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Assurance: Users of Cochrane Reviews should be assured that Cochrane Reviews are produced in an independent manner.

See the Funding Arbiter information about here for information about the about the role of the Funding Arbiter and the Funding Arbitration Research Integrity Editors and Conflict of Interest (CoI) Panel in the implementation and for clarifications or guidance on funding issues. 

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2.1. Disclosure of potential conflicts of interest by authors

The form from used by Cochrane is based on the the ICMJE Form for Disclosure of Potential Conflicts of Interest.

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Section

Heading

Content

1

Identifying information

This information, including the Cochrane Protocol or Review title, Author(s), Cochrane Review Group, and Cochrane Review ID, is added automatically.

2

The work under consideration for publication

This section asks for information about the work that you have submitted for publication. The time frame for this reporting is that of the work itself, from the initial conception and planning to the present.

The requested information is about resources that you received, either directly or indirectly (via your institution), to enable you to complete the work. Checking "No" means that you did the work without receiving any financial support from any third party -- that is, the work was supported by funds from the same institution that pays your salary and that institution did not receive third-party funds with which to pay you. If you or your institution received funds from a third party to support the work, such as a government granting agency, charitable foundation or commercial sponsor, check "Yes". Then complete the appropriate boxes to indicate the type of support and whether the payment went to you, or to your institution, or both.

3

Relevant financial activities outside the submitted work

This section asks about your financial relationships with entities in the bio-medical arena that could be perceived to influence, or that give the appearance of potentially influencing, what you wrote in the submitted work.

You should

disclose interactions with ANY entity that could be considered broadly

provide details of any financial relationships or activities that are relevant to the

work. For example, if your article is about testing an epidermal growth factor receptor (EGFR) antagonist in lung cancer, you should report all associations with entities pursuing diagnostic or therapeutic strategies in cancer in general, not just in the area of EGFR or lung cancer

review. Financial interests are considered relevant if the payment comes from a commercial organization that has a financial interest in the topic of the Cochrane Library content. This means that the commercial organization has developed (or is known to be developing), or distributed (anywhere in the world), an intervention or potential comparator related to the topic of the review.

Report all sources of revenue paid (or promised to be paid) directly to you or your institution on your behalf over the 36 months prior to submission of the work. This should include all monies from sources with relevance to the submitted work, not just monies from the entity that sponsored the research.

Please note that your interactions with the work's sponsor that are outside the submitted work should also be listed here. If there is any question, it is usually better to disclose a relationship than not to do so.

For grants you have received for work outside the submitted work, you should disclose support ONLY from entities that could be perceived to be affected financially by the published work, such as drug companies, or foundations supported by entities that could be perceived to have a financial stake in the outcome. Public funding sources, such as government agencies, charitable foundations or academic institutions, need not be disclosed. For example, if a government agency sponsored a study in which you have been involved and drugs were provided by a pharmaceutical company, you need only list the pharmaceutical company.

4

Other relationships

Use this section to report other relationships or activities that readers could perceive to have influenced, or that give the appearance of potentially influencing, what you wrote in the submitted work.

5

Declarations of interest statement

Use this section to write your declarations of interest statement for inclusion in the review.

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All potentially important conflicts (as described in the paragraphs above) should be referred to the Funding Arbiter Research Integrity Editors and CoI Panel unless it is clear that the conflicts prohibit the author or team from further involvement (e.g. the author is directly employed by a commercial organisation with an interest in the intervention or holds a patent relating to the intervention) or that the conflicts do not prohibit the author or team from further involvement (e.g., employment in a relevant clinical speciality).

For conflicts other than those related to direct employment, review funding and the holding of patents, there must be a majority of non-conflicted authors authors (>50%) for any particular review and the lead (first) author must have no conflicts. For example, if two authors in a review team have received travel grants from a commercial interest, there must be at least three other non-conflicted authors and the lead (first) author must have no conflicts.

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Individuals who are employed by a company that has a real or potential financial interest in the outcome of the Cochrane Review (including but not limited to drug companies or medical device manufacturers), or who hold or have applied for a patent related to the Cochrane Review are prohibited from being Cochrane Review authors. In most cases, employment would be characterised by the affiliation statement made by the author at the title registration, protocol, or review stage of the Cochrane Review. Any questions about what constitutes "employment by a company with a financial interest” should be referred to the Funding ArbiterResearch Integrity Editors and CoI Panel.

Health professionals might wish to evaluate an element of their practice. Any such employment should be declared. This does not prevent someone from being a review author and if this declared conflict is in isolation such an individual is counted as non-conflicted from the perspective of the need to have a majority of non-conflicted authors. Please note that this does not apply to the situation of someone who is evaluating a practice that they have been responsible for developing, or who has a specific commercial interest in disseminating this intervention to other practitioners.

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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 Cochrane Review, but who are not covered by the restriction above may need review by the Funding Arbiter panelResearch Integrity Editors and CoI Panel. 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 provided that a majority (>50%) of the review authors and lead author have no relevant conflicts of interests, it may be possible for an author who has a declared interest as listed in the previous sentence to be a Cochrane Review author. If there is any doubt, a referral should be made to the Research Integrity Editors and CoI Panel using the referral form.

2.2.4. Cochrane Review author also an author on a study listed in the review

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