a) When did the 2020 CoI Policy come into effect?
The 2020 CoI Policy came into effect on 14 October 2020 and applies to any titles that were registered on or after this date, and to any update where work began after this date. For any reviews or updates that are in progress before this date, the Commercial Sponsorship Policy (2014) applies. A visual representation of which policy applies based on when a review/update began can be seen here.
b) Why does Cochrane have more than one CoI Policy for Cochrane Library content?
The revised 2020 CoI Policy came into effect on 14 October 2020, but at that time many Cochrane Reviews were already underway. The Commercial Sponsorship Policy (2014) will be applied to reviews and updates that started before 14 October 2020.
c) How do I know which policy to use?
The 2020 CoI Policy came into effect on 14 October 2020. It applies to any titles that were registered on or after this date, and to any update where work began after this date. As the policy is not being applied retrospectively, the Commercial Sponsorship Policy (2014) will still apply to reviews or updates that were in progress before this date. A visual representation of which policy applies based on when a review/update began can be seen here.
d) Is the 2020 CoI Policy being applied retrospectively to reviews that are already underway?
No, the 2020 CoI Policy only applies to titles that were registered after 14 October 2020 and updates where work began after this date. For all other reviews and updates that were already underway on 14 October, the Commercial Sponsorship Policy (2014) applies.
a) Are there limits on who can fund Cochrane Library content?
Yes, Cochrane Library content cannot be directly funded by any commercial organization with a financial interest in the topic of the review. In all cases, funding sources must be declared, and funders cannot interfere with any aspect of review production (e.g. design, conduct, or publication of a review or update).
b) Does funding from a not-for-profit organization constitute a Conflict of Interest?
While not-for-profit organizations may not gain financially as a result of taking a specific position about a healthcare intervention, they may still try to influence the conduct, conclusions or publication of that review. If there appears to be a risk of undue influence, the matter should be discussed as early as possible with the Research Integrity Editors and Conflict of Interest Panel via the CoI referral form.
a) Have there been any changes to what is considered a financial interest in the 2020 CoI Policy?
No, the types of activity that are considered financial interests have not changed (see Section 5 Funding and Interests). There have however been changes to which authors can have conflicts. The first and last author must now be free of all conflicts and the proportion of authors who must be free of all conflicts has increased to from >50% to >67% (two thirds).
b) What is meant by a ‘relevant’ financial interest?
A relevant financial interest is any payment made to an author by a commercial organization that manufactures (or is known to be developing), or distributes (anywhere in the world), an intervention or potential comparator related to the topic of the review. This includes payments such as speaker fees, honoraria, consultancies, membership of advisory boards and payment of travel expenses.
If there is any doubt about whether a particular relationship or activity is relevant, authors should declare it. This ensures that the editorial team has all the information required when evaluating whether the author team complies with the policy.
c) If a payment was made for work that was unrelated to the topic of the current review, does this payment still count as a financial interest?
Yes, it does not matter whether the work itself was related to the topic of the review. What is important is whether the commercial organization has an interest in the outcome of the review (i.e. they manufacture (or are known to be developing) or distribute an intervention or potential comparator related to the topic of the review).
d) If the findings of a review are not in favour of a particular intervention, does having an interest related to that intervention still count as a financial interest?
As declarations of interest are first made before work on the review begins, it would also not be feasible to consider the outcome of the review when determining whether a financial interest is relevant.
e) Is a financial interest still relevant if the payment was made to the author’s institution rather than to the author directly?
Payments made by a commercial organization with an interest in the outcome of the review to an authors’ employer rather than the author themselves should always be declared. However whether it is considered (and treated as) a ‘direct financial interest’ (see Section 5.2 of the policy) depends on whether the individual has any access to or direct control of the funds. If, after reading the policy you are unsure whether a specific payment to an author’s institution constitutes a direct financial interest, you should submit a referral to the Research Integrity Editors and Conflict of Interest Panel here.
f) Are there any financial interests that prevent someone from being an author on a Cochrane Systematic Review?
