1. Funding and interests
   1. Funding of Cochrane Library content

If the creation of Cochrane Library content is supported by direct external funding, the following rules apply.

• Cochrane Library content cannot be directly funded or produced by any commercial organization with a financial interest in the topic.
• Funders of Cochrane Library content should be declared in the ‘Sources of support’ section of the review or protocol, which should include an explanation of the funder’s role.
• Funders of Cochrane Reviews cannot interfere with review production, that is, the design, conduct, or publication of a review or its update.
• Funding may come from external non-commercial granting bodies such as governments and not-for-profit organizations.
  2. Direct financial interests

Financial interests must be declared by all people involved in creating Cochrane Library content. For some specific Cochrane Reviews, where funding comes from a commercial organization with a financial interest in the outcome of the review (e.g., it is developing, manufacturing or marketing an intervention that is the subject of the review or could be a comparator), financial interests must be declared by Cochrane Review Group editorial team members and by all authors (see Section 5.6), peer reviewers (see Section 5.7) and translators. Cochrane Review Group editorial staff (paid and unpaid) must also declare any financial interests that relate to the Review Group’s topic areas (see Section 5.5). All financial support must be declared and there are no thresholds.

The following WILL prevent authorship of Cochrane Library content and are prohibited for Cochrane Review Group editorial staff (see Section 5.5 for timeframes).

• Current or past employment (part-time or full-time) (see Section 5.5 for timeframes) by a commercial organization with a financial interest in the topic of specific Cochrane Library content.
• Personal ownership of a patent for an intervention, diagnostic test or prognostic marker that is relevant to the topic of specific Cochrane Library content. This is not intended to cover patents developed, but not owned by individuals.

The following MAY prevent authorship of Cochrane Library content (see Section 5.5 for timeframes) and are PROHIBITED for Cochrane Review Group editorial staff. This list is not intended to be exhaustive; if there is any doubt refer to the Conflict of Interest Arbiters (see section 8.1).

• Payment from relevant organizations with a financial interest for work carried out on their behalf, such as speaker fees, honoraria, consultancies, and membership of advisory boards.
• Support for sabbaticals and study tours.
• Travel, accommodation, subsistence and conference registration expenses.
• Ownership of stock/shares in healthcare-related companies with a financial interest.
• Payment for legal advice related to the topic of specific Cochrane Library content.
• Royalties relevant to the topic of the Cochrane Library content.
• Funding for research in the subject area of the topic of specific Cochrane Library content.
• Financial support for fellowships and other professional placements.

Income from relevant private professional practice should be declared, but will not normally prevent contribution to the creation of Cochrane Library content. If there are concerns that the author derives a significant income from one particular intervention relevant to the topic, this should be discussed with the Conflict of Interest Arbiters (see section 8.1).

1. 3. Indirect financial interests

An indirect financial interest exists when payments from a commercial organization with a financial interest (as described in section 5.2) are made on behalf of the individual to their employer or home institution.

• All such payments must be declared.
• If the individual has any access to or control of the funds, this must be declared, and will be treated as explained in section 5.2.
• If the individual has no access or direct control of the funds, this should be declared, but does not constitute a conflict of interest.
  4. Other (non-financial) relevant interests

Other, non-financial interests may result in an actual or perceived risk of conflict that could influence the development of Cochrane Library content. All those involved in the production of Cochrane Library content should think critically about how their perspectives, experiences, and positions have shaped their contribution to the review. Transparency is key, and relevant declarations are mandatory, however they WILL NOT prevent participation in the creation of Cochrane Library content.

The types of interests that should be considered, and declared, include, but are not limited to:

• published opinions: the publication in medical journals, the public press, broadcast and social media of opinions relevant to the topic of and interventions mentioned in the Cochrane Library content;
• work as a health professional or advisor on the topic or broader area relevant to the topic of the Cochrane Library content, whether in public or private practice;
• any affiliation to an organization (including not-for-profit) that has a declared ideological or political opinion relevant to the Cochrane Library content;
• financial interests of close personal contacts (see definitions), when known and relevant, to the topic of the Cochrane Library content.

1. 5. Timeframes for declaration of interests

Authors of Cochrane Reviews should declare relevant conflicts of interests (financial and non-financial) that existed in a prescribed period before the review title was registered and also any that arise during the writing of the review.

Timeframes for declaration of interests (financial and non-financial) by authors in Cochrane Reviews are shown below.

• Authors should declare all relevant interests that existed 36 months before title registration, through to review publication.
• If an author’s contribution started after the date of title registration, the relevant timeframe is the 36 months before his/her involvement began, through to review publication.
• If a review is to be updated without the publication of a new protocol, the relevant timeframe is the 36 months before the date of the decision to update, through to review publication
• For peer reviewers the time period of interest is the 36 months before the invitation to referee the review.

