Recommendations For The Conduct, Reporting, Editing, And Publication Of .

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Unauthorized reproduction of this article is prohibitedRecommendations for the Conduct, Reporting, Editing, andPublication of Scholarly Work in Medical JournalsUpdated May 2022I. About the RecommendationsA. Purpose of the RecommendationsB. Who Should Use the Recommendations?C. History of the RecommendationsII. Roles and Responsibilities of Authors, Contributors,Reviewers, Editors, Publishers, and OwnersA. Defining the Role of Authors and Contributors1. Why Authorship Matters2. Who Is an Author?3. Non-Author ContributorsB. Disclosure of Financial and Non-Financial Relationships and Activities, and Conflicts of Interest1. Participantsa. Authorsb. Peer Reviewersc. Editors and Journal Staff2. Reporting Relationships and ActivitiesC. Responsibilities in the Submission and Peer-ReviewProcess1. Authorsa. Predatory or Pseudo-Journals2. Journalsa. Confidentialityb. Timelinessc. Peer Reviewd. Integritye. Diversity and Inclusionf. Journal Metrics3. Peer ReviewersD. Journal Owners and Editorial Freedom1. Journal Owners2. Editorial FreedomE. Protection of Research ParticipantsIII. Publishing and Editorial Issues Related to Publicationin Medical JournalsA. Corrections, Retractions, Republications, andVersion ControlB. Scientific Misconduct, Expressions of Concern,and RetractionC. CopyrightD. Overlapping Publications1. Duplicate Submission2. Duplicate and Prior Publication3. Preprintsa. Choosing a Preprint Archiveb. Submitting Manuscripts That Are in PreprintArchives to a Peer-Reviewed Journalc. Referencing Preprints in Submitted Manuscripts4. Acceptable Secondary Publication5. Manuscripts Based on the Same DatabaseE. CorrespondenceF. FeesG.H.I.J.K.L.Supplements, Theme Issues, and Special SeriesSponsorship and PartnershipsElectronic PublishingAdvertisingJournals and the MediaClinical Trials1. Registration2. Data SharingIV. Manuscript Preparation and SubmissionA. Preparing a Manuscript for Submission to aMedical Journal1. General Principles2. Reporting Guidelines3. Manuscript Sectionsa. Title Pageb. Abstractc. Introductiond. Methodsi. Selection and Description of Participantsii. Technical Informationiii. Statisticse. Resultsf. Discussiong. Referencesi. General Considerationsii. Style and Formath. Tablesi. Illustrations (Figures)j. Units of Measurementk. Abbreviations and SymbolsB. Sending the Manuscript to the JournalI. ABOUTTHERECOMMENDATIONSA. Purpose of the RecommendationsICMJE developed these recommendations to reviewbest practice and ethical standards in the conduct andreporting of research and other material published inmedical journals, and to help authors, editors, and othersinvolved in peer review and biomedical publishing create and distribute accurate, clear, reproducible, unbiased medical journal articles. The recommendations mayalso provide useful insights into the medical editing andpublishing process for the media, patients and their families, and general readers.B. Who Should Use the Recommendations?These recommendations are intended primarily foruse by authors who might submit their work for publicationto ICMJE member journals. Many non-ICMJE journals voluntarily use these recommendations (see ndations/). The ICMJEencourages that use but has no authority to monitor or1

Unauthorized reproduction of this article is prohibitedRecommendations for the Conduct, Reporting, Editing, and Publication of Scholarly Work in Medical Journalsenforce it. In all cases, authors should use these recommendations along with individual journals' instructions toauthors. Authors should also consult guidelines for thereporting of specific study types (e.g., the CONSORTguidelines for the reporting of randomized trials); seewww.equator-network.org.Journals that follow these recommendations areencouraged to incorporate them into their instructions toauthors and to make explicit in those instructions thatthey follow ICMJE recommendations. Journals that wishto be identified on the ICMJE website as following theserecommendations should notify the ICMJE secretariat at ndations/journal-listing-request-form/. Journals that in the past haverequested such identification but who no longer follow ICMJErecommendations should use the same means to request removal from this list.The ICMJE encourages wide dissemination of theserecommendations and reproduction of this document inits entirety for educational, not-for-profit purposes without regard for copyright, but all uses of the recommendations and document should direct readers to www.icmje.org for the official, most recent version, as theICMJE updates the recommendations periodically whennew issues arise.C. History of the RecommendationsThe ICMJE has produced multiple editions of thisdocument, previously known as the Uniform Requirements for Manuscripts Submitted to Biomedical Journals(URMs). The URM