Description Unauthorized reproduction of this article is prohibited Recommendations for the Conduct, Reporting, Editing, and Publication of

Description

Unauthorized reproduction of this article is prohibited
Recommendations for the Conduct, Reporting, Editing, and
Publication of Scholarly Work in Medical Journals
Updated December 2021
I. About the Recommendations
A. Purpose of the Recommendations
B. Who Should Use the Recommendations?
C. History of the Recommendations
II. Roles and Responsibilities of Authors, Contributors,
Reviewers, Editors, Publishers, and Owners
A. Defining the Role of Authors and Contributors
1. Why Authorship Matters
2. Who Is an Author?
3. Non-Author Contributors
B. Disclosure of Financial and Non-Financial Relationships and Activities, and Conflicts of Interest
1. Participants
a. Authors
b. Peer Reviewers
c. Editors and Journal Staff
2. Reporting Relationships and Activities
C. Responsibilities in the Submission and Peer-Review
Process
1. Authors
a. Predatory or Pseudo-Journals
2. Journals
a. Confidentiality
b. Timeliness
c. Peer Review
d. Integrity
e. Diversity and Inclusion
f. Journal Metrics
3. Peer Reviewers
D. Journal Owners and Editorial Freedom
1. Journal Owners
2. Editorial Freedom
E. Protection of Research Participants
III. Publishing and Editorial Issues Related to Publication
in Medical Journals
A. Corrections, Retractions, Republications, and
Version Control
B. Scientific Misconduct, Expressions of Concern,
and Retraction
C. Copyright
D. Overlapping Publications
1. Duplicate Submission
2. Duplicate and Prior Publication
3. Preprints
a. Choosing a Preprint Archive
b. Submitting Manuscripts That Are in Preprint
Archives to a Peer-Reviewed Journal
c. Referencing Preprints in Submitted Manuscripts
4. Acceptable Secondary Publication
5. Manuscripts Based on the Same Database
E. Correspondence
F. Fees
G. Supplements, Theme Issues, and Special Series
H. Sponsorship and Partnerships
I. Electronic Publishing
J. Advertising
K. Journals and the Media
L. Clinical Trials
1. Registration
2. Data Sharing
IV. Manuscript Preparation and Submission
A. Preparing a Manuscript for Submission to a
Medical Journal
1. General Principles
2. Reporting Guidelines
3. Manuscript Sections
a. Title Page
b. Abstract
c. Introduction
d. Methods
i. Selection and Description of Participants
ii. Technical Information
iii. Statistics
e. Results
f. Discussion
g. References
i. General Considerations
ii. Style and Format
h. Tables
i. Illustrations (Figures)
j. Units of Measurement
k. Abbreviations and Symbols
B. Sending the Manuscript to the Journal
I. ABOUT THE RECOMMENDATIONS
A. Purpose of the Recommendations
ICMJE developed these recommendations to review
best practice and ethical standards in the conduct and
reporting of research and other material published in
medical journals, and to help authors, editors, and others
involved in peer review and biomedical publishing create and distribute accurate, clear, reproducible, unbiased medical journal articles. The recommendations may
also provide useful insights into the medical editing and
publishing process for the media, patients and their families, and general readers.
B. Who Should Use the Recommendations?
These recommendations are intended primarily for
use by authors who might submit their work for publication
to ICMJE member journals. Many non-ICMJE journals voluntarily use these recommendations (see www.icmje.org/
journals-following-the-icmje-recommendations/). The ICMJE
encourages that use but has no authority to monitor or
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enforce it. In all cases, authors should use these recommendations along with individual journals’ instructions to
authors. Authors should also consult guidelines for the
reporting of specific study types (e.g., the CONSORT
guidelines for the reporting of randomized trials); see
www.equator-network.org.
Journals that follow these recommendations are
encouraged to incorporate them into their instructions to
authors and to make explicit in those instructions that
they follow ICMJE recommendations. Journals that wish
to be identified on the ICMJE website as following these
recommendations should notify the ICMJE secretariat at www.
icmje.org/journals-following-the-icmje-recommendations/
journal-listing-request-form/. Journals that in the past have
requested such identification but who no longer follow ICMJE
recommendations should use the same means to request removal from this list.
The ICMJE encourages wide dissemination of these
recommendations and reproduction of this document in
its entirety for educational, not-for-profit purposes without regard for copyright, but all uses of the recommendations and document should direct readers to www.
icmje.org for the official, most recent version, as the
ICMJE updates the recommendations periodically when
new issues arise.
C. History of the Recommendations
The ICMJE has produced multiple editions of this
document, previously known as the Uniform Requirements for Manuscripts Submitted to Biomedical Journals
(URMs). The URM was first published in 1978 as a way of
standardizing manuscript format and preparation across
journals. Over the years, issues in publishing that went
well beyond manuscript preparation arose, resulting in
the development of separate statements, updates to the
document, and its renaming as “Recommendations for
the Conduct, Reporting, Editing, and Publication of
Scholarly Work in Medical Journals” to reflect its broader
scope. Previous versions of the document may be found
in the “Archives” section of www.icmje.org.
II. ROLES AND RESPONSIBILITIES OF AUTHORS,
CONTRIBUTORS, REVIEWERS, EDITORS,
PUBLISHERS, AND OWNERS
A. Defining the Role of Authors and Contributors
1. Why Authorship Matters
Authorship confers credit and has important academic, social, and financial implications. Authorship also
implies responsibility and accountability for published
work. The following recommendations are intended to
ensure that contributors who have made substantive intellectual contributions to a paper are given credit as
authors, but also that contributors credited as authors
understand their role in taking responsibility and being
accountable for what is published.
Because authorship does not communicate what
contributions qualified an individual to be an author,
some journals now request and publish information
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about the contributions of each person named as having
participated in a submitted study, at least for original
research. Editors are strongly encouraged to develop
and implement a contributorship policy. Such policies
remove much of the ambiguity surrounding contributions, but leave unresolved the question of the quantity
and quality of contribution that qualify an individual for
authorship. The ICMJE has thus developed criteria for
authorship that can be used by all journals, including
those that distinguish authors from other contributors.
2. Who Is an Author?
The ICMJE recommends that authorship be based
on the following 4 criteria:
1. Substantial contributions to the conception or design
of the work; or the acquisition, analysis, or interpretation of data for the work; AND
2. Drafting the work or revising it critically for important
intellectual content; AND
3. Final approval of the version to be published; AND
4. Agreement to be accountable for all aspects of the
work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved.
In addition to being accountable for the parts of the
work he or she has done, an author should be able to
identify which co-authors are responsible for specific
other parts of the work. In addition, authors should have
confidence in the integrity of the contributions of their
co-authors.
All those designated as authors should meet all four
criteria for authorship, and all who meet the four criteria
should be identified as authors. Those who do not meet
all four criteria should be acknowledged—see Section II.
A.3 below. These authorship criteria are intended to
reserve the status of authorship for those who deserve
credit and can take responsibility for the work. The criteria are not intended for use as a means to disqualify colleagues from authorship who otherwise meet authorship
criteria by denying them the opportunity to meet criterion #s 2 or 3. Therefore, all individuals who meet the
first criterion should have the opportunity to participate
in the review, drafting, and final approval of the
manuscript.
The individuals who conduct the work are responsible for identifying who meets these criteria and ideally
should do so when planning the work, making modifications as appropriate as the work progresses. We encourage collaboration and co-authorship with colleagues in
the locations where the research is conducted. It is the
collective responsibility of the authors, not the journal to
which the work is submitted, to determine that all people
named as authors meet all four criteria; it is not the role
of journal editors to determine who qualifies or does not
qualify for authorship or to arbitrate authorship conflicts.
If agreement cannot be reached about who qualifies for
authorship, the institution(s) where the work was performed, not the journal editor, should be asked to investigate. The criteria used to determine the order in which
authors are listed on the byline may vary, and are to be
decided collectively by the author group and not by
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editors. If authors request removal or addition of an
author after manuscript submission or publication, journal editors should seek an explanation and signed statement of agreement for the requested change from all
listed authors and from the author to be removed or
added.
The corresponding author is the one individual who
takes primary responsibility for communication with the
journal during the manuscript submission, peer-review,
and publication process. The corresponding author typically ensures that all the journal’s administrative requirements, such as providing details of authorship, ethics
committee approval, clinical trial registration documentation, and disclosures of relationships and activities, are
properly completed and reported, although these duties
may be delegated to one or more co-authors. The corresponding author should be available throughout the
submission and peer-review process to respond to editorial queries in a timely way, and should be available after publication to respond to critiques of the work and
cooperate with any requests from the journal for data or
additional information should questions about the paper
arise after publication. Although the corresponding
author has primary responsibility for correspondence
with the journal, the ICMJE recommends that editors
send copies of all correspondence to all listed authors.
When a large multi-author group has conducted the
work, the group ideally should decide who will be an
author before the work is started and confirm who is an
author before submitting the manuscript for publication.