For all other types of Cochrane Library content, authors should declare all relevant interests that existed 36 months before work on the content started, through to publication.

1. 6. Restrictions for authors of Cochrane Library content involved in clinical trials

Some restrictions are placed on people who have been involved in the conduct, analysis and publication of clinical studies.

• Anyone involved in the creation of Cochrane Library content should declare whether they have had any direct involvement in the conduct, analysis, and publication of clinical studies (such as randomized clinical trials) that are relevant to the topic of the specific review, and whether if the study was industry-controlled or industry-supported (see definitions). Direct involvement means named or other close involvement in the study design, conduct, analysis, or reporting. This would include chief investigators and members of advisory boards, but not usually members of independent data and safety monitoring committees. or site investigators.
• Anyone engaged in creating Cochrane Library content, who has had any involvement in the conduct, analysis, and publication of a study that is relevant to the topic of a review, 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, or perform GRADE assessments of that study.
• Cochrane Review authors who have 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.

2. Rules relating to declared interests
   1. Rules for authors of Cochrane Library content

The following rules apply to authors of Cochrane Library content:

• A person who is currently employed (part-time or full-time) or was employed (part-time or full-time) in the recent past (see section 5.5) by a commercial organization with a financial interest in the specific topic/review CANNOT be an author of any relevant Cochrane Library content. For Cochrane Reviews this rule applies to the 36-month period before title registration through to publication of the completed review (see section 5.5).
• A person who fully or partially owns an organization with a financial interest in the topic CANNOT be an author of any relevant Cochrane Library content.
• Someone who personally holds, or has applied for, a patent related to the topic CANNOT be an author of any relevant Cochrane Library content.
• Where Cochrane Library content has multiple authors, at least 67% (two-thirds) of them should have no relevant financial conflicts.
• The first and last authors of Cochrane Library content must have no relevant financial conflicts. For Cochrane Reviews this rule applies to the 36-month period preceding title registration through to publication of the completed review (see section 5.5).
• Authors joining the author team of a Cochrane Review after the publication of the protocol or after publication of the full review (for an update) must be free of relevant financial conflicts of interest for 36 months before joining the team.
• For Cochrane Review updates the relevant time period is 36 months before the date the decision was made by the CRG and author team to update the review, through to publication of the completed update.
• When committing to produce Cochrane Library content authors must complete a ‘Declaration of interest’ form. For review authors this must be done at title registration, annually thereafter  until publication and just prior to publication, and for authors of review updates it must be done at the time of the decision to update the review, annually thereafter  until publication and just prior to publication.
• Declarations of other (non-financial) interests WILL NOT PREVENT participation in the development of Cochrane Library content.
  2. Rules for Cochrane Review Groups/Networks and the Editorial & Methods Department

The following restrictions apply to all Cochrane Review Group (CRG) and Networks (paid and unpaid) and all staff of the Editorial and Methods Department (EMD):

• No CRG or CRG Network is permitted to accept funding from any commercial organization with a financial interest in the CRG topic area.
• All editorial team members of CRGs (paid and unpaid) and EMD staff must have NO relevant financial conflicts of interest (see Section 5.2 and 5.3).
• Anyone newly appointed to a role in the CRGs or EMD must be free of relevant financial conflicts of interest from the date of appointment.
• All full and part-time editorial staff of CRGs and the EMD must complete the Declaration of interest form and update it annually (between January and March each year).
• All CRG and EMD staff, including Co-ordinating Editors, in post at the time of this policy launch (date xxxx) who have financial conflicts of interest should not sign off reviews of topics relevant to those interests, and, if they remain in post, should have divested themselves of those interests within five years from xxxx (date of policy taking effect), so that by xxxx they will be free of such interests.
• CRG Editors and any others with unpaid roles in Cochrane must complete the Declaration of interest form and update it annually (between January and March each year).
• Editors with conflicts of interest should not undertake peer review or be a contact editor or provide sign-off on Cochrane Reviews to which their conflicts relate.
• Editors are prohibited from being employees of commercial organizations with a financial interest in the CRG topic area.
  3. Rules for peer reviewers

The following restrictions apply to anyone engaged in peer reviewing Cochrane Library content.
 

