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Recommendations for the Conduct, Reporting, Editing, and


Publication of Scholarly Work in Medical Journals
Updated May 2023

I. About the Recommendations F. Fees


A. Purpose of the Recommendations G. Supplements, Theme Issues, and Special Series
B. Who Should Use the Recommendations? H. Sponsorship and Partnerships
C. History of the Recommendations I. Electronic Publishing
II. Roles and Responsibilities of Authors, Contributors, J. Advertising
Reviewers, Editors, Publishers, and Owners K. Journals and the Media
A. Defining the Role of Authors and Contributors L. Clinical Trials
1. Why Authorship Matters 1. Registration
2. Who Is an Author? 2. Data Sharing
3. Non-Author Contributors IV. Manuscript Preparation and Submission
4. Artificial Intelligence (AI)–Assisted Technology A. Preparing a Manuscript for Submission to a
B. Disclosure of Financial and Non-Financial Relation- Medical Journal
ships and Activities, and Conflicts of Interest 1. General Principles
1. Participants 2. Reporting Guidelines
a. Authors 3. Manuscript Sections
b. Peer Reviewers a. Title Page
c. Editors and Journal Staff b. Abstract
2. Reporting Relationships and Activities c. Introduction
C. Responsibilities in the Submission and Peer-Review d. Methods
i. Selection and Description of Participants
Process
ii. Technical Information
1. Authors
iii. Statistics
a. Predatory or Pseudo-Journals
e. Results
2. Journals
f. Discussion
a. Confidentiality
g. References
b. Timeliness
i. General Considerations
c. Peer Review
ii. Style and Format
d. Integrity
h. Tables
e. Diversity and Inclusion
i. Illustrations (Figures)
f. Journal Metrics
j. Units of Measurement
3. Peer Reviewers
k. Abbreviations and Symbols
D. Journal Owners and Editorial Freedom
1. Journal Owners B. Sending the Manuscript to the Journal
2. Editorial Freedom
E. Protection of Research Participants
III. Publishing and Editorial Issues Related to Publication I. ABOUT THE RECOMMENDATIONS
in Medical Journals A. Purpose of the Recommendations
A. Corrections, Retractions, Republications, and ICMJE developed these recommendations to review
Version Control best practice and ethical standards in the conduct and
B. Scientific Misconduct, Expressions of Concern, reporting of research and other material published in
and Retraction medical journals, and to help authors, editors, and others
C. Copyright involved in peer review and biomedical publishing cre-
D. Overlapping Publications ate and distribute accurate, clear, reproducible, unbia-
1. Duplicate Submission sed medical journal articles. The recommendations may
2. Duplicate and Prior Publication also provide useful insights into the medical editing and
3. Preprints publishing process for the media, patients and their fami-
a. Choosing a Preprint Archive lies, and general readers.
b. Submitting Manuscripts That Are in Preprint
Archives to a Peer-Reviewed Journal B. Who Should Use the Recommendations?
c. Referencing Preprints in Submitted Manu- These recommendations are intended primarily for
scripts use by authors who might submit their work for publication
4. Acceptable Secondary Publication to ICMJE member journals. Many non-ICMJE journals vol-
5. Manuscripts Based on the Same Database untarily use these recommendations (see www.icmje.org/
E. Correspondence journals-following-the-icmje-recommendations/). The ICMJE
1
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Recommendations for the Conduct, Reporting, Editing, and Publication of Scholarly Work in Medical Journals

encourages that use but has no authority to monitor or some journals now request and publish information
enforce it. In all cases, authors should use these recommen- about the contributions of each person named as having
dations along with individual journals' instructions to participated in a submitted study, at least for original
authors. Authors should also consult guidelines for the research. Editors are strongly encouraged to develop
reporting of specific study types (e.g., the CONSORT and implement a contributorship policy. Such policies
guidelines for the reporting of randomized trials); see remove much of the ambiguity surrounding contribu-
www.equator-network.org. tions, but leave unresolved the question of the quantity
Journals that follow these recommendations are and quality of contribution that qualify an individual for
encouraged to incorporate them into their instructions to authorship. The ICMJE has thus developed criteria for
authors and to make explicit in those instructions that authorship that can be used by all journals, including
they follow ICMJE recommendations. Journals that wish those that distinguish authors from other contributors.
to be identified on the ICMJE website as following these
2. Who Is an Author?
recommendations should notify the ICMJE secretariat at www.
The ICMJE recommends that authorship be based
icmje.org/journals-following-the-icmje-recommendations/
on the following 4 criteria:
journal-listing-request-form/. Journals that in the past have
1. Substantial contributions to the conception or design
requested such identification but who no longer follow ICMJE of the work; or the acquisition, analysis, or interpreta-
recommendations should use the same means to request re- tion of data for the work; AND
moval from this list. 2. Drafting the work or reviewing it critically for impor-
The ICMJE encourages wide dissemination of these tant intellectual content; AND
recommendations and reproduction of this document in 3. Final approval of the version to be published; AND
its entirety for educational, not-for-profit purposes with- 4. Agreement to be accountable for all aspects of the
out regard for copyright, but all uses of the recommen- work in ensuring that questions related to the accu-
dations and document should direct readers to www. racy or integrity of any part of the work are appropri-
icmje.org for the official, most recent version, as the ately investigated and resolved.
ICMJE updates the recommendations periodically when In addition to being accountable for the parts of the
new issues arise. work done, an author should be able to identify which
co-authors are responsible for specific other parts of the
C. History of the Recommendations work. In addition, authors should have confidence in the
The ICMJE has produced multiple editions of this integrity of the contributions of their co-authors.
document, previously known as the Uniform Require- All those designated as authors should meet all four
ments for Manuscripts Submitted to Biomedical Journals criteria for authorship, and all who meet the four criteria
(URMs). The URM was first published in 1978 as a way of should be identified as authors. Those who do not meet
standardizing manuscript format and preparation across all four criteria should be acknowledged—see Section II.
journals. Over the years, issues in publishing that went A.3 below. These authorship criteria are intended to
well beyond manuscript preparation arose, resulting in reserve the status of authorship for those who deserve
the development of separate statements, updates to the credit and can take responsibility for the work. The crite-
ria are not intended for use as a means to disqualify col-
document, and its renaming as “Recommendations for
leagues from authorship who otherwise meet authorship
the Conduct, Reporting, Editing, and Publication of
criteria by denying them the opportunity to meet crite-
Scholarly Work in Medical Journals” to reflect its broader rion #s 2 or 3. Therefore, all individuals who meet the
scope. Previous versions of the document may be found first criterion should have the opportunity to partici-
in the “Archives” section of www.icmje.org. pate in the review, drafting, and final approval of the
manuscript.
II. ROLES AND RESPONSIBILITIES OF AUTHORS, The individuals who conduct the work are responsi-
ble for identifying who meets these criteria and ideally
CONTRIBUTORS, REVIEWERS, EDITORS, should do so when planning the work, making modifica-
PUBLISHERS, AND OWNERS tions as appropriate as the work progresses. We encour-
A. Defining the Role of Authors and Contributors age collaboration and co-authorship with colleagues in
1. Why Authorship Matters the locations where the research is conducted. It is the
Authorship confers credit and has important aca- collective responsibility of the authors, not the journal to
demic, social, and financial implications. Authorship also which the work is submitted, to determine that all people
implies responsibility and accountability for published named as authors meet all four criteria; it is not the role
work. The following recommendations are intended to of journal editors to determine who qualifies or does not
ensure that contributors who have made substantive in- qualify for authorship or to arbitrate authorship conflicts.
tellectual contributions to a paper are given credit as If agreement cannot be reached about who qualifies for
authors, but also that contributors credited as authors authorship, the institution(s) where the work was per-
understand their role in taking responsibility and being formed, not the journal editor, should be asked to inves-
accountable for what is published. tigate. The criteria used to determine the order in which
Because authorship does not communicate what authors are listed on the byline may vary, and are to be
contributions qualified an individual to be an author, decided collectively by the author group and not by
2 www.icmje.org
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Recommendations for the Conduct, Reporting, Editing, and Publication of Scholarly Work in Medical Journals

editors. If authors request removal or addition of an general supervision of a research group or general
author after manuscript submission or publication, jour- administrative support; and writing assistance, technical
nal editors should seek an explanation and signed state- editing, language editing, and proofreading. Those whose
ment of agreement for the requested change from all contributions do not justify authorship may be acknowl-
listed authors and from the author to be removed or edged individually or together as a group under a single
added. heading (e.g., “Clinical Investigators” or “Participating
The corresponding author is the one individual who Investigators”), and their contributions should be specified
takes primary responsibility for communication with the (e.g., “served as scientific advisors,” “critically reviewed the
journal during the manuscript submission, peer-review, study proposal,” “collected data,” “provided and cared for
and publication process. The corresponding author typi- study patients,” “participated in writing or technical editing
cally ensures that all the journal's administrative require- of the manuscript”).
ments, such as providing details of authorship, ethics Because acknowledgment may imply endorsement
committee approval, clinical trial registration documen- by acknowledged individuals of a study's data and conclu-
tation, and disclosures of relationships and activities, are sions, editors are advised to require that the correspond-
properly completed and reported, although these duties ing author obtain written permission to be acknowledged
may be delegated to one or more co-authors. The corre- from all acknowledged individuals.
sponding author should be available throughout the
submission and peer-review process to respond to edi- 4. Artificial Intelligence (AI)–Assisted Technology
torial queries in a timely way, and should be available af- At submission, the journal should require authors to
ter publication to respond to critiques of the work and disclose whether they used artificial intelligence (AI)–
cooperate with any requests from the journal for data or assisted technologies (such as Large Language Models
additional information should questions about the paper [LLMs], chatbots, or image creators) in the production of
arise after publication. Although the corresponding submitted work. Authors who use such technology
author has primary responsibility for correspondence should describe, in both the cover letter and the submit-
with the journal, the ICMJE recommends that editors ted work, how they used it. Chatbots (such as ChatGPT)
send copies of all correspondence to all listed authors. should not be listed as authors because they cannot be
When a large multi-author group has conducted the responsible for the accuracy, integrity, and originality of
work, the group ideally should decide who will be an the work, and these responsibilities are required for
author before the work is started and confirm who is an authorship (see Section II.A.1). Therefore, humans are
author before submitting the manuscript for publication. responsible for any submitted material that included the
All members of the group named as authors should use of AI-assisted technologies. Authors should carefully
meet all four criteria for authorship, including approval review and edit the result because AI can generate
of the final manuscript, and they should be able to take authoritative-sounding output that can be incorrect,
public responsibility for the work and should have full incomplete, or biased. Authors should not list AI and AI-
assisted technologies as an author or co-author, nor cite
confidence in the accuracy and integrity of the work of
AI as an author. Authors should be able to assert that
other group authors. They will also be expected as indi-
there is no plagiarism in their paper, including in text and
viduals to complete disclosure forms.
images produced by the AI. Humans must ensure there is
Some large multi-author groups designate author-
appropriate attribution of all quoted material, including
ship by a group name, with or without the names of indi- full citations.
viduals. When submitting a manuscript authored by a
group, the corresponding author should specify the B. Disclosure of Financial and Non-Financial
group name if one exists, and clearly identify the group Relationships and Activities, and Conflicts of
members who can take credit and responsibility for the Interest
work as authors. The byline of the article identifies who is Public trust in the scientific process and the credibil-
directly responsible for the manuscript, and MEDLINE ity of published articles depend in part on how transpar-
lists as authors whichever names appear on the byline. If ently an author's relationships and activities, directly or
the byline includes a group name, MEDLINE will list the topically related to a work, are handled during the plan-
names of individual group members who are authors or ning, implementation, writing, peer review, editing, and
who are collaborators, sometimes called non-author con- publication of scientific work.
tributors, if there is a note associated with the byline The potential for conflict of interest and bias exists
clearly stating that the individual names are elsewhere in when professional judgment concerning a primary inter-
the paper and whether those names are authors or est (such as patients' welfare or the validity of research)
collaborators. may be influenced by a secondary interest (such as finan-
cial gain). Perceptions of conflict of interest are as impor-
3. Non-Author Contributors tant as actual conflicts of interest.
Contributors who meet fewer than all 4 of the above Individuals may disagree on whether an author's
criteria for authorship should not be listed as authors, relationships or activities represent conflicts. Although
but they should be acknowledged. Examples of activities the presence of a relationship or activity does not always
that alone (without other contributions) do not qualify a indicate a problematic influence on a paper's content,
contributor for authorship are acquisition of funding; perceptions of conflict may erode trust in science as
www.icmje.org 3
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Recommendations for the Conduct, Reporting, Editing, and Publication of Scholarly Work in Medical Journals

