CP-ACPJ220177 1..20

Recommendations for the Conduct, Reporting, Editing, and

Publication of Scholarly Work in Medical Journals

Updated January 2024

I. About the Recommendations

A. Purpose of the Recommendations

B. Who Should Use the Recommendations?

C. History of the Recommendations

II. Roles and Responsibilities of Authors, Contributors,

Reviewers, Editors, Publishers, and Owners

A. Deﬁning the Role of Authors and Contributors

1. Why Authorship Matters

2. Who Is an Author?

3. Non-Author Contributors

4. Artiﬁcial Intelligence (AI)–Assisted Technology

B. Disclosure of Financial and Non-Financial Relation-

ships and Activities, and Conﬂic ts of Interest

1. Participants

a. Authors

b. Peer Reviewers

c. Editors and Journal Staff

2. Reporting Relationships and Activities

C. Responsibilities in the Submission and Peer-Review

Process

1. Authors

a. Predatory or Pseudo-Journals

2. Journals

a. Conﬁdentiality

b. Timeliness

c. Peer Review

d. Integrity

e. Diversity and Inclusion

f. Journal Metrics

3. Peer Reviewers

D. Journal Owners and Editorial Freedom

1. Journal Owners

2. Editorial Freedom

E. Protection of Research Participants

III. Publishing and Editorial Issues Related to Publication

in Medical Journals

A. Corrections, Retractions, Republications, and

Version Control

B. Scientiﬁc Misconduct, Expressions of Concern,

and Retraction

C. Copyright

D. Overlapping Publications

1. Duplicate Submission

2. Duplicate and Prior Publication

3. Preprints

a. Choosing a Preprint Archive

b. Submitting Manuscripts That Are in Preprint

Archives to a Peer-Reviewed Journal

c. Referencing Preprints in Submitted Manu-

scripts

4. Acceptable Secondary Publication

5. Manuscripts Based on the Same Database

E. Correspondence

F. Fees

G. Supplements, Theme Issues, and Special Series

H. Sponsorship and Partnerships

I. Electronic Publishing

J. Advertising

K. Journals and the Media

L. Clinical Trials

1. Registration

2. Data Sharing

IV. Manuscript Preparation and Submission

A. Preparing a Manuscript for Submission to a

Medical Journal

1. General Principles

2. Reporting Guidelines

3. Manuscript Sections

a. Title Page

b. Abstract

c. Introduction

d. Methods

i. Selection and Description of Participants

ii. Data Collection and Measurements

iii. Statistics

e. Results

f. Discussion

g. References

i. General Considerations

ii. Style and Format

h. Tables

i. Illustrations (Figures)

j. Units of Measurement

k. Abbreviations and Symbols

B. Sending the Manuscript to the Journal

I. ABOUT THE RECOMMENDATIONS

A. Purpose of the Recommendations

ICMJE developed these recommendations to review

best practice and ethical standards in the conduct and

reporting of research and other material published in

medical journals, and to help authors, editors, and others

involved in peer review and biomedical publishing cre-

ate and distribute accurate, clear, reproducible, unbia-

sed medical journal articles. The recommendations may

also provide useful insights into the medical editing and

publishing process for the media, patients and their fami-

lies, and general readers.

B. Who Should Use the Recommendations?

These recommendations are intended primarily for

use by authors who might submit their work for publication

to ICMJE member journals. Many non-ICMJE journals vol-

untarily use these recommendations (see www.icmje.org/

journals-following-the- icmje-recommendations/). The ICMJE

encourages that use but has no authority to monitor or

enforce it. In all cases, authors shou ld use these recommen-

dations along with individual journals' instructions to

authors . Authors should also consult guidelines for the

reporting of speciﬁc study types (e.g., the CONSORT

guidelines for the reporting of randomized trials); see

www.equator-network.org.

Journals that follow these recommendations are

encouraged to incorporate them into their instructions to

authors and to make explicit in those instructions that

they follow ICMJE recommendations. Journals that wish

to be identiﬁed on the ICMJE website as following these

recommendations should notify the ICMJE secretariat at www.

icmje.org/journals-following -the-icmje-recommendati ons/

journal-listing-request-form/. Journals that in the past have

requested such identiﬁcation but who no longer follow ICMJE

recommendations should use the same means to request re-

moval from this list.

The ICMJE encourages wide dissemination of these

recommendations and reproduction of this document in

its entirety for educational, not-for-proﬁt purposes with-

out regard for copyright, but all uses of the recommen-

dations and document should direct readers to www.

icmje.org for the ofﬁcial, most recent version, as the

ICMJE updates the recommendations periodically when

new issues arise.

C. History of the Recommendations

The ICMJE has produced multiple editions of this

document, previously known as the Uniform Require-

ments for Manuscripts Submitted to Biomedical Journals

(URMs). The URM was ﬁrst published in 1978 as a way of

standardizing manuscript format and preparation across

journals. Over the years, issues in publishing that went

well beyond manuscript preparation arose, resulting in

the development of separate statements, updates to the

document, and its renaming as “Recommendations for

the Conduct, Reporting, Editing, and Publication of

Scholarly Work in Medical Journals” to reﬂect its broader

scope. Previous versions of the document may be found

in the “Archives” section of www.icmje.org.

II. ROLES AND RESPONSIBILITIES OF AUTHORS,

ONTRIBUTORS,REVIEWERS,EDITORS,

UBLISHERS, AND OWNERS

A. Deﬁning the Role of Authors and Contributors

1. Why Authorship Matters

Authorship confers credit and has important aca-

demic, social, and ﬁnancial implications. Authorship also

implies responsibility and accountability for published

work. The following recommendations are intended to

ensure that contributors who have made substantive in-

tellectual contributions to a paper are given credit as

authors, but also that contributors credited as authors

understand their role in taking responsibility and being

accountable for what is published.

Editors should be aware of the practice of excluding

local researchers from low-income and middle-income

countries (LMICs) from authorship when data are from

LMICs. Inclusion of local authors adds to fairness, con-

text, and implications of the research. Lack of inclusion of

local investigators as authors should prompt questioning

and may lead to rejection.

Because authorship does not communicate what

contributions qualiﬁed an individual to be an author,

some journals now request and publish information

about the contributions of each person named as having

participated in a submitted study, at least for original

research. Editors are strongly encouraged to develop

and implement a contributorship policy. Such policies

remove much of the ambiguity surrounding contribu-

tions, but leave unresolved the question of the quantity

and quality of contribution that qualify an individual for

authorship. The ICMJE has thus developed criteria for

authorship that can be used by all journals, including

those that distinguish authors from other contributors.

2. Who Is an Author?

The ICMJE recommends that authorship be based

on the following 4 criteria:

1. Substantial contributions to the conception or design

of the work; or the acquisition, analysis, or interpreta-

tion of data for the work; AND

2. Drafting the work or reviewing it critically for impor-

tant intellectual content; AND

3. Final approval of the version to be published; AND

4. Agreement to be accountable for all aspects of the

work in ensuring that questions related to the accu-

racy or integrity of any part of the work are appropri-

ately investigated and resolved.

In addition to being accountable for the parts of the

work done, an author should be able to identify which

co-authors are responsible for speciﬁc other parts of the

work. In addition, authors should have conﬁdence in the

integrity of the contributions of their co-authors.

All those designated as authors should meet all four

criteria for authorship, and all who meet the four criteria

should be identiﬁed as authors. Those who do not meet

all four criteria should be acknowledged—see Section II.

A.3 below. These authorship criteria are intended to

reserve the status of authorship for those who deserve

credit and can take responsibility for the work. The crite-

ria are not intended for use as a means to disqualify col-

leagues from authorship who otherwise meet authorship

criteria by denying them the opportunity to meet crite-

rion #s 2 or 3. The re fo re, a ll ind iv id ua ls wh o mee t the

ﬁrst criterion should have the opportunity to partici-

pate in the review, drafting, and ﬁnal approval of the

manuscript.

The individuals who conduct the work are responsi-

ble for identifying who meets these criteria and ideally

should do so when planning the work, making modiﬁca-

tions as appropriate as the work progresses. We encour-

age collaboration and co-authorship with colleagues in

the locations where the research is conducted. It is the

collective responsibility of the authors, not the journal to

which the work is submitted, to determine that all people

named as authors meet all four criteria; it is not the role

of journal editors to determine who qualiﬁes or does not

Recommendations for the Conduct, Reporting, Editing, and Publication of Scholarly Work in Medical Journals

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qualify for authorship or to arbitrate authorship conﬂicts.

If agreement cannot be reached about who qualiﬁes for

authorship, the institution(s) where the work was per-

formed, not the journal editor, should be asked to inves-

tigate. The criteria used to determine the order in which

authors are listed on the byline may vary, and are to be

decided collectively by the author group and not by edi-

tors. If authors request removal or addition of an author

after manuscript submission or publication, journal edi-

tors should seek an explanation and signed statement of

agreement for the requested change from all listed

authors and from the author to be removed or added.

The corresponding author is the one individual who

takes primary responsibility for communication with the

journal during the manuscript submission, peer-review,

and publication process. The corresponding author typi-

cally ensures that all the journal's administrative require-

ments, such as providing details of authorship, ethics

committee approval, clinical trial registration documen-

tation, and disclosures of relationships and activities, are

properly completed and reported, although these duties

may be delegated to one or more co-authors. The corre-

sponding author should be available throughout the

submission and peer-review process to respond to edi-

torial queries in a timely way, and should be available af-

ter publication to respond to critiques of the work and

cooperate with any requests from the journal for data or

additional information should questions about the paper

arise after publication. Although the corresponding

author has primary responsibility for correspondence

with the journal, the ICMJE recommends that editors

send copies of all correspondence to all listed authors.

When a large multi-author group has conducted the

work, the group ideally should decide who will be an

author before the work is started and conﬁrm who is an

author before submitting the manuscript for publication.

All members of the group named as authors should

meet all four criteria for authorship, including approval

of the ﬁnal manuscript, and they should be able to take

public responsibility for the work and should have full

conﬁdence in the accuracy and integrity of the work of

other group authors. They will also be expected as indi-

viduals to complete disclosure forms.

Some large multi-author groups designate author-

ship by a group name, with or without the names of indi-

viduals. When submitting a manuscript authored by a

group, the corresponding author should specify the

group name if one exists, and clearly identify the group

members who can take credit and responsibility for the

work as authors. The byline of the article identiﬁes who is

directly responsible for the manuscript, and MEDLINE

lists as authors whichever names appear on the byline. If

the byline includes a group name, MEDLINE will list the

names of individual group members who are authors or

who are collaborators, sometimes called non-author con-

tributors, if there is a note associated with the byline

clearly stating that the individual names are elsewhere in

the paper and whether those names are authors or

collaborators.

3. Non-Author Contributors

Contributors who meet fewer than all 4 of the above

criteria for authorship should not be listed as authors,

but they should be acknowledged. Examples of activities

that alone (without other contributions) do not qualify a

contributor for authorship are acquisition of funding;

general supervision of a research group or general

administrative support; and writing assistance, technical

editing, language editing, and pr oofreading. Those whose

contributions do not justify authorship may be acknowl-

edged individually or together as a group under a single

heading (e.g., “Clinical Investigators” or “Particip ating

Investigators”), and their contributions should be speciﬁed

(e.g., “served as scientiﬁcadvisors,”“critically reviewed the

study proposal,”“collected data,”“provided and cared for

study patients,”“participated in writing or technical editing

of the manuscript”).

Because acknowledgment may imply endorsement

by acknowledged individuals of a study's data and conclu-

sions, editors are advised to require that the correspond-

ing author obtain written permission to be acknowledged

from all acknowledged individuals.

Use of AI for writing assistance should be reported in

the acknowledgment section.

4. Artiﬁcial Intelligence (AI)–Assisted Technology

At submission, the journal should require authors to

disclose whether they used Artiﬁcial Intelligence (AI)–

assisted technologies (such as Large Language Models

[LLMs], chatbots, or image creators) in the production of

submitted work. Authors who use such technology

should describe, in both the cover letter and the submit-

ted work in the appropriate section if applicable, how

they used it. For example, if AI was used for writing assis-

tance, describe this in the acknowledgment section (see

Section II.A.3). If AI was used for data collection, analysis,

or ﬁgure generation, authors should describe this use in

the methods (see Section IV.A.3.d). Chatbots (such as

ChatGPT) should not be listed as authors because they

cannot be responsible for the accuracy, integrity, and

originality of the work, and these responsibilities are

required for authorship (see Section II.A.1). Therefore,

humans are responsible for any submitted material that

included the use of AI-assisted technologies. Authors

should carefully review and edit the result because AI

can generate authoritative-sounding output that can

be incorrect, incomplete, or biased. Authors should

not list AI and AI-assisted technologies as an author or

co-author, nor cite AI as an author. Authors should be

able to assert that there is no plagiarism in their paper,

including in text and images produced by the AI. Humans

must ensure there is appropriate attribution of all quoted

material, including full citations.

B. Disclosure of Financial and Non-Financial

Relationships and Activities, and Conﬂicts of

Interest

Public trust in the scientiﬁc process and the credibil-

ity of published articles depend in part on how transpar-

ently an author's relationships and activities, directly or

topically related to a work, are handled during the

Recommendations for the Conduct, Reporting, Editing, and Publication of Scholarly Work in Medical Journals

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planning, implementation, writing, peer review, editing,

and publication of scientiﬁcwork.

The potential for conﬂict of interest and bias exists

when professional judgment concerning a primary inter-

est (such as patients' welfare or the validity of research)

may be inﬂuenced by a secondary interest (such as ﬁnan-

cial gain). Perceptions of conﬂict of interest are as impor-

tant as actual conﬂicts of interest.

Individuals may disagree on whether an author's

relationships or activities represent conﬂicts. Although

the presence of a relationship or activity does not always

indicate a problematic inﬂuence on a paper's content,

perceptions of conﬂict may erode trust in science as

much as actual conﬂicts of interest. Ultimately, readers

must be able to make their own judgments regarding

whether an author's relationships and activities are perti-

nent to a paper's content. These judgments require

transparent disclosures. An author's complete disclosure

demonstrates a commitment to transparency and helps

to maintain trust in the scientiﬁcprocess.

Financial relationships (such as employment, consul-

tancies, stock ownership or options, honoraria, patents,

and paid expert testimony) are the most easily identiﬁa-

ble, the ones most often judged to represent potential

conﬂicts of interest and thus the most likely to undermine

the credibility of the journal, the authors, and science

itself. Other interests may also represent or be perceived

as conﬂicts, such as personal relationships or rivalries,

academic competition, and intellectual beliefs.

Authors should avoid entering into agreements with

study sponsors, both for-proﬁt and nonproﬁt, that inter-

fere with authors' access to all of the study's data or that

interfere with their ability to analyze and interpret the

data and to prepare and publish manuscripts independ-

ently when and where they choose. Policies that dictate

where authors may publish their work violate this princi-

ple of academic freedom. Authors may be required to

provide the journal with the agreements in conﬁdence.

Purposeful failure to report those relationships or

activities speciﬁed on the journal's disclosure form is a

form of misconduct, as is discussed in Section III.B.

Disclosure of potential conﬂicts of interest is distinct

and extends beyond direct support for this work. Within

a manuscript, the funding statement should include only

direct support of the work described. Support for an indi-

vidual's contribution for the work should be reported as

such. General institutional support for an author's time

on the work should be distinguished from direct overall

funding of the work. An appropriate funding statement

might be: “This study was funded by A; Dr. F’stimeon

the work was supported by B.”

1. Participants

All participants in the peer-review and publication pro-

cess—not only authors but also peer reviewers, editors, and

editorial board members of journals—must consider and

disclose their relationships and activities when fulﬁlling their

rolesintheprocessofarticlereviewandpublication.

a. Authors

When authors submit a manuscript of any type or for-

mat they are responsible for disclosing all relationships

and activities that might bias or be seen to bias their

work. The ICMJE has developed a Disclosure Form to

facilitate and standardize authors' disclosures. ICMJE

member journals require that authors use this form, and

ICMJE encourages other journals to adopt it.

b. Peer Reviewers

Reviewers should be asked at the time they are

asked to critique a manuscript if they have relationships

or activities that could complicate their review. Reviewers

must disclose to editors any relationships or activities

that could bias their opinions of the manuscript, and

should recuse themselves from reviewing speciﬁcmanu-

scripts if the potential for bias exists. Reviewers must not

use knowledge of the work they're reviewing before its

publication to further their own interests.

c. Editors and Journal Staff

Editors who make ﬁnal decisions about manuscripts

should recuse themselves from editorial decisions if they

have relation ships or activ ities that p ose potentia l conﬂicts

related to articles under consideration. Other editorial staff

members who participate in editorial decisions must pro-

vide editors with a current description of their relation-

ships and activities (as they might relate to editorial

judgments) and recuse themselves from any decisions

in which an interest that poses a potential conﬂict exists.

Editorial staff must not use information gained through

working with manuscripts for private gain. Editors should

regularly publish their own disclosure statements and

those of their journal staff. Guest editors should follow

these same procedures.

Journal s should take extra prec aution s and have a

stated policy for evaluation of manuscripts submitted by

individuals involved in editorial decisions. Further guidance

is available from COPE (https://publicationethics.org/ﬁles/

A_Short_Guide_to_Ethical_Editing.pdf) and WAME (http://

wame.org/conﬂict-of-interest-in-peer-reviewed-medical-

journals).

2. Reporting Relationships and Activities

Articles should be published with statements or sup-

porting documents, such as the ICMJE Disclosure Form,

declaring:

•

Authors' relationships and activities; and

•

Sources of support for the work, including sponsor

names along with explanations of the role of those

sources if any in study design; collection, analysis,

and interpretation of data; writing of the report; any

restrictions regarding the submission of the report

for publication; or a statement declaring that the sup-

porting source had no such involvement or restric-

tions regarding publication; and

•

Whether the authors had access to the study data,

with an explanation of the nature and extent of

access, including whether access is ongoing.

To support the above statements, editors may

request that authors of a study sponsored by a funder

Recommendations for the Conduct, Reporting, Editing, and Publication of Scholarly Work in Medical Journals

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with a proprietary or ﬁnancial interest in the outcome

sign a statement, such as “I had full access to all of the

data in this study and I take complete responsibility for

the integrity of the data and the accuracy of the data

analysis.”

C. Responsibilities in the Submission and

Peer-Review Process

1. Authors

Authors should abide by all principles of authorship

and declaration of relationships and activities detailed in

Sections II.A and II.B of this document.

a. Predatory or Pseudo-Journals

A growing number of entities are advertising them-

selves as “scholarly medical journals” yet do not function

as such. These journals (“predatory” or “pseudo-jour-

nals”) accept and publish almost all submissions and

charge article processing (or publication) fees, often

informing authors about this after a paper's acceptance

for publication. They often claim to perform peer review

but do not and may purposefully use names similar to

well-established journals. They may state that they are

members of ICMJE but are not (see www.icmje.org for

current members of the ICMJE) and that they follow the

recommendations of organizations such as the ICMJE,

COPE, and WAME. Researchers must be aware of the ex-

istence of such entities and avoid submitting research to

them for publication. Authors have a responsibility to

evaluate the integrity, history, practices, and reputation

of the journals to which they submit manuscripts.

Guidance from various organizations is available to help

identify the characteristics of reputable peer-reviewed

journals (www.wame.org/identifying-predatory-or-pseudo-

journals and www.wame.org/principles-of-transparency-

and-best-practice-in-scho larly-publishing).

Seeking the assistance of scientiﬁc mentors, senior

colleagues, and others with many years of scholarly pub-

lishing experience may also be helpful.

Authors should avoid citing articles in predatory or

pseudo-journals.

2. Journals

a. Conﬁdentiality

Manuscripts submitted to journals are privileged

communications that are authors' private, conﬁdential

property, and authors may be harmed by premature dis-

closure of any or all of a manuscript's details.

Editors therefore must not share information about

manuscripts, including whether they have been received

and are under review, their content and status in the

review process, criticism by reviewers, and their ultimate

fate, to anyone other than the authors and reviewers.

Editors should be aware that using AI technology in the

processing of manuscripts may violate conﬁdentiality.

Requests from third parties to use manuscripts and

reviews for legal proceedings should be politely refused,

and editors should do their best not to provide such con-

ﬁdential material should it be subpoenaed.

Editors must also make clear that reviewers should

keep manuscripts, associated material, and the informa-

tion they contain strictly conﬁdential. Instructions to

reviewers should include guidance about AI use.

Reviewers and editorial staff members must not publicly

discuss the authors' work, and reviewers must not

appropriate authors' ideas before the manuscript is

published. Reviewers must not retain the manuscript for

their personal use and should destroy paper copies of

manuscripts and delete electronic copies after submit-

ting their reviews.

When a manuscript is rejected, it is best practice for

journals to delete copies of it from their editorial systems

unless retention is required by local regulations. Journals

that retain copies of rejected manuscripts should dis-

close this practice in their Information for Authors.

When a manuscript is published, jo urnals should

keep copies of the original submission, reviews, revisions,

and correspondence for at least three years and possibly

in perpetuity, depending on local regulations, to help an-

swer future questions about the work should they arise.

Editors should not publish or publicize peer reviewers'

comments without permission of the reviewer and author.

If journal policy is to anonymize authors to reviewer identity

and comments are not signed, that identity must not

be revealed to the author or anyone else without the

reviewers' expressed w ritten permission.

Conﬁdentiality may have to be breached if dishon-

esty or fraud is alleged, but editors should notify authors

or reviewers if they intend to do so and conﬁdentiality

must otherwise be honored.

b. Timeliness

Editors should do all they can to ensure timely proc-

essing of manuscripts with the resources available to

them. If editors intend to publish a manuscript, they

should attempt to do so in a timely manner and any

planned delays should be negotiated with the authors. If

a journal has no intention of proceeding with a manu-

script, editors should endeavor to reject the manuscript

as soon as possible to allow authors to submit to a differ-

ent journal.

c. Peer Review

Peer review is the critical assessment of manuscripts

submitted to journals by experts who are usually not part

of the editorial staff. Because unbiased, independent,

critical assessment is an intrinsic part of all scholarly

work, including scientiﬁc research, peer review is an im-

portant extension of the scientiﬁc process.

The actual value of peer review is widely debated,

but the process facilitates a fair hearing for a manuscript

among members of the scientiﬁc community. More prac-

tically, it helps editors decide which manuscripts are suit-

able for their journals. Peer review often helps authors

and editors improve the quality of reporting.

It is the responsibility of the journal to ensure that

systems are in place for selection of appropriate

reviewers. It is the responsibility of the editor to ensure

that reviewers have access to all materials that may be

Recommendations for the Conduct, Reporting, Editing, and Publication of Scholarly Work in Medical Journals

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relevant to the evaluation of the manuscript, including

supplementary material for e-only publication, and to

ensure that reviewer comments are properly assessed

and interpreted in the context of their declared relation-

ships and activities.

A peer-reviewed journal is under no obligation to

send submitted manuscripts for review, and under no

obligation to follow reviewer recommendations, favor-

able or negative. The editor of a journal is ultimately re-

sponsible for the selection of all its content, and editorial

decisions may be informed by issues unrelated to the

quality of a manuscript, such as suitability for the journal.

An editor can reject any article at any time before publi-

cation, including after acceptance if concerns arise about

the integrity of the work.

Journals may differ in the number and kinds of

manuscripts they send for review, the number and types

of reviewers they seek for each manuscript, whether the

review process is open or an onymized, and other aspects

of the review process. For thi s reas on and as a service

to authors, journals should publish a clear, transparent

description of their peer-review process for all types

of manuscripts.

Journals should notify reviewers of the ultimate deci-

sion to accept or reject a paper, and should acknowl-

edge the contribution of peer reviewers to their journal.

Editors are encouraged to share reviewers' comments

with co-reviewers of the same paper, so reviewers can

learn from each other in the review process.

As part of peer review, editors are encouraged to

review research protocols, plans for statistical analysis if sep-

arate from the protoc ol, and/ or contrac ts associ ated with

project-speciﬁc studies. Editors should encourage authors

to make such documents p ublicly av ailable at the time of or

after publi cation, before accepting such s tudies for publica-

tion. Some journals may requir e publi c posti ng of these

documents as a condition of acceptance for publication.

Journal requirements for independent data analysis

and for public data availability vary, reﬂecting evolving

views of the importance of data availability for pre- and

post-publication peer review. Some journal editors cur-

rently request a statistical analysis of trial data by an in-

dependent biostatistician before accepting studies for

publication. Others ask authors to say whether the study

data are available to third parties to view and/or use/

reanalyze, while still others encourage or require

authors to share their data with others for review or

reanalysis. Each journal should establish and publish

their speciﬁc requirements for data analysis and post in

a place that potential authors can easily access.

Some people believe that true scientiﬁc peer review

begins only on the date a paper is published. In that spirit,

medical journals should have a mechanism for readers to

submit comments, questions, or criticisms about published

articles, and authors have a responsibility to respond

appropriately and cooperate with any requests from the

journal for data or additional information should questions

about the paper arise after publicat ion (see Section III).

ICMJE believes investigators have a duty to maintain

the primary data and analytic procedures underpinning

the published results for at least 10 years. The ICMJE

encourages the preservation of these data in a data re-

pository to ensure their longer-term availability.

d. Integrity

Editorial decisions should be based on the relevance

of a manuscript to the journal and on the manuscript's

originality, quality, and contribution to evidence about

important questions. Those decisions should not be

inﬂuenced by commercial interests, personal relation-

ships or agendas, or ﬁndings that are negative or that

credibly challenge accepted wisdom. In addition,

authors should submit for publication or otherwise make

publicly available, and editors should not exclude from

consideration for publication, studies with ﬁndings that

are not statistically signiﬁcant or that have inconclusive

ﬁndings. Such studies may provide evidence that, com-

bined with that from other studies through meta-analysis,

might still help answer important questions, and a public

record of such negative or inconclusive ﬁndings may pre-

vent unwarranted replication of effort or otherwise be

valuable for other researchers considering similar work.

Journals should clearly state their appeals process

and should have a system for responding to appeals and

complaints.

e. Diversity and Inclusion

To improve academic culture, editors should seek to

engage a broad and diverse array of authors, reviewers,

editorial staff, editorial board members, and readers.

f. Journal Metrics

The journal impact factor is widely misused as a

proxy for research and journal quality and as a measure

of the importance of speciﬁc research projects or the

merits of individual researchers, including their suitability

for hiring, promotion, tenure, prizes, or research funding.

ICMJE recommends that journals reduce the emphasis

on impact factor as a single measure, but rather provide

a range of article and journal metrics relevant to their

readers and authors.

3. Peer Reviewers

Manuscripts submitted to journals are privileged

communications that are authors' private, conﬁdential

property, and authors may be harmed by premature dis-

closure of any or all of a manuscript's details.

Reviewers therefore should keep manuscripts and

the information they contain strictly conﬁde ntial. Reviewers

must not publicly discuss authors' work and must not

appropriate authors' ideas before the manuscript is

published. Reviewers must not retain the manuscript for their

personal use and should destroy copies of manuscripts after

submitting their reviews.

Reviewers who seek assistance from a trainee or col-

league in the performance of a review should acknowl-

edge these individuals' contributions in the written

comments submitted to the editor. Reviewers must

maintain the conﬁdentiality of the manuscript as outlined

above, which may prohibit the uploading of the manu-

script to software or other AI technologies where

Recommendations for the Conduct, Reporting, Editing, and Publication of Scholarly Work in Medical Journals

6 www.icmje.org

conﬁdentiality cannot be assured. Reviewers must

request permission from the journal prior to using AI

technology to facilitate their review. Reviewers should be

aware that AI can generate authoritative-sounding output

that can be incorrect, incomplete, or biased.

Reviewers are expected to respond promptly to

requests to review and to submit reviews within the time

agreed. Reviewers' comments should be constructive,

honest, and polite.

Reviewers should declare their relationships and

activities that might bias their evaluation of a manuscript

and recuse themselves from the peer-review process if a

conﬂict exists.

D. Journal Owners and Editorial Freedom

1. Journal Owners

Owners and editors of medical journals share a com-

mon purpose, but they have different responsibilities,

and sometimes those differences lead to conﬂicts. A

medical journal should explicitly state its governance

and relationship to a journal owner (e.g., a sponsoring

society).

Medical publishing contributes to carbon emissions

that exacerbate climate change, which is an urgent threat

to human well-being and planetary health. Editors, pub-

lishers, journal owners, and other stakeholders should

work together to develop immediate strategies to

reduce carbon emissions, with a goal toward achieving

net zero carbon emissions.

It is the responsibility of medical journal owners to

appoint and dismiss editors. Owners should provide edi-

tors at the time of their appointment with a contract that

clearly states their rights and duties, authority, the gen-

eral terms of their appointment, and mechanisms for

resolving conﬂict. The editor's performance may be

assessed using mutually agreed-upon measures, includ-

ing but not necessarily limited to readership, manuscript

submissions and handling times, and various journal

metrics.

Owners should only dismiss editors for substantial

reasons, such as scientiﬁc misconduct, disagreement

with the long-term editorial direction of the journal, inad-

equate performance by agreed-upon performance met-

rics, or inappropriate behavior that is incompatible with a

position of trust.

Appointments and dismissals should be based on

evaluations by a panel of independent experts, rather

than by a small number of executives of the owning orga-

nization. This is especially necessary in the case of dis-

missals because of the high value society places on

freedom of speech within science and because it is often

the responsibility of editors to challenge the status quo

in ways that may conﬂict with the interests of the journal's

owners.

2. Editorial Freedom

TheICMJEadoptstheWorldAssociationofMedical

Editors' deﬁnition of editorial freedom (http://wame.org/

editorial-independence), which holds that editors-in-

chief have full authority over the entire editorial content

of their journal and the timing of publication of that

content. Journal owners should not interfere in the evalu-

ation, selection, scheduling, or editing of individual

articles either directly or by creating an environment that

strongly inﬂuences decisions. Editors should base edito-

rial decisions on the validity of the work and its impor-

tance to the journal's readers, not on the commercial

implications for the journal, and editors should be free to

express critical but responsible views about all aspects of

medicine without fear of retribution, even if these views

conﬂict with the commercial goals of the publisher.

Editors-in-chief should also have the ﬁnal say in deci-

sions about which advertisements or sponsored content,

including supplements, the journal will and will not carry,

and they should have ﬁnal say in use of the journal brand

and in overall policy regarding commercial use of journal

content.

Journals are encouraged to establish an independ-

ent and diverse editorial advisory board to help the edi-

tor establish and maintain editorial policy. To support

editorial decisions and potentially controversial expres-

sions of opinion, owners should ensure that appropriate

insurance is obtained in the event of legal action against

the editors, and should ensure that legal advice is avail-

able when necessary. If legal problems arise, the editor

should inform their legal adviser and their owner and/or

publisher as soon as possible. Editors should defend the

conﬁdentiality of authors and peer reviewers (names and

reviewer comments) in accordance with ICMJE policy

(see Section II.C.2.a). Editors should take all reasonable

steps to check the facts in journal commentary, including

that in news sections and social media postings, and

should ensure that staff working for the journal adhere to

best journalistic practices including contemporaneous

note-taking and seeking a response from all parties

when possible before publication. Such practices in sup-

port of truth and public interest may be particularly rele-

vant in defense against legal allegations of libel.

To secure editorial freedom in practice, the editor

should have direct access to the highest level of ownership,

not to a delegated manager or administrat ive ofﬁcer.

Editors and editors' organizations are obliged to sup-

port the concept of editorial freedom and to draw major

transgressions of such freedom to the attention of the

international medical, academic, and lay communities.

E. Protection of Research Participants

All investigators should ensure that the planning,

conduct, and reporting of human research are in accord-

ance with the Helsinki Declaration as revised in 2013

(www.wma.net/policies-post/wma-declaration-of-helsinki-

ethical-principles-for-medical-research-involving-human-

sub jects/). All authors should seek approval to conduct

research from an independent local, regional, or national

review body (e.g., ethics committee, institutional review

board), and be prepared to provide documentation

when requested by editors. If doubt exists whether the

research was conducted in accordance with the Helsinki

Declaration, the authors must explain the rationale for

their approach and demonstrate that the local, regional,

Recommendations for the Conduct, Reporting, Editing, and Publication of Scholarly Work in Medical Journals

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or national review body explicitly approved the doubtful

aspects of the study. Approval by a responsible review

body does not preclude editors from forming their own

judgment whether the conduct of the research was

appropriate.

Patients have a right to privacy that should not be

violated without informed consent. Identifying informa-

tion, including names, initials, or hospital numbers,

should not be published in written descriptions, photo-

graphs, or pedigrees unless the information is essential

for scientiﬁc purposes and the patient (or parent or

guardian) gives written informed consent for publication.

Informed consent for this purpose requires that an identi-

ﬁable patient be shown the manuscript to be published.

Authors should disclose to these patients whether any

potential identiﬁable material might be available via the

Internet as well as in print after publication. Patient con-

sent should be written and archived with the journal, the

authors, or both, as dictated by local regulations or laws.

Applicable laws vary from locale to locale, and journals

should establish their own policies with legal guidance.

Since a journal that archives the consent will be aware of

patient identity, some journals may decide that patient

conﬁdentiality is better guarded by having the author

archive the consent and instead providing the journal

with a written statement that attests that they have

received and archived written patient consent.

Nonessential identifying details should be omitted.

Informed consent should be obtained if there is any

doubt that anonymity can be maintained. For example,

masking the eye region in photographs of patients is

inadequate protection of anonymity. If identifying char-

acteristics are deidentiﬁed, authors should provide

assurance, and editors should so note, that such changes

do not distort scientiﬁcmeaning.

The requirement for informed consent should be

included in the journal's instructions for authors. When

informed consent has been obtained, it should be indi-

cated in the published article.

When reporting experiments on animals, authors

should indicate whether institutional and national stand-

ards for the care and use of laboratory animals were

followed.

III. PUBLISHING AND EDITORIAL ISSUES

RELATED TO PUBLICATION IN MEDICAL

JOURNALS

A. Corrections, Retractions, Republications, and

Version Control

Honest errors are a part of science and publishing

and require publication of a correction when they are

detected. Corrections are needed for errors of fact.

Matters of debate are best handled as letters to the edi-

tor, as print or electronic correspondence, or as posts in

a journal-sponsored online forum. Updates of previous

publications (e.g., an updated systematic review or clini-

cal guideline) are considered a new publication rather

than a version of a previously published article.

If a correction is needed, journals should follow these

minimum standards:

•

The journal should publish a correction notice as

soon as possible detailing changes from and citing

the original publication; the correction should be on

an electronic or numbered print page that is

included in an electronic or a print Table of Contents

to ensure proper indexing.

•

The journal should also post a new article version

with details of the changes from the original version

and the date(s) on which the changes were made.

•

The journal should archive all prior versions of the ar-

ticle. This archive can be either directly accessible to

readers or can be made available to the reader on

request.

•

Previous electronic versions should prominently note

that there are more recent versions of the article.

•

The citation should be to the most recent version.

Pervasive errors can result from a coding problem

or a miscalculation and may result in extensive inaccura-

cies throughout an article. If such errors do not change

the direction or signiﬁcance of the results, interpreta-

tions, and conclusions of the article, a correction should

be published that follows the minimum standards noted

above.

Errors serious enough to invalidate a paper's results

and conclusions may require retraction. However, retrac-

tion with republication (also referred to as “replacem ent”)

can be considered in cases where honest error (e.g., a

misclassiﬁcation or miscalculation) leads to a major

change in the direction or signiﬁcance of the results, inter-

pretations, and conclusions. If the error is judged to be

unintentional, the underlying science appears valid, and

the changed version of the paper survives further review

and editorial scrutiny, then retraction with republication of

the changed paper, with an explanation, allows full correc-

tion of the scientiﬁc literature. In such cases, it is helpful to

show the extent of the changes in suppl ementa ry material

or in an appendix, for complete transparency.

B. Scientiﬁc Misconduct, Expressions of

Concern, and Retraction

Scientiﬁc misconduct in research and non-research

publications includes but is not necessarily limited to

data fabrication; data falsiﬁcation, including deceptive

manipulation of images; purposeful failure to disclose rela-

tionships and activities; and plagiarism. Some people con-

sider failure to publish the results of clinical trials and other

human studies a form of scientiﬁc misconduct. While each

of these practices is problematic, they are not equivalent.

Each situation requires individual assessment by relevant

stakeholders. When scientiﬁc misconduct is alleged, or

concerns are otherwise raised about the conduct or integ-

rity of work described in submitted or published papers,

the editor should initiate appro priate proced ures detaile d

by such committees as the Committee on Publication Ethics

(COPE) (http://publicationethics.org/resources/ﬂow charts),

consid er info rming t he inst itutions and fund ers, an d may

choose to publish an expression of concern pending the

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outcomes of those procedures. If the procedures involve an

investigation at the authors' institution, the editor should

seek to discover the outcome of that investigation; notify

readers of the outcome if appropriate; and if the inve stiga-

tion proves scientiﬁc misconduct, publish a retraction of the

article. There may be circumstances in which no misconduct

is proven, but an exchange of letters to the editor could be

published to highlight matters of debate to readers.

Expressions of concern and retractions should not

simply be a letter to the editor. Rather, they should be

prominently labelled, appear on an electronic or num-

bered print page that is included in an electronic or a

print Table of Contents to ensure proper indexing, and

include in their heading the title of the original article.

Online, the retraction and original article should be

linked in both directions and the retracted article should

be clearly labelled as retracted in all its forms (abstract,

full text, PDF). Ideally, the authors of the retraction should

be the same as those of the article, but if they are unwill-

ing or unable the editor may under certain circumstances

accept retractions by other responsible persons, or the

editor may be the sole author of the retraction or expres-

sion of concern. The text of the retraction should explain

why the article is being retracted and include a complete

citation reference to that article.

Retracted articles should remain in the public do-

main and be clearly labelled as retracted.

The validity of previous work by the author of a fraud-

ulent paper cannot be assumed. Editors may ask the

author's institution to assure them of the validity of other

work published in their journals, or they may retract it. If

this is not done, editors may choose to publish an

announcement expressing concern that the validity of

previously published work is uncertain.

The integrity of research may also be compromised

by inappropriate methodology that could lead to

retraction.

See COPE ﬂowcharts for further guidance on retrac-

tions and expressions of concern. See Section IV.A.1.g.i for

guidance about avoiding referencing retracted articles.

C. Copyright

Journals should make clear the type of copyright

under which work will be published, and if the journal

retains copyright, should detail the journal's position on

the transfer of copyright for all types of content, including

audio, video, protocols, and data sets. Medical journals

may ask authors to transfer copyright to the journal. Some

journals require transfer of a publication license. Some

journals do not require transfer of copyright and rely on

such vehicles as Creative Commons licenses. The copy-

right status of articles in a given journal can vary: Some

content cannot be copyrighted (e.g., articles written by

employees of some governments in the course of their

work). Editors may waive copyright on other content, and

some content may be protected under other agreements.

D. Overlapping Publications

1. Duplicate Submission

Authors should not submit the same manuscript, in

the same or different languages, simultaneously to more

than one journal. The rationale for this standard is the

potential for disagreement when two (or more) journals

claim the right to publish a manuscript that has been sub-

mitted simultaneously to more than one journal, and the

possibility that two or more journals will unknowingly

and unnecessarily undertake the work of peer review,

edit the same manuscript, and publish the same article.

2. Duplicate and Prior Publication

Duplicate publication is publication of a paper that

overlaps substantially with one already published, with-

out clear, visible reference to the previous publication.

Prior publication may include release of information in

the public domain.

Readers of medical journals deserve to be able to

trust that what they are reading is original unless there is

a clear statement that the author and editor are intention-

ally republishing an article (which might be considered

for historic or landmark papers, for example). The bases

of this position are international copyright laws, ethical

conduct, and cost-effective use of resources. Duplicate

publication of original research is particularly problem-

atic because it can result in inadvertent double-counting

of data or inappropriate weighting of the results of a sin-

gle study, which distorts the available evidence.

When authors submit a manuscript reporting work

that has already been reported in large part in a pub-

lished article or is contained in or closely related to

another paper that has been submitted or accepted for

publication elsewhere, the letter of submission should

clearly say so and the authors should provide copies of

the related material to help the editor decide how to

handle the submission. See also Section IV.B.

This recommendation does not prevent a journa l from

considering a complete report tha t follows publication of a

preliminary report, such as a letter to the editor, a preprint,

or an abstract or poster displayed at a scientiﬁcmeeting.

The ICMJE does not consider results or data contained in

assessment reports published by health technology

assessment agencies, medical regulat ors, medi cal device

regulators, or other regulatory agencies to be duplicate

publication. It also does not prevent journals from consid-

ering a paper that has been presented at a scientiﬁc meet -

ing but was not published in full, or that is being

considered for publication in proceedings or similar for-

mat. Press reports of scheduled meetings are not usually

regarded a s breach es of this rule, but th ey may be if addi-

tional data tables or ﬁgures enrich such reports. Authors

should also consider how dissemination of their ﬁndings

outside of scientiﬁcpresentationsatmeetingsmaydimin-

ish the priority journal editors assign to their work.

Authors who choose to post their work on a preprint

server should choose one that clearly identiﬁes preprints

as not peer-reviewed work and includes disclosures of

authors' relationships and activities. It is the author's

responsibility to inform a journal if the work has been

previously posted on a preprint server. In addition, it is

the author's (and not the journal editors') responsibility

to ensure that preprints are amended to point readers to

subsequent versions, including the ﬁnal published arti-

cle. See Section III.D.3.

Recommendations for the Conduct, Reporting, Editing, and Publication of Scholarly Work in Medical Journals

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In the event of a public health emergency (as deﬁned

by public health ofﬁcials), information with immediate

implications for public health should be disseminated

without concern that this will preclude subsequent consid-

erationforpublicationinajournal.Weencourageeditors

to give priority to authors who have made crucial data

publicly available without delay.

Sharing with public media, government agencies, or

manufacturers the scientiﬁc information described in a

paper or a letter to the editor that has been accepted but

not yet published violates the policies of many journals.

Such reporting may be warranted when the paper or

letter describes major therapeutic advances; report-

able diseases; or public health hazards, such as serious

advers e effec ts of drugs, vaccines, other biological

products, medical devices. This reporting, whether in

print or o nline, should not jeopardize publication, but

should be discussed with and agreed upon by the edi-

tor in advance when possible.

The ICMJE will not consider as prior publication the

posting of trial results in any registry that meets the crite-

ria noted in Section III.L if results are limited to a brief

structured abstract or tables (to include participants en-

rolled, key outcomes, and adverse events). The ICMJE

encourages authors to include a statement with the

registration that indicates that the results have not yet

been publis hed i n a peer-reviewed journal, and to update

the results registry with the full journal citation when the

results are published.

Editors of different journals may together decide to

simultaneously or jointly publish an article if they believe

that doing so would be in the best interest of public

health. However, the National Library of Medicine (NLM)

indexes all such simultaneously published joint publica-

tions separately, so editors should include a statement

making the simultaneous publication clear to readers.

Authors who attempt duplicate publication without

such notiﬁcation should expect at least prompt rejection

of the submitted manuscript. If the editor was not aware

of the violations and the article has already been pub-

lished, then the article might warrant retraction with or

without the author's explanation or approval.

See COPE ﬂowcharts for further guidance on han-

dling duplicate publication.

3. Preprints

Posting of work as a preprint may inﬂuence a jour-

nal’s interest in or priority for peer review and publication

of that work. Journals should clearly describe their poli-

cies related to the posting and citing of preprints in their

Information for Authors. Authors should become familiar

with the policies of journals they wish to submit their

work to prior to posting work on a preprint server.

a. Choosing a Preprint Archive

There has been an increase in preprint archives in

biomedicine. There are both beneﬁts and harms in dis-

semination of scientiﬁc ﬁndings prior to peer review. To

maximize potential beneﬁts and minimize potential

harms, authors who wish to make preprints of non–peer-

reviewed work publicly available should choose preprint

archives that have the following characteristics:

•

Clearly identify preprints as work that is not peer

reviewed;

•

Require authors to document disclosures of interest;

•

Require authors to indicate funding source(s);

•

Have a clear process for preprint archive users to

notify archive administrators about concerns related

to posted preprints—a public commenting feature is

desirable for this purpose;

•

Maintain metadata for preprints that are withdrawn

from posting and post withdrawal notices indicating

the timing and reason for withdrawal of a preprint; and

•

Have a mechanism for authors to indicate when the

preprint article has been subsequently published in a

peer-reviewed journal.

b. Submitting Manuscripts That Are in Preprint Arch-

ives to a Peer-Reviewed Journal

Authors should inform a journal if the work submit-

ted to the journal has been posted on a preprint server

and provide a link to the preprint, whether the posting

occurs prior to submission or during the peer-review

process. It is also helpful to indicate in the text of the

manuscript, perhaps in the introduction, that a preprint is

available and how reviewers can access that preprint. In

addition, it is the authors’ (and not the journal editors’)

responsibility to ensure that preprints are amended to

point readers to subsequent versions of the work, includ-

ing the published article. Authors should not post in the

preprint archive the published article nor interim ver-

sions that are produced during the peer-review process

that incorporate revisions based on journal feedback.

c. Referencing Preprints in Submitted Manuscripts

When preprints are cited in submitted manuscripts

or published articles, the citation should clearly indicate

that the reference is a preprint. When a preprint article

has been subsequently published in a peer-reviewed

journal, authors should cite the subsequent published

article rather than the preprint article whenever appro-

priate. Journals should include the word “preprint” fol-

lowing the citation information in the reference list and

consider indicating that the cited material is a preprint

in the text. The citation should include the link to the

preprint and DOI if the preprint archive issues DOIs.

Authors should be cautious about referencing preprints

that were posted and never subsequently published in

a peer-reviewed journal, but the time interval of con-

cern will vary depending on the topic and speciﬁc rea-

sons for citation.

4. Acceptable Secondary Publication

Secondary publication of material published in other

journals or online may be justiﬁable and beneﬁcial, espe-

cially when intended to disseminate important informa-

tion to the widest possible audience (e.g., guidelines

produced by government agencies and professional

organizations in the same or a different language).

Recommendations for the Conduct, Reporting, Editing, and Publication of Scholarly Work in Medical Journals

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Secondary publication for various other reasons may

also be justiﬁable provided the following conditions are

met:

1. The authors have received approval from the editors

of both j ournals (the ed itor concerned with secondary

publication must have access to the primary version).

2. The priority of the primary publication is respected

by a publication interval negotiated by both editors

with the authors.

3. The paper for secondary publication is intended for a

different group of readers; an abbreviated version

could be sufﬁcient.

4. The secondary version faithfully reﬂects the authors,

data, and interpretations of the primary version.

5. The secondary version informs readers, peers, and

documenting agencies that the paper has been pub-

lished in whole or in part elsewhere—for example,

with a note that might read, “This article is based on a

study ﬁrst reported in the [journal title, with full refer-

ence]”—and the secondary version cites the primary

reference.

6. The title of the secondary publication should indicate

that it is a secondary publication (complete or

abridged republication or translation) of a primary

publication. Of note, the NLM does not consider

translations to be “republications” and does not cite

or index them when the original article was published

in a journal that is indexed in MEDLINE.

When the same journal simultaneously publishes an

article in multiple languages, the MEDLINE citation will

note the multiple languages (e.g., Angelo M. Journal net-

working in nursing: a challenge to be shared. Rev Esc

Enferm USP. 2011 Dec 45[6]:1281-2,1279-80,1283-4.

Article in English, Portuguese, and Spanish. No abstract

available. PMID: 22241182).

5. Manuscripts Based on the Same Database

If editors receive manuscripts from separate research

groups or from the same group analyzing the same data

set (e.g., from a public database, or systematic reviews or

meta-analyses of the same evidence), the manuscripts

should be considered independently because they may

differ in their analytic methods, conclusions, or both. If

the data interpretation and conclusions are similar, it

may be reasonable although not mandatory for editors

to give preference to the manuscript submitted ﬁrst.

Editors might consider publishing more than one manu-

script that overlap in this way because different analytical

approaches may be complementary and equally valid,

but manuscripts based upon the same data set should

add substantially to each other to warrant consideration

for publication as separate papers, with appropriate cita-

tion of previous publications from the same data set to

allow for transparency.

Secondary analyses of clinical trial data should cite

any primary publication, clearly state that it contains sec-

ondary analyses/results, and use the same identifying

trial registration number as the primary trial and unique,

persistent data set identiﬁer.

Sometimes for large trials it is planned from the be-

ginning to produce numerous separate publications

regarding separate research questions but using the

same original participant sample. In this case authors

may use the original single trial registration number, if all

the outcome parameters were deﬁned in the original

registration. If the authors registered several substudies

as separate entries in, for example, ClinicalTrials.gov,

then the unique trial identiﬁer should be given for the study

in question. The main issue is transparency, so no matter

what model is used it should be obvious for the reader.

E. Correspondence

Medical journals should provide readers with a

mechanism for submitting comments, questions, or

criticisms about published articles, usually but not neces-

sarily always through a correspondence section or online

forum. The authors of articles discussed in correspon-

dence or an online forum have a responsibility to res-

pond to substantial criticisms of their work using those

same mechanisms and should be asked by editors to

respond. Authors of correspondence should be asked to

declare any competing relationships or activities.

Correspondence may be edited for length, gram-

matical correctness, and journal style. Alternatively, edi-

tors may choose to make available to readers unedited

correspondence, for example, via an online commenting

system. Such commenting is not indexed in MEDLINE

unless it is subsequently published on a numbered elec-

tronic or print page. However the journal handles corre-

spondence, it should make known its practice. In all

instances, editors must make an effort to screen discour-

teous, inaccurate, or libellous comments.

Responsible debate, critique, and disagreement are

important features of science, and journal editors should

encourage such discourse ideally within their own jour-

nals about the material they have published. Editors,

however, have the prerogative to reject correspondence

that is irrelevant, uninteresting, or lacking cogency, but

they also have a responsibility to allow a range of opin-

ions to be expressed and to promote debate.

In the interests of fairness and to keep correspon-

dence within manageable proportions, journals may

want to set time limits for responding to published mate-

rial and for debate on a given topic.

F. Fees

Journals should be transparent about their types

of revenue streams. Any fees or charges that are

required for manuscript p rocessing a nd/or pub lishing

materials in the journal shall be clearly stated in a place

that is easy for p oten ti al authors to ﬁnd prior to submit-

ting th eir manuscripts for review or explained to

authors before they begin preparing their manuscript

for submission (http://publicationethics.org/ﬁles/u7140

/Principles_of_Transparency_and_Best_Practice_in_Scholarly_

Publishing.pdf).

G. Supplements, Theme Issues, and Special

Series

Supplements are collections of papers that deal with

related issues or topics, are published as a separate issue

of the journal or as part of a regular issue, and may be

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funded by sources other than the journal's publisher.

Because funding sources can bias the content of supple-

ments through the choice of topics and viewpoints, jour-

nals should adopt the following principles, which also

apply to theme issues or special series that have external

funding and/or guest editors:

1. The journal editor must be given and must take full

responsibility for the policies, practices, and content

of supplements, including complete control of the

decision to select authors, peer reviewers, and con-

tent for the supplement. Editing by the funding orga-

nization should not be permitted.

2. The journal editor has the right to appoint one or

more external editors of the supplement and must

take responsibility for the work of those editors.

3. The journal editor must retain the authority to send

supplement manuscripts for external peer review and

to reject manuscripts submitted for the supplement

with or without external review. These conditions

should be made known to authors and any external

editors of the supplement before beginning editorial

work on it.

4. The source of the idea for the supplement, sources of

funding for the supplement's research and publica-

tion, and products of the funding source related to

content considered in the supplement should be

clearly stated in the introductory material.

5. Advertising in supplements should follow the same

policies as those of the primary journal.

6. Journal editors must enable readers to distinguish

readily between ordinary editorial pages and supple-

ment pages.

7. Journal and supplement editors must not accept per-

sonal favors or direct remuneration from sponsors of

supplements.

8. Secondary publication in supplements (republication

of papers published elsewhere) should be clearly

identiﬁed by the citation of the original paper and by

the title.

9. The same principles of authorship and disclosure of

relationships and activities discussed elsewhere in

this document should be applied to supplements.

H. Sponsorship or Partnership

Various entities may seek interactions with journals

or editors in the form of sponsorships, partnerships,

meetings, or other types of activities. To preserve edito-

rial independence, these interactions should be gov-

erned by the same principles outlined above for

Supplements, Theme Issues, and Special Series (Section

III.G).

I. Electronic Publishing

Most medical journals are now published in elec-

tronic as well as print versions, and some are published

only in electronic form. Principles of print and electronic

publishing are identical, and the recommendations of

this document apply equally to both. However, elec-

tronic publishing provides opportunities for versioning

and raises issues about link stability and content preser-

vation that are addressed here.

Recommendations for corrections and versioning

are detailed in Section III.A.

Electronic publishing allows linking to sites and

resources beyond journals over which journal editors

have no editorial control. For this reason, and because

links to external sites could be perceived as implying

endorsement of those sites, journals should be cautious

about external linking. When a journal does link to an

external site, it should state that it does not endorse or

take responsibility or liability for any content, advertising,

products, or other materials on the linked sites, and does

not take responsibility for the sites' availability.

Permanent preservation of journal articles on a jour-

nal's website, or in an independent archive or a credible

repository, is essential for the historical record. Remo-

ving an article from a journal's website in its entirety is

almost never justiﬁed as copies of the article may have

been downloaded even if its online posting was brief.

Such archives should be freely accessible or accessible to

archive members. Deposition in multiple archives is en-

couraged. However, if nece ssary for legal reason s (e.g.,

libel action), the URL for the removed article must contain

a detaile d re ason for the removal, and the articl e mus t be

retained in the journal's internal archive.

Permanent preservation of a journal's total content is

the responsibility of the journal publisher, who in the

event of journal termination should be certain the journal

ﬁles are transferred to a responsible third party who can

make the content available.

Journal websites should post the date that nonarticle

web pages, such as those listing journal staff, editorial

board members, and instructions for authors, were last

updated.

J. Advertising

Most medical journals carry advertising, which gen-

erates income for their publishers, but journals should

not be dominated by advertisements, and advertising

must not be allowed to inﬂuence editorial decisions.

Journals should have formal, explicit, written policies

for advertising in both print and electronic versions. Best

practice prohibits selling advertisements intended to be

juxtaposed with editorial content on the same product.

Advertisements should be clearly identiﬁable as adver-

tisements. Editors should have full and ﬁnal authority for

approving print and online advertisements and for

enforcing advertising policy.

Journals should not carry advertisements for prod-

ucts proven to be seriously harmful to health. Editors

should ensure that existing regulatory or industry stand-

ards for advertisements speci

ﬁc to their country are

enforced, or develop their own standards. The interests

of organizations or agencies should not control classiﬁed

and other nondisplay advertising, except where required

by law. Editors should consider all criticisms of advertise-

ments for publication.

K. Journals and the Media

Journals' interactions with media should balance

competing priorities. The general public has a legitimate

interest in all journal content and is entitled to important

Recommendations for the Conduct, Reporting, Editing, and Publication of Scholarly Work in Medical Journals

12 www.icmje.org

information within a reasonable amount of time, and edi-

tors have a responsibility to facilitate that. However,

media reports of scientiﬁc research before it has been

peer-reviewed and fully vetted may lead to dissemina-

tion of inaccurate or premature conclusions, and doctors

in practice need to have research reports available in full

detail before they can advise patients about the reports'

conclusions.

An embargo system has been established in some

countries and by some journals to assist this balance,

and to prevent publication of stories in the general

media before publication of the original research in the

journal. For the media, the embargo creates a “level

playing ﬁeld,” which most reporters and writers appreci-

ate since it minimizes the pressure on them to publish

stories before competitors when they have not had time

to prepare carefully. Consistency in the timing of public

release of biomedical information is also important in

minimizing economic chaos, since some articles contain

information that has potential to inﬂuence ﬁnancial mar-

kets. The ICMJE acknowledges criticisms of embargo

systems as being self-serving of journals' interests and an

impediment to rapid dissemination of scientiﬁcinforma-

tion, but believes the beneﬁts of the systems outweigh

their harms.

The following principles apply equally to print and

electronic publishing and may be useful to editors as

they seek to establish policies on interactions with the

media:

•

Editors can foster the orderly transmission of medical

information from researchers, through peer-reviewed

journals, to the public. This can be accomplished by

an agreement with authors that they will not publicize

their work while their manuscript is under considera-

tion or awaiting publication and an agreement with

the media that they will not release stories before pub-

lication of the original research in the journal, in return

for which the journal will cooperate with them in pre-

paring accurate stories by issuing, for example, a

press release.

•

Editors need to keep in mind that an embargo sys-

tem works on the honor system—no formal enforce-

ment or policing mechanism exists. The decision of a

signiﬁcant number of media outlets or biomedical

journals not to respect the embargo system would

lead to its rapid dissolution.

•

Notwithstanding authors' belief in their work, very lit-

tle medical research has such clear and urgently im-

portant clinical implications for the public's health

that the news must be released before full publica-

tion in a journal. When such exceptional circumstan-

ces occur, the appropriate authorities responsible for

public health should decide whether to disseminate

information to physicians and the media in advance

and should be responsible for this decision. If the

author and the appropriate authorities wish to have a

manuscript considered by a particular journal, the

editor should be consulted before any public

release. If editors acknowledge the need for

immediate release, they should waive their policies

limiting prepublication publicity.

•

Policies designed to limit prepublication publicity

should not apply to accounts in the media of presen-

tations at scientiﬁc meetings or to the abstracts from

these meetings (see Duplicate Publication). Resear-

chers who present their work at a scientiﬁc meeting

should feel free to discuss their presentations with

reporters but should be discouraged from offering

more detail about their study than was presented in

the talk, or should consider how giving such detail

might diminish the priority journal editors assign to

their work (see Duplicate Publication).

•

When an article is close to being published, editors

or journal staff should help the media prepare accu-

rate reports by providing news releases, answering

questions, supplying advance copies of the article, or

referring reporters to appropriate experts. This assis-

tance should be contingent on the media's coopera-

tion in timing the release of a story to coincide with

publication of the article.

L. Clinical Trials

1. Registration

The ICMJE's clinical trial registration policy is

detailed in a series of editorials (see News and Editorials

[www.icmje.org/news-and-editorials/] and FAQs [www.

icmje.org/about-icmje/faqs/]).

Brieﬂy, the ICMJE requires, and recommends that all

medical journal editors require, registration of clinical tri-

als in a public trials registry at or before the time of ﬁrst

patient enrollment as a condition of consideration for

publication. Editors requesting inclusion of their journal

on the ICMJE website list of publications that follow

ICMJE guidance (www.icmje.org/journals.html) should

recognize that the listing implies enforcement by the

journal of ICMJE's trial registration policy.

ICMJE uses the date trial registration materials were

ﬁrst submitted to a registry as the date of registration.

When there is a substantial delay between the submis-

sion of registration materials and their posting at the trial

registry, editors may inquire about the circumstances

that led to the delay.

The ICMJE deﬁnes a clinical trial as any research pro-

ject that prospectively assigns people or a group of peo-

ple to an intervention, with or without concurrent

comparison or control groups, to study the relationship

between a health-related intervention and a health out-

come. Health-related interventions are those used to

modify a biomedical or health-related outcome; examples

include drugs, surgical pro cedure s, de vices , beha viora l

treatments, educational programs, dietary interventions,

quality improvement interventions, and process-of-care

changes. Health outcomes are any biomedical or health-

related measures obtained in patients or participants,

including pha rmaco kineti c measur es and adverse ev ents.

The ICMJE does not deﬁne the timing of ﬁrst participant

enrollment, but best practice dictates registration by the

time of ﬁrst participant consent.

Recommendations for the Conduct, Reporting, Editing, and Publication of Scholarly Work in Medical Journals

www.icmje.org 13

The ICMJE accepts publicly accessible registration in

any registry that is a primary register of the WHO

International Clinical Trials Registry Platform (ICTRP)

(www.who.int/clinical-trials-registry-platform/network/who-

data-set) that includes the minimum acceptable 24-item

trial registration data set or in ClinicalTrials.gov, which is a

data provider to the WHO ICTRP. The ICMJE endorses

these registries because they meet several criteria. They

are accessible to the public at no charge , open to all

prospective registrants, man aged by a not-for-proﬁtorga-

nization, have a mechanism to ensure the validity of the

registration data, and are electronically searchable. An

acceptable registry must include the minimum 24-item

trial registration data set (http: //prsinfo.clinicaltrials.gov/

trainTrainer/WHO-ICMJE-ClinTrialsgov-Cross-Ref.pdf or

www.who.int/clinical-trials-registry-platform) at the time of

registration and before enrollment of the ﬁrst participant.

The ICMJE considers inadequate trial registrations

missing any of the 24 data ﬁelds, those that have ﬁelds

that contain uninformative information, or registrations

that are not made publicly accessible such as phase I tri-

als submitted to the CTIS (Clinical Trials Information

System) and trials of devices for which the information

is placed in a “lock box.” In order to comply with

ICMJE policy, in vesti gators registering trials of devic es

at ClinicalTrials.gov must “opt out” of the lock box by electing

public posting prior to device approval. Approval to conduct

a study from an independent local, regional, or national

review body (e.g., ethics committee, institutional review

board) does not fulﬁll the ICMJE requirement for pro-

spective clinical trial registration. Although not a required

item, the ICMJE encourages authors to include a state-

ment that indicates that the results have not yet been

published in a peer-reviewed journal, and to update the

registratio n with the full journal citation when the results

are published.

The purpose of clinical trial registration is to prevent

selective publication and selective reporting of research

outcomes, to prevent unnecessary duplication of research

effort, to help patients and the public know what trials

are planned or ongoing into which they might want to

enroll, and to help give ethics review boards consider-

ing approval of new studies a view of similar work and

data relevant to the research they are considering.

Retrospective registration, for example at the time of

manuscript submission, meets none of these purposes.

Those purposes apply also to research with alt ernative

designs, for example observational studies. For that

reason, the ICMJE encourages registration of research

with non-trial designs, but because t he exposure or

intervention in non-trial research is n ot d ict ated by the

researchers, the ICMJE does not require it.

Secondary data analyses of primary (parent) clinical

trials should not be registered as separate clinical trials,

but instead should reference the trial registration num-

ber of the primary trial.

The ICMJE expects authors to ensure that they have

met the requirements of their funding and regulatory

agencies regarding aggregate clinical trial results report-

ing in clinical trial registries. It is the authors', and not the

journal editors', responsibility to explain any discrepan-

cies between results reported in registries and journal

publications. The ICMJE will not consider as prior publi-

cation the posting of trial results in any registry that

meets the above criteria if results are limited to a brief

structured abstract or tables (to include trial participants

enrolled, baseline characteristics, primary and secondary

outcomes, and adverse events).

The ICMJE recommends that journals publish the

trial registration number at the end of the abstract. The

ICMJE also recommends that, whenever a registration

number is available, authors list this number the ﬁrst time

they use a trial acronym to refer either to the trial they are

reporting or to other trials that they mention in the

manuscript.

Editors may consider whether the circumstances

involved in a failure to appropriately register a clinical

trial were likely to have been intended to or resulted in

biased reporting. Because of the importance of prospec-

tive trial registration, if an exception to this policy is

made, trials must be registered and the authors should

indicate in the publication when registration was com-

pleted and why it was delayed. Editors should publish a

statement indicating why an exception was allowed. The

ICMJE emphasizes that such exceptions should be rare,

and that authors failing to prospectively register a trial

risk its inadmissibility to our journals.

2. Data Sharing

The ICMJE's data sharing statement policy is detailed

in an editorial (see Updates and Editorials [www.icmje.

org/update.html]).

1. As of 1 July 2018 manuscripts submitted to ICMJE

journals that report the results of clinical trials must

contain a data sharing statement as described below.

2. Clinical trials that begin enrolling participants on or

after 1 January 2019 must i nclude a dat a sharing plan

in the trial's registration. The ICMJ E's policy regardin g

trial registration is explained at www.icmje.org/

recommendations/browse/publishing-and-editorial-

issues/clinical-trial-registration.html. If the data shar-

ing p lan changes after registration this should be

reﬂected in the statement submitted and pub-

lished with th e manuscript, and u pdated in t he

registry record.

Data sharing statements must indicate the following:

whether individual deidentiﬁed participant data (includ-

ing data dictionaries) will be shared (“undecided” is not

an acceptable answer); what data in particular will be

shared; whether additional, related documents will be

available (e.g., study protocol, statistical analysis plan,

etc.); when the data will become available and for how

long; by what access criteria data will be shared (includ-

ing with whom, for what types of analyses, and by what

mechanism). Illustrative examples of data sharing state-

ments that would meet these requirements are provided

in Table 1.

Authors of secondary analyses using shared data

must attest that their use was in accordance with the

terms (if any) agreed to upon their receipt. They must

also reference the source of the data using its unique,

persistent identiﬁer to provide appropriate credit to

those who generated it and allow searching for the stud-

ies it has supported. Authors of secondary analyses must

Recommendations for the Conduct, Reporting, Editing, and Publication of Scholarly Work in Medical Journals

14 www.icmje.org

explain completely how theirs differ from previous analy-

ses. In addition, those who generate and then share clini-

cal trial data sets deserve substantial credit for their

efforts. Those using data collected by others should seek

collaboration with those who collected the data. As col-

laboration will not always be possible, practical, or

desired, the efforts of those who generated the data

must be recognized.

IV. MANUSCRIPT PREPARATION AND

SUBMISSION

A. Preparing a Manuscript for Submission to a

Medical Journal

1. General Principles

The text of articles reporting original research is usu-

ally divided into Introduction, Methods, Results, and

Discussion sections. This so-called “IMRAD” structure is

not an arbitrary publication format but a reﬂection of the

process of scientiﬁc discovery. Articles often need sub-

headings within these sections to further organize their

content. Other types of articles, such as meta-analyses,

may require different formats, while case reports, narra-

tive reviews, and editorials may have less structured or

unstructured formats.

Electronic formats have created opportunities for

adding details or sections, layering information, cross-

linking, or extracting portions of articles in electronic ver-

sions. Supplementary electronic-only material should be

submitted and sent for peer review simultaneously with

the primary manuscript.

2. Reporting Guidelines

Reporting guidelines ha ve been developed for differ-

ent study designs; examples include CONSORT (www.

consort-statement.org) for randomized trials, STROBE

for observational studies (http: //strobe-sta tement.org/),

PRISMA for systematic reviews and meta-analyses

(http://prisma-statement.org/), and STARD for studies of

diagnostic accuracy (http://www.equator-network.org/

reporting-guidelines/stard/). Journals are encouraged to

ask authors to follow these guidelines because they help

authors describe the study in enough detail for it to be

evaluated by editors, reviewers, readers, and other

researchers evaluating the medical literature. Authors

are encouraged to refer to the SAGER guidelines for

reporting of sex and gender information in study design,

data analyses, results, and interpretation of ﬁndings:

www.equator-network.org/reporting-guidelines/

sager-guidelines/. Authors of review manuscripts are

Table 1. Examples of Data Sharing Statements That Fulﬁll These ICMJE Requirements

Example 1 Example 2 Example 3 Example 4

Will individual participant

data be available

(including data

dictionaries)?

Yes Yes Yes No

What data in particular

will be shared?

All of the individual participant

data collected during the

trial, after deidentiﬁcation.

Individual participant data that

underlie the results reported

in this article, after deidenti-

ﬁcation (text, tables, ﬁgures,

and appendices).

Individual participant data that

underlie the results reported

in this article, after deidenti-

ﬁcation (text, tables, ﬁgures,

and appendices).

Not available

What other documents

will be available?

Study Protocol, Statistical

Analysis Plan, Informed

Consent Form, Clinical

Study Report, Analytic Code

Study Protocol, Statistical

Analysis Plan, Analytic Code

Study Protocol Not available

When will data be avail-

able (start and end

dates)?

Immediately following publica-

tion. No end date.

Beginning 3 months and end-

ing 5 years following article

publication.

Beginning 9 months and end-

ing 36 months following arti-

cle publication.

Not applicable

With whom? Anyone who wishes to access

the data.

Researchers who provide a

methodologically sound

proposal.

Investigators whose proposed

use of the data has been

approved by an independ-

ent review committee

(learned intermediary) iden-

tiﬁed for this purpose.

Not applicable

For what types of

analyses?

Any purpose. To achieve aims in the

approved proposal.

For individual participant data

meta-analysis.

Not applicable

By what mechanism will

data be made

available?

Data are available indeﬁnitely

at (Link to be included).

Proposals should be directed

to xxx@yyy.

To gain access, data reques-

tors will need to sign a data

access agreement. Data are

available for 5 years at a

third-party website (Link to

be included).

Proposals may be submitted

up to 36 months following

article publication. After 36

months the data will be

available in our University's

data warehouse but without

investigator support other

than deposited metadata.

Information regarding sub-

mitting proposals and

accessing data may be

found at (Link to be

provided).

Not applicable

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

Recommendations for the Conduct, Reporting, Editing, and Publication of Scholarly Work in Medical Journals

www.icmje.org 15

encouraged to describe the method s used for locating,

selecting, extracting, and synthesizing data; this is manda-

tory for systematic reviews. Good sources for reporting

guidelines are the EQUATOR Network (www.equator -

network.o rg/home/) and the NLM's Research Reporting

Guidelines and Initiatives (www.nlm.nih.gov/services/

research_report_guide.html).

3. Manuscript Sections

The following are general requirements for reporting

within sections of all study designs and manuscript formats.

a. Title Page

General information about an article and its authors

is presented on a manuscript title page and usually

includes the article title, author information, any disclaim-

ers, sources of support, word count, and sometimes the

number of tables and ﬁgures.

Article title. The title provides a distilled description

of the complete article and should include information

that, along with the abstract, will make electronic retrieval

of the article sensitive and speciﬁc. Reporting guidelines

recommend and some journals require that information

about the study design be a part of the title (particularly

important for randomized trials and systematic reviews

and meta-analyses). Some journals require a short title,

usually no more than 40 characters (including letters and

spaces) on the title page or as a separate entry in an elec-

tronic submission system. Electronic submission systems

may restrict the number of characters in the title.

Author information. Each author's highest academic

degrees should be listed, although some journals do not

publish these. The name of the department(s) and institu-

tion(s) or organizations where the work should be attrib-

uted should be speciﬁed. Most electronic submission

systems require that authors provide full contact information,

including land mail and e-mail addresses, but the title page

should list the corresponding authors' telepho ne number

and e-mail address. ICMJE encourages the listing of authors'

Open Researcher and Contributor Identiﬁcation (ORCID).

Disclaimers. An example of a disclaimer is an

author's statement that the views expressed in the sub-

mitted article are his or her own and not an ofﬁcial posi-

tion of the institution or funder.

Source(s) of support. These include grants, equip-

ment, drugs, and/or other support that facilitated con-

duct of the work described in the article or the writing of

the article itself. Inappropriate attribution of funding

sources and afﬁliations are misleading and should be

avoided.

Word count. A word count for the paper's text,

excluding its abstract, acknowledgments, tables, ﬁgure

legends, and references, allows editors and reviewers to

assess whether the information contained in the paper

warrants the paper's length, and whether the submitted

manuscript ﬁts within the journal's formats and word lim-

its. A separate word count for the abstract is useful for

the same reason.

Number of ﬁgures and tables. Some submission sys-

tems require speciﬁcation of the number of ﬁgures and

tables before uploading the relevant ﬁles. These num-

bers allow editorial staff and reviewers to conﬁrm that all

ﬁgures and tables were actually included with the manu-

script and, because tables and ﬁgures occupy space, to

assess if the information provided by the ﬁgures and

tables warrants the paper's length and if the manuscript

ﬁts within the journal's space limits.

Disclosure of relationships and activities.Disclosure

information for each author needs to be part of the

manuscript; each journal should develop standards with

regard to the form the information should take and

where it will be posted. The ICMJE has developed a uni-

form Disclosure Form for use by ICMJE member journals

(www.icmje.org/coi_disclosure.pdf), and the ICMJE en-

courages other journals to adopt it. Despite availability

of the form, editors may require disclosure of relation-

ships and activities on the manuscript title page or other

Disclosure section in the manuscript to save the work of

collecting forms from each author prior to making an edi-

torial decision or to save reviewers and readers the work

of reading each author's form.

b. Abstract

Original research, systematic reviews, and meta-

analyses require structured abstracts. The abstract

should provide the context or background for the study

and should state the study's purpose, basic procedures

(selection of study participants, settings, measurements,

analytical methods), main ﬁn dings (giving speciﬁc effect

sizes and their statistical and clinical signiﬁcance, if possi-

ble), and principal conclusions. It should emphasize new

and important aspects of the study or observations, note

important limitations, and not overinterpret ﬁndings.

Clinical trial abstr acts should inc lude items that the

CONSORT group has identiﬁed as essential (www. consort-

statement.org/resources/downloads/extensions/consort-

extension-for-abstracts-2008pdf/). Funding sources should

be listed separately after the abstract to facilitate

proper display and indexing for search retrieval by

MEDLINE. The funding statement should include

only direct support of the work described. General

institutional support for an autho r’stimeonthework

should be distingu ished from direct overall funding

of the work. An appropriate funding statement might

be: “This study was funded by ABC; Dr. F’stimeon

the work was supported by XYZ.”

Because abstracts are the only substantive portion of

the article indexed in many electronic databases, and the

only portion many readers read, authors need to ensure

that they accurately reﬂect the content of the article.

Unfortunately, information in abstracts often differs from

that in the text. Authors and editors should work in the

process of revision and review to ensure that information

is consistent in both places. The format required for

structured abstracts differs from journal to journal, and

some journals use more than one format; authors need

to prepare their abstracts in the format speciﬁed by the

journal they have chosen.

The ICMJE recommends that journals publish the

clinical trial registration number at the end of the

abstract. The ICMJE also recommends that, when a

registration number is available, authors list that number

the ﬁrst time they use a trial acronym to refer to the trial

they are reporting or to other trials that they mention in

the manuscript. If the data have been deposited in a

Recommendations for the Conduct, Reporting, Editing, and Publication of Scholarly Work in Medical Journals

16 www.icmje.org

public repository and/or are being used in a secondary

analysis, authors should state at the end of the abstract

the unique, persistent data set identiﬁer; repository

name; and number.

c. Introduction

Provide a context or background for the study (that

is, the nature of the problem and its signiﬁcance). State

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-

sions from the work being reported.

d. Methods

The guiding principle of the Methods section should

be clarity about how and why a study was done in a par-

ticular way. The Methods section should aim to be sufﬁ-

ciently detailed such that others with access to the data

would be able to reproduce the results. In general, the

section should include only information that was avail-

able at the time the plan or protocol for the study was

being written; all information obtained during the study

belongs in the Results section. If an organization was

paid or otherwise contracted to help conduct the

research (examples include data collection and manage-

ment), then this should be detailed in the methods.

The Methods section should include a statement

indicating that the research was approved by an inde-

pendent local, regional or national review body (e.g.,

ethics committee, institutional review board). If doubt

exists whether the research was conducted in accord-

ance with the Helsinki Declaration, the authors must

explain the rationale for their approach and demonstrate

that the local, regional or national review body explicitly

approved the doubtful aspects of the study. See Section

II.E.

Authors who used AI technology to conduct the

study should describe its use in the methods section in

sufﬁcient detail to enable replication of the approach,

including the tool used, version, and prompts where

applicable.

i. Selection and Description of Participants

Clearly describe the selection of observational or ex-

perimental participants (healthy individuals or patients,

including controls), including eligibility and exclusion cri-

teria and a description of the source population.

Because the relevance of such variables as age, sex, or

ethnicity is not always known at the time of study design,

researchers should aim for inclusion of representative

populations into all study types and at a minimum pro-

vide descriptive data for these and other relevant demo-

graphic variables. Comment on how representative the

study sample is of the larger population of interest.

Ensure correct use of the terms sex (when reporting

biological factors) and gender (identity, psychosocial or

cultural factors), and, unless inappropriate, report the sex

and/or gender of study participants, the sex of animals

or cells, and describe the methods used to determine

sex and gender. If the study was done involving an exclu-

sive population, for example in only one sex, authors

should justify why. Authors should deﬁne how they

determined race or ethnicity and justify their relevance. In

the case where race or ethnicity was not collected,

explain why it was not collected. Race and ethnicity are

social and not biological cons tructs; authors should inter-

pret results associa ted with rac e and ethni city in that con-

text. Authors should use neutral, precise, and respectful

language to describe study participants and avoid the

use of terminology that might stigmatize participants.

ii. Data Collection and Measurements

Specify the study's main and secondary objectives—

usually identiﬁed as primary and secondary outcomes.

Identify methods, equipment (give the manufacturer's

name and address in parentheses), and procedures in

sufﬁcient detail to allow others to reproduce the results.

Give references to established methods, including statis-

tical methods (see below); provide references and brief

descriptions for methods that have been published but

are not well-known; describe new or substantially modi-

ﬁed methods, give the reasons for using them, and eval-

uate their limitations. Identify precisely all drugs and

chemicals used, including generic name(s), dose(s), and

route(s) of administration. Identify appropriate scientiﬁc

names and gene names.

iii. Statistics

Describe statistical methods with enough detail to

enable a knowledgeable reader with access to the origi-

nal data to judge its appropriateness for the study and to

verify the reported results. When possible, quantify ﬁnd-

ings and present them with appropriate indicators of

measurement error or uncertainty (such as conﬁdence

intervals). Avoid relying solely on statistical hypothesis

testing, such as P values, which fail to convey important

information about effect size and precision of estimates.

References for the design of the study and statistical

methods should be to standard works when possible

(with pages stated). Deﬁne statistical terms, abbrevia-

tions, and most symbols. Specify the statistical software

package(s) and versions used. Distinguish prespeciﬁed

from exploratory analyses, including subgroup analyses.

e. Results

Present your results in logical sequence in the text,

tables, and ﬁgures, giving the main or most important

ﬁndings ﬁrst. Do not repeat all the data in the tables or

ﬁgures in the text; emphasize or summarize only the

most important observations. Provide data on all primary

and secondary outcomes identiﬁed in the Methods sec-

tion. Extra or supplementary materials and technical

details can be placed in an appendix where they will be

accessible but will not interrupt the ﬂow of the text, or

they can be published solely in the electronic version of

the journal.