All members of the group named as authors should
meet all four criteria for authorship, including approval
of the final manuscript, and they should be able to take
public responsibility for the work and should have full
confidence in the accuracy and integrity of the work of
other group authors. They will also be expected as individuals to complete disclosure forms.
Some large multi-author groups designate authorship by a group name, with or without the names of individuals. When submitting a manuscript authored by a
group, the corresponding author should specify the
group name if one exists, and clearly identify the group
members who can take credit and responsibility for the
work as authors. The byline of the article identifies who is
directly responsible for the manuscript, and MEDLINE
lists as authors whichever names appear on the byline. If
the byline includes a group name, MEDLINE will list the
names of individual group members who are authors or
who are collaborators, sometimes called non-author contributors, if there is a note associated with the byline
clearly stating that the individual names are elsewhere in
the paper and whether those names are authors or
collaborators.
3. Non-Author Contributors
Contributors who meet fewer than all 4 of the above
criteria for authorship should not be listed as authors,
but they should be acknowledged. Examples of activities
that alone (without other contributions) do not qualify a
contributor for authorship are acquisition of funding;
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general supervision of a research group or general
administrative support; and writing assistance, technical
editing, language editing, and proofreading. Those
whose contributions do not justify authorship may be
acknowledged individually or together as a group under
a single heading (e.g., “Clinical Investigators” or
“Participating Investigators”), and their contributions
should be specified (e.g., “served as scientific advisors,”
“critically reviewed the study proposal,” “collected data,”
“provided and cared for study patients,” “participated in
writing or technical editing of the manuscript”).
Because acknowledgment may imply endorsement
by acknowledged individuals of a study’s data and conclusions, editors are advised to require that the corresponding author obtain written permission to be
acknowledged from all acknowledged individuals.
B. Disclosure of Financial and Non-Financial
Relationships and Activities, and Conflicts of
Interest
Public trust in the scientific process and the credibility of published articles depend in part on how transparently an author’s relationships and activities, directly or
topically related to a work, are handled during the planning, implementation, writing, peer review, editing, and
publication of scientific work.
The potential for conflict of interest and bias 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.
Individuals may disagree on whether an author’s
relationships or activities represent conflicts. Although
the presence of a relationship or activity does not always
indicate a problematic influence on a paper’s content,
perceptions of conflict may erode trust in science as
much as actual conflicts of interest. Ultimately, readers
must be able to make their own judgments regarding
whether an author’s relationships and activities are pertinent to a paper’s content. These judgments require
transparent disclosures. An author’s complete disclosure
demonstrates a commitment to transparency and helps
to maintain trust in the scientific process.
Financial relationships (such as employment, consultancies, stock ownership or options, honoraria, patents,
and paid expert testimony) are the most easily identifiable, the ones most often judged to represent potential
conflicts of interest and thus the most likely to undermine
the credibility of the journal, the authors, and science
itself. Other interests may also represent or be perceived
as conflicts, such as personal relationships or rivalries,
academic competition, and intellectual beliefs.
Authors should avoid entering into agreements with
study sponsors, both for-profit and nonprofit, that interfere with authors’ access to all of the study’s data or that
interfere with their ability to analyze and interpret the
data and to prepare and publish manuscripts independently when and where they choose. Policies that dictate
where authors may publish their work violate this
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principle of academic freedom. Authors may be required
to provide the journal with the agreements in confidence.
Purposeful failure to report those relationships or
activities specified on the journal’s disclosure form is a
form of misconduct, as is discussed in Section III.B.
1. Participants
All participants in the peer-review and publication process—not only authors but also peer reviewers, editors, and
editorial board members of journals—must consider and
disclose their relationships and activities when fulfilling their
roles in the process of article review and publication.
a. Authors
When authors submit a manuscript of any type or format they are responsible for disclosing all relationships
and activities that might bias or be seen to bias their
work. The ICMJE has developed a Disclosure Form to
facilitate and standardize authors’ disclosures. ICMJE
member journals require that authors use this form, and
ICMJE encourages other journals to adopt it.

Sources of support for the work, including sponsor
names along with explanations of the role of those
sources if any in study design; collection, analysis,
and interpretation of data; writing of the report; any
restrictions regarding the submission of the report
for publication; or a statement declaring that the supporting source had no such involvement or restrictions regarding publication; and
• Whether the authors had access to the study data,
with an explanation of the nature and extent of
access, including whether access is ongoing.
To support the above statements, editors may
request that authors of a study sponsored by a funder
with a proprietary or financial interest in the outcome
sign a statement, such as “I had full access to all of the
data in this study and I take complete responsibility for
the integrity of the data and the accuracy of the data
analysis.”
C. Responsibilities in the Submission and
Peer-Review Process
1. Authors
b. Peer Reviewers
Reviewers should be asked at the time they are
asked to critique a manuscript if they have relationships
or activities that could complicate their review. Reviewers
must disclose to editors any relationships or activities
that could bias their opinions of the manuscript, and
should recuse themselves from reviewing specific manuscripts if the potential for bias exists. Reviewers must not
use knowledge of the work they’re reviewing before its
publication to further their own interests.
c. Editors and Journal Staff
Editors who make final decisions about manuscripts
should recuse themselves from editorial decisions if they
have relationships or activities that pose potential conflicts related to articles under consideration. Other editorial staff members who participate in editorial decisions
must provide editors with a current description of their
relationships and activities (as they might relate to editorial judgments) and recuse themselves from any decisions in which an interest that poses a potential conflict
exists. Editorial staff must not use information gained
through working with manuscripts for private gain.
Editors should regularly publish their own disclosure
statements and those of their journal staff. Guest editors
should follow these same procedures.
Journals should take extra precautions and have a
stated policy for evaluation of manuscripts submitted by
individuals involved in editorial decisions. Further guidance
is available from COPE (
A_Short_Guide_to_Ethical_Editing.pdf) and WAME (http://
wame.org/conflict-of-interest-in-peer-reviewed-medicaljournals).
Authors should abide by all principles of authorship
and declaration of relationships and activities detailed in
Sections II.A and II.B of this document.
a. Predatory or Pseudo-Journals
A growing number of entities are advertising themselves as “scholarly medical journals” yet do not function
as such. These journals (“predatory” or “pseudo-journals”) accept and publish almost all submissions and
charge article processing (or publication) fees, often
informing authors about this after a paper’s acceptance
for publication. They often claim to perform peer review
but do not and may purposefully use names similar to
well-established journals. They may state that they are
members of ICMJE but are not (see www.icmje.org for
current members of the ICMJE) and that they follow the
recommendations of organizations such as the ICMJE,
COPE, and WAME. Researchers must be aware of the existence of such entities and avoid submitting research to
them for publication. Authors have a responsibility to
evaluate the integrity, history, practices, and reputation
of the journals to which they submit manuscripts.
Guidance from various organizations is available to help
identify the characteristics of reputable peer-reviewed
journals (www.wame.org/identifying-predatory-or-pseudojournals and www.wame.org/principles-of-transparencyand-best-practice-in-scholarly-publishing).
Seeking the assistance of scientific mentors, senior
colleagues, and others with many years of scholarly publishing experience may also be helpful.
Authors should avoid citing articles in predatory or
pseudo-journals.
2. Journals
2. Reporting Relationships and Activities
a. Confidentiality
Articles should be published with statements or supporting documents, such as the ICMJE Disclosure Form,
declaring:
• Authors’ relationships and activities; and
Manuscripts submitted to journals are privileged
communications that are authors’ private, confidential
property, and authors may be harmed by premature disclosure of any or all of a manuscript’s details.
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Editors therefore must not share information about
manuscripts, including whether they have been received
and are under review, their content and status in the
review process, criticism by reviewers, and their ultimate
fate, to anyone other than the authors and reviewers.
Requests from third parties to use manuscripts and
reviews for legal proceedings should be politely refused,
and editors should do their best not to provide such confidential material should it be subpoenaed.
Editors must also make clear that reviewers should
keep manuscripts, associated material, and the information they contain strictly confidential. Reviewers and editorial staff members must not publicly discuss the authors’
work, and reviewers must not appropriate authors’ ideas
before the manuscript is published. Reviewers must not
retain the manuscript for their personal use and should
destroy paper copies of manuscripts and delete electronic
copies after submitting their reviews.
When a manuscript is rejected, it is best practice for
journals to delete copies of it from their editorial systems
unless retention is required by local regulations. Journals
that retain copies of rejected manuscripts should disclose this practice in their Information for Authors.
When a manuscript is published, journals should
keep copies of the original submission, reviews, revisions, and correspondence for at least three years and
possibly in perpetuity, depending on local regulations,
to help answer future questions about the work should
they arise.
Editors should not publish or publicize peer reviewers’
comments without permission of the reviewer and author.
If journal policy is to blind authors to reviewer identity and
comments are not signed, that identity must not be
revealed to the author or anyone else without the
reviewers’ expressed written permission.