much as actual conflicts of interest. Ultimately, readers members who participate in editorial decisions must pro-
must be able to make their own judgments regarding vide editors with a current description of their relation-
whether an author's relationships and activities are perti- ships and activities (as they might relate to editorial
nent to a paper's content. These judgments require judgments) and recuse themselves from any decisions
transparent disclosures. An author's complete disclosure in which an interest that poses a potential conflict exists.
demonstrates a commitment to transparency and helps Editorial staff must not use information gained through
to maintain trust in the scientific process. working with manuscripts for private gain. Editors should
Financial relationships (such as employment, consul-
regularly publish their own disclosure statements and
tancies, stock ownership or options, honoraria, patents,
those of their journal staff. Guest editors should follow
and paid expert testimony) are the most easily identifia-
these same procedures.
ble, the ones most often judged to represent potential
Journals should take extra precautions and have a
conflicts of interest and thus the most likely to undermine
stated policy for evaluation of manuscripts submitted by
the credibility of the journal, the authors, and science
individuals involved in editorial decisions. Further guidance
itself. Other interests may also represent or be perceived
is available from COPE (https://publicationethics.org/files/
as conflicts, such as personal relationships or rivalries, A_Short_Guide_to_Ethical_Editing.pdf) and WAME (http://
academic competition, and intellectual beliefs. wame.org/conflict-of-interest-in-peer-reviewed-medical-
Authors should avoid entering into agreements with journals).
study sponsors, both for-profit and nonprofit, that inter-
fere with authors' access to all of the study's data or that 2. Reporting Relationships and Activities
interfere with their ability to analyze and interpret the Articles should be published with statements or sup-
data and to prepare and publish manuscripts independ- porting documents, such as the ICMJE Disclosure Form,
ently when and where they choose. Policies that dictate declaring:
where authors may publish their work violate this princi- • Authors' relationships and activities; and
ple of academic freedom. Authors may be required to • Sources of support for the work, including sponsor
provide the journal with the agreements in confidence. names along with explanations of the role of those
Purposeful failure to report those relationships or sources if any in study design; collection, analysis,
activities specified on the journal's disclosure form is a and interpretation of data; writing of the report; any
form of misconduct, as is discussed in Section III.B. restrictions regarding the submission of the report
for publication; or a statement declaring that the sup-
1. Participants porting source had no such involvement or restric-
All participants in the peer-review and publication pro- tions regarding publication; and
cess—not only authors but also peer reviewers, editors, and • Whether the authors had access to the study data,
editorial board members of journals—must consider and with an explanation of the nature and extent of
disclose their relationships and activities when fulfilling their access, including whether access is ongoing.
roles in the process of article review and publication. To support the above statements, editors may
request that authors of a study sponsored by a funder
a. Authors with a proprietary or financial interest in the outcome
When authors submit a manuscript of any type or for- sign a statement, such as “I had full access to all of the
mat they are responsible for disclosing all relationships data in this study and I take complete responsibility for
and activities that might bias or be seen to bias their the integrity of the data and the accuracy of the data
work. The ICMJE has developed a Disclosure Form to analysis.”
facilitate and standardize authors' disclosures. ICMJE
member journals require that authors use this form, and C. Responsibilities in the Submission and
ICMJE encourages other journals to adopt it. Peer-Review Process
1. Authors
b. Peer Reviewers Authors should abide by all principles of authorship
Reviewers should be asked at the time they are and declaration of relationships and activities detailed in
asked to critique a manuscript if they have relationships Sections II.A and II.B of this document.
or activities that could complicate their review. Reviewers
must disclose to editors any relationships or activities a. Predatory or Pseudo-Journals
that could bias their opinions of the manuscript, and A growing number of entities are advertising them-
should recuse themselves from reviewing specific manu- selves as “scholarly medical journals” yet do not function
scripts if the potential for bias exists. Reviewers must not as such. These journals (“predatory” or “pseudo-jour-
use knowledge of the work they're reviewing before its nals”) accept and publish almost all submissions and
publication to further their own interests. charge article processing (or publication) fees, often
informing authors about this after a paper's acceptance
c. Editors and Journal Staff for publication. They often claim to perform peer review
Editors who make final decisions about manuscripts but do not and may purposefully use names similar to
should recuse themselves from editorial decisions if they well-established journals. They may state that they are
have relationships or activities that pose potential conflicts members of ICMJE but are not (see www.icmje.org for
related to articles under consideration. Other editorial staff current members of the ICMJE) and that they follow the
4 www.icmje.org
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Recommendations for the Conduct, Reporting, Editing, and Publication of Scholarly Work in Medical Journals

recommendations of organizations such as the ICMJE, or reviewers if they intend to do so and confidentiality
COPE, and WAME. Researchers must be aware of the ex- must otherwise be honored.
istence of such entities and avoid submitting research to
them for publication. Authors have a responsibility to b. Timeliness
evaluate the integrity, history, practices, and reputation Editors should do all they can to ensure timely proc-
of the journals to which they submit manuscripts. essing of manuscripts with the resources available to
Guidance from various organizations is available to help them. If editors intend to publish a manuscript, they
identify the characteristics of reputable peer-reviewed should attempt to do so in a timely manner and any
journals (www.wame.org/identifying-predatory-or-pseudo- planned delays should be negotiated with the authors. If
journals and www.wame.org/principles-of-transparency- a journal has no intention of proceeding with a manu-
and-best-practice-in-scholarly-publishing). script, editors should endeavor to reject the manuscript
Seeking the assistance of scientific mentors, senior as soon as possible to allow authors to submit to a differ-
colleagues, and others with many years of scholarly pub- ent journal.
lishing experience may also be helpful.
Authors should avoid citing articles in predatory or c. Peer Review
pseudo-journals. Peer review is the critical assessment of manuscripts
submitted to journals by experts who are usually not part
2. Journals of the editorial staff. Because unbiased, independent,
critical assessment is an intrinsic part of all scholarly
a. Confidentiality work, including scientific research, peer review is an im-
Manuscripts submitted to journals are privileged portant extension of the scientific process.
communications that are authors' private, confidential The actual value of peer review is widely debated,
property, and authors may be harmed by premature dis- but the process facilitates a fair hearing for a manuscript
closure of any or all of a manuscript's details. among members of the scientific community. More prac-
Editors therefore must not share information about tically, it helps editors decide which manuscripts are suit-
manuscripts, including whether they have been received able for their journals. Peer review often helps authors
and are under review, their content and status in the and editors improve the quality of reporting.
review process, criticism by reviewers, and their ultimate It is the responsibility of the journal to ensure that
fate, to anyone other than the authors and reviewers. systems are in place for selection of appropriate
Requests from third parties to use manuscripts and reviewers. It is the responsibility of the editor to ensure
reviews for legal proceedings should be politely refused, that reviewers have access to all materials that may be
and editors should do their best not to provide such con- relevant to the evaluation of the manuscript, including
fidential material should it be subpoenaed. supplementary material for e-only publication, and to
Editors must also make clear that reviewers should ensure that reviewer comments are properly assessed
keep manuscripts, associated material, and the informa- and interpreted in the context of their declared relation-
tion they contain strictly confidential. Reviewers and edito- ships and activities.
rial staff members must not publicly discuss the authors' A peer-reviewed journal is under no obligation to
work, and reviewers must not appropriate authors' ideas send submitted manuscripts for review, and under no
before the manuscript is published. Reviewers must not obligation to follow reviewer recommendations, favor-
retain the manuscript for their personal use and should able or negative. The editor of a journal is ultimately re-
destroy paper copies of manuscripts and delete electronic sponsible for the selection of all its content, and editorial
copies after submitting their reviews. decisions may be informed by issues unrelated to the
When a manuscript is rejected, it is best practice for quality of a manuscript, such as suitability for the journal.
journals to delete copies of it from their editorial systems An editor can reject any article at any time before publi-
unless retention is required by local regulations. Journals cation, including after acceptance if concerns arise about
that retain copies of rejected manuscripts should dis- the integrity of the work.
close this practice in their Information for Authors. Journals may differ in the number and kinds of
When a manuscript is published, journals should manuscripts they send for review, the number and types
keep copies of the original submission, reviews, revisions, of reviewers they seek for each manuscript, whether the
and correspondence for at least three years and possibly review process is open or anonymized, and other aspects
in perpetuity, depending on local regulations, to help an- of the review process. For this reason and as a service
swer future questions about the work should they arise. to authors, journals should publish a clear, transparent
Editors should not publish or publicize peer reviewers' description of their peer-review process for all types
comments without permission of the reviewer and author. of manuscripts.
If journal policy is to anonymize authors to reviewer identity Journals should notify reviewers of the ultimate deci-
and comments are not signed, that identity must not sion to accept or reject a paper, and should acknowl-
be revealed to the author or anyone else without the edge the contribution of peer reviewers to their journal.
reviewers' expressed written permission. Editors are encouraged to share reviewers' comments
Confidentiality may have to be breached if dishon- with co-reviewers of the same paper, so reviewers can
esty or fraud is alleged, but editors should notify authors learn from each other in the review process.
www.icmje.org 5
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Recommendations for the Conduct, Reporting, Editing, and Publication of Scholarly Work in Medical Journals

