An official Cochrane policy. Last updated March 2014.
Cochrane policy on commercial sponsorship of Cochrane Reviews and Cochrane Groups
See also information about the policy in the Conflicts of interest and Cochrane Groups section of the Cochrane Community site and in the Conflicts of interest and Cochrane Reviews section of the Editorial and Publishing Policy Resource.
Prepared by: Cindy Farquhar, Sophie Hill, Lisa Bero, David Tovey
Date: 8 March 2014
Principles informing this policy
Whilst Cochrane has adopted the uniform requirements for declaration of conflicts of interests (CoI) framework produced by the International Committee of Medical Journal Editors, Cochrane and the Cochrane Database of Systematic Reviews differ from many journals in two ways: 1) certain types of sponsorship are forbidden and 2) we ask for disclosure of CoI at the beginning of a review process (title registration). Such declarations may be managed within the group processes or be referred to the Funding Arbiter for discussion and decision making.
Independence: Cochrane Reviews must be independent of conflicts of interest associated with commercial sponsorship and should be conducted by people or organizations that are free of such bias
Free from interference: The process for conducting Cochrane Reviews and the Cochrane Groups and contributors responsible for producing Cochrane Reviews should operate free from interference.
Assurance: Users of Cochrane Reviews should be assured that Cochrane Reviews are produced in an independent manner.
‘Commercial sponsor or source’: any for-profit manufacturer or any other for-profit source with a real or potential vested interest in the findings of a specific review.
This definition is not intended to include government departments, not-for-profit medical insurance companies and health management organizations, although clauses 6-8 below are relevant for all funders. Also not included are for-profit companies that do not have real or potential vested interests in Cochrane Reviews (e.g. banks).
Appropriate ‘Funder’ of a Cochrane Review: a body which provides a grant, contract, gift ,or other form of financial support for one, several, or all authors of a review (or the funding may go to their institution(s)) where the funder has no commercial or vested interest in the finding of the review.
Conflict of Interest of a Cochrane author or editor: Conflict of interest is defined as "a set of conditions in which professional judgement concerning a primary interest (such as patients' welfare or the validity of research) may be unduly influenced by a secondary interest (such as financial gain) or may be perceived to be influenced by a secondary interest.”
Policy affecting Cochrane Reviews and Groups
Scope of policy
This policy affects the people who conduct Cochrane Reviews (‘authors’), referees and editors, and all Cochrane Groups (Governing Board, Centres, Review Groups, Fields, Methods Groups, Consumer Network, and the Central Executive Team).
Commercial funding of reviews or authors
The intent of clauses 1-5 is to ensure the independence of Cochrane Reviews by making sure there is no bias associated with commercial conflicts of interest in the conduct of Cochrane Reviews.
- Cochrane Reviews cannot be funded or conducted by commercial sponsors or commercial sources with a real or potential vested interest in the findings of a specific review.
Individuals who are currently employed or where employed any time in the last three years by a company that has a real or potential financial interest in the outcome of the review (including but not limited to drug companies or medical device manufacturers); or who hold or have applied for a patent related to the review are prohibited from being Cochrane Review authors. In most cases, current or previous employment would be characterized by the affiliation statement made by the author at the title registration, protocol, or review stage of the review. Any questions about what constitutes "employment by a company with a financial interest” should be referred to the Funding Arbiter.
- Authors who in the last three years have received financial support from commercial sponsors or sources who have a real or potential financial interest in the findings of the review, but who are not covered by the restriction above 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.
- Editors with conflicts of interest with a given product/drug/non-drug intervention should not undertake peer review or be a contact editor, or provide sign-off on a review that involves that product, drug, non-drug intervention, or a competing intervention. Co-ordinating Editors with conflicts of interest should assign the relevant review to another editor within their group. Editors are prohibited from being employees of a pharmaceutical company or medical device manufacturer.