Confidentiality may have to be breached if dishonesty or fraud is alleged, but editors should notify authors
or reviewers if they intend to do so and confidentiality
must otherwise be honored.
b. Timeliness
Editors should do all they can to ensure timely processing of manuscripts with the resources available to
them. If editors intend to publish a manuscript, they
should attempt to do so in a timely manner and any
planned delays should be negotiated with the authors. If
a journal has no intention of proceeding with a manuscript, editors should endeavor to reject the manuscript
as soon as possible to allow authors to submit to a different journal.
c. Peer Review
Peer review is the critical assessment of manuscripts
submitted to journals by experts who are usually not part
of the editorial staff. Because unbiased, independent,
critical assessment is an intrinsic part of all scholarly
work, including scientific research, peer review is an important extension of the scientific process.
The actual value of peer review is widely debated,
but the process facilitates a fair hearing for a manuscript
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among members of the scientific community. More practically, it helps editors decide which manuscripts are suitable for their journals. Peer review often helps authors
and editors improve the quality of reporting.
It is the responsibility of the journal to ensure that
systems are in place for selection of appropriate
reviewers. It is the responsibility of the editor to ensure
that reviewers have access to all materials that may be
relevant to the evaluation of the manuscript, including
supplementary material for e-only publication, and to
ensure that reviewer comments are properly assessed
and interpreted in the context of their declared relationships and activities.
A peer-reviewed journal is under no obligation to
send submitted manuscripts for review, and under no
obligation to follow reviewer recommendations, favorable or negative. The editor of a journal is ultimately responsible for the selection of all its content, and editorial
decisions may be informed by issues unrelated to the
quality of a manuscript, such as suitability for the journal.
An editor can reject any article at any time before publication, including after acceptance if concerns arise about
the integrity of the work.
Journals may differ in the number and kinds of
manuscripts they send for review, the number and types
of reviewers they seek for each manuscript, whether the
review process is open or blinded, and other aspects of
the review process. For this reason and as a service to
authors, journals should publish a clear, transparent
description of their peer-review process for all types of
manuscripts.
Journals should notify reviewers of the ultimate decision to accept or reject a paper, and should acknowledge the contribution of peer reviewers to their journal.
Editors are encouraged to share reviewers’ comments
with co-reviewers of the same paper, so reviewers can
learn from each other in the review process.
As part of peer review, editors are encouraged to
review research protocols, plans for statistical analysis if
separate from the protocol, and/or contracts associated
with project-specific studies. Editors should encourage
authors to make such documents publicly available at
the time of or after publication, before accepting such
studies for publication. Some journals may require public
posting of these documents as a condition of acceptance
for publication.
Journal requirements for independent data analysis
and for public data availability are in flux at the time of
this revision, reflecting evolving views of the importance
of data availability for pre- and post-publication peer
review. Some journal editors currently request a statistical analysis of trial data by an independent biostatistician
before accepting studies for publication. Others ask
authors to say whether the study data are available to
third parties to view and/or use/reanalyze, while still
others encourage or require authors to share their data
with others for review or reanalysis. Each journal should
establish and publish their specific requirements for data
analysis and post in a place that potential authors can
easily access.
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Some people believe that true scientific peer review
begins only on the date a paper is published. In that spirit,
medical journals should have a mechanism for readers to
submit comments, questions, or criticisms about published
articles, and authors have a responsibility to respond
appropriately and cooperate with any requests from the
journal for data or additional information should questions
about the paper arise after publication (see Section III).
ICMJE believes investigators have a duty to maintain
the primary data and analytic procedures underpinning
the published results for at least 10 years. The ICMJE
encourages the preservation of these data in a data repository to ensure their longer-term availability.
d. Integrity
Editorial decisions should be based on the relevance
of a manuscript to the journal and on the manuscript’s
originality, quality, and contribution to evidence about
important questions. Those decisions should not be
influenced by commercial interests, personal relationships or agendas, or findings that are negative or that
credibly challenge accepted wisdom. In addition,
authors should submit for publication or otherwise make
publicly available, and editors should not exclude from
consideration for publication, studies with findings that
are not statistically significant or that have inconclusive
findings. Such studies may provide evidence that, combined with that from other studies through meta-analysis,
might still help answer important questions, and a public
record of such negative or inconclusive findings may prevent unwarranted replication of effort or otherwise be
valuable for other researchers considering similar work.
Journals should clearly state their appeals process
and should have a system for responding to appeals and
complaints.
script is published. Reviewers must not retain the manuscript for their personal use and should destroy copies of
manuscripts after submitting their reviews.
Reviewers who seek assistance from a trainee or colleague in the performance of a review should acknowledge these individuals’ contributions in the written
comments submitted to the editor. These individuals
must maintain the confidentiality of the manuscript as
outlined above.
Reviewers are expected to respond promptly to
requests to review and to submit reviews within the time
agreed. Reviewers’ comments should be constructive,
honest, and polite.
Reviewers should declare their relationships and
activities that might bias their evaluation of a manuscript
and recuse themselves from the peer-review process if a
conflict exists.
D. Journal Owners and Editorial Freedom
1. Journal Owners
The journal impact factor is widely misused as a
proxy for research and journal quality and as a measure
of the importance of specific research projects or the
merits of individual researchers, including their suitability
for hiring, promotion, tenure, prizes, or research funding.
ICMJE recommends that journals reduce the emphasis
on impact factor as a single measure, but rather provide
a range of article and journal metrics relevant to their
readers and authors.
Owners and editors of medical journals share a common purpose, but they have different responsibilities,
and sometimes those differences lead to conflicts.
It is the responsibility of medical journal owners to
appoint and dismiss editors. Owners should provide editors at the time of their appointment with a contract that
clearly states their rights and duties, authority, the general terms of their appointment, and mechanisms for
resolving conflict. The editor’s performance may be
assessed using mutually agreed-upon measures, including but not necessarily limited to readership, manuscript
submissions and handling times, and various journal
metrics.
Owners should only dismiss editors for substantial
reasons, such as scientific misconduct, disagreement
with the long-term editorial direction of the journal, inadequate performance by agreed-upon performance metrics, or inappropriate behavior that is incompatible with a
position of trust.
Appointments and dismissals should be based on
evaluations by a panel of independent experts, rather
than by a small number of executives of the owning organization. This is especially necessary in the case of dismissals because of the high value society places on
freedom of speech within science and because it is often
the responsibility of editors to challenge the status quo
in ways that may conflict with the interests of the journal’s
owners.
A medical journal should explicitly state its governance and relationship to a journal owner (e.g., a sponsoring society).
3. Peer Reviewers
2. Editorial Freedom
Manuscripts submitted to journals are privileged
communications that are authors’ private, confidential
property, and authors may be harmed by premature disclosure of any or all of a manuscript’s details.
Reviewers therefore should keep manuscripts and
the information they contain strictly confidential.
Reviewers must not publicly discuss authors’ work and
must not appropriate authors’ ideas before the manu-
The ICMJE adopts the World Association of Medical
Editors’ definition of editorial freedom (
editorial-independence), which holds that editors-inchief have full authority over the entire editorial content
of their journal and the timing of publication of that content. Journal owners should not interfere in the evaluation, selection, scheduling, or editing of individual
articles either directly or by creating an environment that
e. Diversity and Inclusion
To improve academic culture, editors should seek to
engage a broad and diverse array of authors, reviewers,
editorial staff, editorial board members, and readers.
f. Journal Metrics
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strongly influences decisions. Editors should base editorial decisions on the validity of the work and its importance to the journal’s readers, not on the commercial
implications for the journal, and editors should be free to
express critical but responsible views about all aspects of
medicine without fear of retribution, even if these views
conflict with the commercial goals of the publisher.
Editors-in-chief should also have the final say in decisions about which advertisements or sponsored content,
including supplements, the journal will and will not carry,
and they should have final say in use of the journal brand
and in overall policy regarding commercial use of journal
content.
Journals are encouraged to establish an independent and diverse editorial advisory board to help the editor establish and maintain editorial policy. To support
editorial decisions and potentially controversial expressions of opinion, owners should ensure that appropriate
insurance is obtained in the event of legal action against
the editors, and should ensure that legal advice is available when necessary. If legal problems arise, the editor
should inform their legal adviser and their owner and/or
publisher as soon as possible. Editors should defend the
confidentiality of authors and peer reviewers (names and
reviewer comments) in accordance with ICMJE policy
(see Section II.C.2.a). Editors should take all reasonable
steps to check the facts in journal commentary, including
that in news sections and social media postings, and
should ensure that staff working for the journal adhere to
best journalistic practices including contemporaneous
note-taking and seeking a response from all parties
when possible before publication. Such practices in support of truth and public interest may be particularly relevant in defense against legal allegations of libel.
To secure editorial freedom in practice, the editor
should have direct access to the highest level of ownership,
not to a delegated manager or administrative officer.
Editors and editors’ organizations are obliged to support the concept of editorial freedom and to draw major
transgressions of such freedom to the attention of the
international medical, academic, and lay communities.
Patients have a right to privacy that should not be
violated without informed consent. Identifying information, including names, initials, or hospital numbers,
should not be published in written descriptions, photographs, or pedigrees unless the information is essential
for scientific purposes and the patient (or parent or
guardian) gives written informed consent for publication.
Informed consent for this purpose requires that an identifiable patient be shown the manuscript to be published.