As part of peer review, editors are encouraged to f. Journal Metrics


review research protocols, plans for statistical analysis if sep- The journal impact factor is widely misused as a
arate from the protocol, and/or contracts associated with proxy for research and journal quality and as a measure
project-specific studies. Editors should encourage authors of the importance of specific research projects or the
to make such documents publicly available at the time of or merits of individual researchers, including their suitability
after publication, before accepting such studies for publica- for hiring, promotion, tenure, prizes, or research funding.
tion. Some journals may require public posting of these ICMJE recommends that journals reduce the emphasis
documents as a condition of acceptance for publication. on impact factor as a single measure, but rather provide
Journal requirements for independent data analysis a range of article and journal metrics relevant to their
and for public data availability vary, reflecting evolving readers and authors.
views of the importance of data availability for pre- and
post-publication peer review. Some journal editors cur- 3. Peer Reviewers
rently request a statistical analysis of trial data by an in- Manuscripts submitted to journals are privileged
dependent biostatistician before accepting studies for communications that are authors' private, confidential
publication. Others ask authors to say whether the study property, and authors may be harmed by premature dis-
data are available to third parties to view and/or use/ closure of any or all of a manuscript's details.
reanalyze, while still others encourage or require Reviewers therefore should keep manuscripts and
authors to share their data with others for review or the information they contain strictly confidential. Reviewers
reanalysis. Each journal should establish and publish must not publicly discuss authors' work and must not
their specific requirements for data analysis and post in appropriate authors' ideas before the manuscript is
a place that potential authors can easily access. published. Reviewers must not retain the manuscript for their
Some people believe that true scientific peer review personal use and should destroy copies of manuscripts after
begins only on the date a paper is published. In that spirit, submitting their reviews.
medical journals should have a mechanism for readers to Reviewers who seek assistance from a trainee or col-
submit comments, questions, or criticisms about published league in the performance of a review should acknowl-
articles, and authors have a responsibility to respond edge these individuals' contributions in the written
appropriately and cooperate with any requests from the comments submitted to the editor. Reviewers must
journal for data or additional information should questions maintain the confidentiality of the manuscript as outlined
about the paper arise after publication (see Section III). above, which may prohibit the uploading of the manu-
ICMJE believes investigators have a duty to maintain script to software or other AI technologies where confi-
the primary data and analytic procedures underpinning dentiality cannot be assured. Reviewers should disclose
the published results for at least 10 years. The ICMJE to journals if and how AI technology is being used to facil-
encourages the preservation of these data in a data re- itate their review. Reviewers should be aware that AI can
pository to ensure their longer-term availability. generate authoritative-sounding output that can be incor-
rect, incomplete, or biased.
d. Integrity Reviewers are expected to respond promptly to
Editorial decisions should be based on the relevance requests to review and to submit reviews within the time
of a manuscript to the journal and on the manuscript's agreed. Reviewers' comments should be constructive,
originality, quality, and contribution to evidence about honest, and polite.
important questions. Those decisions should not be Reviewers should declare their relationships and
influenced by commercial interests, personal relation- activities that might bias their evaluation of a manuscript
ships or agendas, or findings that are negative or that and recuse themselves from the peer-review process if a
credibly challenge accepted wisdom. In addition, conflict exists.
authors should submit for publication or otherwise make
publicly available, and editors should not exclude from D. Journal Owners and Editorial Freedom
consideration for publication, studies with findings that 1. Journal Owners
are not statistically significant or that have inconclusive Owners and editors of medical journals share a com-
findings. Such studies may provide evidence that, com- mon purpose, but they have different responsibilities,
bined with that from other studies through meta-analysis, and sometimes those differences lead to conflicts.
might still help answer important questions, and a public It is the responsibility of medical journal owners to
record of such negative or inconclusive findings may pre- appoint and dismiss editors. Owners should provide edi-
vent unwarranted replication of effort or otherwise be tors at the time of their appointment with a contract that
valuable for other researchers considering similar work. clearly states their rights and duties, authority, the gen-
Journals should clearly state their appeals process eral terms of their appointment, and mechanisms for
and should have a system for responding to appeals and resolving conflict. The editor's performance may be
complaints. assessed using mutually agreed-upon measures, includ-
ing but not necessarily limited to readership, manuscript
e. Diversity and Inclusion submissions and handling times, and various journal
To improve academic culture, editors should seek to metrics.
engage a broad and diverse array of authors, reviewers, Owners should only dismiss editors for substantial
editorial staff, editorial board members, and readers. reasons, such as scientific misconduct, disagreement
6 www.icmje.org
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Recommendations for the Conduct, Reporting, Editing, and Publication of Scholarly Work in Medical Journals

with the long-term editorial direction of the journal, inad- To secure editorial freedom in practice, the editor
equate performance by agreed-upon performance met- should have direct access to the highest level of ownership,
rics, or inappropriate behavior that is incompatible with a not to a delegated manager or administrative officer.
position of trust. Editors and editors' organizations are obliged to sup-
Appointments and dismissals should be based on port the concept of editorial freedom and to draw major
evaluations by a panel of independent experts, rather transgressions of such freedom to the attention of the
than by a small number of executives of the owning orga- international medical, academic, and lay communities.
nization. This is especially necessary in the case of dis-
missals because of the high value society places on E. Protection of Research Participants
freedom of speech within science and because it is often All investigators should ensure that the planning,
the responsibility of editors to challenge the status quo conduct, and reporting of human research are in accord-
in ways that may conflict with the interests of the journal's ance with the Helsinki Declaration as revised in 2013
owners. (www.wma.net/policies-post/wma-declaration-of-helsinki-
A medical journal should explicitly state its gover- ethical-principles-for-medical-research-involving-human-
nance and relationship to a journal owner (e.g., a spon- subjects/). All authors should seek approval to conduct
soring society).
research from an independent local, regional, or national
2. Editorial Freedom
review body (e.g., ethics committee, institutional review
The ICMJE adopts the World Association of Medical board). If doubt exists whether the research was con-
Editors' definition of editorial freedom (http://wame.org/ ducted in accordance with the Helsinki Declaration, the
editorial-independence), which holds that editors-in- authors must explain the rationale for their approach and
chief have full authority over the entire editorial content demonstrate that the local, regional, or national review
of their journal and the timing of publication of that con- body explicitly approved the doubtful aspects of the
tent. Journal owners should not interfere in the evalua- study. Approval by a responsible review body does not
tion, selection, scheduling, or editing of individual preclude editors from forming their own judgment
articles either directly or by creating an environment that whether the conduct of the research was appropriate.
strongly influences decisions. Editors should base edito- Patients have a right to privacy that should not be
rial decisions on the validity of the work and its impor- violated without informed consent. Identifying informa-
tance to the journal's readers, not on the commercial tion, including names, initials, or hospital numbers,
implications for the journal, and editors should be free to should not be published in written descriptions, photo-
express critical but responsible views about all aspects of graphs, or pedigrees unless the information is essential
medicine without fear of retribution, even if these views for scientific purposes and the patient (or parent or
conflict with the commercial goals of the publisher. guardian) gives written informed consent for publication.
Editors-in-chief should also have the final say in deci- Informed consent for this purpose requires that an identi-
sions about which advertisements or sponsored content, fiable patient be shown the manuscript to be published.
including supplements, the journal will and will not carry, Authors should disclose to these patients whether any
and they should have final say in use of the journal brand potential identifiable material might be available via the
and in overall policy regarding commercial use of journal Internet as well as in print after publication. Patient con-
content. sent should be written and archived with the journal, the
Journals are encouraged to establish an independ- authors, or both, as dictated by local regulations or laws.
ent and diverse editorial advisory board to help the edi- Applicable laws vary from locale to locale, and journals
tor establish and maintain editorial policy. To support should establish their own policies with legal guidance.
editorial decisions and potentially controversial expres- Since a journal that archives the consent will be aware of
sions of opinion, owners should ensure that appropriate patient identity, some journals may decide that patient
insurance is obtained in the event of legal action against confidentiality is better guarded by having the author
the editors, and should ensure that legal advice is avail- archive the consent and instead providing the journal
able when necessary. If legal problems arise, the editor with a written statement that attests that they have
should inform their legal adviser and their owner and/or received and archived written patient consent.
publisher as soon as possible. Editors should defend the Nonessential identifying details should be omitted.
confidentiality of authors and peer reviewers (names and Informed consent should be obtained if there is any
reviewer comments) in accordance with ICMJE policy doubt that anonymity can be maintained. For example,
(see Section II.C.2.a). Editors should take all reasonable masking the eye region in photographs of patients is
steps to check the facts in journal commentary, including inadequate protection of anonymity. If identifying char-
that in news sections and social media postings, and acteristics are deidentified, authors should provide
should ensure that staff working for the journal adhere to assurance, and editors should so note, that such changes
best journalistic practices including contemporaneous do not distort scientific meaning.
note-taking and seeking a response from all parties The requirement for informed consent should be
when possible before publication. Such practices in sup- included in the journal's instructions for authors. When
port of truth and public interest may be particularly rele- informed consent has been obtained, it should be indi-
vant in defense against legal allegations of libel. cated in the published article.
www.icmje.org 7
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Recommendations for the Conduct, Reporting, Editing, and Publication of Scholarly Work in Medical Journals

