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Croat Med J. 2010 August; 51(4): 285–286.
PMCID: PMC2931431

Uniform ICMJE Conflict of Interest Declaration Form: Report of Test Use in Croatian Medical Journal in 2009-2010

The International Committee of Medical Journal Editors (ICMJE), of which the Croatian Medical Journal (CMJ) is a member journal, published the revised uniform conflict of interest declaration form on July 1, 2010 (1). ICMJE journals used the test version of the form during the last year, after the publication of its initial statement on the new form for declaring conflict of interest (2). The form was made available for the public use since October 2009 (2). The main purpose of the uniform declaration statement was to simplify and standardize reporting on conflicts of interest in the biomedical research community but also to make important information accessible to the wider readership. The uniform declaration form of the ICMJE came in the middle of the debate in the United States (US) about the need for the transparency in the relationships between physicians and industry. The debate resulted in the Physician Payment Sunshine Act (3), which will come into effect in the US in 2013. This act would require yearly reporting of all physician payments over a cumulative value of US $100 and the statement would be available to the public.

To provide the evidence for the revision of the declaration form and set the baseline data for future follow-up, we present our experience with the use of the new uniform conflict disclosure obtained from authors of manuscripts who were selected to fill out the ICMJE form (264 contributors for 67 manuscripts submitted from November 18, 2009 to June 30, 2010).

A conflict of interest was rarely reported – the total number of such declarations was 37 (14%), regardless of the type of conflict. A conflict of interest as money paid to the author was declared by 15 (5.5%) authors (Table 1). This money was declared as a grant, consulting fee, travel support, payment for writing/reviewing, or support in writing or chemicals/equipment. Money paid to the institution was declared by 22.3% of the authors (Table 1), mostly in the form of a grant, and less frequently as writing/reviewing activities, consulting fees, or travel support. In the section of support provided as writing, medicines or equipment, the authors listed computer equipment and provision of reagents in several cases. Other types of financial support were stated in 2 cases but no information in the comment section was provided.

Table 1
Conflicts of interest declared by authors (n = 264) for the work under consideration for publication with the examples of declared conflict as stated in the form

In one case, the text from the example form from the ICMJE Web site (Sample ICMJE Uniform Disclosure Form for Potential Conflicts of Interest, available at http://www.icmje.org/sample_disclosure.pdf) was sent to us. This may be due to the confusion of authors who are not native speakers of English, and who probably mistook the example form for the official form available for download. This could be avoided by providing the example form as a protected document that cannot be modified. The ICMJE is currently developing a glossary of terms used in the declaration form, which will be translated in main languages and will hopefully make the use of the form easier for non-English-speaking authors.

The declared funding for the work related to the submitted manuscript (Section 2 of the form) came mostly from public sources, such as ministries of science or non-profit organizations (Table 2). Only a small percentage of authors declared funding by industry (1.1%) or university (0.7%).

Table 2
Entity categories and purposes of funding of work related to the submitted manuscript from authors submitting conflict of interest declaration form (n = 264)

Other relevant financial relationships outside the submitted work (Section 3 of the form) were reported by a small fraction of authors, for the following categories: board memberships paid to the institution, honoraria, and covering of travel/accommodation expenses (Table 3). Other categories listed in this section were not declared.

Table 3
Information about relevant financial relationship outside the submitted work*

Financial relationships involving spouses/partners/children (Section 4 of the form) and nonfinancial relationships (Section 5 of the form) were not declared by any author.

We observed some misunderstandings in filling out the form, again possibly due to the lack of familiarity with the specific English terminology. For example, several authors reported grant/project funding by a ministry or similar institution as personal payments. We hope that the coming ICMJE glossary and its translations will help the authors not only to fill in the form but to learn more about the principles of declaring conflict of interest and its different categories. We also plan to help our authors by reviewing the submitted forms and clarifying any misunderstanding in direct communication with the authors.

We kindly invite our authors to continue providing their comments and suggestions for the further improvement of the declaration form. From July 1, 2010, filling out of the form is obligatory for all submitted manuscripts. We will continue the follow-up and analysis in declaring potential conflicts of interest of our contributors, as a part of our standard publishing policy and active participation in promoting transparency in association of biomedical researchers and funding entities.

References

1. Drazen JM, de Leeuw PW, Laine C, Mulrow C, Deangelis CD, Frizelle FA, et al. Toward more uniform conflict disclosures: the updated ICMJE conflict of interest reporting form. Croat Med J. 2010;51:288–9. [PMC free article] [PubMed]
2. Drazen JM, Van Der Weyden MB, Sahni P, Rosenberg J, Marusic A, Laine C, et al. Uniform format for disclosure of competing interests in ICMJE journals. Croat Med J. 2009;50:427–8. doi: 10.3325/cmj.2009.50.427. [PMC free article] [PubMed] [Cross Ref]
3. 111th Congress (2009-2010). H.R.3590 Patient Protection and Affordable Care Act (Engrossed Amendment Senate - EAS). SEC. 6002. Transparency reports and reporting of physician ownership or investment interests. Washington DC: The Library of Congress. Available from: http://thomas.loc.gov/cgi-bin/query/z?c111:H.R.3590.eas: Accessed: August 5, 2010.

Articles from Croatian Medical Journal are provided here courtesy of Medicinska Naklada