Authors should disclose to these patients whether any
potential identifiable material might be available via the
Internet as well as in print after publication. Patient consent should be written and archived with the journal, the
authors, or both, as dictated by local regulations or laws.
Applicable laws vary from locale to locale, and journals
should establish their own policies with legal guidance.
Since a journal that archives the consent will be aware of
patient identity, some journals may decide that patient
confidentiality is better guarded by having the author
archive the consent and instead providing the journal
with a written statement that attests that they have
received and archived written patient consent.
Nonessential identifying details should be omitted.
Informed consent should be obtained if there is any
doubt that anonymity can be maintained. For example,
masking the eye region in photographs of patients is
inadequate protection of anonymity. If identifying characteristics are deidentified, authors should provide
assurance, and editors should so note, that such changes
do not distort scientific meaning.
The requirement for informed consent should be
included in the journal’s instructions for authors. When
informed consent has been obtained, it should be indicated in the published article.
When reporting experiments on animals, authors
should indicate whether institutional and national standards for the care and use of laboratory animals were
followed.
E. Protection of Research Participants
All investigators should ensure that the planning,
conduct, and reporting of human research are in accordance with the Helsinki Declaration as revised in 2013
(www.wma.net/policies-post/wma-declaration-of-helsinkiethical-principles-for-medical-research-involving-humansubjects/). All authors should seek approval to conduct
research from an independent local, regional, or national
review body (e.g., ethics committee, institutional review
board). If doubt exists whether the research was conducted in accordance with the Helsinki Declaration, the
authors must explain the rationale for their approach and
demonstrate that the local, regional, or national review
body explicitly approved the doubtful aspects of the
study. Approval by a responsible review body does not
preclude editors from forming their own judgment
whether the conduct of the research was appropriate.
A. Corrections, Retractions, Republications, and
Version Control
Honest errors are a part of science and publishing
and require publication of a correction when they are
detected. Corrections are needed for errors of fact.
Matters of debate are best handled as letters to the editor, as print or electronic correspondence, or as posts in
a journal-sponsored online forum. Updates of previous
publications (e.g., an updated systematic review or clinical guideline) are considered a new publication rather
than a version of a previously published article.
If a correction is needed, journals should follow these
minimum standards:
• The journal should publish a correction notice as
soon as possible detailing changes from and citing
the original publication; the correction should be on
an electronic or numbered print page that is
www.icmje.org
III. PUBLISHING AND EDITORIAL ISSUES
RELATED TO PUBLICATION IN MEDICAL
JOURNALS
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included in an electronic or a print Table of Contents
to ensure proper indexing.
• The journal should also post a new article version
with details of the changes from the original version
and the date(s) on which the changes were made.
• The journal should archive all prior versions of the article. This archive can be either directly accessible to
readers or can be made available to the reader on
request.
• Previous electronic versions should prominently note
that there are more recent versions of the article.
• The citation should be to the most recent version.
Pervasive errors can result from a coding problem or
a miscalculation and may result in extensive inaccuracies
throughout an article. If such errors do not change the
direction or significance of the results, interpretations,
and conclusions of the article, a correction should be
published that follows the minimum standards noted
above.
Errors serious enough to invalidate a paper’s results
and conclusions may require retraction. However, retraction with republication (also referred to as “replacement”)
can be considered in cases where honest error (e.g., a
misclassification or miscalculation) leads to a major
change in the direction or significance of the results, interpretations, and conclusions. If the error is judged to be
unintentional, the underlying science appears valid, and
the changed version of the paper survives further review
and editorial scrutiny, then retraction with republication of
the changed paper, with an explanation, allows full correction of the scientific literature. In such cases, it is helpful to
show the extent of the changes in supplementary material
or in an appendix, for complete transparency.
is proven, but an exchange of letters to the editor could be
published to highlight matters of debate to readers.
Expressions of concern and retractions should not
simply be a letter to the editor. Rather, they should be
prominently labelled, appear on an electronic or numbered print page that is included in an electronic or a
print Table of Contents to ensure proper indexing, and
include in their heading the title of the original article.
Online, the retraction and original article should be
linked in both directions and the retracted article should
be clearly labelled as retracted in all its forms (abstract,
full text, PDF). Ideally, the authors of the retraction should
be the same as those of the article, but if they are unwilling or unable the editor may under certain circumstances
accept retractions by other responsible persons, or the
editor may be the sole author of the retraction or expression of concern. The text of the retraction should explain
why the article is being retracted and include a complete
citation reference to that article.
Retracted articles should remain in the public domain and be clearly labelled as retracted.
The validity of previous work by the author of a fraudulent paper cannot be assumed. Editors may ask the
author’s institution to assure them of the validity of other
work published in their journals, or they may retract it. If
this is not done, editors may choose to publish an
announcement expressing concern that the validity of
previously published work is uncertain.
The integrity of research may also be compromised
by inappropriate methodology that could lead to
retraction.
See COPE flowcharts for further guidance on retractions and expressions of concern. See Section IV.A.1.g.i
for guidance about avoiding referencing retracted
articles.
B. Scientific Misconduct, Expressions of
Concern, and Retraction
Scientific misconduct in research and non-research
publications includes but is not necessarily limited to
data fabrication; data falsification, including deceptive
manipulation of images; purposeful failure to disclose relationships and activities; and plagiarism. Some people consider failure to publish the results of clinical trials and other
human studies a form of scientific misconduct. While each
of these practices is problematic, they are not equivalent.
Each situation requires individual assessment by relevant
stakeholders. When scientific misconduct is alleged, or
concerns are otherwise raised about the conduct or integrity of work described in submitted or published papers,
the editor should initiate appropriate procedures detailed
by such committees as the Committee on Publication Ethics
(COPE) (
consider informing the institutions and funders, and may
choose to publish an expression of concern pending the
outcomes of those procedures. If the procedures involve an
investigation at the authors’ institution, the editor should
seek to discover the outcome of that investigation; notify
readers of the outcome if appropriate; and if the investigation proves scientific misconduct, publish a retraction of the
article. There may be circumstances in which no misconduct
C. Copyright
Journals should make clear the type of copyright
under which work will be published, and if the journal
retains copyright, should detail the journal’s position on
the transfer of copyright for all types of content, including audio, video, protocols, and data sets. Medical journals may ask authors to transfer copyright to the journal.
Some journals require transfer of a publication license.
Some journals do not require transfer of copyright and
rely on such vehicles as Creative Commons licenses. The
copyright status of articles in a given journal can vary:
Some content cannot be copyrighted (e.g., articles written by employees of some governments in the course of
their work). Editors may waive copyright on other content, and some content may be protected under other
agreements.
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D. Overlapping Publications
1. Duplicate Submission
Authors should not submit the same manuscript, in
the same or different languages, simultaneously to more
than one journal. The rationale for this standard is the
potential for disagreement when two (or more) journals
claim the right to publish a manuscript that has been submitted simultaneously to more than one journal, and the
possibility that two or more journals will unknowingly
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and unnecessarily undertake the work of peer review,
edit the same manuscript, and publish the same article.
2. Duplicate and Prior Publication
Duplicate publication is publication of a paper that
overlaps substantially with one already published, without clear, visible reference to the previous publication.
Prior publication may include release of information in
the public domain.
Readers of medical journals deserve to be able to
trust that what they are reading is original unless there is
a clear statement that the author and editor are intentionally republishing an article (which might be considered
for historic or landmark papers, for example). The bases
of this position are international copyright laws, ethical
conduct, and cost-effective use of resources. Duplicate
publication of original research is particularly problematic because it can result in inadvertent double-counting
of data or inappropriate weighting of the results of a single study, which distorts the available evidence.
When authors submit a manuscript reporting work
that has already been reported in large part in a published article or is contained in or closely related to
another paper that has been submitted or accepted for
publication elsewhere, the letter of submission should
clearly say so and the authors should provide copies of
the related material to help the editor decide how to
handle the submission. See also Section IV.B.
This recommendation does not prevent a journal
from considering a complete report that follows publication of a preliminary report, such as a letter to the editor, a
preprint, or an abstract or poster displayed at a scientific
meeting. It also does not prevent journals from considering a paper that has been presented at a scientific meeting but was not published in full, or that is being
considered for publication in proceedings or similar format. Press reports of scheduled meetings are not usually
regarded as breaches of this rule, but they may be if additional data tables or figures enrich such reports. Authors
should also consider how dissemination of their findings
outside of scientific presentations at meetings may diminish the priority journal editors assign to their work.
Authors who choose to post their work on a preprint
server should choose one that clearly identifies preprints
as not peer-reviewed work and includes disclosures of
authors’ relationships and activities. It is the author’s
responsibility to inform a journal if the work has been
previously posted on a preprint server. In addition, it is
the author’s (and not the journal editors’) responsibility
to ensure that preprints are amended to point readers to
subsequent versions, including the final published article. See Section III.D.3.