When reporting experiments on animals, authors B. Scientific Misconduct, Expressions of


should indicate whether institutional and national stand- Concern, and Retraction
ards for the care and use of laboratory animals were Scientific misconduct in research and non-research
followed. publications includes but is not necessarily limited to
data fabrication; data falsification, including deceptive
manipulation of images; purposeful failure to disclose rela-
III. PUBLISHING AND EDITORIAL ISSUES
tionships and activities; and plagiarism. Some people con-
RELATED TO PUBLICATION IN MEDICAL sider failure to publish the results of clinical trials and other
JOURNALS human studies a form of scientific misconduct. While each
A. Corrections, Retractions, Republications, and of these practices is problematic, they are not equivalent.
Version Control Each situation requires individual assessment by relevant
Honest errors are a part of science and publishing stakeholders. When scientific misconduct is alleged, or
and require publication of a correction when they are concerns are otherwise raised about the conduct or integ-
detected. Corrections are needed for errors of fact. rity of work described in submitted or published papers,
Matters of debate are best handled as letters to the edi- the editor should initiate appropriate procedures detailed
tor, as print or electronic correspondence, or as posts in by such committees as the Committee on Publication Ethics
a journal-sponsored online forum. Updates of previous (COPE) (http://publicationethics.org/resources/flowcharts),
publications (e.g., an updated systematic review or clini- consider informing the institutions and funders, and may
cal guideline) are considered a new publication rather choose to publish an expression of concern pending the
than a version of a previously published article. outcomes of those procedures. If the procedures involve an
If a correction is needed, journals should follow these investigation at the authors' institution, the editor should
minimum standards: seek to discover the outcome of that investigation; notify
• The journal should publish a correction notice as readers of the outcome if appropriate; and if the investiga-
soon as possible detailing changes from and citing tion proves scientific misconduct, publish a retraction of the
the original publication; the correction should be on article. There may be circumstances in which no misconduct
an electronic or numbered print page that is is proven, but an exchange of letters to the editor could be
included in an electronic or a print Table of Contents published to highlight matters of debate to readers.
to ensure proper indexing. Expressions of concern and retractions should not
• The journal should also post a new article version simply be a letter to the editor. Rather, they should be
with details of the changes from the original version prominently labelled, appear on an electronic or num-
and the date(s) on which the changes were made. bered print page that is included in an electronic or a
• The journal should archive all prior versions of the ar- print Table of Contents to ensure proper indexing, and
ticle. This archive can be either directly accessible to include in their heading the title of the original article.
readers or can be made available to the reader on Online, the retraction and original article should be
request. linked in both directions and the retracted article should
• Previous electronic versions should prominently note be clearly labelled as retracted in all its forms (abstract,
that there are more recent versions of the article. full text, PDF). Ideally, the authors of the retraction should
• The citation should be to the most recent version. be the same as those of the article, but if they are unwill-
Pervasive errors can result from a coding problem ing or unable the editor may under certain circumstances
or a miscalculation and may result in extensive inaccura- accept retractions by other responsible persons, or the
cies throughout an article. If such errors do not change editor may be the sole author of the retraction or expres-
the direction or significance of the results, interpreta- sion of concern. The text of the retraction should explain
tions, and conclusions of the article, a correction should why the article is being retracted and include a complete
be published that follows the minimum standards noted citation reference to that article.
above. Retracted articles should remain in the public do-
Errors serious enough to invalidate a paper's results main and be clearly labelled as retracted.
and conclusions may require retraction. However, retrac- The validity of previous work by the author of a fraud-
tion with republication (also referred to as “replacement”) ulent paper cannot be assumed. Editors may ask the
can be considered in cases where honest error (e.g., a author's institution to assure them of the validity of other
work published in their journals, or they may retract it. If
misclassification or miscalculation) leads to a major
this is not done, editors may choose to publish an
change in the direction or significance of the results, inter- announcement expressing concern that the validity of
pretations, and conclusions. If the error is judged to be previously published work is uncertain.
unintentional, the underlying science appears valid, and The integrity of research may also be compromised
the changed version of the paper survives further review by inappropriate methodology that could lead to
and editorial scrutiny, then retraction with republication of retraction.
the changed paper, with an explanation, allows full correc- See COPE flowcharts for further guidance on retrac-
tion of the scientific literature. In such cases, it is helpful to tions and expressions of concern. See Section IV.A.1.g.i
show the extent of the changes in supplementary material for guidance about avoiding referencing retracted
or in an appendix, for complete transparency. articles.
8 www.icmje.org
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Recommendations for the Conduct, Reporting, Editing, and Publication of Scholarly Work in Medical Journals

C. Copyright regulators, or other regulatory agencies to be duplicate


Journals should make clear the type of copyright publication. It also does not prevent journals from consid-
under which work will be published, and if the journal ering a paper that has been presented at a scientific meet-
retains copyright, should detail the journal's position on ing but was not published in full, or that is being
the transfer of copyright for all types of content, includ- considered for publication in proceedings or similar for-
ing audio, video, protocols, and data sets. Medical jour- mat. Press reports of scheduled meetings are not usually
nals may ask authors to transfer copyright to the journal. regarded as breaches of this rule, but they may be if addi-
Some journals require transfer of a publication license. tional data tables or figures enrich such reports. Authors
Some journals do not require transfer of copyright and should also consider how dissemination of their findings
rely on such vehicles as Creative Commons licenses. The outside of scientific presentations at meetings may dimin-
copyright status of articles in a given journal can vary: ish the priority journal editors assign to their work.
Some content cannot be copyrighted (e.g., articles writ- Authors who choose to post their work on a preprint
ten by employees of some governments in the course of server should choose one that clearly identifies preprints
their work). Editors may waive copyright on other con- as not peer-reviewed work and includes disclosures of
tent, and some content may be protected under other authors' relationships and activities. It is the author's
agreements. responsibility to inform a journal if the work has been
previously posted on a preprint server. In addition, it is
D. Overlapping Publications
the author's (and not the journal editors') responsibility
1. Duplicate Submission
Authors should not submit the same manuscript, in to ensure that preprints are amended to point readers to
the same or different languages, simultaneously to more subsequent versions, including the final published arti-
than one journal. The rationale for this standard is the cle. See Section III.D.3.
potential for disagreement when two (or more) journals In the event of a public health emergency (as defined
claim the right to publish a manuscript that has been sub- by public health officials), information with immediate
mitted simultaneously to more than one journal, and the implications for public health should be disseminated
possibility that two or more journals will unknowingly without concern that this will preclude subsequent consid-
and unnecessarily undertake the work of peer review, eration for publication in a journal. We encourage editors
edit the same manuscript, and publish the same article. to give priority to authors who have made crucial data
publicly available without delay.
2. Duplicate and Prior Publication Sharing with public media, government agencies, or
Duplicate publication is publication of a paper that manufacturers the scientific information described in a
overlaps substantially with one already published, with- paper or a letter to the editor that has been accepted but
out clear, visible reference to the previous publication. not yet published violates the policies of many journals.
Prior publication may include release of information in Such reporting may be warranted when the paper or
the public domain. letter describes major therapeutic advances; report-
Readers of medical journals deserve to be able to able diseases; or public health hazards, such as serious
trust that what they are reading is original unless there is adverse effects of drugs, vaccines, other biological
a clear statement that the author and editor are intention- products, medical devices. This reporting, whether in
ally republishing an article (which might be considered print or online, should not jeopardize publication, but
for historic or landmark papers, for example). The bases should be discussed with and agreed upon by the edi-
of this position are international copyright laws, ethical tor in advance when possible.
conduct, and cost-effective use of resources. Duplicate The ICMJE will not consider as prior publication the
publication of original research is particularly problem- posting of trial results in any registry that meets the crite-
atic because it can result in inadvertent double-counting ria noted in Section III.L if results are limited to a brief
of data or inappropriate weighting of the results of a sin- structured abstract or tables (to include participants en-
gle study, which distorts the available evidence. rolled, key outcomes, and adverse events). The ICMJE
When authors submit a manuscript reporting work encourages authors to include a statement with the
that has already been reported in large part in a pub-
registration that indicates that the results have not yet
lished article or is contained in or closely related to
been published in a peer-reviewed journal, and to update
another paper that has been submitted or accepted for
the results registry with the full journal citation when the
publication elsewhere, the letter of submission should
clearly say so and the authors should provide copies of results are published.
the related material to help the editor decide how to Editors of different journals may together decide to
handle the submission. See also Section IV.B. simultaneously or jointly publish an article if they believe
This recommendation does not prevent a journal from that doing so would be in the best interest of public
considering a complete report that follows publication of a health. However, the National Library of Medicine (NLM)
preliminary report, such as a letter to the editor, a preprint, indexes all such simultaneously published joint publica-
or an abstract or poster displayed at a scientific meeting. tions separately, so editors should include a statement
The ICMJE does not consider results or data contained in making the simultaneous publication clear to readers.
assessment reports published by health technology Authors who attempt duplicate publication without
assessment agencies, medical regulators, medical device such notification should expect at least prompt rejection
www.icmje.org 9
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Recommendations for the Conduct, Reporting, Editing, and Publication of Scholarly Work in Medical Journals

