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Recommendations for the Conduct, Reporting, Editing, and


Publication of Scholarly Work in Medical Journals
Updated January 2024

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

qualify for authorship or to arbitrate authorship conflicts. 3. Non-Author Contributors


If agreement cannot be reached about who qualifies for Contributors who meet fewer than all 4 of the above
authorship, the institution(s) where the work was per- criteria for authorship should not be listed as authors,
formed, not the journal editor, should be asked to inves- but they should be acknowledged. Examples of activities
tigate. The criteria used to determine the order in which that alone (without other contributions) do not qualify a
authors are listed on the byline may vary, and are to be contributor for authorship are acquisition of funding;
decided collectively by the author group and not by edi- general supervision of a research group or general
tors. If authors request removal or addition of an author administrative support; and writing assistance, technical
after manuscript submission or publication, journal edi- editing, language editing, and proofreading. Those whose
tors should seek an explanation and signed statement of contributions do not justify authorship may be acknowl-
agreement for the requested change from all listed edged individually or together as a group under a single
authors and from the author to be removed or 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 Use of AI for writing assistance should be reported in
the acknowledgment section.
submission and peer-review process to respond to edi-
torial queries in a timely way, and should be available af- 4. Artificial Intelligence (AI)–Assisted Technology
ter publication to respond to critiques of the work and At submission, the journal should require authors to
cooperate with any requests from the journal for data or disclose whether they used Artificial Intelligence (AI)–
additional information should questions about the paper assisted technologies (such as Large Language Models
arise after publication. Although the corresponding [LLMs], chatbots, or image creators) in the production of
author has primary responsibility for correspondence submitted work. Authors who use such technology
with the journal, the ICMJE recommends that editors should describe, in both the cover letter and the submit-
send copies of all correspondence to all listed authors. ted work in the appropriate section if applicable, how
When a large multi-author group has conducted the they used it. For example, if AI was used for writing assis-
work, the group ideally should decide who will be an tance, describe this in the acknowledgment section (see
author before the work is started and confirm who is an Section II.A.3). If AI was used for data collection, analysis,
author before submitting the manuscript for publication. or figure generation, authors should describe this use in
All members of the group named as authors should the methods (see Section IV.A.3.d). Chatbots (such as
meet all four criteria for authorship, including approval ChatGPT) should not be listed as authors because they
of the final manuscript, and they should be able to take cannot be responsible for the accuracy, integrity, and
public responsibility for the work and should have full originality of the work, and these responsibilities are
confidence in the accuracy and integrity of the work of required for authorship (see Section II.A.1). Therefore,
other group authors. They will also be expected as indi- humans are responsible for any submitted material that
viduals to complete disclosure forms. included the use of AI-assisted technologies. Authors
Some large multi-author groups designate author- should carefully review and edit the result because AI
ship by a group name, with or without the names of indi- can generate authoritative-sounding output that can
viduals. When submitting a manuscript authored by a be incorrect, incomplete, or biased. Authors should
not list AI and AI-assisted technologies as an author or
group, the corresponding author should specify the
co-author, nor cite AI as an author. Authors should be
group name if one exists, and clearly identify the group
able to assert that there is no plagiarism in their paper,
members who can take credit and responsibility for the
including in text and images produced by the AI. Humans
work as authors. The byline of the article identifies who is must ensure there is appropriate attribution of all quoted
directly responsible for the manuscript, and MEDLINE material, including full citations.
lists as authors whichever names appear on the byline. If
the byline includes a group name, MEDLINE will list the B. Disclosure of Financial and Non-Financial
names of individual group members who are authors or Relationships and Activities, and Conflicts of
who are collaborators, sometimes called non-author con- Interest
tributors, if there is a note associated with the byline Public trust in the scientific process and the credibil-
clearly stating that the individual names are elsewhere in ity of published articles depend in part on how transpar-
the paper and whether those names are authors or ently an author's relationships and activities, directly or
collaborators. topically related to a work, are handled during the
www.icmje.org 3
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Recommendations for the Conduct, Reporting, Editing, and Publication of Scholarly Work in Medical Journals

planning, implementation, writing, peer review, editing, a. Authors


and publication of scientific work. When authors submit a manuscript of any type or for-
The potential for conflict of interest and bias exists mat they are responsible for disclosing all relationships
when professional judgment concerning a primary inter- and activities that might bias or be seen to bias their
est (such as patients' welfare or the validity of research) work. The ICMJE has developed a Disclosure Form to
facilitate and standardize authors' disclosures. ICMJE
may be influenced by a secondary interest (such as finan-
member journals require that authors use this form, and
cial gain). Perceptions of conflict of interest are as impor- ICMJE encourages other journals to adopt it.
tant as actual conflicts of interest.
Individuals may disagree on whether an author's b. Peer Reviewers
relationships or activities represent conflicts. Although Reviewers should be asked at the time they are
the presence of a relationship or activity does not always asked to critique a manuscript if they have relationships
indicate a problematic influence on a paper's content, or activities that could complicate their review. Reviewers
perceptions of conflict may erode trust in science as must disclose to editors any relationships or activities
much as actual conflicts of interest. Ultimately, readers that could bias their opinions of the manuscript, and
must be able to make their own judgments regarding should recuse themselves from reviewing specific manu-
whether an author's relationships and activities are perti- scripts if the potential for bias exists. Reviewers must not
nent to a paper's content. These judgments require use knowledge of the work they're reviewing before its
transparent disclosures. An author's complete disclosure publication to further their own interests.
demonstrates a commitment to transparency and helps
to maintain trust in the scientific process. c. Editors and Journal Staff
Financial relationships (such as employment, consul- Editors who make final decisions about manuscripts
tancies, stock ownership or options, honoraria, patents, should recuse themselves from editorial decisions if they
and paid expert testimony) are the most easily identifia- have relationships or activities that pose potential conflicts
ble, the ones most often judged to represent potential related to articles under consideration. Other editorial staff
conflicts of interest and thus the most likely to undermine members who participate in editorial decisions must pro-
the credibility of the journal, the authors, and science vide editors with a current description of their relation-
itself. Other interests may also represent or be perceived ships and activities (as they might relate to editorial
judgments) and recuse themselves from any decisions
as conflicts, such as personal relationships or rivalries,
in which an interest that poses a potential conflict exists.
academic competition, and intellectual beliefs.
Authors should avoid entering into agreements with Editorial staff must not use information gained through
working with manuscripts for private gain. Editors should
study sponsors, both for-profit and nonprofit, that inter-
regularly publish their own disclosure statements and
fere with authors' access to all of the study's data or that
those of their journal staff. Guest editors should follow
interfere with their ability to analyze and interpret the
these same procedures.
data and to prepare and publish manuscripts independ-
Journals should take extra precautions and have a
ently when and where they choose. Policies that dictate stated policy for evaluation of manuscripts submitted by
where authors may publish their work violate this princi- individuals involved in editorial decisions. Further guidance
ple of academic freedom. Authors may be required to is available from COPE (https://publicationethics.org/files/
provide the journal with the agreements in confidence. A_Short_Guide_to_Ethical_Editing.pdf) and WAME (http://
Purposeful failure to report those relationships or wame.org/conflict-of-interest-in-peer-reviewed-medical-
activities specified on the journal's disclosure form is a journals).
form of misconduct, as is discussed in Section III.B.
Disclosure of potential conflicts of interest is distinct 2. Reporting Relationships and Activities
and extends beyond direct support for this work. Within Articles should be published with statements or sup-
a manuscript, the funding statement should include only porting documents, such as the ICMJE Disclosure Form,
direct support of the work described. Support for an indi- declaring:
• Authors' relationships and activities; and
vidual's contribution for the work should be reported as
• Sources of support for the work, including sponsor
such. General institutional support for an author's time
names along with explanations of the role of those
on the work should be distinguished from direct overall sources if any in study design; collection, analysis,
funding of the work. An appropriate funding statement and interpretation of data; writing of the report; any
might be: “This study was funded by A; Dr. F’s time on restrictions regarding the submission of the report
the work was supported by B.” for publication; or a statement declaring that the sup-
porting source had no such involvement or restric-
1. Participants tions regarding publication; and
All participants in the peer-review and publication pro- • Whether the authors had access to the study data,
cess—not only authors but also peer reviewers, editors, and with an explanation of the nature and extent of
editorial board members of journals—must consider and access, including whether access is ongoing.
disclose their relationships and activities when fulfilling their To support the above statements, editors may
roles in the process of article review and publication. request that authors of a study sponsored by a funder
4 www.icmje.org
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Recommendations for the Conduct, Reporting, Editing, and Publication of Scholarly Work in Medical Journals