Give numeric results not only as derivatives (e.g.,

percentages) but also as the absolute numbers from

which the derivatives were calculated. Restrict tables and

ﬁgures to those needed to explain the argument of the

paper and to assess supporting data. Use graphs as an

alternative to tables with many entries; do not duplicate

data in graphs and tables. Avoid nontechnical uses of

technical terms in statistics, such as “random” (which

Recommendations for the Conduct, Reporting, Editing, and Publication of Scholarly Work in Medical Journals

www.icmje.org 17

implies a randomizing device), “normal,”“signiﬁcant,”

“correlations,” and “sample.”

Separate reporting of data by demographic varia-

bles, such as age and sex, facilitate pooling of data for

subgroups across studies and should be routine, unless

there are compelling reasons not to stratify reporting,

which should be explained.

f. Discussion

It is useful to begin the discussion by brieﬂysumma-

rizing the main ﬁndings, and explore possible mecha-

nisms or explanations for these ﬁndings. Emphasize the

new and important aspects of your study and put your

ﬁndings in the context of the totality of the relevant evi-

dence. State the limitations of your study, and explore

the implications of your ﬁndings for future research and

for clinical practice or policy. Discuss the inﬂuence or

association of variables, such as sex and/or gender, on

your ﬁndings, where appropriate, and the limitations of

the data. Do not repeat in detail data or other informa-

tion given in other parts of the manuscript, such as in the

Introduction or the Results section.

Link the conclusions with the goals of the study but

avoid unqualiﬁed statements and conclusions not

adequately supported by the data. In particular, distin-

guish between clinical and statistical signiﬁcance, and

avoid making statements on economic beneﬁts and

costs unless the manuscript includes the appropriate

economic data and analyses. Avoid claiming priority or

alluding to work that has not been completed. State new

hypotheses when warranted, but label them clearly.

g. References

i. General Considerations

Authors should provide direct references to original

research sources whenever possible. References should

be made to published articles rather than to abstracts

whenever possible. References should not be used by

authors, editors, or peer reviewers to promote self-inter-

ests. Authors should avoid citing articles from predatory

or pseudo-journals. When preprints are cited, the cita-

tion should clearly indicate that the reference is a pre-

print (also see Section III.D.3). Although references to

review articles can be an efﬁcient way to guide readers

to a body of literature, review articles do not always

reﬂect original work accurately. On the other hand,

extensive lists of references to original work on a topic

can use excessive space. Fewer references to key origi-

nal papers often serve as well as more exhaustive lists,

particularly since references can now be added to the

electronic version of published papers, and since elec-

tronic literature searching allows readers to retrieve pub-

lished literature efﬁciently.

References to papers accepted but not yet pub-

lished should be designated as “in press” or “forthcom-

ing.” Information from manuscripts submitted but not

accepted should be cited in the text as “unpublished

observations” with written permission from the source.

Published articles should reference the unique, per-

sistent identiﬁers of the data sets employed.

Avoid citing a “personal communication” unless it

provides essential information not available from a pub-

lic source, in which case the name of the person and

date of communication should be cited in parentheses in

the text. For scientiﬁc articles, obtain written permission

and conﬁrmation of accuracy from the source of a perso-

nal communication.

Referencing AI-generated material as the primary

source is not acceptable.

Some but not all journals check the accuracy of all

reference citations; thus, citation errors sometimes

appear in the published version of articles. To minimize

such errors, references should be veriﬁed using either an

electronic bibliographic source, such as PubMed, or

print copies from original sources. Authors are responsi-

ble for checking that none of the references cite

retracted articles except in the context of referring to the

retraction. For articles published in journals indexed in

MEDLINE, the ICMJE considers PubMed the authorita-

tive source for information about retractions. Authors can

identify retracted articles in MEDLINE by searching

PubMed for “Retracted publication [pt]”, where the term

“pt” in square brackets stands for publication type, or

by going directly to the PubMed's list of retracted publi-

cations (https://www.ncbi.nlm.nih.gov/pubmed/?term=

retracted+publication+[pt]).

References should be numbered consecutively in

the order in which they are ﬁrst mentioned in the text.

Identify references in text, tables, and legends by Arabic

numerals in parentheses.

Referencescitedonlyintablesorﬁgure legends

should be numbered in accordance with the sequence

established by the ﬁrst identiﬁcation in the text of the par-

ticular table or ﬁgure. The titles of journals should be

abbrevi ated according to the style used for MEDLINE

(www.ncbi.nlm.nih.gov/nlmcatalog/journals). Journals

vary on whether they ask authors to cite electronic refer-

ences within parenthe ses in the text or in numbered refer-

ences following the text. Authors should consul t with the

journal to which they plan to submit the ir work.

ii. Style and Format

References should follow the standards summarized

in the NLM's Sample References (www.nlm.nih.gov/bsd/

uniform_requirements.html) webpage and detailed in

the NLM's Citing Medicine, 2nd edition (www.ncbi.nlm.

nih.gov/books/NBK7256/). These resources are regularly

updated as new media develop, and currently include

guidance for print documents; unpublished material;

audio and visual media; material on CD-ROM, DVD, or

disk; and material on the Internet.

h. Tables

Tables capture information concisely and display it

efﬁciently; they also provide information at any desired

level of detail and precision. Including data in tables

rather than text frequently makes it possible to reduce

the length of the text.

Prepare tables according to the speciﬁc journal's

requirements; to avoid errors it is best if tables can be

directly imported into the journal's publication software.

Recommendations for the Conduct, Reporting, Editing, and Publication of Scholarly Work in Medical Journals

18 www.icmje.org

Number tables consecutively in the order of their ﬁrst

citation in the text and supply a title for each. Titles in

tables should be short but self-explanatory, containing

information that allows readers to understand the table's

content without having to go back to the text. Be sure

that each table is cited in the text.

Give each column a short or an abbreviated heading.

Authors should place explanatory matter in footnotes,

not in the heading. Explain all nonstandard abbreviations

in footnotes, and use symbols to explain information if

needed. Symbols may vary from journal to journal (alpha-

bet letter or such symbols as *, †, ‡, §), so check each

journal's instructions for authors for required practice.

Identify statistical measures of variations, such as stand-

ard deviation and standard error of the mean.

If you use data from another published or unpub-

lished source, obtain permission and acknowledge that

source fully.

Additional tables containing backup data too exten-

sive to publish in print may be appropriate for publica-

tion in the electronic version of the journal, deposited

with an archival service, or made available to readers

directly by the authors. An appropriate statement should

be added to the text to inform readers that this addi-

tional information is available and where it is located.

Submit such tables for consideration with the paper so

that they will be available to the peer reviewers.

i. Illustrations (Figures)

Digital images of manuscript illustrations should be

submitted in a suitable format for print publication. Most

submission systems have detailed instructions on the

quality of images and check them after manuscript

upload. For print submissions, ﬁgures should be either

professionally drawn and photographed, or submitted

as photographic-quality digital prints.

For radiological and other clinical and diagnostic

images, as well as pictures of pathology specimens or

photomicrographs, send high-resolution photographic

image ﬁles. Before-and-after images should be taken

with the same intensity, direction, and color of light.

Since blots are used as primary evidence in many scien-

tiﬁc articles, editors may require deposition of the origi-

nal photographs of blots on the journal's website.

Although some journals redraw ﬁgures, many do

not. Letters, numbers, and symbols on ﬁgures should

therefore be clear and consistent throughout, and large

enough to remain legible when the ﬁgure is reduced for

publication. Figures should be made as self-explanatory

as possible, since many will be used directly in slide pre-

sentations. Titles and detailed explanations belong in the

legends—not on the illustrations themselves.

Photomicrographs should have internal scale

markers. Symbols, arrows, or letters used in photomicro-

graphs should contrast with the background. Explain the

internal scale and identify the method of staining in

photomicrographs.

Figures should be numbered consecutively accord-

ing to the order in which they have been cited in the text.

If a ﬁgure has been published previously, acknowledge

the original source and submit written permission from

the copyright holder to reproduce it. Permission is

required irrespective of authorship or publisher except

for documents in the public domain.

In the manuscript, legends for illustrations should be

on a separate page, with Arabic numerals corresponding

to the illustrations. When symbols, arrows, numbers, or

letters are used to identify parts of the illustrations, iden-

tify and explain each one clearly in the legend.

j. Units of Measurement

Measurements of length, height, weight, and volume

should be reported in metric units (meter, kilogram, or li-

ter) or their decimal multiples.

Temperatures should be in degrees Celsius. Blood

pressures should be in millimeters of mercury, unless

other units are speciﬁcally required by the journal.

Journals vary in the units they use for reporting he-

matologic, clinical chemistry, and other measurements.

Authors must consult the Information for Authors of the

particular journal and should report laboratory informa-

tion in both local and International System of Units (SI).

Editors may request that authors add alternative or

non-SI units, since SI units are not universally used. Drug

concentrations may be reported in either SI or mass

units, but the alternative should be provided in parenthe-

ses where appropriate.

k. Abbreviations and Symbols

Use only standard abbreviations; use of nonstandard

abbreviations can be confusing to readers. Avoid abbre-

viations in the title of the manuscript. The spelled-out

abbreviation followed by the abbreviation in parentheses

should b e used on ﬁrst mention unless the abbr eviation is

a standard unit of measurement.

B. Sending the Manuscript to the Journal

Manuscripts should be accompanied by a cover let-

ter or a completed journal submission form, which

should include the following information:

A full statement to the editor about all submissions

and previous reports that might be regarded as redun-

dant publication of the same or very similar work. Any

such work should be referred to speciﬁcally and refer-

enced in the new paper. Copies of such material should

be included with the submitted paper to help the editor

address the situation. See also Section III.D.2.

Astatementofﬁnancial or other relationships and

activities that might lead to a conﬂict of interest, if that in-

formation is not included in the manuscript itself or in an

authors' form. See also Section II.B.

A statement on authorship. Journals that do not use

contribution declarations for all authors may require that

the submission letter includes a statement that the manu-

script has been read and approved by all the authors,

that the requirements for authorship as stated earlier in

this document have been met, and that each author

believes that the manuscript represents honest work if

that information is not provided in another form. See

also Section II.A.

Recommendations for the Conduct, Reporting, Editing, and Publication of Scholarly Work in Medical Journals

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Contact information for the author responsible for

communicating with other authors about revisions and

ﬁnal approval of the proofs, if that information is not

included in the manuscript itself.

The letter or form should inform editors if concerns

have been raised (e.g., via institutional and/or regulatory

bodies) regarding the conduct of the research or if cor-

rective action has been recommended. The letter or

form should give any additional information that may be

helpful to the editor, such as the type or format of article

in the particular journal that the manuscript represents. If

the manuscript has been submitted previously to

another journal, it is helpful to include the previous edi-

tor's and reviewers' comments with the submitted manu-

script, along with the authors' responses to those

comments. Editors encourage authors to submit these

previous communications. Doing so may expedite the

review process and encourages transparency and shar-

ing of expertise.

Many journals provide a presubmission checklist to

help the author ensure that all the components of the

submission have been included. Some journals also

require that authors complete checklists for reports of

certain study types (e.g., the CONSORT checklist for

reports of randomized controlled trials). Authors should

look to see if the journal uses such checklists, and send

them with the manuscript if they are requested.

The manuscript must be accompanied by permission

to reproduce previously published material, use previ-

ously published illustrations, report information about

identiﬁable persons, or to acknowledge people for their

contributions.

Recommendations for the Conduct, Reporting, Editing, and Publication of Scholarly Work in Medical Journals

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