Yes, the following people cannot be authors on a Cochrane Review:
- Anyone who is or has been employed by a commercial organization with a financial interest in the topic of the review
- Anyone who owns (or part owns) a commercial organization with an interest in the topic of the review
- Anyone who owns or has applied for a patent related to the topic of the review
The above preclude authorship on a Cochrane Review if they occur within the 36 months prior to title registration/work began on an update through to publication of the review/update.
There are additional restrictions for first and last authors, who must be free of all conflicts (i.e. they must have no financial interests relating to the review and cannot have been involved in any industry-controlled studies that are eligible for inclusion in the review).
g) If an author group of an existing Cochrane Review is compliant with the 2014 CoI Policy, what should be done to make an update compliant with the 2020 CoI Policy?
Many existing Cochrane Reviews will already be compliant with the 2020 CoI Policy, however some may need changes in authorship when they are updated. Any changes should be made at the point of deciding to do the update to ensure that all authors fully meet the authorship criteria. The composition of the author group may need to be changed to ensure that 67% (two thirds) of the authors group is free from all conflicts and changes may be required to who will be last author on the review, as last authors must now be free of all conflicts.
It is possible that by the time a decision is made to update a review, some authors will no longer have relevant conflicts within the 36-month time period.
h) If fewer than 67% (two-thirds) of an author group is free from conflicts, can authors be added to make the review compliant?
Any changes to the composition of an author group must be reflected in the contribution of the authors. Such changes should be made at the point of deciding to update the review to ensure that authors all meet authorship criteria. Changes to the composition of the author team cannot be made simply to make the team compliant with the policy and must be justified on the grounds of contribution to the review. Authors’ contributions should be in line with the ICMJE criteria for authorship.
i) Where can I find information on which companies make various pharmaceutical products in order to determine whether a financial interest is relevant?
We have put together a list of websites/databases that can be used to identify which companies make particular pharmaceutical products. This can be used to help determine whether a financial interest is relevant to a particular review.
j) Does non-commercial funding (e.g. grants received by a university or Government) need to be declared?
No, non-commercial funding received by an author (e.g. grants received from a University or government) does not need to be declared in the Declaration of Interest (DoI) form. It is only payments from commercial organizations that have an interest in the topic area of the review that need to be declared under the CoI policy (as well as relevant non-financial interests and involvement in studies that may be eligible for inclusion). If the non-commercial funding was funding for the review, it should instead be declared in the ‘sources of support’ section of the review (see question 2b above).
k) As an Editor, what should I do if an author declares something in a Declaration of Interest (DoI) form that I don’t think is relevant to the particular review?
Authors of Cochrane Reviews are only required to declare interests/activities in their DoI forms that are relevant to the particular review for which they are completing the DoI form. This is to ensure that relevant interests are not obscured by interests that are not relevant to that particular review.
If an author includes an interest/activity in their DoI form that the editor believes is not relevant (for example, if it is outside of the relevant timeframe), it is important that the editor does not omit this information when drafting the DoI statement without clarifying this with the author. If the author agrees that the interest/activity is not relevant to that particular review, it can be omitted from the DoI statement. If the author still believes that a particular interest/activity should be declared, it should be included in the DoI statement.
If you are unsure whether an interest/activity is relevant to a particular review this should be discussed with the Research Integrity Editors and Conflict of Interest Panel via the CoI referral form.
a) Are there any non-financial interest that prohibit authorship on a Cochrane Review?
No, non-financial interests should be declared, but they will not prohibit authorship on a review.
b) Some authors have built a career on a particular intervention; they may have helped to developed it and evidence of efficacy means they may get more research funding. Is this considered financial CoI?
No, this would not be considered a financial CoI as financial interests are defined as payment received by an author from a commercial organization with a financial interest in the topic of the review.
It could however be considered a professional (non-financial) interest which should be declared but would not prohibit authorship. If the author has been involved in the primary studies which are eligible for inclusion in the review then some restrictions may apply (see Section 5.6 of the policy).
a) What are the rules around authors who have been involved in included clinical studies?
There are some additional restrictions of authorship of Cochrane Reviews relating to involvement in included studies. These are:
- Anyone who has been involved in an industry-controlled study that is eligible for inclusion in the review cannot be first or last author on the review.