with a proprietary or financial interest in the outcome Editors must also make clear that reviewers should
sign a statement, such as “I had full access to all of the keep manuscripts, associated material, and the informa-
data in this study and I take complete responsibility for tion they contain strictly confidential. Instructions to
the integrity of the data and the accuracy of the data reviewers should include guidance about AI use.
analysis.” Reviewers and editorial staff members must not publicly
discuss the authors' work, and reviewers must not
C. Responsibilities in the Submission and appropriate authors' ideas before the manuscript is
Peer-Review Process published. Reviewers must not retain the manuscript for
1. Authors their personal use and should destroy paper copies of
Authors should abide by all principles of authorship manuscripts and delete electronic copies after submit-
and declaration of relationships and activities detailed in ting their reviews.
Sections II.A and II.B of this document. When a manuscript is rejected, it is best practice for
journals to delete copies of it from their editorial systems
a. Predatory or Pseudo-Journals unless retention is required by local regulations. Journals
A growing number of entities are advertising them- that retain copies of rejected manuscripts should dis-
selves as “scholarly medical journals” yet do not function close this practice in their Information for Authors.
as such. These journals (“predatory” or “pseudo-jour- When a manuscript is published, journals should
nals”) accept and publish almost all submissions and keep copies of the original submission, reviews, revisions,
charge article processing (or publication) fees, often and correspondence for at least three years and possibly
informing authors about this after a paper's acceptance in perpetuity, depending on local regulations, to help an-
for publication. They often claim to perform peer review swer future questions about the work should they arise.
but do not and may purposefully use names similar to Editors should not publish or publicize peer reviewers'
well-established journals. They may state that they are comments without permission of the reviewer and author.
members of ICMJE but are not (see www.icmje.org for If journal policy is to anonymize authors to reviewer identity
current members of the ICMJE) and that they follow the and comments are not signed, that identity must not
recommendations of organizations such as the ICMJE, be revealed to the author or anyone else without the
COPE, and WAME. Researchers must be aware of the ex- reviewers' expressed written permission.
istence of such entities and avoid submitting research to Confidentiality may have to be breached if dishon-
them for publication. Authors have a responsibility to esty or fraud is alleged, but editors should notify authors
evaluate the integrity, history, practices, and reputation or reviewers if they intend to do so and confidentiality
of the journals to which they submit manuscripts. must otherwise be honored.
Guidance from various organizations is available to help
identify the characteristics of reputable peer-reviewed b. Timeliness
journals (www.wame.org/identifying-predatory-or-pseudo- Editors should do all they can to ensure timely proc-
journals and www.wame.org/principles-of-transparency- essing of manuscripts with the resources available to
and-best-practice-in-scholarly-publishing). them. If editors intend to publish a manuscript, they
Seeking the assistance of scientific mentors, senior should attempt to do so in a timely manner and any
colleagues, and others with many years of scholarly pub- planned delays should be negotiated with the authors. If
lishing experience may also be helpful. a journal has no intention of proceeding with a manu-
Authors should avoid citing articles in predatory or script, editors should endeavor to reject the manuscript
pseudo-journals. as soon as possible to allow authors to submit to a differ-
ent journal.
2. Journals
c. Peer Review
a. Confidentiality
Peer review is the critical assessment of manuscripts
Manuscripts submitted to journals are privileged
submitted to journals by experts who are usually not part
communications that are authors' private, confidential of the editorial staff. Because unbiased, independent,
property, and authors may be harmed by premature dis- critical assessment is an intrinsic part of all scholarly
closure of any or all of a manuscript's details. work, including scientific research, peer review is an im-
Editors therefore must not share information about portant extension of the scientific process.
manuscripts, including whether they have been received The actual value of peer review is widely debated,
and are under review, their content and status in the but the process facilitates a fair hearing for a manuscript
review process, criticism by reviewers, and their ultimate among members of the scientific community. More prac-
fate, to anyone other than the authors and reviewers. tically, it helps editors decide which manuscripts are suit-
Editors should be aware that using AI technology in the able for their journals. Peer review often helps authors
processing of manuscripts may violate confidentiality. and editors improve the quality of reporting.
Requests from third parties to use manuscripts and It is the responsibility of the journal to ensure that
reviews for legal proceedings should be politely refused, systems are in place for selection of appropriate
and editors should do their best not to provide such con- reviewers. It is the responsibility of the editor to ensure
fidential material should it be subpoenaed. that reviewers have access to all materials that may be
www.icmje.org 5
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Recommendations for the Conduct, Reporting, Editing, and Publication of Scholarly Work in Medical Journals

relevant to the evaluation of the manuscript, including the published results for at least 10 years. The ICMJE
supplementary material for e-only publication, and to encourages the preservation of these data in a data re-
ensure that reviewer comments are properly assessed pository to ensure their longer-term availability.
and interpreted in the context of their declared relation-
ships and activities. d. Integrity
A peer-reviewed journal is under no obligation to Editorial decisions should be based on the relevance
send submitted manuscripts for review, and under no of a manuscript to the journal and on the manuscript's
obligation to follow reviewer recommendations, favor- originality, quality, and contribution to evidence about
important questions. Those decisions should not be
able or negative. The editor of a journal is ultimately re-
influenced by commercial interests, personal relation-
sponsible for the selection of all its content, and editorial
ships or agendas, or findings that are negative or that
decisions may be informed by issues unrelated to the
credibly challenge accepted wisdom. In addition,
quality of a manuscript, such as suitability for the journal. authors should submit for publication or otherwise make
An editor can reject any article at any time before publi- publicly available, and editors should not exclude from
cation, including after acceptance if concerns arise about consideration for publication, studies with findings that
the integrity of the work. are not statistically significant or that have inconclusive
Journals may differ in the number and kinds of findings. Such studies may provide evidence that, com-
manuscripts they send for review, the number and types bined with that from other studies through meta-analysis,
of reviewers they seek for each manuscript, whether the might still help answer important questions, and a public
review process is open or anonymized, and other aspects record of such negative or inconclusive findings may pre-
of the review process. For this reason and as a service vent unwarranted replication of effort or otherwise be
to authors, journals should publish a clear, transparent valuable for other researchers considering similar work.
description of their peer-review process for all types Journals should clearly state their appeals process
of manuscripts. and should have a system for responding to appeals and
Journals should notify reviewers of the ultimate deci- complaints.
sion to accept or reject a paper, and should acknowl-
edge the contribution of peer reviewers to their journal. e. Diversity and Inclusion
Editors are encouraged to share reviewers' comments To improve academic culture, editors should seek to
with co-reviewers of the same paper, so reviewers can engage a broad and diverse array of authors, reviewers,
learn from each other in the review process. editorial staff, editorial board members, and readers.
As part of peer review, editors are encouraged to
review research protocols, plans for statistical analysis if sep- f. Journal Metrics
arate from the protocol, and/or contracts associated with The journal impact factor is widely misused as a
project-specific studies. Editors should encourage authors proxy for research and journal quality and as a measure
to make such documents publicly available at the time of or of the importance of specific research projects or the
after publication, before accepting such studies for publica- merits of individual researchers, including their suitability
tion. Some journals may require public posting of these for hiring, promotion, tenure, prizes, or research funding.
documents as a condition of acceptance for publication. ICMJE recommends that journals reduce the emphasis
Journal requirements for independent data analysis on impact factor as a single measure, but rather provide
and for public data availability vary, reflecting evolving a range of article and journal metrics relevant to their
views of the importance of data availability for pre- and readers and authors.
post-publication peer review. Some journal editors cur-
rently request a statistical analysis of trial data by an in- 3. Peer Reviewers
dependent biostatistician before accepting studies for Manuscripts submitted to journals are privileged
publication. Others ask authors to say whether the study communications that are authors' private, confidential
data are available to third parties to view and/or use/ property, and authors may be harmed by premature dis-
reanalyze, while still others encourage or require closure of any or all of a manuscript's details.
authors to share their data with others for review or Reviewers therefore should keep manuscripts and
reanalysis. Each journal should establish and publish the information they contain strictly confidential. Reviewers
their specific requirements for data analysis and post in must not publicly discuss authors' work and must not
a place that potential authors can easily access. appropriate authors' ideas before the manuscript is
Some people believe that true scientific peer review published. Reviewers must not retain the manuscript for their
begins only on the date a paper is published. In that spirit, personal use and should destroy copies of manuscripts after
medical journals should have a mechanism for readers to submitting their reviews.
submit comments, questions, or criticisms about published Reviewers who seek assistance from a trainee or col-
articles, and authors have a responsibility to respond league in the performance of a review should acknowl-
appropriately and cooperate with any requests from the edge these individuals' contributions in the written
journal for data or additional information should questions comments submitted to the editor. Reviewers must
about the paper arise after publication (see Section III). maintain the confidentiality of the manuscript as outlined
ICMJE believes investigators have a duty to maintain above, which may prohibit the uploading of the manu-
the primary data and analytic procedures underpinning script to software or other AI technologies where
6 www.icmje.org
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Recommendations for the Conduct, Reporting, Editing, and Publication of Scholarly Work in Medical Journals