In the event of a public health emergency (as defined
by public health officials), information with immediate
implications for public health should be disseminated
without concern that this will preclude subsequent consideration for publication in a journal. We encourage editors
to give priority to authors who have made crucial data
publicly available (e.g., in a gene bank) without delay.
www.icmje.org
Sharing with public media, government agencies, or
manufacturers the scientific information described in a
paper or a letter to the editor that has been accepted but
not yet published violates the policies of many journals.
Such reporting may be warranted when the paper or letter describes major therapeutic advances; reportable
diseases; or public health hazards, such as serious
adverse effects of drugs, vaccines, other biological products, medical devices. This reporting, whether in print or
online, should not jeopardize publication, but should be
discussed with and agreed upon by the editor in
advance when possible.
The ICMJE will not consider as prior publication the
posting of trial results in any registry that meets the criteria noted in Section III.L if results are limited to a brief
(500 word) structured abstract or tables (to include participants enrolled, key outcomes, and adverse events).
The ICMJE encourages authors to include a statement
with the registration that indicates that the results have
not yet been published in a peer-reviewed journal, and
to update the results registry with the full journal citation
when the results are published.
Editors of different journals may together decide to
simultaneously or jointly publish an article if they believe
that doing so would be in the best interest of public
health. However, the National Library of Medicine (NLM)
indexes all such simultaneously published joint publications separately, so editors should include a statement
making the simultaneous publication clear to readers.
Authors who attempt duplicate publication without
such notification should expect at least prompt rejection
of the submitted manuscript. If the editor was not aware
of the violations and the article has already been published, then the article might warrant retraction with or
without the author’s explanation or approval.
See COPE flowcharts for further guidance on handling duplicate publication.
3. Preprints
Posting of work as a preprint may influence a journal’s interest in or priority for peer review and publication
of that work. Journals should clearly describe their policies related to the posting and citing of preprints in their
Information for Authors. Authors should become familiar
with the policies of journals they wish to submit their
work to prior to posting work on a preprint server.
a. Choosing a Preprint Archive
There has been an increase in preprint archives in
biomedicine. There are both benefits and harms in dissemination of scientific findings prior to peer review. To
maximize potential benefits and minimize potential
harms, authors who wish to make preprints of non–peerreviewed work publicly available should choose preprint
archives that have the following characteristics:
• Clearly identify preprints as work that is not peer
reviewed;
• Require authors to document disclosures of interest;
• Require authors to indicate funding source(s);
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Have a clear process for preprint archive users to
notify archive administrators about concerns related
to posted preprints—a public commenting feature is
desirable for this purpose;
• Maintain metadata for preprints that are withdrawn
from posting and post withdrawal notices indicating
the timing and reason for withdrawal of a preprint; and
• Have a mechanism for authors to indicate when the
preprint article has been subsequently published in a
peer-reviewed journal.
b. Submitting Manuscripts That Are in Preprint Archives to a Peer-Reviewed Journal
Authors should inform a journal if the work submitted to the journal has been posted on a preprint server
and provide a link to the preprint, whether the posting
occurs prior to submission or during the peer-review
process. It is also helpful to indicate in the text of the
manuscript, perhaps in the introduction, that a preprint is
available and how reviewers can access that preprint. In
addition, it is the authors’ (and not the journal editors’)
responsibility to ensure that preprints are amended to
point readers to subsequent versions of the work, including the published article. Authors should not post in the
preprint archive the published article nor interim versions that are produced during the peer-review process
that incorporate revisions based on journal feedback.
c. Referencing Preprints in Submitted Manuscripts
When preprints are cited in submitted manuscripts
or published articles, the citation should clearly indicate
that the reference is a preprint. When a preprint article
has been subsequently published in a peer-reviewed
journal, authors should cite the subsequent published article rather than the preprint article whenever appropriate. Journals should include the word “preprint”
following the citation information in the reference list
and consider indicating that the cited material is a preprint in the text. The citation should include the link to
the preprint and DOI if the preprint archive issues DOIs.
Authors should be cautious about referencing preprints
that were posted and never subsequently published in a
peer-reviewed journal, but the time interval of concern
will vary depending on the topic and specific reasons for
citation.
4. Acceptable Secondary Publication
Secondary publication of material published in other
journals or online may be justifiable and beneficial, especially when intended to disseminate important information to the widest possible audience (e.g., guidelines
produced by government agencies and professional
organizations in the same or a different language).
Secondary publication for various other reasons may
also be justifiable provided the following conditions are
met:
1. The authors have received approval from the editors
of both journals (the editor concerned with secondary publication must have access to the primary
version).
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2. The priority of the primary publication is respected
by a publication interval negotiated by both editors
with the authors.
3. The paper for secondary publication is intended for a
different group of readers; an abbreviated version
could be sufficient.
4. The secondary version faithfully reflects the authors,
data, and interpretations of the primary version.
5. The secondary version informs readers, peers, and
documenting agencies that the paper has been published in whole or in part elsewhere—for example,
with a note that might read, “This article is based on a
study first reported in the [journal title, with full reference]”—and the secondary version cites the primary
reference.
6. The title of the secondary publication should indicate
that it is a secondary publication (complete or
abridged republication or translation) of a primary
publication. Of note, the NLM does not consider
translations to be “republications” and does not cite
or index them when the original article was published
in a journal that is indexed in MEDLINE.
When the same journal simultaneously publishes an
article in multiple languages, the MEDLINE citation will
note the multiple languages (e.g., Angelo M. Journal networking in nursing: a challenge to be shared. Rev Esc
Enferm USP. 2011 Dec 45[6]:1281-2,1279-80,1283-4.
Article in English, Portuguese, and Spanish. No abstract
available. PMID: 22241182).
5. Manuscripts Based on the Same Database
If editors receive manuscripts from separate research
groups or from the same group analyzing the same data
set (e.g., from a public database, or systematic reviews or
meta-analyses of the same evidence), the manuscripts
should be considered independently because they may
differ in their analytic methods, conclusions, or both. If
the data interpretation and conclusions are similar, it
may be reasonable although not mandatory for editors
to give preference to the manuscript submitted first.
Editors might consider publishing more than one manuscript that overlap in this way because different analytical
approaches may be complementary and equally valid,
but manuscripts based upon the same data set should
add substantially to each other to warrant consideration
for publication as separate papers, with appropriate citation of previous publications from the same data set to
allow for transparency.
Secondary analyses of clinical trial data should cite
any primary publication, clearly state that it contains secondary analyses/results, and use the same identifying
trial registration number as the primary trial and unique,
persistent data set identifier.
Sometimes for large trials it is planned from the beginning to produce numerous separate publications
regarding separate research questions but using the
same original participant sample. In this case authors
may use the original single trial registration number, if all
the outcome parameters were defined in the original
registration. If the authors registered several substudies
as separate entries in, for example, ClinicalTrials.gov,
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then the unique trial identifier should be given for the study
in question. The main issue is transparency, so no matter
what model is used it should be obvious for the reader.
E. Correspondence
Medical journals should provide readers with a
mechanism for submitting comments, questions, or
criticisms about published articles, usually but not necessarily always through a correspondence section or online
forum. The authors of articles discussed in correspondence or an online forum have a responsibility to respond to substantial criticisms of their work using those
same mechanisms and should be asked by editors to
respond. Authors of correspondence should be asked to
declare any competing relationships or activities.
Correspondence may be edited for length, grammatical correctness, and journal style. Alternatively, editors may choose to make available to readers unedited
correspondence, for example, via an online commenting
system. Such commenting is not indexed in MEDLINE
unless it is subsequently published on a numbered electronic or print page. However the journal handles correspondence, it should make known its practice. In all
instances, editors must make an effort to screen discourteous, inaccurate, or libellous comments.
Responsible debate, critique, and disagreement are
important features of science, and journal editors should
encourage such discourse ideally within their own journals about the material they have published. Editors,
however, have the prerogative to reject correspondence
that is irrelevant, uninteresting, or lacking cogency, but
they also have a responsibility to allow a range of opinions to be expressed and to promote debate.
In the interests of fairness and to keep correspondence within manageable proportions, journals may
want to set time limits for responding to published material and for debate on a given topic.
F. Fees
Journals should be transparent about their types
of revenue streams. Any fees or charges that are
required for manuscript processing and/or publishing
materials in the journal shall be clearly stated in a place
that is easy for potential authors to find prior to submitting their manuscripts for review or explained to
authors before they begin preparing their manuscript
for submission (
/Principles_of_Transparency_and_Best_Practice_in_Scholarly_
Publishing.pdf).
G. Supplements, Theme Issues, and Special
Series
Supplements are collections of papers that deal with
related issues or topics, are published as a separate issue
of the journal or as part of a regular issue, and may be
funded by sources other than the journal’s publisher.
Because funding sources can bias the content of supplements through the choice of topics and viewpoints, journals should adopt the following principles, which also
apply to theme issues or special series that have external
funding and/or guest editors:
www.icmje.org
1. The journal editor must be given and must take full
responsibility for the policies, practices, and content
of supplements, including complete control of the
decision to select authors, peer reviewers, and content for the supplement. Editing by the funding organization should not be permitted.
2. The journal editor has the right to appoint one or
more external editors of the supplement and must
take responsibility for the work of those editors.
