Intended for healthcare professionals

  1. Quinn Grundy, assistant professor1 2,
  2. Adam G Dunn, associate professor3 4,
  3. Lisa Bero, professor2
  1. 1Lawrence S Bloomberg Faculty of Nursing, University of Toronto, Toronto, Ontario, Canada
  2. 2Charles Perkins Centre, School of Pharmacy, University of Sydney, Sydney, New South Wales, Australia
  3. 3Centre for Health Informatics, Australian Institute of Health Innovation, Macquarie University, Sydney, NSW, Australia
  4. 4Discipline of Biomedical Informatics and Digital Health, School of Medical Sciences, Faculty of Medicine and Health, The University of Sydney, Sydney, New South Wales, Australia
  1. Correspondence to: Q Grundy quinn.grundy{at}utoronto.ca
    or @QuinnGrundy on Twitter

Enforced, structured reporting and processes to assess relevance are required to make conflict of interest disclosures fit for purpose, argue Quinn Grundy, Adam Dunn, and Lisa Bero

Transparency of financial interests is expected in medical research, but our ability to assess bias is limited because disclosures are incomplete, inconsistent, and difficult to access at scale. True transparency involves more than just making conflict of interest disclosures available; they also need to be accessible, accurate, complete, and clear about relevance. There have been several calls for standardising the reporting of conflict of interests12 since the Institute of Medicine first recommended it 10 years ago.3 The International Committee of Medical Journal Editors (ICMJE) and Committee on Publication Ethics (COPE) recommend that journal editors require published statements declaring authors’ conflicts of interest.45

Despite the apparent policy consensus, disclosure practices are plagued by recurring problems with non-disclosure and inconsistent reporting. The result is that the policy conversation is fixated on the shortcomings of the disclosure system rather than on how to deal with relationships that threaten research integrity. The ICMJE is consulting on updating its declaration form to improve transparency, completeness, and consistency of disclosures. We also need to enforce accessible, accurate reporting and develop processes to assess relevance so that we can move the debate forward, from being about greater transparency to being about greater independence from commercial influence.

Trouble with existing declarations

In our study of the prevalence of conflict of interest disclosures in a random sample of 1002 biomedical articles, authors disclosed a conflict of interest in 23% of articles and said they had no conflict in 64%; 14% of articles did not include a disclosure statement.6 Though the included journals stated that they follow ICMJE recommendations, we found it hard to arrive at these figures because disclosure statements were often inaccessible, inconsistent, or missing key information necessary to judge relevance.

Poor accessibility

Most articles contain conflict of interest statements in the online and PDF version. In others, however, the statements are only available online, as supplementary files, or on separate web pages, or are unavailable because links to disclosure statements are broken or missing. Some journals provide links to a PDF of the authors’ uploaded ICMJE forms instead of providing complete summaries and some include only the links with no disclosure in the article at all. The longest supplementary PDF we found totalled 94 pages (for 31 authors).7 Occasionally, articles have more than one conflict of interest disclosure statement published in different locations, and these statements may be inconsistent.89

Inconsistency

Journals use diverse headings to identify conflict of interest statements (box 1), suggesting that they have not implemented a clear and consistent definition. This makes it challenging to automate extraction of disclosures for analysis, even from well structured web pages. Since March 2017, some publishers have included conflicts of interest in the metadata used by PubMed.10 This could be a way to improve accessibility by centralising where disclosures are recorded.

Box 1

Headings and keywords that journals use to indicate conflict of interest statements

  • Acknowledgments

  • COI

  • Commercial relationships

  • Competing interests

  • Competing conflict of interest

  • Conflict of interest

  • Declaration of interest

  • Disclosures

  • Disclosure statement

  • Duality of interest

  • Financial conflict of interest

  • Financial interest

  • Potential conflict of interest

  • Proprietary or commercial interest

  • Receipt of benefits

  • Sources of funding

RETURN TO TEXT

Conflict of interest statements are often conflated with statements about the funding of the research presented, making it difficult to assess individual authors’ conflicts of interest and study sponsorship separately. We argue that these disclosures should be reported separately because some evidence suggests that funding source and author conflict of interest are independently associated with risk of bias,1112 though the likelihood of confounding is high.13

When conflict of interest disclosures are identified, substantial variability in the language used to make disclosures makes it difficult to interpret the meaning. We identified 130 different ways of stating “no conflicts of interest” across the 637 articles whose authors declared no conflict of interest,6 ranging from one word (“nil” or “none”) to a 62 word statement:

“The authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties. No writing assistance was utilized in the production of this manuscript.”