confidentiality cannot be assured. Reviewers must content. Journal owners should not interfere in the evalu-
request permission from the journal prior to using AI ation, selection, scheduling, or editing of individual
technology to facilitate their review. Reviewers should be articles either directly or by creating an environment that
aware that AI can generate authoritative-sounding output strongly influences decisions. Editors should base edito-
that can be incorrect, incomplete, or biased. rial decisions on the validity of the work and its impor-
Reviewers are expected to respond promptly to tance to the journal's readers, not on the commercial
requests to review and to submit reviews within the time implications for the journal, and editors should be free to
agreed. Reviewers' comments should be constructive, express critical but responsible views about all aspects of
honest, and polite. medicine without fear of retribution, even if these views
Reviewers should declare their relationships and conflict with the commercial goals of the publisher.
activities that might bias their evaluation of a manuscript Editors-in-chief should also have the final say in deci-
and recuse themselves from the peer-review process if a sions about which advertisements or sponsored content,
conflict exists. including supplements, the journal will and will not carry,
and they should have final say in use of the journal brand
D. Journal Owners and Editorial Freedom and in overall policy regarding commercial use of journal
1. Journal Owners content.
Owners and editors of medical journals share a com- Journals are encouraged to establish an independ-
mon purpose, but they have different responsibilities, ent and diverse editorial advisory board to help the edi-
and sometimes those differences lead to conflicts. A tor establish and maintain editorial policy. To support
medical journal should explicitly state its governance
editorial decisions and potentially controversial expres-
and relationship to a journal owner (e.g., a sponsoring
sions of opinion, owners should ensure that appropriate
society).
insurance is obtained in the event of legal action against
Medical publishing contributes to carbon emissions
that exacerbate climate change, which is an urgent threat the editors, and should ensure that legal advice is avail-
to human well-being and planetary health. Editors, pub- able when necessary. If legal problems arise, the editor
lishers, journal owners, and other stakeholders should should inform their legal adviser and their owner and/or
work together to develop immediate strategies to publisher as soon as possible. Editors should defend the
reduce carbon emissions, with a goal toward achieving confidentiality of authors and peer reviewers (names and
net zero carbon emissions. reviewer comments) in accordance with ICMJE policy
It is the responsibility of medical journal owners to (see Section II.C.2.a). Editors should take all reasonable
appoint and dismiss editors. Owners should provide edi- steps to check the facts in journal commentary, including
tors at the time of their appointment with a contract that that in news sections and social media postings, and
clearly states their rights and duties, authority, the gen- should ensure that staff working for the journal adhere to
eral terms of their appointment, and mechanisms for best journalistic practices including contemporaneous
resolving conflict. The editor's performance may be note-taking and seeking a response from all parties
assessed using mutually agreed-upon measures, includ- when possible before publication. Such practices in sup-
ing but not necessarily limited to readership, manuscript port of truth and public interest may be particularly rele-
submissions and handling times, and various journal vant in defense against legal allegations of libel.
metrics. To secure editorial freedom in practice, the editor
Owners should only dismiss editors for substantial should have direct access to the highest level of ownership,
reasons, such as scientific misconduct, disagreement not to a delegated manager or administrative officer.
with the long-term editorial direction of the journal, inad- Editors and editors' organizations are obliged to sup-
equate performance by agreed-upon performance met- port the concept of editorial freedom and to draw major
rics, or inappropriate behavior that is incompatible with a transgressions of such freedom to the attention of the
position of trust. international medical, academic, and lay communities.
Appointments and dismissals should be based on
evaluations by a panel of independent experts, rather E. Protection of Research Participants
than by a small number of executives of the owning orga- All investigators should ensure that the planning,
nization. This is especially necessary in the case of dis- conduct, and reporting of human research are in accord-
missals because of the high value society places on ance with the Helsinki Declaration as revised in 2013
freedom of speech within science and because it is often
(www.wma.net/policies-post/wma-declaration-of-helsinki-
the responsibility of editors to challenge the status quo
ethical-principles-for-medical-research-involving-human-
in ways that may conflict with the interests of the journal's
subjects/). All authors should seek approval to conduct
owners.
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), and be prepared to provide documentation
Editors' definition of editorial freedom (http://wame.org/ when requested by editors. If doubt exists whether the
editorial-independence), which holds that editors-in- research was conducted in accordance with the Helsinki
chief have full authority over the entire editorial content Declaration, the authors must explain the rationale for
of their journal and the timing of publication of that their approach and demonstrate that the local, regional,
www.icmje.org 7
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Recommendations for the Conduct, Reporting, Editing, and Publication of Scholarly Work in Medical Journals

or national review body explicitly approved the doubtful If a correction is needed, journals should follow these
aspects of the study. Approval by a responsible review minimum standards:
body does not preclude editors from forming their own • The journal should publish a correction notice as
judgment whether the conduct of the research was soon as possible detailing changes from and citing
appropriate. the original publication; the correction should be on
Patients have a right to privacy that should not be an electronic or numbered print page that is
violated without informed consent. Identifying informa- included in an electronic or a print Table of Contents
tion, including names, initials, or hospital numbers, to ensure proper indexing.
should not be published in written descriptions, photo- • The journal should also post a new article version
graphs, or pedigrees unless the information is essential with details of the changes from the original version
for scientific purposes and the patient (or parent or and the date(s) on which the changes were made.
guardian) gives written informed consent for publication. • The journal should archive all prior versions of the ar-
Informed consent for this purpose requires that an identi- ticle. This archive can be either directly accessible to
fiable patient be shown the manuscript to be published. readers or can be made available to the reader on
Authors should disclose to these patients whether any request.
potential identifiable material might be available via the • Previous electronic versions should prominently note
Internet as well as in print after publication. Patient con- that there are more recent versions of the article.
sent should be written and archived with the journal, the • The citation should be to the most recent version.
authors, or both, as dictated by local regulations or laws. Pervasive errors can result from a coding problem
Applicable laws vary from locale to locale, and journals or a miscalculation and may result in extensive inaccura-
should establish their own policies with legal guidance. cies throughout an article. If such errors do not change
Since a journal that archives the consent will be aware of the direction or significance of the results, interpreta-
patient identity, some journals may decide that patient tions, and conclusions of the article, a correction should
confidentiality is better guarded by having the author be published that follows the minimum standards noted
archive the consent and instead providing the journal above.
with a written statement that attests that they have Errors serious enough to invalidate a paper's results
received and archived written patient consent. and conclusions may require retraction. However, retrac-
Nonessential identifying details should be omitted. tion with republication (also referred to as “replacement”)
Informed consent should be obtained if there is any can be considered in cases where honest error (e.g., a
doubt that anonymity can be maintained. For example, misclassification or miscalculation) leads to a major
masking the eye region in photographs of patients is change in the direction or significance of the results, inter-
inadequate protection of anonymity. If identifying char- pretations, and conclusions. If the error is judged to be
acteristics are deidentified, authors should provide unintentional, the underlying science appears valid, and
assurance, and editors should so note, that such changes the changed version of the paper survives further review
do not distort scientific meaning. and editorial scrutiny, then retraction with republication of
The requirement for informed consent should be the changed paper, with an explanation, allows full correc-
included in the journal's instructions for authors. When tion of the scientific literature. In such cases, it is helpful to
informed consent has been obtained, it should be indi- show the extent of the changes in supplementary material
cated in the published article. or in an appendix, for complete transparency.
When reporting experiments on animals, authors
should indicate whether institutional and national stand- B. Scientific Misconduct, Expressions of
ards for the care and use of laboratory animals were Concern, and Retraction
followed. Scientific misconduct in research and non-research
publications includes but is not necessarily limited to
data fabrication; data falsification, including deceptive
III. PUBLISHING AND EDITORIAL ISSUES manipulation of images; purposeful failure to disclose rela-
RELATED TO PUBLICATION IN MEDICAL tionships and activities; and plagiarism. Some people con-
JOURNALS sider failure to publish the results of clinical trials and other
A. Corrections, Retractions, Republications, and human studies a form of scientific misconduct. While each
Version Control of these practices is problematic, they are not equivalent.
Honest errors are a part of science and publishing Each situation requires individual assessment by relevant
and require publication of a correction when they are stakeholders. When scientific misconduct is alleged, or
detected. Corrections are needed for errors of fact. concerns are otherwise raised about the conduct or integ-
Matters of debate are best handled as letters to the edi- rity of work described in submitted or published papers,
tor, as print or electronic correspondence, or as posts in the editor should initiate appropriate procedures detailed
a journal-sponsored online forum. Updates of previous by such committees as the Committee on Publication Ethics
publications (e.g., an updated systematic review or clini- (COPE) (http://publicationethics.org/resources/flowcharts),
cal guideline) are considered a new publication rather consider informing the institutions and funders, and may
than a version of a previously published article. choose to publish an expression of concern pending the
8 www.icmje.org
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Recommendations for the Conduct, Reporting, Editing, and Publication of Scholarly Work in Medical Journals

