comply with policy 1 day Editorial Base  
B6c Request DoI statement 1 day Editorial Base NEW 2021 DoI statement request to EMD
B6d Create DoI statement 5 days CRG Advisor  
B6e Insert DoI statement into RevMan 1 day Editorial Base  

Email template available here (NEW 2021 DoI statement request to EMD)

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