Editorial and Publishing Policy Resource
Implementing the conflict of interest policy in practice

Potential scenarios and actions for editorial teams and authors

Date: March 2015
Authors: David Tovey, Ruth Foxlee, Harriet MacLehose; Cochrane Editorial Unit

In 2014, Cochrane engaged Dr Donna Odierna (University of California San Francisco) to undertake an audit of compliance with Cochrane conflict of interest (COI) policy. In the course of managing the output of that project, the Cochrane Editorial Unit team identified some common examples where application of Cochrane’s policy was either unclear or disputed. We have grouped the examples into five categories:

  1. Author employment
  2. Other financial support for authors from commercial sponsors or sources
  3. Funding or conduct by commercial sponsors or sources
  4. Author involvement in the conduct of included trials
  5. Review dissemination

All the examples shown below should be considered in the context of the information provided in the Conflicts of interest and Cochrane Reviews section of the Editorial Publishing Policy Resource: 

  1. A ‘commercial sponsor or source’ is defined as any for-profit manufacturer or any other for-profit source with a real or potential vested interest in the findings of a specific review 
  2. Authors who in the last 3 years have received financial support from commercial sponsors or sources with a real or potential financial interest in the findings of the review, should declare these interests at the earliest possible stage in the editorial process. Such financial support may include remuneration from a consultancy, grants, fees, fellowships, support for sabbaticals, royalties, stocks from pharmaceutical companies, advisory board membership or otherwise. In such cases, at the funding arbiter’s discretion, and only where a majority of the review authors and lead author have no relevant COIs, it may be possible for an author who has a declared interest as listed in the previous sentence to be a Cochrane review author.
  3. The ‘lead author’ is the first named author in the review by-line.

 

1. Author employment 

No.

Scenario 

Complies with policy?

Action 

1

An author(s) is employed by a commercial sponsor that does not produce the intervention covered in the review nor any competing intervention.

Unclear

Refer to Funding Arbiter. The onus is on the author(s) to justify why the employment does not constitute a conflict.

2

An author(s) is employed by a commercial sponsor that does not produce the intervention covered in the review but does produce a competing intervention.

No

Review cannot proceed with conflicted author(s). If disputed, refer to Funding Arbiter.

3

An author(s) goes to work for commercial sponsor at some point during the preparation of the protocol or review. 

No

Author(s) cannot continue to work on review. Refer to Funding Arbiter if there is concern that author(s) might have influenced the review such that it should not be published.

 

4

An author(s) goes to work for commercial sponsor after the review is published.

Unclear

Seek clarification from the author(s) on whether this move was known prior to publication. If not, no action (compliant) but remove author for update. 

If the team had knowledge of the move before publication, get details and refer Funding Arbiter. The onus is on the author(s) to justify compliance.

5

An author(s) is employed by an organisation that conducts clinical trials, some of which are funded by a commercial sponsor with an interest in the intervention under investigation.

Yes

None.

6

An author(s) was paid through a commercially-funded clinical fellowship, with no mention of what restriction applied to the fellowship.

Unclear

In most cases this would be compliant but the Group should request details from the author(s) about what (if any) restrictions applied to the fellowship. If unrestricted, review considered as compliant (although should be declared). If restricted, refer to Funding Arbiter, for example if the terms of the clinical fellowship required completion of the review in question.

 

2. Other financial support for author(s) from commercial sponsors or sources

No.

Scenario 

Complies with policy?

Action 

7

50% or more of the author(s) have ties to commercial sponsors or sources other than being paid directly (e.g. consultancy, grants, fees, fellowships, support for sabbaticals, travel bursary, etc.)

No

Author with this type of conflict cannot be lead author. If not lead author and there are a majority of non-conflicted authors, review can proceed. 

If half or more of the authors have a conflict, review cannot proceed or should be referred to Funding Arbiter.

8

Research grants and/or honoraria from commercial sponsors or sources are received by research accounts/groups to which an author(s) belongs, but are not received directly by the author(s). 

Unclear

Refer to Funding Arbiter.

9

An author(s) attended an academic programme sponsored by a commercial sponsor.

Unclear

If actual attendance not funded, as declared by author(s) , no action – compliant.

If attendance funded, it is considered conflicted, therefore review cannot proceed (if the majority of authors are conflicted). If disputed, refer to Funding Arbiter.

10

An author(s) is recipient of a fellowship or studentship that is partially funded by a commercial sponsor. 

Yes

None.

11

Only one of several author(s) on the review (i.e. less than 50%) acted as a consultant for the manufacturer of one of the interventions being considered in the review. 