outcomes of those procedures. If the procedures involve an than one journal. The rationale for this standard is the
investigation at the authors' institution, the editor should potential for disagreement when two (or more) journals
seek to discover the outcome of that investigation; notify claim the right to publish a manuscript that has been sub-
readers of the outcome if appropriate; and if the investiga- mitted simultaneously to more than one journal, and the
tion proves scientific misconduct, publish a retraction of the possibility that two or more journals will unknowingly
article. There may be circumstances in which no misconduct and unnecessarily undertake the work of peer review,
edit the same manuscript, and publish the same article.
is proven, but an exchange of letters to the editor could be
published to highlight matters of debate to readers. 2. Duplicate and Prior Publication
Expressions of concern and retractions should not Duplicate publication is publication of a paper that
simply be a letter to the editor. Rather, they should be overlaps substantially with one already published, with-
prominently labelled, appear on an electronic or num- out clear, visible reference to the previous publication.
bered print page that is included in an electronic or a Prior publication may include release of information in
print Table of Contents to ensure proper indexing, and the public domain.
include in their heading the title of the original article. Readers of medical journals deserve to be able to
Online, the retraction and original article should be trust that what they are reading is original unless there is
linked in both directions and the retracted article should a clear statement that the author and editor are intention-
be clearly labelled as retracted in all its forms (abstract, ally republishing an article (which might be considered
full text, PDF). Ideally, the authors of the retraction should for historic or landmark papers, for example). The bases
be the same as those of the article, but if they are unwill- of this position are international copyright laws, ethical
ing or unable the editor may under certain circumstances conduct, and cost-effective use of resources. Duplicate
accept retractions by other responsible persons, or the publication of original research is particularly problem-
editor may be the sole author of the retraction or expres- atic because it can result in inadvertent double-counting
sion of concern. The text of the retraction should explain of data or inappropriate weighting of the results of a sin-
why the article is being retracted and include a complete gle study, which distorts the available evidence.
citation reference to that article. When authors submit a manuscript reporting work
Retracted articles should remain in the public do- that has already been reported in large part in a pub-
main and be clearly labelled as retracted. lished article or is contained in or closely related to
The validity of previous work by the author of a fraud- another paper that has been submitted or accepted for
ulent paper cannot be assumed. Editors may ask the publication elsewhere, the letter of submission should
author's institution to assure them of the validity of other clearly say so and the authors should provide copies of
work published in their journals, or they may retract it. If the related material to help the editor decide how to
this is not done, editors may choose to publish an handle the submission. See also Section IV.B.
announcement expressing concern that the validity of This recommendation does not prevent a journal from
previously published work is uncertain. considering a complete report that follows publication of a
The integrity of research may also be compromised preliminary report, such as a letter to the editor, a preprint,
by inappropriate methodology that could lead to or an abstract or poster displayed at a scientific meeting.
retraction. The ICMJE does not consider results or data contained in
See COPE flowcharts for further guidance on retrac- assessment reports published by health technology
tions and expressions of concern. See Section IV.A.1.g.i for assessment agencies, medical regulators, medical device
guidance about avoiding referencing retracted articles. regulators, or other regulatory agencies to be duplicate
publication. It also does not prevent journals from consid-
C. Copyright
ering a paper that has been presented at a scientific meet-
Journals should make clear the type of copyright
ing but was not published in full, or that is being
under which work will be published, and if the journal
considered for publication in proceedings or similar for-
retains copyright, should detail the journal's position on
mat. Press reports of scheduled meetings are not usually
the transfer of copyright for all types of content, including
regarded as breaches of this rule, but they may be if addi-
audio, video, protocols, and data sets. Medical journals
tional data tables or figures enrich such reports. Authors
may ask authors to transfer copyright to the journal. Some
should also consider how dissemination of their findings
journals require transfer of a publication license. Some
outside of scientific presentations at meetings may dimin-
journals do not require transfer of copyright and rely on
such vehicles as Creative Commons licenses. The copy- ish the priority journal editors assign to their work.
right status of articles in a given journal can vary: Some Authors who choose to post their work on a preprint
content cannot be copyrighted (e.g., articles written by server should choose one that clearly identifies preprints
employees of some governments in the course of their as not peer-reviewed work and includes disclosures of
work). Editors may waive copyright on other content, and authors' relationships and activities. It is the author's
some content may be protected under other 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 to ensure that preprints are amended to point readers to
Authors should not submit the same manuscript, in subsequent versions, including the final published arti-
the same or different languages, simultaneously to more cle. See Section III.D.3.
www.icmje.org 9
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Recommendations for the Conduct, Reporting, Editing, and Publication of Scholarly Work in Medical Journals

In the event of a public health emergency (as defined harms, authors who wish to make preprints of non–peer-
by public health officials), information with immediate reviewed work publicly available should choose preprint
implications for public health should be disseminated archives that have the following characteristics:
without concern that this will preclude subsequent consid- • Clearly identify preprints as work that is not peer
eration for publication in a journal. We encourage editors reviewed;
to give priority to authors who have made crucial data • Require authors to document disclosures of interest;
publicly available without delay. • Require authors to indicate funding source(s);
Sharing with public media, government agencies, or • Have a clear process for preprint archive users to
manufacturers the scientific information described in a notify archive administrators about concerns related
paper or a letter to the editor that has been accepted but to posted preprints—a public commenting feature is
not yet published violates the policies of many journals. desirable for this purpose;
Such reporting may be warranted when the paper or • Maintain metadata for preprints that are withdrawn
letter describes major therapeutic advances; report- from posting and post withdrawal notices indicating
able diseases; or public health hazards, such as serious the timing and reason for withdrawal of a preprint; and
adverse effects of drugs, vaccines, other biological • Have a mechanism for authors to indicate when the
products, medical devices. This reporting, whether in preprint article has been subsequently published in a
print or online, should not jeopardize publication, but peer-reviewed journal.
should be discussed with and agreed upon by the edi-
tor in advance when possible. b. Submitting Manuscripts That Are in Preprint Arch-
The ICMJE will not consider as prior publication the ives to a Peer-Reviewed Journal
posting of trial results in any registry that meets the crite- Authors should inform a journal if the work submit-
ria noted in Section III.L if results are limited to a brief ted to the journal has been posted on a preprint server
structured abstract or tables (to include participants en- and provide a link to the preprint, whether the posting
rolled, key outcomes, and adverse events). The ICMJE occurs prior to submission or during the peer-review
encourages authors to include a statement with the process. It is also helpful to indicate in the text of the
registration that indicates that the results have not yet manuscript, perhaps in the introduction, that a preprint is
been published in a peer-reviewed journal, and to update available and how reviewers can access that preprint. In
the results registry with the full journal citation when the addition, it is the authors’ (and not the journal editors’)
responsibility to ensure that preprints are amended to
results are published.
Editors of different journals may together decide to point readers to subsequent versions of the work, includ-
ing the published article. Authors should not post in the
simultaneously or jointly publish an article if they believe
preprint archive the published article nor interim ver-
that doing so would be in the best interest of public
sions that are produced during the peer-review process
health. However, the National Library of Medicine (NLM)
that incorporate revisions based on journal feedback.
indexes all such simultaneously published joint publica-
tions separately, so editors should include a statement c. Referencing Preprints in Submitted Manuscripts
making the simultaneous publication clear to readers. When preprints are cited in submitted manuscripts
Authors who attempt duplicate publication without or published articles, the citation should clearly indicate
such notification should expect at least prompt rejection that the reference is a preprint. When a preprint article
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).
10 www.icmje.org
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Recommendations for the Conduct, Reporting, Editing, and Publication of Scholarly Work in Medical Journals