3. The journal editor must retain the authority to send
supplement manuscripts for external peer review and
to reject manuscripts submitted for the supplement
with or without external review. These conditions
should be made known to authors and any external
editors of the supplement before beginning editorial
work on it.
4. The source of the idea for the supplement, sources of
funding for the supplement’s research and publication, and products of the funding source related to
content considered in the supplement should be
clearly stated in the introductory material.
5. Advertising in supplements should follow the same
policies as those of the primary journal.
6. Journal editors must enable readers to distinguish
readily between ordinary editorial pages and supplement pages.
7. Journal and supplement editors must not accept personal favors or direct remuneration from sponsors of
supplements.
8. Secondary publication in supplements (republication
of papers published elsewhere) should be clearly
identified by the citation of the original paper and by
the title.
9. The same principles of authorship and disclosure of
relationships and activities discussed elsewhere in
this document should be applied to supplements.
H. Sponsorship or Partnership
Various entities may seek interactions with journals
or editors in the form of sponsorships, partnerships,
meetings, or other types of activities. To preserve editorial independence, these interactions should be governed by the same principles outlined above for
Supplements, Theme Issues, and Special Series (Section
III.G).
I. Electronic Publishing
Most medical journals are now published in electronic as well as print versions, and some are published
only in electronic form. Principles of print and electronic
publishing are identical, and the recommendations of
this document apply equally to both. However, electronic publishing provides opportunities for versioning
and raises issues about link stability and content preservation that are addressed here.
Recommendations for corrections and versioning
are detailed in Section III.A.
Electronic publishing allows linking to sites and
resources beyond journals over which journal editors
have no editorial control. For this reason, and because
links to external sites could be perceived as implying
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endorsement of those sites, journals should be cautious
about external linking. When a journal does link to an
external site, it should state that it does not endorse or
take responsibility or liability for any content, advertising,
products, or other materials on the linked sites, and does
not take responsibility for the sites’ availability.
Permanent preservation of journal articles on a journal’s website, or in an independent archive or a credible
repository, is essential for the historical record. Removing an article from a journal’s website in its entirety is
almost never justified as copies of the article may have
been downloaded even if its online posting was brief.
Such archives should be freely accessible or accessible to
archive members. Deposition in multiple archives is encouraged. However, if necessary for legal reasons (e.g.,
libel action), the URL for the removed article must contain
a detailed reason for the removal, and the article must be
retained in the journal’s internal archive.
Permanent preservation of a journal’s total content is
the responsibility of the journal publisher, who in the
event of journal termination should be certain the journal
files are transferred to a responsible third party who can
make the content available.
Journal websites should post the date that nonarticle
web pages, such as those listing journal staff, editorial
board members, and instructions for authors, were last
updated.
J. Advertising
Most medical journals carry advertising, which generates income for their publishers, but journals should
not be dominated by advertisements, and advertising
must not be allowed to influence editorial decisions.
Journals should have formal, explicit, written policies
for advertising in both print and electronic versions. Best
practice prohibits selling advertisements intended to be
juxtaposed with editorial content on the same product.
Advertisements should be clearly identifiable as advertisements. Editors should have full and final authority for
approving print and online advertisements and for
enforcing advertising policy.
Journals should not carry advertisements for products proven to be seriously harmful to health. Editors
should ensure that existing regulatory or industry standards for advertisements specific to their country are
enforced, or develop their own standards. The interests
of organizations or agencies should not control classified
and other nondisplay advertising, except where required
by law. Editors should consider all criticisms of advertisements for publication.
K. Journals and the Media
Journals’ interactions with media should balance
competing priorities. The general public has a legitimate
interest in all journal content and is entitled to important
information within a reasonable amount of time, and editors have a responsibility to facilitate that. However,
media reports of scientific research before it has been
peer-reviewed and fully vetted may lead to dissemination of inaccurate or premature conclusions, and doctors
12
in practice need to have research reports available in full
detail before they can advise patients about the reports’
conclusions.
An embargo system has been established in some
countries and by some journals to assist this balance,
and to prevent publication of stories in the general
media before publication of the original research in the
journal. For the media, the embargo creates a “level
playing field,” which most reporters and writers appreciate since it minimizes the pressure on them to publish
stories before competitors when they have not had time
to prepare carefully. Consistency in the timing of public
release of biomedical information is also important in
minimizing economic chaos, since some articles contain
information that has potential to influence financial markets. The ICMJE acknowledges criticisms of embargo
systems as being self-serving of journals’ interests and an
impediment to rapid dissemination of scientific information, but believes the benefits of the systems outweigh
their harms.
The following principles apply equally to print and
electronic publishing and may be useful to editors as
they seek to establish policies on interactions with the
media:
• Editors can foster the orderly transmission of medical
information from researchers, through peer-reviewed
journals, to the public. This can be accomplished by
an agreement with authors that they will not publicize
their work while their manuscript is under consideration or awaiting publication and an agreement with
the media that they will not release stories before publication of the original research in the journal, in return
for which the journal will cooperate with them in preparing accurate stories by issuing, for example, a
press release.
• Editors need to keep in mind that an embargo system works on the honor system—no formal enforcement or policing mechanism exists. The decision of a
significant number of media outlets or biomedical
journals not to respect the embargo system would
lead to its rapid dissolution.
• Notwithstanding authors’ belief in their work, very little medical research has such clear and urgently important clinical implications for the public’s health
that the news must be released before full publication in a journal. When such exceptional circumstances occur, the appropriate authorities responsible for
public health should decide whether to disseminate
information to physicians and the media in advance
and should be responsible for this decision. If the
author and the appropriate authorities wish to have a
manuscript considered by a particular journal, the
editor should be consulted before any public
release. If editors acknowledge the need for immediate release, they should waive their policies limiting
prepublication publicity.
• Policies designed to limit prepublication publicity
should not apply to accounts in the media of presentations at scientific meetings or to the abstracts from
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these meetings (see Duplicate Publication). Researchers who present their work at a scientific meeting
should feel free to discuss their presentations with
reporters but should be discouraged from offering
more detail about their study than was presented in
the talk, or should consider how giving such detail
might diminish the priority journal editors assign to
their work (see Duplicate Publication).
• When an article is close to being published, editors
or journal staff should help the media prepare accurate reports by providing news releases, answering
questions, supplying advance copies of the article, or
referring reporters to appropriate experts. This assistance should be contingent on the media’s cooperation in timing the release of a story to coincide with
publication of the article.
L. Clinical Trials
1. Registration
The ICMJE’s clinical trial registration policy is
detailed in a series of editorials (see News and Editorials
[www.icmje.org/news-and-editorials/] and FAQs [www.
icmje.org/about-icmje/faqs/]).
Briefly, the ICMJE requires, and recommends that all
medical journal editors require, registration of clinical trials in a public trials registry at or before the time of first
patient enrollment as a condition of consideration for
publication. Editors requesting inclusion of their journal
on the ICMJE website list of publications that follow
ICMJE guidance (www.icmje.org/journals.html) should
recognize that the listing implies enforcement by the
journal of ICMJE’s trial registration policy.
ICMJE uses the date trial registration materials were
first submitted to a registry as the date of registration.
When there is a substantial delay between the submission of registration materials and their posting at the trial
registry, editors may inquire about the circumstances
that led to the delay.
The ICMJE defines a clinical trial as any research project that prospectively assigns people or a group of people to an intervention, with or without concurrent
comparison or control groups, to study the relationship
between a health-related intervention and a health outcome. Health-related interventions are those used to
modify a biomedical or health-related outcome; examples include drugs, surgical procedures, devices, behavioral treatments, educational programs, dietary interventions, quality improvement interventions, and process-of-care changes. Health outcomes are any biomedical or health-related measures obtained in patients or
participants, including pharmacokinetic measures and
adverse events. The ICMJE does not define the timing of
first participant enrollment, but best practice dictates
registration by the time of first participant consent.
The ICMJE accepts publicly accessible registration in
any registry that is a primary register of the WHO
International Clinical Trials Registry Platform (ICTRP)
(www.who.int/clinical-trials-registry-platform/network/whodata-set) that includes the minimum acceptable 24-item
trial registration data set or in ClinicalTrials.gov, which is a
www.icmje.org
data provider to the WHO ICTRP. The ICMJE endorses
these registries because they meet several criteria. They
are accessible to the public at no charge, open to all
prospective registrants, managed by a not-for-profit organization, have a mechanism to ensure the validity of the
registration data, and are electronically searchable. An
acceptable registry must include the minimum 24-item
trial registration data set (
trainTrainer/WHO-ICMJE-ClinTrialsgov-Cross-Ref.pdf or
www.who.int/clinical-trials-registry-platform) at the time of
registration and before enrollment of the first participant.