- Anyone who has been involved in the conduct, analysis, and publication of a study that could be included in the review cannot determine the overall study inclusion and exclusion criteria or make study eligibility decisions about, extract data from, carry out the risk of bias assessment for, or perform GRADE assessments of that study.
- Involvement in an industry-controlled study that is eligible for inclusion in the review counts towards the portion of conflicted authors when determining whether 67% (two thirds) of authors are free of all conflicts.
b) What is the difference between an industry-controlled and industry-supported study?
An industry-controlled study is defined as a study with funding by a commercial organization where the organization is involved in the design, analysis or reporting of the study. An industry-supported study is where no commercial organization has any role in the design, analysis or reporting of the study. A commercial organization may however provide some or all funding and material, or non-financial support (e.g. placebo or active drugs, diagnostic or other test access).
c) Why is it important to know whether a study was industry-controlled or industry-supported?
There are different restrictions of on authors who have been involved in industry-controlled versus industry-supported studies. Anyone who has been involved in an industry-controlled study relevant to the topic of the review cannot be first or last author on the review. Their involvement in the industry-controlled study also counts towards the portion of conflicted authors when determining whether 67% (two thirds) of authors are free of all conflicts.
Any author who has been involved in the conduct, analysis, and publication of a study that could be included in the review (regardless of whether it was industry-controlled or industry-supported) cannot determine the overall study inclusion and exclusion criteria; and cannot make study eligibility decisions about, extract data from, carry out the risk of bias assessment for, or perform GRADE assessments of that study.
d) Is being an author of an included study considered a conflict of interest when calculating whether 67% (two thirds) of authors are free of conflicts?
Yes, but only if the study was industry controlled. If the study was only industry supported, this does not count when calculating the proportion of conflicts in the author team.
e) Will there be retrospective application of the rules on involvement in included studies? Many Cochrane Reviews were set up by people who ran trials in the topic.
No, the 2020 CoI Policy is not being applied retrospectively. For existing reviews, it will only apply when the review is next updated (if work begins on the update after 14 October 2020). If any of the authors were involved in conducting clinical studies that are eligible for inclusion in the review, they may be affected at this point. This specifically impacts first or last authors who have been involved in industry-controlled studies.
f) Where the first/last author from the previous version of a review is now considered conflicted due to authoring included studies, does this mean they can no longer have the role of first/last author on an update?
Yes, if the first or last author of a Cochrane Review was involved in an industry-controlled study that is eligible for inclusion in the review they could not have the same position on a future update. They can still be an author on the review provided that 67% (two thirds) of the author group is free of conflicts. If the study they were involved in was industry-supported, they can still be first or last author.
a) How does the 2020 CoI policy apply to Living Systematic Reviews?
Living Systematic Reviews (LSRs) are Cochrane Reviews and therefore the 2020 CoI Policy applies to them in the same way it does to reviews that are updated less frequently.
For LSRs that began before the 2020 CoI Policy launch date (14 October 2020), it applies from the first time new studies are identified and added (i.e. when the review is updated) after the launch date.
b) How frequently should Declarations of Interest forms be updated for Living Systematic Reviews?
Updates to Living Systematic Reviews (LSRs) may be published very frequently which would make it impractical for authors to complete a new Declaration of Interest (DoI) each time an update to the review is published. Authors of LSRs must therefore complete their DoI forms at the following time points:
- Title registration
- Annually until publication of the review
- Just prior to publication of the protocol
- Just prior to publication of the review
- 6 monthly thereafter
Authors must inform the editorial team immediately if they acquire any additional relevant financial interests outside of these timepoints.
a) Do authors of overview reviews have to declare their involvement in clinical trials?
No, authors of overview reviews do not need to declare involvement in clinical trials as they will not be extracting data from the primary studies. Instead, they need to declare involvement in included reviews, and cannot be involved in any assessments of those reviews.
b) How do I collect information from authors about their involvement in included reviews?
The Declaration of Interest (DoI) form does not contain a section for authors of overview reviews to declare their involvement in included reviews. Managing Editors should therefore contact authors of overview reviews by email to ask them if they were involved in any reviews that would be eligible for inclusion in the overview review.
a) What additional restrictions are there on first and last authors?