Some of the variants change the meaning of the statement, suggesting that conflicts of interest might exist but are not disclosed (table 1).

Table 1

Categories of statements indicating no conflict of interest

View this table:

Missing information

Compounding the problems of accessibility and semantics is the problem of relevance and who should judge this. Current reporting practices rely on authors to judge the relevance of any interests to the work under consideration, though journal policies and procedures and editorial discretion may also influence what gets reported. For example, the ICMJE form asks authors to “disclose interactions with any entity that could be considered broadly relevant to the work.”

Journal editors, peer reviewers, and readers should be able to judge the relevance of disclosed interests to the work to evaluate whether a conflict of interest exists. However, the necessary contextual information is typically lacking in statements and forms. The result is that although conflict of interest disclosure is widespread, disclosures are not meaningful.

Obfuscation

Authors sometimes seek to define relevance in disclosure statements using adjectives such as “potential,” “relevant,” and “financial” to modify “conflict of interest” or contextualising statements by stating that disclosures pertained to “this work” or “this manuscript.” In some cases, authors disclose seemingly relevant financial ties but make statements that obfuscate whether the disclosed relationship constitutes a conflict of interest.9 For example, in an angiography clinical trial, the authors reported receiving speakers’ fees and unrestricted grants from multiple medical device manufacturers with related products under the heading “Sources of funding” but included nothing under “Disclosures.”14

In other cases, authors provide disclosures that include personal and professional biographical information, funding information that should be in another section of the article, or ambiguous descriptors that may obscure key signals of risk of bias such as financial relationships with industry. For example, one article with 17 authors had a 706 word disclosure statement that was located only in the 63 pages of supplementary ICMJE forms; it included numerous conflicts of interest, as defined by the ICMJE, among disclosures of receipt of public funding and honorariums from not-for-profit organisations (eg, public universities, hospitals); one of the authors disclosed receipt of personal fees from 42 bodies outside of the submitted work, including 23 drug and medical device companies.15 Designations such as “unpaid consultancy” may mask the nature of the relationship with industry and fail to make transparent other transfers of value such as paid travel.16

What should happen next?

To strengthen transparency while minimising burden on authors and editors, the biomedical research community should develop a public, comprehensive, structured, author centric database of financial interests.2317 The Institute of Medicine has proposed a detailed taxonomy for conflicts of interest,17 which could serve as a standardised digital template for disclosure while providing adequate detail about the nature of the relationship or interest.

Table 2 sets our recommendations to help authors, editors, and peer reviewers identify, evaluate, and report conflicts of interest, drawing from the work of the ICMJE,4 Institute of Medicine,1 and the US Open Payments system.18

Table 2

Policy recommendations for identification, evaluation, and reporting of conflicts of interest and how they compare with ICMJE recommendations

View this table:

The Open Payments database, created through the US Physicians Payments Sunshine Act, is a notable model in achieving transparency, though it applies only to prescribing clinicians and certain manufacturers in the US. Access to these detailed, accurate, structured data has enabled researchers to understand the extent and the impact of physicians’ relationships with drug and device companies.192021 The success of the Open Payments database argues for other countries to establish their own open payment databases and for any registry to be publicly funded and coupled with enforcement mechanisms.