was first published in 1978 as a way ofstandardizing manuscript format and preparation acrossjournals. Over the years, issues in publishing that wentwell beyond manuscript preparation arose, resulting inthe development of separate statements, updates to thedocument, and its renaming as “Recommendations forthe Conduct, Reporting, Editing, and Publication ofScholarly Work in Medical Journals” to reflect its broaderscope. Previous versions of the document may be foundin the “Archives” section of www.icmje.org.II. ROLES AND RESPONSIBILITIES OF AUTHORS,CONTRIBUTORS, REVIEWERS, EDITORS,PUBLISHERS, AND OWNERSA. Defining the Role of Authors and Contributors1. Why Authorship MattersAuthorship confers credit and has important academic, social, and financial implications. Authorship alsoimplies responsibility and accountability for publishedwork. The following recommendations are intended toensure that contributors who have made substantive intellectual contributions to a paper are given credit asauthors, but also that contributors credited as authorsunderstand their role in taking responsibility and beingaccountable for what is published.Because authorship does not communicate whatcontributions qualified an individual to be an author,some journals now request and publish information2about the contributions of each person named as havingparticipated in a submitted study, at least for originalresearch. Editors are strongly encouraged to developand implement a contributorship policy. Such policiesremove much of the ambiguity surrounding contributions, but leave unresolved the question of the quantityand quality of contribution that qualify an individual forauthorship. The ICMJE has thus developed criteria forauthorship that can be used by all journals, includingthose that distinguish authors from other contributors.2. Who Is an Author?The ICMJE recommends that authorship be basedon the following 4 criteria:1. Substantial contributions to the conception or designof the work; or the acquisition, analysis, or interpretation of data for the work; AND2. Drafting the work or revising it critically for importantintellectual content; AND3. Final approval of the version to be published; AND4. Agreement to be accountable for all aspects of thework in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved.In addition to being accountable for the parts of thework he or she has done, an author should be able toidentify which co-authors are responsible for specificother parts of the work. In addition, authors should haveconfidence in the integrity of the contributions of theirco-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 meetall four criteria should be acknowledged—see Section II.A.3 below. These authorship criteria are intended toreserve the status of authorship for those who deservecredit and can take responsibility for the work. The criteria are not intended for use as a means to disqualify colleagues from authorship who otherwise meet authorshipcriteria by denying them the opportunity to meet criterion #s 2 or 3. Therefore, all individuals who meet thefirst criterion should have the opportunity to participatein the review, drafting, and final approval of themanuscript.The individuals who conduct the work are responsible for identifying who meets these criteria and ideallyshould do so when planning the work, making modifications as appropriate as the work progresses. We encourage collaboration and co-authorship with colleagues inthe locations where the research is conducted. It is thecollective responsibility of the authors, not the journal towhich the work is submitted, to determine that all peoplenamed as authors meet all four criteria; it is not the roleof journal editors to determine who qualifies or does notqualify for authorship or to arbitrate authorship conflicts.If agreement cannot be reached about who qualifies forauthorship, the institution(s) where the work was performed, not the journal editor, should be asked to investigate. The criteria used to determine the order in whichauthors are listed on the byline may vary, and are to bedecided collectively by the author group and not bywww.icmje.org

Unauthorized reproduction of this article is prohibitedRecommendations for the Conduct, Reporting, Editing, and Publication of Scholarly Work in Medical Journalseditors. If authors request removal or addition of anauthor after manuscript submission or publication, journal editors should seek an explanation and signed statement of agreement for the requested change from alllisted authors and from the author to be removed oradded.The corresponding author is the one individual whotakes primary responsibility for communication with thejournal during the manuscript submission, peer-review,and publication process. The corresponding author typically ensures that all the journal's administrative requirements, such as providing details of authorship, ethicscommittee approval, clinical trial registration documentation, and disclosures of relationships and activities, areproperly completed and reported, although these dutiesmay be delegated to one or more co-authors. The corresponding author should be available throughout thesubmission and peer-review process to respond to editorial queries in a timely way, and should be available after publication to respond to critiques of the work andcooperate with any requests from the journal for data oradditional information should questions about the paperarise after publication. Although the correspondingauthor has primary responsibility for correspondencewith the journal, the ICMJE recommends that editorssend copies of all correspondence to all listed authors.When a large multi-author group has conducted thework, the group ideally should decide who will be anauthor before the work is started and confirm who is anauthor before submitting the manuscript for publication.All members of the group named as authors shouldmeet all four criteria for authorship, including approvalof the final manuscript, and they should be able to takepublic responsibility for the work and should have fullconfidence in the accuracy and integrity of the work ofother group authors. They will also be expected as individuals to complete disclosure forms.Some large multi-author groups designate authorship by a group name, with or without the names of individuals. When submitting a manuscript authored by agroup, the corresponding author should specify thegroup name if one exists, and clearly identify the groupmembers who can take credit and responsibility for thework as authors. The byline of the article identifies who isdirectly responsible for the manuscript, and MEDLINElists as authors whichever names appear on the byline. Ifthe byline includes a group name, MEDLINE will list thenames of individual group members who are authors orwho are collaborators, sometimes called non-author contributors, if there is a note associated with the bylineclearly stating that the individual names are elsewhere inthe paper and whether those names are authors orcollaborators.3. Non-Author ContributorsContributors who meet fewer than all 4 of the abovecriteria for authorship should not be listed as authors,but they should be acknowledged. Examples of activitiesthat alone (without other contributions) do not qualify acontributor for authorship are acquisition of funding;www.icmje.orggeneral supervision of a research group or generaladministrative support; and writing assistance, technicalediting, language editing, and proofreading. Thosewhose contributions do not justify authorship may beacknowledged individually or together as a group undera single heading (e.g., “Clinical Investigators” or“Participating Investigators”), and their contributionsshould be specified (e.g., “served as scientific advisors,”“critically reviewed the study proposal,” “collected data,”“provided and cared for study patients,” “participated inwriting or technical editing of the manuscript”).Because acknowledgment may imply endorsementby acknowledged individuals of a study's data and conclusions, editors are advised to require that the corresponding author obtain written permission to beacknowledged from all acknowledged individuals.B. Disclosure of Financial and Non-FinancialRelationships and Activities, and Conflicts ofInterestPublic trust in the scientific process and the credibility of published articles depend in part on how transparently an author's relationships and activities, directly ortopically related to a work, are handled during the planning, implementation, writing, peer review, editing, andpublication of scientific work.The potential for conflict of interest and bias existswhen professional judgment concerning a primary interest (such as patients' welfare or the validity of research)may be influenced by a secondary interest (such as financial gain). Perceptions of conflict of interest are as important as actual conflicts of interest.Individuals may disagree on whether an author'srelationships or activities represent conflicts. Althoughthe presence of a relationship or activity does not alwaysindicate a problematic influence on a paper's content,perceptions of conflict may erode trust in science asmuch as actual conflicts of interest. Ultimately, readersmust be able to make their own judgments regardingwhether an author's relationships and activities are pertinent to a paper's content. These judgments requiretransparent disclosures. An author's complete disclosuredemonstrates a commitment to transparency and helpsto maintain trust in the scientific process.Financial relationships (such as employment, consultancies, stock ownership or options, honoraria, patents,and paid expert testimony) are the most easily identifiable, the ones most often judged to represent potentialconflicts of interest and thus the most likely to underminethe credibility of the journal, the authors, and scienceitself. Other interests may also represent or be perceivedas conflicts, such as personal relationships or rivalries,academic competition, and intellectual beliefs.Authors should avoid entering into agreements withstudy sponsors, both for-profit and nonprofit, that interfere with authors' access to all of the study's data or thatinterfere with their ability to analyze and interpret thedata and to prepare and publish manuscripts independently when and where they choose. Policies that dictatewhere authors may publish their work violate this3

Unauthorized reproduction of this article is prohibitedRecommendations for the Conduct, Reporting, Editing, and Publication of Scholarly Work in Medical Journalsprinciple of academic freedom. Authors may be requiredto provide the journal with the agreements in confidence.Purposeful failure to report those relationships oractivities specified on the journal's disclosure form is aform of misconduct, as is discussed in Section III.B.1. ParticipantsAll participants in the peer-review and publication process—not only authors but also peer reviewers, editors, andeditorial board members of journals—must consider anddisclose their relationships and activities when fulfilling theirroles in the process of article review and publication.a. AuthorsWhen authors submit a manuscript of any type or format they are responsible for disclosing all relationshipsand activities that might bias or be seen to bias theirwork. The ICMJE has developed a Disclosure Form tofacilitate and standardize authors' disclosures. ICMJEmember journals require that authors use this form, andICMJE encourages other journals to adopt it. Sources of support for the work, including sponsornames along with explanations of the role of thosesources if any in study design; collection, analysis,and interpretation of data; writing of the report; anyrestrictions regarding the submission of the reportfor publication; or a statement declaring that the supporting source had no such involvement or restrictions regarding publication; and Whether the authors had access to the study data,with an explanation of the nature and extent ofaccess, including whether access is ongoing.To support the above statements, editors mayrequest that authors of a study sponsored by a funderwith a proprietary or financial interest in the outcomesign a statement, such as “I had full access to all of thedata in this study and I take complete responsibility forthe integrity of the data and the accuracy of the dataanalysis.”C. Responsibilities in the Submission andPeer-Review Process1. Authorsb. Peer ReviewersReviewers should be asked at the time they areasked to critique a manuscript if they have relationshipsor activities that could complicate their review. Reviewersmust disclose to editors any relationships or activitiesthat could bias their opinions of the manuscript, andshould recuse themselves from reviewing specific manuscripts if the potential for bias exists. Reviewers must notuse knowledge of the work they're reviewing before itspublication to further their own interests.c. Editors and Journal StaffAuthors should abide by all principles of authorshipand declaration of relationships and activities detailed inSections II.A and II.B of this document.a. Predatory or Pseudo-JournalsA growing number of entities are advertising themselves as “scholarly medical journals” yet do not functionas such. These journals (“predatory” or “pseudo-journals”) accept and publish almost all submissions andcharge article processing (or publication) fees, ofteninforming authors about this after a paper's acceptancefor publication. They often claim to perform peer reviewbut do not and may purposefully use names similar towell-established journals. They may state that they aremembers of ICMJE but are not (see www.icmje.org forcurrent members of the ICMJE) and that they follow therecommendations of organizations such as the ICMJE,COPE, and WAME. Researchers must be aware of the existence of such entities and avoid submitting research tothem for publication. Authors have a responsibility toevaluate the integrity, history, practices, and reputationof the journals to which they submit manuscripts.Guidance from various organizations is available to helpidentify the characteristics of reputable peer-reviewedjournals als and actice-in-scholarly-publishing).Seeking the assistance of scientific mentors, seniorcolleagues, and others with many years of scholarly publishing experience may also be helpful.Authors should avoid citing articles in predatory orpseudo-journals.Editors who make final decisions about manuscriptsshould recuse themselves from editorial decisions if theyhave relationships or activities that pose potential conflicts related to articles under consideration. Other editorial staff members who participate in editorial decisionsmust provide editors with a current description of theirrelationships and activities (as they might relate to editorial judgments) and recuse themselves from any decisions in which an interest that poses a potential conflictexists. Editorial staff must not use information gainedthrough working with manuscripts for private gain.Editors should regularly publish their own disclosurestatements and those of their journal staff. Guest editorsshould follow these same procedures.Journals should take extra precautions and have astated policy for evaluation of manuscripts submitted byindividuals involved in editorial decisions. Further guidanceis available from COPE (https://publicationethics.org/files/A Short Guide to Ethical Editing.pdf) and WAME iewed-medicaljournals).2. Journals2. Reporting Relationships and Activitiesa. ConfidentialityArticles should be published with statements or supporting documents, such as the ICMJE Disclosure Form,declaring: Authors' relationships and activities; andManuscripts submitted to journals are privilegedcommunications that are authors' private, confidentialproperty, and authors may be harmed by premature disclosure of any or all of a manuscript's details.4www.icmje.org

Unauthorized reproduction of this article is prohibitedRecommendations for the Conduct, Reporting, Editing, and Publication of Scholarly Work in Medical JournalsEditors therefore must not share information aboutmanuscripts, including whether they have been receivedand are under review, their content and status in thereview process, criticism by reviewers, and their ultimatefate, to anyone other than the authors and reviewers.Requests from third parties to use manuscripts andreviews for legal proceedings should be politely refused,and editors should do their best not to provide such confidential material should it be subpoenaed.Editors must also make clear that reviewers shouldkeep manuscripts, associated material, and the information they contain strictly confidential. Reviewers and editorial staff members must not publicly discuss the authors'work, and reviewers must not appropriate authors' ideasbefore the manuscript is published. Reviewers must notretain the manuscript for their personal use and shoulddestroy paper copies of manuscripts and delete electroniccopies after submitting 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 disclose this practice in their Information for Authors.When a manuscript is published, journals shouldkeep copies of the original submission, reviews, revisions, and correspondence for at least three years andpossibly in perpetuity, depending on local regulations,to help answer future questions about the work shouldthey arise.Editors should not publish or publicize peer reviewers'comments without permission of the reviewer and author.If journal policy is to blind authors to reviewer identity andcomments are not signed, that identity must not berevealed to the author or anyone else without thereviewers' expressed written permission.Confidentiality may have to be breached if dishonesty or fraud is alleged, but editors should notify authorsor reviewers if they intend to do so and confidentialitymust otherwise be honored.b. TimelinessEditors should do all they can to ensure timely processing of manuscripts with the resources available tothem. If editors intend to publish a manuscript, theyshould attempt to do so in a timely manner and anyplanned delays should be negotiated with the authors. Ifa journal has no intention of proceeding with a manuscript, editors should endeavor to reject the manuscriptas soon as possible to allow authors to submit to a different journal.c. Peer ReviewPeer review is the critical assessment of manuscriptssubmitted to journals by experts who are usually not partof the editorial staff. Because unbiased, independent,critical assessment is an intrinsic part of all scholarlywork, including scientific research, peer review is an important extension of the scientific process.The actual value of peer review is widely debated,but the process facilitates a fair hearing for a manuscriptwww.icmje.orgamong members of the scientific community. More practically, it helps editors decide which manuscripts are suitable for their journals. Peer review often helps authorsand editors improve the quality of reporting.It is the responsibility of the journal to ensure thatsystems are in place for selection of appropriatereviewers. It is the responsibility of the editor to ensurethat reviewers have access to all materials that may berelevant to the evaluation of the manuscript, includingsupplementary material for e-only publication, and toensure that reviewer comments are properly assessedand interpreted in the context of their declared relationships and activities.A peer-reviewed journal is under no obligation tosend submitted manuscripts for review, and under noobligation to follow reviewer recommendations, favorable or negative. The editor of a journal is ultimately responsible for the selection of all its content, and editorialdecisions may be informed by issues unrelated to thequality of a manuscript, such as suitability for the journal.An editor can reject any article at any time before publication, including after acceptance if concerns arise aboutthe integrity of the work.Journals may differ in the number and kinds ofmanuscripts they send for review, the number and typesof reviewers they seek for each manuscript, whether thereview process is open or blinded, and other aspects ofthe review process. For this reason and as a service toauthors, journals should publish a clear, transparentdescription of their peer-review process for all types ofmanuscripts.Journals should notify reviewers of the ultimate decision to accept or reject a paper, and should acknowledge the contribution of peer reviewers to their journal.Editors are encouraged to share reviewers' commentswith co-reviewers of the same paper, so reviewers canlearn from each other in the review process.As part of peer review, editors are encouraged toreview research protocols, plans for statistical analysis ifseparate from the protocol, and/or contracts associatedwith project-specific studies. Editors should encourageauthors to make such documents publicly available atthe time of or after publication, before accepting suchstudies for publication. Some journals may require publicposting of these documents as a condition of acceptancefor publication.Journal requirements for independent data analysisand for public data availability are in flux at the time ofthis revision, reflecting evolving views of the importanceof data availability for pre- and post-publication peerreview. Some journal editors currently request a statistical analysis of trial data by an independent biostatisticianbefore accepting studies for publication. Others askauthors to say whether the study data are available tothird parties to view and/or use/reanalyze, while stillothers encourage or require authors to share their datawith others for review or reanalysis. Each journal shouldestablish and publish their specific requirements for dataanalysis and post in a place that potential authors caneasily access.5

Unauthorized reproduction of this article is prohibitedRecommendations for the Conduct, Reporting, Editing, and Publication of Scholarly Work in Medical JournalsSome people believe that true scientific peer reviewbegins only on the date a paper is published. In that spirit,medical 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 thejournal 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 underpinningthe published results for at least 10 years. The ICMJEencourages the preservation of these data in a data repository to ensure their longer-term availability.d. IntegrityEditorial decisions should be based on the relevanceof a manuscript to the journal and on the manuscript'soriginality, quality, and contribution to evidence aboutimportant questions. Those decisions should not beinfluenced by commercial interests, personal relationships or agendas, or findings that are negative or thatcredibly challenge accepted wisdom. In addition,authors should submit for publication or otherwise makepublicly available, and editors should not exclude fromconsideration for publication, studies with findings thatare not statistically significant or that have inconclusivefindings. Such studies may provide evidence that, combined with that from other studies through meta-analysis,might still help answer important questions, and a publicrecord of such negative or inconclusive findings may prevent unwarranted replication of effort or otherwise bevaluable for other researchers considering similar work.Journals should clearly state their appeals processand should have a system for responding to appeals andcomplaints.script is published. Reviewers must not retain the manuscript for their personal use and should destroy copies ofmanuscripts after submitting their reviews.Reviewers who seek assistance from a trainee or colleague in the performance of a review should acknowledge these individuals' contributions in the writtencomments submitted to the editor. These individualsmust maintain the confidentiality of the manuscript asoutlined above.Reviewers are expected to respond promptly torequests to review and to submit reviews within the timeagreed. Reviewers' comments should be constructive,honest, and polite.Reviewers should declare their relationships andactivities that might bias their evaluation of a manuscriptand

All those designated as authors should meet all four criteria for authorship, and all who meet the four criteria should be identified as authors. Those who do not meet all four criteria should be acknowledged—see Section II. A.3 below. These authorship criteria are intended to reserve the status of authorship for those who deserve