In addition to the rules relating to CoI for all authors, the 2020 CoI Policy states that first and last authors must be free of all conflicts. This means:
- The first and last author must be free of relevant financial interests
- Anyone who has had direct involvement in the design, conduct, analysis and publication of industry-controlled clinical studies that are relevant to the topic of a review cannot be the first or last author of that Cochrane Review
b) Why are there additional restrictions on the first and last authors?
The first and last author of a review are usually those who have had the greatest influence on a review. It is therefore important to ensure that the people in these important positions in the author team are particularly free from CoI which could potentially influence the design or conduct of the review.
a) How far back should interests be declared?
The relevant timeframe for interests that should be declared is from 36 months before title registration through to publication of the review. For updates it is the 36 months prior to work beginning on the update through to publication of the update.
In practice, this means that authors must declare all relevant interests from 36 months before the title is registered (or before work began for an update) plus any that they accumulate during the time that they are working on the review/update up until the date that the review/update is published. It is important that authors inform the editorial team immediately if they acquire any additional relevant financial interests while working on the review/update as some financial interests prevent authorship.
For authors joining during the process, the relevant timeframe is from 36 months before their involvement, through to publication.
b) At what point in the process should interests be declared/updated?
All review authors must complete a Declaration of Interest (DoI) form at the following time points:
- Title registration (for reviews) / point at which the decision is made to update (for updates)
- Annually until publication of the review / update
- Just prior to publication of the protocol
- Just prior to publication of the review / update
In practice, for a review, this means that authors will be asked to complete their first DoI form just before title registration. They will then be required to complete another DoI form annually from that date throughout the whole process of conducting and writing the review, until the review is published. In addition to this, authors must complete another DoI form just prior to publication of the protocol, and another just prior to publication of the review. After completing the DoI form just prior to protocol publication, the next 'annual' declaration is taken to be one year on from completion of that form. An example of when DoI forms would be required for a typical review is as follows:
- Before title registration - first DoI form completed
- One year on from completion of first DoI form - second DoI form completed
- Just prior to publication of the protocol - third DoI form completed
- One year on from completion of third DoI form - fourth DoI form completed
- One year on from completion of fourth DoI form - fifth DoI form completed
- Just prior to publication of the review - sixth DoI form completed
Each time a DoI form is completed, the timeframe for declaring interests is from 36 months before the title is registered through to the date that they are completing that particular DoI form. This means that at the point of completing the final DoI form just before publication of the review, the DoI form may cover a timeframe of many years - from 36 months before title registration through to the point that the review is published and will therefore include any CoI acquired during the process of conducting / writing the review as well as those existing in the 36 months before title registration.
DoI forms must also be updated at any point during the review/update process if an author gains a new CoI. It is the authors’ responsibility to ensure Declaration of Interest forms are kept up to date and to alert the editorial team to any changes in CoI.
c) If an author joins the author team once a review is underway, does the review process need to be paused until Declarations of Interest for the new author have been checked?
Authors joining the author team of a Cochrane Review during the process (i.e. after title registration for a review, and after work begins for an update) must be checked for compliance with the CoI policy before they can begin any work on the review. The new author must complete a Declaration of Interest (DoI) form and the editor must check that that the individual author and the author group as a whole still comply with the CoI policy before the new author can participate in the review.
Whether to pause the review process entirely is an editorial decision. If the editor is happy that the existing authors are able to work on the review without the new author, work can continue until the new author’s DoI form has been checked. If the existing author group are unable to continue work on the review without the participation of the new author, the review process must be paused until the new author’s DoI form has been checked.
a) Whose responsibility is it to ensure CoIs are correctly declared?
It is the authors’ responsibility to ensure that Declaration of Interest forms are completed accurately and that there is an accurate declaration of interest in the protocol/review/update.
b) What should be done if an author gains a potential CoI during the review process?
It is the author’s responsibility to immediately inform the Cochrane editorial team if they gain any new relevant interests during the process of conducting the protocol/review/update or if their Declaration of Interests form is no longer up to date. The editor should assess whether the new interest is relevant to the review. If it is relevant to the review, this should be discussed with the Research Integrity Editors and Conflict of Interest Panel via the CoI referral form.
c) Can a Declaration of Interest (DoI) form be completed on behalf of authors?