• Employees (full-time or part-time) of an organization with a financial interest in the topic of specific Cochrane Library content should not act as peer reviewers.
• Those with a direct financial interest (see section 5.2) in an intervention or any comparators considered in the review should not act as peer reviewers.
• Peer reviewers must complete the ‘Peer reviewer declaration of interest’ form in Archie every time they undertake peer review of a Cochrane Review, or annually, if doing so more than once a year.
  4. Not-for-profit organizations

Not-for-profit organizations that employ Cochrane authors, or fund reviews, may have a specific interest in the conclusions of a Cochrane Review. They may or may not gain financially as a result of taking a specific position about a healthcare intervention, but they may try to influence the conduct, conclusions or publication of that review. For example, a high-profile charity or foundation that has a well-documented position on a particular healthcare intervention may fund a Cochrane Review (directly or via an intermediary research organization) or provide substantive primary research funding in the topic area of the review. Although it is not possible to draft specific rules about this issue, the CRG should raise this issue with authors, and, if there appears to be a risk (real or perceived) of inappropriate interference, the matter should be discussed with the Conflict of Interest Arbiters (see section 8.1) and the Editor in Chief as early as possible.

3. Responsibilities
   1. Authors’ responsibilities

• Authors of Cochrane Library content must provide an accurate and complete declaration of relevant financial and non-financial interests.
• Declarations should be made at the earliest opportunity in the editorial process. For Cochrane Reviews, this is usually at the time of submitting a review proposal form.
• The declarations provided by authors should be clear and detailed enough for readers to be able to understand the potential implications of what is being declared.
• Authors of Cochrane Reviews should declare all relevant interests before title registration, annually throughout review development, and again before review publication. If an author acquires a conflict of interest while the review is being written, this should be reported to the CRG immediately and referred to the Conflict of Interest Arbiter where necessary.
  2. Cochrane Review Group and Editorial Methods Department responsibilities

• The CRGs should check and clarify all Cochrane Review authors’ declarations before title registration, protocol publication, and review publication.
• Titles with author teams that breach the policy in any of the ways outlined above MUST NOT be registered until appropriate changes are made to ensure that the team is unconflicted. Once work on the review is underway, changes to the author line-up will generally not be permitted as a means of addressing a breach of this policy.
• The CRGs should check that the author team does not breach the requirements of this policy at any key stage after title registration - that is, protocol submission, protocol publication, review submission and review publication. Where there is concern, CRG staff should manage issues in line with the policy and, if necessary, should seek further advice from the Conflict of Interest Arbiters (see section 8.1).
• When authors have declared non-financial interests that together might result in the Cochrane Library product being perceived as being biased, CRG staff should discuss the issue(s) with the Conflict of Interest Arbiters (see section 8.1).
• The CRGs should check peer reviewers’ declarations at the time they are invited to peer review and when they submit their reports.
• The EMD should check and clarify all authors’ declarations for other Cochrane Library content (i.e., podcasts, editorials and Cochrane Clinical Answers) at the time of commissioning, and before publication.
• A designated member of the EMD is responsible for checking that all members of the department comply with the policy.

4. Policy governance
   1. Conflict of Interest Arbiters and Panel

The Conflict of Interest Arbiters and the Conflict of Interest Panel (formerly known as the Funding Arbiters and Funding Arbiter Panel) provide guidance on conflicts of interest in the context of Cochrane Library content. They provide advice on implementation of the policy and arbitrate potential policy breaches. The terms of reference and remit of the Conflict of Interest Arbiters and the Conflict of Interest Panel is available here.

The Conflict of Interest Panel reports to the Conflict of Interest Arbiters, who in turn report to the Editor in Chief of the Cochrane Library.

Queries about the application of this policy can be referred to the Conflict of Interest Arbiters using the form available at LINK. The Conflict of Interest Arbiters are supported by a member of the EMD who can be contacted via fundingarbiter@cochrane.org

1. 2. Appeals

Appeals against the decisions of the Conflict of Interest Arbiters should be made via fundingarbiter@cochrane.org . As a first step the Conflict of Interest Arbiters will consult the Conflict of Interest Panel (if it has not previously been involved). If the Panel agrees with the decision made by the Conflict of Interest Arbiters, a further appeal can be made to the Editor in Chief who will make the final decision in consultation with the Editorial Board.

1. 3. Non-adherence

Unpublished Cochrane Library content that is considered to be in breach of this policy will be referred to the Conflict of Interest Arbiters and may be rejected for publication, subject to appeal (see section 8.2).

Published Cochrane Library content which is considered to be in breach of this policy will be referred to the Conflict of Interest Arbiters and may be removed from the Library after discussion with the Editor in Chief, subject to appeal (see section 8.2).

Wilful failure to disclose relevant conflicts of interest will be considered to be a form of scientific misconduct. (Need to link to the Cochrane Policy on Scientific Misconduct when available).

1. 4. Policy audit

A full audit of Cochrane Library content to determine adherence to this policy will be carried out every four years by the EMD in collaboration with the Conflict of Interest Arbiters and Panel, and no sooner than 18 months after any changes or revision to the policy. Partial audits and spot checks may be carried out at the discretion of the Editor in Chief.

A review of cases referred to the Conflict of Interest Arbiters and the results of the audits may be used to inform development of resources to support the implementation of the policy by those producing Cochrane Library content.

5. Version history