Declarations of interest and the removal of the public funding exemption

Not all journals use the term ‘conflicts of interest’ as a part of disclosure. Other perhaps broader terms including ‘disclosure summary’ or ‘declarations of interest’ have also been used. Such terms may not automatically carry the negative connotation associated with ‘conflicts’ and hence invite more complete disclosure.

In our ‘Instructions for Authors’ for Climacteric, in the section ‘Declaration of interest’, we state our intention to adhere in principle to the Conflict of Interest policy recommended by the International Committee of Medical Journal Editors (ICMJE)¹. The ICMJE has stated ‘A conflict of interest exists when professional judgment concerning a primary interest (such as patients’ welfare or the validity of research) may be influenced by a secondary interest (such as financial gain). Perceptions of conflict of interest are as important as actual conflicts of interest’². Additionally, they stated ‘Financial relationships (such as employment, consultancies, stock ownership or options, honoraria, patents, and paid expert testimony) are the most easily identifiable conflicts of interest and the most likely to undermine the credibility of the journal, the authors, and of science itself. However, conflicts can occur for other reasons, such as personal relationships or rivalries, academic competition, and intellectual beliefs’². ‘Climacteric – The Journal of The International Menopause Society’ is one of the journals listed on the ICMJE website as following the ICMJE recommendations.

‘The ICMJE (previously known as the Vancouver Group) is not an open membership organization. It is a small working group of general medical journals’³. Currently, the ICMJE membership consists of 11 journals, as well as The US National Library of Medicine and the World Association of Medical Editors⁴.

The ICMJE Form for Disclosure of Potential Conflicts of Interest in section 2 addresses ‘The work under consideration for publication’ and, in section 3, ‘Relevant financial activities outside the submitted work’. Section 3 states ‘You should disclose interactions with ANY entity that could be considered broadly relevant to the work … 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 … 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’⁵.

This editorial proposes that the exemption granted to the reporting of public funding sources of relevant financial activities outside the submitted work is not appropriate and should be deleted. As noted previously, governments have become the largest third-party payers for health care in many countries and hence the potential for conflict of interest between government-funded research and researchers, editors and peer reviewers⁶. Additionally, long-term funding from any source can affect relationships or rivalries, academic competition, and intellectual beliefs. In many cases, individuals and institutions have received funding from government institutions for many years, for instance the Women’s Health Initiative (WHI) funded by the US National Institutes of Health. Just one example of the issue created was demonstrated in a response to a recent editorial on conflicts of interest in government-funded studies, the authors (who were WHI investigators) reported no conflict of interest⁷. This was allowed by the exemption granted to the reporting of public funding sources on the ICMJE disclosure form. Yet, as noted by another author, ‘An immediate concern is that they state they have no conflicts of interest, yet both are WHI investigators, which must count as a conflict of interest for a number of reasons…’⁸.

If we are to truly address the issue of conflicts of interest in scientific research and publications, all sources of potential conflicts should be treated equally and the ICMJE disclosure form should be revised. Additionally, the ICMJE should consider the use of a term such as ‘declarations of interest’ to encourage more complete disclosure.

Conflict of interest

Dr Pickar has received consultant fees from Pfizer, Shionogi, Radius Health, and TherapeuticsMD; and has stock options with TherapeuticsMD.

Source of funding

Nil.