Unclear

If not first author(s), no action – compliant. 

If first author(s), non-compliant and that author(s) cannot be the first author(s).

12

An author(s) who declares no specific conflicts of interest is the partner of another author(s) on the review who does declare potential conflicts. 

Unclear

Refer to Funding Arbiter (if lead author or the majority of authors are conflicted). The onus on author(s) to explain why the conflict declared by partner does not apply. 

3. Funding or conduct by commercial sponsors or sources

No.

Issue 

Complies with policy? 

Action 

13

The original review was supported by an unrestricted educational grant from a commercial sponsor and published in a non-Cochrane journal. It was subsequently converted to a Cochrane Review and then updated without the support of any commercial sponsor. 

Yes 

None.

14

The original review was conducted as part of a guideline development project, which was supported through an unrestricted educational grant from a commercial sponsor, and then updated with the support of a health charity. 

Unclear

 

If health charity is not associated with a commercial sponsor, as clarified by author(s), then no action. 

If health charity is associated with a commercial sponsor, as clarified by author(s), non-compliant. If disputed or in doubt, refer to Funding Arbiter.

15

The original review was supported by a commercial sponsor but was subsequently updated without any further support from commercial sources.

Unclear

Refer to Funding Panel. This would generally be compliant but should be referred to be safe. The original funding should be noted in the acknowledgements.

16

The original review was supported through an unrestricted grant from a commercial sponsor; however this grant was used to support research on a range of treatment options, not just those produced by the commercial sponsor. The update is proceeding without commercial support.

Unclear

Refer to Funding Arbiter with full details of the other projects funded by the grants and more information on exactly what aspects of the original review were funded.

 

17

Financial support for the original review was provided by a commercial sponsor through an unrestricted educational grant (with no mention of whether the subsequent update was carried out without the support of any commercial sponsor). 

Unclear

Refer to Funding Arbiter. Would only be compliant if the update was done without support of the commercial sponsor.

18

One source of support listed is from a commercial organisation but not one with an obvious interest in the intervention being considered.

Unclear

If author(s) has adequately justified why source of support is not a conflict, no action: compliant.

If author(s) has not justified why source of support is not a conflict, refer to Funding Arbiter.

4. Author(s) involvement in the conduct of included trials 

No.

Issue 

Complies with policy?

Action 

19

An author(s) conducted a study that was funded by the manufacturer of intervention(s) being considered.

Yes

None – provided the author(s) declare the COI, do not appraise their own studies for inclusion or risk of bias, and are not responsible for data extraction.

20

An author(s) conducted an investigator-led RCT that evaluated the intervention of interest in a related condition (not the condition considered in the review), for which financial support was provided by a manufacturer of the intervention(s) being considered. 

Yes

None – provided these author(s) do not appraise their studies for inclusion or risk of bias, and are not responsible for data extraction. Whilst this conflict should be declared, it is considered as non-conflicted when determining whether there is a majority of non-conflicted author(s). 

21

An author(s) is undertaking a trial that would possibly been eligible for inclusion in the review at the time of writing. 

Yes

None – provided these author(s) do not appraise their studies for inclusion or risk of bias, and are not responsible for data extraction. Whilst this conflict should be declared it is counted as non-conflicted when determining whether there is a majority of non-conflicted author(s).

22

After the review was published an author(s) received funding from a manufacturer of the intervention(s) being considered to conduct an investigator-led study in that same area.

Yes

None – however if the subsequent study is eligible for inclusion in a future update of the review, the conditions set out in scenario No.19 apply.

23

An author(s) was involved in the recruitment of patients into clinical trials funded by a commercial sponsor.

Yes

None – provided these author(s) do not appraise their studies for inclusion or risk of bias, and are not responsible for data extraction. Whilst this conflict should be declared it is counted as non-conflicted when determining whether there is a majority of non-conflicted author(s).

5. Review dissemination

No.

Issue 

Complies with policy?

Action 

24

The author(s)  received funding from a manufacturer of the intervention being considered to disseminate the findings of the original review (with no mention of whether the subsequent update was carried out without any commercial sponsor involvement)

Yes

None in terms of the original review, but for a subsequent update this would be considered as a relevant conflict of interest if the author(s) who received the funding is still in the author team.

25

On completion of the review, the author(s) received funding for translation of the review from a manufacturer of the intervention(s) under investigation.

Yes

None in terms of the original review, but for a subsequent update this would be considered as a relevant conflict of interest if the author(s) who received the funding is still in the author team.

Section info
Describe change
New section added.
Change date
24 March 2015