Uniform COI Disclosure Policy for Journal Submissions

The Chronicle of Higher Education draws attention to a CSPI initiative urging journal editors to adopt a shared uniform policy on disclosure of financial and other potential sources of conflict of interest. I was pleased to see that CSPI (Center for Science in the Public Interest) engaged journal editors (Barnett Kramer, JNCI; Thomas Babor, Addiction; Wendy Cowles Husser, J Am College Surgeons) and bioethicists (Arthur Caplan and Jonathan Moreno, both from UPenn) in preparing A Common Standard for Conflict of Interest Disclosure. On the other hand, they don’t break new ground with this effort.

They frame the problem as being one in which different journals have different rules, some not especially clear, which leaves authors unsure of what each journal requires or whether their own potential conflicts are relevant for a specific manuscript. If all journals required the same blanket disclosure, authors wouldn’t have to think about which relationships were important to disclose to which journal at what time point. This sort of gets back to Dr. Rubenfeld’s suggestion in The Lancet for a Conflict Vitae, but does not address the failure of such disclosure to resolve the underlying problems (perhaps even paradoxically compounding the influence of the competing interest).

The CSPI model recommends disclosure for the prior 3 years of:

“any financial relationship of any size from … any kind of employment, grant funding, consulting, travel, or paid testimony, as well as patents, stock ownership, or membership on private sector or other advisory boards. In addition to relationships with companies, authors should disclose ties to nonprofit organizations that receive 50 percent or more of their funding from corporate sources.”

The inspiration for this last recommendation comes from the lung CT investigators at Cornell, whose tobacco industry funding was, as reported by the NYT and discussed in the JNCI (among many other journals), laundered through the Foundation for Lung Cancer Detection, Prevention and Treatment. Of course, why stop there? Why not also have the investigator disclose the type of funding mechanism involved, in case this happens to be a research services agreement that conveys power to the sponsor to select which data can be published?

As with Nature’s current policy, the CSPI approach does not require listing exact dollar amounts. This makes sense since even seemingly token levels of support can be influential (look at movement away from free pens and pizza from pharma). Although the potential undue influence of patents and licensing income can come into play at the most basic level of research, the public understands pretty quickly that clinical researchers who receive millions of dollars might be influenced with regard to recommending that company’s drugs. Indeed, the Prescription Project recently reported that 64% of Americans want to know about their physicians’ financial ties to the pharmaceutical industry.

Getting back to the CSPI document, more intriguing, perhaps, are the recommendations for disclosing non-financial conflicts of interest:

“Authors may have strongly-held views about the article being submitted for publication. Authors should consider disclosing and editors may choose to print any affiliations or expressions of these views that may be relevant. These may be personal, political, or intellectual and may include any expression of strongly held views relevant to the subject of the submission. Such disclosures may be original, or they make reference to opinions previously expressed in books or monographs, op-eds or public comments, or to sworn testimony before or lobbying of legislators or legislative bodies. Disclosable non-financial conflicts of interest would also include membership or affiliation with non-governmental organizations that have an interest in the submission.”

Looking around the blogosphere, some of these disclosures could constitute a separate manuscript.

The white paper also devotes some attention to the need for and hows of disclosure on the part of editors and reviewers as well as suggestions for enforcement options (e.g., no manuscripts accepted for review for 3 years) when authors fail to disclose all their financial ties, which are subsequently discovered through whistleblowing or other means. Authors would like to be sure, for example, that journal editors do not have financially inspired bias for or against certain articles. The case of the NEJM reviewer who sent a damaging manuscript in advance of publication to the affected company (GSK) suggests that more safeguards are needed to prevent peers from using what they learn through reviewing manuscripts to protect (or enhance) their stock portfolio is important as well.

Obviously, this is not new territory in the scientific publishing world. The Council of Science Editors weighs in on this matter in their White Paper on Promoting Integrity in Scientific Journal Publications, as does the International Committee of Medical Journal Editors in their Uniform Requirements for Manuscripts Submitted to Biomedical Journals. Similarly, AAMC (including a Feb 2008 joint report with AAU), FASEB, AAHRPP, and IOM, to name a few, all have their own COI toolkits and reports.

These groups provide guidance for their constituencies rather than attempt to set uniform disclosure requirements, though, so perhaps the CSPI effort is the next logical step. Perhaps, too, it makes sense that the most effective gate at which to catch undue influence due to financial or other conflicts is at the point when the completed project is put forth for public scrutiny, especially if the authors must submit a comprehensive blanket disclosure versus what they judge to be relevant to that particular manuscript (e.g., a conflict no longer apparent, possibly due to habituation to the source or sponsor of the conflict, to an author may be readily apparent to an editor). In any case, I’m sure we’ll be hearing plenty more on this score from many sources.

1 Comment »

  1. BB said

    Would be interesting to look for pubs from VCU and see how the obvious COI is handled.

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