of the submitted manuscript. If the editor was not aware has been subsequently published in a peer-reviewed
of the violations and the article has already been pub- journal, authors should cite the subsequent published
lished, then the article might warrant retraction with or article rather than the preprint article whenever appro-
without the author's explanation or approval. priate. Journals should include the word “preprint” fol-
See COPE flowcharts for further guidance on han- lowing the citation information in the reference list and
dling duplicate publication. consider indicating that the cited material is a preprint
in the text. The citation should include the link to the
3. Preprints preprint and DOI if the preprint archive issues DOIs.
Posting of work as a preprint may influence a jour- Authors should be cautious about referencing preprints
nal’s interest in or priority for peer review and publication that were posted and never subsequently published in
of that work. Journals should clearly describe their poli- a peer-reviewed journal, but the time interval of con-
cies related to the posting and citing of preprints in their cern will vary depending on the topic and specific rea-
Information for Authors. Authors should become familiar sons for citation.
with the policies of journals they wish to submit their
work to prior to posting work on a preprint server. 4. Acceptable Secondary Publication
Secondary publication of material published in other
a. Choosing a Preprint Archive journals or online may be justifiable and beneficial, espe-
There has been an increase in preprint archives in cially when intended to disseminate important informa-
biomedicine. There are both benefits and harms in dis- tion to the widest possible audience (e.g., guidelines
semination of scientific findings prior to peer review. To produced by government agencies and professional
maximize potential benefits and minimize potential organizations in the same or a different language).
harms, authors who wish to make preprints of non–peer- Secondary publication for various other reasons may
reviewed work publicly available should choose preprint also be justifiable provided the following conditions are
archives that have the following characteristics: met:
• Clearly identify preprints as work that is not peer 1. The authors have received approval from the editors
reviewed; of both journals (the editor concerned with second-
• Require authors to document disclosures of interest; ary publication must have access to the primary
• Require authors to indicate funding source(s); version).
• Have a clear process for preprint archive users to 2. The priority of the primary publication is respected
notify archive administrators about concerns related by a publication interval negotiated by both editors
with the authors.
to posted preprints—a public commenting feature is
3. The paper for secondary publication is intended for a
desirable for this purpose;
different group of readers; an abbreviated version
• Maintain metadata for preprints that are withdrawn
could be sufficient.
from posting and post withdrawal notices indicating 4. The secondary version faithfully reflects the authors,
the timing and reason for withdrawal of a preprint; and data, and interpretations of the primary version.
• Have a mechanism for authors to indicate when the 5. The secondary version informs readers, peers, and
preprint article has been subsequently published in a documenting agencies that the paper has been pub-
peer-reviewed journal. lished in whole or in part elsewhere—for example,
with a note that might read, “This article is based on a
b. Submitting Manuscripts That Are in Preprint Arch- study first reported in the [journal title, with full refer-
ives to a Peer-Reviewed Journal ence]”—and the secondary version cites the primary
Authors should inform a journal if the work submit- reference.
ted to the journal has been posted on a preprint server 6. The title of the secondary publication should indicate
and provide a link to the preprint, whether the posting that it is a secondary publication (complete or
occurs prior to submission or during the peer-review abridged republication or translation) of a primary
process. It is also helpful to indicate in the text of the publication. Of note, the NLM does not consider
manuscript, perhaps in the introduction, that a preprint is translations to be “republications” and does not cite
available and how reviewers can access that preprint. In or index them when the original article was published
addition, it is the authors’ (and not the journal editors’) in a journal that is indexed in MEDLINE.
responsibility to ensure that preprints are amended to When the same journal simultaneously publishes an
point readers to subsequent versions of the work, includ- article in multiple languages, the MEDLINE citation will
ing the published article. Authors should not post in the note the multiple languages (e.g., Angelo M. Journal net-
preprint archive the published article nor interim ver- working in nursing: a challenge to be shared. Rev Esc
sions that are produced during the peer-review process Enferm USP. 2011 Dec 45[6]:1281-2,1279-80,1283-4.
that incorporate revisions based on journal feedback. Article in English, Portuguese, and Spanish. No abstract
available. PMID: 22241182).
c. Referencing Preprints in Submitted Manuscripts
When preprints are cited in submitted manuscripts 5. Manuscripts Based on the Same Database
or published articles, the citation should clearly indicate If editors receive manuscripts from separate research
that the reference is a preprint. When a preprint article groups or from the same group analyzing the same data
10 www.icmje.org
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Recommendations for the Conduct, Reporting, Editing, and Publication of Scholarly Work in Medical Journals

set (e.g., from a public database, or systematic reviews or In the interests of fairness and to keep correspon-
meta-analyses of the same evidence), the manuscripts dence within manageable proportions, journals may
should be considered independently because they may want to set time limits for responding to published mate-
differ in their analytic methods, conclusions, or both. If rial and for debate on a given topic.
the data interpretation and conclusions are similar, it
may be reasonable although not mandatory for editors F. Fees
to give preference to the manuscript submitted first. Journals should be transparent about their types
Editors might consider publishing more than one manu- of revenue streams. Any fees or charges that are
script that overlap in this way because different analytical required for manuscript processing and/or publishing
approaches may be complementary and equally valid, materials in the journal shall be clearly stated in a place
but manuscripts based upon the same data set should that is easy for potential authors to find prior to submit-
add substantially to each other to warrant consideration ting their manuscripts for review or explained to
for publication as separate papers, with appropriate cita- authors before they begin preparing their manuscript
tion of previous publications from the same data set to for submission (http://publicationethics.org/files/u7140
allow for transparency. /Principles_of_Transparency_and_Best_Practice_in_Scholarly_
Secondary analyses of clinical trial data should cite Publishing.pdf).
any primary publication, clearly state that it contains sec-
ondary analyses/results, and use the same identifying G. Supplements, Theme Issues, and Special
trial registration number as the primary trial and unique, Series
persistent data set identifier. Supplements are collections of papers that deal with
Sometimes for large trials it is planned from the be- related issues or topics, are published as a separate issue
ginning to produce numerous separate publications of the journal or as part of a regular issue, and may be
regarding separate research questions but using the funded by sources other than the journal's publisher.
same original participant sample. In this case authors Because funding sources can bias the content of supple-
may use the original single trial registration number, if all ments through the choice of topics and viewpoints, jour-
the outcome parameters were defined in the original nals should adopt the following principles, which also
registration. If the authors registered several substudies apply to theme issues or special series that have external
as separate entries in, for example, ClinicalTrials.gov, funding and/or guest editors:
then the unique trial identifier should be given for the study 1. The journal editor must be given and must take full
in question. The main issue is transparency, so no matter responsibility for the policies, practices, and content
what model is used it should be obvious for the reader. of supplements, including complete control of the
decision to select authors, peer reviewers, and con-
E. Correspondence tent for the supplement. Editing by the funding orga-
Medical journals should provide readers with a nization should not be permitted.
mechanism for submitting comments, questions, or 2. The journal editor has the right to appoint one or
criticisms about published articles, usually but not neces- more external editors of the supplement and must
sarily always through a correspondence section or online take responsibility for the work of those editors.
forum. The authors of articles discussed in correspon- 3. The journal editor must retain the authority to send
dence or an online forum have a responsibility to res- supplement manuscripts for external peer review and
pond to substantial criticisms of their work using those to reject manuscripts submitted for the supplement
same mechanisms and should be asked by editors to with or without external review. These conditions
respond. Authors of correspondence should be asked to should be made known to authors and any external
declare any competing relationships or activities. editors of the supplement before beginning editorial
Correspondence may be edited for length, gram- work on it.
matical correctness, and journal style. Alternatively, edi- 4. The source of the idea for the supplement, sources of
tors may choose to make available to readers unedited funding for the supplement's research and publica-
correspondence, for example, via an online commenting tion, and products of the funding source related to
system. Such commenting is not indexed in MEDLINE content considered in the supplement should be
unless it is subsequently published on a numbered elec- clearly stated in the introductory material.
tronic or print page. However the journal handles corre- 5. Advertising in supplements should follow the same
spondence, it should make known its practice. In all policies as those of the primary journal.
instances, editors must make an effort to screen discour- 6. Journal editors must enable readers to distinguish
teous, inaccurate, or libellous comments. readily between ordinary editorial pages and supple-
Responsible debate, critique, and disagreement are ment pages.
important features of science, and journal editors should 7. Journal and supplement editors must not accept per-
encourage such discourse ideally within their own jour- sonal favors or direct remuneration from sponsors of
nals about the material they have published. Editors, supplements.
however, have the prerogative to reject correspondence 8. Secondary publication in supplements (republication
that is irrelevant, uninteresting, or lacking cogency, but of papers published elsewhere) should be clearly
they also have a responsibility to allow a range of opin- identified by the citation of the original paper and by
ions to be expressed and to promote debate. the title.
www.icmje.org 11
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Recommendations for the Conduct, Reporting, Editing, and Publication of Scholarly Work in Medical Journals

9. The same principles of authorship and disclosure of Journals should have formal, explicit, written policies
relationships and activities discussed elsewhere in for advertising in both print and electronic versions. Best
this document should be applied to supplements. practice prohibits selling advertisements intended to be
juxtaposed with editorial content on the same product.
H. Sponsorship or Partnership Advertisements should be clearly identifiable as adver-
Various entities may seek interactions with journals tisements. Editors should have full and final authority for
or editors in the form of sponsorships, partnerships, approving print and online advertisements and for
meetings, or other types of activities. To preserve edito- enforcing advertising policy.
rial independence, these interactions should be gov- Journals should not carry advertisements for prod-
erned by the same principles outlined above for ucts proven to be seriously harmful to health. Editors
Supplements, Theme Issues, and Special Series (Section should ensure that existing regulatory or industry stand-
III.G). ards for advertisements specific to their country are
enforced, or develop their own standards. The interests
I. Electronic Publishing
of organizations or agencies should not control classified
Most medical journals are now published in elec-
and other nondisplay advertising, except where required
tronic as well as print versions, and some are published
by law. Editors should consider all criticisms of advertise-
only in electronic form. Principles of print and electronic
ments for publication.
publishing are identical, and the recommendations of
this document apply equally to both. However, elec-
K. Journals and the Media
tronic publishing provides opportunities for versioning
Journals' interactions with media should balance
and raises issues about link stability and content preser-
competing priorities. The general public has a legitimate
vation that are addressed here.
interest in all journal content and is entitled to important
Recommendations for corrections and versioning
information within a reasonable amount of time, and edi-
are detailed in Section III.A.
tors have a responsibility to facilitate that. However,
Electronic publishing allows linking to sites and
media reports of scientific research before it has been
resources beyond journals over which journal editors
peer-reviewed and fully vetted may lead to dissemina-
have no editorial control. For this reason, and because
tion of inaccurate or premature conclusions, and doctors
links to external sites could be perceived as implying
in practice need to have research reports available in full
endorsement of those sites, journals should be cautious
about external linking. When a journal does link to an detail before they can advise patients about the reports'
external site, it should state that it does not endorse or conclusions.
take responsibility or liability for any content, advertising, An embargo system has been established in some
products, or other materials on the linked sites, and does countries and by some journals to assist this balance,
not take responsibility for the sites' availability. and to prevent publication of stories in the general
Permanent preservation of journal articles on a jour- media before publication of the original research in the
nal's website, or in an independent archive or a credible journal. For the media, the embargo creates a “level
repository, is essential for the historical record. Remo- playing field,” which most reporters and writers appreci-
ving an article from a journal's website in its entirety is ate since it minimizes the pressure on them to publish
almost never justified as copies of the article may have stories before competitors when they have not had time
been downloaded even if its online posting was brief. to prepare carefully. Consistency in the timing of public
Such archives should be freely accessible or accessible to release of biomedical information is also important in
archive members. Deposition in multiple archives is en- minimizing economic chaos, since some articles contain
couraged. However, if necessary for legal reasons (e.g., information that has potential to influence financial mar-
libel action), the URL for the removed article must contain kets. The ICMJE acknowledges criticisms of embargo
a detailed reason for the removal, and the article must be systems as being self-serving of journals' interests and an
retained in the journal's internal archive. impediment to rapid dissemination of scientific informa-
Permanent preservation of a journal's total content is tion, but believes the benefits of the systems outweigh
the responsibility of the journal publisher, who in the their harms.
event of journal termination should be certain the journal The following principles apply equally to print and
electronic publishing and may be useful to editors as
files are transferred to a responsible third party who can
they seek to establish policies on interactions with the
make the content available.
media:
Journal websites should post the date that nonarticle
• Editors can foster the orderly transmission of medical
web pages, such as those listing journal staff, editorial
board members, and instructions for authors, were last information from researchers, through peer-reviewed
updated. journals, to the public. This can be accomplished by
an agreement with authors that they will not publicize
J. Advertising their work while their manuscript is under considera-
Most medical journals carry advertising, which gen- tion or awaiting publication and an agreement with
erates income for their publishers, but journals should the media that they will not release stories before pub-
not be dominated by advertisements, and advertising lication of the original research in the journal, in return
must not be allowed to influence editorial decisions. for which the journal will cooperate with them in
12 www.icmje.org
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Recommendations for the Conduct, Reporting, Editing, and Publication of Scholarly Work in Medical Journals

