New ICMJE Recommendations published
21/12/2018The International Committee of Medical Journal Editors (ICMJE) has just updated the Recommendations for the Conduct, Reporting, Editing, and Publication of Scholarly Work in Medical Journals (PDF), formerly known as Uniform Requirements for Manuscripts and followed by hundreds of biomedical journals. The main changes are small but quite meaningful and they include issues regarding:
– conflict of interest and misconduct,
– trial registration date and the “lock box”, and
– patients’ participation in research.
All authors preparing to submit their papers to biomedical journals and all biomedical editors and peer reviewers should be aware of these changes. The ICMJE have very helpfully highlighted the 2018 changes (PDF) within the text of the guideline PDF and we summarise and comment on key changes below.
What are the Recommendations?
The ICMJE Recommendations document is a set of minimum standards for best editorial and ethical practices in biomedical publishing, created in 1978 by a group of editors from a number of major biomedical journals “to help authors, editors, and others involved in peer review and biomedical publishing create and distribute accurate, clear, reproducible, unbiased medical journal articles.” A meeting was held in Vancouver, where a format for bibliographical references, which became known as the “Vancouver style”, was first established and now is adopted by most journals. The recommendations document was originally called the “Uniform Requirements for Manuscripts Submitted to Biomedical Journals”, aimed at authors preparing manuscripts, and it has been updated many times since 1997, including not only basic formatting and references, but many other editorial policies and styles.
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What is changed in this 2018 revision?
Conflicts of interest and misconduct
The document now sets out more clearly issues about conflicts of interest, and states that the purposeful failure to disclose any conflicts of interest is a form of misconduct. It also describes a journal’s responsibility to publish its policy for the evaluation of manuscripts submitted for publication. This includes ensuring that the roles of all individuals involved in peer review are made clear, even non-financial conflicts of interest for those involved in the editorial process should be disclosed.
Why is this important?
By describing as a misconduct the failure to disclose conflicts of interest, this description ceases to be an “additional feature” of a manuscript submission, and pressure is put on editors to require it from authors. This contributes to research transparency, as readers will be able to read the conflicts of interest disclosure (even when there is none to declare) in all papers, not just in some of them.
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Journal metrics
An important item has been added to the Recommendations: “Journal metrics”. The ICMJE clearly recommends that journals’ reduce the emphasis on impact factors as a single measure of a journals’ quality. This is in accordance with the DORA Declaration, which advocates that journal-based metrics should not be used as a surrogate measure of the quality of individual research articles, scientific productivity or as the only journal performance metric. The UK EQUATOR Centre is a signatory of DORA.
Why is this important?
Impact factor is frequently (mis)used as the primary parameter to compare the scientific output of individual researchers and to measure the quality of a journal. However, impact factor has a number of deficiencies, including the fact that the data used to calculate it are not transparent nor publicly available. As there are several other ways to measure scientific output, the adoption of only one by editors and funders is clearly biased.
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Preprint data publication
The increase in the use of preprint databases in the last two decades has prompted ICMJE to publish a position statement about it: according to the new item added to the Recommendations, authors who choose to post their research in preprint servers should preferably use databases that make it clear for the readers that the publications are not peer-reviewed. The authors must also inform the journal, during paper submission, that the work is available in a preprint database. Finally, ICMJE recommends that, after the publication of the peer-reviewed paper in a biomedical journal, the preprints are amended in accordance with the changes made by reviewers, including the final published article. By clearly referencing the previous publication in a preprint database, including the comments and amendments, the authors avoid a breach to the rule regarding duplicate or redundant publication.
Why is this important?
Readers have the right to know if a publication has been peer-reviewed or not, and how. This clear description increases publication transparency.
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Data sharing
The ICMJE now clearly encourages editors to give priority to publishing the work of authors who have shared their data, i.e., crucial data has been made available publicly in data sharing systems. This is particularly important in situations of public health emergency or gene databanks, for which data availability without delay may foster scientific development.
Why is this important?
Shared data allows peers to review the analyses and other researchers to reproduce the studies.
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Trial registration date and the “lock box”
The previous version of the Recommendations already contained the requirement of clinical trial registration at or before the time of the first patient enrolment as a condition for consideration for publication. Now, the revision of the Recommendations also states that the date of the trial registration to be considered should be the day when trial registration materials were first submitted to a registry. This means that the moment that a group of researchers start the registration process (which may take some time) is to be considered by editors as the registration date – and not the end of the process. This is because there may be substantial delay between the beginning of trial registration, when researchers start to send materials to the database, and the final posting at the registry, and editors may enquire of the authors about the reasons for the delay.
Another issue regarding trial registration is the so-called “lock box”. The ClinicalTrials.gov database allows the registration of medical devices to be automatically placed in this “lock box”, in which the registered information is not publicly accessible immediately following registration, but rather it is delayed. ICMJE’s policy now mandates that researchers registering trials of devices must opt-out of this delay and allow public posting prior to the device approval.
Finally, a detail change in the new Recommendations that might go unnoticed is also important to highlight here: the last version had already described, as mandatory, a statement in the trial registration that the participants’ data “will be shared”, but now it adds: “’undecided’ is not an acceptable answer”. This means that researchers registering clinical trials must declare that data will be shared, and that they cannot decide about this later. Rather, they must decide about sharing data during trial registration.
Why is this important?
Delays in registration might be due to changes in methods, outcome definitions and other issues. It is necessary to describe the trial methods clearly to allow transparency in the eventual scientific publication.
The public has the right to know that a medical device is under evaluation for approval, and how the research about the device is being conducted. The lock box keeps information closed to the public.
ICMJE now requires that researchers decide to share or not to share participants’ data very early in the research design, and during trial registration. This adds to the transparency of trial reporting, as the public will be able to require the data to be shared for reproducibility.
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Patients’ participation in research
The previous versions of the Recommendations defined how the study participants should be described in biomedical manuscripts. They also stated that authors should define how they determined race or ethnicity (in the studies where this was relevant) and justify the relevance of reporting results on race and ethnicity. The new Recommendations now ask authors to use “neutral, precise and respectful language” to describe the study participants and their characteristics, and to “avoid the use of terminology that might stigmatize” them.
Why is this important?
The ethical issues of patients’ participation in research is improved: in the open access era, researchers should know that the way they refer to patients may affect patients’ lives and well-being, because scientific literature is now often openly available to everybody to read.
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To access the newly updated ICMJE recommendations please visit: