annotations are inserted here to assist in identifying changes … · 2019-12-12 · journals. over...

Recommendations for the Conduct Reporting Editing andPublication of Scholarly Work in Medical JournalsUpdated December 2018

I About the RecommendationsA Purpose of the RecommendationsB Who Should Use the RecommendationsC History of the Recommendations

II Roles and Responsibilities of Authors ContributorsReviewers Editors Publishers and OwnersA Defining the Role of Authors and Contributors

1 Why Authorship Matters2 Who Is an Author3 Non-Author Contributors

B Conflicts of Interest1 Participants

a Authorsb Peer Reviewersc Editors and Journal Staff

2 Reporting Conflicts of InterestC Responsibilities in the Submission and Peer-Review

Process1 Authors

a Predatory or Pseudo-Journals2 Journals

a Confidentialityb Timelinessc Peer Reviewd Integritye Journal Metrics

3 Peer ReviewersD Journal Owners and Editorial Freedom

1 Journal Owners2 Editorial Freedom

E Protection of Research ParticipantsIII Publishing and Editorial Issues Related to Publication

in Medical JournalsA Corrections Retractions Republications and Ver-

sion ControlB Scientific Misconduct Expressions of Concern

and RetractionC CopyrightD Overlapping Publications

1 Duplicate Submission2 Duplicate and Prior Publication3 Acceptable Secondary Publication4 Manuscripts Based on the Same Database

E CorrespondenceF FeesG Supplements Theme Issues and Special SeriesH Sponsorship of PartnershipsI Electronic PublishingJ Advertising

K Journals and the Media

L Clinical Trialsi Registration

ii Data SharingIV Manuscript Preparation and Submission

A Preparing a Manuscript for Submission to a Med-ical Journal1 General Principles2 Reporting Guidelines3 Manuscript Sections

a Title Pageb Abstractc Introductiond Methods

i Selection and Description of Participantsii Technical Information

iii Statisticse Resultsf Discussiong References

i General Considerationsii Style and Format

h Tablesi Illustrations (Figures)j Units of Measurementk Abbreviations and Symbols

B Sending the Manuscript to the Journal

I ABOUT THE RECOMMENDATIONS

A Purpose of the RecommendationsICMJE developed these recommendations to review

best practice and ethical standards in the conduct and re-porting of research and other material published in medicaljournals and to help authors editors and others involvedin peer review and biomedical publishing create and dis-tribute accurate clear reproducible unbiased medical journalarticles The recommendations may also provide useful in-sights into the medical editing and publishing process for themedia patients and their families and general readers

B Who Should Use the RecommendationsThese recommendations are intended primarily for use

by authors who might submit their work for publication toICMJE member journals Many non-ICMJE journals vol-untarily use these recommendations (see wwwicmjeorgjournals-following-the-icjme-recommendations) The ICMJEencourages that use but has no authority to monitor orenforce it In all cases authors should use these recommen-dations along with individual journalsrsquo instructions to au-thors Authors should also consult guidelines for the re-porting of specific study types (eg the CONSORT

1

Unauthorized reproduction of this article is prohibited

Annotations are inserted here to assist in identifying changes made in December 2019

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2019
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Disclosure of Financial and Non-Financial Relationships and Activities and
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e Diversity and Inclusion
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guidelines for the reporting of randomized trials) seewwwequator-networkorg

Journals that follow these recommendations are en-couraged to incorporate them into their instructions toauthors and to make explicit in those instructions that theyfollow ICMJE recommendations Journals that wish to beidentified on the ICMJE website as following these recom-mendations should notify the ICMJE secretariat at wwwicmjeorgjournals-following-the-icmje-recommendationsjournal-listing-request-form Journals that in the pasthave requested such identification but who no longer fol-low ICMJE recommendations should use the same meansto request removal from this list

The ICMJE encourages wide dissemination of theserecommendations and reproduction of this document in itsentirety for educational not-for-profit purposes withoutregard for copyright but all uses of the recommendationsand document should direct readers to wwwicmjeorg forthe official most recent version as the ICMJE updates therecommendations periodically when new issues arise

C History of the RecommendationsThe 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 wayof standardizing manuscript format and preparation acrossjournals Over the years issues in publishing that went wellbeyond manuscript preparation arose resulting in the de-velopment of separate statements up-dates to the docu-ment and its renaming as ldquoRecommendations for theConduct Reporting Editing and Publication of ScholarlyWork in Medical Journalsrdquo to reflect its broader scopePrevious versions of the document may be found in theldquoArchivesrdquo section of wwwicmjeorg

II ROLES AND RESPONSIBILITIES OF AUTHORSCONTRIBUTORS REVIEWERS EDITORS PUBLISHERSAND OWNERS

A Defining the Role of Authors and Contributors1 Why Authorship Matters

Authorship confers credit and has important aca-demic social and financial implications Authorship alsoimplies responsibility and accountability for publishedwork The following recommendations are intended toensure that contributors who have made substantive intel-lectual contributions to a paper are given credit as authorsbut also that contributors credited as authors understandtheir role in taking responsibility and being accountable forwhat is published

Because authorship does not communicate what con-tributions qualified an individual to be an author somejournals now request and publish information about thecontributions of each person named as having participatedin a submitted study at least for original research Editorsare strongly encouraged to develop and implement a con-

tributorship policy Such policies remove much of the am-biguity surrounding contributions but leave unresolvedthe question of the quantity and quality of contributionthat qualify an individual for authorship The ICMJE hasthus developed criteria for authorship that can be used byall journals including those that distinguish authors fromother contributors

2 Who Is an Author

The ICMJE recommends that authorship be based onthe following 4 criteria

1 Substantial contributions to the conception or de-sign of the work or the acquisition analysis or interpre-tation of data for the work AND

2 Drafting the work or revising it critically for im-portant intellectual content AND

3 Final approval of the version to be published AND4 Agreement to be accountable for all aspects of the

work in ensuring that questions related to the accuracy orintegrity of any part of the work are appropriately investi-gated and resolved

In addition to being accountable for the parts of thework he or she has done an author should be able toidentify which co-authors are responsible for specific otherparts of the work In addition authors should have confidencein the integrity of the contributions of their co-authors

All those designated as authors should meet all fourcriteria for authorship and all who meet the four criteriashould be identified as authors Those who do not meet allfour criteria should be acknowledgedmdashsee Section IIA3below These authorship criteria are intended to reserve thestatus of authorship for those who deserve credit and cantake responsibility for the work The criteria are not in-tended for use as a means to disqualify colleagues fromauthorship who otherwise meet authorship criteria by de-nying them the opportunity to meet criterion s 2 or 3Therefore all individuals who meet the first criterionshould have the opportunity to participate in the reviewdrafting and final approval of the manuscript

The individuals who conduct the work are responsiblefor identifying who meets these criteria and ideally shoulddo so when planning the work making modifications asappropriate as the work progresses We encourage collabo-ration and co-authorship with colleagues in the locationswhere the research is conducted It is the collective respon-sibility of the authors not the journal to which the work issubmitted to determine that all people named as authorsmeet all four criteria it is not the role of journal editors todetermine who qualifies or does not qualify for authorshipor to arbitrate authorship conflicts If agreement cannot bereached about who qualifies for authorship the institu-tion(s) where the work was performed not the journaleditor should be asked to investigate If authors requestremoval or addition of an author after manuscript submis-sion or publication journal editors should seek an expla-nation and signed statement of agreement for the requested

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

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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 editors
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change from all listed authors and from the author to beremoved or added

The corresponding author is the one individual whotakes primary responsibility for communication with thejournal during the manuscript submission peer reviewand publication process and typically ensures that all thejournalrsquos administrative requirements such as providingdetails of authorship ethics committee approval clinicaltrial registration documentation and gathering conflict ofinterest forms and statements are properly completed al-though these duties may be delegated to one or more co-authors The corresponding author should be availablethroughout the submission and peer-review process to re-spond to editorial queries in a timely way and should beavailable after publication to respond to critiques of thework and cooperate with any requests from the journal fordata or additional information should questions about thepaper arise after publication Although the correspondingauthor has primary responsibility for correspondence withthe journal the ICMJE recommends that editors send cop-ies of all correspondence to all listed authors

When a large multi-author group has conducted thework the group ideally should decide who will be an au-thor before the work is started and confirm who is anauthor before submitting the manuscript for publicationAll members of the group named as authors should meetall four criteria for authorship including approval of thefinal manuscript and they should be able to take publicresponsibility for the work and should have full confidencein the accuracy and integrity of the work of other groupauthors They will also be expected as individuals to com-plete conflict-of-interest disclosure forms

Some large multi-author groups designate authorshipby a group name with or without the names of individu-als When submitting a manuscript authored by a groupthe corresponding author should specify the group name ifone exists and clearly identify the group members who cantake credit and responsibility for the work as authors Thebyline of the article identifies who is directly responsiblefor the manuscript and MEDLINE lists as authors which-ever names appear on the byline If the byline includes agroup name MEDLINE will list the names of individualgroup members who are authors or who are collaboratorssometimes called non-author contributors if there is a noteassociated with the byline clearly stating that the individualnames are elsewhere in the paper and whether those namesare authors or collaborators

3 Non-Author Contributors

Contributors who meet fewer than all 4 of the abovecriteria for authorship should not be listed as authors butthey should be acknowledged Examples of activities thatalone (without other contributions) do not qualify a con-tributor for authorship are acquisition of funding generalsupervision of a research group or general administrativesupport and writing assistance technical editing language

editing and proofreading Those whose contributions donot justify authorship may be acknowledged individuallyor together as a group under a single heading (eg ldquoClin-ical Investigatorsrdquo or ldquoParticipating Investigatorsrdquo) andtheir contributions should be specified (eg ldquoserved as scien-tific advisorsrdquo ldquocritically reviewed the study proposalrdquo ldquocol-lected datardquo ldquoprovided and cared for study patientsrdquo ldquopartic-ipated in writing or technical editing of the manuscriptrdquo)

Because acknowledgment may imply endorsement byacknowledged individuals of a studyrsquos data and conclu-sions editors are advised to require that the correspondingauthor obtain written permission to be acknowledged fromall acknowledged individuals

B Conflicts of InterestPublic trust in the scientific process and the credibility

of published articles depend in part on how transparentlyconflicts of interest are handled during the planning im-plementation writing peer review editing and publica-tion of scientific work

A conflict of interest exists when professional judg-ment concerning a primary interest (such as patientsrsquo wel-fare or the validity of research) may be influenced by asecondary interest (such as financial gain) Perceptions ofconflict of interest are as important as actual conflicts ofinterest

Financial relationships (such as employment consul-tancies stock ownership or options honoraria patentsand paid expert testimony) are the most easily identifiableconflicts of interest and the most likely to undermine thecredibility of the journal the authors and science itselfHowever conflicts can occur for other reasons such aspersonal relationships or rivalries academic competitionand intellectual beliefs Authors should avoid entering in toagreements with study sponsors both for-profit and non-profit that interfere with authorsrsquo access to all of thestudyrsquos data or that interfere with their ability to analyzeand interpret the data and to prepare and publish manu-scripts independently when and where they chooseAuthors may be required to provide the journal with theagreements in confidence

Purposeful failure to disclose conflicts of interest is aform of misconduct as is discussed in Section IIIB

1 Participants

All participants in the peer-review and publicationprocessmdashnot only authors but also peer reviewers editorsand editorial board members of journalsmdashmust considertheir conflicts of interest when fulfilling their roles in theprocess of article review and publication and must discloseall relationships that could be viewed as potential conflictsof interest

a Authors

When authors submit a manuscript of any type orformat they are responsible for disclosing all financial and


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The corresponding author
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disclosures of relationships and activities
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an authors relationships and activities directly or topically related to a work
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The potential for
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and bias
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paraIndividuals may disagree on whether an authors relationships or activities represent conflicts Although the presence of a relationship or activity does not always indicate a problematic influence on a papers 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 authors relationships and activities are pertinent to a papers content These judgments require transparent disclosures An authors complete disclosure demonstrates a commitment to transparency and helps to maintain trust in the scientific process
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the ones most often judged to represent potential conflicts of interest and thus the
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Other interests may also represent or be perceived as conflicts
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Policies that dictate where authors may publish their work violate this principle of academic freedom
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report those relationships or activities specified on the journals disclosure form
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and disclose their relationships and activities
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and reported

personal relationships that might bias or be seen to biastheir work The ICMJE has developed a Form for Disclo-sure of Conflicts of Interest to facilitate and standardizeauthorsrsquo disclosures ICMJE member journals require thatauthors use this form and ICMJE encourages other jour-nals to adopt it

b Peer Reviewers

Reviewers should be asked at the time they are askedto critique a manuscript if they have conflicts of interestthat could complicate their review Reviewers must discloseto editors any conflicts of interest that could bias theiropinions of the manuscript and should recuse themselvesfrom reviewing specific manuscripts if the potential for biasexists Reviewers must not use knowledge of the worktheyrsquore reviewing before its publication to further theirown interests

c Editors and Journal Staff

Editors who make final decisions about manuscriptsshould recuse themselves from editorial decisions if theyhave conflicts of interest or relationships that pose poten-tial conflicts related to articles under consideration Othereditorial staff members who participate in editorial deci-sions must provide editors with a current description oftheir financial interests or other conflicts (as they mightrelate to editorial judgments) and recuse themselves fromany decisions in which a conflict of interest exists Editorialstaff must not use information gained through workingwith manuscripts for private gain Editors should publishregular disclosure statements about potential conflicts ofinterests related to their own commitments and those oftheir journal staff Guest editors should follow these sameprocedures

Journals should take extra precautions and have astated policy for evaluation of manuscripts submitted byindividuals involved in editorial decisions Further guid-ance is available from COPE (httpspublicationethicsorgfilesA_Short_Guide_to_Ethical_Editingpdf) and WAME(httpwameorgconflict-of-interest-in-peer-reviewed-medical-journals)

2 Reporting Conflicts of Interest

Articles should be published with statements or sup-porting documents such as the ICMJE conflict of interestform declaring

ndash Authorsrsquo conflicts of interest andndash Sources of support for the work including sponsor

names along with explanations of the role of those sourcesif any in study design collection analysis and interpreta-tion of data writing of the report the decision to submitthe report for publication or a statement declaring that thesupporting source had no such involvement and

ndash Whether the authors had access to the study datawith an explanation of the nature and extent of accessincluding whether access is ongoing

To support the above statements editors may requestthat authors of a study sponsored by a funder with a pro-prietary or financial interest in the outcome sign a state-ment such as ldquoI had full access to all of the data in thisstudy and I take complete responsibility for the integrity ofthe data and the accuracy of the data analysisrdquo

C Responsibilities in the Submission and Peer-ReviewProcess1 Authors

Authors should abide by all principles of authorshipand declaration of conflicts of interest detailed in sectionIIA and B of this document

a Predatory or Pseudo-Journals

A growing number of entities are advertising them-selves as ldquoscholarly medical journalsrdquo yet do not function assuch These journals (ldquopredatoryrdquoor ldquopseudo-journalsrdquo) ac-cept and publish almost all submissions and charge articleprocessing (or publication) fees often informing authorsabout this after a paperrsquos acceptance for publication Theyoften claim to perform peer review but do not and maypurposefully use names similar to well established journalsThey may state that they are members of ICMJE but arenot (see wwwicmjeorg for current members of theICMJE) and that they follow the recommendations of or-ganizations such as the ICMJE COPE and WAME Re-searchers must be aware of the existence of such entitiesand avoid submitting research to them for publicationAuthors have a responsibility to evaluate the integrityhistory practices and reputation of the journals to whichthey submit manuscripts Guidance from various organiza-tions is available to help identify the characteristics of rep-utable peer-reviewed journals (wwwwameorgidentifying-predatory-or-pseudo-journals and wwwwameorgaboutprinciples-of-transparency-and-best-practice) Seeking the as-sistance of scientific mentors senior colleagues and otherswith many years of scholarly publishing experience may alsobe helpful

2 Journals

a Confidentiality

Manuscripts submitted to journals are privileged com-munications that are authorsrsquo private confidential prop-erty and authors may be harmed by premature disclosureof any or all of a manuscriptrsquos details

Editors therefore must not share information aboutmanuscripts including whether they have been receivedand are under review their content and status in the reviewprocess criticism by reviewers and their ultimate fate toanyone other than the authors and reviewers Requestsfrom third parties to use manuscripts and reviews for legalproceedings should be politely refused and editors should


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and activities
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relationships or activities
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or activities
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relationships and activities
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an interest that poses a potential
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regularly
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their own
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Disclosure Form
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any restrictions regarding the submission of
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or restrictions regarding publication
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paraAuthors should avoid citing articles in predatory or pseudo-journals
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do their best not to provide such confidential materialshould it be subpoenaed

Editors must also make clear that reviewers shouldkeep manuscripts associated material and the informationthey contain strictly confidential Reviewers and editorialstaff members must not publicly discuss the authorsrsquo workand reviewers must not appropriate authorsrsquo ideas beforethe manuscript is published Reviewers must not retain themanuscript for their personal use and should destroy papercopies of manuscripts and delete electronic copies aftersubmitting their reviews

When a manuscript is rejected it is best practice forjournals to delete copies of it from their editorial systemsunless retention is required by local regulations Journalsthat retain copies of rejected manuscripts should disclosethis practice in their Information for Authors

When a manuscript is published journals should keepcopies of the original submission reviews revisions andcorrespondence for at least three years and possibly in per-petuity depending on local regulations to help answerfuture questions about the work should they arise

Editors should not publish or publicize peer reviewersrsquocomments without permission of the reviewer and authorIf journal policy is to blind authors to reviewer identity andcomments are not signed that identity must not be re-vealed to the author or anyone else without the reviewersrsquoexpressed written permission

Confidentiality may have to be breached if dishonestyor fraud is alleged but editors should notify authors orreviewers if they intend to do so and confidentiality mustotherwise be honored

b Timeliness

Editors should do all they can to ensure timely pro-cessing of manuscripts with the resources available to themIf editors intend to publish a manuscript they should at-tempt to do so in a timely manner and any planned delaysshould be negotiated with the authors If a journal has nointention of proceeding with a manuscript editors shouldendeavor to reject the manuscript as soon as possible toallow authors to submit to a different journal

c Peer Review

Peer review is the critical assessment of manuscriptssubmitted to journals by experts who are usually not partof the editorial staff Because unbiased independent crit-ical assessment is an intrinsic part of all scholarly workincluding scientific research peer review is an importantextension of the scientific process

The actual value of peer review is widely debated butthe process facilitates a fair hearing for a manuscript amongmembers of the scientific community More practically ithelps editors decide which manuscripts are suitable fortheir journals Peer review often helps authors and editorsimprove the quality of reporting

It is the responsibility of the journal to ensure thatsystems are in place for selection of appropriate reviewersIt is the responsibility of the editor to ensure that reviewershave access to all materials that may be relevant to theevaluation of the manuscript including supplementarymaterial for e-only publication and to ensure that reviewercomments are properly assessed and interpreted in the con-text of their declared conflicts of interest

A peer-reviewed journal is under no obligation to sendsubmitted manuscripts for review and under no obligationto follow reviewer recommendations favorable or negativeThe editor of a journal is ultimately responsible for theselection of all its content and editorial decisions may beinformed by issues unrelated to the quality of a manu-script such as suitability for the journal An editor can rejectany article at any time before publication including after ac-ceptance if concerns arise about the integrity of the work

Journals may differ in the number and kinds of man-uscripts they send for review the number and types ofreviewers they seek for each manuscript whether the reviewprocess is open or blinded and other aspects of the reviewprocess For this reason and as a service to authors journalsshould publish a description of their peer-review process

Journals should notify reviewers of the ultimate deci-sion to accept or reject a paper and should acknowledgethe contribution of peer reviewers to their journal Editorsare encouraged to share reviewersrsquo comments with co-reviewers of the same paper so reviewers can learn fromeach other in the review process

As part of peer review editors are encouraged to re-view research protocols plans for statistical analysis if sep-arate from the protocol andor contracts associated withproject-specific studies Editors should encourage authorsto make such documents publicly available at the time ofor after publication before accepting such studies for pub-lication Some journals may require public posting of thesedocuments as a condition of acceptance for publication

Journal requirements for independent data analysisand for public data availability are in flux at the time of thisrevision reflecting evolving views of the importance of dataavailability for pre- and post-publication peer review Somejournal editors currently request a statistical analysis of trialdata by an independent biostatistician before acceptingstudies for publication Others ask authors to say whetherthe study data are available to third parties to view andorusereanalyze while still others encourage or require au-thors to share their data with others for review or reanaly-sis Each journal should establish and publish their specificrequirements for data analysis and post in a place thatpotential authors can easily access

Some people believe that true scientific peer reviewbegins only on the date a paper is published In that spiritmedical journals should have a mechanism for readers tosubmit comments questions or criticisms about publishedarticles and authors have a responsibility to respondappropriately and cooperate with any requests from the


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journal for data or additional information should questionsabout the paper arise after publication (see Section III)

ICMJE believes investigators have a duty to maintainthe primary data and analytic procedures underpinning thepublished results for at least 10 years The ICMJE encour-ages the preservation of these data in a data repository toensure their longer-term availability

d Integrity

Editorial decisions should be based on the relevance ofa manuscript to the journal and on the manuscriptrsquos orig-inality quality and contribution to evidence about impor-tant questions Those decisions should not be influencedby commercial interests personal relationships or agendasor findings that are negative or that credibly challenge ac-cepted wisdom In addition authors should submit forpublication or otherwise make publicly available and edi-tors should not exclude from consideration for publicationstudies with findings that are not statistically significant orthat have inconclusive findings Such studies may provideevidence that combined with that from other studiesthrough meta-analysis might still help answer importantquestions and a public record of such negative or incon-clusive findings may prevent unwarranted replication ofeffort or otherwise be valuable for other researchers consid-ering similar work

Journals should clearly state their appeals process andshould have a system for responding to appeals andcomplaints

e Journal Metrics

The journal impact factor is widely misused as a proxyfor research and journal quality and as a measure of theimportance of specific research projects or the merits ofindividual researchers including their suitability for hiringpromotion tenure prizes or research funding ICMJE rec-ommends that journals reduce the emphasis on impact factoras a single measure but rather provide a range of article andjournal metrics relevant to their readers and authors

3 Peer Reviewers


Reviewers therefore should keep manuscripts and theinformation they contain strictly confidential Reviewersmust not publicly discuss authorsrsquo work and must not ap-propriate authorsrsquo ideas before the manuscript is publishedReviewers must not retain the manuscript for their per-sonal use and should destroy copies of manuscripts aftersubmitting their reviews

Reviewers are expected to respond promptly to re-quests to review and to submit reviews within the timeagreed Reviewersrsquo comments should be constructive hon-est and polite

Reviewers should declare their conflicts of interest andrecuse themselves from the peer-review process if a conflictexists

D Journal Owners and Editorial Freedom1 Journal Owners

Owners and editors of medical journals share a com-mon purpose but they have different responsibilities andsometimes those differences lead to conflicts

It is the responsibility of medical journal owners toappoint and dismiss editors Owners should provide edi-tors at the time of their appointment with a contract thatclearly states their rights and duties authority the generalterms of their appointment and mechanisms for resolvingconflict The editorrsquos performance may be assessed usingmutually agreed-upon measures including but not neces-sarily limited to readership manuscript submissions andhandling times and various journal metrics

Owners should only dismiss editors for substantial rea-sons such as scientific misconduct disagreement with thelong-term editorial direction of the journal inadequateperformance by agreed-upon performance metrics or in-appropriate behavior that is incompatible with a positionof trust

Appointments and dismissals should be based on eval-uations by a panel of independent experts rather than by asmall number of executives of the owning organizationThis is especially necessary in the case of dismissals becauseof the high value society places on freedom of speechwithin science and because it is often the responsibility ofeditors to challenge the status quo in ways that may con-flict with the interests of the journalrsquos owners

A medical journal should explicitly state its governanceand relationship to a journal owner (eg a sponsoringsociety)

2 Editorial Freedom

The ICMJE adopts the World Association of MedicalEditorsrsquo definition of editorial freedom (httpwameorgeditorial-independence) which holds that editors-in-chiefhave full authority over the entire editorial content of theirjournal and the timing of publication of that content Journalowners should not interfere in the evaluation selection sched-uling or editing of individual articles either directly or bycreating an environment that strongly influences decisionsEditors should base editorial decisions on the validity of thework and its importance to the journalrsquos readers not on thecommercial implications for the journal and editors should befree to express critical but responsible views about all aspects ofmedicine without fear of retribution even if these views con-flict with the commercial goals of the publisher


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relationships and activities that might bias their evaluation of a manuscript
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f
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e Diversity and Inclusion 13To improve academic culture editors should seek to engage a broad and diverse array of authors reviewers editorial staff editorial board members and readers
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paraReviewers who seek assistance from a trainee or colleague in the performance of a review should acknowledge these individuals contributions in the written comments submitted to the editor These individuals must maintain the confidentiality of the manuscript as outlined above 13
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Editors-in-chief should also have the final say in deci-sions about which advertisements or sponsored contentincluding supplements the journal will and will not carryand they should have final say in use of the journal brandand in overall policy regarding commercial use of journalcontent

Journals are encouraged to establish an independenteditorial advisory board to help the editor establish andmaintain editorial policy Editors should seek to engage abroad and diverse array of authors reviewers editorialstaff editorial board members and readers To supporteditorial decisions and potentially controversial expressionsof opinion owners should ensure that appropriate insur-ance is obtained in the event of legal action against theeditors and should ensure that legal advice is availablewhen necessary If legal problems arise the editor shouldinform their legal adviser and their owner andor publisheras soon as possible Editors should defend the confidenti-ality of authors and peer-reviewers (names and reviewercomments) in accordance with ICMJE policy (see SectionII C2a) Editors should take all reasonable steps to checkthe facts in journal commentary including that in newssections and social media postings and should ensure thatstaff working for the journal adhere to best journalisticpractices including contemporaneous note-taking andseeking a response from all parties when possible beforepublication Such practices in support of truth and publicinterest may be particularly relevant in defense against legalallegations of libel

To secure editorial freedom in practice the editorshould have direct access to the highest level of ownershipnot to a delegated manager or administrative officer

Editors and editorsrsquo organizations are obliged to sup-port the concept of editorial freedom and to draw majortransgressions of such freedom to the attention of the in-ternational medical academic and lay communities

E Protection of Research ParticipantsAll investigators should ensure that the planning con-

duct and reporting of human research are in accordancewith the Helsinki Declaration as revised in 2013(wwwwmanetpolicies-postwma-declaration-of-helsinki-ethical-principles-for-medical-research-involving-human-subjects) All authors should seek approval to conductresearch from an independent local regional or nationalreview body (eg ethics committee institutional reviewboard) If doubt exists whether the research was conductedin accordance with the Helsinki Declaration the authorsmust explain the rationale for their approach and demon-strate that the local regional or national review body ex-plicitly approved the doubtful aspects of the study Ap-proval by a responsible review body does not precludeeditors from forming their own judgment whether the con-duct of the research was appropriate

Patients have a right to privacy that should not beviolated without informed consent Identifying informa-

tion including names initials or hospital numbers shouldnot be published in written descriptions photographs orpedigrees unless the information is essential for scientificpurposes and the patient (or parent or guardian) gives writ-ten informed consent for publication Informed consentfor this purpose requires that an identifiable patient beshown the manuscript to be published Authors shoulddisclose to these patients whether any potential identifiablematerial might be available via the Internet as well as inprint after publication Patient consent should be writtenand archived with the journal the authors or both asdictated by local regulations or laws Applicable laws varyfrom locale to locale and journals should establish theirown policies with legal guidance Since a journal that ar-chives the consent will be aware of patient identity somejournals may decide that patient confidentiality is betterguarded by having the author archive the consent and in-stead providing the journal with a written statement thatattests that they have received and archived written patientconsent

Nonessential identifying details should be omitted In-formed consent should be obtained if there is any doubtthat anonymity can be maintained For example maskingthe eye region in photographs of patients is inadequateprotection of anonymity If identifying characteristics arede-identified authors should provide assurance and edi-tors should so note that such changes do not distort sci-entific meaning

The requirement for informed consent should be in-cluded in the journalrsquos instructions for authors When in-formed consent has been obtained it should be indicatedin the published article

When reporting experiments on animals authors shouldindicate whether institutional and national standards forthe care and use of laboratory animals were followed Fur-ther guidance on animal research ethics is available fromthe International Association of Veterinary Editorsrsquo Con-sensus Author Guidelines on Animal Ethics and Welfare(httpwwwveteditorsorgconsensus-author-guidelines-on-animal-ethics-and-welfare-for-editors)

III PUBLISHING AND EDITORIAL ISSUES RELATED TO

PUBLICATION IN MEDICAL JOURNALS

A Corrections Retractions Republications and VersionControl

Honest errors are a part of science and publishing andrequire publication of a correction when they are detectedCorrections are needed for errors of fact Matters of debateare best handled as letters to the editor as print or elec-tronic correspondence or as posts in a journal-sponsoredonline forum Updates of previous publications (eg anupdated systematic review or clinical guideline) are consid-ered a new publication rather than a version of a previouslypublished article


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If a correction is needed journals should follow theseminimum standards

bull The journal should publish a correction notice assoon as possible detailing changes from and citing the orig-inal publication the correction should be on an electronicor numbered print page that is included in an electronic ora print Table of Contents to ensure proper indexing

bull The journal should also post a new article versionwith details of the changes from the original version andthe date(s) on which the changes were made

bull The journal should archive all prior versions of thearticle This archive can be either directly accessible toreaders or can be made available to the reader on request

bull Previous electronic versions should prominentlynote that there are more recent versions of the article

bull The citation should be to the most recent versionPervasive errors can result from a coding problem or a

miscalculation and may result in extensive inaccuraciesthroughout an article If such errors do not change thedirection or significance of the results interpretations andconclusions of the article a correction should be publishedthat follows the minimum standards noted above

Errors serious enough to invalidate a paperrsquos resultsand conclusions may require retraction However retrac-tion with republication (also referred to as ldquoreplacementrdquo)can be considered in cases where honest error (eg a mis-classification or miscalculation) leads to a major change inthe direction or significance of the results interpretationsand conclusions If the error is judged to be unintentionalthe underlying science appears valid and the changed ver-sion of the paper survives further review and editorial scru-tiny then retraction with republication of the changed pa-per with an explanation allows full correction of thescientific literature In such cases it is helpful to show theextent of the changes in supplementary material or in anappendix for complete transparency

B Scientific Misconduct Expressions of Concern andRetraction

Scientific misconduct in research and non-researchpublications includes but is not necessarily limited to datafabrication data falsification including deceptive manipu-lation of images purposeful failure to disclose conflicts ofinterest and plagiarism Some people consider failure topublish the results of clinical trials and other human stud-ies a form of scientific misconduct While each of thesepractices is problematic they are not equivalent Each sit-uation requires individual assessment by relevant stake-holders When scientific misconduct is alleged or concernsare otherwise raised about the conduct or integrity of workdescribed in submitted or published papers the editor shouldinitiate appropriate procedures detailed by such commit-tees as the Committee on Publication Ethics (COPE) (pub-licationethicsorgresourcesflowcharts) consider informingthe institutions and funders and may choose to publish anexpression of concern pending the outcomes of those pro-

cedures If the procedures involve an investigation at theauthorsrsquo institution the editor should seek to discover theoutcome of that investigation notify readers of the out-come if appropriate and if the investigation proves scien-tific misconduct publish a retraction of the article Theremay be circumstances in which no misconduct is provenbut an exchange of letters to the editor could be publishedto highlight matters of debate to readers

Expressions of concern and retractions should not sim-ply be a letter to the editor Rather they should be prom-inently labelled appear on an electronic or numbered printpage that is included in an electronic or a print Table ofContents to ensure proper indexing and include in theirheading the title of the original article Online the retrac-tion and original article should be linked in both directionsand the retracted article should be clearly labelled as re-tracted in all its forms (abstract full text PDF) Ideally theauthors of the retraction should be the same as those of thearticle but if they are unwilling or unable the editor mayunder certain circumstances accept retractions by other re-sponsible persons or the editor may be the sole author ofthe retraction or expression of concern The text of theretraction should explain why the article is being retractedand include a complete citation reference to that articleRetracted articles should remain in the public domain andbe clearly labelled as retracted

The validity of previous work by the author of a fraud-ulent paper cannot be assumed Editors may ask the au-thorrsquos institution to assure them of the validity of otherwork published in their journals or they may retract it Ifthis is not done editors may choose to publish an an-nouncement expressing concern that the validity of previ-ously published work is uncertain

The integrity of research may also be compromised byinappropriate methodology that could lead to retraction

See COPE flowcharts for further guidance on retrac-tions and expressions of concern See Section IVgi forguidance about avoiding referencing retracted articles

C CopyrightJournals should make clear the type of copyright under

which work will be published and if the journal retainscopyright should detail the journalrsquos position on the trans-fer of copyright for all types of content including audiovideo protocols and data sets Medical journals may askauthors to transfer copyright to the journal Some journalsrequire transfer of a publication license Some journals donot require transfer of copyright and rely on such vehiclesas Creative Commons licenses The copyright status of ar-ticles in a given journal can vary Some content cannot becopyrighted (eg articles written by employees of somegovernments in the course of their work) Editors maywaive copyright on other content and some content maybe protected under other agreements


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D Overlapping Publications1 Duplicate Submission

Authors should not submit the same manuscript inthe same or different languages simultaneously to morethan one journal The rationale for this standard is thepotential for disagreement when two (or more) journalsclaim the right to publish a manuscript that has been sub-mitted simultaneously to more than one journal and thepossibility that two or more journals will unknowingly andunnecessarily undertake the work of peer review edit thesame manuscript and publish the same article

2 Duplicate and Prior Publication

Duplicate publication is publication of a paper thatoverlaps substantially with one already published withoutclear visible reference to the previous publication Priorpublication may include release of information in the pub-lic domain

Readers of medical journals deserve to be able to trustthat what they are reading is original unless there is a clearstatement that the author and editor are intentionally re-publishing an article (which might be considered for his-toric or landmark papers for example) The bases of thisposition are international copyright laws ethical conductand cost-effective use of resources Duplicate publication oforiginal research is particularly problematic because it canresult in inadvertent double-counting of data or inappro-priate weighting of the results of a single study whichdistorts the available evidence

When authors submit a manuscript reporting workthat has already been reported in large part in a publishedarticle or is contained in or closely related to another paperthat has been submitted or accepted for publication else-where the letter of submission should clearly say so andthe authors should provide copies of the related material tohelp the editor decide how to handle the submission Seealso Section IVB

This recommendation does not prevent a journal fromconsidering a complete report that follows publication of apreliminary report such as a letter to the editor a preprintor an abstract or poster displayed at a scientific meeting Italso does not prevent journals from considering a paperthat has been presented at a scientific meeting but was notpublished in full or that is being considered for publica-tion in proceedings or similar format Press reports ofscheduled meetings are not usually regarded as breaches ofthis rule but they may be if additional data tables or fig-ures enrich such reports Authors should also consider howdissemination of their findings outside of scientific presen-tations at meetings may diminish the priority journal edi-tors assign to their work

Authors who choose to post their work on a preprintserver should choose one that clearly identifies preprints asnot peer-reviewed work and includes statements of con-flicts of interest It is the authorrsquos responsibility to inform a

journal if the work has been previously posted on apreprint server In addition it is the authorrsquos (and not thejournal editorsrsquo) responsibility to ensure that preprints areamended to point readers to subsequent versions includingthe final published article

In the event of a public health emergency (as definedby public health officials) information with immediate im-plications for public health should be disseminated withoutconcern that this will preclude subsequent considerationfor publication in a journal We encourage editors to givepriority to authors who have made crucial data publiclyavailable (eg in a gene bank) without delay

Sharing with public media government agencies ormanufacturers the scientific information described in a pa-per or a letter to the editor that has been accepted but notyet published violates the policies of many journals Suchreporting may be warranted when the paper or letter de-scribes major therapeutic advances reportable diseases orpublic health hazards such as serious adverse effects ofdrugs vaccines other biological products medical de-vices This reporting whether in print or online shouldnot jeopardize publication but should be discussedwith and agreed upon by the editor in advance whenpossible

The ICMJE will not consider as prior publication theposting of trial results in any registry that meets the criterianoted in Section IIIL if results are limited to a brief (500word) structured abstract or tables (to include participantsenrolled key outcomes and adverse events) The ICMJEencourages authors to include a statement with the regis-tration that indicates that the results have not yet beenpublished in a peer-reviewed journal and to update theresults registry with the full journal citation when the re-sults are published

Editors of different journals may together decide tosimultaneously or jointly publish an article if they believethat doing so would be in the best interest of public healthHowever the National Library of Medicine (NLM) in-dexes all such simultaneously published joint publicationsseparately so editors should include a statement makingthe simultaneous publication clear to readers

Authors who attempt duplicate publication withoutsuch notification should expect at least prompt rejection ofthe submitted manuscript If the editor was not awareof the violations and the article has already been publishedthen the article might warrant retraction with or withoutthe authorrsquos explanation or approval

See COPE flowcharts for further guidance on han-dling duplicate publication

3 Acceptable Secondary Publication

Secondary publication of material published in otherjournals or online may be justifiable and beneficial espe-cially when intended to disseminate important informationto the widest possible audience (eg guidelines produced


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by government agencies and professional organizations inthe same or a different language) Secondary publicationfor various other reasons may also be justifiable providedthe following conditions are met

1 The authors have received approval from the edi-tors of both journals (the editor concerned with secondarypublication must have access to the primary version)

2 The priority of the primary publication is respectedby a publication interval negotiated by both editors withthe authors

3 The paper for secondary publication is intended fora different group of readers an abbreviated version couldbe sufficient

4 The secondary version faithfully reflects the dataand interpretations of the primary version

5 The secondary version informs readers peers anddocumenting agencies that the paper has been published inwhole or in part elsewheremdashfor example with a note thatmight read ldquoThis article is based on a study first reportedin the [journal title with full reference]rdquomdashand the second-ary version cites the primary reference

6 The title of the secondary publication should indi-cate that it is a secondary publication (complete orabridged republication or translation) of a primary publi-cation Of note the NLM does not consider translations tobe ldquorepublicationsrdquo and does not cite or index them whenthe original article was published in a journal that is in-dexed in MEDLINE

When the same journal simultaneously publishes anarticle in multiple languages the MEDLINE citation willnote the multiple languages (eg Angelo M Journal net-working in nursing a challenge to be shared Rev Esc En-ferm USP 2011 Dec 45[6]1281-21279-801283-4 Arti-cle in English Portuguese and Spanish No abstractavailable PMID 22241182)

4 Manuscripts Based on the Same Database

If editors receive manuscripts from separate researchgroups or from the same group analyzing the same data set(eg from a public database or systematic reviews ormeta-analyses of the same evidence) the manuscriptsshould be considered independently because they may dif-fer in their analytic methods conclusions or both If thedata interpretation and conclusions are similar it may bereasonable although not mandatory for editors to give pref-erence to the manuscript submitted first Editors mightconsider publishing more than one manuscript that overlapin this way because different analytical approaches may becomplementary and equally valid but manuscripts basedupon the same dataset should add substantially to eachother to warrant consideration for publication as separatepapers with appropriate citation of previous publicationsfrom the same dataset to allow for transparency

Secondary analyses of clinical trial data should cite anyprimary publication clearly state that it contains secondary

analysesresults and use the same identifying trial registra-tion number as the primary trial and unique persistentdataset identifier

Sometimes for large trials it is planned from the be-ginning to produce numerous separate publications regard-ing separate research questions but using the same originalparticipant sample In this case authors may use the origi-nal single trial registration number if all the outcome pa-rameters were defined in the original registration If theauthors registered several substudies as separate entries infor example clinicaltrialsgov then the unique trial identi-fier should be given for the study in question The mainissue is transparency so no matter what model is used itshould be obvious for the reader

E CorrespondenceMedical journals should provide readers with a mech-

anism for submitting comments questions or criticismsabout published articles usually but not necessarily alwaysthrough a correspondence section or online forum Theauthors of articles discussed in correspondence or an onlineforum have a responsibility to respond to substantial criti-cisms of their work using those same mechanisms andshould be asked by editors to respond Authors of corre-spondence should be asked to declare any competing orconflicting interests

Correspondence may be edited for length grammati-cal correctness and journal style Alternatively editors maychoose to make available to readers unedited correspon-dence for example via an online commenting systemSuch commenting is not indexed in Medline unless it issubsequently published on a numbered electronic or printpage However the journal handles correspondence itshould make known its practice In all instances editorsmust make an effort to screen discourteous inaccurate orlibellous comments

Responsible debate critique and disagreement are im-portant features of science and journal editors should en-courage such discourse ideally within their own journalsabout the material they have published Editors howeverhave the prerogative to reject correspondence that is irrel-evant uninteresting or lacking cogency but they also havea responsibility to allow a range of opinions to be expressedand to promote debate

In the interests of fairness and to keep correspondencewithin manageable proportions journals may want to settime limits for responding to published material and fordebate on a given topic

F FeesJournals should be transparent about their types of

revenue streams Any fees or charges that are required formanuscript processing andor publishing materials in thejournal shall be clearly stated in a place that is easy forpotential authors to find prior to submitting their manu-scripts for review or explained to authors before they begin


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preparing their manuscript for submission (httppublicationethicsorgfilesu7140Principles_of_Transparency_and_Best_Practice_in_Scholarly_Publishingpdf)

G Supplements Theme Issues and Special SeriesSupplements are collections of papers that deal with

related issues or topics are published as a separate issue ofthe journal or as part of a regular issue and may be fundedby sources other than the journalrsquos publisher Becausefunding sources can bias the content of supplementsthrough the choice of topics and viewpoints journalsshould adopt the following principles which also apply totheme issues or special series that have external fundingandor guest editors

1 The journal editor must be given and must takefull responsibility for the policies practices and content ofsupplements including complete control of the decision toselect authors peer reviewers and content for the supple-ment Editing by the funding organization should not bepermitted

2 The journal editor has the right to appoint one ormore external editors of the supplement and must takeresponsibility for the work of those editors

3 The journal editor must retain the authority tosend supplement manuscripts for external peer review andto reject manuscripts submitted for the supplement with orwithout external review These conditions should be madeknown to authors and any external editors of the supple-ment before beginning editorial work on it

4 The source of the idea for the supplement sourcesof funding for the supplementrsquos research and publicationand products of the funding source related to content con-sidered in the supplement should be clearly stated in theintroductory material

5 Advertising in supplements should follow the samepolicies as those of the primary journal

6 Journal editors must enable readers to distinguishreadily between ordinary editorial pages and supplementpages

7 Journal and supplement editors must not acceptpersonal favors or direct remuneration from sponsors ofsupplements

8 Secondary publication in supplements (republica-tion of papers published elsewhere) should be clearly iden-tified by the citation of the original paper and by the title

9 The same principles of authorship and disclosure ofpotential conflicts of interest discussed elsewhere in thisdocument should be applied to supplements

H Sponsorship or PartnershipVarious entities may seek interactions with journals or

editors in the form of sponsorships partnerships meetingsor other types of activities To preserve editorial indepen-dence these interactions should be governed by the sameprinciples outlined above for Supplements Theme Issuesand Special Series (Section IIIG)

I Electronic PublishingMost medical journals are now published in electronic

as well as print versions and some are published only inelectronic form Principles of print and electronic publish-ing are identical and the recommendations of this docu-ment apply equally to both However electronic publish-ing provides opportunities for versioning and raises issuesabout link stability and content preservation that are ad-dressed here

Recommendations for corrections and versioning aredetailed in Section IIIA

Electronic publishing allows linking to sites and re-sources beyond journals over which journal editors have noeditorial control For this reason and because links to ex-ternal sites could be perceived as implying endorsement ofthose sites journals should be cautious about external link-ing When a journal does link to an external site it shouldstate that it does not endorse or take responsibility or lia-bility for any content advertising products or other ma-terials on the linked sites and does not take responsibilityfor the sitesrsquo availability

Permanent preservation of journal articles on a jour-nalrsquos website or in an independent archive or a crediblerepository is essential for the historical record Removingan article from a journalrsquos website in its entirety is almostnever justified as copies of the article may have been down-loaded even if its online posting was brief Such archivesshould be freely accessible or accessible to archive mem-bers Deposition in multiple archives is encouraged How-ever if necessary for legal reasons (eg libel action) theURL for the removed article must contain a detailed reasonfor the removal and the article must be retained in thejournalrsquos internal archive

Permanent preservation of a journalrsquos total content isthe responsibility of the journal publisher who in the eventof journal termination should be certain the journal filesare transferred to a responsible third party who can makethe content available

Journal websites should post the date that nonarticleweb pages such as those listing journal staff editorialboard members and instructions for authors were last up-dated

J AdvertisingMost medical journals carry advertising which gener-

ates income for their publishers but journals should not bedominated by advertisements and advertising must not beallowed to influence editorial decisions

Journals should have formal explicit written policiesfor advertising in both print and electronic versions Bestpractice prohibits selling advertisements intended to bejuxtaposed with editorial content on the same productAdvertisements should be clearly identifiable as advertise-ments Editors should have full and final authority for ap-proving print and online advertisements and for enforcingadvertising policy


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Journals should not carry advertisements for productsproven to be seriously harmful to health Editors shouldensure that existing regulatory or industry standards foradvertisements specific to their country are enforced ordevelop their own standards The interests of organizationsor agencies should not control classified and other nondis-play advertising except where required by law Editorsshould consider all criticisms of advertisements forpublication

K Journals and the MediaJournalsrsquo interactions with media should balance com-

peting priorities The general public has a legitimate inter-est in all journal content and is entitled to important in-formation within a reasonable amount of time and editorshave a responsibility to facilitate that However media re-ports of scientific research before it has been peer-reviewedand fully vetted may lead to dissemination of inaccurate orpremature conclusions and doctors in practice need tohave research reports available in full detail before they canadvise patients about the reportsrsquo conclusions

An embargo system has been established in somecountries and by some journals to assist this balance andto prevent publication of stories in the general media be-fore publication of the original research in the journal Forthe media the embargo creates a ldquolevel playing fieldrdquowhich most reporters and writers appreciate since it mini-mizes the pressure on them to publish stories before com-petitors when they have not had time to prepare carefullyConsistency in the timing of public release of biomedicalinformation is also important in minimizing economicchaos since some articles contain information that haspotential to influence financial markets The ICMJE ac-knowledges criticisms of embargo systems as being self-serving of journalsrsquo interests and an impediment to rapiddissemination of scientific information but believe thebenefits of the systems outweigh their harms

The following principles apply equally to print andelectronic publishing and may be useful to editors as theyseek to establish policies on interactions with the media

bull Editors can foster the orderly transmission of med-ical information from researchers through peer-reviewedjournals to the public This can be accomplished by anagreement with authors that they will not publicize theirwork while their manuscript is under consideration orawaiting publication and an agreement with the media thatthey will not release stories before publication of the orig-inal research in the journal in return for which the journalwill cooperate with them in preparing accurate stories byissuing for example a press release

bull Editors need to keep in mind that an embargo sys-tem works on the honor systemmdashno formal enforcementor policing mechanism exists The decision of a significantnumber of media outlets or biomedical journals not to respectthe embargo system would lead to its rapid dissolution

bull Notwithstanding authorsrsquo belief in their work verylittle medical research has such clear and urgently impor-tant clinical implications for the publicrsquos health that thenews must be released before full publication in a journalWhen such exceptional circumstances occur the appropri-ate authorities responsible for public health should decidewhether to disseminate information to physicians and themedia in advance and should be responsible for this decisionIf the author and the appropriate authorities wish to have amanuscript considered by a particular journal the editorshould be consulted before any public release If editors ac-knowledge the need for immediate release they should waivetheir policies limiting prepublication publicity

bull Policies designed to limit prepublication publicityshould not apply to accounts in the media of presentationsat scientific meetings or to the abstracts from these meet-ings (see Duplicate Publication) Researchers who presenttheir work at a scientific meeting should feel free to discusstheir presentations with reporters but should be discour-aged from offering more detail about their study than waspresented in the talk or should consider how giving suchdetail might diminish the priority journal editors assign totheir work (see Duplicate Publication)

bull When an article is close to being published editorsor journal staff should help the media prepare accuratereports by providing news releases answering questionssupplying advance copies of the article or referring report-ers to appropriate experts This assistance should be con-tingent on the mediarsquos cooperation in timing the release ofa story to coincide with publication of the article


The ICMJErsquos clinical trial registration policy is detailed ina series of editorials (see Updates and Editorials [wwwicmjeorgnews-and-editorials] and FAQs [wwwicmjeorgabout-icmjefaqs])

Briefly the ICMJE requires and recommends that allmedical journal editors require registration of clinical trialsin a public trials registry at or before the time of firstpatient enrollment as a condition of consideration for pub-lication Editors requesting inclusion of their journal onthe ICMJE website list of publications that follow ICMJEguidance [icmjeorgjournalshtml] should recognize thatthe listing implies enforcement by the journal of ICMJErsquostrial registration policy

ICMJE uses the date trial registration materials werefirst submitted to a registry as the date of registrationWhen there is a substantial delay between the submissionof registration materials and their posting at the trial reg-istry editors may inquire about the circumstances that ledto the delay

The ICMJE defines a clinical trial as any research proj-ect that prospectively assigns people or a group of people toan intervention with or without concurrent comparison orcontrol groups to study the relationship between a health-


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related intervention and a health outcome Health-relatedinterventions are those used to modify a biomedical orhealth-related outcome examples include drugs surgicalprocedures devices behavioral treatments educationalprograms dietary interventions quality improvement in-terventions and process-of-care changes Health outcomesare any biomedical or health-related measures obtained inpatients or participants including pharmacokinetic mea-sures and adverse events The ICMJE does not define thetiming of first participant enrollment but best practice dic-tates registration by the time of first participant consent

The ICMJE accepts publicly accessible registrationin any registry that is a primary register of the WHOInternational Clinical Trials Registry Platform (ICTRP)(wwwwhointictrpnetworkprimaryenindexhtml) orin ClinicalTrialsgov which is a data provider to theWHO ICTRP The ICMJE endorses these registries be-cause they meet several criteria They are accessible tothe public at no charge open to all prospective regis-trants managed by a not-for-profit organization have amechanism to ensure the validity of the registrationdata and are electronically searchable An acceptableregistry must include the minimum 21 item trial re-gistration dataset (httpprsinfoclinicaltrialsgovtrainTrainerWHO-ICMJE-ClinTrialsgov-Cross-Refpdf or wwwwhointictrpnetworktrdsenindexhtml) at the time ofregistration and before enrollment of the first participantThe ICMJE considers inadequate trial registrations missingany of the 21 data fields those that have fields that containuninformative information or registrations that are notmade publicly accessible such as phase I trials submitted tothe EU-CTR and trials of devices for which the informa-tion is placed in a ldquolock boxrdquo In order to comply withICMJE policy investigators registering trials of devices atClinicalTrialsgov must ldquoopt outrdquo of the lock box by elect-ing public posting prior to device approval Although not arequired item the ICMJE encourages authors to include astatement that indicates that the results have not yet beenpublished in a peer-reviewed journal and to update theregistration with the full journal citation when the resultsare published

The purpose of clinical trial registration is to preventselective publication and selective reporting of researchoutcomes to prevent unnecessary duplication of researcheffort to help patients and the public know what trials areplanned or ongoing into which they might want to enrolland to help give ethics review boards considering approvalof new studies a view of similar work and data relevant tothe research they are considering Retrospective registra-tion for example at the time of manuscript submissionmeets none of these purposes Those purposes apply also toresearch with alternative designs for example observationalstudies For that reason the ICMJE encourages registrationof research with non-trial designs but because the exposureor intervention in non-trial research is not dictated by theresearchers the ICMJE does not require it

Secondary data analyses of primary (parent) clinicaltrials should not be registered as separate clinical trials butinstead should reference the trial registration number ofthe primary trial

The ICMJE expects authors to ensure that they havemet the requirements of their funding and regulatory agen-cies regarding aggregate clinical trial results reporting inclinical trial registries It is the authorsrsquo and not the journaleditorsrsquo responsibility to explain any discrepancies betweenresults reported in registries and journal publications TheICMJE will not consider as prior publication the postingof trial results in any registry that meets the above criteria ifresults are limited to a brief (500 word) structured abstractor tables (to include trial participants enrolled baselinecharacteristics primary and secondary outcomes and ad-verse events)

The ICMJE recommends that journals publish thetrial registration number at the end of the abstract TheICMJE also recommends that whenever a registrationnumber is available authors list this number the first timethey use a trial acronym to refer either to the trial theyare reporting or to other trials that they mention in themanuscript

Editors may consider whether the circumstances in-volved in a failure to appropriately register a clinical trialwere likely to have been intended to or resulted in biasedreporting Because of the importance of prospective trialregistration if an exception to this policy is made trialsmust be registered and the authors should indicate in thepublication when registration was completed and why itwas delayed Editors should publish a statement indicatingwhy an exception was allowed The ICMJE emphasizesthat such exceptions should be rare and that authors fail-ing to prospectively register a trial risk its inadmissibililtyto our journals

ii Data Sharing

The ICMJErsquos data sharing statement policy isdetailed in an editorial (see Updates and Editorials[wwwicmjeorgupdatehtml])

1 As of 1 July 2018 manuscripts submitted to ICMJEjournals that report the results of clinical trials must con-tain a data sharing statement as described below

2 Clinical trials that begin enrolling participants on orafter 1 January 2019 must include a data sharing plan in thetrialrsquos registration The ICMJErsquos policy regarding trial registra-tion is explained at wwwicmjeorgrecommendationsbrowsepublishing-and-editorial-issuesclinical-trial-registrationhtmlIf the data sharing plan changes after registration thisshould be reflected in the statement submitted and pub-lished with the manuscript and updated in the registryrecord

Data sharing statements must indicate the followingwhether individual deidentified participant data (includingdata dictionaries) will be shared (ldquoundecidedrdquo is not an


wwwicmjeorg 13



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ICMJE
Callout
that includes the minimum acceptable 24-item trial registration dataset
ICMJE
Cross-Out
ICMJE
Callout
24-
ICMJE
Cross-Out
ICMJE
Callout
24
ICMJE
Callout
Approval to conduct a study from an independent local regional or national review body (eg ethics committee institutional review board) does not fulfill the ICMJE requirement for prospective clinical trial registration

acceptable answer) what data in particular will be sharedwhether additional related documents will be available(eg study protocol statistical analysis plan etc) whenthe data will become available and for how long by whataccess criteria data will be shared (including with whomfor what types of analyses and by what mechanism) Illus-trative examples of data sharing statements that wouldmeet these requirements are provided in the Table

Authors of secondary analyses using shared data mustattest that their use was in accordance with the terms (ifany) agreed to upon their receipt They must also referencethe source of the data using its unique persistent identifierto provide appropriate credit to those who generated it andallow searching for the studies it has supported Authors ofsecondary analyses must explain completely how theirs dif-fer from previous analyses In addition those who generateand then share clinical trial data sets deserve substantialcredit for their efforts Those using data collected by others

should seek collaboration with those who collected thedata As collaboration will not always be possible practicalor desired the efforts of those who generated the data mustbe recognized

IV MANUSCRIPT PREPARATION AND SUBMISSION

A Preparing a Manuscript for Submission to a MedicalJournal1 General Principles

The text of articles reporting original research is usu-ally divided into Introduction Methods Results and Dis-cussion sections This so-called ldquoIMRADrdquo structure is notan arbitrary publication format but a reflection of the pro-cess of scientific discovery Articles often need subheadingswithin these sections to further organize their contentOther types of articles such as meta-analyses may require

Table Examples of Data Sharing Statements That Fulfill These ICMJE Requirements

Example 1 Example 2 Example 3 Example 4

Will individual participantdata be available(including datadictionaries)

Yes Yes Yes No

What data in particularwill be shared

All of the individualparticipant data collectedduring the trial afterdeidentification

Individual participant datathat underlie the resultsreported in this articleafter deidentification(text tables figuresand appendices)

Individual participant data thatunderlie the results reportedin this article afterdeidentification (text tablesfigures and appendices)

Not available

What other documentswill be available

Study Protocol StatisticalAnalysis Plan InformedConsent Form ClinicalStudy Report AnalyticCode

Study Protocol StatisticalAnalysis Plan AnalyticCode

Study Protocol Not available

When will data beavailable (start andend dates)

Immediately followingpublication No end date

Beginning 3 months andending 5 yearsfollowing articlepublication

Beginning 9 months andending 36 months followingarticle publication

Not applicable

With whom Anyone who wishes to accessthe data

Researchers who providea methodologicallysound proposal

Investigators whose proposeduse of the data has beenapproved by anindependent reviewcommittee (learnedintermediary) identified forthis purpose

Not applicable

For what types ofanalyses

Any purpose To achieve aims in theapproved proposal

For individual participant datameta-analysis

Not applicable

By what mechanism willdata be madeavailable

Data are available indefinitelyat (Link to be included)

Proposals should bedirected to xxxyyyTo gain access datarequestors will need tosign a data accessagreement Data areavailable for 5 years ata third party website(Link to be included)

Proposals may be submittedup to 36 months followingarticle publication After 36months the data will beavailable in our Universityrsquosdata warehouse but withoutinvestigator support otherthan deposited metadataInformation regardingsubmitting proposals andaccessing data may befound at (Link to beprovided)

Not applicable

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


14 wwwicmjeorg



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different formats while case reports narrative reviews andeditorials may have less structured or unstructured formats

Electronic formats have created opportunities for add-ing details or sections layering information cross-linkingor extracting portions of articles in electronic versionsSupplementary electronic-only material should be submit-ted and sent for peer review simultaneously with the pri-mary manuscript

2 Reporting Guidelines

Reporting guidelines have been developed for differentstudy designs examples include CONSORT (wwwconsort-statementorg) for randomized trials STROBE for obser-vational studies (httpstrobe-statementorg) PRISMAfor systematic reviews and meta-analyses (httpprisma-statementorg) and STARD for studies of diagnostic accu-racy (httpwwwequator-networkorgreporting-guidelinesstard) Journals are encouraged to ask authors to followthese guidelines because they help authors describe thestudy in enough detail for it to be evaluated by editorsreviewers readers and other researchers evaluating themedical literature Authors of review manuscripts are en-couraged to describe the methods used for locating select-ing extracting and synthesizing data this is mandatory forsystematic reviews Good sources for reporting guidelinesare the EQUATOR Network (wwwequator-networkorghome) and the NLMrsquos Research Reporting Guidelinesand Initiatives (wwwnlmnihgovservicesresearch_report-_guidehtml)

3 Manuscript Sections

The following are general requirements for reportingwithin sections of all study designs and manuscript formats

a Title Page

General information about an article and its authorsis presented on a manuscript title page and usually in-cludes the article title author information any disclaimerssources of support word count and sometimes the num-ber of tables and figures

Article title The title provides a distilled descriptionof the complete article and should include informationthat along with the abstract will make electronic re-trieval of the article sensitive and specific Reportingguidelines recommend and some journals require thatinformation about the study design be a part of the title(particularly important for randomized trials and sys-tematic reviews and meta-analyses) Some journals re-quire a short title usually no more than 40 characters(including letters and spaces) on the title page or as aseparate entry in an electronic submission system Elec-tronic submission systems may restrict the number ofcharacters in the title

Author information Each authorrsquos highest academicdegrees 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 sys-tems require that authors provide full contact informationincluding land mail and e-mail addresses but the title pageshould list the corresponding authorsrsquo telephone and faxnumbers and e-mail address ICMJE encourages the listingof authorsrsquo Open Researcher and Contributor Identifica-tion (ORCID)

Disclaimers An example of a disclaimer is an authorrsquosstatement that the views expressed in the submitted articleare his or her own and not an official position of the insti-tution or funder

Source(s) of support These include grants equipmentdrugs andor other support that facilitated conduct of thework described in the article or the writing of the articleitself

Word count A word count for the paperrsquos text exclud-ing its abstract acknowledgments tables figure legendsand references allows editors and reviewers to assesswhether the information contained in the paper warrantsthe paperrsquos length and whether the submitted manuscriptfits within the journalrsquos formats and word limits A separateword count for the abstract is useful for the same reason

Number of figures and tables Some submission systemsrequire specification of the number of figures and tablesbefore uploading the relevant files These numbers alloweditorial staff and reviewers to confirm that all figures andtables were actually included with the manuscript andbecause tables and figures occupy space to assess if theinformation provided by the figures and tables warrants thepaperrsquos length and if the manuscript fits within the jour-nalrsquos space limits

Conflict of interest declaration Conflict of interest in-formation for each author needs to be part of the manu-script each journal should develop standards with regardto the form the information should take and where it willbe posted The ICMJE has developed a uniform conflict ofinterest disclosure form for use by ICMJE member jour-nals (wwwicmjeorgcoi_disclosurepdf ) and the ICMJEencourages other journals to adopt it Despite availabilityof the form editors may require conflict of interest decla-rations on the manuscript title page to save the work ofcollecting forms from each author prior to making an ed-itorial decision or to save reviewers and readers the work ofreading each authorrsquos form

b Abstract

Original research systematic reviews and meta-analyses require structured abstracts The abstract shouldprovide the context or background for the study and shouldstate the studyrsquos purpose basic procedures (selection ofstudy participants settings measurements analyticalmethods) main findings (giving specific effect sizes andtheir statistical and clinical significance if possible) and


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ICMJE
Cross-Out
ICMJE
Cross-Out
ICMJE
Callout
Disclosure of relationships and activities
ICMJE
Callout
Disclosure
ICMJE
Cross-Out
ICMJE
Callout
Disclosure Form
ICMJE
Callout
ICMJE
Callout
or other Disclosure section in the manuscript
ICMJE
Cross-Out

principal conclusions It should emphasize new and impor-tant aspects of the study or observations note importantlimitations and not overinterpret findings Clinical trialabstracts should include items that the CONSORT grouphas identified as essential (wwwconsort-statementorgresourcesdownloadsextensionsconsort-extension-for-abstracts-2008pdf) Funding sources should be listed sep-arately after the abstract to facilitate proper display andindexing for search retrieval by MEDLINE

Because abstracts are the only substantive portion ofthe article indexed in many electronic databases and theonly portion many readers read authors need to ensurethat they accurately reflect the content of the article Un-fortunately information in abstracts often differs from thatin the text Authors and editors should work in the processof revision and review to ensure that information is consis-tent in both places The format required for structuredabstracts differs from journal to journal and some journalsuse more than one format authors need to prepare theirabstracts in the format specified by the journal they havechosen

The ICMJE recommends that journals publish theclinical trial registration number at the end of the ab-stract The ICMJE also recommends that when a reg-istration number is available authors list that numberthe first time they use a trial acronym to refer to the trialthey are reporting or to other trials that they mention inthe manuscript If the data have been deposited in apublic repository andor are being used in a secondaryanalysis authors should state at the end of the abstractthe unique persistent data set identifier repositoryname and number

c Introduction

Provide a context or background for the study (that isthe nature of the problem and its significance) State thespecific purpose or research objective of or hypothesistested by the study or observation Cite only directly per-tinent references and do not include data or conclusionsfrom the work being reported

d Methods

The guiding principle of the Methods section shouldbe 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 datawould be able to reproduce the results In general thesection should include only information that was availableat the time the plan or protocol for the study was beingwritten all information obtained during the study belongsin the Results section If an organization was paid or oth-erwise contracted to help conduct the research (examplesinclude data collection and management) then this shouldbe detailed in the methods

The Methods section should include a statement indi-

cating that the research was approved by an independentlocal regional or national review body (eg ethics com-mittee institutional review board) If doubt exists whetherthe research was conducted in accordance with the Hel-sinki Declaration the authors must explain the rationalefor their approach and demonstrate that the local regionalor national review body explicitly approved the doubtfulaspects of the study See Section IIE

i Selection and Description of Participants

Clearly describe the selection of observational or ex-perimental participants (healthy individuals or patients in-cluding controls) including eligibility and exclusion crite-ria and a description of the source population Because therelevance of such variables as age sex or ethnicity is notalways known at the time of study design researchersshould aim for inclusion of representative populations intoall study types and at a minimum provide descriptive datafor these and other relevant demographic variables Ensurecorrect use of the terms sex (when reporting biologicalfactors) and gender (identity psychosocial or cultural fac-tors) and unless inappropriate report the sex andor gen-der of study participants the sex of animals or cells anddescribe the methods used to determine sex and gender Ifthe study was done involving an exclusive population forexample in only one sex authors should justify why exceptin obvious cases (eg prostate cancer) Authors should de-fine how they determined race or ethnicity and justify theirrelevance Authors should use neutral precise and respect-ful language to describe study participants and avoid theuse of terminology that might stigmatize participants

ii Technical Information

Specify the studyrsquos main and secondary objectivesmdashusually identified as primary and secondary outcomesIdentify methods equipment (give the manufacturerrsquosname and address in parentheses) and procedures in suffi-cient detail to allow others to reproduce the results Givereferences to established methods including statisticalmethods (see below) provide references and brief descrip-tions for methods that have been published but are notwell-known describe new or substantially modified meth-ods give the reasons for using them and evaluate theirlimitations Identify precisely all drugs and chemicals usedincluding generic name(s) dose(s) and route(s) of admin-istration Identify appropriate scientific names and genenames

iii Statistics

Describe statistical methods with enough detail to en-able a knowledgeable reader with access to the original datato judge its appropriateness for the study and to verify thereported results When possible quantify findings andpresent them with appropriate indicators of measurementerror or uncertainty (such as confidence intervals) Avoid


16 wwwicmjeorg



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ICMJE
Callout
para

relying solely on statistical hypothesis testing such as Pvalues which fail to convey important information abouteffect size and precision of estimates References for thedesign of the study and statistical methods should be tostandard works when possible (with pages stated) Definestatistical terms abbreviations and most symbols Specifythe statistical software package(s) and versions used Dis-tinguish prespecified from exploratory analyses includingsubgroup analyses

e Results

Present your results in logical sequence in the texttables and figures giving the main or most importantfindings first Do not repeat all the data in the tables orfigures in the text emphasize or summarize only the mostimportant observations Provide data on all primary andsecondary outcomes identified in the Methods section Ex-tra or supplementary materials and technical details can beplaced in an appendix where they will be accessible but willnot interrupt the flow of the text or they can be publishedsolely in the electronic version of the journal

Give numeric results not only as derivatives (eg per-centages) but also as the absolute numbers from which thederivatives were calculated and specify the statistical sig-nificance attached to them if any Restrict tables and fig-ures to those needed to explain the argument of the paperand to assess supporting data Use graphs as an alternativeto tables with many entries do not duplicate data ingraphs and tables Avoid nontechnical uses of technicalterms in statistics such as ldquorandomrdquo (which implies arandomizing device) ldquonormalrdquo ldquosignificantrdquo ldquocorrela-tionsrdquo and ldquosamplerdquo

Separate reporting of data by demographic variablessuch as age and sex facilitate pooling of data for subgroupsacross studies and should be routine unless there are com-pelling reasons not to stratify reporting which should beexplained

f Discussion

It is useful to begin the discussion by briefly summa-rizing the main findings and explore possible mechanismsor explanations for these findings Emphasize the new andimportant aspects of your study and put your findings inthe context of the totality of the relevant evidence Statethe limitations of your study and explore the implicationsof your findings for future research and for clinical practiceor policy Discuss the influence or association of variablessuch as sex andor gender on your findings where appropri-ate and the limitations of the data Do not repeat in detaildata or other information given in other parts of the manu-script such as in the Introduction or the Results section

Link the conclusions with the goals of the study butavoid unqualified statements and conclusions not ade-quately supported by the data In particular distinguishbetween clinical and statistical significance and avoid mak-

ing statements on economic benefits and costs unless themanuscript includes the appropriate economic data andanalyses Avoid claiming priority or alluding to work thathas not been completed State new hypotheses when war-ranted but label them clearly

g References

i General Considerations

Authors should provide direct references to originalresearch sources whenever possible References should notbe used by authors editors or peer reviewers to promoteself-interests Although references to review articles can bean efficient way to guide readers to a body of literaturereview articles do not always reflect original work accu-rately On the other hand extensive lists of references tooriginal work on a topic can use excessive space Fewerreferences to key original papers often serve as well as moreexhaustive lists particularly since references can now beadded to the electronic version of published papers andsince electronic literature searching allows readers to re-trieve published literature efficiently

Do not use conference abstracts as references they canbe cited in the text in parentheses but not as page foot-notes References to papers accepted but not yet publishedshould be designated as ldquoin pressrdquo or ldquoforthcomingrdquo Infor-mation from manuscripts submitted but not acceptedshould be cited in the text as ldquounpublished observationsrdquowith written permission from the source

Published articles should reference the unique persis-tent identifiers of the datasets employed

Avoid citing a ldquopersonal communicationrdquo unless itprovides essential information not available from a publicsource in which case the name of the person and date ofcommunication should be cited in parentheses in the textFor scientific articles obtain written permission and con-firmation of accuracy from the source of a personal com-munication

Some but not all journals check the accuracy of allreference citations thus citation errors sometimes appearin the published version of articles To minimize such er-rors references should be verified using either an electronicbibliographic source such as PubMed or print copies fromoriginal sources Authors are responsible for checking thatnone of the references cite retracted articles except in thecontext of referring to the retraction For articles publishedin journals indexed in MEDLINE the ICMJE considersPubMed the authoritative source for information aboutretractions Authors can identify retracted articles in MED-LINE by searching PubMed for ldquoRetracted publication[pt]rdquo where the term ldquoptrdquo in square brackets stands forpublication type or by going directly to the PubMedrsquos listof retracted publications (httpswwwncbinlmnihgovpubmedtermretractedpublication[pt])

References should be numbered consecutively in theorder in which they are first mentioned in the text Identify


wwwicmjeorg 17



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ICMJE
Cross-Out
ICMJE
Callout
Authors should avoid citing articles from predatory or pseudo-journals
ICMJE
Cross-Out

references in text tables and legends by Arabic numeralsin parentheses

References cited only in tables or figure legends shouldbe numbered in accordance with the sequence establishedby the first identification in the text of the particular tableor figure The titles of journals should be abbreviated ac-cording to the style used for MEDLINE (wwwncbinlmnihgovnlmcatalogjournals) Journals vary on whetherthey ask authors to cite electronic references within paren-theses in the text or in numbered references following thetext Authors should consult with the journal to which theyplan to submit their work

ii Style and Format

References should follow the standards summarized inthe NLMrsquos International Committee of Medical JournalEditors (ICMJE) Recommendations for the Conduct Re-porting Editing and Publication of Scholarly Work inMedical Journals Sample References (wwwnlmnihgovbsduniform_requirementshtml) webpage and detailed inthe NLMrsquos Citing Medicine 2nd edition (wwwncbinlmnihgovbooksNBK7256) These resources are regularlyupdated as new media develop and currently include guid-ance for print documents unpublished material audio andvisual media material on CD-ROM DVD or disk andmaterial on the Internet

h Tables

Tables capture information concisely and display itefficiently they also provide information at any desiredlevel of detail and precision Including data in tables ratherthan text frequently makes it possible to reduce the lengthof the text

Prepare tables according to the specific journalrsquos re-quirements to avoid errors it is best if tables can be directlyimported into the journalrsquos publication software Numbertables consecutively in the order of their first citation in thetext and supply a title for each Titles in tables should beshort but self-explanatory containing information that al-lows readers to understand the tablersquos content without hav-ing to go back to the text Be sure that each table is cited inthe text

Give each column a short or an abbreviated headingAuthors should place explanatory matter in footnotes notin the heading Explain all nonstandard abbreviations infootnotes and use symbols to explain information ifneeded Symbols may vary from journal to journal (alpha-bet letter or such symbols as dagger Dagger sect) so check eachjournalrsquos instructions for authors for required practiceIdentify statistical measures of variations such as standarddeviation and standard error of the mean

If you use data from another published or unpublishedsource obtain permission and acknowledge that sourcefully

Additional tables containing backup data too extensiveto publish in print may be appropriate for publication inthe electronic version of the journal deposited with anarchival service or made available to readers directly by theauthors An appropriate statement should be added to thetext to inform readers that this additional information isavailable and where it is located Submit such tables forconsideration with the paper so that they will be availableto the peer reviewers

i Illustrations (Figures)

Digital images of manuscript illustrations should besubmitted in a suitable format for print publication Mostsubmission systems have detailed instructions on the qual-ity of images and check them after manuscript upload Forprint submissions figures should be either professionallydrawn and photographed or submitted as photographic-quality digital prints

For radiological and other clinical and diagnostic im-ages as well as pictures of pathology specimens or photo-micrographs send high-resolution photographic imagefiles Before-and-after images should be taken with thesame intensity direction and color of light Since blots areused as primary evidence in many scientific articles editorsmay require deposition of the original photographs of blotson the journalrsquos website

Although some journals redraw figures many do notLetters numbers and symbols on figures should thereforebe clear and consistent throughout and large enough toremain legible when the figure is reduced for publicationFigures should be made as self-explanatory as possiblesince many will be used directly in slide presentationsTitles and detailed explanations belong in the legendsmdashnot on the illustrations themselves

Photomicrographs should have internal scale mark-ers Symbols arrows or letters used in photomicro-graphs should contrast with the background Explain theinternal scale and identify the method of staining in pho-tomicrographs

Figures should be numbered consecutively accordingto the order in which they have been cited in the text If afigure has been published previously acknowledge theoriginal source and submit written permission from thecopyright holder to reproduce it Permission is requiredirrespective of authorship or publisher except for docu-ments in the public domain

In the manuscript legends for illustrations should beon a separate page with Arabic numerals corresponding tothe illustrations When symbols arrows numbers or let-ters are used to identify parts of the illustrations identifyand explain each one clearly in the legend


18 wwwicmjeorg



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j Units of Measurement

Measurements of length height weight and volumeshould be reported in metric units (meter kilogram orliter) or their decimal multiples

Temperatures should be in degrees Celsius Bloodpressures should be in millimeters of mercury unless otherunits are specifically required by the journal

Journals vary in the units they use for reporting hema-tologic clinical chemistry and other measurements Au-thors must consult the Information for Authors of the par-ticular journal and should report laboratory information inboth local and International System of Units (SI)

Editors may request that authors add alternative ornon-SI units since SI units are not universally used Drugconcentrations may be reported in either SI or mass unitsbut the alternative should be provided in parentheseswhere appropriate

k Abbreviations and Symbols

Use only standard abbreviations use of nonstandardabbreviations can be confusing to readers Avoid abbrevia-tions in the title of the manuscript The spelled-out abbre-viation followed by the abbreviation in parenthesis shouldbe used on first mention unless the abbreviation is a stan-dard unit of measurement

B Sending the Manuscript to the JournalManuscripts should be accompanied by a cover letter

or a completed journal submission form which should in-clude the following information

A full statement to the editor about all submissions andprevious reports that might be regarded as redundant publica-tion of the same or very similar work Any such work shouldbe referred to specifically and referenced in the new paperCopies of such material should be included with the sub-mitted paper to help the editor address the situation Seealso Section IIID2

A statement of financial or other relationships that mightlead to a conflict of interest if that information is not includedin the manuscript itself or in an authorsrsquo form See also Sec-tion IIB

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 manuscript has been read and approved by all the au-thors that the requirements for authorship as stated earlier in this document have been met and that each au-thor believes that the manuscript represents honest work if that information is not provided in another form See also Section IIA

Contact information for the author responsible forcommunicating with other authors about revisions and fi-nal approval of the proofs if that information is not in-cluded in the manuscript itself

The letter or form should inform editors if concernshave been raised (eg via institutional andor regulatorybodies) regarding the conduct of the research or if correc-tive action has been recommended The letter or formshould give any additional information that may be helpfulto the editor such as the type or format of article in theparticular journal that the manuscript represents If themanuscript has been submitted previously to another jour-nal it is helpful to include the previous editorrsquos and review-ersrsquo comments with the submitted manuscript along withthe authorsrsquo responses to those comments Editors encour-age authors to submit these previous communications Do-ing so may expedite the review process and encouragestransparency and sharing of expertise

Many journals provide a presubmission checklist tohelp the author ensure that all the components of the sub-mission have been included Some journals also requirethat authors complete checklists for reports of certain studytypes (eg the CONSORT checklist for reports of ran-domized controlled trials) Authors should look to seeif the journal uses such checklists and send them with themanuscript if they are requested

The manuscript must be accompanied by permission toreproduce previously published material use previously pub-lished illustrations report information about identifiable per-sons or to acknowledge people for their contributions


wwwicmjeorg 19



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ICMJE
Callout
and activities

guidelines for the reporting of randomized trials) seewwwequator-networkorg

Journals that follow these recommendations are en-couraged to incorporate them into their instructions toauthors and to make explicit in those instructions that theyfollow ICMJE recommendations Journals that wish to beidentified on the ICMJE website as following these recom-mendations should notify the ICMJE secretariat at wwwicmjeorgjournals-following-the-icmje-recommendationsjournal-listing-request-form Journals that in the pasthave requested such identification but who no longer fol-low ICMJE recommendations should use the same meansto request removal from this list

The ICMJE encourages wide dissemination of theserecommendations and reproduction of this document in itsentirety for educational not-for-profit purposes withoutregard for copyright but all uses of the recommendationsand document should direct readers to wwwicmjeorg forthe official most recent version as the ICMJE updates therecommendations periodically when new issues arise

C History of the RecommendationsThe 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 wayof standardizing manuscript format and preparation acrossjournals Over the years issues in publishing that went wellbeyond manuscript preparation arose resulting in the de-velopment of separate statements up-dates to the docu-ment and its renaming as ldquoRecommendations for theConduct Reporting Editing and Publication of ScholarlyWork in Medical Journalsrdquo to reflect its broader scopePrevious versions of the document may be found in theldquoArchivesrdquo section of wwwicmjeorg

II ROLES AND RESPONSIBILITIES OF AUTHORSCONTRIBUTORS REVIEWERS EDITORS PUBLISHERSAND OWNERS

A Defining the Role of Authors and Contributors1 Why Authorship Matters

Authorship confers credit and has important aca-demic social and financial implications Authorship alsoimplies responsibility and accountability for publishedwork The following recommendations are intended toensure that contributors who have made substantive intel-lectual contributions to a paper are given credit as authorsbut also that contributors credited as authors understandtheir role in taking responsibility and being accountable forwhat is published

Because authorship does not communicate what con-tributions qualified an individual to be an author somejournals now request and publish information about thecontributions of each person named as having participatedin a submitted study at least for original research Editorsare strongly encouraged to develop and implement a con-

tributorship policy Such policies remove much of the am-biguity surrounding contributions but leave unresolvedthe question of the quantity and quality of contributionthat qualify an individual for authorship The ICMJE hasthus developed criteria for authorship that can be used byall journals including those that distinguish authors fromother contributors

2 Who Is an Author

The ICMJE recommends that authorship be based onthe following 4 criteria

1 Substantial contributions to the conception or de-sign of the work or the acquisition analysis or interpre-tation of data for the work AND

2 Drafting the work or revising it critically for im-portant intellectual content AND

3 Final approval of the version to be published AND4 Agreement to be accountable for all aspects of the

work in ensuring that questions related to the accuracy orintegrity of any part of the work are appropriately investi-gated and resolved

In addition to being accountable for the parts of thework he or she has done an author should be able toidentify which co-authors are responsible for specific otherparts of the work In addition authors should have confidencein the integrity of the contributions of their co-authors

All those designated as authors should meet all fourcriteria for authorship and all who meet the four criteriashould be identified as authors Those who do not meet allfour criteria should be acknowledgedmdashsee Section IIA3below These authorship criteria are intended to reserve thestatus of authorship for those who deserve credit and cantake responsibility for the work The criteria are not in-tended for use as a means to disqualify colleagues fromauthorship who otherwise meet authorship criteria by de-nying them the opportunity to meet criterion s 2 or 3Therefore all individuals who meet the first criterionshould have the opportunity to participate in the reviewdrafting and final approval of the manuscript

The individuals who conduct the work are responsiblefor identifying who meets these criteria and ideally shoulddo so when planning the work making modifications asappropriate as the work progresses We encourage collabo-ration and co-authorship with colleagues in the locationswhere the research is conducted It is the collective respon-sibility of the authors not the journal to which the work issubmitted to determine that all people named as authorsmeet all four criteria it is not the role of journal editors todetermine who qualifies or does not qualify for authorshipor to arbitrate authorship conflicts If agreement cannot bereached about who qualifies for authorship the institu-tion(s) where the work was performed not the journaleditor should be asked to investigate If authors requestremoval or addition of an author after manuscript submis-sion or publication journal editors should seek an expla-nation and signed statement of agreement for the requested


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14 wwwicmjeorg



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