The ICMJE considers inadequate trial registrations
missing any of the 24 data fields, those that have fields
that contain uninformative information, or registrations
that are not made publicly accessible such as phase I trials submitted to the EU-CTR and trials of devices for
which the information is placed in a “lock box.” In order
to comply with ICMJE policy, investigators registering trials of devices at ClinicalTrials.gov must “opt out” of the
lock box by electing public posting prior to device approval. Approval to conduct a study from an independent local, regional, or national review body (e.g., ethics
committee, institutional review board) does not fulfill the
ICMJE requirement for prospective clinical trial registration. Although not a required item, the ICMJE encourages authors to include a statement that indicates that
the results have not yet been published in a peerreviewed journal, and to update the registration with the
full journal citation when the results are published.
The purpose of clinical trial registration is to prevent
selective publication and selective reporting of research
outcomes, to prevent unnecessary duplication of
research effort, to help patients and the public know
what trials are planned or ongoing into which they might
want to enroll, and to help give ethics review boards considering approval of new studies a view of similar work
and data relevant to the research they are considering.
Retrospective registration, for example at the time of
manuscript submission, meets none of these purposes.
Those purposes apply also to research with alternative
designs, for example observational studies. For that reason, the ICMJE encourages registration of research with
non-trial designs, but because the exposure or intervention in non-trial research is not dictated by the researchers, the ICMJE does not require it.
Secondary data analyses of primary (parent) clinical
trials should not be registered as separate clinical trials,
but instead should reference the trial registration number of the primary trial.
The ICMJE expects authors to ensure that they have
met the requirements of their funding and regulatory
agencies regarding aggregate clinical trial results reporting in clinical trial registries. It is the authors’, and not the
journal editors’, responsibility to explain any discrepancies between results reported in registries and journal
publications. The ICMJE will not consider as prior publication the posting of trial results in any registry that
meets the above criteria if results are limited to a brief
(500 word) structured abstract or tables (to include trial
13
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Recommendations for the Conduct, Reporting, Editing, and Publication of Scholarly Work in Medical Journals
participants enrolled, baseline characteristics, primary
and secondary outcomes, and adverse events).
The ICMJE recommends that journals publish the
trial registration number at the end of the abstract. The
ICMJE also recommends that, whenever a registration
number is available, authors list this number the first time
they use a trial acronym to refer either to the trial they are
reporting or to other trials that they mention in the
manuscript.
Editors may consider whether the circumstances
involved in a failure to appropriately register a clinical
trial were likely to have been intended to or resulted in
biased reporting. Because of the importance of prospective trial registration, if an exception to this policy is
made, trials must be registered and the authors should
indicate in the publication when registration was completed and why it was delayed. Editors should publish a
statement indicating why an exception was allowed. The
ICMJE emphasizes that such exceptions should be rare,
and that authors failing to prospectively register a trial
risk its inadmissibililty to our journals.
2. Data Sharing
The ICMJE’s data sharing statement policy is
detailed in an editorial (see Updates and Editorials
[www.icmje.org/update.html]).
1. As of 1 July 2018 manuscripts submitted to ICMJE
journals that report the results of clinical trials must
contain a data sharing statement as described below.
2. Clinical trials that begin enrolling participants on or
after 1 January 2019 must include a data sharing plan
in the trial’s registration. The ICMJE’s policy regarding trial registration is explained at www.icmje.org/
recommendations/browse/publishing-and-editorialissues/clinical-trial-registration.html. If the data sharing plan changes after registration this should be
reflected in the statement submitted and published
with the manuscript, and updated in the registry
record.
Data sharing statements must indicate the
following: whether individual deidentified participant
data (including data dictionaries) will be shared
(“undecided” is not an acceptable answer); what data in
particular will be shared; whether additional, related
documents will be available (e.g., study protocol,
statistical analysis plan, etc.); when the data will become
available and for how long; by what access criteria
data will be shared (including with whom, for what
types of analyses, and by what mechanism). Illustrative
examples of data sharing statements that would meet
these requirements are provided in the Table.
Authors of secondary analyses using shared data
must attest that their use was in accordance with the
terms (if any) agreed to upon their receipt. They must
also reference the source of the data using its unique,
persistent identifier to provide appropriate credit to
those who generated it and allow searching for the studies it has supported. Authors of secondary analyses must
explain completely how theirs differ from previous analyses. In addition, those who generate and then share clinical trial data sets deserve substantial credit for their
14
efforts. Those using data collected by others should seek
collaboration with those who collected the data. As collaboration will not always be possible, practical, or
desired, the efforts of those who generated the data
must be recognized.
IV. MANUSCRIPT PREPARATION AND
SUBMISSION
A. Preparing a Manuscript for Submission to a
Medical Journal
1. General Principles
The text of articles reporting original research is usually divided into Introduction, Methods, Results, and
Discussion sections. This so-called “IMRAD” structure is
not an arbitrary publication format but a reflection of the
process of scientific discovery. Articles often need subheadings within these sections to further organize their
content. Other types of articles, such as meta-analyses,
may require different formats, while case reports, narrative reviews, and editorials may have less structured or
unstructured formats.
Electronic formats have created opportunities for
adding details or sections, layering information, crosslinking, or extracting portions of articles in electronic versions. Supplementary electronic-only material should be
submitted and sent for peer review simultaneously with
the primary manuscript.
2. Reporting Guidelines
Reporting guidelines have been developed for different study designs; examples include CONSORT (www.
consort-statement.org) for randomized trials, STROBE
for observational studies (
PRISMA for systematic reviews and meta-analyses
( and STARD for studies of
diagnostic accuracy (
reporting-guidelines/stard/). Journals are encouraged to
ask authors to follow these guidelines because they help
authors describe the study in enough detail for it to be
evaluated by editors, reviewers, readers, and other
researchers evaluating the medical literature. Authors of
review manuscripts are encouraged to describe the
methods used for locating, selecting, extracting, and synthesizing data; this is mandatory for systematic reviews.
Good sources for reporting guidelines are the EQUATOR
Network (www.equator-network.org/home/) and the
NLM’s Research Reporting Guidelines and Initiatives
(www.nlm.nih.gov/services/research_report_guide.html).
3. Manuscript Sections
The following are general requirements for reporting
within sections of all study designs and manuscript
formats.
a. Title Page
General information about an article and its authors
is presented on a manuscript title page and usually
includes the article title, author information, any disclaimers, sources of support, word count, and sometimes the
number of tables and figures.
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Recommendations for the Conduct, Reporting, Editing, and Publication of Scholarly Work in Medical Journals
Table. Examples of Data Sharing Statements That Fulfill These ICMJE Requirements*
Example 1
Example 2
Example 3
Example 4
Will individual participant
data be available
(including data
dictionaries)?
What data in particular
will be shared?
Yes
Yes
Yes
No
All of the individual participant
data collected during the
trial, after deidentification.
Study Protocol, Statistical
Analysis Plan, Informed
Consent Form, Clinical
Study Report, Analytic Code
Immediately following publication. No end date.
Individual participant data that
underlie the results reported
in this article, after deidentification (text, tables, figures,
and appendices).
Study Protocol
Not available
What other documents
will be available?
Individual participant data that
underlie the results reported
in this article, after deidentification (text, tables, figures,
and appendices).
Study Protocol, Statistical
Analysis Plan, Analytic Code
Beginning 3 months and ending 5 years following article
publication.
Researchers who provide a
methodologically sound
proposal.
Beginning 9 months and ending 36 months following article publication.
Investigators whose proposed
use of the data has been
approved by an independent review committee
(learned intermediary) identified for this purpose.
For individual participant data
meta-analysis.
Proposals may be submitted
up to 36 months following
article publication. After 36
months the data will be
available in our University’s
data warehouse but without
investigator support other
than deposited metadata.
Information regarding submitting proposals and
accessing data may be
found at (Link to be
provided).
When will data be available (start and end
dates)?
With whom?
For what types of
analyses?
By what mechanism will
data be made
available?
Anyone who wishes to access
the data.
Any purpose.
Data are available indefinitely
at (Link to be included).
To achieve aims in the
approved proposal.
Proposals should be directed
to xxx@yyy.
To gain access, data requestors will need to sign a data
access agreement. Data are
available for 5 years at a
third-party website (Link to
be included).
Not available
Not applicable
Not applicable
Not applicable
Not applicable
*These examples are meant to illustrate a range of, but not all, data sharing options.
Article title. The title provides a distilled description
of the complete article and should include information
that, along with the abstract, will make electronic retrieval
of the article sensitive and specific. Reporting guidelines
recommend and some journals require that information
about the study design be a part of the title (particularly
important for randomized trials and systematic reviews
and meta-analyses). Some journals require a short title,
usually no more than 40 characters (including letters and
spaces) on the title page or as a separate entry in an electronic submission system. Electronic submission systems
may restrict the number of characters in the title.
Author information. Each author’s highest academic
degrees should be listed, although some journals do not
publish these. The name of the department(s) and institution(s) or organizations where the work should be attributed should be specified. Most electronic submission
systems require that authors provide full contact information, including land mail and e-mail addresses, but the
title page should list the corresponding authors’ telephone and fax numbers and e-mail address. ICMJE
encourages the listing of authors’ Open Researcher and
Contributor Identification (ORCID).
www.icmje.org
Disclaimers. An example of a disclaimer is an
author’s statement that the views expressed in the submitted article are his or her own and not an official position of the institution or funder.