preparing accurate stories by issuing, for example, a ICMJE uses the date trial registration materials were
press release. first submitted to a registry as the date of registration.
• Editors need to keep in mind that an embargo sys- When there is a substantial delay between the submis-
tem works on the honor system—no formal enforce- sion of registration materials and their posting at the trial
ment or policing mechanism exists. The decision of a registry, editors may inquire about the circumstances
significant number of media outlets or biomedical that led to the delay.
journals not to respect the embargo system would The ICMJE defines a clinical trial as any research pro-
lead to its rapid dissolution. ject that prospectively assigns people or a group of peo-
• Notwithstanding authors' belief in their work, very lit- ple to an intervention, with or without concurrent
tle medical research has such clear and urgently im- comparison or control groups, to study the relationship
portant clinical implications for the public's health between a health-related intervention and a health out-
come. Health-related interventions are those used to
that the news must be released before full publica-
modify a biomedical or health-related outcome; examples
tion in a journal. When such exceptional circumstan-
include drugs, surgical procedures, devices, behavioral
ces occur, the appropriate authorities responsible for
treatments, educational programs, dietary interventions,
public health should decide whether to disseminate
quality improvement interventions, and process-of-care
information to physicians and the media in advance changes. Health outcomes are any biomedical or health-
and should be responsible for this decision. If the related measures obtained in patients or participants,
author and the appropriate authorities wish to have a including pharmacokinetic measures and adverse events.
manuscript considered by a particular journal, the The ICMJE does not define the timing of first participant
editor should be consulted before any public enrollment, but best practice dictates registration by the
release. If editors acknowledge the need for immedi- time of first participant consent.
ate release, they should waive their policies limiting The ICMJE accepts publicly accessible registration in
prepublication publicity. any registry that is a primary register of the WHO
• Policies designed to limit prepublication publicity International Clinical Trials Registry Platform (ICTRP)
should not apply to accounts in the media of presen- (www.who.int/clinical-trials-registry-platform/network/who-
tations at scientific meetings or to the abstracts from data-set) that includes the minimum acceptable 24-item
these meetings (see Duplicate Publication). Resear- trial registration data set or in ClinicalTrials.gov, which is a
chers who present their work at a scientific meeting data provider to the WHO ICTRP. The ICMJE endorses
should feel free to discuss their presentations with these registries because they meet several criteria. They
reporters but should be discouraged from offering are accessible to the public at no charge, open to all
more detail about their study than was presented in prospective registrants, managed by a not-for-profit orga-
the talk, or should consider how giving such detail nization, have a mechanism to ensure the validity of the
might diminish the priority journal editors assign to registration data, and are electronically searchable. An
acceptable registry must include the minimum 24-item
their work (see Duplicate Publication).
trial registration data set (http://prsinfo.clinicaltrials.gov/
• When an article is close to being published, editors
trainTrainer/WHO-ICMJE-ClinTrialsgov-Cross-Ref.pdf or
or journal staff should help the media prepare accu-
www.who.int/clinical-trials-registry-platform) at the time of
rate reports by providing news releases, answering registration and before enrollment of the first participant.
questions, supplying advance copies of the article, or The ICMJE considers inadequate trial registrations
referring reporters to appropriate experts. This assis- missing any of the 24 data fields, those that have fields
tance should be contingent on the media's coopera- that contain uninformative information, or registrations
tion in timing the release of a story to coincide with that are not made publicly accessible such as phase I tri-
publication of the article. als submitted to the CTIS (Clinical Trials Information
System) and trials of devices for which the information
L. Clinical Trials is placed in a “lock box.” In order to comply with
1. Registration ICMJE policy, investigators registering trials of devices
The ICMJE's clinical trial registration policy is at ClinicalTrials.gov must “opt out” of the lock box by electing
detailed in a series of editorials (see News and Editorials public posting prior to device approval. Approval to conduct
[www.icmje.org/news-and-editorials/] and FAQs [www. a study from an independent local, regional, or national
icmje.org/about-icmje/faqs/]). review body (e.g., ethics committee, institutional review
Briefly, the ICMJE requires, and recommends that all board) does not fulfill the ICMJE requirement for pro-
medical journal editors require, registration of clinical tri- spective clinical trial registration. Although not a required
als in a public trials registry at or before the time of first item, the ICMJE encourages authors to include a state-
patient enrollment as a condition of consideration for ment that indicates that the results have not yet been
publication. Editors requesting inclusion of their journal published in a peer-reviewed journal, and to update the
on the ICMJE website list of publications that follow registration with the full journal citation when the results
ICMJE guidance (www.icmje.org/journals.html) should are published.
recognize that the listing implies enforcement by the The purpose of clinical trial registration is to prevent
journal of ICMJE's trial registration policy. selective publication and selective reporting of research
www.icmje.org 13
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Recommendations for the Conduct, Reporting, Editing, and Publication of Scholarly Work in Medical Journals

outcomes, to prevent unnecessary duplication of research trial registration is explained at www.icmje.org/


effort, to help patients and the public know what trials recommendations/browse/publishing-and-editorial-
are planned or ongoing into which they might want to issues/clinical-trial-registration.html. If the data shar-
enroll, and to help give ethics review boards consider- ing plan changes after registration this should be
ing approval of new studies a view of similar work and reflected in the statement submitted and pub-
lished with the manuscript, and updated in the
data relevant to the research they are considering.
registry record.
Retrospective registration, for example at the time of Data sharing statements must indicate the following:
manuscript submission, meets none of these purposes. whether individual deidentified participant data (includ-
Those purposes apply also to research with alternative ing data dictionaries) will be shared (“undecided” is not
designs, for example observational studies. For that an acceptable answer); what data in particular will be
reason, the ICMJE encourages registration of research shared; whether additional, related documents will be
with non-trial designs, but because the exposure or available (e.g., study protocol, statistical analysis plan,
intervention in non-trial research is not dictated by the etc.); when the data will become available and for how
researchers, the ICMJE does not require it. long; by what access criteria data will be shared (includ-
Secondary data analyses of primary (parent) clinical ing with whom, for what types of analyses, and by what
trials should not be registered as separate clinical trials, mechanism). Illustrative examples of data sharing state-
but instead should reference the trial registration num- ments that would meet these requirements are provided
ber of the primary trial. in Table 1.
The ICMJE expects authors to ensure that they have Authors of secondary analyses using shared data
met the requirements of their funding and regulatory must attest that their use was in accordance with the
agencies regarding aggregate clinical trial results report- terms (if any) agreed to upon their receipt. They must
ing in clinical trial registries. It is the authors', and not the also reference the source of the data using its unique,
journal editors', responsibility to explain any discrepan- persistent identifier to provide appropriate credit to
cies between results reported in registries and journal those who generated it and allow searching for the stud-
publications. The ICMJE will not consider as prior publi- ies it has supported. Authors of secondary analyses must
cation the posting of trial results in any registry that explain completely how theirs differ from previous analy-
meets the above criteria if results are limited to a brief ses. In addition, those who generate and then share clini-
structured abstract or tables (to include trial participants cal trial data sets deserve substantial credit for their
enrolled, baseline characteristics, primary and secondary efforts. Those using data collected by others should seek
outcomes, and adverse events). collaboration with those who collected the data. As col-
laboration will not always be possible, practical, or
The ICMJE recommends that journals publish the
desired, the efforts of those who generated the data
trial registration number at the end of the abstract. The
must be recognized.
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 IV. MANUSCRIPT PREPARATION AND
reporting or to other trials that they mention in the SUBMISSION
manuscript. A. Preparing a Manuscript for Submission to a
Editors may consider whether the circumstances
Medical Journal
involved in a failure to appropriately register a clinical
1. General Principles
trial were likely to have been intended to or resulted in
The text of articles reporting original research is usu-
biased reporting. Because of the importance of prospec- ally divided into Introduction, Methods, Results, and
tive trial registration, if an exception to this policy is Discussion sections. This so-called “IMRAD” structure is
made, trials must be registered and the authors should not an arbitrary publication format but a reflection of the
indicate in the publication when registration was com- process of scientific discovery. Articles often need sub-
pleted and why it was delayed. Editors should publish a headings within these sections to further organize their
statement indicating why an exception was allowed. The content. Other types of articles, such as meta-analyses,
ICMJE emphasizes that such exceptions should be rare, may require different formats, while case reports, narra-
and that authors failing to prospectively register a trial tive reviews, and editorials may have less structured or
risk its inadmissibililty to our journals. unstructured formats.
Electronic formats have created opportunities for
2. Data Sharing adding details or sections, layering information, cross-
The ICMJE's data sharing statement policy is detailed linking, or extracting portions of articles in electronic ver-
in an editorial (see Updates and Editorials [www.icmje. sions. Supplementary electronic-only material should be
org/update.html]). submitted and sent for peer review simultaneously with
1. As of 1 July 2018 manuscripts submitted to ICMJE the primary manuscript.
journals that report the results of clinical trials must
contain a data sharing statement as described below. 2. Reporting Guidelines
2. Clinical trials that begin enrolling participants on or Reporting guidelines have been developed for differ-
after 1 January 2019 must include a data sharing plan ent study designs; examples include CONSORT (www.
in the trial's registration. The ICMJE's policy regarding consort-statement.org) for randomized trials, STROBE
14 www.icmje.org
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Recommendations for the Conduct, Reporting, Editing, and Publication of Scholarly Work in Medical Journals

Table 1. Examples of Data Sharing Statements That Fulfill These ICMJE Requirements*
Example 1 Example 2 Example 3 Example 4
Will individual participant Yes Yes Yes No
data be available
(including data
dictionaries)?
What data in particular All of the individual participant Individual participant data that Individual participant data that Not available
will be shared? data collected during the underlie the results reported underlie the results reported
trial, after deidentification. in this article, after deidenti- in this article, after deidenti-
fication (text, tables, figures, fication (text, tables, figures,
and appendices). and appendices).
What other documents Study Protocol, Statistical Study Protocol, Statistical Study Protocol Not available
will be available? Analysis Plan, Informed Analysis Plan, Analytic Code
Consent Form, Clinical
Study Report, Analytic Code
When will data be avail- Immediately following publica- Beginning 3 months and end- Beginning 9 months and end- Not applicable
able (start and end tion. No end date. ing 5 years following article ing 36 months following arti-
dates)? publication. cle publication.
With whom? Anyone who wishes to access Researchers who provide a Investigators whose proposed Not applicable
the data. methodologically sound use of the data has been
proposal. approved by an independ-
ent review committee
(learned intermediary) iden-
tified for this purpose.
For what types of Any purpose. To achieve aims in the For individual participant data Not applicable
analyses? approved proposal. meta-analysis.
By what mechanism will Data are available indefinitely Proposals should be directed Proposals may be submitted Not applicable
data be made at (Link to be included). to xxx@yyy. up to 36 months following
available? To gain access, data reques- article publication. After 36
tors will need to sign a data months the data will be
access agreement. Data are available in our University's
available for 5 years at a data warehouse but without
third-party website (Link to investigator support other
be included). than deposited metadata.
Information regarding sub-
mitting proposals and
accessing data may be
found at (Link to be
provided).