ORCID would be well placed to act as a repository for information on conflict of interests given its international scope and strong uptake among biomedical journals. ORCID is a not-for-profit organisation, funded through member contributions, that provides researchers with a unique, persistent digital identifier and infrastructure to support automated linkages across their professional activities.22 With leadership from organisations such as ICMJE and COPE, the manuscript submission software used by journals could, for example, include an interface to allow authors to automatically export relevant disclosures from a registry such as ORCID.2

Enforcement

The variability in how conflicts of interest are reported is probably related to journals having differing requirements for statements rather than a consequence of author intentions. Currently, the onus is on authors to disclose, which makes a breach of this honour system a serious violation of trust. Journal editors often do not have the information or resources needed to identify or verify authors’ conflicts of interest.23 The ICMJE recently revised its policy to include purposeful non-disclosure of conflicts of interest as a form of scientific misconduct.4

However, 14% of articles published in journals claiming to adhere to the ICMJE recommendations still do not routinely include conflict of interest statements.6 ICMJE has limited ability to enforce its guidance but, at minimum, organisations such as COPE should not permit membership to journals that do not conform to these standards.

Assessment of relevance

Though the ICMJE recommends that authors report details on the funding source and the specific role of the sponsor in the design, conduct, and publication of the research, there is no equivalent requirement for authors to provide such structured detail in their declarations of conflicts of interest.4 For example, when an author discloses personal fees from multiple entities, there is rarely information about the scope or extent of the relationships, how the scientific work relates to a company’s products, or the specific reason for the receipt of payment.

We propose that authors make use of public databases, where these exist, to report and maintain a structured and comprehensive list of their disclosures, and that these complete disclosures are made publicly available through a link in the article. Separately, we suggest that authors state which interests are relevant to the manuscript and why, that this statement is peer reviewed and adjudicated by editors and is visibly and succinctly included in all forms of the manuscript under the standard heading “conflicts of interest.” Box 2 provides a sample statement.

Box 2

Sample conflict of interest disclosure statement including relevance

Conflicts of interest: DD holds a leadership position in an advocacy organisation (National Sexual Health Association) and is a clinical specialist, deriving income from diagnosing and treating sexual health conditions. DD is engaged as a consultant (BioX Company) and receives research funding from companies (GlaxoSmithKline and Merck). The intervention tested in this study is made by BioX, and all of the companies mentioned above market vaccines related to sexual health. DD holds a patent for a diagnostic test for tuberculosis, unrelated to this study.

[Link to full disclosure statement]

RETURN TO TEXT

Enforced and structured reporting of conflicts of interest would enable large scale retrospective studies of the association between conflicts of interest and research methods, results, and conclusions. Future work should also consider randomised trials of structured reporting systems to assess author, editor, peer reviewer, and consumer usability and acceptability, and the effect on assessment of risk of bias in published work.

Conflict of interest disclosures should help us to evaluate risk of bias in biomedical research, but currently they only muddy the waters. Instead of providing an obvious and clear signal to readers of biomedical research, current practices obfuscate the underlying relationships or flood the signal with noise. To improve consistency, and as a necessary step towards achieving greater independence for healthcare research, we need consensus around the definition of conflict of interest and harmonisation of practices across journals and publishers.

Key messages

  • Disclosures of conflicts of interest in published biomedical articles vary widely in terms of location, format, wording, and content

  • Inconsistency creates problems with accessibility, semantics, and assessment of relevance

  • To assess research integrity, disclosures must be accessible, complete, accurate, and meaningful

  • A central database and standardised reporting are needed to improve transparency

Footnotes

  • Contributors and sources: The authors conduct qualitative and quantitative meta-research related to bias and conflicts of interest in biomedical research. All authors contributed to the planning, writing, and editing of this article. QG conducted the descriptive analyses of conflict of interest reporting and is the guarantor.

  • Competing interests: We have read and understood BMJ policy on declaration of interests and declare support from the Canadian Institutes of Health Research and National Health and Medical Research Council.

  • Provenance and peer review: Not commissioned; externally peer reviewed.

  • This article is part of a collection on commercial interests, transparency, and independence, based on ideas generated by BMJ editors in collaboration with external advisers Ray Moynihan (Bond University) and Lisa Bero (University of Sydney).

References

View Abstract