Secondary publication for various other reasons may regarding separate research questions but using the
also be justifiable provided the following conditions are same original participant sample. In this case authors
met: may use the original single trial registration number, if all
1. The authors have received approval from the editors the outcome parameters were defined in the original
of both journals (the editor concerned with secondary registration. If the authors registered several substudies
publication must have access to the primary version). as separate entries in, for example, ClinicalTrials.gov,
2. The priority of the primary publication is respected then the unique trial identifier should be given for the study
by a publication interval negotiated by both editors in question. The main issue is transparency, so no matter
with the authors. what model is used it should be obvious for the reader.
3. The paper for secondary publication is intended for a
different group of readers; an abbreviated version E. Correspondence
could be sufficient. Medical journals should provide readers with a
4. The secondary version faithfully reflects the authors, mechanism for submitting comments, questions, or
data, and interpretations of the primary version. criticisms about published articles, usually but not neces-
5. The secondary version informs readers, peers, and sarily always through a correspondence section or online
documenting agencies that the paper has been pub- forum. The authors of articles discussed in correspon-
lished in whole or in part elsewhere—for example, dence or an online forum have a responsibility to res-
with a note that might read, “This article is based on a pond to substantial criticisms of their work using those
study first reported in the [journal title, with full refer- same mechanisms and should be asked by editors to
ence]”—and the secondary version cites the primary respond. Authors of correspondence should be asked to
reference. declare any competing relationships or activities.
6. The title of the secondary publication should indicate Correspondence may be edited for length, gram-
that it is a secondary publication (complete or matical correctness, and journal style. Alternatively, edi-
abridged republication or translation) of a primary tors may choose to make available to readers unedited
publication. Of note, the NLM does not consider correspondence, for example, via an online commenting
translations to be “republications” and does not cite system. Such commenting is not indexed in MEDLINE
or index them when the original article was published unless it is subsequently published on a numbered elec-
in a journal that is indexed in MEDLINE. tronic or print page. However the journal handles corre-
When the same journal simultaneously publishes an spondence, it should make known its practice. In all
article in multiple languages, the MEDLINE citation will instances, editors must make an effort to screen discour-
note the multiple languages (e.g., Angelo M. Journal net- teous, inaccurate, or libellous comments.
working in nursing: a challenge to be shared. Rev Esc Responsible debate, critique, and disagreement are
Enferm USP. 2011 Dec 45[6]:1281-2,1279-80,1283-4. important features of science, and journal editors should
Article in English, Portuguese, and Spanish. No abstract encourage such discourse ideally within their own jour-
available. PMID: 22241182). nals about the material they have published. Editors,
however, have the prerogative to reject correspondence
5. Manuscripts Based on the Same Database that is irrelevant, uninteresting, or lacking cogency, but
If editors receive manuscripts from separate research they also have a responsibility to allow a range of opin-
groups or from the same group analyzing the same data ions to be expressed and to promote debate.
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
www.icmje.org 11
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Recommendations for the Conduct, Reporting, Editing, and Publication of Scholarly Work in Medical Journals

funded by sources other than the journal's publisher. Recommendations for corrections and versioning
Because funding sources can bias the content of supple- are detailed in Section III.A.
ments through the choice of topics and viewpoints, jour- Electronic publishing allows linking to sites and
nals should adopt the following principles, which also resources beyond journals over which journal editors
apply to theme issues or special series that have external have no editorial control. For this reason, and because
funding and/or guest editors: links to external sites could be perceived as implying
1. The journal editor must be given and must take full endorsement of those sites, journals should be cautious
responsibility for the policies, practices, and content about external linking. When a journal does link to an
of supplements, including complete control of the external site, it should state that it does not endorse or
take responsibility or liability for any content, advertising,
decision to select authors, peer reviewers, and con-
products, or other materials on the linked sites, and does
tent for the supplement. Editing by the funding orga-
not take responsibility for the sites' availability.
nization should not be permitted. Permanent preservation of journal articles on a jour-
2. The journal editor has the right to appoint one or
nal's website, or in an independent archive or a credible
more external editors of the supplement and must
repository, is essential for the historical record. Remo-
take responsibility for the work of those editors.
ving an article from a journal's website in its entirety is
3. The journal editor must retain the authority to send
almost never justified as copies of the article may have
supplement manuscripts for external peer review and
been downloaded even if its online posting was brief.
to reject manuscripts submitted for the supplement
Such archives should be freely accessible or accessible to
with or without external review. These conditions
archive members. Deposition in multiple archives is en-
should be made known to authors and any external
couraged. However, if necessary for legal reasons (e.g.,
editors of the supplement before beginning editorial
libel action), the URL for the removed article must contain
work on it.
a detailed reason for the removal, and the article must be
4. The source of the idea for the supplement, sources of
retained in the journal's internal archive.
funding for the supplement's research and publica-
Permanent preservation of a journal's total content is
tion, and products of the funding source related to
the responsibility of the journal publisher, who in the
content considered in the supplement should be
event of journal termination should be certain the journal
clearly stated in the introductory material.
5. Advertising in supplements should follow the same files are transferred to a responsible third party who can
policies as those of the primary journal. make the content available.
6. Journal editors must enable readers to distinguish Journal websites should post the date that nonarticle
readily between ordinary editorial pages and supple- web pages, such as those listing journal staff, editorial
ment pages. board members, and instructions for authors, were last
7. Journal and supplement editors must not accept per- updated.
sonal favors or direct remuneration from sponsors of
supplements. J. Advertising
8. Secondary publication in supplements (republication Most medical journals carry advertising, which gen-
of papers published elsewhere) should be clearly erates income for their publishers, but journals should
identified by the citation of the original paper and by not be dominated by advertisements, and advertising
the title. must not be allowed to influence editorial decisions.
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
12 www.icmje.org
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Recommendations for the Conduct, Reporting, Editing, and Publication of Scholarly Work in Medical Journals

information within a reasonable amount of time, and edi- immediate release, they should waive their policies
tors have a responsibility to facilitate that. However, limiting prepublication publicity.
media reports of scientific research before it has been • Policies designed to limit prepublication publicity
peer-reviewed and fully vetted may lead to dissemina- should not apply to accounts in the media of presen-
tion of inaccurate or premature conclusions, and doctors tations at scientific meetings or to the abstracts from
in practice need to have research reports available in full these meetings (see Duplicate Publication). Resear-
detail before they can advise patients about the reports' chers who present their work at a scientific meeting
conclusions. should feel free to discuss their presentations with
An embargo system has been established in some reporters but should be discouraged from offering
countries and by some journals to assist this balance,
more detail about their study than was presented in
and to prevent publication of stories in the general
the talk, or should consider how giving such detail
media before publication of the original research in the
might diminish the priority journal editors assign to
journal. For the media, the embargo creates a “level
playing field,” which most reporters and writers appreci- their work (see Duplicate Publication).
• When an article is close to being published, editors
ate since it minimizes the pressure on them to publish
stories before competitors when they have not had time or journal staff should help the media prepare accu-
to prepare carefully. Consistency in the timing of public rate reports by providing news releases, answering
release of biomedical information is also important in questions, supplying advance copies of the article, or
minimizing economic chaos, since some articles contain referring reporters to appropriate experts. This assis-
information that has potential to influence financial mar- tance should be contingent on the media's coopera-
kets. The ICMJE acknowledges criticisms of embargo tion in timing the release of a story to coincide with
systems as being self-serving of journals' interests and an publication of the article.
impediment to rapid dissemination of scientific informa-
tion, but believes the benefits of the systems outweigh L. Clinical Trials
their harms. 1. Registration
The following principles apply equally to print and The ICMJE's clinical trial registration policy is
electronic publishing and may be useful to editors as detailed in a series of editorials (see News and Editorials
they seek to establish policies on interactions with the [www.icmje.org/news-and-editorials/] and FAQs [www.
media: icmje.org/about-icmje/faqs/]).
• Editors can foster the orderly transmission of medical Briefly, the ICMJE requires, and recommends that all
information from researchers, through peer-reviewed medical journal editors require, registration of clinical tri-
journals, to the public. This can be accomplished by als in a public trials registry at or before the time of first
an agreement with authors that they will not publicize patient enrollment as a condition of consideration for
their work while their manuscript is under considera- publication. Editors requesting inclusion of their journal
tion or awaiting publication and an agreement with on the ICMJE website list of publications that follow
the media that they will not release stories before pub- ICMJE guidance (www.icmje.org/journals.html) should
lication of the original research in the journal, in return recognize that the listing implies enforcement by the
for which the journal will cooperate with them in pre- journal of ICMJE's trial registration policy.
paring 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
that led to the delay.
significant number of media outlets or biomedical
The ICMJE defines a clinical trial as any research pro-
journals not to respect the embargo system would
ject that prospectively assigns people or a group of peo-
lead to its rapid dissolution.
ple to an intervention, with or without concurrent
• Notwithstanding authors' belief in their work, very lit-
comparison or control groups, to study the relationship
tle medical research has such clear and urgently im- between a health-related intervention and a health out-
portant clinical implications for the public's health 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 time of first participant consent.
www.icmje.org 13
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Recommendations for the Conduct, Reporting, Editing, and Publication of Scholarly Work in Medical Journals

The ICMJE accepts publicly accessible registration in publications. The ICMJE will not consider as prior publi-
any registry that is a primary register of the WHO cation the posting of trial results in any registry that
International Clinical Trials Registry Platform (ICTRP) meets the above criteria if results are limited to a brief
(www.who.int/clinical-trials-registry-platform/network/who- structured abstract or tables (to include trial participants
data-set) that includes the minimum acceptable 24-item enrolled, baseline characteristics, primary and secondary
trial registration data set or in ClinicalTrials.gov, which is a outcomes, and adverse events).
data provider to the WHO ICTRP. The ICMJE endorses The ICMJE recommends that journals publish the
these registries because they meet several criteria. They trial registration number at the end of the abstract. The
are accessible to the public at no charge, open to all ICMJE also recommends that, whenever a registration
prospective registrants, managed by a not-for-profit orga-
number is available, authors list this number the first time
nization, have a mechanism to ensure the validity of the
they use a trial acronym to refer either to the trial they are
registration data, and are electronically searchable. An
acceptable registry must include the minimum 24-item reporting or to other trials that they mention in the
trial registration data set (http://prsinfo.clinicaltrials.gov/ manuscript.
trainTrainer/WHO-ICMJE-ClinTrialsgov-Cross-Ref.pdf or Editors may consider whether the circumstances
www.who.int/clinical-trials-registry-platform) at the time of involved in a failure to appropriately register a clinical
registration and before enrollment of the first participant. trial were likely to have been intended to or resulted in
The ICMJE considers inadequate trial registrations biased reporting. Because of the importance of prospec-
missing any of the 24 data fields, those that have fields tive trial registration, if an exception to this policy is
that contain uninformative information, or registrations made, trials must be registered and the authors should
that are not made publicly accessible such as phase I tri- indicate in the publication when registration was com-
pleted and why it was delayed. Editors should publish a
als submitted to the CTIS (Clinical Trials Information
statement indicating why an exception was allowed. The
System) and trials of devices for which the information
ICMJE emphasizes that such exceptions should be rare,
is placed in a “lock box.” In order to comply with
and that authors failing to prospectively register a trial
ICMJE policy, investigators registering trials of devices
risk its inadmissibility to our journals.
at ClinicalTrials.gov must “opt out” of the lock box by electing
public posting prior to device approval. Approval to conduct 2. Data Sharing
a study from an independent local, regional, or national The ICMJE's data sharing statement policy is detailed
review body (e.g., ethics committee, institutional review in an editorial (see Updates and Editorials [www.icmje.
board) does not fulfill the ICMJE requirement for pro-
org/update.html]).
spective clinical trial registration. Although not a required
1. As of 1 July 2018 manuscripts submitted to ICMJE
item, the ICMJE encourages authors to include a state-
journals that report the results of clinical trials must
ment that indicates that the results have not yet been
contain a data sharing statement as described below.
published in a peer-reviewed journal, and to update the
2. Clinical trials that begin enrolling participants on or
registration with the full journal citation when the results
after 1 January 2019 must include a data sharing plan
are published.
in the trial's registration. The ICMJE's policy regarding
The purpose of clinical trial registration is to prevent
trial registration is explained at www.icmje.org/
selective publication and selective reporting of research
recommendations/browse/publishing-and-editorial-
outcomes, to prevent unnecessary duplication of research
issues/clinical-trial-registration.html. If the data shar-
effort, to help patients and the public know what trials ing plan changes after registration this should be
are planned or ongoing into which they might want to reflected in the statement submitted and pub-
enroll, and to help give ethics review boards consider- lished with the manuscript, and updated in the
ing approval of new studies a view of similar work and registry record.
data relevant to the research they are considering. Data sharing statements must indicate the following:
Retrospective registration, for example at the time of whether individual deidentified participant data (includ-
manuscript submission, meets none of these purposes. ing data dictionaries) will be shared (“undecided” is not
Those purposes apply also to research with alternative an acceptable answer); what data in particular will be
designs, for example observational studies. For that shared; whether additional, related documents will be
reason, the ICMJE encourages registration of research available (e.g., study protocol, statistical analysis plan,
with non-trial designs, but because the exposure or etc.); when the data will become available and for how
intervention in non-trial research is not dictated by the long; by what access criteria data will be shared (includ-
researchers, the ICMJE does not require it. ing with whom, for what types of analyses, and by what
Secondary data analyses of primary (parent) clinical mechanism). Illustrative examples of data sharing state-
trials should not be registered as separate clinical trials, ments that would meet these requirements are provided
but instead should reference the trial registration num- in Table 1.
ber of the primary trial. Authors of secondary analyses using shared data
The ICMJE expects authors to ensure that they have must attest that their use was in accordance with the
met the requirements of their funding and regulatory terms (if any) agreed to upon their receipt. They must
agencies regarding aggregate clinical trial results report- also reference the source of the data using its unique,
ing in clinical trial registries. It is the authors', and not the persistent identifier to provide appropriate credit to
journal editors', responsibility to explain any discrepan- those who generated it and allow searching for the stud-
cies between results reported in registries and journal ies it has supported. Authors of secondary analyses must
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.

explain completely how theirs differ from previous analy- Electronic formats have created opportunities for
ses. In addition, those who generate and then share clini- adding details or sections, layering information, cross-
cal trial data sets deserve substantial credit for their linking, or extracting portions of articles in electronic ver-
efforts. Those using data collected by others should seek sions. Supplementary electronic-only material should be
collaboration with those who collected the data. As col- submitted and sent for peer review simultaneously with
laboration will not always be possible, practical, or the primary manuscript.
desired, the efforts of those who generated the data
must be recognized. 2. Reporting Guidelines
Reporting guidelines have been developed for differ-
ent study designs; examples include CONSORT (www.
IV. MANUSCRIPT PREPARATION AND consort-statement.org) for randomized trials, STROBE
SUBMISSION for observational studies (http://strobe-statement.org/),
A. Preparing a Manuscript for Submission to a PRISMA for systematic reviews and meta-analyses
Medical Journal (http://prisma-statement.org/), and STARD for studies of
1. General Principles diagnostic accuracy (http://www.equator-network.org/
The text of articles reporting original research is usu- reporting-guidelines/stard/). Journals are encouraged to
ally divided into Introduction, Methods, Results, and ask authors to follow these guidelines because they help
Discussion sections. This so-called “IMRAD” structure is authors describe the study in enough detail for it to be
not an arbitrary publication format but a reflection of the evaluated by editors, reviewers, readers, and other
process of scientific discovery. Articles often need sub- researchers evaluating the medical literature. Authors
headings within these sections to further organize their are encouraged to refer to the SAGER guidelines for
content. Other types of articles, such as meta-analyses, reporting of sex and gender information in study design,
may require different formats, while case reports, narra- data analyses, results, and interpretation of findings:
tive reviews, and editorials may have less structured or www.equator-network.org/reporting-guidelines/
unstructured formats. sager-guidelines/. Authors of review manuscripts are
www.icmje.org 15
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Recommendations for the Conduct, Reporting, Editing, and Publication of Scholarly Work in Medical Journals

encouraged to describe the methods used for locating, figures and tables were actually included with the manu-
selecting, extracting, and synthesizing data; this is manda- script and, because tables and figures occupy space, to
tory for systematic reviews. Good sources for reporting assess if the information provided by the figures and
guidelines are the EQUATOR Network (www.equator- tables warrants the paper's length and if the manuscript
network.org/home/) and the NLM's Research Reporting fits within the journal's space limits.
Guidelines and Initiatives (www.nlm.nih.gov/services/ Disclosure of relationships and activities. Disclosure
research_report_guide.html). information for each author needs to be part of the
manuscript; each journal should develop standards with
3. Manuscript Sections regard to the form the information should take and
The following are general requirements for reporting where it will be posted. The ICMJE has developed a uni-
within sections of all study designs and manuscript formats. form Disclosure Form for use by ICMJE member journals
(www.icmje.org/coi_disclosure.pdf), and the ICMJE en-
a. Title Page courages other journals to adopt it. Despite availability
General information about an article and its authors of the form, editors may require disclosure of relation-
is presented on a manuscript title page and usually ships and activities on the manuscript title page or other
includes the article title, author information, any disclaim- Disclosure section in the manuscript to save the work of
ers, sources of support, word count, and sometimes the collecting forms from each author prior to making an edi-
number of tables and figures. torial decision or to save reviewers and readers the work
Article title. The title provides a distilled description of reading each author's form.
of the complete article and should include information
that, along with the abstract, will make electronic retrieval b. Abstract
of the article sensitive and specific. Reporting guidelines Original research, systematic reviews, and meta-
recommend and some journals require that information analyses require structured abstracts. The abstract
about the study design be a part of the title (particularly should provide the context or background for the study
important for randomized trials and systematic reviews and should state the study's purpose, basic procedures
and meta-analyses). Some journals require a short title, (selection of study participants, settings, measurements,
usually no more than 40 characters (including letters and analytical methods), main findings (giving specific effect
spaces) on the title page or as a separate entry in an elec- sizes and their statistical and clinical significance, if possi-
tronic submission system. Electronic submission systems ble), and principal conclusions. It should emphasize new
may restrict the number of characters in the title. and important aspects of the study or observations, note
Author information. Each author's highest academic important limitations, and not overinterpret findings.
degrees should be listed, although some journals do not Clinical trial abstracts should include items that the
publish these. The name of the department(s) and institu- CONSORT group has identified as essential (www.consort-
tion(s) or organizations where the work should be attrib- statement.org/resources/downloads/extensions/consort-
uted should be specified. Most electronic submission extension-for-abstracts-2008pdf/). Funding sources should
systems require that authors provide full contact information, be listed separately after the abstract to facilitate
proper display and indexing for search retrieval by
including land mail and e-mail addresses, but the title page
MEDLINE. The funding statement should include
should list the corresponding authors' telephone number
only direct support of the work described. General
and e-mail address. ICMJE encourages the listing of authors'
institutional support for an author’s time on the work
Open Researcher and Contributor Identification (ORCID). should be distinguished from direct overall funding
Disclaimers. An example of a disclaimer is an of the work. An appropriate funding statement might
author's statement that the views expressed in the sub- be: “This study was funded by ABC; Dr. F’s time on
mitted article are his or her own and not an official posi-
the work was supported by XYZ.”
tion of the institution or funder.
Because abstracts are the only substantive portion of
Source(s) of support. These include grants, equip-
the article indexed in many electronic databases, and the
ment, drugs, and/or other support that facilitated con-
only portion many readers read, authors need to ensure
duct of the work described in the article or the writing of
that they accurately reflect the content of the article.
the article itself. Inappropriate attribution of funding Unfortunately, information in abstracts often differs from
sources and affiliations are misleading and should be that in the text. Authors and editors should work in the
avoided. process of revision and review to ensure that information
Word count. A word count for the paper's text, is consistent in both places. The format required for
excluding its abstract, acknowledgments, tables, figure structured abstracts differs from journal to journal, and
legends, and references, allows editors and reviewers to some journals use more than one format; authors need
assess whether the information contained in the paper to prepare their abstracts in the format specified by the
warrants the paper's length, and whether the submitted journal they have chosen.
manuscript fits within the journal's formats and word lim- The ICMJE recommends that journals publish the
its. A separate word count for the abstract is useful for clinical trial registration number at the end of the
the same reason. abstract. The ICMJE also recommends that, when a
Number of figures and tables. Some submission sys- registration number is available, authors list that number
tems require specification of the number of figures and the first time they use a trial acronym to refer to the trial
tables before uploading the relevant files. These num- they are reporting or to other trials that they mention in
bers allow editorial staff and reviewers to confirm that all the manuscript. If the data have been deposited in a
16 www.icmje.org
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Recommendations for the Conduct, Reporting, Editing, and Publication of Scholarly Work in Medical Journals

public repository and/or are being used in a secondary determined race or ethnicity and justify their relevance. In
analysis, authors should state at the end of the abstract the case where race or ethnicity was not collected,
the unique, persistent data set identifier; repository explain why it was not collected. Race and ethnicity are
name; and number. social and not biological constructs; authors should inter-
pret results associated with race and ethnicity in that con-
c. Introduction text. Authors should use neutral, precise, and respectful
Provide a context or background for the study (that language to describe study participants and avoid the
is, the nature of the problem and its significance). State
use of terminology that might stigmatize participants.
the specific purpose or research objective of, or hypoth-
esis tested by, the study or observation. Cite only directly
pertinent references, and do not include data or conclu- ii. Data Collection and Measurements
sions from the work being reported. Specify the study's main and secondary objectives—
usually identified as primary and secondary outcomes.
d. Methods Identify methods, equipment (give the manufacturer's
The guiding principle of the Methods section should name and address in parentheses), and procedures in
be clarity about how and why a study was done in a par- sufficient detail to allow others to reproduce the results.
ticular way. The Methods section should aim to be suffi- Give references to established methods, including statis-
ciently detailed such that others with access to the data tical methods (see below); provide references and brief
would be able to reproduce the results. In general, the descriptions for methods that have been published but
section should include only information that was avail- are not well-known; describe new or substantially modi-
able at the time the plan or protocol for the study was fied methods, give the reasons for using them, and eval-
being written; all information obtained during the study uate their limitations. Identify precisely all drugs and
belongs in the Results section. If an organization was chemicals used, including generic name(s), dose(s), and
paid or otherwise contracted to help conduct the route(s) of administration. Identify appropriate scientific
research (examples include data collection and manage- names and gene names.
ment), then this should be detailed in the methods.
The Methods section should include a statement iii. Statistics
indicating that the research was approved by an inde- Describe statistical methods with enough detail to
pendent local, regional or national review body (e.g., enable a knowledgeable reader with access to the origi-
ethics committee, institutional review board). If doubt nal data to judge its appropriateness for the study and to
exists whether the research was conducted in accord- verify the reported results. When possible, quantify find-
ings and present them with appropriate indicators of
ance with the Helsinki Declaration, the authors must
measurement error or uncertainty (such as confidence
explain the rationale for their approach and demonstrate
intervals). Avoid relying solely on statistical hypothesis
that the local, regional or national review body explicitly testing, such as P values, which fail to convey important
approved the doubtful aspects of the study. See Section information about effect size and precision of estimates.
II.E. References for the design of the study and statistical
Authors who used AI technology to conduct the methods should be to standard works when possible
study should describe its use in the methods section in (with pages stated). Define statistical terms, abbrevia-
sufficient detail to enable replication of the approach, tions, and most symbols. Specify the statistical software
including the tool used, version, and prompts where package(s) and versions used. Distinguish prespecified
applicable. from exploratory analyses, including subgroup analyses.

i. Selection and Description of Participants e. Results


Clearly describe the selection of observational or ex- Present your results in logical sequence in the text,
perimental participants (healthy individuals or patients, tables, and figures, giving the main or most important
including controls), including eligibility and exclusion cri- findings first. Do not repeat all the data in the tables or
teria and a description of the source population. figures in the text; emphasize or summarize only the
Because the relevance of such variables as age, sex, or most important observations. Provide data on all primary
ethnicity is not always known at the time of study design, and secondary outcomes identified in the Methods sec-
researchers should aim for inclusion of representative tion. 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 technical terms in statistics, such as “random” (which
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Recommendations for the Conduct, Reporting, Editing, and Publication of Scholarly Work in Medical Journals