*These examples are meant to illustrate a range of, but not all, data sharing options.

for observational studies (http://strobe-statement.org/), a. Title Page


PRISMA for systematic reviews and meta-analyses General information about an article and its authors
(http://prisma-statement.org/), and STARD for studies of is presented on a manuscript title page and usually
diagnostic accuracy (http://www.equator-network.org/ includes the article title, author information, any disclaim-
reporting-guidelines/stard/). Journals are encouraged to ers, sources of support, word count, and sometimes the
ask authors to follow these guidelines because they help number of tables and figures.
authors describe the study in enough detail for it to be Article title. The title provides a distilled description
evaluated by editors, reviewers, readers, and other of the complete article and should include information
researchers evaluating the medical literature. Authors that, along with the abstract, will make electronic retrieval
are encouraged to refer to the SAGER guidelines for of the article sensitive and specific. Reporting guidelines
reporting of sex and gender information in study design, recommend and some journals require that information
data analyses, results, and interpretation of findings: about the study design be a part of the title (particularly
www.equator-network.org/reporting-guidelines/sager- important for randomized trials and systematic reviews
guidelines/. Authors of review manuscripts are encour- and meta-analyses). Some journals require a short title,
aged to describe the methods used for locating, selecting,
usually no more than 40 characters (including letters and
extracting, and synthesizing data; this is mandatory for sys-
spaces) on the title page or as a separate entry in an elec-
tematic reviews. Good sources for reporting guidelines
tronic submission system. Electronic submission systems
are the EQUATOR Network (www.equator-network.org/
home/) and the NLM's Research Reporting Guidelines may restrict the number of characters in the title.
and Initiatives (www.nlm.nih.gov/services/research_report_ Author information. Each author's highest academic
guide.html). degrees should be listed, although some journals do not
publish these. The name of the department(s) and institu-
3. Manuscript Sections tion(s) or organizations where the work should be attrib-
The following are general requirements for reporting uted should be specified. Most electronic submission
within sections of all study designs and manuscript formats. systems require that authors provide full contact information,
www.icmje.org 15
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Recommendations for the Conduct, Reporting, Editing, and Publication of Scholarly Work in Medical Journals

including land mail and e-mail addresses, but the title page Because abstracts are the only substantive portion of
should list the corresponding author's telephone number the article indexed in many electronic databases, and the
and e-mail address. ICMJE encourages the listing of authors' only portion many readers read, authors need to ensure
Open Researcher and Contributor Identification (ORCID). that they accurately reflect the content of the article.
Disclaimers. An example of a disclaimer is an Unfortunately, information in abstracts often differs from
author's statement that the views expressed in the sub- that in the text. Authors and editors should work in the
mitted article are his or her own and not an official posi- process of revision and review to ensure that information
tion of the institution or funder. is consistent in both places. The format required for
Source(s) of support. These include grants, equip- structured abstracts differs from journal to journal, and
ment, drugs, and/or other support that facilitated con- some journals use more than one format; authors need
duct of the work described in the article or the writing of to prepare their abstracts in the format specified by the
the article itself. Inappropriate attribution of funding journal they have chosen.
sources and affiliations are misleading and should be The ICMJE recommends that journals publish the
avoided. clinical trial registration number at the end of the
Word count. A word count for the paper's text, abstract. The ICMJE also recommends that, when a
registration number is available, authors list that number
excluding its abstract, acknowledgments, tables, figure
the first time they use a trial acronym to refer to the trial
legends, and references, allows editors and reviewers to they are reporting or to other trials that they mention in
assess whether the information contained in the paper the manuscript. If the data have been deposited in a
warrants the paper's length, and whether the submitted public repository and/or are being used in a secondary
manuscript fits within the journal's formats and word lim- analysis, authors should state at the end of the abstract
its. A separate word count for the abstract is useful for the unique, persistent data set identifier; repository
the same reason. name; and number.
Number of figures and tables. Some submission sys-
tems require specification of the number of figures and c. Introduction
tables before uploading the relevant files. These num- Provide a context or background for the study (that
bers allow editorial staff and reviewers to confirm that all is, the nature of the problem and its significance). State
figures and tables were actually included with the manu- the specific purpose or research objective of, or hypoth-
script and, because tables and figures occupy space, to esis tested by, the study or observation. Cite only directly
assess if the information provided by the figures and pertinent references, and do not include data or conclu-
tables warrants the paper's length and if the manuscript sions from the work being reported.
fits within the journal's space limits.
Disclosure of relationships and activities. Disclosure d. Methods
information for each author needs to be part of the The guiding principle of the Methods section should
manuscript; each journal should develop standards with be clarity about how and why a study was done in a par-
regard to the form the information should take and ticular way. The Methods section should aim to be suffi-
where it will be posted. The ICMJE has developed a uni- ciently detailed such that others with access to the data
form Disclosure Form for use by ICMJE member journals would be able to reproduce the results. In general, the
(www.icmje.org/coi_disclosure.pdf), and the ICMJE en- section should include only information that was avail-
courages other journals to adopt it. Despite availability able at the time the plan or protocol for the study was
of the form, editors may require disclosure of relation- being written; all information obtained during the study
ships and activities on the manuscript title page or other belongs in the Results section. If an organization was
Disclosure section in the manuscript to save the work of paid or otherwise contracted to help conduct the
collecting forms from each author prior to making an edi- research (examples include data collection and manage-
torial decision or to save reviewers and readers the work
ment), then this should be detailed in the methods.
of reading each author's form.
The Methods section should include a statement
b. Abstract
indicating that the research was approved by an inde-
Original research, systematic reviews, and meta- pendent local, regional or national review body (e.g.,
analyses require structured abstracts. The abstract ethics committee, institutional review board). If doubt
should provide the context or background for the study exists whether the research was conducted in accord-
and should state the study's purpose, basic procedures ance with the Helsinki Declaration, the authors must
(selection of study participants, settings, measurements, explain the rationale for their approach and demonstrate
analytical methods), main findings (giving specific effect that the local, regional or national review body explicitly
sizes and their statistical and clinical significance, if possi- approved the doubtful aspects of the study. See Section
ble), and principal conclusions. It should emphasize new II.E.
and important aspects of the study or observations, note
important limitations, and not overinterpret findings. i. Selection and Description of Participants
Clinical trial abstracts should include items that the
Clearly describe the selection of observational or ex-
CONSORT group has identified as essential (www.consort-
statement.org/resources/downloads/extensions/consort- perimental participants (healthy individuals or patients,
extension-for-abstracts-2008pdf/). Funding sources should including controls), including eligibility and exclusion cri-
be listed separately after the abstract to facilitate teria and a description of the source population.
proper display and indexing for search retrieval by Because the relevance of such variables as age, sex, or
MEDLINE. ethnicity is not always known at the time of study design,
16 www.icmje.org
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Recommendations for the Conduct, Reporting, Editing, and Publication of Scholarly Work in Medical Journals

researchers should aim for inclusion of representative section. Extra or supplementary materials and technical
populations into all study types and at a minimum pro- details can be placed in an appendix where they will be
vide descriptive data for these and other relevant demo- accessible but will not interrupt the flow of the text, or
graphic variables. Comment on how representative the they can be published solely in the electronic version of
study sample is of the larger population of interest. the journal.
Ensure correct use of the terms sex (when reporting Give numeric results not only as derivatives (e.g.,
biological factors) and gender (identity, psychosocial or percentages) but also as the absolute numbers from
cultural factors), and, unless inappropriate, report the sex which the derivatives were calculated. Restrict tables and
and/or gender of study participants, the sex of animals figures to those needed to explain the argument of the
or cells, and describe the methods used to determine paper and to assess supporting data. Use graphs as an
sex and gender. If the study was done involving an exclu- alternative to tables with many entries; do not duplicate
sive population, for example in only one sex, authors data in graphs and tables. Avoid nontechnical uses of
should justify why. Authors should define how they deter- technical terms in statistics, such as “random” (which
mined race or ethnicity and justify their relevance. In the implies a randomizing device), “normal,” “significant,”
case where race or ethnicity was not collected, explain “correlations,” and “sample.”
why it was not collected. Race and ethnicity are social and Separate reporting of data by demographic varia-
not biological constructs; authors should interpret results bles, such as age and sex, facilitate pooling of data for
associated with race and ethnicity in that context. Authors subgroups across studies and should be routine, unless
should use neutral, precise, and respectful language to there are compelling reasons not to stratify reporting,
describe study participants and avoid the use of terminol- which should be explained.
ogy that might stigmatize participants.
f. Discussion
ii. Technical Information It is useful to begin the discussion by briefly summa-
Specify the study's main and secondary objectives— rizing the main findings, and explore possible mecha-
usually identified as primary and secondary outcomes. nisms or explanations for these findings. Emphasize the
Identify methods, equipment (give the manufacturer's new and important aspects of your study and put your
name and address in parentheses), and procedures in findings in the context of the totality of the relevant evi-
sufficient detail to allow others to reproduce the results. dence. State the limitations of your study, and explore
Give references to established methods, including statis- the implications of your findings for future research and
tical methods (see below); provide references and brief for clinical practice or policy. Discuss the influence or
descriptions for methods that have been published but association of variables, such as sex and/or gender, on
are not well-known; describe new or substantially modi- your findings, where appropriate, and the limitations of
fied methods, give the reasons for using them, and eval- the data. Do not repeat in detail data or other informa-
uate their limitations. Identify precisely all drugs and tion given in other parts of the manuscript, such as in the
chemicals used, including generic name(s), dose(s), and Introduction or the Results section.
route(s) of administration. Identify appropriate scientific Link the conclusions with the goals of the study but
names and gene names. avoid unqualified statements and conclusions not
adequately supported by the data. In particular, distin-
iii. Statistics guish between clinical and statistical significance, and
Describe statistical methods with enough detail to avoid making statements on economic benefits and
enable a knowledgeable reader with access to the origi- costs unless the manuscript includes the appropriate
nal data to judge its appropriateness for the study and to economic data and analyses. Avoid claiming priority or
verify the reported results. When possible, quantify find- alluding to work that has not been completed. State new
ings and present them with appropriate indicators of hypotheses when warranted, but label them clearly.
measurement error or uncertainty (such as confidence
intervals). Avoid relying solely on statistical hypothesis g. References
testing, such as P values, which fail to convey important
information about effect size and precision of estimates. i. General Considerations
References for the design of the study and statistical Authors should provide direct references to original
methods should be to standard works when possible research sources whenever possible. References should
(with pages stated). Define statistical terms, abbrevia- not be used by authors, editors, or peer reviewers to pro-
tions, and most symbols. Specify the statistical software mote self-interests. Authors should avoid citing articles
package(s) and versions used. Distinguish prespecified from predatory or pseudo-journals. When preprints are
from exploratory analyses, including subgroup analyses. cited, the citation should clearly indicate that the refer-
ence is a preprint (also see Section III.D.3). Although
e. Results references to review articles can be an efficient way to
Present your results in logical sequence in the text, guide readers to a body of literature, review articles do
tables, and figures, giving the main or most important not always reflect original work accurately. On the other
findings first. Do not repeat all the data in the tables or hand, extensive lists of references to original work on a
figures in the text; emphasize or summarize only the topic can use excessive space. Fewer references to key
most important observations. Provide data on all primary original papers often serve as well as more exhaustive
and secondary outcomes identified in the Methods lists, particularly since references can now be added to
www.icmje.org 17
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Recommendations for the Conduct, Reporting, Editing, and Publication of Scholarly Work in Medical Journals