No, all DoI forms must be completed by the author as it is the author’s responsibility to declare all relevant interest that relate to a review, and they are the only ones who have access to the relevant information to complete it. By submitting the form, they are confirming that they included all the required information.
a) What should I do if I am not sure whether I have a CoI relating to a specific review?
If after reading the policy and the other resources in the CoI portal you are unsure whether you have a CoI you can submit a referral to the Research Integrity Editors and CoI panel. This can be done via the referral form which can be accessed here and provides information about the referral process.
b) How do I submit a referral to the Research Integrity Editors and CoI panel?
You can submit a referral to the Research Integrity Editors and CoI panel online here. They can be contacted with any concerns relating to a specific Cochrane Review or other Cochrane Library content or for general queries about how the policy should be applied.
You can find more information on the Research Integrity Editors and CoI panel here.
a) Where can I find out more about the 2020 CoI Policy and how to apply it?
The full 2020 CoI Policy can be found online here. As well as the policy, there are also a number of different resources available in the CoI portal including training videos, case scenarios, and flowcharts. These will be kept updated.
b) Where can I get a quick overview of the 2020 CoI Policy?
A quick guide to the 2020 CoI Policy is available through the CoI portal and can be accessed here. This can be used to get an overview of the policy but is not intended to replace reading the full policy.
c) What should I do if I still have questions?
You can submit a question to the Research Integrity Editors and CoI Panel. They arbitrate on potential breaches of the CoI Policy and provide general guidance on how the policy should be applied. For information on how to contact them, please click here.
d) Is Cochrane doing anything to work with other journals to make their policies tighter?
Cochrane is not in a position to directly influence the approach taken by other journals when it comes to their CoI policies. However, part of the Research Integrity Editors’ role is to advance Cochrane’s Research Integrity Agenda, in part by modelling and promoting rigorous CoI management. Other biomedical journals such as BMJ are considering implementing more rigorous CoI policies, which is certainly something Cochrane would welcome and encourage.
a) Why was the 2020 CoI policy update needed?
Cochrane has been recognized as a strong and reputable research organization with respect to Conflict of Interest. The previous CoI Policy was generally well adopted, and a recent audit showed that 90% of Cochrane Reviews were compliant. However, Cochrane strives to attain the highest levels of objectivity and ensure user confidence in the quality of Cochrane Library content. The 2020 CoI Policy was created to strengthen on the 2014 CoI Policy and uphold the principles of independence, freedom from interference, assurance and transparency.
b) What are the main differences between the 2020 and 2014 CoI policies?
The main changes in the 2020 CoI Policy are as follows:
- It focuses on Cochrane Library content only and those involved in creating it. A companion policy to cover other Cochrane contributors will be developed separately, but in the meanwhile the 2014 CoI Policy applies to all other contributors
- The proportion of conflict free authors required in a team has increased from a simple majority (>50%) to two-thirds or more (≥67%)
- Last authors will be treated in the same way as first authors and must be entirely free of conflicts
- Authors of industry-funded clinical studies eligible for inclusion in a Cochrane Review will be prohibited from being the first or last author on that review
- The difference between payments made to the individual’s home institution rather than to them personally has been clarified
- Reviews funded by not-for-profit organizations with a specific interest in the outcome may be assessed by Cochrane’s Research Integrity Editors and CoI and the Editor in Chief
- All Cochrane Review Group and Editorial and Methods Department staff should be free from relevant financial conflicts of interest
c) How was the 2020 CoI Policy created?
The 2020 CoI Policy was created through a rigorous policy revision process that occurred in 2019. In it, the Project Board examined conflict of interest policies from 33 healthcare-related organizations; conducted an open, online survey resulting in contributions from nearly 1000 respondents; and interviewed 16 internal and external stakeholders. A series of recommendations were made to strengthen the existing policy, which were approved by the Governing Board. Based on these recommendations, the 2020 CoI Policy was written, went through revisions, and was approved by the Governing Board.