- Peer reviewers should be asked to declare CoI using the ICMJE framework.
Disclosure of commercial conflicts of interest
The intent of clauses 6-7 is to ensure that all links between Cochrane authors and commercial sponsorship or sources are disclosed, so that Cochrane users have confidence in the process for the disclosure and management of potential commercial conflicts of interest.
6. At title registration stage, Cochrane authors should declare their conflicts of interest according to the relevant ICMJE criteria.
Commercial interests that should be declared include, but are not limited to: income from private clinical practice (if relevant to the topic), ownership of stocks related to industry, legal advice related to the topic, consultancies, honoraria, fellowships, speaker’s fees, involvement in primary research in the subject area of their review, funding for primary research in the subject area of the review, and any other interests that others may judge relevant. Employment in a speciality relevant to the review should be declared in the interests of transparency, but this does not prevent an individual from being a review author, editor, or peer reviewer.
7.On receipt, the relevant Cochrane Review Group (CRG) will assess whether an author may have a CoI that would prohibit them from participating in the review team. In making this assessment, it is important to consider how the reader would perceive the potential for conflict of interest. All potentially important conflicts (as described in the paragraphs above) should be referred to the funding arbiter unless it is clear that the conflicts prohibit the author from further involvement.
At each stage of the review – title registration, protocol publication, review publication, and updating the CoI declarations should be updated and reviewed by the Managing Editor and Co-ordinating Editor as appropriate.
Cochrane authors who are also the authors of included studies
The intent of clause 8 is to ensure transparency of Cochrane authors who are authors of primary studies.
8. Cochrane authors who include primary studies (which they had conducted) in their review should declare this in the review in the Declarations of Interest section. The CRG should ensure that an editor checks the included data and interpretation against the study report and any available study registration details or protocol.
Funders of Cochrane Reviews
Cochrane Reviews are commonly funded by granting bodies. The intent of clauses 9-11 is to ensure that granting bodies do not interfere in the design and release of reviews and that funding is transparently declared.
9. Funders of Cochrane Reviews cannot interfere with the design or conduct of reviews.
10. Funders cannot delay or prevent the publication of a review or its update.
11. Funding for the review should be declared in the 'Sources of support' section of the review, which should include reference to the role of any sponsors.
Role of the Funding Arbiter
If there are questions about how this policy should be implemented, under what conditions the policy applies, if COIs are unclear, or there is no agreement between the parties, the matter will be referred to the Funding Arbiter Panel who will assess the potential conflict of interest and make a recommendation.
The Funding Arbiter Panel (FAP) is nominated by the Governing Board and contains 3-4 Cochrane contributors and one person external to Cochrane. In making an assessment, the FAP will consider the principles outlined above.
Removal of reviews not meeting policy
The intent of clause 12 is to enforce the policy.
12. Cochrane Reviews (whether new or updates) or protocols that do not meet the above requirements (1-8) from the inception of this policy will be withdrawn after consultation with the FAP and Editor in Chief.
Commercial sponsorship of Cochrane Groups
The intent of clause 13 is to ensure the independence of Cochrane Groups and their activities.
13. No Cochrane Groups are permitted to accept funds from commercial sponsors or commercial sources.
Cochrane Groups which violate this policy by accepting commercial funding may be de-registered, following an investigation by the appropriate body.
The development of derivative products from Cochrane Reviews is the responsibility of Cochrane Trading Company, supported by the Editor in Chief, the and the Governing Board.
14. In developing derivative products, these bodies will adhere to the items above.
15. Authors and CRGs should not receive royalties on sales of reprints of their reviews, since these sales are likely to have been made to commercial sources and might, therefore, be assumed to be equivalent to direct sponsorship of the review or Group. Therefore, the current policy that royalties on reprint sales go to Cochrane centrally, via the Collaboration Trading Company, will continue.
16. There will be an audit of compliance with the policy within six months and the policy will be revisited in two years.