Declaring Authors’ Financial Conflicts of Interest

Keeping in step with the recent WAME postings regarding conflicts of interest, I would like to pose a question to the listserve. We recently received a manuscript with numerous authors, all of whom have extensive financial and consulting arrangements with the study sponsor (as well as other pharmaceutical companies); one author is even an employee of the study sponsor. Additionally, the lines of separation between the roles and contributions of the authors and study sponsor are very blurry, and the first draft of the paper was written by an employee of the study sponsor. We appreciate that the authors were so forthcoming with their conflicts of interest. However, even though the conflicts are clearly stated, is it enough for the authors to simply declare them? In the absence of an independent author, is it acceptable for individuals to serve as authors when they are intertwined with the study sponsor? Any feedback would be great appreciated.

Monica Helton
Managing Editor, The Journal of Pediatrics

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Thank you for raising the nice problem. I think if authors mention their contribution into original work as specified by the ICMJE in uniform requirements starting from conception and design, acquisition, analysis and interpretation of data, drafting the article or revising it critically for important intellectual content and final approval of the submitted version, then it doesn’t matter whether any conflict exists or not.

Ashraful Alam
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The questions asked are:

Q1.Even though the conflicts are clearly stated, is it enough for the authors to simply declare them?

The answer is that it is necessary they declare them, but not sufficient.

What will make it sufficient? The following:

a.       They must present a review of literature, which balances positive findings of their study with contrary findings in the literature.

b.       Limitations of the study and methodological flaws, if any, must be clearly stated.

c.       Whatever positive findings are presented must be clearly and unambiguously evidenced.

d.       At no stage should the paper appear like a campaign pamphlet for the study sponsor.

e.       Peer reviewers must clearly know the conflict of interest involved, and should themselves be non-conflicted.

Another point mentioned is involvement of an employee of the study sponsor as author. Involvement of an employee of the study sponsor as an author, or involvement of even a medical writer, per se, does not make the paper unsuitable, although strongly suspect. The authors must clearly state the role of each author in the writing and designing/execution of the study, including that of the said employee/medical writer.

Q2. In the absence of an independent author, is it acceptable for individuals to serve as authors when they are intertwined with the study sponsor?

The answer is that there is no reason why it cannot be published provided the fact that no independent author is present is clearly stated in the conflict of interest column, and all due processes mentioned above [a-e] are adhered to.

To sum up:

The key points for an editor to remember are essentially two:

Just because somebody has a conflict of interest does not automatically mean he is ethically compromised, but the potential for such compromise is strong.

Editors must have the critical antennae up whenever they receive such submissions. They need not summarily reject them, but they must be doubly careful all the methods to ensure scientific rigour are scrupulously implemented.

Ajai Singh
Editor, Mens Sana Monographs
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Thanks to Dr Ajai for enlighting a very useful prescription. Think of all the points (a-e) to be requested from authors in case of declaring conflicts. In fact, the only outcome of conflicts (biased findings) to be handled individually.