Conflicts of interest and the ICMJE disclosure form

Several years ago, an editorial appeared in Climacteric that addressed the issue of conflicts of interest (COI) in government-funded studies¹. A COI has been said to occur ‘when an individual’s personal interests are in conflict with their professional obligations’². As noted in the editorial, ‘A great part of the discussion has focused on potential relationships between researchers, editors and peer reviewers with industry.’ More recently, the relationships with third-party health-care payers have become of concern when addressing COI. Governments have become one of the largest third-party payers in many countries. Additionally, governments can be a major source of funding for biomedical research and may support some individuals for many years. The editorial further stated that this has ‘created many speaking opportunities and publications, and created a favorable environment for academic promotion. This is not unreasonable but simply deserving of the same consideration as the relationship between researchers and industry.’ The World Association of Medical Editors has indicated that, in addition to industry, ‘Competing interest can be associated with other sources of research funding including government agencies, charities (not-for-profit organizations), and professional and civic organizations, which also have agendas that may be congruent or at odds with research findings’³. How often have there been publications by authors who have received government funding in which no COIs were disclosed or disclosure included only industry sources of funding?

A second editorial in Climacteric a couple of years later addressed the declaration of interest and the removal of the public funding exemption from COI reporting⁴. That editorial notes that Climacteric is one of the journals listed on the website of the International Committee of Medical Journal Editors (ICMJE) as following the ICMJE recommendations. Additionally, in the ‘Instructions for authors’ for Climacteric, in the ‘Disclosure statement’ section, it states that authors are required to upload a completed ICMJE COI form with their manuscript files⁵. Many other medical journals also utilize this form when manuscripts are submitted for publication.

‘The ICMJE is a small working group of general medical journal editors.’ Presently, members of the ICMJE are 14 medical journals, the US National Library of Medicine and the World Association of Medical Editors. It is not an open membership organization⁶. Currently, there exists a public funding exemption on the ICMJE COI form. Under Instructions (section 3), ‘Relevant financial activities outside the submitted work’, the current document states ‘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.’

The editorial proposed that the public funding exemption be removed from the form, again noting that governments have become the largest third-party payers for health care in many countries and that long-term funding from any source can potentially result in COI. It concluded, ‘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.’

Most recently, at the 16th World Congress on Menopause, held in Vancouver in 2018, a lecture on the ethical reporting of data also addressed the concerns related to the public funding exemption on the COI form provided by the ICMJE⁷. Although it may have at one time been appropriate, it is now time for this exemption to be removed from the Instructions and from the ICMJE COI form. Many present felt this exemption should be removed from all COI forms used in medical publishing. Indeed, although Climacteric follows the ICMJE recommendations, the Climacteric ‘Instruction for authors, Disclosure statement’ section states, ‘All sources of funding, including government and non-government organizations and charitable bodies, should be declared.’ At the Congress, the Editor, Associate Editors, and the Editorial Board of Climacteric supported an effort to seek to work with the ICMJE to remove the exemption. The Executive Director of the North American Menopause Society (NAMS), the NAMS Executive Board and the Editor of Menopause also agreed to support this effort. A joint letter requesting this change to the ICMJE’s COI form was emailed to the ICMJE last summer and, on February 16th, we were notified by the ICMJE that they had agreed to the changes. They did note, however, that, due to technical issues involved in changing the form and the associated investment, there would be a delay in implementing the change. We will continue to follow the progress in ultimately having the changes to the ICMJE’s form implemented. We thank NAMS and the ICMJE for their support of this proposal.

几年前, 《更年期》杂志发表了一篇编者按, 讨论了政府资助研究中的利益冲突（COI）问题。COI被认为是“当个人的个人利益与他们的职业义务相冲突时”发生的。正如编者按中所指出的, “讨论的很大一部分集中在研究人员、编辑和同行审稿人与行业之间的潜在关系上。”最近, 在处理COI问题时, 与第三方医疗保健支付者的关系已成为人们关注的焦点。在许多国家, 政府已成为最大的第三方支付方之一。此外, 政府可以成为生物医学研究的主要资金来源, 并可能多年来支持一些个人。这篇编者按进一步指出, 这创造了许多话语权和出版物, 并为学术推广创造了良好的环境。这并不是不合理的, 而是与研究人员与产业之间的关系同样值得考虑。世界医学编辑协会(World Association of Medical Editors)指出, 除了行业之外, “相互竞争的利益可能与其他研究经费来源有关, 包括政府机构、慈善机构(非营利组织)、专业和民间组织, 这些组织的议程也可能与研究结果一致或不一致”。作者的出版物获得了政府资助, 但没有披露COIs, 或只披露了行业资金来源, 这种情况又有多频繁?

几年后, 《更年期》杂志发表了第二篇编者按, 讨论了利益声明和从COI报表中取消公共资金豁免的问题。这篇编者按指出《更年期》是国际医学期刊编辑委员会(ICMJE)网站上列出的遵循ICMJE建议的期刊之一。此外, 在《更年期》的“作者须知”中, 在“披露声明”部分, 规定, 作者必须上传一个完整的ICMJE COI表格与他们的手稿文件。许多其他医学期刊在投稿出版时也使用这种形式。

ICMJE是一个由普通医学杂志编辑组成的小型工作组。目前, ICMJE的成员包括14家医学期刊、美国国家医学图书馆和世界医学编辑协会。它不是一个开放的会员组织。目前, ICMJE COI表格有公共资金豁免。根据指示(第3条), “提交工作之外的相关财务活动”, 目前的文件规定“公共资金来源, 如政府机构、慈善基金会或学术机构, 无需披露。”例如, 如果一个政府机构资助了一项研究, 你参与了这项研究, 而药物是由一家制药公司提供的, 你只需要列出这家制药公司就可以了。

这篇编者按建议将公共资金豁免从表格中删除, 并再次指出, 在许多国家, 政府已成为医疗保健的最大第三方支付者, 任何来源的长期资金都可能导致COI。报告的结论是, “如果我们要真正解决科研和出版物中的利益冲突问题, 就应该平等对待所有潜在冲突的来源, 并修订ICMJE利益声明表。”

最近, 在2018年于温哥华举行的第16届世界更年期大会上, 一场关于数据伦理报告的讲座也谈到了ICMJE提供的COI表格中有关公共资金豁免的问题。虽然它可能曾经是适当的, 现在是时候从指令和ICMJE COI表格中删除这种豁免。许多与会者认为, 这种豁免应该从所有用于医学出版的COI表格中删除。的确, 尽管《更年期》遵循了ICMJE的建议, 但《更年期》中“作者须知、利益声明”一节指出, “所有资金来源, 包括政府和非政府组织以及慈善机构, 都应予以公布。在大会上, 《更年期》杂志的编辑、副编辑和编辑委员会支持为了寻求与ICMJE合作以取消这一豁免而努力。北美更年期协会(NAMS)执行主任、NAMS执行委员会和更年期杂志编辑也同意支持这一努力。去年夏天, 通过电子邮件向ICMJE发出了一封联合信函, 要求对ICMJE的COI表单进行更改。2月16日, ICMJE通知我们, 他们已经同意更改。但是, 他们确实注意到, 由于改变表格和有关的投资涉及的技术问题, 在执行改变时将会有拖延。我们将继续关注最终实现对ICMJE表单的更改的进展。我们感谢NAMS和ICMJE对这一建议的支持。

Potential conflict of interest

Dr Pickar has received consultant fees and has stock options with TherapeuticsMD.

Additional information

Funding

Nil.