Source(s) of support. These include grants, equipment, drugs, and/or other support that facilitated conduct of the work described in the article or the writing of
the article itself. Inappropriate attribution of funding
sources and affiliations are misleading and should be
avoided.
Word count. A word count for the paper’s text,
excluding its abstract, acknowledgments, tables, figure
legends, and references, allows editors and reviewers to
assess whether the information contained in the paper
warrants the paper’s length, and whether the submitted
manuscript fits within the journal’s formats and word limits. A separate word count for the abstract is useful for
the same reason.
Number of figures and tables. Some submission systems require specification of the number of figures and
tables before uploading the relevant files. These numbers allow editorial staff and reviewers to confirm that all
figures and tables were actually included with the manuscript and, because tables and figures occupy space, to
assess if the information provided by the figures and
15
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Recommendations for the Conduct, Reporting, Editing, and Publication of Scholarly Work in Medical Journals
tables warrants the paper’s length and if the manuscript
fits within the journal’s space limits.
Disclosure of relationships and activities. Disclosure
information for each author needs to be part of the
manuscript; each journal should develop standards with
regard to the form the information should take and
where it will be posted. The ICMJE has developed a uniform Disclosure Form for use by ICMJE member journals
(www.icmje.org/coi_disclosure.pdf), and the ICMJE encourages other journals to adopt it. Despite availability
of the form, editors may require disclosure of relationships and activities on the manuscript title page or other
Disclosure section in the manuscript to save the work of
collecting forms from each author prior to making an editorial decision or to save reviewers and readers the work
of reading each author’s form.
b. Abstract
Original research, systematic reviews, and metaanalyses require structured abstracts. The abstract
should provide the context or background for the study
and should state the study’s purpose, basic procedures
(selection of study participants, settings, measurements,
analytical methods), main findings (giving specific effect
sizes and their statistical and clinical significance, if possible), and principal conclusions. It should emphasize new
and important aspects of the study or observations, note
important limitations, and not overinterpret findings.
Clinical trial abstracts should include items that the
CONSORT group has identified as essential (www.
consort-statement.org/resources/downloads/
extensions/consort-extension-for-abstracts-2008pdf/).
Funding sources should be listed separately after the
abstract to facilitate proper display and indexing for
search retrieval by MEDLINE.
Because abstracts are the only substantive portion of
the article indexed in many electronic databases, and the
only portion many readers read, authors need to ensure
that they accurately reflect the content of the article.
Unfortunately, information in abstracts often differs from
that in the text. Authors and editors should work in the
process of revision and review to ensure that information
is consistent in both places. The format required for
structured abstracts differs from journal to journal, and
some journals use more than one format; authors need
to prepare their abstracts in the format specified by the
journal they have chosen.
The ICMJE recommends that journals publish the
clinical trial registration number at the end of the
abstract. The ICMJE also recommends that, when a
registration number is available, authors list that number
the first time they use a trial acronym to refer to the trial
they are reporting or to other trials that they mention in
the manuscript. If the data have been deposited in a
public repository and/or are being used in a secondary
analysis, authors should state at the end of the abstract
the unique, persistent data set identifier; repository
name; and number.
c. Introduction
Provide a context or background for the study (that
is, the nature of the problem and its significance). State
16
the specific purpose or research objective of, or hypothesis tested by, the study or observation. Cite only directly
pertinent references, and do not include data or conclusions from the work being reported.
d. Methods
The guiding principle of the Methods section should
be clarity about how and why a study was done in a particular way. The Methods section should aim to be sufficiently detailed such that others with access to the data
would be able to reproduce the results. In general, the
section should include only information that was available at the time the plan or protocol for the study was
being written; all information obtained during the study
belongs in the Results section. If an organization was
paid or otherwise contracted to help conduct the
research (examples include data collection and management), then this should be detailed in the methods.
The Methods section should include a statement
indicating that the research was approved by an independent local, regional or national review body (e.g.,
ethics committee, institutional review board). If doubt
exists whether the research was conducted in accordance with the Helsinki Declaration, the authors must
explain the rationale for their approach and demonstrate
that the local, regional or national review body explicitly
approved the doubtful aspects of the study. See Section
II.E.
i. Selection and Description of Participants
Clearly describe the selection of observational or experimental participants (healthy individuals or patients,
including controls), including eligibility and exclusion criteria and a description of the source population.
Because the relevance of such variables as age, sex, or
ethnicity is not always known at the time of study design,
researchers should aim for inclusion of representative
populations into all study types and at a minimum provide descriptive data for these and other relevant demographic variables.
Ensure correct use of the terms sex (when reporting
biological factors) and gender (identity, psychosocial or
cultural factors), and, unless inappropriate, report the sex
and/or gender of study participants, the sex of animals
or cells, and describe the methods used to determine
sex and gender. If the study was done involving an exclusive population, for example in only one sex, authors
should justify why, except in obvious cases (e.g., prostate
cancer). Authors should define how they determined
race or ethnicity and justify their relevance. Authors
should use neutral, precise, and respectful language to
describe study participants and avoid the use of terminology that might stigmatize participants.
ii. Technical Information
Specify the study’s main and secondary objectives—
usually identified as primary and secondary outcomes.
Identify methods, equipment (give the manufacturer’s
name and address in parentheses), and procedures in
sufficient detail to allow others to reproduce the results.
Give references to established methods, including
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Recommendations for the Conduct, Reporting, Editing, and Publication of Scholarly Work in Medical Journals
statistical methods (see below); provide references and
brief descriptions for methods that have been published
but are not well-known; describe new or substantially
modified methods, give the reasons for using them, and
evaluate their limitations. Identify precisely all drugs and
chemicals used, including generic name(s), dose(s), and
route(s) of administration. Identify appropriate scientific
names and gene names.
iii. Statistics
Describe statistical methods with enough detail to
enable a knowledgeable reader with access to the original data to judge its appropriateness for the study and to
verify the reported results. When possible, quantify findings and present them with appropriate indicators of
measurement error or uncertainty (such as confidence
intervals). Avoid relying solely on statistical hypothesis
testing, such as P values, which fail to convey important
information about effect size and precision of estimates.
References for the design of the study and statistical
methods should be to standard works when possible
(with pages stated). Define statistical terms, abbreviations, and most symbols. Specify the statistical software
package(s) and versions used. Distinguish prespecified
from exploratory analyses, including subgroup analyses.
e. Results
Present your results in logical sequence in the text,
tables, and figures, giving the main or most important
findings first. Do not repeat all the data in the tables or
figures in the text; emphasize or summarize only the
most important observations. Provide data on all primary
and secondary outcomes identified in the Methods section. Extra or supplementary materials and technical
details can be placed in an appendix where they will be
accessible but will not interrupt the flow of the text, or
they can be published solely in the electronic version of
the journal.
Give numeric results not only as derivatives (e.g.,
percentages) but also as the absolute numbers from
which the derivatives were calculated. Restrict tables and
figures to those needed to explain the argument of the
paper and to assess supporting data. Use graphs as an
alternative to tables with many entries; do not duplicate
data in graphs and tables. Avoid nontechnical uses of
technical terms in statistics, such as “random” (which
implies a randomizing device), “normal,” “significant,”
“correlations,” and “sample.”
Separate reporting of data by demographic variables, such as age and sex, facilitate pooling of data for
subgroups across studies and should be routine, unless
there are compelling reasons not to stratify reporting,
which should be explained.
f. Discussion
It is useful to begin the discussion by briefly summarizing the main findings, and explore possible mechanisms or explanations for these findings. Emphasize the
new and important aspects of your study and put your
findings in the context of the totality of the relevant evidence. State the limitations of your study, and explore
the implications of your findings for future research and
www.icmje.org
for clinical practice or policy. Discuss the influence or
association of variables, such as sex and/or gender, on
your findings, where appropriate, and the limitations of
the data. Do not repeat in detail data or other information given in other parts of the manuscript, such as in the
Introduction or the Results section.
Link the conclusions with the goals of the study but
avoid unqualified statements and conclusions not
adequately supported by the data. In particular, distinguish between clinical and statistical significance, and
avoid making statements on economic benefits and
costs unless the manuscript includes the appropriate
economic data and analyses. Avoid claiming priority or
alluding to work that has not been completed. State new
hypotheses when warranted, but label them clearly.
g. References
i. General Considerations
Authors should provide direct references to original
research sources whenever possible. References should
not be used by authors, editors, or peer reviewers to promote self-interests. Authors should avoid citing articles
from predatory or pseudo-journals. When preprints are
cited, the citation should clearly indicate that the reference is a preprint (also see Section III.D.3). Although
references to review articles can be an efficient way to
guide readers to a body of literature, review articles do
not always reflect original work accurately. On the other
hand, extensive lists of references to original work on a
topic can use excessive space. Fewer references to key
original papers often serve as well as more exhaustive
lists, particularly since references can now be added to
the electronic version of published papers, and since
electronic literature searching allows readers to retrieve
published literature efficiently.
References to papers accepted but not yet published should be designat…
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