implies a randomizing device), “normal,” “significant,” date of communication should be cited in parentheses in
“correlations,” and “sample.” the text. For scientific articles, obtain written permission
Separate reporting of data by demographic varia- and confirmation of accuracy from the source of a perso-
bles, such as age and sex, facilitate pooling of data for nal communication.
subgroups across studies and should be routine, unless Referencing AI-generated material as the primary
there are compelling reasons not to stratify reporting, source is not acceptable.
which should be explained. Some but not all journals check the accuracy of all
reference citations; thus, citation errors sometimes
f. Discussion
appear in the published version of articles. To minimize
It is useful to begin the discussion by briefly summa-
rizing the main findings, and explore possible mecha- such errors, references should be verified using either an
nisms or explanations for these findings. Emphasize the electronic bibliographic source, such as PubMed, or
new and important aspects of your study and put your print copies from original sources. Authors are responsi-
findings in the context of the totality of the relevant evi- ble for checking that none of the references cite
dence. State the limitations of your study, and explore retracted articles except in the context of referring to the
the implications of your findings for future research and retraction. For articles published in journals indexed in
for clinical practice or policy. Discuss the influence or
MEDLINE, the ICMJE considers PubMed the authorita-
association of variables, such as sex and/or gender, on
your findings, where appropriate, and the limitations of tive source for information about retractions. Authors can
the data. Do not repeat in detail data or other informa- identify retracted articles in MEDLINE by searching
tion given in other parts of the manuscript, such as in the PubMed for “Retracted publication [pt]”, where the term
Introduction or the Results section. “pt” in square brackets stands for publication type, or
Link the conclusions with the goals of the study but by going directly to the PubMed's list of retracted publi-
avoid unqualified statements and conclusions not cations (https://www.ncbi.nlm.nih.gov/pubmed/?term=
adequately supported by the data. In particular, distin- retracted+publication+[pt]).
guish between clinical and statistical significance, and
References should be numbered consecutively in
avoid making statements on economic benefits and
costs unless the manuscript includes the appropriate the order in which they are first mentioned in the text.
economic data and analyses. Avoid claiming priority or Identify references in text, tables, and legends by Arabic
alluding to work that has not been completed. State new numerals in parentheses.
hypotheses when warranted, but label them clearly. References cited only in tables or figure legends
should be numbered in accordance with the sequence
g. References established by the first identification in the text of the par-
ticular table or figure. The titles of journals should be
i. General Considerations
abbreviated according to the style used for MEDLINE
Authors should provide direct references to original
research sources whenever possible. References should (www.ncbi.nlm.nih.gov/nlmcatalog/journals). Journals
be made to published articles rather than to abstracts vary on whether they ask authors to cite electronic refer-
whenever possible. References should not be used by ences within parentheses in the text or in numbered refer-
authors, editors, or peer reviewers to promote self-inter- ences following the text. Authors should consult with the
ests. Authors should avoid citing articles from predatory journal to which they plan to submit their work.
or pseudo-journals. When preprints are cited, the cita-
tion should clearly indicate that the reference is a pre- ii. Style and Format
print (also see Section III.D.3). Although references to References should follow the standards summarized
review articles can be an efficient way to guide readers in the NLM's Sample References (www.nlm.nih.gov/bsd/
to a body of literature, review articles do not always
uniform_requirements.html) webpage and detailed in
reflect original work accurately. On the other hand,
extensive lists of references to original work on a topic the NLM's Citing Medicine, 2nd edition (www.ncbi.nlm.
can use excessive space. Fewer references to key origi- nih.gov/books/NBK7256/). These resources are regularly
nal papers often serve as well as more exhaustive lists, updated as new media develop, and currently include
particularly since references can now be added to the guidance for print documents; unpublished material;
electronic version of published papers, and since elec- audio and visual media; material on CD-ROM, DVD, or
tronic literature searching allows readers to retrieve pub- disk; and material on the Internet.
lished 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
accepted should be cited in the text as “unpublished efficiently; they also provide information at any desired
observations” with written permission from the source. level of detail and precision. Including data in tables
Published articles should reference the unique, per- rather than text frequently makes it possible to reduce
sistent identifiers of the data sets employed. the length of the text.
Avoid citing a “personal communication” unless it Prepare tables according to the specific journal's
provides essential information not available from a pub- requirements; to avoid errors it is best if tables can be
lic source, in which case the name of the person and directly imported into the journal's publication software.
18 www.icmje.org
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Recommendations for the Conduct, Reporting, Editing, and Publication of Scholarly Work in Medical Journals

Number tables consecutively in the order of their first the original source and submit written permission from
citation in the text and supply a title for each. Titles in the copyright holder to reproduce it. Permission is
tables should be short but self-explanatory, containing required irrespective of authorship or publisher except
information that allows readers to understand the table's for documents in the public domain.
content without having to go back to the text. Be sure In the manuscript, legends for illustrations should be
that each table is cited in the text. on a separate page, with Arabic numerals corresponding
Give each column a short or an abbreviated heading. to the illustrations. When symbols, arrows, numbers, or
Authors should place explanatory matter in footnotes, letters are used to identify parts of the illustrations, iden-
not in the heading. Explain all nonstandard abbreviations tify and explain each one clearly in the legend.
in footnotes, and use symbols to explain information if
j. Units of Measurement
needed. Symbols may vary from journal to journal (alpha-
Measurements of length, height, weight, and volume
bet letter or such symbols as *, †, ‡, §), so check each should be reported in metric units (meter, kilogram, or li-
journal's instructions for authors for required practice. ter) or their decimal multiples.
Identify statistical measures of variations, such as stand- Temperatures should be in degrees Celsius. Blood
ard deviation and standard error of the mean. pressures should be in millimeters of mercury, unless
If you use data from another published or unpub- other units are specifically required by the journal.
lished source, obtain permission and acknowledge that Journals vary in the units they use for reporting he-
source fully. matologic, clinical chemistry, and other measurements.
Additional tables containing backup data too exten- Authors must consult the Information for Authors of the
sive to publish in print may be appropriate for publica- particular journal and should report laboratory informa-
tion in the electronic version of the journal, deposited tion in both local and International System of Units (SI).
with an archival service, or made available to readers Editors may request that authors add alternative or
directly by the authors. An appropriate statement should non-SI units, since SI units are not universally used. Drug
be added to the text to inform readers that this addi- concentrations may be reported in either SI or mass
tional information is available and where it is located. units, but the alternative should be provided in parenthe-
Submit such tables for consideration with the paper so ses where appropriate.
that they will be available to the peer reviewers.
k. Abbreviations and Symbols
i. Illustrations (Figures) Use only standard abbreviations; use of nonstandard
Digital images of manuscript illustrations should be abbreviations can be confusing to readers. Avoid abbre-
submitted in a suitable format for print publication. Most
viations in the title of the manuscript. The spelled-out
submission systems have detailed instructions on the
abbreviation followed by the abbreviation in parentheses
quality of images and check them after manuscript
upload. For print submissions, figures should be either should be used on first mention unless the abbreviation is
professionally drawn and photographed, or submitted a standard unit of measurement.
as photographic-quality digital prints.
For radiological and other clinical and diagnostic B. Sending the Manuscript to the Journal
Manuscripts should be accompanied by a cover let-
images, as well as pictures of pathology specimens or
ter or a completed journal submission form, which
photomicrographs, send high-resolution photographic
should include the following information:
image files. Before-and-after images should be taken
A full statement to the editor about all submissions
with the same intensity, direction, and color of light.
and previous reports that might be regarded as redun-
Since blots are used as primary evidence in many scien-
dant publication of the same or very similar work. Any
tific articles, editors may require deposition of the origi-
such work should be referred to specifically and refer-
nal photographs of blots on the journal's website.
enced in the new paper. Copies of such material should
Although some journals redraw figures, many do
be included with the submitted paper to help the editor
not. Letters, numbers, and symbols on figures should
address the situation. See also Section III.D.2.
therefore be clear and consistent throughout, and large
enough to remain legible when the figure is reduced for A statement of financial or other relationships and
publication. Figures should be made as self-explanatory activities that might lead to a conflict of interest, if that in-
as possible, since many will be used directly in slide pre- formation is not included in the manuscript itself or in an
sentations. Titles and detailed explanations belong in the authors' form. See also Section II.B.
legends—not on the illustrations themselves. A statement on authorship. Journals that do not use
Photomicrographs should have internal scale contribution declarations for all authors may require that
markers. Symbols, arrows, or letters used in photomicro- the submission letter includes a statement that the manu-
graphs should contrast with the background. Explain the script has been read and approved by all the authors,
internal scale and identify the method of staining in that the requirements for authorship as stated earlier in
photomicrographs. this document have been met, and that each author
Figures should be numbered consecutively accord- believes that the manuscript represents honest work if
ing to the order in which they have been cited in the text. that information is not provided in another form. See
If a figure has been published previously, acknowledge also Section II.A.
www.icmje.org 19
Unauthorized reproduction of this article is prohibited
Recommendations for the Conduct, Reporting, Editing, and Publication of Scholarly Work in Medical Journals

Contact information for the author responsible for previous communications. Doing so may expedite the
communicating with other authors about revisions and review process and encourages transparency and shar-
final approval of the proofs, if that information is not ing of expertise.
included in the manuscript itself. Many journals provide a presubmission checklist to
The letter or form should inform editors if concerns help the author ensure that all the components of the
have been raised (e.g., via institutional and/or regulatory submission have been included. Some journals also
bodies) regarding the conduct of the research or if cor- require that authors complete checklists for reports of
rective action has been recommended. The letter or certain study types (e.g., the CONSORT checklist for
form should give any additional information that may be reports of randomized controlled trials). Authors should
helpful to the editor, such as the type or format of article look to see if the journal uses such checklists, and send
in the particular journal that the manuscript represents. If them with the manuscript if they are requested.
the manuscript has been submitted previously to The manuscript must be accompanied by permission
another journal, it is helpful to include the previous edi- to reproduce previously published material, use previ-
tor's and reviewers' comments with the submitted manu- ously published illustrations, report information about
script, along with the authors' responses to those identifiable persons, or to acknowledge people for their
comments. Editors encourage authors to submit these contributions.

20 www.icmje.org

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