the electronic version of published papers, and since audio and visual media; material on CD-ROM, DVD, or
electronic literature searching allows readers to retrieve disk; and material on the Internet.
published literature efficiently.
References to papers accepted but not yet pub- h. Tables
lished should be designated as “in press” or “forthcom- Tables capture information concisely and display it
ing.” Information from manuscripts submitted but not efficiently; they also provide information at any desired
accepted should be cited in the text as “unpublished level of detail and precision. Including data in tables
observations” with written permission from the source. rather than text frequently makes it possible to reduce
Published articles should reference the unique, per- the length of the text.
sistent identifiers of the data sets employed. Prepare tables according to the specific journal's
Avoid citing a “personal communication” unless it requirements; to avoid errors it is best if tables can be
provides essential information not available from a pub-
directly imported into the journal's publication software.
lic source, in which case the name of the person and
Number tables consecutively in the order of their first
date of communication should be cited in parentheses in
the text. For scientific articles, obtain written permission citation in the text and supply a title for each. Titles in
and confirmation of accuracy from the source of a perso- tables should be short but self-explanatory, containing
nal communication. information that allows readers to understand the table's
Referencing AI-generated material as the primary content without having to go back to the text. Be sure
source is not acceptable. that each table is cited in the text.
Some but not all journals check the accuracy of all Give each column a short or an abbreviated heading.
reference citations; thus, citation errors sometimes Authors should place explanatory matter in footnotes,
appear in the published version of articles. To minimize not in the heading. Explain all nonstandard abbreviations
such errors, references should be verified using either an in footnotes, and use symbols to explain information if
electronic bibliographic source, such as PubMed, or needed. Symbols may vary from journal to journal (alpha-
print copies from original sources. Authors are responsi- bet letter or such symbols as *, †, ‡, §), so check each
ble for checking that none of the references cite journal's instructions for authors for required practice.
retracted articles except in the context of referring to the Identify statistical measures of variations, such as stand-
retraction. For articles published in journals indexed in ard deviation and standard error of the mean.
MEDLINE, the ICMJE considers PubMed the authorita- If you use data from another published or unpub-
tive source for information about retractions. Authors can lished source, obtain permission and acknowledge that
identify retracted articles in MEDLINE by searching source fully.
PubMed for “Retracted publication [pt]”, where the term Additional tables containing backup data too exten-
“pt” in square brackets stands for publication type, or sive to publish in print may be appropriate for publica-
by going directly to the PubMed's list of retracted publi- tion in the electronic version of the journal, deposited
cations (https://www.ncbi.nlm.nih.gov/pubmed/?term= with an archival service, or made available to readers
retracted+publication+[pt]). directly by the authors. An appropriate statement should
References should be numbered consecutively in be added to the text to inform readers that this addi-
the order in which they are first mentioned in the text. tional information is available and where it is located.
Identify references in text, tables, and legends by Arabic Submit such tables for consideration with the paper so
numerals in parentheses. that they will be available to the peer reviewers.
References cited only in tables or figure legends
should be numbered in accordance with the sequence i. Illustrations (Figures)
established by the first identification in the text of the par- Digital images of manuscript illustrations should be
ticular table or figure. The titles of journals should be submitted in a suitable format for print publication. Most
submission systems have detailed instructions on the
abbreviated according to the style used for MEDLINE
quality of images and check them after manuscript
(www.ncbi.nlm.nih.gov/nlmcatalog/journals). Journals
upload. For print submissions, figures should be either
vary on whether they ask authors to cite electronic refer- professionally drawn and photographed, or submitted
ences within parentheses in the text or in numbered refer- as photographic-quality digital prints.
ences following the text. Authors should consult with the For radiological and other clinical and diagnostic
journal to which they plan to submit their work. images, as well as pictures of pathology specimens or
photomicrographs, send high-resolution photographic
ii. Style and Format image files. Before-and-after images should be taken
References should follow the standards summarized with the same intensity, direction, and color of light.
in the NLM's Sample References (www.nlm.nih.gov/bsd/ Since blots are used as primary evidence in many scien-
uniform_requirements.html) webpage and detailed in tific articles, editors may require deposition of the origi-
the NLM's Citing Medicine, 2nd edition (www.ncbi.nlm. nal photographs of blots on the journal's website.
nih.gov/books/NBK7256/). These resources are regularly Although some journals redraw figures, many do
updated as new media develop, and currently include not. Letters, numbers, and symbols on figures should
guidance for print documents; unpublished material; therefore be clear and consistent throughout, and large
18 www.icmje.org
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Recommendations for the Conduct, Reporting, Editing, and Publication of Scholarly Work in Medical Journals

enough to remain legible when the figure is reduced for A full statement to the editor about all submissions
publication. Figures should be made as self-explanatory and previous reports that might be regarded as redun-
as possible, since many will be used directly in slide pre- dant publication of the same or very similar work. Any
sentations. Titles and detailed explanations belong in the such work should be referred to specifically and refer-
legends—not on the illustrations themselves. enced in the new paper. Copies of such material should
Photomicrographs should have internal scale be included with the submitted paper to help the editor
markers. Symbols, arrows, or letters used in photomicro- address the situation. See also Section III.D.2.
graphs should contrast with the background. Explain the A statement of financial or other relationships and
internal scale and identify the method of staining in activities that might lead to a conflict of interest, if that in-
photomicrographs. formation is not included in the manuscript itself or in an
Figures should be numbered consecutively accord- authors' form. See also Section II.B.
ing to the order in which they have been cited in the text. A statement on authorship. Journals that do not use
If a figure has been published previously, acknowledge contribution declarations for all authors may require that
the original source and submit written permission from the submission letter includes a statement that the manu-
the copyright holder to reproduce it. Permission is
script has been read and approved by all the authors,
required irrespective of authorship or publisher except
that the requirements for authorship as stated earlier in
for documents in the public domain.
In the manuscript, legends for illustrations should be this document have been met, and that each author
on a separate page, with Arabic numerals corresponding believes that the manuscript represents honest work if
to the illustrations. When symbols, arrows, numbers, or that information is not provided in another form. See
letters are used to identify parts of the illustrations, iden- also Section II.A.
tify and explain each one clearly in the legend. Contact information for the author responsible for
communicating with other authors about revisions and
j. Units of Measurement final approval of the proofs, if that information is not
Measurements of length, height, weight, and volume included in the manuscript itself.
should be reported in metric units (meter, kilogram, or li- The letter or form should inform editors if concerns
ter) or their decimal multiples. have been raised (e.g., via institutional and/or regulatory
Temperatures should be in degrees Celsius. Blood bodies) regarding the conduct of the research or if cor-
pressures should be in millimeters of mercury, unless rective action has been recommended. The letter or
other units are specifically required by the journal. form should give any additional information that may be
Journals vary in the units they use for reporting he- helpful to the editor, such as the type or format of article
matologic, clinical chemistry, and other measurements. in the particular journal that the manuscript represents. If
Authors must consult the Information for Authors of the the manuscript has been submitted previously to
particular journal and should report laboratory informa- another journal, it is helpful to include the previous edi-
tion in both local and International System of Units (SI). tor's and reviewers' comments with the submitted manu-
Editors may request that authors add alternative or script, along with the authors' responses to those
non-SI units, since SI units are not universally used. Drug comments. Editors encourage authors to submit these
concentrations may be reported in either SI or mass previous communications. Doing so may expedite the
units, but the alternative should be provided in parenthe- review process and encourages transparency and shar-
ses where appropriate. ing of expertise.
Many journals provide a presubmission checklist to
k. Abbreviations and Symbols help the author ensure that all the components of the
Use only standard abbreviations; use of nonstandard submission have been included. Some journals also
abbreviations can be confusing to readers. Avoid abbre- require that authors complete checklists for reports of
viations in the title of the manuscript. The spelled-out certain study types (e.g., the CONSORT checklist for
abbreviation followed by the abbreviation in parentheses reports of randomized controlled trials). Authors should
should be used on first mention unless the abbreviation is look to see if the journal uses such checklists, and send
a standard unit of measurement. them with the manuscript if they are requested.
The manuscript must be accompanied by permission
B. Sending the Manuscript to the Journal to reproduce previously published material, use previ-
Manuscripts should be accompanied by a cover let- ously published illustrations, report information about
ter or a completed journal submission form, which identifiable persons, or to acknowledge people for their
should include the following information: contributions.

www.icmje.org 19

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